EMEA-002727-PIP03-23 - paediatric investigation plan

nivolumab

relatlimab

Key facts

• Invented name:
  Opdualag
• Active substance:
  • nivolumab
  • relatlimab
• Therapeutic area:
  Neoplasms benign, malignant and unspecified (incl cysts and polyps)
• Decision number:
  P/0169/2024
• PIP number:
  EMEA-002727-PIP03-23
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of melanoma
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  06/05/2024
• Compliance check done:
  Ne

Decision

P/0169/2024: EMA decision of 6 May 2024 on the agreement of a paediatric investigation plan and on the granting of a waiver for nivolumab / relatlimab (Opdualag), (EMEA-002727-PIP03-23)

Adopted Reference Number: EMA/178738/2024