EMA/PE/0000232936 - paediatric investigation plan

atigotatug

nivolumab

Key facts

• Active substance:
  • atigotatug
  • nivolumab
• Therapeutic area:
  Neoplasms benign, malignant and unspecified (incl cysts and polyps)
• Decision number:
  EMA/PE/0000232936
• PIP number:
  EMA/PE/0000232936
• Pharmaceutical form(s):
  All pharmaceutical forms
• Condition(s) / indication(s):
  Treatment of small cell lung cancer
• 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:
  21/03/2025
• Compliance check done:
  Nu

Decision

EMA/PE/0000232936: EMA decision of 21 March 2025 on the granting of a product specific waiver for atigotatug / nivolumab

Adopted Reference Number: EMADOC-1700519818-1979356