Nucala
mepolizumab
Asthma
Date of authorisation:
Revision: 18
Last updated:
MedicineHumanAuthorised
EMEA-000069-PIP01-07-M07 - paediatric investigation plan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: P/0384/2020
Route(s) of administration: Subcutaneous use
Pharmaceutical form(s):
Powder for solution for infusion
Solution for injection in pre-filled syringe
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
EMEA-000069-PIP02-10-M08 - paediatric investigation plan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: P/0239/2017
Route(s) of administration: Intravenous useSubcutaneous use
Pharmaceutical form(s):
Powder for solution for injection/infusion
Solution for injection
Decision date:
Last updated:
Compliance check: ✔
PIPHuman
Thrombin alfa - paediatric investigation plan
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Haematology-Hemostaseology
PIP number: P/62/2008
Route(s) of administration: Epilesional use
Pharmaceutical form(s):
Powder and solvent for reconstitution
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
EMEA-000069-PIP05-16 - paediatric investigation plan
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Pneumology-allergology
PIP number: P/0119/2017
Route(s) of administration: Subcutaneous use
Pharmaceutical form(s):
Solution for injection
Powder for solution for injection
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
Recothrom
Date of withdrawal:
Last updated:
MedicineHumanWithdrawn application
Bosatria
mepolizumab
Date of withdrawal:
Last updated:
MedicineHumanWithdrawn application