Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Olanzapine Glenmark   
Auth. number : EU/1/09/587
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.
Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response.
Olanzapine is indicated for the treatment of moderate to severe manic episode. In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder.
Marketing Authorisation Holder: Glenmark Pharmaceuticals Europe Limited
Laxmi House, 2B Draycott Avenue, Kenton, Middlesex, HA3 0BU, United Kingdom

  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
07/12/2009 Centralised - Authorisation EMEA/H/C/1085 (2009)9923 of 03/12/2009
01/06/2010 Centralised - Variation EMEA/H/C/1085/WS/2 (2010)3496 of 26/05/2010
27/01/2011 Centralised - Variation EMEA/H/C/1085/WS/68 (2011)459 of 24/01/2011
08/12/2011 Centralised - Variation EMEA/H/C/1085/IG/123
Updated with Decision(2012)1378 of 27/02/2012
29/02/2012 Centralised - Variation EMEA/H/C/1085/WS/202 (2012)1378 of 27/02/2012
20/04/2012 Centralised - Variation EMEA/H/C/1085/N/7
Updated with Decision(2012)5093 of 16/07/2012
18/07/2012 Centralised - Variation EMEA/H/C/1085/WS/262 (2012)5093 of 16/07/2012
23/08/2012 Centralised - Variation EMEA/H/C/1085/IG/202/G
Updated with Decision(2012)7727 of 25/10/2012
29/10/2012 Centralised - Variation EMEA/H/C/1085/WS/285 (2012)7727 of 25/10/2012
12/12/2012 Centralised - Variation EMEA/H/C/1085/WS/319 (2012)9544 of 10/12/2012
23/01/2014 Centralised - Variation EMEA/H/C/1085/WS/424
17/02/2014 Centralised - Variation EMEA/H/C/1085/IG/412/G
06/03/2014 Centralised - Variation EMEA/H/C/1085/IB/17/G