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.
Sycrest : EPAR - Summary for the public (PDF/83.12 KB)
First published: 22/09/2010
Last updated: 26/01/2016
|Agency product number||
asenapine (as maleate)
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
|Date of issue of marketing authorisation valid throughout the European Union||
28/07/2020 Sycrest - EMEA/H/C/001177 - IA/0037
- 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
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Sycrest is indicated for the treatment of moderate to severe manic episodes associated with bipolar I disorder in adults.