EMEA-002573-PIP02-23 - paediatric investigation plan

amivantamab

Key facts

• Invented name:
  Rybrevant
• Active substance:
  amivantamab
• Therapeutic area:
  Neoplasms benign, malignant and unspecified (incl cysts and polyps)
• Decision number:
  P/0166/2024
• PIP number:
  EMEA-002573-PIP02-23
• Pharmaceutical form(s):
  All pharmaceutical forms
• Condition(s) / indication(s):
  Treatment of colorectal 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:
  06/05/2024
• Compliance check done:
  No

Decision

P/0166/2024: EMA decision of 6 May 2024 on the granting of a product specific waiver for amivantamab (Rybrevant), (EMEA-002573-PIP02-23)

Adopted Reference Number: EMA/178740/2024