EMEA-000228-PIP01-08-M04

Key facts

Invented name
Sycrest
Active substance
Asenapine (maleate)
Therapeutic area
Psychiatry
Decision number
P/0299/2014
PIP number
EMEA-000228-PIP01-08-M04
Pharmaceutical form(s)
Sublingual tablets
Condition(s) / indication(s)
Treatment of bipolar I disorder
Route(s) of administration
Oral use
Contact for public enquiries
N.V. Organon
The Netherlands
Tel. +33 180464738
E-mail: pip.information@merck.com
Decision type
PM: decision on the application for modification of an agreed PIP
Compliance procedure number
EMEA-C-000228-PIP01-08-M04
Compliance opinion date
18/08/2017
Compliance outcome
positive

Decision

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