EMEA-002057-PIP01-16

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
Contact for public enquiries
Les Laboratoires Servier
Tel. + 33 1 55 72 60 00
E-mail: mail.pip.enquiries@servier.com
Decision type
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)

Decision

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