EMEA-002846-PIP01-20 - paediatric investigation plan

lurbinectedin

Key facts

• Active substance:
  lurbinectedin
• Therapeutic area:
  Oncology
• Decision number:
  P/0446/2020
• PIP number:
  EMEA-002846-PIP01-20
• Pharmaceutical form(s):
  Powder for concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of small cell lung cancer
• Route(s) of administration:
  Intravenous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  01/12/2020
• Compliance check done:
  Ne

Decision

P/0446/2020 : EMA decision of 1 December 2020 on the granting of a product specific waiver for lurbinectedin (EMEA-002846-PIP01-20)

Adopted Reference Number: EMA/578894/2020