EMEA-001154-PIP01-11 - paediatric investigation plan

antithrombin alfa

Key facts

• Invented name:
  • ATryn
  • ATryn
• Active substance:
  antithrombin alfa
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/226/2011
• PIP number:
  EMEA-001154-PIP01-11
• Pharmaceutical form(s):
  Powder for solution for infusion
• Condition(s) / indication(s):
  Treatment of antithrombin deficiency
• Route(s) of administration:
  Intravenous use
• Decision type:
  RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
• Decision date:
  27/09/2011
• Compliance check done:
  Nej

Decision

P/226/2011: EMA decision of 27 September 2011 on the refusal of a product specific waiver for antithrombin alfa (ATryn) (EMEA-001154-PIP01-11)

Adopted Reference Number: EMA/710340/2011