EMEA-002846-PIP02-22 - paediatric investigation plan

Lurbinectedin

Key facts

• Active Substance:
  Lurbinectedin
• Therapeutic area:
  Oncology
• Decision number:
  P/0229/2022
• PIP number:
  EMEA-002846-PIP02-22
• Pharmaceutical form(s):
  All pharmaceutical forms
• Condition(s) / indication(s):
  Treatment of malignant mesothelioma
• Route(s) of administration:
  All routes of administration
• Contact for public enquiries:

  Pharma Mar, S.A.

  Email: [e-mail]; Tel. [phone];

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  08/07/2022

Decision

P/229/2022 : EMA decision of 8 July 2022 on the granting of a product specific waiver for lurbinectedin (EMEA-002846-PIP02-22)

AdoptedReference Number: EMA/575429/2022