EMEA-003455-PIP01-23 - paediatric investigation plan

Methyl-(1-{[6-{[(1S)-1-cyclopropylethyl]amino}-2-(pyrazolo[5,1-b][1,3]thiazol-7-yl)-pyrimidin-4-yl]carbonyl}piperidin-4-yl)carbamate mono(4-methylbenzenesulfonate)

Key facts

• Active substance:
  Methyl-(1-{[6-{[(1S)-1-cyclopropylethyl]amino}-2-(pyrazolo[5,1-b][1,3]thiazol-7-yl)-pyrimidin-4-yl]carbonyl}piperidin-4-yl)carbamate mono(4-methylbenzenesulfonate)
• Therapeutic area:
  Oncology
• Decision number:
  P/0425/2023
• PIP number:
  EMEA-003455-PIP01-23
• Pharmaceutical form(s):
  All pharmaceutical forms
• Condition(s) / indication(s):
  Treatment of lung cancer
• Route(s) of administration:
  All routes of administration
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  27/10/2023
• Compliance check done:
  No

Decision

P/0425/2023 : EMA decision of 27 October 2023 on the granting of a product specific waiver for 2-((R)-3-(1-(1-((R)-1-(2,4-dichlorophenyl)ethyl)-3- (trifluoromethyl)-......benzenesulfonate,(EMEA-003455-PIP01-23)

Adopted Reference Number: EMA/469371/2023