EMEA-002716-PIP01-19 - paediatric investigation plan

propan-2-yl 2-[5-( acryloylamino )-4-{ [2-( dimethylamino )ethyl] ( methyl)amino }-2-methoxyanilino ]-4- ( 1 methyl-1 H-indol-3-yl)pyrimidine-5-carboxylate

Key facts

• Active substance:
  propan-2-yl 2-[5-( acryloylamino )-4-{ [2-( dimethylamino )ethyl] ( methyl)amino }-2-methoxyanilino ]-4- ( 1 methyl-1 H-indol-3-yl)pyrimidine-5-carboxylate
• Therapeutic area:
  Oncology
• Decision number:
  P/0161/2020
• PIP number:
  EMEA-002716-PIP01-19
• Pharmaceutical form(s):
  Capsule, hard
• Condition(s) / indication(s):
  Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid tissue neoplasms)
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  16/04/2020
• Compliance check done:
  No

Decision

P/0161/2020: EMA decision of 16 April 2020 on the granting of a product specific waiver for propan-2-yl 2-[5-(acryloylamino)-4-{[2-(dimethylamino)ethyl](methyl)amino}-2-methoxyanilino]-4-(1methyl-1H-indol-3-yl)pyrimidine-5-carboxylate (TAK-788)

Adopted Reference Number: EMA/194800/2020