Package leafletCISMeF resources Type

https://www.ema.europa.eu/en/medicines/human/EPAR/winrevair
2025
false
false
false
Netherlands
French
English
syndication feed
summary of product characteristics
package leaflet
drug evaluation
treatment outcome
sotatercept
sotatercept
orphan drug production
sotatercept
hypertension, pulmonary
injections, subcutaneous
drug approval
europe
adult
drug therapy, combination
activins
risk management
pregnancy
breast feeding
aged
drug evaluation, preclinical

---
https://www.ema.europa.eu/en/medicines/human/EPAR/eurneffy
2025
false
false
false
Netherlands
French
English
syndication feed
summary of product characteristics
package leaflet
drug evaluation
treatment outcome
epinephrine
epinephrine
drug approval
europe
epinephrine
emergency treatment
adult
child
adolescent
anaphylaxis
administration, intranasal
adrenergic agents
adrenergic agents
bronchodilator agents
bronchodilator agents
vasoconstrictor agents
vasoconstrictor agents
risk management
Product containing only epinephrine in nasal dose form (medicinal product form)
drug interactions
pregnancy
breast feeding

---
mResvia - Single-stranded 5' capped mRNA encoding the Respiratory syncytial virus glycoprotein F stabilized in the prefusion conformation
https://www.ema.europa.eu/en/medicines/human/EPAR/mresvia
2025
false
false
false
Netherlands
French
English
syndication feed
summary of product characteristics
package leaflet
drug evaluation
Single-stranded 5' capped mRNA encoding the Respiratory syncytial virus glycoprotein F stabilized in the prefusion conformation
mRNA Vaccines
respiratory syncytial virus infections
vaccination
respiratory syncytial virus vaccines
respiratory syncytial virus vaccines

---
https://www.ema.europa.eu/en/medicines/human/EPAR/balversa
2025
false
false
false
Netherlands
French
English
syndication feed
summary of product characteristics
package leaflet
drug evaluation
treatment outcome
erdafitinib
erdafitinib
erdafitinib
drug approval
europe
Balversa
Metastatic Urothelial Carcinoma
Unresectable Urothelial Carcinoma
urologic neoplasms
adult
urologic neoplasms
FGFR3 Gene Alteration Positive
administration, oral
continuity of patient care
Tyrosine Kinase Inhibitors
Tyrosine Kinase Inhibitors
FGFR Inhibitor
FGFR Inhibitor
risk management
product surveillance, postmarketing
drug interactions
pregnancy
breast feeding
Female of Childbearing Potential
antineoplastic agents
antineoplastic agents
drug evaluation, preclinical

---
https://www.ema.europa.eu/en/medicines/human/EPAR/piasky
2025
false
false
false
Netherlands
French
English
syndication feed
summary of product characteristics
package leaflet
drug evaluation
treatment outcome
Crovalimab
Crovalimab
crovalimab
drug approval
europe
antibodies, monoclonal, humanized
antibodies, monoclonal, humanized
adult
adolescent
paroxysmal nocturnal hemoglobinuria
infusions, intravenous
complement C5
complement inactivating agents
complement inactivating agents
risk management
product surveillance, postmarketing
injections, subcutaneous
drug interactions
pregnancy
breast feeding
drug evaluation, preclinical

---
https://www.ema.europa.eu/en/medicines/human/EPAR/tauvid
2025
false
false
false
Netherlands
French
English
syndication feed
summary of product characteristics
package leaflet
drug evaluation
(18F)flortaucipir
(18F)flortaucipir
drug approval
europe
7-(6-fluoropyridin-3-yl)-5H-pyrido(4,3-b)indole
7-(6-fluoropyridin-3-yl)-5H-pyrido(4,3-b)indole
flortaucipir (18F)
adult
Imaging of brain (procedure)
cerebrum
cognition disorders
alzheimer disease
Positron-Emission tomography
radionuclide imaging
injections, intravenous
radiopharmaceuticals
radiopharmaceuticals
risk management
product surveillance, postmarketing
pregnancy
breast feeding
Female of Childbearing Potential
tau proteins
drug evaluation, preclinical

---
https://www.ema.europa.eu/en/medicines/human/EPAR/akantior
2025
false
false
false
Netherlands
French
English
syndication feed
summary of product characteristics
package leaflet
drug evaluation
treatment outcome
polihexanide
polihexanide
orphan drug production
adult
adolescent
drug approval
europe
polihexanide
Product containing only polihexanide (medicinal product)
acanthamoeba keratitis
administration, ophthalmic
acanthamoeba
risk management
pregnancy
breast feeding
antiprotozoal agents
antiprotozoal agents
drug evaluation, preclinical

---
https://www.ema.europa.eu/en/medicines/human/EPAR/ordspono
2025
false
false
false
Netherlands
French
English
syndication feed
summary of product characteristics
package leaflet
drug evaluation
treatment outcome
Odronextamab
Odronextamab
odronextamab
drug approval
europe
Anti-CD20/Anti-CD3 Bispecific Antibody
Anti-CD20/Anti-CD3 Bispecific Antibody
antibodies, bispecific
antibodies, bispecific
Antineoplastic Agents, Immunological
Antineoplastic Agents, Immunological
adult
lymphoma, follicular
lymphoma, large B-Cell, diffuse
Recurrent Diffuse Large B-Cell Lymphoma
Refractory Diffuse Large B-Cell Lymphoma
Recurrent Follicular Lymphoma
Refractory Follicular Lymphoma
recurrence
Cytokine Release Syndrome
infusions, intravenous
risk management
product surveillance, postmarketing
continuity of patient care
pregnancy
breast feeding
antigens, CD20
CD3 Complex
drug evaluation, preclinical

---
https://www.ema.europa.eu/en/medicines/human/EPAR/enzalutamide-viatris
2025
false
false
false
Netherlands
French
English
syndication feed
summary of product characteristics
package leaflet
drug evaluation
treatment outcome
enzalutamide
enzalutamide
drugs, generic

---
https://www.ema.europa.eu/en/medicines/human/EPAR/nilotinib-accord
2025
false
false
false
Netherlands
French
English
syndication feed
summary of product characteristics
package leaflet
drug evaluation
treatment outcome
nilotinib
nilotinib
drugs, generic

---
https://www.ema.europa.eu/en/medicines/human/EPAR/wezenla
2025
false
false
false
Netherlands
French
English
syndication feed
summary of product characteristics
package leaflet
drug evaluation
treatment outcome
Ustekinumab
Ustekinumab
biosimilar pharmaceuticals

---
https://www.ema.europa.eu/en/medicines/human/EPAR/fruzaqla
2025
false
false
false
Netherlands
French
English
syndication feed
summary of product characteristics
package leaflet
drug evaluation
treatment outcome
fruquintinib
fruquintinib
administration, oral
drug approval
europe
VEGFR Tyrosine Kinase Inhibitor
fruquintinib
VEGFR Tyrosine Kinase Inhibitor
receptors, vascular endothelial growth factor
Tyrosine Kinase Inhibitors
Tyrosine Kinase Inhibitors
risk management
product surveillance, postmarketing
antineoplastic agents
antineoplastic agents
neoplasm metastasis
colorectal neoplasms
Metastatic Colorectal Carcinoma
Refractory Colorectal Carcinoma
adult
drug interactions
aged
pregnancy
breast feeding
drug evaluation, preclinical

---
https://www.ema.europa.eu/en/medicines/human/EPAR/tofidence
2025
false
false
false
Netherlands
French
English
syndication feed
summary of product characteristics
package leaflet
drug evaluation
treatment outcome
tocilizumab
tocilizumab
biosimilar pharmaceuticals

---
https://www.ema.europa.eu/en/medicines/human/EPAR/buprenorphine-neuraxpharm
2025
false
false
false
Netherlands
French
English
syndication feed
summary of product characteristics
package leaflet
drug evaluation
treatment outcome
buprenorphine
buprenorphine
risk management
drug approval
europe
buprenorphine
opiate substitution treatment
opioid-related disorders
adult
adolescent
administration, sublingual
Sublingual Film Dosage Form
Opioid Receptor Agonist
narcotic antagonists
drug interactions
pregnancy
breast feeding
prescription drug misuse
drug evaluation, preclinical

---
https://www.ema.europa.eu/en/medicines/human/EPAR/tuznue
2025
false
false
false
Netherlands
French
English
syndication feed
summary of product characteristics
package leaflet
drug evaluation
treatment outcome
Trastuzumab
Trastuzumab
biosimilar pharmaceuticals

---
https://www.ema.europa.eu/en/medicines/human/EPAR/vevizye
2025
false
false
false
Netherlands
French
English
syndication feed
summary of product characteristics
package leaflet
drug evaluation
treatment outcome
cyclosporine
cyclosporine
ciclosporin
drug approval
europe
risk management
administration, ophthalmic
keratoconjunctivitis sicca
Product containing only ciclosporin in ocular dose form (medicinal product form)
adult
pregnancy
breast feeding
Calcineurin Inhibitors
Calcineurin Inhibitors
drug evaluation, preclinical
ophthalmic solutions

---
https://www.ema.europa.eu/en/medicines/human/EPAR/ituxredi
2025
false
false
false
Netherlands
French
English
syndication feed
summary of product characteristics
package leaflet
drug evaluation
treatment outcome
Rituximab
Rituximab
biosimilar pharmaceuticals

---
https://www.ema.europa.eu/en/medicines/human/EPAR/epruvy
2025
false
false
false
Netherlands
French
English
syndication feed
summary of product characteristics
package leaflet
drug evaluation
treatment outcome
Ranibizumab
Ranibizumab
biosimilar pharmaceuticals

---
https://ansm.sante.fr/tableau-acces-derogatoire/ivosidenib
2025
false
false
false
France
French
administration, oral
summary of product characteristics
cholangiocarcinoma
guidelines for drug use
leukemia, myeloid, acute
glioma
myelodysplastic syndromes
antineoplastic agents
ivosidenib
ivosidenib
neoplasm metastasis
package leaflet
antineoplastic combined chemotherapy protocols

---
https://ansm.sante.fr/tableau-acces-derogatoire/jakavi-5-mg-comprime
2025
false
false
false
France
French
insurance, health, reimbursement
ruxolitinib phosphate
ruxolitinib
administration, oral
graft vs host disease
Steroid Refractory Graft Versus Host Disease
acute disease
chronic disease
pharmaceutical solutions
child
guidelines for drug use
summary of product characteristics
package leaflet
tablets

---
https://ansm.sante.fr/tableau-acces-derogatoire/rybrevant
2025
false
false
false
France
French
summary of product characteristics
amivantamab
Antineoplastic Agents, Immunological
amivantamab
advanced non-small cell lung cancer with activating epidermal growth factor receptor exon 20 insertion mutations
carcinoma, non-small-cell lung
guidelines for drug use
package leaflet
EGFR Exon 19 Deletion Mutation
EGFR NP_005219.2:p.L858R
EGFR Exon 20 Insertion Mutation

---
https://ansm.sante.fr/tableau-acces-derogatoire/imcivree#
2025
false
false
false
France
French
setmelanotide
adult
adolescent
child
obesity
obesity
bardet-biedl syndrome
continuity of patient care
drug monitoring
product surveillance, postmarketing
setmelanotide
injections, subcutaneous
guidelines for drug use
package leaflet
summary of product characteristics
technical report

---
https://ansm.sante.fr/tableau-acces-derogatoire/teclistamab
2025
false
false
false
France
French
drug information
Teclistamab
adult
multiple myeloma
Recurrent Multiple Myeloma
Refractory Multiple Myeloma
summary of product characteristics
package leaflet
antibodies, monoclonal
Antineoplastic Agents, Immunological
teclistamab

---
https://ansm.sante.fr/tableau-acces-derogatoire/enhertu-100-mg-poudre-pour-solution-a-diluer-pour-perfusion
2025
false
false
false
France
French
summary of product characteristics
package leaflet
guidelines for drug use
Metastatic Gastric Adenocarcinoma
stomach neoplasms
adenocarcinoma
neoplasm metastasis
Locally Advanced Gastric Adenocarcinoma
Metastatic Gastroesophageal Junction Adenocarcinoma
Locally Advanced Gastroesophageal Junction Adenocarcinoma
HER2/Neu Positive
trastuzumab deruxtecan
infusions, intravenous
trastuzumab deruxtecan
Antineoplastic Agents, Immunological
breast neoplasms
Metastatic HER2-Positive Breast Carcinoma
Unresectable HER2-Positive Breast Carcinoma
Refractory HER2-Positive Breast Carcinoma
HER2-Low Breast Carcinoma
Metastatic HER2-Low Breast Carcinoma
neoplasm recurrence, local

---
https://ansm.sante.fr/tableau-acces-derogatoire/imfinzi-50-mg-ml-solution-a-diluer-pour-perfusion
2025
false
false
false
France
French
summary of product characteristics
package leaflet
durvalumab
guidelines for drug use
Unresectable Biliary Tract Carcinoma
antineoplastic combined chemotherapy protocols
Metastatic Biliary Tract Carcinoma
durvalumab
adult
Cisplatin/Durvalumab/Gemcitabine Regimen
infusions, intravenous
cisplatin
carcinoma, hepatocellular
carcinoma, non-small-cell lung
small cell lung carcinoma
bronchial neoplasms

---
https://ansm.sante.fr/tableau-marr/rivaroxaban
2025
false
false
false
France
French
Rivaroxaban
risk management
guidelines for drug use
continuity of patient care
administration, oral
medication errors
hemorrhage
Drug-Related side effects and adverse reactions
Rivaroxaban
package leaflet
video recording

---
https://www.ema.europa.eu/en/medicines/human/EPAR/axitinib-accord
2025
false
false
false
Netherlands
French
English
syndication feed
summary of product characteristics
package leaflet
drug evaluation
treatment outcome
Axitinib
Axitinib
drugs, generic

---
https://www.ema.europa.eu/en/medicines/human/EPAR/loqtorzi
2025
false
false
false
Netherlands
French
English
syndication feed
summary of product characteristics
package leaflet
drug evaluation
treatment outcome
toripalimab
toripalimab

---
https://www.ema.europa.eu/en/medicines/human/EPAR/anzupgo
2025
false
false
false
Netherlands
French
English
syndication feed
summary of product characteristics
package leaflet
drug evaluation
treatment outcome
delgocitinib
delgocitinib

---
https://www.ema.europa.eu/en/medicines/human/EPAR/vyloy
2025
false
false
false
Netherlands
French
English
syndication feed
summary of product characteristics
package leaflet
drug evaluation
treatment outcome
zolbetuximab
zolbetuximab
orphan drug production

---
https://www.ema.europa.eu/en/medicines/human/EPAR/kayfanda
2025
false
false
false
Netherlands
French
English
syndication feed
summary of product characteristics
package leaflet
drug evaluation
treatment outcome
odevixibat
odevixibat

---
https://www.ema.europa.eu/en/medicines/human/EPAR/iqirvo
2025
false
false
false
Netherlands
French
English
syndication feed
summary of product characteristics
package leaflet
drug evaluation
treatment outcome
administration, oral
elafibranor
elafibranor
orphan drug production

---
https://www.ema.europa.eu/en/medicines/human/EPAR/hympavzi
2025
false
false
false
Netherlands
French
English
syndication feed
summary of product characteristics
package leaflet
drug evaluation
treatment outcome
marstacimab
marstacimab

---
https://www.ema.europa.eu/en/medicines/human/EPAR/truqap
2025
false
false
false
Netherlands
French
English
syndication feed
summary of product characteristics
package leaflet
drug evaluation
treatment outcome
capivasertib
capivasertib

---
https://www.ema.europa.eu/en/medicines/human/EPAR/altuvoct
2025
false
false
false
Netherlands
French
English
syndication feed
summary of product characteristics
package leaflet
drug evaluation
treatment outcome
Efanesoctocog Alfa
Efanesoctocog Alfa
orphan drug production

---
Flucelvax - influenza vaccine (surface antigen, inactivated, prepared in cell cultures)
https://www.ema.europa.eu/en/medicines/human/EPAR/flucelvax
2025
false
false
false
Netherlands
French
English
syndication feed
summary of product characteristics
package leaflet
drug evaluation
treatment outcome
antigens, surface
influenza, human
influenza vaccines
vaccines, inactivated
Antigen of Influenza virus surface protein (substance)

---
https://www.ema.europa.eu/en/medicines/human/EPAR/elahere
2025
false
false
false
Netherlands
French
English
syndication feed
summary of product characteristics
package leaflet
drug evaluation
treatment outcome
mirvetuximab soravtansine
mirvetuximab soravtansine

---
https://www.ema.europa.eu/en/medicines/human/EPAR/pomalidomide-teva
2025
false
false
false
Netherlands
French
English
syndication feed
summary of product characteristics
package leaflet
drug evaluation
drugs, generic
treatment outcome
pomalidomide
pomalidomide

---
https://www.ema.europa.eu/en/medicines/human/EPAR/alhemo
2025
false
false
false
Netherlands
French
English
syndication feed
summary of product characteristics
package leaflet
drug evaluation
treatment outcome
concizumab
concizumab

---
https://www.ema.europa.eu/en/medicines/human/EPAR/afqlir
2025
false
false
false
Netherlands
French
English
syndication feed
summary of product characteristics
package leaflet
drug evaluation
treatment outcome
aflibercept
aflibercept
biosimilar pharmaceuticals

---
https://www.ema.europa.eu/en/medicines/human/EPAR/opuviz
2025
false
false
false
Netherlands
French
English
syndication feed
summary of product characteristics
package leaflet
drug evaluation
treatment outcome
aflibercept
aflibercept
biosimilar pharmaceuticals

---
https://www.ema.europa.eu/en/medicines/human/EPAR/eltrombopag-viatris
2025
false
false
false
Netherlands
French
English
syndication feed
summary of product characteristics
package leaflet
drug evaluation
treatment outcome
eltrombopag
eltrombopag
drugs, generic

---
https://www.ema.europa.eu/en/medicines/human/EPAR/imuldosa
2025
false
false
false
Netherlands
French
English
syndication feed
summary of product characteristics
package leaflet
drug evaluation
treatment outcome
Ustekinumab
Ustekinumab
biosimilar pharmaceuticals

---
https://www.ema.europa.eu/en/medicines/human/EPAR/absimky
2025
false
false
false
Netherlands
French
English
syndication feed
summary of product characteristics
package leaflet
drug evaluation
treatment outcome
Ustekinumab
Ustekinumab
biosimilar pharmaceuticals

---
https://www.ema.europa.eu/en/medicines/human/EPAR/eksunbi
2025
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
Ustekinumab
Ustekinumab
biosimilar pharmaceuticals

---
Fluenz - influenza vaccine (live attenuated, nasal)
https://www.ema.europa.eu/en/medicines/human/EPAR/fluenz
2025
false
false
false
France
French
English
syndication feed
summary of product characteristics
package leaflet
drug evaluation
influenza, human
influenza vaccines
vaccination
Trivalent Live-Attenuated Influenza Vaccine

---
GalliaPharm - Gallium (68Ga) chloride / Germanium (68Ge) chloride
https://www.ema.europa.eu/en/medicines/human/EPAR/galliapharm
2025
false
false
false
Netherlands
French
English
syndication feed
summary of product characteristics
package leaflet
drug evaluation
radionuclide generators
Gallium (68Ga) chloride
Positron-Emission tomography
Positron Emission Tomography with Radiolabeled Targeting Agent
Radioisotopic Labeling

---
https://www.ema.europa.eu/en/medicines/human/EPAR/agilus
2025
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
drug approval
europe
dantrolene
Dantrolene sodium, hemiheptahydrate
Dantrolene sodium, hemiheptahydrate
dantrolene
dantrolene
malignant hyperthermia
muscle relaxants, central
muscle relaxants, central
injections, intravenous
risk management
drug interactions
pregnancy
breast feeding
ryanodine receptor 1
ryanodine receptor calcium release channel
drug evaluation, preclinical

---
https://ansm.sante.fr/tableau-acces-derogatoire/zanidatamab
2025
false
false
false
France
French
infusions, intravenous
zanidatamab
drug information
summary of product characteristics
package leaflet
adult
biliary tract neoplasms
HER2 positive biliary tract cancer
HER2/Neu Expression by Immunohistochemistry 3+
zanidatamab
Locally Advanced Bile Duct Carcinoma
Metastatic Bile Duct Carcinoma
Unresectable Bile Duct Carcinoma
guidelines for drug use

---
https://ansm.sante.fr/tableau-acces-derogatoire/nirogacestat
2025
false
false
false
France
French
administration, oral
nirogacestat
ogsiveo
summary of product characteristics
package leaflet
guidelines for drug use
Desmoid Tumors
Refractory Desmoid Fibromatosis
nirogacestat

---
https://ansm.sante.fr/tableau-acces-derogatoire/vyjuvek
2025
false
false
false
France
French
insurance, health, reimbursement
Beremagene Geperpavec
beremagene geperpavec
drug information
continuity of patient care
guidelines for drug use
administration, cutaneous
epidermolysis bullosa dystrophica
epidermolysis bullosa dystrophica
infant
child
COL7A1 Gene Mutation
summary of product characteristics
package leaflet
gene therapy

---
https://ansm.sante.fr/actualites/decision-du-07-02-2025-portant-exoneration-a-la-reglementation-des-substances-veneneuses-destinees-a-la-medecine-humaine
2025
false
false
false
France
French
desloratadine
legislation, pharmacy
drug information
summary of product characteristics
package leaflet

---
https://www.ema.europa.eu/en/medicines/human/EPAR/penbraya
2025
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation

---
Vimkunya - Chikungunya vaccine (recombinant, adsorbed)
https://www.ema.europa.eu/en/medicines/human/EPAR/vimkunya
2025
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
drug approval
europe
Chikungunya Fever
vaccination
injections, intramuscular
vaccines, Virus-Like particle
vaccines, Virus-Like particle
Chikungunya virus virus-like particle
adjuvants, immunologic
Aluminium hydroxide hydrate (substance)
adolescent
adult
Immunogenicity, Vaccine
vaccine potency
pregnancy
drug evaluation, preclinical

---
https://www.ema.europa.eu/en/medicines/human/EPAR/paxneury
2025
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
drug approval
europe
guanfacine
guanfacine
attention deficit disorder with hyperactivity
child
adolescent
Attention deficit disorder of childhood without mention of hyperactivity
drugs, generic
continuity of patient care
administration, oral
tablets
Product containing only guanfacine in oral dose form (medicinal product form)
guanfacine hydrochloride
guanfacine hydrochloride
Delayed-Action preparations
Product containing precisely guanfacine (as guanfacine hydrochloride) 1 milligram/1 each prolonged-release oral tablet (clinical drug)
Product containing precisely guanfacine (as guanfacine hydrochloride) 2 milligram/1 each prolonged-release oral tablet (clinical drug)
Product containing precisely guanfacine (as guanfacine hydrochloride) 3 milligram/1 each prolonged-release oral tablet (clinical drug)
Product containing precisely guanfacine (as guanfacine hydrochloride) 4 milligram/1 each prolonged-release oral tablet (clinical drug)
drug monitoring
product surveillance, postmarketing
drug interactions
drug evaluation, preclinical
receptor, adrenergic, alpha-2A
Alpha-2 adrenergic receptor agonist (disposition)

---
https://www.ema.europa.eu/en/medicines/human/EPAR/lazcluze
2025
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
lazertinib
lazertinib
drug approval
europe
Tyrosine Kinase Inhibitors
Tyrosine Kinase Inhibitors
lazertinib
Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor
Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor
adult
carcinoma, non-small-cell lung
antineoplastic agents
antineoplastic agents
carcinoma, non-small-cell lung
mutation
EGFR Exon 19 Deletion Mutation
EGFR NP_005219.2:p.L858R
antineoplastic combined chemotherapy protocols
amivantamab
Amivantamab/Lazertinib Regimen
administration, oral
Drug-Related side effects and adverse reactions
venous thromboembolism
EGF Receptors
product surveillance, postmarketing
drug interactions
pregnancy
breast feeding
Lazertinib Mesylate Monohydrate
Lazertinib Mesylate Monohydrate
drug evaluation, preclinical

---
https://www.ema.europa.eu/en/medicines/human/EPAR/kavigale
2025
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
Sipavibart
drug approval
europe
Sipavibart
sipavibart
adolescent
adult
immunocompromised host
COVID-19
infusions, intravenous
injections, intramuscular
Anti-spike Protein SARS-CoV-2 Monoclonal Antibody
antibodies, monoclonal
antibodies, monoclonal
product surveillance, postmarketing
Pre-Exposure Prophylaxis

---
https://www.ema.europa.eu/en/medicines/human/EPAR/yesintek
2025
false
false
false
Netherlands
French
English
Ustekinumab
Ustekinumab
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation

---
Siiltibcy - Mycobacterium tuberculosis derived antigens (rdESAT-6 / rCFP-10)
https://www.ema.europa.eu/en/medicines/human/EPAR/siiltibcy
2025
false
false
false
Netherlands
French
English
syndication feed
summary of product characteristics
package leaflet
drug evaluation
rdESAT-6
rCFP-10
Mycobacterium tuberculosis, antigen ESAT6, fused with Mycobacterium tuberculosis, antigen CFP10
ESAT-6 protein, mycobacterium tuberculosis
CFP-10 protein, mycobacterium tuberculosis
bacterial proteins
recombinant proteins
antigens, bacterial
mycobacterium tuberculosis
tuberculosis
infant
child
adolescent
adult
drug approval
europe
injections, intradermal
skin tests
drug evaluation, preclinical

---
https://www.ema.europa.eu/en/medicines/human/EPAR/baiama
2025
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
aflibercept
aflibercept

---
https://www.ema.europa.eu/en/medicines/human/EPAR/gohibic
2025
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
vilobelimab
vilobelimab
drug approval
europe
vilobelimab
antibodies, monoclonal
antibodies, monoclonal
complement inactivating agents
complement inactivating agents
COVID-19
COVID-19-Associated Acute Respiratory Distress Syndrome
Respiratory Distress Syndrome
infusions, intravenous
product surveillance, postmarketing
complement C5a
adult
drug evaluation, preclinical
pregnancy
breast feeding

---
https://www.ema.europa.eu/en/medicines/human/EPAR/augtyro
2025
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
repotrectinib
repotrectinib
antineoplastic agents
antineoplastic agents
drug approval
europe
repotrectinib
adult
Tyrosine Kinase Inhibitors
Tyrosine Kinase Inhibitors
carcinoma, non-small-cell lung
carcinoma, non-small-cell lung
ROS1 Fusion Gene Positive
Advanced Lung Non-Small Cell Carcinoma
adolescent
NTRK Fusion Gene Positive
Solid Neoplasm
Solid Neoplasm
administration, oral
product surveillance, postmarketing
drug interactions
pregnancy
breast feeding
Anaplastic Lymphoma Kinase
ROS1 protein, human
receptor, trkc
receptor, trkb
receptor, trka
drug evaluation, preclinical

---
https://www.ema.europa.eu/en/medicines/human/EPAR/ahzantive
2025
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
aflibercept
aflibercept

---
https://www.ema.europa.eu/en/medicines/human/EPAR/eydenzelt
2025
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
aflibercept
aflibercept

---
https://www.ema.europa.eu/en/medicines/human/EPAR/emcitate
2025
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
3,3',5-triiodothyroacetic acid
3,3',5-triiodothyroacetic acid
orphan drug production
tiratricol
drug approval
europe
triiodothyronine
thyrotoxicosis
Allan-Herndon-Dudley Syndrome
administration, oral
drug interactions
pregnancy
breast feeding
drug evaluation, preclinical

---
https://www.ema.europa.eu/en/medicines/human/EPAR/zefylti
2025
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
Filgrastim
Filgrastim

---
https://www.ema.europa.eu/en/medicines/human/EPAR/obodence
2025
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
Denosumab
Denosumab

---
https://www.ema.europa.eu/en/medicines/human/EPAR/nemluvio
2025
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
nemolizumab
nemolizumab
drug approval
europe
nemolizumab
adult
adolescent
dermatitis, atopic
antibodies, monoclonal, humanized
antibodies, monoclonal, humanized
Prurigo nodularis (disorder)
injections, subcutaneous
product surveillance, postmarketing
drug interactions
pregnancy
breast feeding
IL31RA protein, human
receptors, interleukin
drug evaluation, preclinical

---
https://www.ema.europa.eu/en/medicines/human/EPAR/korjuny
2025
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
catumaxomab
catumaxomab
catumaxomab
drug approval
europe
product surveillance, postmarketing
antibodies, bispecific
antibodies, bispecific
Malignant Peritoneal Effusion
ascites
EPCAM protein, human
Epithelial Cell Adhesion Molecule
Intra-Abdominal infusions
T-cell Engaging Bispecific Antibody
adult
pregnancy
breast feeding
CD3 Complex

---
https://www.ema.europa.eu/en/medicines/human/EPAR/andembry
2025
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
Garadacimab
Garadacimab
drug approval
europe
garadacimab
angioedemas, hereditary
adult
adolescent
Hereditary angioedema attack
injections, subcutaneous
risk management
product surveillance, postmarketing
antibodies, monoclonal
antibodies, monoclonal
pregnancy
breast feeding
factor xiia
drug evaluation, preclinical

---
https://www.ema.europa.eu/en/medicines/human/EPAR/beyonttra
2025
false
false
false
Netherlands
French
English
syndication feed
summary of product characteristics
package leaflet
treatment outcome
Acoramidis
Acoramidis
Acoramidis Hydrochloride
Acoramidis Hydrochloride
acoramidis
drug approval
europe
product surveillance, postmarketing
administration, oral
amyloidosis, hereditary, Transthyretin-Related
Hereditary ATTR amyloidosis
Wild type ATTR amyloidosis
adult
amyloidosis
cardiomyopathies
drug interactions
Pharmacological Chaperone
drug evaluation, preclinical

---
https://www.ema.europa.eu/en/medicines/human/EPAR/rytelo
2025
false
false
false
Netherlands
French
English
syndication feed
summary of product characteristics
package leaflet
drug evaluation
treatment outcome
Imetelstat Sodium
Imetelstat Sodium
imetelstat
imetelstat
drug approval
europe
imetelstat
myelodysplastic syndromes
anemia
adult
orphan drug production
infusions, intravenous
Telomerase Inhibitor
Telomerase Inhibitor
telomerase
product surveillance, postmarketing
Antisense Oligonucleotides
drug evaluation, preclinical

---
https://www.ema.europa.eu/en/medicines/human/EPAR/wainzua
2025
false
false
false
Netherlands
French
English
syndication feed
summary of product characteristics
package leaflet
drug evaluation
treatment outcome
eplontersen
eplontersen
drug approval
europe
eplontersen
amyloidosis, hereditary, Transthyretin-Related
adult
injections, subcutaneous
oligonucleotides, antisense
oligonucleotides, antisense
risk management
eplontersen sodium
eplontersen sodium
product surveillance, postmarketing
pregnancy
breast feeding
Female of Childbearing Potential
drug evaluation, preclinical

---
https://www.ema.europa.eu/en/medicines/human/EPAR/hetronifly
2025
false
false
false
Netherlands
French
English
syndication feed
summary of product characteristics
package leaflet
drug evaluation
treatment outcome
Serplulimab
Serplulimab
drug approval
europe
antibodies, monoclonal
antibodies, monoclonal
serplulimab
small cell lung carcinoma
neoplasm metastasis
adult
Antineoplastic Agents, Immunological
Antineoplastic Agents, Immunological
antineoplastic combined chemotherapy protocols
carboplatin
etoposide
infusions, intravenous
programmed cell death 1 receptor
risk management
product surveillance, postmarketing
Extensive Stage Lung Small Cell Carcinoma
pregnancy
breast feeding
Female of Childbearing Potential
drug evaluation, preclinical

---
Ixchiq - Chikungunya vaccine (live)
https://www.ema.europa.eu/en/medicines/human/EPAR/ixchiq
2025
false
false
false
Netherlands
French
English
syndication feed
summary of product characteristics
package leaflet
drug evaluation
vaccine potency
Immunogenicity, Vaccine
Chikungunya vaccine (live)
Chikungunya Fever
vaccination
Chikungunya virus, strain delta5nsP3, live attenuated
chikungunya virus
injections, intramuscular
viral vaccines
risk management
product surveillance, postmarketing
adolescent
adult
drug approval
europe
drug interactions
pregnancy
breast feeding
drug evaluation, preclinical

---
https://www.ema.europa.eu/en/medicines/human/EPAR/yuvanci
2025
false
false
false
Netherlands
French
English
syndication feed
summary of product characteristics
package leaflet
drug evaluation
treatment outcome
drug combinations
macitentan
macitentan
macitentan and tadalafil
Tadalafil
Tadalafil
drug approval
europe
adult
hypertension, pulmonary
Endothelin A Receptor Antagonists
Endothelin B Receptor Antagonists
phosphodiesterase 5 inhibitors
administration, oral
drug interactions
pregnancy
breast feeding
drug evaluation, preclinical

---
https://www.ema.europa.eu/en/medicines/human/EPAR/obgemsa
2025
false
false
false
Netherlands
French
English
syndication feed
summary of product characteristics
package leaflet
drug evaluation
treatment outcome
vibegron
vibegron
drug approval
europe
vibegron
urinary bladder, overactive
adult
administration, oral
product surveillance, postmarketing
pregnancy
breast feeding
adrenergic beta-3 receptor agonists
adrenergic beta-3 receptor agonists
drug evaluation, preclinical

---
https://www.ema.europa.eu/en/medicines/human/EPAR/eribulin-baxter
2025
false
false
false
Netherlands
French
English
syndication feed
summary of product characteristics
package leaflet
drug evaluation
treatment outcome
eribulin mesylate
eribulin mesylate
drugs, generic

---
https://www.ema.europa.eu/en/medicines/human/EPAR/pomalidomide-accord
2025
false
false
false
Netherlands
French
English
syndication feed
summary of product characteristics
package leaflet
drug evaluation
treatment outcome
pomalidomide
pomalidomide
drugs, generic

---
https://www.ema.europa.eu/en/medicines/human/EPAR/avzivi
2025
false
false
false
Netherlands
French
English
syndication feed
summary of product characteristics
package leaflet
drug evaluation
treatment outcome
Bevacizumab
Bevacizumab
biosimilar pharmaceuticals

---
https://www.ema.europa.eu/en/medicines/human/EPAR/dasatinib-accord-healthcare
2025
false
false
false
Netherlands
French
English
syndication feed
summary of product characteristics
package leaflet
drug evaluation
treatment outcome
Dasatinib
Dasatinib
drugs, generic

---
https://www.ema.europa.eu/en/medicines/human/EPAR/fymskina
2025
false
false
false
Netherlands
French
English
syndication feed
summary of product characteristics
package leaflet
drug evaluation
treatment outcome
Ustekinumab
Ustekinumab
biosimilar pharmaceuticals

---
https://www.ema.europa.eu/en/medicines/human/EPAR/otulfi
2025
false
false
false
Netherlands
French
English
syndication feed
summary of product characteristics
package leaflet
drug evaluation
treatment outcome
Ustekinumab
Ustekinumab
biosimilar pharmaceuticals

---
https://www.ema.europa.eu/en/medicines/human/EPAR/pomalidomide-krka
2025
false
false
false
Netherlands
French
English
syndication feed
summary of product characteristics
package leaflet
drug evaluation
treatment outcome
pomalidomide
pomalidomide
drugs, generic

---
https://www.ema.europa.eu/en/medicines/human/EPAR/cejemly
2025
false
false
false
Netherlands
French
English
syndication feed
summary of product characteristics
package leaflet
drug evaluation
treatment outcome
sugemalimab
sugemalimab
drug approval
europe
sugemalimab
antibodies, monoclonal, humanized
antibodies, monoclonal, humanized
Antineoplastic Agents, Immunological
Antineoplastic Agents, Immunological
adult
neoplasm metastasis
carcinoma, non-small-cell lung
antineoplastic combined chemotherapy protocols
infusions, intravenous
PD-L1 Inhibitors
PD-L1 Inhibitors
product surveillance, postmarketing
ALK Gene Alteration Negative
RET Gene Alteration Negative
ROS1 Gene Alteration Negative
Sensitizing EGFR Mutation Negative
drug interactions
pregnancy
breast feeding
drug evaluation, preclinical

---
https://www.ema.europa.eu/en/medicines/human/EPAR/zegalogue
2025
false
false
false
Netherlands
French
English
syndication feed
summary of product characteristics
package leaflet
drug evaluation
treatment outcome
dasiglucagon
dasiglucagon
dasiglucagon
drug approval
europe
glucagon
zegalogue
hypoglycemia
adult
child
adolescent
diabetes mellitus
injections, subcutaneous
product surveillance, postmarketing
drug interactions
pregnancy
breast feeding
drug evaluation, preclinical

---
https://www.ema.europa.eu/en/medicines/human/EPAR/beqvez
2025
false
false
false
Netherlands
French
English
syndication feed
summary of product characteristics
package leaflet
drug evaluation
treatment outcome
Fidanacogene Elaparvovec
Fidanacogene Elaparvovec
fidanacogene elaparvovec
drug approval
europe
Gene Therapy Agents
Gene Therapy Agents
hemophilia B
infusions, intravenous
continuity of patient care
Infusion-Related Reaction
factor IX
product surveillance, postmarketing
risk management
drug interactions
Female of Childbearing Potential
pregnancy
breast feeding
drug evaluation, preclinical
adult

---
https://www.ema.europa.eu/en/medicines/human/EPAR/pomalidomide-zentiva
2025
false
false
false
Netherlands
French
English
syndication feed
summary of product characteristics
package leaflet
drug evaluation
treatment outcome
pomalidomide
pomalidomide

---
https://www.ema.europa.eu/en/medicines/human/EPAR/apexelsin
2025
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
paclitaxel
paclitaxel

---
https://www.ema.europa.eu/en/medicines/human/EPAR/theralugand
2025
false
false
false
Netherlands
French
English
syndication feed
summary of product characteristics
package leaflet
drug evaluation
Lutetium (177Lu) chloride
Lutetium-177
Radioisotopic Labeling
drug approval
europe
risk management
Precursor Radiopharmaceutical Dosage Form

---
https://ansm.sante.fr/tableau-acces-derogatoire/jemperli
2024
false
false
false
France
French
summary of product characteristics
package leaflet
dostarlimab
guidelines for drug use
antineoplastic agents
infusions, intravenous
antineoplastic combined chemotherapy protocols
carboplatin
paclitaxel
Carboplatin/Dostarlimab/Paclitaxel Regimen
adult
endometrial neoplasms
Recurrent Endometrial Carcinoma
Advanced Endometrial Carcinoma

---
https://ansm.sante.fr/actualites/quelle-information-sur-les-dispositifs-medicaux-contenant-du-cobalt
2024
false
false
false
France
French
product surveillance, postmarketing
equipment and supplies note
cobalt
Product containing cobalt (medicinal product)
medical devices
summary of product characteristics
package leaflet

---
https://ansm.sante.fr/tableau-acces-derogatoire/niraparib-acetate-dabiraterone
2024
false
false
false
France
French
summary of product characteristics
package leaflet
drug combinations
administration, oral
Abiraterone Acetate/Niraparib
Abiraterone Acetate
niraparib
antineoplastic agents
guidelines for drug use
antineoplastic combined chemotherapy protocols
metastatic castration resistant prostate cancer
prostatic neoplasms, Castration-Resistant
niraparib and abiraterone

---
https://ansm.sante.fr/tableau-acces-derogatoire/bylvay
2024
false
false
false
France
French
insurance, health, reimbursement
odevixibat
odevixibat
summary of product characteristics
package leaflet
guidelines for drug use
infant
child
pruritus
cholestatic pruritus in Alagille syndrome
alagille syndrome

---
https://ansm.sante.fr/tableau-acces-derogatoire/concizumab
2024
false
false
false
France
French
concizumab
guidelines for drug use
summary of product characteristics
package leaflet
technical report
hemophilia A
hemophilia B
hemorrhage
adolescent

---
https://ansm.sante.fr/tableau-acces-derogatoire/dabrafenib
2024
false
false
false
France
French
dabrafenib
drug information
guidelines for drug use
administration, oral
summary of product characteristics
package leaflet
Disintegrating Tablet Dosage Form
glioma
dabrafenib
child
BRAF Inhibitor
infant

---
https://ansm.sante.fr/tableau-acces-derogatoire/trametinib
2024
false
false
false
France
French
summary of product characteristics
package leaflet
administration, oral
Powder for Oral Solution Dosage Form
child
guidelines for drug use
trametinib
trametinib
drug information
glioma
BRAF Inhibitor

---
https://www.ema.europa.eu/en/medicines/human/EPAR/vueway
2024
false
false
false
Netherlands
French
English
syndication feed
summary of product characteristics
package leaflet
drug evaluation
gadopiclenol
contrast media
gadopiclenol
drug approval
europe
gadopiclenol
magnetic resonance imaging
adult
child
product surveillance, postmarketing
central nervous system
liver
kidney
pancreas
lung
prostate
breast
musculoskeletal system
Gadolinium Enhancement
injections, intravenous
pregnancy
breast feeding

---
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://ansm.sante.fr/tableau-acces-derogatoire/scemblix-20-mg-40-mg-comprimes-pellicules
2024
false
false
false
France
French
asciminib
administration, oral
guidelines for drug use
asciminib
protein kinase inhibitors
summary of product characteristics
package leaflet
leukemia, lymphocytic, acute, L2
leukemia, lymphocytic, acute, L2
mutation
T315I mutation
leukemia, myelogenous, chronic, bcr-abl positive
leukemia, myelogenous, chronic, bcr-abl positive

---
https://ansm.sante.fr/tableau-acces-derogatoire/dupixent
2024
false
false
false
France
French
summary of product characteristics
package leaflet
injections, subcutaneous
dupilumab
adult
Prurigo nodularis (disorder)
guidelines for drug use
prurigo
dupilumab
dermatitis, atopic
child

---
https://ansm.sante.fr/tableau-acces-derogatoire/breyanzi
2024
false
false
false
France
French
Lisocabtagene Maraleucel
Product containing only lisocabtagene maraleucel in parenteral dose form (medicinal product form)
summary of product characteristics
package leaflet
guidelines for drug use
lymphoma, large B-Cell, diffuse
adult
Recurrent High Grade B-Cell Lymphoma
Refractory High Grade B-Cell Lymphoma
Recurrent Primary Mediastinal Large B-Cell Lymphoma
Refractory Primary Mediastinal Large B-Cell Lymphoma
Refractory Diffuse Large B-Cell Lymphoma
Recurrent Diffuse Large B-Cell Lymphoma
infusions, intravenous
continuity of patient care
immunotherapy, adoptive
antigens, CD19
lisocabtagene maraleucel

---
https://ansm.sante.fr/tableau-acces-derogatoire/ciclograft-20mg-ml-collyre-en-solution-en-recipient-unidose
2024
false
false
false
false
France
French
package leaflet
cyclosporine
administration, ophthalmic
guidelines for drug use
corneal transplantation
graft rejection
summary of product characteristics

---
https://www.ema.europa.eu/en/medicines/human/EPAR/libmyris
2024
false
false
false
Netherlands
French
English
Adalimumab
Adalimumab
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
biosimilar pharmaceuticals
drug approval
europe
injections, subcutaneous
drug interactions
pregnancy
breast feeding
arthritis, psoriatic
psoriasis
hidradenitis suppurativa
crohn disease
panuveitis
arthritis, rheumatoid
colitis, ulcerative
uveitis, posterior
uveitis, intermediate
Chronic anterior uveitis (disorder)
spondylitis, ankylosing
arthritis, juvenile
adalimumab
Tumor Necrosis Factor Inhibitors
Tumor Necrosis Factor Inhibitors

---
2024
false
false
false
France
French
osimertinib
summary of product characteristics
package leaflet
guidelines for drug use
administration, oral
carcinoma, non-small-cell lung
carcinoma, non-small-cell lung
mutation
bronchial neoplasms
bronchial neoplasms
EGF Receptors
antineoplastic agents
antineoplastic agents
protein kinase inhibitors
protein kinase inhibitors
osimertinib
EGFR NP_005219.2:p.L858R
EGFR Exon 19 Deletion Mutation
ErbB Receptors
acrylamides
aniline compounds

---
https://ansm.sante.fr/tableau-marr/ranibizumab
2024
false
false
false
France
French
risk management
Ranibizumab
Ranibizumab
patients guideline
intravitreal injections
patient education handout
package leaflet
ranibizumab

---
https://www.ema.europa.eu/medicines/human/EPAR/Metalyse
2024
false
United Kingdom
French
English
syndication feed
Acute cerebrovascular accident due to ischemia (disorder)
Ischemic Stroke
myocardial infarction
thrombolytic therapy
tissue plasminogen activator
tissue plasminogen activator
tissue plasminogen activator
tissue plasminogen activator
fibrinolytic agents
fibrinolytic agents
fibrinolytic agents
fibrinolytic agents
treatment outcome
drug evaluation
injections, intravenous
tenecteplase
tissue plasminogen activator
drug evaluation
summary of product characteristics
package leaflet
tissue plasminogen activator
Tenecteplase
Tenecteplase

---
https://ansm.sante.fr/tableau-atu-rtu/kymriah-1-2-x-106-6-x-108-cellules-dispersion-pour-perfusion
2024
false
false
false
France
French
guidelines for drug use
summary of product characteristics
package leaflet
tisagenlecleucel
tisagenlecleucel
lymphoma, follicular
adult
Refractory Follicular Lymphoma
Recurrent Follicular Lymphoma
tisagenlecleucel
risk management
infusions, intravenous
antineoplastic agents
antineoplastic agents
patients guideline

---
https://ansm.sante.fr/tableau-marr/thalidomide
2024
false
false
false
France
French
risk management
thalidomide
teratogens
abnormalities, drug-induced
pregnancy
thalidomide
guideline
forms
patient education handout
continuity of patient care
Neuropathy peripheral
thromboembolism
Drug-Related side effects and adverse reactions
pregnancy tests
contraception
package leaflet

---
https://ansm.sante.fr/actualites/lansm-publie-son-rapport-dhemovigilance-de-lannee-2023
2024
false
false
false
France
French
blood safety
france
hemovigilance
technical report
summary of product characteristics
package leaflet

---
https://www.ema.europa.eu/en/medicines/human/EPAR/adzynma
2024
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
orphan drug production
child
adult
congenital thrombotic thrombocytopenic purpura
enzyme replacement therapy
ADAMTS13 protein, human
recombinant proteins
ADAMTS13 Protein
ADAMTS13 Protein
risk management
pregnancy
breast feeding
drug approval
europe
injections, intravenous
von willebrand factor
product surveillance, postmarketing
aged
apadamtase alfa and cinaxadamtase alfa

---
https://ansm.sante.fr/tableau-marr/sulfate-de-sodium-anhydre-sulfate-de-magnesium-heptahydrate-sulfate-de-potassium
2024
false
false
false
France
French
risk management
guidelines for drug use
package leaflet
patients guideline
drug combinations
colonoscopy
cathartics
administration, oral
magnesium sulfate
potassium sulfate
sodium sulfate
magnesium sulfate, heptahydrate

---
https://www.ema.europa.eu/en/medicines/human/EPAR/steqeyma
2024
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
drug approval
europe
injections, subcutaneous
biosimilar pharmaceuticals
Ustekinumab
Ustekinumab
arthritis, psoriatic
psoriasis
crohn disease
drug interactions
pregnancy
breast feeding
ustekinumab

---
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/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://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/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
enalapril
enalapril
drug approval
europe
child
infant
adolescent
heart failure
administration, oral
Orally Disintegrating Tablet Dosage Form
angiotensin-converting enzyme inhibitors
angiotensin-converting enzyme inhibitors
infant, newborn
drug interactions
pregnancy
breast feeding
drug evaluation, preclinical

---
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
Jaypirca
drug approval
europe
antineoplastic agents
antineoplastic agents
adult
lymphoma, mantle-cell
BTK Inhibitor
Agammaglobulinaemia Tyrosine Kinase
Tyrosine Kinase Inhibitors
Tyrosine Kinase Inhibitors
Refractory Mantle Cell Lymphoma
Recurrent Mantle Cell Lymphoma
administration, oral
drug interactions
pregnancy
breast feeding
product surveillance, postmarketing
aged
drug evaluation, preclinical

---
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
multiple sclerosis
drug approval
europe
infusions, intravenous
immunologic factors
immunologic factors
drug interactions
pregnancy
breast feeding
continuity of patient care
drug evaluation, preclinical
adult
integrin alpha4beta1

---
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
drug approval
europe
adult
adolescent
hiv infections
HIV-1
Pre-Exposure Prophylaxis
administration, oral
injections, intramuscular
Delayed-Action preparations
HIV integrase inhibitors
HIV integrase inhibitors
drug interactions
pregnancy
breast feeding
drug evaluation, preclinical

---
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://ansm.sante.fr/tableau-acces-derogatoire/irenat
2024
false
false
false
France
French
administration, oral
pharmaceutical solutions
sodium perchlorate
summary of product characteristics
package leaflet
drug information
Iodine-Induced Hyperthyroidism
Hypothyroidism due to iodide organification defect (disorder)

---
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
relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy
elranatamab

---
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.has-sante.fr/jcms/p_3515581/fr/finlee-spexotras-dabrafenib-trametinib-gliome-pediatrie
2024
false
false
false
France
insurance, health, reimbursement
treatment outcome
antineoplastic combined chemotherapy protocols
dabrafenib
protein kinase inhibitors
antineoplastic agents
child
infant
Childhood Low Grade Glioma
malignant glioma
Childhood Malignant Glioma
BRAF V600E Mutation Present
guidelines for drug use
package leaflet
summary of product characteristics
Trametinib Dimethyl Sulfoxide
administration, oral
trametinib
evaluation of the transparency committee
dabrafenib
Dabrafenib/Trametinib Regimen
glioma
trametinib

---
https://www.has-sante.fr/jcms/p_3516966/fr/loargys-pegzilarginase-deficit-en-arginase-1
2024
false
false
false
France
ARG1 protein, human
insurance, health, reimbursement
treatment outcome
orphan drug production
package leaflet
summary of product characteristics
adult
pegzilarginase
adolescent
child
guidelines for drug use
enzyme replacement therapy
continuity of patient care
evaluation of the transparency committee
hyperargininemia
Arginase-1
Pegzilarginase

---
https://www.ema.europa.eu/en/medicines/human/EPAR/spexotras
2024
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
trametinib
trametinib
antineoplastic agents
protein kinase inhibitors
administration, oral
drug approval
Trametinib Dimethyl Sulfoxide
orphan drug production
infant
child
europe
trametinib
antineoplastic combined chemotherapy protocols
glioma
Dabrafenib/Trametinib Regimen
Childhood Malignant Glioma
Childhood Low Grade Glioma
malignant glioma
glioma
BRAF V600E Mutation Present
Mitogen-Activated Protein Kinase Kinase Inhibitor
drug evaluation, preclinical

---
https://www.ema.europa.eu/en/medicines/human/EPAR/finlee
2024
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
dabrafenib
dabrafenib
dabrafenib
drug approval
orphan drug production
glioma
malignant glioma
infant
child
antineoplastic combined chemotherapy protocols
Dabrafenib/Trametinib Regimen
Childhood Low Grade Glioma
Childhood Malignant Glioma
europe
Dabrafenib Mesylate
protein kinase inhibitors
protein kinase inhibitors
antineoplastic agents
antineoplastic agents
BRAF V600E Mutation Present
administration, oral
BRAF Inhibitor
proto-oncogene proteins b-raf
drug interactions
drug evaluation, preclinical

---
https://www.ema.europa.eu/en/medicines/human/EPAR/rystiggo
2024
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
rozanolixizumab
rozanolixizumab
drug approval
europe
orphan drug production
rozanolixizumab
immunosuppressive agents
immunosuppressive agents
adult
myasthenia gravis
Adult-onset myasthenia gravis
drug therapy, combination
infusions, subcutaneous
product surveillance, postmarketing
drug interactions
pregnancy
breast feeding
drug evaluation, preclinical
fc receptor, neonatal
generalised myasthenia gravis with anti-acetylcholine receptor antibody

---
https://www.ema.europa.eu/en/medicines/human/EPAR/loargys
2024
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
Pegzilarginase
Pegzilarginase
pegzilarginase
enzyme replacement therapy
drug approval
europe
hyperargininemia
orphan drug production
child
adolescent
adult
pregnancy
breast feeding
drug interactions
drug evaluation, preclinical
infusions, intravenous
injections, subcutaneous

---
https://ansm.sante.fr/tableau-acces-derogatoire/fabhalta
2024
false
false
false
France
French
Iptacopan
iptacopan
summary of product characteristics
package leaflet
guidelines for drug use
paroxysmal nocturnal hemoglobinuria
adult
anemia, hemolytic
complement factor B
C3 Glomerulonephritis

---
https://www.ema.europa.eu/en/medicines/human/EPAR/pyzchiva
2024
false
false
false
Netherlands
French
English
Ustekinumab
Ustekinumab
drug approval
europe
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
biosimilar pharmaceuticals
ustekinumab
psoriasis
arthritis, psoriatic
drug interactions
pregnancy
breast feeding
crohn disease
colitis, ulcerative
Product containing only ustekinumab in parenteral dose form (medicinal product form)
infusions, intravenous
Interleukin Inhibitors
Interleukin Inhibitors
Interleukin-12
Interleukin-23
injections, subcutaneous

---
https://www.ema.europa.eu/en/medicines/human/EPAR/skyclarys
2024
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
Omaveloxolone
Omaveloxolone
drug approval
europe
orphan drug production
friedreich ataxia
continuity of patient care
administration, oral
product surveillance, postmarketing
adult
drug interactions
pregnancy
breast feeding
drug evaluation, preclinical
omaveloxolone

---
https://www.ema.europa.eu/en/medicines/human/EPAR/jubbonti
2024
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
Denosumab
Denosumab
drug approval
europe
biosimilar pharmaceuticals

---
https://www.ema.europa.eu/en/medicines/human/EPAR/filspari
2024
false
false
false
Netherlands
French
English
drug approval
europe
sparsentan
sparsentan
orphan drug production
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
adult
glomerulonephritis, iga
Primary immunoglobulin A nephropathy (disorder)
administration, oral
product surveillance, postmarketing
aged
drug interactions
pregnancy
breast feeding
Endothelin A Receptor Antagonists
Endothelin A Receptor Antagonists
angiotensin II receptor antagonists
angiotensin II receptor antagonists
drug evaluation, preclinical
sparsentan

---
https://www.ema.europa.eu/en/medicines/human/EPAR/awiqli
2024
false
false
false
Netherlands
French
English
drug approval
europe
insulin icodec
insulin icodec
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
insulin icodec
adult
diabetes mellitus, type 1
Delayed-Action preparations
injections, subcutaneous
drug therapy, combination
diabetes mellitus, type 2
product surveillance, postmarketing
drug interactions
pregnancy
breast feeding
hypoglycemic agents
hypoglycemic agents

---
https://www.ema.europa.eu/en/medicines/human/EPAR/omlyclo
2024
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
drug approval
europe
Omalizumab
Omalizumab
biosimilar pharmaceuticals

---
https://www.ema.europa.eu/en/medicines/human/EPAR/lytenava
2024
false
false
false
Netherlands
French
English
drug approval
europe
Bevacizumab
Bevacizumab
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation

---
https://www.ema.europa.eu/en/medicines/human/EPAR/dabigatran-etexilate-leon-farma
2024
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
drugs, generic
drug approval
europe
dabigatran etexilate
dabigatran etexilate

---
https://www.ema.europa.eu/en/medicines/human/EPAR/tizveni
2024
false
false
false
Netherlands
French
English
drug approval
europe
tislelizumab
tislelizumab
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
tislelizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents, Immunological
carcinoma, non-small-cell lung
adult
antineoplastic combined chemotherapy protocols
infusions, intravenous
programmed cell death 1 receptor
product surveillance, postmarketing
drug interactions
pregnancy
breast feeding
drug evaluation, preclinical

---
https://www.ema.europa.eu/en/medicines/human/EPAR/apremilast-accord
2024
false
false
false
Netherlands
French
English
drug approval
europe
apremilast
apremilast
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
drugs, generic

---
https://www.ema.europa.eu/en/medicines/human/EPAR/voydeya
2024
false
false
false
Netherlands
French
English
drug approval
europe
danicopan
danicopan
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
orphan drug production
adult
paroxysmal nocturnal hemoglobinuria
administration, oral
complement factor D
product surveillance, postmarketing
drug interactions
pregnancy
breast feeding
danicopan
drug evaluation, preclinical

---
https://www.ema.europa.eu/en/medicines/human/EPAR/ibuprofen-genorph
2024
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
drugs, generic
ibuprofen
ibuprofen

---
https://www.ema.europa.eu/en/medicines/human/EPAR/ryzneuta
2024
false
false
false
Netherlands
French
English
drug approval
europe
Efbemalenograstim alfa
Efbemalenograstim alfa
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
efbemalenograstim alfa
neutropenia
febrile neutropenia
injections, subcutaneous
neutropenia
Cytotoxic Chemotherapy
product surveillance, postmarketing
drug interactions
pregnancy
breast feeding
colony-stimulating factors
drug evaluation, preclinical

---
https://www.ema.europa.eu/en/medicines/human/EPAR/emblaveo
2024
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
drug approval
europe
drug combinations
avibactam
avibactam
aztreonam
aztreonam
anti-bacterial agents
anti-bacterial agents
adult
beta-Lactamase Inhibitors
beta-Lactamase Inhibitors
intraabdominal infections
complicated intra-abdominal infections
Healthcare-Associated Pneumonia
pyelonephritis
Gram-Negative aerobic bacteria
Gram-Negative bacterial infections
infusions, intravenous
drug interactions
pregnancy
breast feeding
drug evaluation, preclinical
aztreonam and beta-lactamase inhibitor

---
Incellipan - influenza vaccine (surface antigen, inactivated, prepared in cell cultures)
https://www.ema.europa.eu/en/medicines/human/EPAR/incellipan
2024
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation

---
https://www.ema.europa.eu/en/medicines/human/EPAR/celldemic
2024
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation

---
https://www.ema.europa.eu/en/medicines/human/EPAR/zynyz-0
2024
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
drug approval
europe
Retifanlimab
Retifanlimab
orphan drug production
retifanlimab
Antineoplastic Agents, Immunological
Antineoplastic Agents, Immunological
antibodies, monoclonal
carcinoma, merkel cell
Metastatic Merkel Cell Carcinoma
Locally Advanced Merkel Cell Carcinoma
Unresectable Merkel Cell Carcinoma
Recurrent Merkel Cell Carcinoma
adult
infusions, intravenous
programmed cell death 1 receptor
product surveillance, postmarketing
drug interactions
pregnancy
breast feeding
drug evaluation, preclinical

---
https://www.ema.europa.eu/en/medicines/human/EPAR/nintedanib-accord
2024
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
drug approval
europe
nintedanib
nintedanib
drugs, generic

---
https://www.ema.europa.eu/en/medicines/human/EPAR/veoza
2024
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
drug approval
europe
fezolinetant
fezolinetant
fezolinetant
hot flashes
menopause
receptors, neurokinin-3
Neurokinin-3 Receptor Antagonist
Neurokinin-3 Receptor Antagonist
neurokinin B
product surveillance, postmarketing
drug interactions
drug evaluation, preclinical

---
https://www.ema.europa.eu/en/medicines/human/EPAR/niapelf
2024
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
drug approval
europe
Paliperidone Palmitate
Paliperidone Palmitate
drugs, generic

---
https://www.ema.europa.eu/en/medicines/human/EPAR/exblifep
2024
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
drug approval
europe
cefepime, enmetazobactam drug combination
cefepime, enmetazobactam drug combination
enmetazobactam
enmetazobactam
Cefepime
Cefepime
beta-Lactamase Inhibitors
beta-Lactamase Inhibitors
anti-bacterial agents
anti-bacterial agents
adult
pyelonephritis
urinary tract infections
Healthcare-Associated Pneumonia
pneumonia, ventilator-associated
bacteremia
infusions, intravenous
product surveillance, postmarketing
drug interactions
pregnancy
breast feeding
cefepime and beta-lactamase inhibitor
drug evaluation, preclinical

---
https://www.ema.europa.eu/en/medicines/human/EPAR/casgevy
2024
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
drug approval
europe
Exagamglogene Autotemcel
Exagamglogene Autotemcel
exagamglogene autotemcel
beta-Thalassemia
Transfusion Dependent Beta Thalassemia
anemia, sickle cell
adolescent
adult
orphan drug production
infusions, intravenous
hematopoietic stem cell transplantation
transplantation conditioning
drug interactions
pregnancy
breast feeding
drug evaluation, preclinical
cell therapy

---
https://www.ema.europa.eu/en/medicines/human/EPAR/pomalidomide-viatris
2024
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
drug approval
europe
pomalidomide
pomalidomide
drugs, generic

---
https://www.ema.europa.eu/en/medicines/human/EPAR/naveruclif
2024
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
drug approval
europe
paclitaxel
paclitaxel
drugs, generic

---
https://www.ema.europa.eu/en/medicines/human/EPAR/velsipity
2024
false
false
false
Netherlands
French
English
syndication feed
summary of product characteristics
package leaflet
drug evaluation
treatment outcome
drug approval
europe
etrasimod
etrasimod
colitis, ulcerative
etrasimod
administration, oral
adult
product surveillance, postmarketing
drug interactions
pregnancy
breast feeding
drug evaluation, preclinical
Etrasimod Arginine
Etrasimod Arginine
Immunomodulating Agents
Immunomodulating Agents
Sphingosine-1-phosphate Receptor Modulator
Sphingosine-1-phosphate Receptor Modulator

---
https://www.ema.europa.eu/en/medicines/human/EPAR/mevlyq
2024
false
false
false
Netherlands
French
English
syndication feed
summary of product characteristics
package leaflet
drug evaluation
treatment outcome
drug approval
europe
eribulin
eribulin
drugs, generic

---
https://www.ema.europa.eu/en/medicines/human/EPAR/uzpruvo
2024
false
false
false
Netherlands
French
English
drug approval
europe
Ustekinumab
Ustekinumab
syndication feed
summary of product characteristics
package leaflet
drug evaluation
biosimilar pharmaceuticals

---
https://www.ema.europa.eu/en/medicines/human/EPAR/rimmyrah
2024
false
false
false
Netherlands
French
English
syndication feed
summary of product characteristics
package leaflet
drug evaluation
treatment outcome
drug approval
europe
Ranibizumab
Ranibizumab
biosimilar pharmaceuticals

---
https://www.ema.europa.eu/en/medicines/human/EPAR/azacitidine-kabi
2024
false
false
false
Netherlands
French
English
syndication feed
summary of product characteristics
package leaflet
drug evaluation
treatment outcome
drugs, generic
drug approval
azacitidine
azacitidine

---
https://ansm.sante.fr/informations-de-securite/nouvelles-conditions-de-prescription-et-de-delivrance-des-specialites-a-base-dacetate-de-medroxyprogesterone-depo-provera-150-mg-3-ml-et-de-medrogestone-colprone-5-mg-liees-au-risque-de-meningiome-a-compter-du-1er-juillet-2024
2024
false
false
false
France
French
guidelines for drug use
meningioma
risk management
legislation, drug
medroxyprogesterone acetate
Drug-Related side effects and adverse reactions
medrogestone
progesterone congeners
medrogestone
medroxyprogesterone
drug prescriptions
Renewal of prescription (procedure)
professional role
physicians
pharmacists
summary of product characteristics
package leaflet

---
https://ansm.sante.fr/tableau-marr/ranibizumab-3
2024
false
false
false
France
French
risk management
Ranibizumab
package leaflet
patient education handout
drug information
Ranibizumab

---
https://ansm.sante.fr/tableau-acces-derogatoire/beremagene-geperpavec
2024
false
false
false
France
French
Beremagene Geperpavec
beremagene geperpavec
summary of product characteristics
package leaflet
guidelines for drug use
genetic therapy
gene therapy
biological products
epidermolysis bullosa dystrophica
infant
child
adolescent
adult
wounds
mutation
COL7A1 Gene Mutation

---
https://ansm.sante.fr/tableau-acces-derogatoire/blincyto
2024
false
false
false
France
French
insurance, health, reimbursement
blinatumomab
Consolidation Therapy
guidelines for drug use
summary of product characteristics
package leaflet
blinatumomab
infusions, intravenous
B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative
precursor b-cell lymphoblastic leukemia-lymphoma
Measurable Residual Disease Negativity

---
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/qdenga
2023
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
drug approval
europe
vaccines, attenuated
dengue vaccines
dengue vaccines
dengue
dengue virus vaccines
adult
adolescent
child
injections, subcutaneous
product surveillance, postmarketing
drug interactions
pregnancy
breast feeding
drug evaluation, preclinical

---
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

---
PUBLIÉ LE 25/01/2023
https://ansm.sante.fr/actualites/point-de-situation-sur-la-surveillance-des-vaccins-contre-la-covid-19-periode-du-22-12-2022-au-19-01-2023
2023
false
false
false
France
French
mRNA Vaccine
mRNA Vaccines
NVX-CoV2373 adjuvated lipid nanoparticle
summary of product characteristics
package leaflet
drug information
pharmacovigilance
adverse drug reaction reporting systems
france
vaccination
Drug-Related side effects and adverse reactions
drug monitoring
mRNA vaccine
Administration of vaccine product containing only severe acute respiratory syndrome coronavirus 2 antigen (procedure)
Covid-19 vaccines
COVID-19
COVID-19 Vaccines

---
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://ansm.sante.fr/tableau-acces-derogatoire/nexviadyme-100-mg-poudre-pour-solution-a-diluer-pour-perfusion
2023
false
false
false
France
French
summary of product characteristics
package leaflet
infusions, intravenous
Avalglucosidase Alfa
glycogen storage disease type ii
guidelines for drug use

---
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://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/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/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://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://ansm.sante.fr/actualites/arret-de-commercialisation-du-medicament-josacine-josamycine
2023
false
false
false
France
French
josamycin
drug recalls
drug information
summary of product characteristics
package leaflet

---
PUBLIÉ LE 27/02/2023
https://ansm.sante.fr/actualites/point-de-situation-sur-la-surveillance-des-vaccins-contre-le-covid-19-periode-du-13-01-2023-au-16-02-2023
2023
false
false
false
France
French
mRNA Vaccine
mRNA Vaccines
NVX-CoV2373 adjuvated lipid nanoparticle
summary of product characteristics
package leaflet
drug information
pharmacovigilance
adverse drug reaction reporting systems
france
vaccination
Drug-Related side effects and adverse reactions
drug monitoring
mRNA vaccine
Administration of vaccine product containing only severe acute respiratory syndrome coronavirus 2 antigen (procedure)
Covid-19 vaccines
COVID-19
COVID-19 Vaccines

---
https://ansm.sante.fr/tableau-acces-derogatoire/natriumthiosulfat-10-solution-pour-perfusion-natriumthiosulfat-25-solution-pour-perfusion
2023
false
false
false
France
French
summary of product characteristics
package leaflet
insurance, health, reimbursement
sodium thiosulfate
guidelines for drug use
Subcutaneous calcification (disorder)
calciphylaxis
injections, intravenous
Hyperthermic Intraperitoneal Chemotherapy
Drug-Related side effects and adverse reactions
Administration of hyperthermic antineoplastic agent into thoracic cavity (procedure)
cisplatin
antidotes
chelating agents
antioxidants

---
https://www.ema.europa.eu/en/medicines/human/EPAR/dimethyl-fumarate-accord
2023
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
drugs, generic

---
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

---
https://www.ema.europa.eu/en/medicines/human/EPAR/kauliv
2023
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
biosimilar pharmaceuticals

---