EMEA-000753-PIP01-11 - paediatric investigation plan

Recombinant porcine factor VIII, B-domain deleted
PIPHuman

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
Contact for public enquiries

Baxalta Innovations GmbH

E-mail: medinfoEMEA@takeda.com
Tel. +44 (0)3333 000181

Decision type
W: decision granting a waiver in all age groups for all conditions or indications
Decision date

Decision

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