EMA/PE/0000239927 - paediatric investigation plan

[2-Chloro-3-(trifluoromethyl)phenyl][(4R)-1-(5-fluoro-2-pyrimidinyl)-4-methyl-1,4,6,7-tetrahydro-5H-[1,2,3]triazolo[4,5-c]pyridin-5-yl]methanone

Key facts

• Active substance:
  [2-Chloro-3-(trifluoromethyl)phenyl][(4R)-1-(5-fluoro-2-pyrimidinyl)-4-methyl-1,4,6,7-tetrahydro-5H-[1,2,3]triazolo[4,5-c]pyridin-5-yl]methanone
• Therapeutic area:
  Nervous system disorders
• Decision number:
  EMA/PE/0000239927
• PIP number:
  EMA/PE/0000239927
• Pharmaceutical form(s):
  • Capsule, hard
  • Oral suspension
• Condition(s) / indication(s):
  Treatment of amyotrophic lateral sclerosis
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  27/03/2025
• Compliance check done:
  No

Decision

EMA/PE/0000239927: EMA decision of 27 March 2025 on the granting of a product specific waiver for [2-Chloro-3-(trifluoromethyl)phenyl][(4R)-1-(5-fluoro- 2-pyrimidinyl)-4-methyl-1,4,6,7-tetrahydro-5H-[1,2,3]triazolo[4,5-c]pyridin-5-yl]methanone

Adopted Reference Number: EMADOC-1700519818-2008276