EMEA-002690-PIP02-22 - paediatric investigation plan

sotorasib

Key facts

• Invented name:
  Lumykras
• Active Substance:
  sotorasib
• Therapeutic area:
  Oncology
• Decision number:
  P/0089/2023
• PIP number:
  EMEA-002690-PIP02-22
• Pharmaceutical form(s):
  All pharmaceutical forms
• Condition(s) / indication(s):
  Treatment of colorectal carcinoma
• Route(s) of administration:
  All routes of administration
• Contact for public enquiries:

  Amgen Europe B.V

  United Kingdom ; [e-mail] ; + 44 1223420305 ; + 44 1223426814

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  10/03/2024

Decision

P/0089/2023 : EMA decision of 10 March 2023 on the granting of a product specific waiver for sotorasib (Lumykras), (EMEA-002690-PIP02-22)

Reference Number: EMA/74651/2023