Midazolam hydrochloride

Key facts

Invented name
Buccolam
Active substance
Midazolam Hydrochloride
Therapeutic area
Neurology
Decision number
P/155/2009
PIP number
Midazolam hydrochloride
Pharmaceutical form(s)
Oromucosal solution
Condition(s) / indication(s)
Epileptic seizures
Route(s) of administration
Oromucosal use
Contact for public enquiries
Auralis Limited
E-mail: medinfo@auralis.co.uk
Country: United Kingdom
Phone: +44 1748828868
Fax: +44 8703837414
Decision type
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Compliance procedure number
EMEA-C-000395-PIP01-08
Compliance opinion date
06/08/2010
Compliance outcome
positive

Decision

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