EMEA-002840-PIP02-22 - paediatric investigation plan

Ziltivekimab

Key facts

• Active Substance:
  Ziltivekimab
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0011/2023
• PIP number:
  EMEA-002840-PIP02-22
• Pharmaceutical form(s):
  All pharmaceutical forms
• Condition(s) / indication(s):
  Treatment of heart failure
• Route(s) of administration:
  All routes of administration
• Contact for public enquiries:

  Novo Nordisk A/S

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

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  31/01/2023

Decision

P/0011/2023 : EMA decision of 31 January 2023 on the granting of a product specific waiver for ziltivekimab (EMEA-002840-PIP02-22)

Reference Number: EMA/29535/2023