EMEA-002575-PIP02-20 - paediatric investigation plan

pralsetinib

Key facts

• Invented name:
  Gavreto
• Active Substance:
  pralsetinib
• Therapeutic area:
  Oncology
• Decision number:
  P/0271/2021
• PIP number:
  EMEA-002575-PIP02-20
• Pharmaceutical form(s):
  Capsule (hard)
• Condition(s) / indication(s):
  Treatment of thyroid cancer
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Roche Registration GmbH

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

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  09/07/2021

Decision

P/0271/2021: EMA decision of 9 July 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for pralsetinib (EMEA-002575-PIP02-20)

Reference Number: EMA/357806/2021