Human plasma proteins - paediatric investigation plan

Human plasma proteins

Key facts

• Active Substance:
  Human plasma proteins
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/116/2009
• PIP number:
  Human plasma proteins
• Pharmaceutical form(s):
  Solution for infusion
• Condition(s) / indication(s):
  • Thrombotic thrombocytopenic purpura
  • Treatment of acquired coagulation factor deficiency
  • Hereditary deficiency of clotting factors
• Route(s) of administration:
  Intravenous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  16/06/2009

Decision

P/116/2009: European Medicines Agency decision of 16 June 2009 on the granting of a product specific waiver for human plasma proteins (EMEA-000507-PIP01-08) in accordance with Regulation (EC) No 1901/2006 of the Europe...

AdoptedReference Number: EMEA/351605/2009