Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Zalasta   
Auth. number : EU/1/07/415
INN : 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: Olanzapine is indicated for the treatment of schizophrenia
Marketing Authorisation Holder: Krka, d. d., Novo Mesto
Šmarješka cesta 6, 8501 Novo mesto, Slovenija

  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
01/10/2007 Centralised - Authorisation EMEA/H/C/792 (2007)4518 of 27/09/2007
06/12/2007 Centralised - Variation EMEA/H/C/792/IA/2
14/01/2008 Centralised - Variation EMEA/H/C/792/N/1
Updated with Decision(2008)1316 of 02/04/2008
04/04/2008 Centralised - Variation EMEA/H/C/792/II/3 (2008)1316 of 02/04/2008
10/07/2008 Centralised - Variation EMEA/H/C/795/II/4 (2008)3589 of 08/07/2008
26/08/2008 Centralised - Variation EMEA/H/C/792/II/5 (2008)4648 of 22/08/2008
28/11/2008 Centralised - Variation EMEA/H/C/792/II/6 (2008)7693 of 26/11/2008
20/05/2009 Centralised - Variation EMEA/H/C/792/IA/8
21/07/2009 Centralised - Variation EMEA/H/C/792/II/7 (2009)5871 of 17/07/2009
04/11/2009 Centralised - Variation EMEA/H/C/792/II/9 (2009)8605 of 30/10/2009
03/11/2010 Centralised - Variation EMEA/H/C/792/IB/12
Updated with Decision(2011)5389 of 20/07/2011
16/03/2011 Centralised - Variation EMEA/H/C/792/IB/13
Updated with Decision(2011)5389 of 20/07/2011
25/07/2011 Centralised - Variation (2011)5389 of 20/07/2011
07/02/2012 Centralised - Variation EMEA/H/C/792/IB/16/G
Updated with Decision(2012)5473 of 26/07/2012
07/06/2012 Centralised - Variation EMEA/H/C/792/IA/15/G
Updated with Decision(2012)5473 of 26/07/2012
30/07/2012 Centralised - Renewal EMEA/H/C/792/R/19 (2012)5473 of 26/07/2012
26/09/2012 Centralised - Variation EMEA/H/C/792/IB/20
Updated with Decision(2012)7919 of 29/10/2012
06/11/2012 Centralised - Variation (2012)7919 of 29/10/2012
09/07/2013 Centralised - Variation EMEA/H/C/792/N/21
19/08/2013 Centralised - Variation EMEA/H/C/792/IB/22
11/02/2014 Centralised - Variation EMEA/H/C/792/IB/24/G