EMEA-003557-PIP01-23 - paediatric investigation plan

petosemtamab

Key facts

• Active substance:
  petosemtamab
• Therapeutic area:
  Neoplasms benign, malignant and unspecified (incl cysts and polyps)
• Decision number:
  P/0147/2024
• PIP number:
  EMEA-003557-PIP01-23
• Pharmaceutical form(s):
  Solution for infusion
• Condition(s) / indication(s):
  Treatment of head and neck epithelial malignant neoplasms
• Route(s) of administration:
  Intravenous use
• 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/0147/2024: EMA decision of 6 May 2024 on the granting of a product specific waiver for petosemtamab (EMEA-003557-PIP01-23)

Adopted Reference Number: EMA/155809/2024