EMEA-000753-PIP01-11 - paediatric investigation plan

Recombinant porcine factor VIII, B-domain deleted

Key facts

• Active Substance:
  Recombinant porcine factor VIII, B-domain deleted
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0040/2012
• PIP number:
  EMEA-000753-PIP01-11
• Pharmaceutical form(s):
  • Powder for solution for injection
  • Powder and solvent for solution for injection
• Condition(s) / indication(s):
  Treatment of acquired haemophilia A
• Route(s) of administration:
  Intravenous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  24/02/2012

Decision

P/40/2012: EMA decision of 24 February 2012 on the granting of a product specific waiver for recombinant porcine factor VIII, B-domain deleted (EMEA-000753-PIP01-11)

AdoptedReference Number: EMA/8530/2012