EMEA-002762-PIP02-20 - paediatric investigation plan

Bispecific antibody binding to clotting factor IX and X (Mim8)

Key facts

• Active Substance:
  Bispecific antibody binding to clotting factor IX and X (Mim8)
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0450/2020
• PIP number:
  EMEA-002762-PIP02-20
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of Haemophilia A
• 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:
  01/12/2020

Decision

P/0450/2020 : EMA decision of 1 December 2020 on the agreement of a paediatric investigation plan and on the granting of a deferral for bispecific antibody binding to clotting factor IX and X (Mim8) (EMEA-002762-PIP02-20)

AdoptedReference Number: EMA/599313/2020