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Search results (10)
Decision type:
PM: decision on the application for modification of an agreed PIP
Therapeutic area:
Gastroentology-Hepatology
PIP number:
P/0488/2023
Route(s) of administration:
Oral useTablet
Pharmaceutical form(s):
Oral solution
Decision date:
Last updated:
Compliance check:
✔
PIPHuman
Maralixibat chloride
Alagille Syndrome
Date of authorisation:
Revision:
7
Last updated:
MedicineHumanAuthorised
Decision type:
PM: decision on the application for modification of an agreed PIP
Therapeutic area:
Gastroentology-Hepatology
PIP number:
P/0298/2022
Route(s) of administration:
Oral use
Pharmaceutical form(s):
Oral liquid
Tablet
Decision date:
Last updated:
Compliance check:
✖
PIPHuman
Date of designation:
Positive
Last updated:
OrphanHuman
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/0245/2021
Route(s) of administration:
Oral use
Pharmaceutical form(s):
Oral solution
Decision date:
Last updated:
Compliance check:
✖
PIPHuman
Date of designation:
Withdrawn
Last updated:
OrphanHuman
Date of designation:
Withdrawn
Last updated:
OrphanHuman
maralixibat
Date of withdrawal:
Last updated:
MedicineHumanApplication withdrawn
Date of designation:
Positive
Last updated:
OrphanHuman
Date of designation:
Positive
Last updated:
OrphanHuman