Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Sycrest   
Auth. number : EU/1/10/640
INN : asenapine
ATC: Anatomical main group: N - Nervous system
Therapeutic subgroup: N05 - Psycholeptics
Pharmacological subgroup: N05A - Antipsychotics
Chemical subgroup: N05AH - Diazepines, oxazepines, thiazepines and oxepines
Chemical substance: 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

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 is 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 - Notification 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
Updated with Decision(2014)996 of 11/02/2014
21/02/2013 Centralised - Variation EMEA/H/C/1177/II/12
Updated with Decision(2014)996 of 11/02/2014
23/01/2014 Centralised - Notification EMEA/H/C/177/N/15
Updated with Decision(2014)996 of 11/02/2014
13/02/2014 Centralised - Yearly update (2014)996 of 11/02/2014