MenQuadfi
meningococcal group A, C, W-135 and Y conjugate vaccine
Meningitis, Meningococcal
Date of authorisation:
Revision: 12
Last updated:
MedicineHumanAuthorised
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
Nimenrix
meningococcal groups A, C, W-135 and Y conjugate vaccine
Meningitis, Meningococcal
Date of authorisation:
Revision: 36
Last updated:
MedicineHumanAuthorised
EMEA-001930-PIP01-16-M04 - paediatric investigation plan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: P/0222/2022
Route(s) of administration: Intramuscular use
Pharmaceutical form(s):
Solution for injection
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
Zektayos - Hepjuvo
obeticholic acid
Date of withdrawal:
Last updated:
MedicineHumanWithdrawn application
EMEA-000429-PIP01-08-M04 - paediatric investigation plan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: P/0089/2015
Route(s) of administration: Intramuscular use
Pharmaceutical form(s):
Powder and solvent for solution for injection
Decision date:
Last updated:
Compliance check: ✔
PIPHuman
EMEA-001304-PIP02-13-M05 - paediatric investigation plan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: P/0041/2021
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