Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Olazax Disperzi   
Auth. number : EU/1/09/592
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 s.r.o.
City Tower, Hvězdova 1716/2b, CZ-14078 Praha 4, Česká republika

  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
14/12/2009 Centralised - Authorisation EMEA/H/C/1088 (2009)10229 of 10/12/2009
28/05/2010 Centralised - Variation EMEA/H/C/1088/WS/2 (2010)3500 of 26/05/2010
25/01/2011 Centralised - Variation EMEA/H/C/1088/WS/68 (2011)394 of 21/01/2011
09/01/2012 Centralised - Variation EMEA/H/C/1088/IG/132/G
Updated with Decision(2012)891 of 09/02/2012
13/02/2012 Centralised - Variation EMEA/H/C/1088/IB/WS/202 (2012)891 of 09/02/2012
27/08/2012 Centralised - Variation EMEA/H/C/1088/IB/WS/263 (2012)6038 of 23/08/2012
29/10/2012 Centralised - Variation EMEA/H/C/1088/IB/WS/285 (2012)7737 of 25/10/2012
30/01/2013 Centralised - Variation EMEA/H/C/1088/WS/319 (2013)527 of 28/01/2013
23/01/2014 Centralised - Variation EMEA/H/C/1088/IB/WS/424