EMEA-001407-PIP03-20 - paediatric investigation plan

nivolumab

Key facts

• Invented name:
  Opdivo
• Active substance:
  nivolumab
• Therapeutic area:
  Oncology
• Decision number:
  P/0280/2020
• PIP number:
  EMEA-001407-PIP03-20
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of all conditions in the category of malignant neoplasms (except central nervous system neoplasms, haematopoietic and lymphoid tissue neoplasms other than Hodgkin lymphoma)
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  20/07/2020
• Compliance check done:
  No

Decision

P/0280/2020 : EMA decision of 20 July 2020 on the granting of a product specific waiver for Nivolumab (Opdivo) (EMEA-001407-PIP03-20)

Adopted Reference Number: EMA/392270/2020