EMEA-002727-PIP02-23 - paediatric investigation plan

relatlimab

nivolumab

Key facts

• Invented name:
  Opdualag
• Active substance:
  • relatlimab
  • nivolumab
• Therapeutic area:
  Neoplasms benign, malignant and unspecified (incl cysts and polyps)
• Decision number:
  P/0458/2023
• PIP number:
  EMEA-002727-PIP02-23
• Pharmaceutical form(s):
  • Concentrate for solution for infusion
  • Solution for injection
• Condition(s) / indication(s):
  Treatment of all conditions included in the category of malignant neoplasms (except central nervous system tumours, hematopoietic and lymphoid tissue neoplasms and melanoma)
• Route(s) of administration:
  • Subcutaneous use
  • Intravenous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  01/12/2023
• Compliance check done:
  No

Decision

P/0458/2023 : EMA decision of 1 December 2023 on the granting of a product-specific waiver for nivolumab / relatlimab (Opdualag), (EMEA-002727PIP02-23)

Adopted Reference Number: EMA/526337/2023