EMEA-002057-PIP01-16 - paediatric investigation plan

5-(4-Fluoro-1-benzothiophen-2-yl)-8-methyl-1,9-dihydro-2H-[1,3]oxazolo[4,5-H][2,3]benzodiazepin-2-one (S44819)

Key facts

• Active substance:
  5-(4-Fluoro-1-benzothiophen-2-yl)-8-methyl-1,9-dihydro-2H-[1,3]oxazolo[4,5-H][2,3]benzodiazepin-2-one (S44819)
• Therapeutic area:
  Neurology
• Decision number:
  P/0286/2017
• PIP number:
  EMEA-002057-PIP01-16
• Pharmaceutical form(s):
  Powder for oral suspension
• Condition(s) / indication(s):
  Treatment of ischemic stroke to improve recovery
• 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:
  04/10/2017
• Compliance check done:
  No

Decision

P/0286/2017: EMA decision of 4 October 2017 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for 5-(4-Fluoro-1-benzothiophen-2-yl)-8-methyl-1,9-dihydr...

Adopted Reference Number: EMA/565789/2017