EMA/PE/0000232774 - paediatric investigation plan

7-fluoro-1-isopropyl-3-methyl-8-(6-(3-(piperidin-1-yl)propoxy)pyridin-3-yl)-1,3-dihydro-2H-imidazo[4,5-c]quinolin-2-one (AZD1390)

Key facts

• Active substance:
  7-fluoro-1-isopropyl-3-methyl-8-(6-(3-(piperidin-1-yl)propoxy)pyridin-3-yl)-1,3-dihydro-2H-imidazo[4,5-c]quinolin-2-one (AZD1390)
• Therapeutic area:
  Neoplasms benign, malignant and unspecified (incl cysts and polyps)
• Decision number:
  EMA/PE/0000232774
• PIP number:
  EMA/PE/0000232774
• Pharmaceutical form(s):
  • Film-coated tablet
  • Age-appropriate oral dosage form
• Condition(s) / indication(s):
  Treatment of malignant neoplasms of the central nervous system
• Route(s) of administration:
  • Oral use
  • Gastric use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  16/04/2025
• Compliance check done:
  Ne

Decision

EMA/PE/0000232774 : EMA decision of 16 April 2025 on the agreement of a paediatric investigation plan and on the granting of a deferral for 7-fluoro-1- isopropyl-3-methyl-8-(6-(3-(piperidin-1-yl)propoxy)pyridin-3-yl)-1,3-dihydro-2H-imidazo.....(AZD1390)

Adopted Reference Number: EMADOC-1700519818-2022970