EMEA-002765-PIP02-21 - paediatric investigation plan

Ribociclib

Key facts

• Invented name:
  Kisqali
• Active Substance:
  Ribociclib
• Therapeutic area:
  Oncology
• Decision number:
  P/0020/2022
• PIP number:
  EMEA-002765-PIP02-21
• Pharmaceutical form(s):
  • Age-appropriate oral liquid dosage form
  • Film-coated tablet
• Condition(s) / indication(s):
  Treatment of neuroblastoma
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Novartis Europharm Limited

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

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  31/01/2022

Decision

P/0020/2022 : EMA decision of 31 January 2022 on the agreement of a paediatric investigation plan and on the granting of a waiver for ribociclib (Kisqali), (EMEA-002765-PIP02-21)

AdoptedReference Number: EMA/8294/2022