EMEA-003429-PIP02-23 - paediatric investigation plan

domvanalimab

Key facts

• Active substance:
  domvanalimab
• Therapeutic area:
  Oncology
• Decision number:
  P/0330/2023
• PIP number:
  EMEA-003429-PIP02-23
• Pharmaceutical form(s):
  All pharmaceutical forms
• Condition(s) / indication(s):
  • Treatment of gastric and gastroesophageal junction adenocarcinoma
  • Treatment of oesophageal carcinoma
• Route(s) of administration:
  All routes of administration
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  08/08/2023
• Compliance check done:
  No

Decision

P/0330/2023 : EMA decision of 8 August 2023 on the granting of a product specific waiver for domvanalimab, (EMEA-003429-PIP02-23)

Reference Number: EMA/344572/2023