Sycrest

RSS

asenapine

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Sycrest. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Sycrest.

This EPAR was last updated on 20/03/2018

Authorisation details

Product details
Name
Sycrest
Agency product number
EMEA/H/C/001177
Active substance
asenapine maleate 
International non-proprietary name (INN) or common name
asenapine
Therapeutic area (MeSH)
Bipolar Disorder
Anatomical therapeutic chemical (ATC) code
N05AH05
Publication details
Marketing-authorisation holder
N.V. Organon
Revision
15
Date of issue of marketing authorisation valid throughout the European Union
01/09/2010
Contact address
Kloosterstraat 6
NL-5349 AB Oss
The Netherlands

Product information

08/02/2018 Sycrest - EMEA/H/C/001177 - II/0030

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Psycholeptics

Therapeutic indication

Sycrest is indicated for the treatment of moderate to severe manic episodes associated with bipolar I disorder in adults.

Assessment history

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