EMEA-002840-PIP01-20 - paediatric investigation plan

Ziltivekimab

Key facts

• Active Substance:
  Ziltivekimab
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0498/2020
• PIP number:
  EMEA-002840-PIP01-20
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Prevention of cardiovascular events in patients with atherosclerosis
• Route(s) of administration:
  Subcutaneous use
• 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:
  22/12/2020

Decision

P/0498/2020: EMA decision of 22 December 2020 on the granting of a product specific waiver for ziltivekimab (EMEA-002840-PIP01-20)

Adopted