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 10/11/2021

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
20
Date of issue of marketing authorisation valid throughout the European Union
01/09/2010
Contact address

Kloosterstraat 6
5349 AB Oss
The Netherlands

Product information

27/10/2021 Sycrest - EMEA/H/C/001177 - N/0043

Product information documents contain:

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.

Assessment history

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