EMEA-001177-PIP02-20 - paediatric investigation plan

trametinib

Key facts

• Active Substance:
  trametinib
• Therapeutic area:
  Oncology
• Decision number:
  P/0424/2020
• PIP number:
  EMEA-001177-PIP02-20
• Pharmaceutical form(s):
  • Film-coated tablet
  • Powder for oral solution
• Condition(s) / indication(s):
  Treatment of glioma
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Novartis Europharm Limited

  E-mail: [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:
  23/10/2020
• Compliance procedure number:
  EMEA-C-001177-PIP02-20
• Compliance opinion date:
  27/09/2022
• Compliance outcome:
  Positive

Decision

P/0424/2020 : EMA decision of 23 October 2020 on the agreement of a paediatric investigation plan and on the granting of a waiver for trametinib (EMEA-001177-PIP02-20)

AdoptedReference Number: EMA/494583/2020