EMEA-002535-PIP04-21 - paediatric investigation plan
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Infectious diseases
PIP number: P/0370/2022
Route(s) of administration: Oral useIntravenous use
Pharmaceutical form(s):
Tablet
Powder for oral solution
Powder for solution for injection or infusion
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
NovoSeven
eptacog alfa (activated)
Hemophilia B
Thrombasthenia
Factor VII Deficiency
Hemophilia A
Date of authorisation:
Revision: 38
Last updated:
MedicineHumanAuthorised
HemAryo
eptacog alfa (activated)
Date of withdrawal:
Last updated:
MedicineHumanWithdrawn application
EMEA-001382-PIP01-12 - 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/0270/2013
Route(s) of administration: Intravenous use
Pharmaceutical form(s):
Powder and solvent for solution for injection
Decision date:
Last updated:
Compliance check: ✖
PIPHuman