Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Olanzapine Apotex   

   This product is authorised under a different brandname in the EU in the folowing languages:
   - Olanzapin Apotex (DA)
   - Olanzapin Apotex (DE)
   - Olanzapina Apotex (IT)
Auth. number : EU/1/10/635
Active substance : Olanzapine
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: N05AH03 - Olanzapine
(See WHO ATC Index)
Indication: Treatment of schizophrenia, treatment of moderate to severe manic episode.
Marketing Authorisation Holder: Apotex Europe B.V.
Darwinweg 20, NL- 2333 CR Leiden, 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
14/06/2010 Centralised - Authorisation EMEA/H/C/1178 (2010)3884 of 10/06/2010
22/11/2010 Centralised - Variation EMEA/H/C/1178/IB/1
Updated with Decision(2011)3441 of 12/05/2011
16/05/2011 Centralised - Variation (2011)3441 of 12/05/2011
07/06/2011 Centralised - Variation EMEA/H/C/1178/IB/4/G
Updated with Decision(2012)771 of 06/02/2012
21/11/2011 Centralised - Variation EMEA/H/C/1178/IB/6
Updated with Decision(2012)771 of 06/02/2012
07/02/2012 Centralised - Variation EMEA/H/C/1178/IB/7
Updated with Decision(2012)6711 of 20/09/2012
08/02/2012 Centralised - Variation (2012)771 of 06/02/2012
24/09/2012 Centralised - Variation (2012)6711 of 20/09/2012
10/10/2012 Centralised - Variation EMEA/H/C/1178/IB/12
Updated with Decision(2012)8701 of 22/11/2012
26/11/2012 Centralised - Variation (2012)8701 of 22/11/2012
05/08/2013 Centralised - Variation EMEA/H/C/1178/IB/14
Updated with Decision(2014)5495 of 28/07/2014
29/07/2014 Centralised - Yearly update (2014)5495 of 28/07/2014
03/09/2014 Centralised - Variation EMEA/H/C/1178/IB/21
Updated with Decision(2015)874 of 11/02/2015
16/02/2015 Centralised - Renewal EMEA/H/C/1178/R/22 (2015)874 of 11/02/2015