EMA/PE/0000232782 - paediatric investigation plan

(1r,2s)-1-(6-bromo-2-methoxyquinolin-3-yl)-2-(2,6-dimethoxypyridin-4-yl)-4-(dimethylamino)-1-(2,3,6-trimethoxypyridin-4-yl)butan-2-ol tartrate

Key facts

• Active substance:
  (1r,2s)-1-(6-bromo-2-methoxyquinolin-3-yl)-2-(2,6-dimethoxypyridin-4-yl)-4-(dimethylamino)-1-(2,3,6-trimethoxypyridin-4-yl)butan-2-ol tartrate
• Therapeutic area:
  Infections and infestations
• Decision number:
  EMA/PE/0000232782
• PIP number:
  EMA/PE/0000232782
• Pharmaceutical form(s):
  • Tablet
  • Age-appropriate formulation
• Route(s) of administration:
  Oral use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  15/03/2025
• Compliance check done:
  Ne

Decision

EMA/PE/0000232782 : EMA decision of 15 May 2025 on agreement of a PIP and on granting of a deferral for (1R,2S)-1-(6- Bromo-2-methoxyquinolin-3-yl)-2-(2,6-dimethoxypyridin-4-yl)-4-(dimethylamino)-1-(2,3,6- trimethoxypyridin-4-yl)butan-2-ol tartrate

Adopted Reference Number: EMADOC-1700519818-2117850