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Pharmaceuticals - Community Register
Community register of medicinal products for human use
|Invented name:||Olanzapine Glenmark Europe|
|Auth. number :||EU/1/09/588|
|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 Generics (Europe) Limited
Laxmi House, 2-B Draycott Avenue, Kenton, Harrow, Middlesex HA3 0BU, 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/1086||(2009)9922 of 03/12/2009|
|01/06/2010||Centralised - Variation||EMEA/H/C/1086/WS/2||(2010)3497 of 26/05/2010|
|27/01/2011||Centralised - Variation||EMEA/H/C/1086/WS/68||(2011)460 of 24/01/2011|
|08/12/2011||Centralised - Variation||EMEA/H/C/1086/IG/123|
|Updated with Decision(2012)1379 of 27/02/2012|
|29/02/2012||Centralised - Variation||EMEA/H/C/1086/WS/202||(2012)1379 of 27/02/2012|
|29/05/2012||Centralised - Variation||EMEA/H/C/1086/N/7|
|Updated with Decision(2012)6138 of 30/08/2012|
|23/08/2012||Centralised - Variation||EMEA/H/C/1086/IG/202/G|
|Updated with Decision(2012)7728 of 25/10/2012|
|03/09/2012||Centralised - Variation||EMEA/H/C/1086/WS/263||(2012)6138 of 30/08/2012|
|29/10/2012||Centralised - Variation||EMEA/H/C/1086/WS/285||(2012)7728 of 25/10/2012|
|12/12/2012||Centralised - Variation||EMEA/H/C/1086/WS/319||(2012)9545 of 10/12/2012|