Advate
octocog alfa
Hemophilia A
Date of authorisation:
Revision: 32
Last updated:
MedicineHumanAuthorised
Kovaltry
octocog alfa
Hemophilia A
Date of authorisation:
Revision: 12
Last updated:
MedicineHumanAuthorised
EMEA-001064-PIP01-10-M03 - paediatric investigation plan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: P/0060/2018
Route(s) of administration: Intravenous use
Pharmaceutical form(s):
Powder and solvent for solution for injection
Decision date:
Last updated:
Compliance check: ✔
PIPHuman
Kogenate Bayer
octocog alfa
Hemophilia A
Date of authorisation:
Revision: 30
Last updated:
MedicineHumanWithdrawn
Helixate NexGen
octocog alfa
Hemophilia A
Date of authorisation:
Revision: 31
Last updated:
MedicineHumanWithdrawn
Iblias
octocog alfa
Hemophilia A
Date of authorisation:
Revision: 4
Last updated:
MedicineHumanWithdrawn
Factor VIII - referral
Article 31 referrals
Status: European Commission final decision
Opinion/position date:
EC decision date:
Last updated:
ReferralHuman
Octocog alfa - paediatric investigation plan
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Haematology-Hemostaseology
PIP number: P/65/2010
Route(s) of administration: Intravenous use
Pharmaceutical form(s):
Powder and solvent for solution for injection
Decision date:
Last updated:
Compliance check: ✖
PIPHuman