EMEA-002619-PIP02-23 - paediatric investigation plan

belzutifan

Key facts

• Active Substance:
  belzutifan
• Therapeutic area:
  Oncology
• Decision number:
  P/0239/2023
• PIP number:
  EMEA-002619-PIP02-23
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  • Treatment of neuroendocrine tumours (excluding neuroblastoma)
  • Treatment of von Hippel-Lindau disease (excluding von Hippel-Lindau disease- associated renal cell carcinoma)
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Merck Sharp & Dohme (Europe) Inc.

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

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  14/06/2023

Decision

P/0239/2023 : EMA decision of 14 June 2023 on the granting of a product specific waiver for belzutifan, (EMEA-002619-PIP02-23)

Reference Number: EMA/238267/2023