EMEA-001154-PIP02-15 - paediatric investigation plan

Antithrombin alfa

Key facts

• Invented name:
  Recombinant human antithrombin
• Active Substance:
  Antithrombin alfa
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0350/2016
• PIP number:
  EMEA-001154-PIP02-15
• Pharmaceutical form(s):
  Powder for solution for infusion
• Condition(s) / indication(s):
  Treatment of antithrombin deficiency
• Route(s) of administration:
  Intravenous use
• Contact for public enquiries:

  GTC Biotherapeutics UK Limited

  France; E-mail: [e-mail]; Tel.: [phone]; Fax: [phone]

• Decision type:
  RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
• Decision date:
  02/12/2016

Decision

P/0350/2016: EMA decision of 2 December 2016on the refusal of a paediatric investigation plan and on the refusal of a deferral and on the refusal of a waiver for antithrombin alfa (Recombinant human antithrombin), (EMEA...

AdoptedReference Number: EMA/742001/2016