EMEA-003230-PIP01-22 - paediatric investigation plan

Vepsitamab

Key facts

• Active Substance:
  Vepsitamab
• Therapeutic area:
  Oncology
• Decision number:
  P/0406/2022
• PIP number:
  EMEA-003230-PIP01-22
• Pharmaceutical form(s):
  All pharmaceutical forms
• Condition(s) / indication(s):
  • Treatment of colorectal carcinoma
  • Treatment of gastric and gastro-oesophageal junction cancer
  • Treatment of pancreatic cancer
• Route(s) of administration:
  All routes of administration
• Contact for public enquiries:

  Amgen Europe B.V

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

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  09/09/2022

Decision

P/0406/2022: EMA decision of 9 September 2022 on the granting of a product specific waiver for vepsitamab (EMEA-003230-PIP01-22)

Reference Number: EMA/709251/2022