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Community Register of medicinal products
Community register of medicinal products for human use
|Invented name:||Olanzapine Glenmark|
|Auth. number :||EU/1/09/587|
|ATC:||N - Nervous system|
N05 - Psycholeptics
N05A - Antipsychotics
N05AH - Diazepines, oxazepines, thiazepines and oxepines
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 Generics (Europe) Limited
Laxmi House, 2-B Draycott Avenue, Kenton, Harrow, Middlesex HA3 OBU, United Kingdom
The section of the Community Register "Package presentations" will no longer be updated as from 2 November 2012.
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 continues to be available in the Community Register.
|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|