Sycrest
asenapine
Table of contents
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.
Authorisation details
Product details | |
---|---|
Name |
Sycrest
|
Agency product number |
EMEA/H/C/001177
|
Active substance |
asenapine (as 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 |
21
|
Date of issue of marketing authorisation valid throughout the European Union |
01/09/2010
|
Contact address |
Kloosterstraat 6 |
Product information
07/12/2022 Sycrest - EMEA/H/C/001177 - IAIN/0046
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
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.
Pharmacotherapeutic group
Psycholeptics
Therapeutic indication
Sycrest is indicated for the treatment of moderate to severe manic episodes associated with bipolar I disorder in adults.