EMEA-002326-PIP04-20 - paediatric investigation plan

Concizumab

Key facts

• Active Substance:
  Concizumab
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0371/2021
• PIP number:
  EMEA-002326-PIP04-20
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  • Treatment of congenital haemophilia A
  • Treatment of congenital haemophilia B
• Route(s) of administration:
  Subcutaneous use
• Contact for public enquiries:

  Novo Nordisk A/S

  E-mail: [e-mail]; Tel: [phone]

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  08/09/2021

Decision

P/0371/2021 : EMA decision of 8 September 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for concizumab, (EMEA-002326-PIP04-20)

AdoptedReference Number: EMA/472068/2021