EMEA-002351-PIP01-18 - paediatric investigation plan

spartalizumab

Key facts

• Active substance:
  spartalizumab
• Therapeutic area:
  Oncology
• Decision number:
  P/0089/2019
• PIP number:
  EMEA-002351-PIP01-18
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of melanoma
• Route(s) of administration:
  Intravenous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  22/03/2019
• Compliance check done:
  No

Decision

P/0089/2019: EMA decision of 22 March 2019 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for spartalizumab (EMEA-002351-PIP01-18)

Adopted Reference Number: EMA/65170/2019