EMEA-002762-PIP02-20-M01 - paediatric investigation plan

denecimig

Key facts

• Active Substance:
  denecimig
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0215/2023
• PIP number:
  EMEA-002762-PIP02-20-M01
• 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:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  14/06/2023

Decision

P/0215/2023 : EMA decision of 14 June 2023 on the acceptance of a modification of an agreed paediatric investigation plan for denecimig (EMEA- 002762-PIP02-20-M01)

Reference Number: EMA/236605/2023