Ocaliva - referral
obeticholic acid
Article 20 procedures
Status: Under evaluation
Last updated:
ReferralHuman
Ocaliva
obeticholic acid
Liver Cirrhosis, Biliary
Date of authorisation:
Revision: 20
Last updated:
MedicineHumanAuthorised
Quinolone- and fluoroquinolone-containing medicinal products - referral
nalidixic acid
pipemidic acid
cinoxacin
enoxacin
pefloxacin
lomefloxacin
ciprofloxacin
levofloxacin
ofloxacin
moxifloxacin
norfloxacin
prulifloxacin
rufloxacin
flumequin
Article 31 referrals
Status: European Commission final decision
Opinion/position date:
EC decision date:
Last updated:
ReferralHuman
Zektayos - Hepjuvo
obeticholic acid
Date of withdrawal:
Last updated:
MedicineHumanWithdrawn application
EMEA-001304-PIP02-13-M06 - paediatric investigation plan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: P/0105/2023
Route(s) of administration: Oral use
Pharmaceutical form(s):
Coated tablet
Tablet
Age-appropriate oral solid dosage form
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
EMEA-001304-PIP03-17 - paediatric investigation plan
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Gastroentology-Hepatology
PIP number: P/0104/2018
Route(s) of administration: Oral use
Pharmaceutical form(s):
Age-appropriate oral solid dosage form
Tablet
Decision date:
Last updated:
Compliance check: ✖
PIPHuman