Preferred Label : ulipristal acetate;
CISMeF synonym : Esmya; ella norpregnadiene;
MeSH synonym : (11beta)-17-(acetyloxy)-11-(4-(dimethylamino)phenyl)-19-norpregna-4,9-diene-3,20-dione;
Is substance : O;
UNII : YF7V70N02B;
Origin ID : C555622;
UMLS CUI : C2723461;
ATC code(s)
ATC code(s)
CISMeF manual mappings
MeSH indexing information
MeSH term(s) associated for indexing
Pharmacological action(s)
Record concept(s)
See also (suggested by CISMeF)
Semantic type(s)
UMLS correspondences (same concept)
https://www.ansm.sante.fr/actualites/arret-de-commercialisation-du-medicament-esmya-ulipristal
2021
false
false
false
France
French
drug information
Safety-Based drug withdrawals
ulipristal acetate
fibroid uterus
ulipristal
leiomyoma
norpregnadienes
---
https://www.inesss.qc.ca/publications/repertoire-des-publications/publication/usage-de-lacetate-dulipristal-ou-du-levonorgestrel-pour-la-contraception-orale-durgence.html
2020
false
false
false
Canada
guidelines for drug use
ulipristal
contraceptive usage
oral contraception
contraception behavior
acetate
contraception oral
emergency contraception
ulipristal acetate
levonorgestrel
contraceptives, oral
contraception, postcoital
acetates
ulipristal
norpregnadienes
---
https://canadiensensante.gc.ca/recall-alert-rappel-avis/hc-sc/2020/73939a-fra.php
2020
false
false
false
Canada
French
pharmacovigilance note
Safety-Based drug withdrawals
canada
ulipristal acetate
Chemical and Drug Induced Liver Injury
ulipristal
leiomyoma
fibroid uterus
norpregnadienes
---
https://www.ansm.sante.fr/actualites/esmya-ulipristal-5-mg-retrait-de-lautorisation-de-mise-sur-le-marche-amm
2020
false
false
false
France
French
pharmacovigilance note
Safety-Based drug withdrawals
ulipristal acetate
drug evaluation
risk assessment
Chemical and Drug Induced Liver Injury
ulipristal
fibroid uterus
leiomyoma
norpregnadienes
---
https://ansm.sante.fr/informations-de-securite/acetate-dulipristal-esmya-ne-plus-utiliser-dans-lattente-des-conclusions-de-levaluation-europeenne-du-risque-hepatique
2020
false
false
false
France
French
risk assessment
pharmacovigilance note
ulipristal acetate
ulipristal
fibroid uterus
acute disease
Hepatitis fulminant
Safety-Based drug withdrawals
hepatitis, Drug-Induced
guidelines for drug use
hepatitis, Drug-Induced
signs and symptoms
leiomyoma
Chemical and Drug Induced Liver Injury
Chemical and Drug Induced Liver Injury
norpregnadienes
---
https://www.ansm.sante.fr/actualites/le-medicament-esmya-ulipristal-ne-doit-plus-etre-utilise-dans-lattente-des-resultats-de-la-reevaluation-de-son-rapport-benefice-risque
2020
false
false
false
France
French
risk assessment
pharmacovigilance note
ulipristal acetate
ulipristal
fibroid uterus
acute disease
Hepatitis fulminant
Safety-Based drug withdrawals
hepatitis, Drug-Induced
leiomyoma
norpregnadienes
Chemical and Drug Induced Liver Injury
---
Health Canada reviews safety of drug Fibristal again following new case of liver injury
https://canadiensensante.gc.ca/recall-alert-rappel-avis/hc-sc/2020/73939a-fra.php
2020
false
false
false
Canada
French
English
ulipristal acetate
pharmacovigilance note
Chemical and Drug Induced Liver Injury
fibroid uterus
ulipristal
leiomyoma
norpregnadienes
---
https://www.has-sante.fr/jcms/c_2908907/fr/esmya-acetate-d-ulipristal-modulateur-des-recepteurs-de-la-progesterone
2019
false
false
false
France
guidelines for drug use
administration, oral
fibroid uterus
treatment outcome
ulipristal
adult
insurance, health, reimbursement
evaluation of the transparency committee
Esmya
ulipristal acetate
norpregnadienes
leiomyoma
---
Intérêt clinique insuffisant pour justifier son remboursement dans le traitement
des fibromes utérins
https://www.has-sante.fr/portail/jcms/c_2908907/fr/esmya
https://www.has-sante.fr/portail/jcms/c_2908907/fr/esmya-acetate-d-ulipristal-modulateur-des-recepteurs-de-la-progesterone
2019
true
false
France
French
ulipristal
guidelines for drug use
administration, oral
ulipristal acetate
insurance, health, reimbursement
treatment outcome
adult
leiomyoma
uterine neoplasms
randomized controlled trials as topic
norpregnadienes
preoperative care
fibroid uterus
evaluation of the transparency committee
---
Summary Safety Review - Fibristal (5 mg ulipristal acetate) - Assessing the potential
risk of rare but serious liver injury
https://hpr-rps.hres.ca/reg-content/resume-examen-innocuite-detail.php?lang=fr&linkID=SSR00210
2019
false
false
false
Canada
French
English
pharmacovigilance note
Chemical and Drug Induced Liver Injury
ulipristal acetate
fibroid uterus
ulipristal
continuity of patient care
drug monitoring
adult
leiomyoma
norpregnadienes
---
https://www.sggg.ch/fileadmin/user_upload/62_franz_Ulipristalacetat_und_andere_medikamentoese_Alternativen_fuer_die_Therapie_von_Uterusmyomen_ersetzt_No_54.pdf
2019
false
false
false
Switzerland
ulipristal acetate
treatment outcome
ulipristal
preoperative period
continuity of patient care
pregnancy
guideline
fibroid uterus
ulipristal acetate
leiomyoma
norpregnadienes
norpregnadienes
---
Health Canada to conduct review of a new potential safety risk of Fibristal (ulipristal
acetate), a medication used to treat fibroids
https://canadiensensante.gc.ca/recall-alert-rappel-avis/hc-sc/2018/66210a-fra.php
2018
false
false
false
false
Canada
French
English
risk assessment
leiomyoma
ulipristal acetate
Chemical and Drug Induced Liver Injury
hepatitis, Drug-Induced
ulipristal
fibroid uterus
pharmacovigilance note
norpregnadienes
---
https://ansm.sante.fr/informations-de-securite/esmya-r-ulipristal-acetate-5-mg-comprimes-risque-potentiel-dhepatotoxicite
2018
false
false
false
France
French
pharmacovigilance note
guidelines for drug use
administration, oral
ulipristal
ulipristal acetate
risk assessment
Chemical and Drug Induced Liver Injury
continuity of patient care
drug monitoring
liver function tests
patients guideline
Chemical and Drug Induced Liver Injury
signs and symptoms
fibroid uterus
Chemical and Drug Induced Liver Injury
mass screening
leiomyoma
norpregnadienes
---
https://ansm.sante.fr/informations-de-securite/esmya-r-acetate-dulipristal-5-mg-comprimes-suspension-des-initiations-et-surveillance-de-la-fonction-hepatique-des-patientes-en-cours-de-traitement
2018
false
false
false
France
French
pharmacovigilance note
administration, oral
ulipristal acetate
ulipristal
continuity of patient care
drug monitoring
liver function tests
transaminases
patients guideline
guidelines for drug use
risk assessment
Chemical and Drug Induced Liver Injury
fibroid uterus
Obstetrician (occupation)
Gynecologist (occupation)
leiomyoma
norpregnadienes
---
https://ansm.sante.fr/actualites/esmya-ulipristal-lansm-recommande-son-initiation-ou-sa-poursuite-uniquement-apres-discussion-des-alternatives-avec-les-patientes
2018
false
false
false
false
France
French
pharmacovigilance note
ulipristal acetate
administration, oral
ulipristal acetate
fibroid uterus
Chemical and Drug Induced Liver Injury
ulipristal acetate
preoperative period
risk
continuity of patient care
forms
information dissemination
patient education handout
ulipristal
Contraindications, Procedure
leiomyoma
norpregnadienes
norpregnadienes
norpregnadienes
Contraindications, Drug
---
http://www.cochrane.org/fr/CD010770/medicaments-pour-traiter-les-fibromes
2017
false
false
false
France
United Kingdom
French
french abstract
premenopause
fibroid uterus
Evidence-Based medicine
treatment outcome
progesterone receptor modulators
review of literature
mifepristone
ulipristal acetate
comparative effectiveness research
asoprisnil
leuprolide acetate
receptors, progesterone
leiomyoma
leuprolide
norpregnadienes
estrenes
oximes
---
http://www.has-sante.fr/portail/jcms/c_2725865/fr/esmya
http://www.has-sante.fr/portail/jcms/c_2725865/fr/esmya-ulipristal-modulateur-des-recepteurs-de-la-progesterone
2016
false
false
false
France
French
evaluation of the transparency committee
administration, oral
adult
fibroid uterus
ulipristal acetate
ulipristal acetate
ulipristal
Female of child bearing age (finding)
guidelines for drug use
insurance, health, reimbursement
treatment outcome
leiomyoma
norpregnadienes
norpregnadienes
---
http://www.has-sante.fr/portail/jcms/c_2045315/fr/esmya
http://www.has-sante.fr/portail/jcms/c_2045315/fr/esmya-ulipristal-modulateur-des-recepteurs-de-la-progesterone
2015
true
France
French
ulipristal
guidelines for drug use
administration, oral
ulipristal acetate
ulipristal acetate
insurance, health, reimbursement
treatment outcome
adult
leiomyoma
uterine neoplasms
randomized controlled trials as topic
metrorrhagia
norpregnadienes
norpregnadienes
preoperative care
fibroid uterus
evaluation of the transparency committee
---
http://www.has-sante.fr/portail/jcms/c_2569065/fr/ellaone
http://www.has-sante.fr/portail/jcms/c_918258/ellaone
2015
false
France
French
emergency contraception
insurance, health, reimbursement
administration, oral
norpregnadienes
contraceptives, postcoital
ulipristal
receptors, progesterone
ulipristal acetate
evaluation of the transparency committee
contraception, postcoital
---
http://www.meddispar.fr/Medicaments/ESMYA-5-B-28/(type)/letter/(value)/E/(cip)/3400922257891
2014
false
true
false
France
French
drug information
administration, oral
drug prescriptions
legislation, pharmacy
ulipristal acetate
ulipristal
norpregnadienes
---
http://www.has-sante.fr/portail/jcms/c_1543129/fr/contraception-durgence-prescription-et-delivrance-a-lavance
http://www.has-sante.fr/portail/jcms/c_1543201/fr/contraception-d-urgence-argumentaire
2013
true
France
French
public health guidelines
health technology assessment
contraceptives, postcoital
contraception, postcoital
levonorgestrel
norpregnadienes
ulipristal acetate
intrauterine devices, copper
economic evaluation
drug prescriptions
treatment outcome
---
Summary Basis of Decision (SBD) for Fibristal
Ulipristal acetate, 5 mg, tablet, oral
https://hpr-rps.hres.ca/reg-content/sommaire-motif-decision-detailTwo.php?linkID=SBD00217
2013
false
Canada
French
English
ulipristal
drug information
Product containing precisely ulipristal acetate 5 milligram/1 each conventional release
oral tablet (clinical drug)
ulipristal acetate
ulipristal acetate
ulipristal
drug approval
canada
administration, oral
adult
leiomyoma
fibroid uterus
receptors, progesterone
treatment outcome
clinical trials, phase iii as topic
endometrium
norpregnadienes
---
http://www.has-sante.fr/portail/jcms/c_1334845/esmya-5-mg-ulipristal-modulateur-des-recepteurs-a-la-progesterone
http://www.has-sante.fr/portail/jcms/c_1334833/esmya-18072012-synthese-ct12237
http://www.has-sante.fr/portail/upload/docs/application/pdf/2012-09/esmya_18072012_avis__ct12237.pdf
2012
false
France
French
ulipristal
ulipristal acetate
ulipristal acetate
administration, oral
guidelines for drug use
pharmacovigilance note
insurance, health, reimbursement
preoperative care
adult
fibroid uterus
fibroid uterus
leiomyoma
leiomyoma
metrorrhagia
treatment outcome
randomized controlled trials as topic
uterine neoplasms
norpregnadienes
norpregnadienes
comparative study
---
http://www.has-sante.fr/portail/jcms/c_1294761/esmya-18072012-avis-ct12237
http://www.has-sante.fr/portail/jcms/c_1294551/esmya
2012
false
France
French
ulipristal
administration, oral
ulipristal acetate
ulipristal acetate
insurance, health, reimbursement
treatment outcome
adult
leiomyoma
uterine neoplasms
randomized controlled trials as topic
metrorrhagia
norpregnadienes
norpregnadienes
preoperative care
fibroid uterus
evaluation of the transparency committee
---
https://www.ema.europa.eu/medicines/human/EPAR/Ulipristal-Acetate-Gedeon-Richter
2012
false
United Kingdom
English
French
ulipristal
drug evaluation
summary of product characteristics
package leaflet
syndication feed
norpregnadienes
norpregnadienes
drug interactions
receptors, progesterone
preoperative care
pregnancy
breast feeding
drug evaluation, preclinical
ulipristal acetate
ulipristal acetate
drug approval
treatment outcome
administration, oral
leiomyoma
adult
progesterone
fibroid uterus
---
https://www.ema.europa.eu/medicines/human/EPAR/Ellaone
2012
United Kingdom
English
French
syndication feed
ulipristal
drug interactions
pregnancy
breast feeding
progesterone
drug evaluation, preclinical
ulipristal
ulipristal
drug approval
drug labeling
treatment outcome
tablets
administration, oral
norpregnadienes
contraceptives, postcoital
contraceptives, postcoital
norpregnadienes
ulipristal acetate
ulipristal acetate
summary of product characteristics
drug evaluation
package leaflet
---
https://www.ema.europa.eu/medicines/human/EPAR/Esmya
2012
false
United Kingdom
English
French
ulipristal
drug evaluation
summary of product characteristics
package leaflet
syndication feed
norpregnadienes
norpregnadienes
drug interactions
receptors, progesterone
preoperative care
pregnancy
breast feeding
cell proliferation
drug evaluation, preclinical
ulipristal acetate
ulipristal acetate
drug approval
treatment outcome
administration, oral
leiomyoma
adult
uterine neoplasms
progesterone
fibroid uterus
metrorrhagia
---
http://www.has-sante.fr/portail/jcms/c_946052/ellaone-ulipristal-modulateur-des-recepteurs-de-la-progesterone
http://www.has-sante.fr/portail/upload/docs/application/pdf/2010-01/ellaone_-_ct-7137.pdf
2010
France
French
ulipristal
norpregnadienes
contraceptives, postcoital
norpregnadienes
insurance, health, reimbursement
receptors, progesterone
treatment outcome
administration, oral
ulipristal acetate
ulipristal acetate
guidelines for drug use
evaluation of the transparency committee
---