EMEA-003364-PIP02-22 - paediatric investigation plan

1-((S)-4-((R)-7-(6-amino-4-methyl-3-(trifluoromethyl)pyridin-2-yl)-6-chloro-8-fluoro- 2-(((S)-1-methylpyrrolidin-2-yl)methoxy)quinazolin-4-yl)-3-methylpiperazin-1-yl)prop- 2-en-1-one adipate

Key facts

• Active Substance:
  1-((S)-4-((R)-7-(6-amino-4-methyl-3-(trifluoromethyl)pyridin-2-yl)-6-chloro-8-fluoro- 2-(((S)-1-methylpyrrolidin-2-yl)methoxy)quinazolin-4-yl)-3-methylpiperazin-1-yl)prop- 2-en-1-one adipate
• Therapeutic area:
  Oncology
• Decision number:
  P/0181/2023
• PIP number:
  EMEA-003364-PIP02-22
• Pharmaceutical form(s):
  All pharmaceutical forms
• Condition(s) / indication(s):
  Treatment of non-small cell lung cancer
• Route(s) of administration:
  All routes of administration
• Contact for public enquiries:

  Roche Registration GmbH; E-mail: [e-mail] ; Tel. [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  15/05/2023

Decision

P/0181/2023 : EMA decision of 15 May 2023 on the granting of a product specific waiver for 1-((S)-4-((R)-7-(6-amino-4-methyl-3- (trifluoromethyl)pyridin-2-yl)-6-chloro-8-fluoro-2-(((S)-1-methylpyrrolidin-2-yl).....(EMEA-003364-PIP02-22)

AdoptedReference Number: EMA/176269/2023