EMEA-003485-PIP01-23 - paediatric investigation plan

N-(2-((2-(dimethylamino)ethyl)(methyl)amino)-5-((4-(1-methyl-1H-indol-3-yl)pyrimidin-2-yl)amino)- 6-(2,2,2-trifluoroethoxy)pyridin-3-yl)acrylamide methanesulfonate

Key facts

• Active Substance:
  N-(2-((2-(dimethylamino)ethyl)(methyl)amino)-5-((4-(1-methyl-1H-indol-3-yl)pyrimidin-2-yl)amino)- 6-(2,2,2-trifluoroethoxy)pyridin-3-yl)acrylamide methanesulfonate
• Therapeutic area:
  Neoplasms benign, malignant and unspecified (incl cysts and polyps)
• Decision number:
  P/0174/2024
• PIP number:
  EMEA-003485-PIP01-23
• 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
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  03/05/2024

Decision

P/0174/2024: EMA decision of 3 May 2024 on the granting of a product specific waiver for N-(2-((2-(dimethylamino)ethyl)(methyl)amino)-5-((4- (1-methyl-1H-indol-3-yl)pyrimidin-2-yl)amino)-6-(2,2,2-trifluoroethoxy)pyridin-3-yl)acrylamide methanesulfonate

Reference Number: EMA/182137/2024