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Community Register of medicinal products

Community register of medicinal products for human use
AUTHORISED  

Product information
Invented name: Sycrest   
Auth. number : EU/1/10/640
INN : asenapine
ATC: N - Nervous system
N05 - Psycholeptics
N05A - Antipsychotics
N05AH - Diazepines, oxazepines, thiazepines and oxepines
N05AH05 - Asenapine
(See WHO ATC Index)
Indication: Treatment of moderate to severe manic episodes associated with bipolar 1disorder in adults
Marketing Authorisation Holder: Organon N.V.
Kloosterstraat 6, NL-5349 AB Oss, Nederland

  EPAR and active package presentations

Package presentations

The section of the Community Register "Package presentations" will no longer be updated as from 2 November 2012.
Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which continues to be available in the Community Register.

 

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
06/09/2010 Centralised - Authorisation EMEA/H/C/1177 (2010)6136 of 01/09/2010
28/01/2011 Centralised - Variation EMEA/H/C/1177/N/1
Updated with Decision(2011)5606 of 27/07/2011
02/08/2011 Centralised - Variation EMEA/H/C/1177/II/3 (2011)5606 of 27/07/2011
26/10/2011 Centralised - Variation EMEA/H/C/1177/II/5 (2011)7791 of 24/10/2011
02/07/2012 Centralised - Variation EMEA/H/C/1177/II/8 (2012)4497 of 27/06/2012
17/10/2012 Centralised - Variation EMEA/H/C/1177/IB/10
Updated with Decision(2012)7928 of 29/10/2012
06/11/2012 Centralised - Variation - (2012)7928 of 29/10/2012
13/12/2012 Centralised - Variation EMEA/H/C/1177/II/11
21/02/2013 Centralised - Variation EMEA/H/C/1177/II/12