EMEA-003168-PIP01-21 - paediatric investigation plan
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Dermatology
PIP number: P/0480/2022
Route(s) of administration: Cutaneous use
Pharmaceutical form(s):
Cream
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
EMEA-003168-PIP01-21 - paediatric investigation plan
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Dermatology
PIP number: P/0480/2022
Route(s) of administration: Cutaneous use
Pharmaceutical form(s):
Cream
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
Hyftor
sirolimus
Angiofibroma
Tuberous Sclerosis
Date of authorisation:
Revision: 2
Last updated:
MedicineHumanAuthorised
EMEA-002982-PIP01-21 - 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/0192/2022
Route(s) of administration: Intravenous use
Pharmaceutical form(s):
Suspension for infusion
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
EMEA-001416-PIP01-12-M03 - paediatric investigation plan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Ophthalmology
PIP number: P/0336/2021
Route(s) of administration: Intravitreal use
Pharmaceutical form(s):
Solution for injection
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
Rapamune
sirolimus
Graft Rejection
Kidney Transplantation
Date of authorisation:
Revision: 46
Last updated:
MedicineHumanAuthorised
EMEA-002213-PIP01-17 - paediatric investigation plan
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Other
PIP number: P/0395/2017
Route(s) of administration: Implantation
Pharmaceutical form(s):
Implant
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
Opsiria
sirolimus
Date of withdrawal:
Last updated:
MedicineHumanWithdrawn application