Preferred Label : pharmacology;
MeSH synonym : mechanism of action; mode of action; pharmacodynamics; pharmacologic action;
Origin ID : Q000494;
UMLS CUI : C1524059;
- Automatic exact mappings (from CISMeF team)
- Metaterm(s)
- See also (suggested by CISMeF)
- Semantic type(s)
https://www.ema.europa.eu/en/medicines/human/EPAR/ebglyss
2024
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
lebrikizumab
lebrikizumab
lebrikizumab
drug approval
europe
dermatitis, atopic
adult
child
adolescent
injections, subcutaneous
risk management
product surveillance, postmarketing
aged
pregnancy
breast feeding
drug interactions
Interleukin-13
drug evaluation, preclinical
---
https://ansm.sante.fr/tableau-atu-rtu/abecma-260-500-x-106-cellules-dispersion-pour-perfusion
2024
false
false
false
France
French
guidelines for drug use
Idecabtagene Vicleucel
Idecabtagene Vicleucel
gene therapy
immunotherapy, adoptive
adult
multiple myeloma
recurrence
Refractory Multiple Myeloma
idecabtagene vicleucel
idecabtagene vicleucel
Recurrent Multiple Myeloma
genetic therapy
---
https://www.ema.europa.eu/en/medicines/human/EPAR/aqumeldi
2024
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
enalapril maleate
enalapril maleate
enalapril
---
https://www.ema.europa.eu/en/medicines/human/EPAR/jaypirca
2024
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
pirtobrutinib
pirtobrutinib
pirtobrutinib
orphan drug production
---
https://www.ema.europa.eu/en/medicines/human/EPAR/degarelix-accord
2024
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
degarelix
degarelix
degarelix
drugs, generic
---
https://www.ema.europa.eu/en/medicines/human/EPAR/tyruko
2024
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
Natalizumab
Natalizumab
natalizumab
biosimilar pharmaceuticals
---
https://www.ema.europa.eu/en/medicines/human/EPAR/tepkinly
2024
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
Epcoritamab
Epcoritamab
epcoritamab
orphan drug production
drug approval
europe
Antineoplastic Agents, Immunological
Antineoplastic Agents, Immunological
adult
lymphoma, large B-Cell, diffuse
Recurrent Diffuse Large B-Cell Lymphoma
Refractory Diffuse Large B-Cell Lymphoma
recurrence
injections, subcutaneous
risk management
product surveillance, postmarketing
pregnancy
breast feeding
drug interactions
aged
drug evaluation, preclinical
---
https://www.ema.europa.eu/en/medicines/human/EPAR/lyfnua
2024
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
Gefapixant
Gefapixant
gefapixant
drug approval
europe
purinergic P2X3 receptor antagonists
purinergic P2X3 receptor antagonists
purinergic P2X receptor antagonists
purinergic P2X receptor antagonists
Chronic Cough
adult
pregnancy
breast feeding
drug interactions
administration, oral
risk management
product surveillance, postmarketing
Refractory chronic cough (disorder)
Unexplained chronic cough (disorder)
aged
drug evaluation, preclinical
---
https://www.ema.europa.eu/en/medicines/human/EPAR/tevimbra
2024
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
tislelizumab
tislelizumab
tislelizumab
orphan drug production
drug approval
europe
Antineoplastic Agents, Immunological
Antineoplastic Agents, Immunological
Esophageal Squamous Cell Carcinoma
neoplasm metastasis
Metastatic Esophageal Squamous Cell Carcinoma
Unresectable Esophageal Squamous Cell Carcinoma
Refractory Esophageal Squamous Cell Carcinoma
adult
infusions, intravenous
risk management
product surveillance, postmarketing
pregnancy
breast feeding
drug interactions
drug evaluation, preclinical
---
https://www.ema.europa.eu/en/medicines/human/EPAR/enrylaze
2024
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
Asparaginase Erwinia chrysanthemi
Asparaginase Erwinia chrysanthemi
asparaginase
---
https://www.ema.europa.eu/en/medicines/human/EPAR/tyenne
2024
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
tocilizumab
tocilizumab
tocilizumab
biosimilar pharmaceuticals
---
https://www.ema.europa.eu/en/medicines/human/EPAR/apretude
2024
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
cabotegravir
cabotegravir
cabotegravir
---
https://www.ema.europa.eu/en/medicines/human/EPAR/talvey
2024
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
Talquetamab
Talquetamab
talquetamab
orphan drug production
multiple myeloma
Triple-Class Refractory Multiple Myeloma
Recurrent Multiple Myeloma
adult
drug approval
europe
Antineoplastic Agents, Immunological
Antineoplastic Agents, Immunological
injections, subcutaneous
pregnancy
breast feeding
drug interactions
drug evaluation, preclinical
---
https://www.ema.europa.eu/en/medicines/human/EPAR/elrexfio
2024
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
europe
drug approval
Elranatamab
Elranatamab
multiple myeloma
recurrence
Progressive Neoplastic Disease
Triple-Class Refractory Multiple Myeloma
adult
Antineoplastic Agents, Immunological
Antineoplastic Agents, Immunological
Recurrent Multiple Myeloma
antibodies, monoclonal
antibodies, monoclonal
pregnancy
breast feeding
drug interactions
drug evaluation, preclinical
injections, subcutaneous
bispecific monoclonal antibodies
bispecific monoclonal antibodies
Immune Effector Cell Associated Neurotoxicity Syndrome
Elranatamab
Cytokine Release Syndrome
continuity of patient care
---
https://www.ema.europa.eu/en/medicines/human/EPAR/zilbrysq
2024
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
drug approval
europe
zilucoplan
zilucoplan
zilucoplan
adult
myasthenia gravis
myasthenia gravis, generalized
generalised myasthenia gravis with anti-acetylcholine receptor antibody
pregnancy
breast feeding
drug interactions
drug evaluation, preclinical
Anti-acetylcholine receptor antibody positivity
myasthenia gravis
risk management
injections, subcutaneous
drug therapy, combination
---
https://www.ema.europa.eu/en/medicines/human/EPAR/vueway
2024
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
gadopiclenol
contrast media
gadopiclenol
---
https://www.ema.europa.eu/en/medicines/human/EPAR/elucirem
2024
false
false
false
Netherlands
French
English
syndication feed
summary of product characteristics
package leaflet
drug evaluation
contrast media
gadopiclenol
gadopiclenol
drug approval
europe
adult
child
adolescent
magnetic resonance imaging
risk management
product surveillance, postmarketing
blood-brain barrier
liver
kidney
pancreas
lung
prostate
breast
musculoskeletal system
---
https://www.ema.europa.eu/en/medicines/human/EPAR/rezzayo
2024
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
Rezafungin
Rezafungin
rezafungin acetate
orphan drug production
drug approval
europe
antifungal agents
antifungal agents
adult
candidiasis, invasive
infusions, intravenous
risk management
product surveillance, postmarketing
pregnancy
breast feeding
drug interactions
Rezafungin Acetate
Rezafungin Acetate
aged
beta-(1,3)-D-glucan synthase
drug evaluation, preclinical
---
https://www.ema.europa.eu/en/medicines/human/EPAR/yesafili
2024
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
aflibercept
aflibercept
aflibercept
biosimilar pharmaceuticals
---
https://www.ema.europa.eu/en/medicines/human/EPAR/inaqovi
2024
false
false
false
Netherlands
French
English
decitabine and cedazuridine drug combination
decitabine and cedazuridine drug combination
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
cedazuridine
cedazuridine
drug approval
europe
antimetabolites, antineoplastic
antimetabolites, antineoplastic
adult
leukemia, myeloid, acute
administration, oral
risk management
product surveillance, postmarketing
pregnancy
breast feeding
drug interactions
decitabine, combinations
drug evaluation, preclinical
Product containing precisely cedazuridine 100 milligram and decitabine 35 milligram/1
each conventional release oral tablet (clinical drug)
---
https://www.ema.europa.eu/en/medicines/human/EPAR/orserdu
2024
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
elacestrant
elacestrant
elacestrant
postmenopause
drug approval
europe
selective estrogen receptor modulators
selective estrogen receptor modulators
breast neoplasms
breast neoplasms, male
Locally Advanced Estrogen Receptor-Positive Breast Carcinoma
Metastatic Estrogen Receptor-Positive Breast Carcinoma
HER2-Negative Breast Carcinoma
administration, oral
risk management
product surveillance, postmarketing
drug interactions
Activating ESR1 Gene Mutation
breast neoplasms
estrogen receptor alpha
drug evaluation, preclinical
---
https://www.ema.europa.eu/en/medicines/human/EPAR/herwenda
2024
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
Trastuzumab
Trastuzumab
trastuzumab
biosimilar pharmaceuticals
---
https://www.ema.europa.eu/en/medicines/human/EPAR/mounjaro
2023
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
drug approval
europe
tirzepatide
tirzepatide
tirzepatide
hypoglycemic agents
hypoglycemic agents
incretins
incretins
adult
diabetes mellitus, type 2
injections, subcutaneous
gastric inhibitory polypeptide
glucagon-like peptide 1
product surveillance, postmarketing
drug interactions
pregnancy
breast feeding
drug evaluation, preclinical
---
https://www.ema.europa.eu/en/medicines/human/EPAR/vanflyta-0
2023
false
false
false
Netherlands
French
English
treatment outcome
drug evaluation
quizartinib
quizartinib
quizartinib
FLT3 Internal Tandem Duplication
leukemia, myeloid, acute
adult
administration, oral
orphan drug production
fms-like tyrosine kinase 3
protein kinase inhibitors
protein kinase inhibitors
Tyrosine Kinase Inhibitors
package leaflet
syndication feed
summary of product characteristics
phenylurea compounds
benzothiazoles
phenylurea compounds
benzothiazoles
---
https://www.ema.europa.eu/en/medicines/human/EPAR/cevenfacta
2023
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
drug approval
europe
eptacog beta
eptacog beta
recombinant FVIIa
recombinant FVIIa
coagulation factor VIIa
product surveillance, postmarketing
adult
adolescent
blood loss, surgical
blood loss, surgical
injections, intravenous
hemophilia A
Genetic Engineering
---
https://www.ema.europa.eu/en/medicines/human/EPAR/ximluci
2023
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
drug approval
europe
Ranibizumab
Ranibizumab
ranibizumab
biosimilar pharmaceuticals
wet macular degeneration
macular edema
diabetic retinopathy
Proliferative Diabetic Retinopathy
choroidal neovascularization
adult
intravitreal injections
vascular endothelial growth factor a
product surveillance, postmarketing
pregnancy
drug evaluation, preclinical
---
https://www.ema.europa.eu/en/medicines/human/EPAR/melatonin-neurim
2023
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
melatonin
melatonin
drug approval
europe
primary insomnia
adult
aged
administration, oral
melatonin
Delayed-Action preparations
drug interactions
pregnancy
breast feeding
drug evaluation, preclinical
---
https://www.ema.europa.eu/en/medicines/human/EPAR/mycapssa
2023
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
octreotide
octreotide
europe
drug approval
orphan drug production
octreotide
adult
acromegaly
administration, oral
drug interactions
pregnancy
breast feeding
drug evaluation, preclinical
---
https://www.ema.europa.eu/en/medicines/human/EPAR/locametz
2023
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
Gozetotide
Gozetotide
drug approval
europe
Positron-Emission tomography
diagnostic uses of chemicals
gallium 68 PSMA-11
prostatic neoplasms
adult
gallium radioisotopes
radiopharmaceuticals
injections, intravenous
FOLH1 protein, human
gallium (68Ga) gozetotide
product surveillance, postmarketing
Radiopharmaceutical Preparation Kit Dosage Form
pregnancy
breast feeding
---
https://www.ema.europa.eu/en/medicines/human/EPAR/pluvicto
2023
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
drug approval
europe
radiopharmaceuticals
Lutetium Lu 177 Vipivotide Tetraxetan
Lutetium Lu 177 Vipivotide Tetraxetan
lutetium (177Lu) vipivotide tetraxetan
radiopharmaceuticals
radiopharmaceuticals
Lutetium-177
prostatic neoplasms, Castration-Resistant
neoplasm metastasis
PSMA-Positive Tumor
antineoplastic combined chemotherapy protocols
injections, intravenous
infusions, intravenous
FOLH1 protein, human
product surveillance, postmarketing
pregnancy
breast feeding
---
https://www.ema.europa.eu/en/medicines/human/EPAR/livmarli
2023
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
drug approval
europe
Maralixibat Chloride
Maralixibat Chloride
maralixibat chloride
maralixibat
maralixibat
infant
child
alagille syndrome
pruritus
Cholestatic pruritus (disorder)
orphan drug production
pharmaceutical solutions
administration, oral
ileal sodium-dependent bile acid transporter
product surveillance, postmarketing
drug interactions
pregnancy
breast feeding
drug evaluation, preclinical
cholestatic pruritus in Alagille syndrome
---
https://www.ema.europa.eu/en/medicines/human/EPAR/teriparatide-sun
2023
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
drug approval
europe
teriparatide
teriparatide
teriparatide
bone density conservation agents
bone density conservation agents
adult
osteoporosis
osteoporosis, postmenopausal
osteoporotic fractures
injections, subcutaneous
drug interactions
drug evaluation, preclinical
---
https://www.ema.europa.eu/en/medicines/human/EPAR/pyrukynd
2023
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
orphan drug production
drug approval
europe
mitapivat
mitapivat
mitapivat
pyruvate kinase deficiency of red cells
administration, oral
product surveillance, postmarketing
adult
drug interactions
pregnancy
breast feeding
drug evaluation, preclinical
---
https://www.ema.europa.eu/en/medicines/human/EPAR/ebvallo
2023
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
drug approval
europe
Tabelecleucel
Tabelecleucel
orphan drug production
adult
child
adolescent
EBV-Related Post-Transplant Lymphoproliferative Disorder
transplantation
lymphoproliferative disorders
injections, intravenous
epstein-barr virus infections
Antineoplastic Agents, Immunological
product surveillance, postmarketing
immunotherapy, adoptive
lymphocyte transfusion
pregnancy
breast feeding
drug evaluation, preclinical
t-lymphocytes
tabelecleucel
---
https://www.ema.europa.eu/en/medicines/human/EPAR/xenpozyme
2023
false
false
false
United Kingdom
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
enzyme replacement therapy
drug approval
europe
olipudase alfa
olipudase alfa
infusions, intravenous
olipudase alfa
Niemann-Pick disease, type B
Niemann-Pick disease, type A
orphan drug production
product surveillance, postmarketing
child
adolescent
adult
pregnancy
breast feeding
drug interactions
drug evaluation, preclinical
---
https://www.ema.europa.eu/en/medicines/human/EPAR/celdoxome-pegylated-liposomal
2023
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
drug approval
europe
doxorubicin hydrochloride
doxorubicin hydrochloride
adult
breast neoplasms
neoplasm metastasis
ovarian neoplasms
sarcoma, kaposi
multiple myeloma
Pegylated Liposomal Doxorubicin Hydrochloride
Pegylated Liposomal Doxorubicin Hydrochloride
antibiotics, antineoplastic
antibiotics, antineoplastic
infusions, intravenous
doxorubicin
drug interactions
pregnancy
breast feeding
drug evaluation, preclinical
---
https://www.ema.europa.eu/en/medicines/human/EPAR/zynlonta
2023
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
loncastuximab tesirine
loncastuximab tesirine
loncastuximab tesirine
Antineoplastic Agents, Immunological
Antineoplastic Agents, Immunological
zynlonta
orphan drug production
lymphoma, large B-Cell, diffuse
High Grade B-Cell Lymphoma
Recurrent High Grade B-Cell Lymphoma
Refractory High Grade B-Cell Lymphoma
infusions, intravenous
product surveillance, postmarketing
adult
aged
pregnancy
breast feeding
Genotoxicity
Antineoplastic Antibody-Drug Conjugate
fertility
drug evaluation, preclinical
drug approval
europe
---
https://www.ema.europa.eu/en/medicines/human/EPAR/pemetrexed-baxter
2023
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
drug approval
europe
Pemetrexed
Pemetrexed
pemetrexed
Malignant Pleural Mesothelioma
carcinoma, non-small-cell lung
drugs, generic
antineoplastic combined chemotherapy protocols
cisplatin
Cisplatin/Pemetrexed Regimen
infusions, intravenous
antimetabolites, antineoplastic
antimetabolites, antineoplastic
drug interactions
pregnancy
breast feeding
drug evaluation, preclinical
Unresectable Pleural Malignant Mesothelioma
---
https://www.ema.europa.eu/en/medicines/human/EPAR/spevigo
2023
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
spesolimab
spesolimab
spesolimab
psoriasis
Generalized pustular psoriasis
interleukin-36 receptor, human
adult
infusions, intravenous
product surveillance, postmarketing
aged
pregnancy
breast feeding
drug evaluation, preclinical
drug approval
europe
---
https://www.ema.europa.eu/en/medicines/human/EPAR/plerixafor-accord
2023
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
plerixafor
plerixafor
drug approval
europe
plerixafor
drugs, generic
adult
infant
child
adolescent
aged
hematopoietic stem cell mobilization
lymphoma
multiple myeloma
injections, subcutaneous
hematopoietic stem cell transplantation
pregnancy
breast feeding
drug evaluation, preclinical
---
https://www.ema.europa.eu/en/medicines/human/EPAR/sotyktu
2023
false
false
false
Netherlands
French
English
drug approval
deucravacitinib
deucravacitinib
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
europe
adult
psoriasis
administration, oral
dermatologic agents
dermatologic agents
Janus Kinase Inhibitors
Janus Kinase Inhibitors
TYK2 kinase
deucravacitinib
product surveillance, postmarketing
continuity of patient care
pregnancy
breast feeding
drug interactions
drug evaluation, preclinical
---
https://www.ema.europa.eu/en/medicines/human/EPAR/bimervax
2023
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
drug approval
vaccine potency
Immunogenicity, Vaccine
COVID-19 Vaccines
COVID-19 Vaccines
COVID-19
vaccines, synthetic
Adjuvants, Vaccine
Covid-19 vaccines
vaccines, peptide
adolescent
adult
immunization, secondary
spike protein, SARS-CoV-2
injections, intramuscular
pregnancy
breast feeding
---
Imjudo - tremelimumab
https://www.ema.europa.eu/en/medicines/human/EPAR/imjudo
2023
false
false
false
United Kingdom
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
tremelimumab
tremelimumab
orphan drug production
drug approval
europe
tremelimumab
antineoplastic agents
antineoplastic agents
carcinoma, hepatocellular
Unresectable Hepatocellular Carcinoma
Advanced Hepatocellular Carcinoma
antineoplastic combined chemotherapy protocols
durvalumab
Durvalumab/Tremelimumab Regimen
infusions, intravenous
CTLA4 protein, human
product surveillance, postmarketing
drug interactions
pregnancy
breast feeding
Female of Childbearing Potential
drug evaluation, preclinical
---
Tremelimumab AstraZeneca - tremelimumab
https://www.ema.europa.eu/en/medicines/human/EPAR/tremelimumab-astrazeneca
2023
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
drug approval
europe
tremelimumab
tremelimumab
tremelimumab
antineoplastic agents
antineoplastic agents
carcinoma, non-small-cell lung
neoplasm metastasis
adult
antineoplastic combined chemotherapy protocols
Metastatic Lung Non-Small Cell Carcinoma
durvalumab
carboplatin
cisplatin
infusions, intravenous
CTLA4 protein, human
product surveillance, postmarketing
Activating EGFR Gene Mutation Negative
Activating ALK Gene Mutation Negative
drug interactions
pregnancy
breast feeding
Female of Childbearing Potential
drug evaluation, preclinical
---
https://www.ema.europa.eu/en/medicines/human/EPAR/livtencity
2023
false
false
false
Netherlands
French
English
drug approval
europe
treatment outcome
maribavir
maribavir
antiviral agents
antiviral agents
maribavir
syndication feed
summary of product characteristics
package leaflet
drug evaluation
orphan drug production
hematopoietic stem cell transplantation
organ transplantation
administration, oral
cytomegalovirus infections
adult
---
https://www.ema.europa.eu/en/medicines/human/EPAR/opzelura
2023
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
drug approval
europe
ruxolitinib
ruxolitinib
ruxolitinib
vitiligo
adult
adolescent
administration, cutaneous
ointments
Janus Kinase Inhibitors
Janus Kinase Inhibitors
JAK1 Inhibitor
JAK2 Inhibitor
janus kinase 1
janus kinase 2
ruxolitinib phosphate
ruxolitinib phosphate
aged
drug interactions
pregnancy
breast feeding
drug evaluation, preclinical
---
https://www.ema.europa.eu/en/medicines/human/EPAR/enjaymo
2023
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
drug approval
europe
sutimlimab
sutimlimab
sutimlimab
orphan drug production
cold agglutinin disease
anemia, hemolytic, autoimmune
adult
infusions, intravenous
product surveillance, postmarketing
drug interactions
pregnancy
breast feeding
drug evaluation, preclinical
---
https://www.ema.europa.eu/en/medicines/human/EPAR/hemgenix
2023
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
drug approval
europe
Etranacogene Dezaparvovec
Etranacogene Dezaparvovec
etranacogene dezaparvovec
gene therapy
orphan drug production
adult
hemophilia B
hemorrhage
infusions, intravenous
factor IX
F9 Gene
product surveillance, postmarketing
drug interactions
pregnancy
drug evaluation, preclinical
---
https://www.ema.europa.eu/en/medicines/human/EPAR/dabigatran-etexilate-accord
2023
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
drug approval
europe
dabigatran etexilate
dabigatran etexilate
drugs, generic
---
https://www.ema.europa.eu/en/medicines/human/EPAR/vafseo
2023
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
drug approval
europe
vadadustat
vadadustat
vadadustat
Hypoxia-Inducible Factor-Proline dioxygenases
enzyme inhibitors
enzyme inhibitors
anemia
renal insufficiency, chronic
Anemia of chronic renal failure (disorder)
renal dialysis
administration, oral
product surveillance, postmarketing
adult
drug interactions
pregnancy
breast feeding
drug evaluation, preclinical
---
https://www.ema.europa.eu/en/medicines/human/EPAR/epysqli
2023
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
drug approval
europe
eculizumab
eculizumab
eculizumab
biosimilar pharmaceuticals
hemoglobinuria, paroxysmal
adult
child
pregnancy
breast feeding
drug interactions
product surveillance, postmarketing
infusions, intravenous
drug evaluation, preclinical
---
https://www.ema.europa.eu/en/medicines/human/EPAR/pombiliti
2023
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
drug approval
europe
Cipaglucosidase Alfa
Cipaglucosidase Alfa
cipaglucosidase alfa
enzyme replacement therapy
glycogen storage disease type ii
Glycogen storage disease type II late onset (disorder)
drug therapy, combination
miglustat
infusions, intravenous
pregnancy
breast feeding
drug evaluation, preclinical
adult
---
https://www.ema.europa.eu/en/medicines/human/EPAR/elfabrio
2023
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
drug approval
europe
Pegunigalsidase Alfa
Pegunigalsidase Alfa
pegunigalsidase alfa
enzyme replacement therapy
adult
fabry disease
infusions, intravenous
product surveillance, postmarketing
pregnancy
breast feeding
drug evaluation, preclinical
---
https://www.ema.europa.eu/en/medicines/human/EPAR/bekemv
2023
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
drug approval
europe
eculizumab
eculizumab
eculizumab
biosimilar pharmaceuticals
adult
adolescent
child
hemoglobinuria, paroxysmal
infusions, intravenous
drug interactions
pregnancy
breast feeding
drug evaluation, preclinical
---
https://www.ema.europa.eu/en/medicines/human/EPAR/tibsovo-0
2023
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
drug approval
europe
ivosidenib
ivosidenib
ivosidenib
orphan drug production
antineoplastic agents
antineoplastic agents
adult
enzyme inhibitors
enzyme inhibitors
antineoplastic combined chemotherapy protocols
Azacitidine/Ivosidenib Regimen
leukemia, myeloid, acute
IDH1 NP_005887.2:p.R132X
leukemia, myeloid, acute
IDH1 Gene Mutation
cholangiocarcinoma
Locally Advanced Cholangiocarcinoma
Metastatic Cholangiocarcinoma
cholangiocarcinoma
mutation
administration, oral
IDH1 protein, human
IDH1 inhibitor
product surveillance, postmarketing
drug interactions
fertility
pregnancy
breast feeding
drug evaluation, preclinical
acute myeloid leukaemia with an IDH1 R132 mutation
locally advanced or metastatic cholangiocarcinoma with an IDH1 R132 mutation
---
https://www.ema.europa.eu/en/medicines/human/EPAR/vegzelma
2023
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
drug approval
europe
Bevacizumab
Bevacizumab
bevacizumab
biosimilar pharmaceuticals
Antineoplastic Agents, Immunological
Antineoplastic Agents, Immunological
adult
antineoplastic combined chemotherapy protocols
colorectal neoplasms
neoplasm metastasis
Colorectal cancer metastatic
breast neoplasms
Breast cancer metastatic
carcinoma, non-small-cell lung
locally advanced or metastatic non-small cell lung cancer other than predominantly
squamous cell histology
kidney neoplasms
ovarian neoplasms
fallopian tube neoplasms
peritoneal neoplasms
advanced primary peritoneal cancer
uterine cervical neoplasms
infusions, intravenous
pregnancy
breast feeding
drug interactions
drug evaluation, preclinical
---
https://www.ema.europa.eu/en/medicines/human/EPAR/lacosamide-adroiq
2023
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
drug approval
europe
Lacosamide
Lacosamide
lacosamide
drugs, generic
epilepsies, partial
adult
adolescent
child
primary generalized tonic-clonic seizures
drug therapy, combination
epilepsy, generalized
epilepsy, idiopathic generalized
infusions, intravenous
anticonvulsants
anticonvulsants
drug interactions
pregnancy
breast feeding
drug evaluation, preclinical
---
https://www.ema.europa.eu/en/medicines/human/EPAR/akeega
2023
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
drug combinations
drug approval
europe
Abiraterone Acetate/Niraparib
Abiraterone Acetate/Niraparib
Abiraterone Acetate
Abiraterone Acetate
niraparib
niraparib
antineoplastic agents
antineoplastic agents
neoplasm metastasis
prostatic neoplasms, Castration-Resistant
metastatic castration resistant prostate cancer
prostatic neoplasms, Castration-Resistant
adult
drug therapy, combination
prednisone
BRCA1 Gene Mutation
BRCA2 Gene Mutation
administration, oral
Poly(ADP-ribose) Polymerase Inhibitors
Poly(ADP-ribose) Polymerase Inhibitors
Poly (ADP-Ribose) Polymerase-1
PARP2 protein, human
Cytochrome P-450 Enzyme Inhibitors
Cytochrome P-450 Enzyme Inhibitors
steroid 17-alpha-hydroxylase
drug interactions
fertility
pregnancy
breast feeding
niraparib and abiraterone
drug evaluation, preclinical
metastatic castration-resistant prostate cancer and BRCA 1/2 mutations in whom chemotherapy
is not clinically indicated
---
https://www.ema.europa.eu/en/medicines/human/EPAR/pedmarqsi
2023
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
drug approval
europe
sodium thiosulfate
sodium thiosulfate
infant
child
adolescent
hearing loss
hearing loss
Drug-Related side effects and adverse reactions
cisplatin
antineoplastic agents
infusions, intravenous
Drug ototoxicity - deafness (disorder)
antioxidants
antioxidants
drug interactions
Ototoxicity
drug evaluation, preclinical
---
https://www.ema.europa.eu/en/medicines/human/EPAR/hyftor
2023
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
sirolimus
sirolimus
drug approval
europe
orphan drug production
Fibrous skin tumor of tuberous sclerosis (disorder)
adenoma sebaceum
adult
child
adolescent
aged
MTOR Inhibitors
MTOR Inhibitors
administration, cutaneous
gels
drug interactions
pregnancy
breast feeding
drug evaluation, preclinical
---
Arexvy - Recombinant respiratory syncytial virus pre-fusion F protein, adjuvanted
with AS01E
https://www.ema.europa.eu/en/medicines/human/EPAR/arexvy
2023
false
false
false
Netherlands
French
English
Immunogenicity, Vaccine
syndication feed
summary of product characteristics
package leaflet
drug evaluation
vaccine potency
drug approval
europe
vaccination
respiratory syncytial virus vaccines
respiratory syncytial virus vaccines
Adjuvants, Vaccine
adult
aged
respiratory syncytial virus infections
bronchitis
pneumonia
Recombinant Viral Vaccine
injections, intramuscular
Viral surface antigen protein (substance)
product surveillance, postmarketing
drug interactions
pregnancy
breast feeding
drug evaluation, preclinical
respiratory syncytial virus vaccines
---
https://www.ema.europa.eu/en/medicines/human/EPAR/omvoh
2023
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
mirikizumab
mirikizumab
drug approval
europe
adult
colitis, ulcerative
injections, subcutaneous
infusions, intravenous
Interleukin-23
product surveillance, postmarketing
aged
pregnancy
breast feeding
mirikizumab
drug evaluation, preclinical
Interleukin Inhibitors
Interleukin Inhibitors
---
https://www.ema.europa.eu/en/medicines/human/EPAR/lytgobi
2023
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
futibatinib
futibatinib
futibatinib
drug approval
europe
receptor, fibroblast growth factor, type 2
FGFR2 Positive
cholangiocarcinoma
neoplasm metastasis
Metastatic Cholangiocarcinoma
Unresectable Cholangiocarcinoma
Refractory Cholangiocarcinoma
adult
administration, oral
Tyrosine Kinase Inhibitors
Tyrosine Kinase Inhibitors
antineoplastic agents
antineoplastic agents
product surveillance, postmarketing
drug interactions
pregnancy
breast feeding
Female of Childbearing Potential
receptors, fibroblast growth factor
drug evaluation, preclinical
---
https://www.ema.europa.eu/en/medicines/human/EPAR/columvi
2023
false
false
false
United Kingdom
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
glofitamab
glofitamab
orphan drug production
adult
Antineoplastic Agents, Immunological
Antineoplastic Agents, Immunological
lymphoma, large B-Cell, diffuse
Refractory Diffuse Large B-Cell Lymphoma
Recurrent Diffuse Large B-Cell Lymphoma
infusions, intravenous
CD3 Complex
antigens, CD20
drug approval
europe
product surveillance, postmarketing
premedication
Cytokine Release Syndrome
Drug-Related side effects and adverse reactions
pregnancy
breast feeding
drug evaluation, preclinical
glofitamab
---
https://www.ema.europa.eu/en/medicines/human/EPAR/briumvi
2023
false
false
false
United Kingdom
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
ublituximab
ublituximab
ublituximab
drug approval
europe
adult
multiple sclerosis, relapsing-remitting
infusions, intravenous
product surveillance, postmarketing
drug interactions
pregnancy
breast feeding
antigens, CD20
drug evaluation, preclinical
---
https://www.ema.europa.eu/en/medicines/human/EPAR/opfolda
2023
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
miglustat
miglustat
miglustat
drug approval
europe
adult
Glycogen storage disease due to acid maltase deficiency, late-onset
adult glycogen storage disease type II
drug therapy, combination
Cipaglucosidase Alfa
administration, oral
capsules
aged
food-drug interactions
pregnancy
breast feeding
drug evaluation, preclinical
---
https://www.ema.europa.eu/en/medicines/human/EPAR/ztalmy
2023
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
drug approval
europe
ganaxolone
ganaxolone
ganaxolone
orphan drug production
child
adolescent
anticonvulsants
anticonvulsants
epilepsy
CDKL5 protein, human
Cyclin-dependent kinase-like 5 deficiency (disorder)
CDKL5-deficiency disorder
administration, oral
GABA modulators
GABA modulators
product surveillance, postmarketing
adult
drug interactions
pregnancy
breast feeding
drug evaluation, preclinical
---
https://www.ema.europa.eu/en/medicines/human/EPAR/pylclari
2023
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
Fluorine F 18 Piflufolastat
Fluorine F 18 Piflufolastat
piflufolastat (18F)
drug approval
europe
adult
prostatic neoplasms
Positron-Emission tomography
FOLH1 protein, human
neoplasm recurrence, local
Presence of direct invasion by primary malignant neoplasm of prostate to periprostatic
tissue (observable entity)
neoplasm staging
fluorine radioisotopes
fluorine radioisotopes
radiopharmaceuticals
product surveillance, postmarketing
injections, intravenous
pregnancy
breast feeding
drug evaluation, preclinical
---
https://www.ema.europa.eu/en/medicines/human/EPAR/qaialdo
2023
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
drug approval
europe
spironolactone
spironolactone
spironolactone
diuretics
diuretics
edema
edema, cardiac
liver cirrhosis
ascites
nephrotic syndrome
hypertension
hyperaldosteronism
hyperaldosteronism
administration, oral
adult
aged
child
infant, newborn
infant
drug interactions
pregnancy
breast feeding
aldosterone antagonists
aldosterone antagonists
drug evaluation, preclinical
---
https://www.ema.europa.eu/en/medicines/human/EPAR/aquipta
2023
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
atogepant
atogepant
drug approval
europe
atogepant
administration, oral
adult
migraine disorders
product surveillance, postmarketing
aged
drug interactions
pregnancy
breast feeding
Calcitonin Gene-Related Peptide Receptor Antagonists
Calcitonin Gene-Related Peptide Receptor Antagonists
drug evaluation, preclinical
---
https://www.ema.europa.eu/en/medicines/human/EPAR/camzyos
2023
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
mavacamten
mavacamten
drug approval
europe
mavacamten
cardiomyopathy, hypertrophic
Cardiomyopathy, Hypertrophic Obstructive
adult
administration, oral
continuity of patient care
product surveillance, postmarketing
New York Heart Association Class II
New York Heart Association Class III
CYP2C19 slow metabolizer status
Cytochrome P-450 CYP2C19
Cytochrome P450 family 2 subfamily C member 19 normal metabolizer (finding)
Cytochrome P450 family 2 subfamily C member 19 rapid metabolizer (finding)
Cytochrome P450 family 2 subfamily C member 19 intermediate metabolizer (finding)
Cytochrome P450 family 2 subfamily C member 19 ultra-rapid metabolizer (finding)
Left Ventricular Ejection Fraction
drug interactions
pregnancy
Female of Childbearing Potential
cardiac myosins
drug evaluation, preclinical
symptomatic (New York Heart Association, NYHA, class II-III) obstructive hypertrophic
cardiomyopathy (oHCM)
---
https://www.ema.europa.eu/en/medicines/human/EPAR/litfulo
2023
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
Ritlecitinib
Ritlecitinib
drug approval
europe
Janus Kinase Inhibitors
Janus Kinase Inhibitors
ritlecitinib
adult
adolescent
alopecia areata
administration, oral
continuity of patient care
immunosuppressive agents
immunosuppressive agents
product surveillance, postmarketing
drug interactions
pregnancy
breast feeding
Female of Childbearing Potential
drug evaluation, preclinical
---
Abrysvo - Respiratory syncytial virus vaccines
https://www.ema.europa.eu/en/medicines/human/EPAR/abrysvo
2023
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
respiratory syncytial virus vaccines
respiratory syncytial virus infections
drug approval
europe
aged
Respiratory syncytial virus bronchitis (disorder)
Pneumonia caused by respiratory syncytial virus (disorder)
pregnancy
pregnant women
adult
infant, newborn, diseases
infant, newborn
infant
bronchiolitis, viral
Respiratory syncytial virus bronchiolitis (disorder)
vaccination
respiratory syncytial virus vaccines
injections, intramuscular
respiratory syncytial virus vaccines
product surveillance, postmarketing
drug interactions
---
https://www.ema.europa.eu/en/medicines/human/EPAR/sprycel
2023
false
true
false
United Kingdom
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
drug approval
europe
Dasatinib
Dasatinib
dasatinib
adult
adolescent
child
antineoplastic agents
antineoplastic agents
protein kinase inhibitors
protein kinase inhibitors
leukemia, myeloid, chronic-phase
leukemia, myeloid, accelerated phase
leukemia, myelogenous, chronic, bcr-abl positive
precursor cell lymphoblastic Leukemia-Lymphoma
---
https://www.ema.europa.eu/en/medicines/human/EPAR/omjjara
2023
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
orphan drug production
N-(cyanomethyl)-4-(2-((4-(4-morpholinyl)phenyl)amino)-4-pyrimidinyl)benzamide
N-(cyanomethyl)-4-(2-((4-(4-morpholinyl)phenyl)amino)-4-pyrimidinyl)benzamide
momelotinib
drug approval
europe
splenomegaly
adult
primary myelofibrosis
risk management
product surveillance, postmarketing
Polycythemia Vera, Post-Polycythemic Myelofibrosis Phase
Post-Essential Thrombocythemia Myelofibrosis
administration, oral
pregnancy
breast feeding
drug interactions
Janus Kinase Inhibitors
Janus Kinase Inhibitors
JAK1 Inhibitor
JAK2 Inhibitor
drug evaluation, preclinical
---
https://www.ema.europa.eu/en/medicines/human/EPAR/ryeqo
2023
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
drug combinations
relugolix
relugolix
drug approval
europe
endometriosis
estradiol
estradiol
relugolix, estradiol and norethisterone
Norethindrone Acetate
Norethindrone Acetate
fibroid uterus
administration, oral
risk management
product surveillance, postmarketing
pregnancy
breast feeding
drug interactions
drug evaluation, preclinical
---
https://ansm.sante.fr/tableau-atu-rtu/sotorasib-120-mg-comprimes-pellicules
2023
false
false
false
France
French
administration, oral
guidelines for drug use
sotorasib
sotorasib
carcinoma, non-small-cell lung
carcinoma, non-small-cell lung
bronchial neoplasms
bronchial neoplasms
summary of product characteristics
package leaflet
adult
neoplasm metastasis
sotorasib
piperazines
pyridines
pyrimidines
piperazines
pyridines
pyrimidines
---
https://ansm.sante.fr/tableau-atu-rtu/venclyxto-10-mg-50mg-100-mg-comprimes-pellicules
2023
false
false
false
France
French
venetoclax
venetoclax
Recurrent Acute Myeloid Leukemia
Refractory Acute Myeloid Leukemia
leukemia, myeloid, acute
precursor cell lymphoblastic Leukemia-Lymphoma
Refractory Acute Lymphoblastic Leukemia
Recurrent Acute Lymphoblastic Leukemia
leukemia, lymphocytic, chronic, B-Cell
drug information
sulfonamides
Bridged Bicyclo Compounds, Heterocyclic
sulfonamides
Bridged Bicyclo Compounds, Heterocyclic
---
https://www.ema.europa.eu/en/medicines/human/EPAR/eladynos
2023
false
false
false
Netherlands
French
English
treatment outcome
drug evaluation
abaloparatide
abaloparatide
summary of product characteristics
package leaflet
syndication feed
abaloparatide
drug approval
europe
osteoporosis, postmenopausal
osteoporotic fractures
injections, subcutaneous
bone density conservation agents
bone density conservation agents
product surveillance, postmarketing
drug interactions
drug evaluation, preclinical
parathyroid hormone-related protein
---
https://www.ema.europa.eu/en/medicines/human/EPAR/sorafenib-accord
2023
false
false
false
Netherlands
French
English
drug approval
europe
Sorafenib
Sorafenib
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
sorafenib
antineoplastic agents
antineoplastic agents
protein kinase inhibitors
protein kinase inhibitors
carcinoma, hepatocellular
carcinoma, renal cell
Advanced Kidney Carcinoma
drugs, generic
administration, oral
drug interactions
pregnancy
breast feeding
drug evaluation, preclinical
---
https://www.ema.europa.eu/en/medicines/human/EPAR/vidprevtyn-beta
2022
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
COVID-19 Vaccines
COVID-19
COVID-19 Vaccines
drug approval
europe
adult
vaccination
pregnancy
breast feeding
immunization, secondary
injections, intramuscular
SARS-CoV-2 B.1.351 variant
spike protein, SARS-CoV-2
covid-19, protein subunit
---
https://www.ema.europa.eu/en/medicines/human/EPAR/tezspire
2022
false
false
false
Netherlands
French
English
treatment outcome
tezepelumab
tezepelumab
syndication feed
summary of product characteristics
package leaflet
drug evaluation
drug therapy, combination
asthma
adult
adolescent
Severe asthma (disorder)
injections, subcutaneous
tezepelumab
product surveillance, postmarketing
drug interactions
pregnancy
breast feeding
drug evaluation, preclinical
---
https://www.ema.europa.eu/en/medicines/human/EPAR/tecvayli
2022
false
false
false
United Kingdom
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
drug approval
europe
Teclistamab
Teclistamab
antibodies, monoclonal
antibodies, monoclonal
Antineoplastic Agents, Immunological
Antineoplastic Agents, Immunological
multiple myeloma
teclistamab
injections, subcutaneous
drug interactions
pregnancy
breast feeding
Triple-Class Refractory Multiple Myeloma
recurrence
product surveillance, postmarketing
bispecific monoclonal antibodies
bispecific monoclonal antibodies
b-cell maturation antigen
CD3 Complex
---
https://www.ema.europa.eu/en/medicines/human/EPAR/beyfortus
2022
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
nirsevimab
nirsevimab
nirsevimab
drug approval
europe
infant, newborn
infant
child
critical illness
respiratory syncytial virus infections
injections, intramuscular
drug interactions
F protein, human respiratory syncytial virus
---
https://www.ema.europa.eu/en/medicines/human/EPAR/sitagliptin-accord
2022
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
sitagliptin
sitagliptin
sitagliptin
drugs, generic
---
https://www.ema.europa.eu/en/medicines/human/EPAR/vyepti
2022
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
eptinezumab
eptinezumab
migraine disorders
eptinezumab
adult
drug approval
europe
chronic disease
Chronic Migraine
aged
infusions, intravenous
Product containing only eptinezumab in parenteral dose form (medicinal product form)
product surveillance, postmarketing
pregnancy
breast feeding
drug interactions
calcitonin gene-related peptide
drug evaluation, preclinical
Refractory migraine (disorder)
---
https://www.ema.europa.eu/en/medicines/human/EPAR/rybrevant
2022
false
false
false
Netherlands
French
English
amivantamab-vmjw
amivantamab-vmjw
amivantamab
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
drug approval
europe
rybrevant
Antineoplastic Agents, Immunological
Antineoplastic Agents, Immunological
adult
aged
carcinoma, non-small-cell lung
bronchial neoplasms
Activating EGFR Exon 20 Mutation
carcinoma, non-small-cell lung
bronchial neoplasms
Gain of Function Mutation
genes, erbb-1
Refractory Lung Non-Small Cell Carcinoma
infusions, intravenous
product surveillance, postmarketing
pregnancy
breast feeding
drug interactions
drug evaluation, preclinical
---
https://www.ema.europa.eu/en/medicines/human/EPAR/dasatinib-accordpharma
2022
false
false
false
Netherlands
French
English
Dasatinib
Dasatinib
Dasatinib Anhydrous
dasatinib
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
drugs, generic
---
https://www.ema.europa.eu/en/medicines/human/EPAR/kerendia
2022
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
finerenone
finerenone
finerenone
diabetic nephropathies
adult
drug approval
europe
diabetes mellitus, type 2
kerendia
chronic disease
aged
administration, oral
receptors, mineralocorticoid
product surveillance, postmarketing
pregnancy
breast feeding
drug interactions
drug evaluation, preclinical
Product containing precisely finerenone 10 milligram/1 each conventional release oral
tablet (clinical drug)
Product containing precisely finerenone 20 milligram/1 each conventional release oral
tablet (clinical drug)
---
https://www.ema.europa.eu/en/medicines/human/EPAR/lonapegsomatropin-ascendis-pharma
2022
false
false
false
Netherlands
French
English
Lonapegsomatropin
Lonapegsomatropin
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
child
adolescent
orphan drug production
drug approval
europe
Growth Hormone Deficiency
growth hormone
injections, subcutaneous
lonapegsomatropin
product surveillance, postmarketing
drug interactions
pregnancy
breast feeding
prodrugs
drug evaluation, preclinical
---
https://www.ema.europa.eu/en/medicines/human/EPAR/wegovy
2022
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
semaglutide
semaglutide
obesity
overweight
drug approval
europe
body mass index
adult
injections, subcutaneous
Glucagon-Like Peptide-1 Receptor
Glucagon-like peptide 1 receptor agonist (disposition)
product surveillance, postmarketing
aged
pregnancy
breast feeding
drug interactions
drug evaluation, preclinical
Product containing only semaglutide in parenteral dose form (medicinal product form)
---
https://www.ema.europa.eu/en/medicines/human/EPAR/ontilyv
2022
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
opicapone
opicapone
opicapone
ongentys
drug approval
europe
parkinson disease
Catechol O-Methyltransferase Inhibitors
Catechol O-Methyltransferase Inhibitors
adult
aged
Product containing precisely opicapone 25 milligram/1 each conventional release oral
capsule (clinical drug)
Product containing precisely opicapone 50 milligram/1 each conventional release oral
capsule (clinical drug)
administration, oral
drug therapy, combination
drug interactions
pregnancy
breast feeding
drug evaluation, preclinical
---
https://www.ema.europa.eu/en/medicines/human/EPAR/okedi
2022
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
risperidone
risperidone
risperidone
schizophrenia
drug approval
europe
injections, intramuscular
Delayed-Action preparations
antipsychotic agents
antipsychotic agents
serotonin antagonists
serotonin antagonists
dopamine antagonists
dopamine antagonists
Product containing only risperidone in parenteral dose form (medicinal product form)
pregnancy
breast feeding
drug interactions
adult
aged
drug evaluation, preclinical
---
https://www.ema.europa.eu/en/medicines/human/EPAR/kapruvia
2022
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
difelikefalin
difelikefalin
difelikefalin
pruritus
renal dialysis
renal insufficiency, chronic
adult
drug approval
europe
injections, intravenous
Hemodialysis-associated pruritus (disorder)
receptors, opioid, kappa
product surveillance, postmarketing
aged
pregnancy
breast feeding
drug evaluation, preclinical
---
https://www.ema.europa.eu/en/medicines/human/EPAR/vaxneuvance
2022
false
false
false
Netherlands
French
English
syndication feed
summary of product characteristics
package leaflet
drug evaluation
vaccination
pneumococcus, purified polysaccharides antigen conjugated
pneumococcal vaccines
vaccines, conjugate
polysaccharides, bacterial
pneumococcal infections
pneumonia, pneumococcal
Invasive Streptococcus pneumoniae disease (disorder)
pneumococcal polysaccharide vaccine
pneumococcal polysaccharide vaccine
Pneumococcal polysaccharide conjugated vaccine (product)
Vaccine Efficacy
Immunogenicity, Vaccine
adult
aged
injections, intramuscular
pregnancy
breast feeding
drug interactions
product surveillance, postmarketing
adjuvants, immunologic
drug evaluation, preclinical
---
https://www.ema.europa.eu/en/medicines/human/EPAR/kimmtrak
2022
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
tebentafusp
tebentafusp
orphan drug production
adult
uveal melanoma
Metastatic Uveal Melanoma
Unresectable Uveal Melanoma
drug approval
europe
uveal neoplasms
melanoma
infusions, intravenous
Cytokine Release Syndrome
product surveillance, postmarketing
pregnancy
breast feeding
HLA-A*02:01 antigen
tebentafusp
---
https://www.ema.europa.eu/en/medicines/human/EPAR/oxbryta
2022
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
voxelotor
voxelotor
voxelotor
orphan drug production
anemia, sickle cell
Oxbryta
drug approval
europe
adolescent
adult
administration, oral
aged
hematologic agents
hematologic agents
product surveillance, postmarketing
pregnancy
breast feeding
drug therapy, combination
drug interactions
hemoglobin, sickle
drug evaluation, preclinical
---
https://www.ema.europa.eu/en/medicines/human/EPAR/ngenla
2022
false
false
false
Netherlands
French
English
Somatrogon
Somatrogon
somatrogon
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
child
adolescent
drug approval
europe
human growth hormone
Growth Hormone Deficiency
injections, subcutaneous
growth hormone, recombinant
growth hormone, recombinant
product surveillance, postmarketing
drug interactions
pregnancy
breast feeding
drug evaluation, preclinical
somatrogon
somatrogon
---
https://www.ema.europa.eu/en/medicines/human/EPAR/vumerity
2022
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
Diroximel Fumarate
Diroximel Fumarate
diroximel fumarate
multiple sclerosis, relapsing-remitting
adult
drug approval
europe
administration, oral
pregnancy
breast feeding
drug interactions
aged
drug evaluation, preclinical
---
https://www.ema.europa.eu/en/medicines/human/EPAR/stimufend
2022
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
pegfilgrastim
pegfilgrastim
pegfilgrastim
biosimilar pharmaceuticals
drug approval
europe
Chemotherapy induced neutropenia
Chemotherapy-Induced febrile neutropenia
injections, subcutaneous
pregnancy
breast feeding
drug interactions
product surveillance, postmarketing
Product containing only pegfilgrastim in parenteral dose form (medicinal product form)
drug evaluation, preclinical
---
https://www.ema.europa.eu/en/medicines/human/EPAR/amifampridine-serb
2022
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
Amifampridine
Amifampridine
amifampridine
drugs, generic
---
https://www.ema.europa.eu/en/medicines/human/EPAR/dimethyl-fumarate-mylan
2022
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
Dimethyl Fumarate
Dimethyl Fumarate
dimethyl fumarate
drugs, generic
administration, oral
drug approval
europe
---
https://www.ema.europa.eu/en/medicines/human/EPAR/breyanzi
2022
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
Lisocabtagene Maraleucel
Lisocabtagene Maraleucel
gene therapy
drug approval
europe
adult
lymphoma, large B-Cell, diffuse
Primary Mediastinal Large B-Cell Lymphoma
Grade 3b Follicular Lymphoma
lymphoma, follicular
infusions, intravenous
Cytokine Release Syndrome
pregnancy
breast feeding
drug interactions
Receptors, Chimeric Antigen
product surveillance, postmarketing
Anti-CD19 CAR T Cells Preparation
aged
continuity of patient care
immunotherapy, adoptive
drug evaluation, preclinical
mediastinal neoplasms
lisocabtagene maraleucel
---
https://www.ema.europa.eu/en/medicines/human/EPAR/padcev
2022
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
enfortumab vedotin
enfortumab vedotin
enfortumab vedotin
drug approval
europe
antineoplastic agents
antineoplastic agents
adult
urogenital neoplasms
Locally Advanced Urothelial Carcinoma
Metastatic Urothelial Carcinoma
Refractory Urothelial Carcinoma
infusions, intravenous
aged
pregnancy
breast feeding
product surveillance, postmarketing
drug interactions
neoplasm metastasis
drug evaluation, preclinical
---
https://www.ema.europa.eu/en/medicines/human/EPAR/apexxnar
2022
false
false
false
Netherlands
French
English
syndication feed
summary of product characteristics
package leaflet
drug evaluation
pneumococcal vaccines
pneumococcus, purified polysaccharides antigen conjugated
vaccines, conjugate
pneumococcal infections
vaccination
pneumonia, pneumococcal
Invasive Streptococcus pneumoniae disease (disorder)
drug approval
europe
Vaccine Efficacy
Immunogenicity, Vaccine
pneumococcal vaccines
drug interactions
polysaccharides, bacterial
adult
pregnancy
breast feeding
injections, intramuscular
product surveillance, postmarketing
aged
---
https://www.ema.europa.eu/en/medicines/human/EPAR/evusheld
2022
false
false
false
Netherlands
French
English
cilgavimab and tixagevimab drug combination
cilgavimab and tixagevimab drug combination
drug combinations
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
tixagevimab and cilgavimab
adult
adolescent
COVID-19
aged
drug approval
europe
pregnancy
breast feeding
injections, intramuscular
continuity of patient care
spike protein, SARS-CoV-2
product surveillance, postmarketing
dna, recombinant
Pre-Exposure Prophylaxis
---
https://www.ema.europa.eu/en/medicines/human/EPAR/tepmetko
2022
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
tepotinib
tepotinib
tepotinib
antineoplastic agents
antineoplastic agents
bronchial neoplasms
carcinoma, non-small-cell lung
drug approval
europe
pregnancy
breast feeding
drug interactions
Product containing precisely tepotinib (as tepotinib hydrochloride) 225 milligram/1
each conventional release oral tablet (clinical drug)
tepmetko
Tepotinib Hydrochloride
adult
bronchial neoplasms
carcinoma, non-small-cell lung
mutation
MET Exon 14 Skipping Mutation
proto-oncogene proteins c-met
protein kinase inhibitors
protein kinase inhibitors
administration, oral
drug evaluation, preclinical
Tyrosine Kinase Inhibitors
---
https://www.ema.europa.eu/en/medicines/human/EPAR/pirfenidone-aet
2022
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
pirfenidone
pirfenidone
pirfenidone
drugs, generic
---
https://www.ema.europa.eu/en/medicines/human/EPAR/sapropterin-dipharma
2022
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
sapropterin
sapropterin
sapropterin
drugs, generic
---
https://www.ema.europa.eu/en/medicines/human/EPAR/lunsumio
2022
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
Mosunetuzumab
Mosunetuzumab
orphan drug production
lymphoma, follicular
adult
antineoplastic agents
antineoplastic agents
infusions, intravenous
drug interactions
pregnancy
breast feeding
drug approval
europe
drug evaluation, preclinical
mosunetuzumab
---
https://www.ema.europa.eu/en/medicines/human/EPAR/zolsketil-pegylated-liposomal
2022
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
doxorubicin
doxorubicin
doxorubicin
antibiotics, antineoplastic
antibiotics, antineoplastic
liposomal doxorubicin
liposomal doxorubicin
Pegylated Liposomal Doxorubicin Hydrochloride
drug approval
europe
adult
breast neoplasms
Metastatic Breast Carcinoma
neoplasm metastasis
ovarian neoplasms
Advanced Ovarian Carcinoma
Platinum-Refractory Ovarian Carcinoma
multiple myeloma
sarcoma, kaposi
AIDS-related kaposi sarcoma
aids-related opportunistic infections
infusions, intravenous
drug interactions
pregnancy
breast feeding
drug evaluation, preclinical
antineoplastic combined chemotherapy protocols
Bevacizumab/Liposomal Doxorubicin Regimen
---
https://www.ema.europa.eu/en/medicines/human/EPAR/camcevi
2022
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
leuprolide
leuprolide
prostatic neoplasms
neoplasms, hormone-dependent
advanced hormone-dependent prostate cancer
antineoplastic agents, hormonal
antineoplastic agents, hormonal
adult
drug approval
europe
aged
Delayed-Action preparations
injections, subcutaneous
drug interactions
Leuprolide Mesylate Injectable Suspension
Product containing only leuprorelin in parenteral dose form (medicinal product form)
leuprorelin
drug evaluation, preclinical
---
https://www.ema.europa.eu/en/medicines/human/EPAR/carvykti
2022
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
Ciltacabtagene Autoleucel
Ciltacabtagene Autoleucel
orphan drug production
multiple myeloma
Recurrent Multiple Myeloma
Refractory Multiple Myeloma
adult
infusions, intravenous
continuity of patient care
product surveillance, postmarketing
drug interactions
pregnancy
breast feeding
immunotherapy, adoptive
drug evaluation, preclinical
ciltacabtagene autoleucel
---
https://www.ema.europa.eu/en/medicines/human/EPAR/dimethyl-fumarate-polpharma
2022
false
false
false
Netherlands
French
English
Dimethyl Fumarate
Dimethyl Fumarate
dimethyl fumarate
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
drugs, generic
administration, oral
---
https://www.ema.europa.eu/en/medicines/human/EPAR/vildagliptin-metformin-hydrochloride-accord
2022
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
Vildagliptin
Vildagliptin
drug combinations
Metformin Hydrochloride
Metformin Hydrochloride
metformin and vildagliptin
drugs, generic
---
https://www.ema.europa.eu/en/medicines/human/EPAR/sondelbay-0
2022
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
teriparatide
teriparatide
teriparatide
biosimilar pharmaceuticals
osteoporotic fractures
osteoporosis
osteoporosis, postmenopausal
male osteoporosis
drug approval
europe
bone density conservation agents
bone density conservation agents
Osteoporosis caused by corticosteroid (disorder)
injections, subcutaneous
Calcium-Regulating Hormones and Agents
Calcium-Regulating Hormones and Agents
pregnancy
breast feeding
drug interactions
product surveillance, postmarketing
drug storage
drug evaluation, preclinical
---
https://www.ema.europa.eu/en/medicines/human/EPAR/truvelog-mix-30
2022
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
insulin aspart
insulin aspart
insulin aspart
biosimilar pharmaceuticals
diabetes mellitus
adolescent
adult
aged
drug approval
europe
pregnancy
breast feeding
injections, subcutaneous
hypoglycemic agents
hypoglycemic agents
product surveillance, postmarketing
insulin aspart, insulin aspart protamine drug combination 30:70
drug interactions
---
https://www.ema.europa.eu/en/medicines/human/EPAR/dimethyl-fumarate-neuraxpharm
2022
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
Dimethyl Fumarate
Dimethyl Fumarate
dimethyl fumarate
drugs, generic
administration, oral
drug approval
europe
---
https://www.ema.europa.eu/en/medicines/human/EPAR/quviviq
2022
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
daridorexant
daridorexant
adult
sleep initiation and maintenance disorders
drug approval
europe
administration, oral
Dual Orexin Receptor Antagonists
Dual Orexin Receptor Antagonists
product surveillance, postmarketing
aged
drug interactions
pregnancy
breast feeding
drug evaluation, preclinical
daridorexant
---
https://www.ema.europa.eu/en/medicines/human/EPAR/vydura
2022
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
rimegepant
rimegepant
rimegepant
migraine with aura
migraine disorders
adult
Product containing precisely rimegepant (as rimegepant sulfate) 75 milligram/1 each
conventional release orodispersible tablet (clinical drug)
drug approval
europe
migraine without aura
administration, oral
receptors, calcitonin gene-related peptide
product surveillance, postmarketing
drug interactions
pregnancy
breast feeding
drug evaluation, preclinical
---
https://www.ema.europa.eu/en/medicines/human/EPAR/xevudy
2022
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
sotrovimab
sotrovimab
sotrovimab
COVID-19
adult
adolescent
drug approval
europe
infusions, intravenous
spike protein, SARS-CoV-2
product surveillance, postmarketing
pregnancy
breast feeding
drug evaluation, preclinical
---
https://www.ema.europa.eu/en/medicines/human/EPAR/covid-19-vaccine-inactivated-adjuvanted-valneva
2022
false
false
false
Netherlands
French
English
syndication feed
summary of product characteristics
package leaflet
drug evaluation
COVID-19 Vaccines
COVID-19
covid-19, inactivated virus
vaccination
drug approval
europe
Vaccine Efficacy
Immunogenicity, Vaccine
adult
vaccines, inactivated
COVID-19 Vaccines
product surveillance, postmarketing
first vaccination
adjuvants, immunologic
injections, intramuscular
SARS-CoV-2
pregnancy
breast feeding
drug interactions
drug evaluation, preclinical
---
https://www.ema.europa.eu/en/medicines/human/EPAR/abiraterone-krka
2022
false
false
false
Netherlands
French
English
syndication feed
summary of product characteristics
package leaflet
drug evaluation
Abiraterone Acetate
Abiraterone Acetate
treatment outcome
abiraterone
drugs, generic
---
https://www.ema.europa.eu/en/medicines/human/EPAR/nuvaxovid
2022
false
false
false
Netherlands
French
English
syndication feed
summary of product characteristics
package leaflet
drug evaluation
COVID-19 Vaccines
vaccination
COVID-19
covid-19, protein subunit
adult
adjuvants, immunologic
Vaccine Efficacy
Immunogenicity, Vaccine
NVX-CoV2373 adjuvated lipid nanoparticle
NVX-CoV2373 adjuvated lipid nanoparticle
recombinant proteins
spike protein, SARS-CoV-2
injections, intramuscular
pregnancy
breast feeding
product surveillance, postmarketing
drug evaluation, preclinical
drug storage
---
https://www.ema.europa.eu/en/medicines/human/EPAR/filsuvez
2022
false
false
false
Netherlands
French
English
Oleogel-S10
Oleogel-S10
syndication feed
summary of product characteristics
package leaflet
drug evaluation
Betulae cortex
orphan drug production
epidermolysis bullosa, junctional
adult
child
adolescent
betula
plant extracts
epidermolysis bullosa dystrophica
plant bark
drug approval
europe
administration, cutaneous
gels
pregnancy
breast feeding
drug evaluation, preclinical
aged
---
https://www.ema.europa.eu/en/medicines/human/EPAR/sugammadex-fresenius-kabi
2022
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
Sugammadex
Sugammadex
drugs, generic
sugammadex
---
https://www.ema.europa.eu/en/medicines/human/EPAR/ganirelix-gedeon-richter
2022
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
drugs, generic
ganirelix
hormone antagonists
ganirelix
ganirelix
---
https://www.ema.europa.eu/en/medicines/human/EPAR/nexviadyme
2022
false
false
false
Netherlands
French
drug approval
europe
avalglucosidase alfa
Avalglucosidase Alfa
Avalglucosidase Alfa
orphan drug production
glycogen storage disease type ii
drug evaluation
summary of product characteristics
syndication feed
package leaflet
enzyme replacement therapy
alpha-Glucosidases
infusions, intravenous
risk management
product surveillance, postmarketing
recombinant proteins
aged
pregnancy
drug evaluation, preclinical
---
https://www.ema.europa.eu/en/medicines/human/EPAR/zokinvy
2022
false
false
false
Netherlands
French
English
lonafarnib
lonafarnib
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
orphan drug production
infant
child
progeria
drug approval
europe
lonafarnib
Laminopathies
administration, oral
Product containing precisely lonafarnib 50 milligram/1 each conventional release oral
capsule (clinical drug)
Product containing precisely lonafarnib 75 milligram/1 each conventional release oral
capsule (clinical drug)
product surveillance, postmarketing
Laminopathies
mutation
zinc metallopeptidase STE24
LMNA Gene
adolescent
adult
drug interactions
pregnancy
breast feeding
drug evaluation, preclinical
---
http://agence-prd.ansm.sante.fr/php/ecodex/extrait.php?specid=60880110
2022
false
false
false
France
French
package leaflet
summary of product characteristics
administration, intranasal
nasal sprays
azelastine
azelastine
adult
adolescent
child
Rhinitis, Allergic
histamine H1 antagonists, non-sedating
histamine H1 antagonists, non-sedating
azelastine
anti-allergic agents
anti-allergic agents
---
http://agence-prd.ansm.sante.fr/php/ecodex/extrait.php?specid=60833559
2022
false
false
false
France
French
ophthalmic solutions
administration, ophthalmic
package leaflet
summary of product characteristics
dexamethasone sodium phosphate
dexamethasone sodium phosphate
glucocorticoids
glucocorticoids
inflammation of anterior eye segment
inflammation
eye diseases
dexamethasone
---
https://www.ema.europa.eu/en/medicines/human/EPAR/uplizna
2022
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
inebilizumab
inebilizumab
Anti-aquaporin 4 antibody positivity
neuromyelitis optica
neuromyelitis optica
infusions, intravenous
inebilizumab
neuromyelitis optica spectrum disorders who are anti-aquaporin 4 antibody positive
anti-aquaporin 4 autoantibody
drug interactions
pregnancy
breast feeding
drug approval
europe
drug evaluation, preclinical
adult
---
https://www.ema.europa.eu/en/medicines/human/EPAR/sunlenca
2022
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
Lenacapavir
Lenacapavir
lenacapavir
drug approval
europe
anti-hiv agents
anti-hiv agents
drug therapy, combination
hiv infections
adult
HIV-1
acquired immunodeficiency syndrome
administration, oral
injections, subcutaneous
product surveillance, postmarketing
multiresistant HIV-1 infection
aged
drug interactions
pregnancy
breast feeding
capsid proteins
drug evaluation, preclinical
---
https://www.ema.europa.eu/en/medicines/human/EPAR/ertapenem-sun
2022
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
Ertapenem
Ertapenem
drugs, generic
drug approval
europe
anti-bacterial agents
anti-bacterial agents
ertapenem
adult
infant
child
adolescent
intraabdominal infections
community-acquired infections
pneumonia, bacterial
gynecological infection
Diabetic foot infection
reproductive tract infections
antibiotic prophylaxis
surgical wound infection
infusions, intravenous
drug interactions
pregnancy
breast feeding
drug evaluation, preclinical
---
https://www.ema.europa.eu/en/medicines/human/EPAR/nulibry
2022
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
orphan drug production
fosdenopterin
fosdenopterin
nulibry
Product containing only fosdenopterin in parenteral dose form (medicinal product form)
drug approval
europe
molybdenum cofactor deficiency, complementation group A
infusions, intravenous
fosdenopterin
product surveillance, postmarketing
Fosdenopterin Hydrobromide
pregnancy
breast feeding
Replacement Therapy
drug evaluation, preclinical
---
https://www.ema.europa.eu/en/medicines/human/EPAR/vyvgart
2022
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
Vyvgart
efgartigimod alfa
efgartigimod alfa
orphan drug production
drug approval
europe
myasthenia gravis, generalized
myasthenia gravis
adult
infusions, intravenous
fc receptor, neonatal
product surveillance, postmarketing
Anti-acetylcholine receptor antibody positivity
drug interactions
pregnancy
breast feeding
efgartigimod alfa
drug evaluation, preclinical
---
https://www.ema.europa.eu/en/medicines/human/EPAR/illuzyce
2022
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
Lutetium-177
Radioisotopic Labeling
drug approval
europe
neuroendocrine tumors
prostatic neoplasms
radiopharmaceuticals
other therapeutic radiopharmaceuticals
Precursor Radiopharmaceutical Solution Dosage Form
---
https://www.ema.europa.eu/en/medicines/human/EPAR/tabrecta
2022
false
false
false
Netherlands
French
English
treatment outcome
capmatinib
capmatinib
syndication feed
summary of product characteristics
package leaflet
drug evaluation
protein kinase inhibitors
protein kinase inhibitors
adult
carcinoma, non-small-cell lung
administration, oral
carcinoma, non-small-cell lung
mutation
product surveillance, postmarketing
Product containing precisely capmatinib 150 milligram/1 each conventional release
oral tablet (clinical drug)
Product containing precisely capmatinib 200 milligram/1 each conventional release
oral tablet (clinical drug)
capmatinib
proto-oncogene proteins c-met
MET Exon 14 Skipping Mutation
drug interactions
pregnancy
breast feeding
drug evaluation, preclinical
bronchial neoplasms
Advanced Lung Non-Small Cell Carcinoma
Refractory Lung Non-Small Cell Carcinoma
Tyrosine Kinase Inhibitors
---
Lupkynis - voclosporin
https://www.ema.europa.eu/en/medicines/human/EPAR/lupkynis
2022
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
voclosporin
voclosporin
Product containing precisely voclosporin 7.9 milligram/1 each conventional release
oral capsule (clinical drug)
administration, oral
drug approval
europe
lupus nephritis
drug therapy, combination
mycophenolate mofetil
adult
Systemic Lupus Erythematosus Nephritis Class III
Systemic Lupus Erythematosus Nephritis Class IV
Systemic Lupus Erythematosus Nephritis Class V
Calcineurin Inhibitors
Calcineurin Inhibitors
product surveillance, postmarketing
drug interactions
pregnancy
breast feeding
drug evaluation, preclinical
---
https://www.ema.europa.eu/en/medicines/human/EPAR/scemblix
2022
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
asciminib
asciminib
orphan drug production
asciminib
antineoplastic agents
antineoplastic agents
leukemia, myelogenous, chronic, bcr-abl positive
Refractory Chronic Myeloid Leukemia, BCR-ABL1 Positive
administration, oral
Tyrosine Kinase Inhibitor
protein kinase inhibitors
protein kinase inhibitors
protein-tyrosine kinases
product surveillance, postmarketing
asciminib hydrochloride
asciminib hydrochloride
drug interactions
pregnancy
breast feeding
drug evaluation, preclinical
Tyrosine Kinase Inhibitors
---
https://www.ema.europa.eu/en/medicines/human/EPAR/thalidomide-lipomed
2022
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
thalidomide
thalidomide
---
https://www.ema.europa.eu/en/medicines/human/EPAR/opdualag
2022
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
drug combinations
Relatlimab
Relatlimab
Nivolumab
Nivolumab
Antineoplastic Agents, Immunological
nivolumab and relatlimab
melanoma
product surveillance, postmarketing
Advanced Cutaneous Melanoma
Metastatic Cutaneous Melanoma
Unresectable Cutaneous Melanoma
adolescent
adult
Immune Checkpoint Inhibitors
Immune Checkpoint Inhibitors
antibodies, monoclonal, humanized
antibodies, monoclonal, humanized
PD-L1 Expression Less than 1 Percent
infusions, intravenous
programmed cell death 1 receptor
receptors, immunologic
Lag3 protein, human
drug interactions
pregnancy
breast feeding
drug evaluation, preclinical
relatlimab
relatlimab
---
https://www.ema.europa.eu/en/medicines/human/EPAR/vabysmo
2022
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
Faricimab
Faricimab
faricimab
antibodies, monoclonal
antibodies, monoclonal
wet macular degeneration
intravitreal injections
vascular endothelial growth factor a
Angiopoietin-2
product surveillance, postmarketing
pregnancy
breast feeding
drug evaluation, preclinical
macular edema
diabetes complications
---
https://www.ema.europa.eu/en/medicines/human/EPAR/evkeeza
2022
false
false
false
Netherlands
French
English
treatment outcome
evinacumab
evinacumab
syndication feed
summary of product characteristics
package leaflet
drug evaluation
evinacumab
infusions, intravenous
Product containing only evinacumab in parenteral dose form (medicinal product form)
adult
adolescent
Homozygous Familial Hypercholesterolemia
product surveillance, postmarketing
pregnancy
breast feeding
ANGPTL3 protein, human
drug evaluation, preclinical
---
https://www.ema.europa.eu/en/medicines/human/EPAR/amvuttra
2022
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
Vutrisiran
Vutrisiran
orphan drug production
vutrisiran
amyloidosis, hereditary, Transthyretin-Related
adult
injections, subcutaneous
product surveillance, postmarketing
RNAi Therapeutics
pregnancy
breast feeding
rna, small interfering
drug evaluation, preclinical
---
https://www.ema.europa.eu/en/medicines/human/EPAR/ranivisio
2022
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
Ranibizumab
Ranibizumab
biosimilar pharmaceuticals
ranibizumab
wet macular degeneration
macular edema
Proliferative Diabetic Retinopathy
diabetic retinopathy
choroidal neovascularization
intravitreal injections
vascular endothelial growth factor a
angiogenesis inhibitors
angiogenesis inhibitors
Product containing precisely ranibizumab 10 milligram/1 milliliter conventional release
solution for injection (clinical drug)
product surveillance, postmarketing
adult
pregnancy
drug evaluation, preclinical
---
https://www.ema.europa.eu/en/medicines/human/EPAR/rayvow
2022
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
lasmiditan
lasmiditan
migraine with aura
migraine without aura
lasmiditan
adult
administration, oral
serotonin receptor agonists
serotonin receptor agonists
product surveillance, postmarketing
Product containing precisely lasmiditan 50 milligram/1 each conventional release oral
tablet (clinical drug)
Product containing only lasmiditan in oral dose form (medicinal product form)
drug interactions
pregnancy
breast feeding
serotonin 1F receptor
drug evaluation, preclinical
---
https://www.ema.europa.eu/en/medicines/human/EPAR/teriflunomide-accord
2022
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
teriflunomide
teriflunomide
drugs, generic
multiple sclerosis, relapsing-remitting
child
adolescent
drug approval
europe
administration, oral
teriflunomide
immunosuppressive agents
immunosuppressive agents
Product containing precisely teriflunomide 14 milligram/1 each conventional release
oral tablet (clinical drug)
adult
aged
drug interactions
pregnancy
breast feeding
drug evaluation, preclinical
---
https://ansm.sante.fr/tableau-atu-rtu/ontozry-12-5-mg-comprime-ontozry-25-mg-comprime-pellicule-ontozry-50-mg-comprime-pellicule-ontozry-100-mg-comprime-pellicule-ontozry-150-mg-comprime-pellicule-ontozry-200-mg-comprime-pellicule
2022
false
false
false
France
French
guidelines for drug use
administration, oral
Cenobamate
Cenobamate
summary of product characteristics
package leaflet
adult
epilepsies, partial
anticonvulsants
anticonvulsants
Product containing only cenobamate in oral dose form (medicinal product form)
carbamates
chlorophenols
tetrazoles
carbamates
chlorophenols
tetrazoles
---
https://www.ema.europa.eu/en/medicines/human/EPAR/saphnelo
2022
false
false
false
United Kingdom
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
drug approval
europe
infusions, intravenous
anifrolumab
anifrolumab
anifrolumab
lupus erythematosus, systemic
adult
---
https://www.ema.europa.eu/en/medicines/human/EPAR/sugammadex-mylan
2022
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
Sugammadex
Sugammadex
drugs, generic
---
https://www.ema.europa.eu/en/medicines/human/EPAR/cibinqo
2022
false
false
false
Netherlands
French
abrocitinib
abrocitinib
abrocitinib
summary of product characteristics
package leaflet
syndication feed
drug evaluation
drug approval
europe
treatment outcome
Janus Kinase Inhibitors
Janus Kinase Inhibitors
adult
dermatitis, atopic
administration, oral
continuity of patient care
product surveillance, postmarketing
aged
drug interactions
pregnancy
breast feeding
janus kinase 1
drug evaluation, preclinical
Tyrosine Kinase Inhibitors
---
https://www.ema.europa.eu/en/medicines/human/EPAR/yselty
2022
false
false
false
Netherlands
French
English
Linzagolix Choline
Linzagolix Choline
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
linzagolix
drug approval
europe
adult
leiomyoma
administration, oral
drug therapy, combination
pregnancy
breast feeding
drug interactions
Gonadotropin releasing hormone receptor antagonist (disposition)
receptors, LHRH
linzagolix
product surveillance, postmarketing
drug evaluation, preclinical
---
https://www.ema.europa.eu/en/medicines/human/EPAR/tecovirimat-siga
2022
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
Tecovirimat
Tecovirimat
tecovirimat
drug approval
europe
antiviral agents
antiviral agents
Mpox (monkeypox)
smallpox
cowpox
smallpox vaccine
Complication of smallpox vaccination (disorder)
adult
adolescent
child
aged
administration, oral
Product containing only tecovirimat in oral dose form (medicinal product form)
product surveillance, postmarketing
pregnancy
breast feeding
drug interactions
viral proteins
drug evaluation, preclinical
---
https://www.ema.europa.eu/en/medicines/human/EPAR/tavneos
2022
false
false
false
Netherlands
French
English
avacopan
avacopan
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
orphan drug production
drug approval
europe
adult
aged
Granulomatosis with Polyangiitis
microscopic polyangiitis
drug therapy, combination
administration, oral
receptor, anaphylatoxin c5a
product surveillance, postmarketing
pregnancy
breast feeding
drug interactions
drug evaluation, preclinical
avacopan
---
https://www.ema.europa.eu/en/medicines/human/EPAR/hukyndra
2022
false
false
false
Netherlands
French
English
Adalimumab
Adalimumab
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
adalimumab
injections, subcutaneous
psoriasis
arthritis, psoriatic
arthritis, juvenile
hidradenitis suppurativa
crohn disease
arthritis, rheumatoid
pregnancy
breast feeding
drug interactions
spondylitis, ankylosing
uveitis
colitis, ulcerative
antirheumatic agents
antirheumatic agents
Tumor Necrosis Factor Inhibitors
Tumor Necrosis Factor Inhibitors
biosimilar pharmaceuticals
---
https://www.ema.europa.eu/en/medicines/human/EPAR/voraxaze-0
2022
false
false
false
Netherlands
French
English
glucarpidase
glucarpidase
glucarpidase
orphan drug production
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
drug approval
europe
adult
adolescent
infant
aged
Methotrexate toxicity
methotrexate
injections, intravenous
methotrexate
methotrexate
product surveillance, postmarketing
pregnancy
breast feeding
drug interactions
drug evaluation, preclinical
---
https://www.ema.europa.eu/en/medicines/human/EPAR/libmyris
2022
false
false
false
Netherlands
French
English
Adalimumab
Adalimumab
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
biosimilar pharmaceuticals
---
https://www.ema.europa.eu/en/medicines/human/EPAR/trodelvy
2022
false
false
false
Netherlands
French
English
sacituzumab govitecan
sacituzumab govitecan
sacituzumab govitecan
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
drug approval
europe
antineoplastic agents
antineoplastic agents
adult
aged
triple negative breast neoplasms
Metastatic Triple-Negative Breast Carcinoma
Unresectable Triple-Negative Breast Carcinoma
Refractory Triple-Negative Breast Carcinoma
infusions, intravenous
continuity of patient care
drug monitoring
product surveillance, postmarketing
pregnancy
breast feeding
drug interactions
Product containing only sacituzumab govitecan in parenteral dose form (medicinal product
form)
SN 38
topoisomerase I inhibitors
drug evaluation, preclinical
---
https://www.ema.europa.eu/en/medicines/human/EPAR/artesunate-amivas
2022
false
false
false
Netherlands
French
English
Artesunate
Artesunate
artesunate
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
orphan drug production
drug approval
europe
antimalarials
antimalarials
adult
adolescent
child
aged
malaria
pregnancy
breast feeding
drug interactions
injections, intravenous
product surveillance, postmarketing
drug evaluation, preclinical
---
https://www.ema.europa.eu/en/medicines/human/EPAR/heplisav-b
2022
false
false
false
Netherlands
French
English
syndication feed
summary of product characteristics
package leaflet
drug evaluation
hepatitis b, purified antigen
hepatitis B surface antigens
drug approval
europe
hepatitis B surface antigens
vaccination
hepatitis B vaccines
hepatitis B vaccines
adjuvants, immunologic
hepatitis B
hepatitis D
adult
aged
injections, intramuscular
immunization schedule
Vaccine Efficacy
Immunogenicity, Vaccine
pregnancy
breast feeding
drug interactions
product surveillance, postmarketing
---
https://www.ema.europa.eu/en/medicines/human/EPAR/rivaroxaban-mylan
2022
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
Rivaroxaban
Rivaroxaban
rivaroxaban
drugs, generic
---
https://pharmacomedicale.org/medicaments/par-specialites/item/antidiabetiques-les-points-essentiels
2022
false
false
false
false
France
French
drug information
hypoglycemic agents
hypoglycemic agents
---
https://www.ema.europa.eu/en/medicines/human/EPAR/senstend
2022
false
false
false
United Kingdom
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
drug approval
europe
Lidocaine, Prilocaine Drug Combination
Lidocaine, Prilocaine Drug Combination
premature ejaculation
administration, cutaneous
anesthetics, local
anesthetics, local
anesthetics, combined
anesthetics, combined
adult
aged
drug interactions
drug evaluation, preclinical
---
https://pharmacomedicale.org/medicaments/par-specialites/item/traitements-de-l-anemie-les-points-essentiels
2022
false
true
false
France
anemia
hematinics
antianemic preparations
drug information
---
https://www.ema.europa.eu/en/medicines/human/EPAR/lenalidomide-krka
2021
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
drug approval
europe
Lenalidomide
Lenalidomide
lenalidomide
angiogenesis inhibitors
angiogenesis inhibitors
drugs, generic
multiple myeloma
lymphoma, follicular
adult
antineoplastic combined chemotherapy protocols
administration, oral
immunologic factors
immunologic factors
aged
drug interactions
pregnancy
breast feeding
Progression-Free Survival
survival analysis
drug evaluation, preclinical
RVD Regimen
Dexamethasone/Lenalidomide Regimen
R-Squared Regimen
---
https://www.ema.europa.eu/en/medicines/human/EPAR/covid-19-vaccine-janssen
2021
false
false
false
Netherlands
French
English
syndication feed
summary of product characteristics
package leaflet
drug evaluation
drug approval
europe
vaccination
injections, intramuscular
Immunogenicity, Vaccine
covid-19, viral vector, non-replicating
adult
aged
Ad26.COV2.S
spike glycoprotein, coronavirus
pregnancy
breast feeding
product surveillance, postmarketing
vaccines, recombinant
dna, recombinant
drug evaluation, preclinical
organisms, genetically modified
vaccines, synthetic
pneumonia, viral
coronavirus infections
pandemics
viral vaccines
coronavirus infections
viral vaccines
coronavirus infections
COVID-19
COVID-19 Vaccines
COVID-19 Vaccines
---
https://www.ema.europa.eu/en/medicines/human/EPAR/lumoxiti
2021
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
drug approval
europe
immunotoxin HA22
immunotoxin HA22
moxetumomab pasudotox
antineoplastic agents
antineoplastic agents
adult
orphan drug production
leukemia, hairy cell
recurrence
Recurrent Hairy Cell Leukemia
Refractory Hairy Cell Leukemia
infusions, intravenous
immunotoxins
immunotoxins
sialic acid binding ig-like lectin 2
product surveillance, postmarketing
aged
pregnancy
breast feeding
drug evaluation, preclinical
bacterial toxins
exotoxins
bacterial toxins
exotoxins
---
https://www.ema.europa.eu/en/medicines/human/EPAR/onbevzi
2021
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
drug approval
europe
Bevacizumab
Bevacizumab
bevacizumab
biosimilar pharmaceuticals
Antineoplastic Agents, Immunological
Antineoplastic Agents, Immunological
angiogenesis inhibitors
angiogenesis inhibitors
adult
aged
colonic neoplasms
rectal neoplasms
neoplasm metastasis
carcinoma, non-small-cell lung
breast neoplasms
carcinoma, renal cell
ovarian neoplasms
fallopian tube neoplasms
peritoneal neoplasms
uterine cervical neoplasms
antineoplastic combined chemotherapy protocols
infusions, intravenous
vascular endothelial growth factors
product surveillance, postmarketing
drug interactions
pregnancy
breast feeding
fertility
drug evaluation, preclinical
Bevacizumab/Capecitabine Regimen
Bevacizumab/Paclitaxel Regimen
Bevacizumab/Erlotinib Regimen
Bevacizumab/Interferon Alfa Regimen
Bevacizumab/Carboplatin/Paclitaxel Regimen
Bevacizumab/Cisplatin/Paclitaxel Regimen
Bevacizumab/Paclitaxel/Topotecan Regimen
Bevacizumab/Carboplatin/Gemcitabine Regimen
---
https://ansm.sante.fr/uploads/2021/03/16/20210315-atuc-bamlanivimab-etesevimab-put-2.pdf
2021
false
false
false
France
French
drug therapy, combination
guideline
health occupations
professional role
risk management
continuity of patient care
drug monitoring
infusions, intravenous
pharmacovigilance
information dissemination
drug prescriptions
Therapy cessation
adult
aged
antibodies, monoclonal, humanized
Etesevimab
Bamlanivimab
spike glycoprotein, coronavirus
adverse drug reaction reporting systems
bamlanivimab
bamlanivimab
pneumonia, viral
coronavirus infections
pandemics
pneumonia, viral
coronavirus infections
pandemics
coronavirus infections
COVID-19
COVID-19
antibodies, monoclonal, humanized
---
https://www.ema.europa.eu/en/medicines/human/EPAR/lenalidomide-krka-dd-novo-mesto
2021
false
false
false
United Kingdom
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
drug approval
europe
Lenalidomide
Lenalidomide
lenalidomide
angiogenesis inhibitors
angiogenesis inhibitors
drugs, generic
multiple myeloma
lymphoma, follicular
adult
antineoplastic combined chemotherapy protocols
administration, oral
immunologic factors
immunologic factors
aged
drug interactions
pregnancy
breast feeding
Progression-Free Survival
survival analysis
drug evaluation, preclinical
myelodysplastic syndromes
lymphoma, mantle-cell
R-Squared Regimen
RVD Regimen
Dexamethasone/Lenalidomide Regimen
---
https://www.ema.europa.eu/en/medicines/human/EPAR/lenalidomide-krka-dd
2021
false
false
false
United Kingdom
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
drug approval
europe
Lenalidomide
Lenalidomide
lenalidomide
angiogenesis inhibitors
angiogenesis inhibitors
drugs, generic
multiple myeloma
lymphoma, follicular
adult
antineoplastic combined chemotherapy protocols
administration, oral
immunologic factors
immunologic factors
aged
drug interactions
pregnancy
breast feeding
Progression-Free Survival
survival analysis
drug evaluation, preclinical
myelodysplastic syndromes
Dexamethasone/Lenalidomide Regimen
R-Squared Regimen
RVD Regimen
---
Kirsty (previously Kixelle)
https://www.ema.europa.eu/en/medicines/human/EPAR/kixelle
2021
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
drug approval
europe
insulin aspart
insulin aspart
biosimilar pharmaceuticals
insulin aspart
diabetes mellitus
child
infant
adolescent
adult
aged
injections, subcutaneous
infusions, subcutaneous
infusions, intravenous
hypoglycemic agents
hypoglycemic agents
product surveillance, postmarketing
drug interactions
pregnancy
breast feeding
drug evaluation, preclinical
---
https://www.ema.europa.eu/en/medicines/human/EPAR/kesimpta
2021
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
europe
drug approval
ofatumumab
ofatumumab
ofatumumab
adult
multiple sclerosis, relapsing-remitting
injections, subcutaneous
Anti-CD20 Monoclonal Antibody
antibodies, monoclonal, humanized
antibodies, monoclonal, humanized
antigens, CD20
product surveillance, postmarketing
drug interactions
pregnancy
breast feeding
aged
drug evaluation, preclinical
antibodies, monoclonal
antibodies, monoclonal
---
https://www.ema.europa.eu/en/medicines/human/EPAR/oyavas
2021
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
Bevacizumab
Bevacizumab
drug approval
europe
bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents, Immunological
biosimilar pharmaceuticals
neoplasm metastasis
colonic neoplasms
rectal neoplasms
breast neoplasms
carcinoma, non-small-cell lung
carcinoma, renal cell
ovarian neoplasms
fallopian tube neoplasms
peritoneal neoplasms
uterine cervical neoplasms
neoplasm recurrence, local
antineoplastic combined chemotherapy protocols
infusions, intravenous
angiogenesis inhibitors
angiogenesis inhibitors
receptors, vascular endothelial growth factor
Anti-VEGF Monoclonal Antibody
product surveillance, postmarketing
adult
aged
drug interactions
pregnancy
breast feeding
survival analysis
drug evaluation, preclinical
---
https://www.ema.europa.eu/en/medicines/human/EPAR/sogroya
2021
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
drug approval
europe
Somapacitan
Somapacitan
human growth hormone
human growth hormone
orphan drug production
hormone replacement therapy
adult
Growth Hormone Deficiency
injections, subcutaneous
product surveillance, postmarketing
Adult growth hormone deficiency (disorder)
aged
drug interactions
pregnancy
breast feeding
somapacitan
human growth hormone
Prolonged-Action preparations
drug evaluation, preclinical
Product containing only somapacitan in parenteral dose form (medicinal product form)
Delayed-Action preparations
---
https://www.ema.europa.eu/en/medicines/human/EPAR/vazkepa
2021
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
drug approval
europe
eicosapentaenoic acid ethyl ester
eicosapentaenoic acid ethyl ester
eicosapentaenoic acid
omega-3-triglycerides incl. other esters and acids
cardiovascular diseases
adult
administration, oral
lipid regulating agents
lipid regulating agents
risk factors
hypertriglyceridemia
drug therapy, combination
hydroxymethylglutaryl-coa reductase inhibitors
pregnancy
breast feeding
dyslipidemias
drug evaluation, preclinical
---
https://www.ema.europa.eu/en/medicines/human/EPAR/bropair-spiromax
2021
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
drug approval
europe
Fluticasone-Salmeterol Drug Combination
Fluticasone-Salmeterol Drug Combination
Fluticasone Propionate
Fluticasone Propionate
salmeterol and fluticasone
Fluticasone Propionate, Salmeterol Xinafoate Drug Combination
Fluticasone Propionate, Salmeterol Xinafoate Drug Combination
adult
adolescent
asthma
administration, inhalation
bronchodilator agents
bronchodilator agents
glucocorticoids
glucocorticoids
adrenergic beta-2 receptor agonists
adrenergic beta-2 receptor agonists
drug interactions
pregnancy
breast feeding
drug evaluation, preclinical
Fluticasone
Fluticasone
---
https://www.ema.europa.eu/en/medicines/human/EPAR/ontozry
2021
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
drug approval
europe
carbamates
carbamates
chlorophenols
chlorophenols
tetrazoles
tetrazoles
cenobamate
anticonvulsants
anticonvulsants
seizures
adult
drug therapy, combination
administration, oral
product surveillance, postmarketing
epilepsies, partial
aged
drug interactions
pregnancy
breast feeding
GABA modulators
drug evaluation, preclinical
Cenobamate
Cenobamate
---
https://www.ema.europa.eu/en/medicines/human/EPAR/rukobia
2021
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
drug approval
europe
Fostemsavir Tromethamine
Fostemsavir Tromethamine
fostemsavir
organophosphates
organophosphates
piperazines
piperazines
anti-hiv agents
anti-hiv agents
hiv infections
hiv fusion inhibitors
hiv fusion inhibitors
HIV-1
adult
acquired immunodeficiency syndrome
drug therapy, combination
drug resistance, multiple, viral
administration, oral
Delayed-Action preparations
product surveillance, postmarketing
aged
drug interactions
pregnancy
breast feeding
prodrugs
Temsavir
drug evaluation, preclinical
fostemsavir
fostemsavir
multiresistant HIV-1 infection
---
https://www.ema.europa.eu/en/medicines/human/EPAR/sunitinib-accord
2021
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
drug approval
europe
Sunitinib
Sunitinib
sunitinib
drugs, generic
adult
gastrointestinal stromal tumors
kidney neoplasms
neoplasm metastasis
pancreatic neoplasms
Pancreatic Neuroendocrine Tumor
Metastatic Kidney Carcinoma
neuroendocrine tumors
administration, oral
protein kinase inhibitors
protein kinase inhibitors
aged
drug interactions
pregnancy
breast feeding
angiogenesis inhibitors
angiogenesis inhibitors
survival analysis
drug evaluation, preclinical
---
https://www.ema.europa.eu/en/medicines/human/EPAR/seffalair-spiromax
2021
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
drug approval
europe
Fluticasone-Salmeterol Drug Combination
Fluticasone-Salmeterol Drug Combination
Fluticasone Propionate
Fluticasone Propionate
salmeterol and fluticasone
Fluticasone Propionate, Salmeterol Xinafoate Drug Combination
Fluticasone Propionate, Salmeterol Xinafoate Drug Combination
adult
adolescent
asthma
administration, inhalation
bronchodilator agents
bronchodilator agents
glucocorticoids
glucocorticoids
adrenergic beta-2 receptor agonists
adrenergic beta-2 receptor agonists
drug interactions
pregnancy
breast feeding
drug evaluation, preclinical
Fluticasone
Fluticasone
---
https://www.ema.europa.eu/en/medicines/human/EPAR/retsevmo
2021
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
drug approval
europe
pyrazoles
pyrazoles
pyridines
pyridines
RET Inhibitor
RET Inhibitor
protein kinase inhibitors
protein kinase inhibitors
Proto-Oncogene Proteins c-ret
antineoplastic agents
antineoplastic agents
product surveillance, postmarketing
RET Gene Mutation
carcinoma, non-small-cell lung
mutation
carcinoma, non-small-cell lung
bronchial neoplasms
Advanced Lung Non-Small Cell Carcinoma
adult
adolescent
thyroid neoplasms
Advanced Thyroid Gland Medullary Carcinoma
Advanced Thyroid Gland Carcinoma
mutagenicity tests
administration, oral
aged
drug interactions
pregnancy
breast feeding
selpercatinib
drug evaluation, preclinical
selpercatinib
selpercatinib
Product containing precisely selpercatinib 40 milligram/1 each conventional release
oral capsule (clinical drug)
Product containing precisely selpercatinib 80 milligram/1 each conventional release
oral capsule (clinical drug)
advanced RET fusion-positive non-small cell lung cancer
advanced RET fusion-positive thyroid cancer
Tyrosine Kinase Inhibitors
---
https://www.ema.europa.eu/en/medicines/human/EPAR/byfavo
2021
false
false
false
Netherlands
French
English
remimazolam
remimazolam
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
drug approval
europe
remimazolam
hypnotics and sedatives
hypnotics and sedatives
adult
conscious sedation
injections, intravenous
product surveillance, postmarketing
Remimazolam Besylate
Remimazolam Besylate
drug interactions
pregnancy
breast feeding
GABA agents
GABA agents
diagnostic techniques and procedures
drug evaluation, preclinical
benzodiazepines
benzodiazepines
---
https://ansm.sante.fr/tableau-atu-rtu/bamlanivimab-700-mg-20-ml-35mg-ml-solution-a-diluer-pour-perfusion
2021
false
false
false
France
French
package leaflet
summary of product characteristics
guidelines for drug use
pneumonia, viral
coronavirus infections
Bamlanivimab
Bamlanivimab
antiviral agents
antiviral agents
antibodies, monoclonal, humanized
antibodies, monoclonal, humanized
infusions, intravenous
adult
bamlanivimab
pandemics
COVID-19
---
https://ansm.sante.fr/tableau-atu-rtu/berotralstat-150-mg-gelule
2021
false
false
false
France
French
Berotralstat
package leaflet
summary of product characteristics
guidelines for drug use
Berotralstat
pyrazoles
pyrazoles
administration, oral
angioedemas, hereditary
plasma kallikrein
Hereditary angioedema attack
berotralstat
berotralstat
berotralstat
---
https://ansm.sante.fr/tableau-atu-rtu/fostemsavir-600-mg-comprime-a-liberation-prolongee
2021
false
false
false
France
French
package leaflet
summary of product characteristics
guidelines for drug use
Fostemsavir
Fostemsavir
administration, oral
drug resistance, multiple, viral
hiv infections
HIV-1
drug therapy, combination
adult
anti-hiv agents
anti-hiv agents
fostemsavir
hiv fusion inhibitors
hiv fusion inhibitors
organophosphates
organophosphates
piperazines
piperazines
fostemsavir
---
https://ansm.sante.fr/tableau-atu-rtu/pemigatinib-4-5-mg-9-mg-et-13-5-mg-comprime
2021
false
false
false
France
French
package leaflet
summary of product characteristics
guidelines for drug use
administration, oral
morpholines
morpholines
pyrimidines
pyrimidines
pyrroles
pyrroles
pemigatinib
cholangiocarcinoma
adult
Locally Advanced Cholangiocarcinoma
Metastatic Cholangiocarcinoma
cholangiocarcinoma
receptor, fibroblast growth factor, type 2
gene rearrangement
gene fusion
recurrence
Recurrent Cholangiocarcinoma
Refractory Cholangiocarcinoma
receptor, fibroblast growth factor, type 2
FGFR Inhibitor
Tyrosine Kinase Inhibitors
pemigatinib
pemigatinib
---
https://ansm.sante.fr/tableau-atu-rtu/risdiplam-0-75-mg-ml-poudre-pour-solution-buvable
2021
false
false
false
France
French
package leaflet
summary of product characteristics
guidelines for drug use
risdiplam
azo compounds
azo compounds
pyrimidines
pyrimidines
administration, oral
neuromuscular agents
neuromuscular agents
5q spinal muscular atrophy
infant
child
spinal muscular atrophies of childhood
Product containing precisely risdiplam 750 microgram/1 milliliter conventional release
oral solution (clinical drug)
Risdiplam
Risdiplam
---
https://ansm.sante.fr/tableau-atu-rtu/upadacitinib-15-mg-et-30-mg-comprime-a-liberation-prolongee
2021
false
false
false
France
French
guidelines for drug use
summary of product characteristics
package leaflet
upadacitinib
upadacitinib
administration, oral
Delayed-Action preparations
upadacitinib
adult
adolescent
dermatitis, atopic
Janus Kinase Inhibitors
Janus Kinase Inhibitors
heterocyclic compounds, 3-ring
heterocyclic compounds, 3-ring
---
https://ansm.sante.fr/tableau-atu-rtu/xarelto-1-mg-ml-granules-pour-suspension-buvable
2021
false
false
false
France
French
guidelines for drug use
package leaflet
summary of product characteristics
Rivaroxaban
Rivaroxaban
---
https://ansm.sante.fr/tableau-atu-rtu/zolgensma-2-x-1013-genomes-de-vecteur-ml-solution-pour-perfusion
2021
false
true
false
France
French
Onasemnogene Abeparvovec
Onasemnogene Abeparvovec
summary of product characteristics
package leaflet
guidelines for drug use
onasemnogene abeparvovec
spinal muscular atrophies of childhood
HMN (Hereditary motor neuropathy) proximal type I
infusions, intravenous
onasemnogene abeparvovec-xioi
Zolgensma
biological products
recombinant fusion proteins
---
https://www.ema.europa.eu/medicines/human/EPAR/Ritemvia
2021
false
United Kingdom
English
French
syndication feed
Rituximab
Rituximab
biosimilar pharmaceuticals
Granulomatosis with Polyangiitis
microscopic polyangiitis
lymphoma, large B-Cell, diffuse
Rituximab 10mg/mL infusion concentrate 50mL vial (product)
antineoplastic agents
lymphoma, follicular
treatment outcome
infusions, intravenous
antigens, CD20
adult
aged
drug interactions
pregnancy
breast feeding
antineoplastic agents
drug therapy, combination
drug evaluation, preclinical
drug approval
rituximab
package leaflet
summary of product characteristics
drug evaluation
---
https://www.ema.europa.eu/en/medicines/human/EPAR/enhertu
2021
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
Trastuzumab Deruxtecan
Trastuzumab Deruxtecan
drug approval
europe
trastuzumab deruxtecan
Tyrosine Kinase Inhibitors
infusions, intravenous
antineoplastic agents
pregnancy
breast feeding
drug interactions
drug monitoring
adult
breast neoplasms
neoplasm metastasis
Unresectable Breast Carcinoma
aged
receptor, erbB-2
drug evaluation, preclinical
trastuzumab deruxtecan
trastuzumab deruxtecan
antineoplastic agents
camptothecin
immunoconjugates
antibodies, monoclonal, humanized
Trastuzumab
immunoconjugates
antibodies, monoclonal, humanized
Trastuzumab
---
https://www.ema.europa.eu/en/medicines/human/EPAR/pemazyre
2021
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
drug approval
europe
pemigatinib
orphan drug production
administration, oral
receptors, fibroblast growth factor
FGFR Inhibitor
FGFR Inhibitor
adult
antineoplastic agents
antineoplastic agents
cholangiocarcinoma
receptor, fibroblast growth factor, type 2
product surveillance, postmarketing
Locally Advanced Cholangiocarcinoma
Metastatic Cholangiocarcinoma
Refractory Cholangiocarcinoma
cholangiocarcinoma
FGFR2 Gene Rearrangement
FGFR2 Gene Fusion Positive
drug interactions
pregnancy
breast feeding
protein kinase inhibitors
protein kinase inhibitors
drug evaluation, preclinical
pemigatinib
pemigatinib
---
https://www.ema.europa.eu/en/medicines/human/EPAR/onivyde-pegylated-liposomal
2021
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
Metastatic Pancreatic Adenocarcinoma
neoplasm metastasis
Pegylated Liposomal Irinotecan
Pegylated Liposomal Irinotecan
liposomes
pancreatic neoplasms
irinotecan sucrosofate
irinotecan sucrosofate
antineoplastic agents
antineoplastic agents
pregnancy
breast feeding
drug interactions
antineoplastic combined chemotherapy protocols
fluorouracil
leucovorin
Fluorouracil/Liposomal Irinotecan/Leucovorin Regimen
orphan drug production
infusions, intravenous
topoisomerase I inhibitors
topoisomerase I inhibitors
aged
DNA topoisomerases, type I
survival analysis
drug evaluation, preclinical
drug approval
europe
Irinotecan hydrochloride trihydrate (substance)
adult
adenocarcinoma
camptothecin
camptothecin
drug combinations
sucrose
sucrose
camptothecin
drug combinations
sucrose
---
https://ansm.sante.fr/tableau-atu-rtu/voxzogo-0-4-mg-poudre-et-solvant-pour-solution-injectable-voxzogo-0-56-mg-poudre-et-solvant-pour-solution-injectable-voxzogo-1-2-mg-poudre-et-solvant-pour-solution-injectable
2021
false
false
false
France
French
guidelines for drug use
vosoritide
vosoritide
child
achondroplasia
package leaflet
vosoritide
natriuretic peptide, C-type
natriuretic peptide, C-type
natriuretic peptide, C-type
---
https://ansm.sante.fr/tableau-atu-rtu/ozawade-4-5-mg-18-mg-comprimes-pellicules
2021
false
false
false
France
French
guidelines for drug use
administration, oral
pitolisant
pitolisant
Excessive Daytime Sleepiness
sleep apnea, obstructive
adult
disorders of excessive somnolence
piperidines
piperidines
---
https://ansm.sante.fr/tableau-atu-rtu/onureg-200-mg-et-300-mg-comprime-pellicule
2021
false
false
false
France
French
administration, oral
azacitidine
azacitidine
guidelines for drug use
adult
leukemia, myeloid, acute
summary of product characteristics
package leaflet
drug monitoring
Product containing precisely azacitidine 200 milligram/1 each conventional release
oral tablet (clinical drug)
Product containing precisely azacitidine 300 milligram/1 each conventional release
oral tablet (clinical drug)
continuity of patient care
antimetabolites, antineoplastic
antimetabolites, antineoplastic
azacitidine
---
https://ansm.sante.fr/tableau-atu-rtu/adtralza-150-mg-solution-injectable-en-seringue-preremplie
2021
false
false
false
France
French
tralokinumab
tralokinumab
guidelines for drug use
summary of product characteristics
package leaflet
adult
dermatitis, atopic
antibodies, monoclonal
antibodies, monoclonal
---