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||
27/10/2021 Sycrest - EMEA/H/C/001177 - N/0043
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Sycrest is indicated for the treatment of moderate to severe manic episodes associated with bipolar I disorder in adults.