EMA/PE/0000238070 - paediatric investigation plan

[4-(Methyl-1H-pyrazol-4-yl)-benzyl]-(6[7-(3-pyrrolidin-1-yl-propoxy)-imidazo[1,2-a]pyridin-3-yl]-pyrimidin-4-yl]-amine

Key facts

• Active substance:
  [4-(Methyl-1H-pyrazol-4-yl)-benzyl]-(6[7-(3-pyrrolidin-1-yl-propoxy)-imidazo[1,2-a]pyridin-3-yl]-pyrimidin-4-yl]-amine
• Therapeutic area:
  Neoplasms benign, malignant and unspecified (incl cysts and polyps)
• Decision number:
  EMA/PE/0000238070
• PIP number:
  EMA/PE/0000238070
• Pharmaceutical form(s):
  • Capsule
  • Film-coated tablet
• Condition(s) / indication(s):
  Treatment of gastrointestinal stromal tumours
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  14/04/2025
• Compliance check done:
  Nei

Decision

EMA/PE/0000238070: EMA decision of 14 April 2025 on the granting of a product specific waiver for [4-(Methyl-1H-pyrazol-4-yl)-benzyl]-(6[7-(3-pyrrolidin-1-yl-propoxy)-imidazo[1,2-a]pyridin-3-yl]-pyrimidin-4-yl]-amine

Adopted Reference Number: EMADOC-1700519818-2039214