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- Olanzapine Apotex
Community Register of medicinal products
Community register of medicinal products for human use |
AUTHORISED |
Product information |
| Invented name: | Olanzapine Apotex
This product is authorized under a different brandname in the EU in the folowing languages:
- Olanzapin Apotex (DA)
- Olanzapin Apotex (DE)
- Olanzapina Apotex (IT)
|
| Auth. number : | EU/1/10/635 |
| INN : | Olanzapine |
| ATC: | N - Nervous system N05 - Psycholeptics N05A - Antipsychotics N05AH - Diazepines, oxazepines, thiazepines and oxepines N05AH03 - Olanzapine (See WHO ATC Index) |
| Indication: | Treatment of schizophrenia, treatment of moderate to severe manic episode. |
| Marketing Authorisation Holder: | Apotex Europe B.V.
Darwinweg 20, NL- 2333 CR Leiden, Nederland |
EPAR and active package presentations
Package presentations
|
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. |
European Commission procedures
| Close date procedure | Procedure type | EMEA number | Decision | summary publ | decision docs | annex |
| 14/06/2010 | Centralised - Authorisation | EMEA/H/C/1178 | (2010)3884 of 10/06/2010 | |||
| 22/11/2010 | Centralised - Variation | EMEA/H/C/1178/IB/1 | ||||
| Updated with Decision(2011)3441 of 12/05/2011 | ||||||
| 16/05/2011 | Centralised - Variation | - | (2011)3441 of 12/05/2011 | |||
| 07/06/2011 | Centralised - Variation | EMEA/H/C/1178/IB/4/G | ||||
| Updated with Decision(2012)771 of 06/02/2012 | ||||||
| 21/11/2011 | Centralised - Variation | EMEA/H/C/1178/IB/6 | ||||
| Updated with Decision(2012)771 of 06/02/2012 | ||||||
| 07/02/2012 | Centralised - Variation | EMEA/H/C/1178/IB/7 | ||||
| Updated with Decision(2012)6711 of 20/09/2012 | ||||||
| 08/02/2012 | Centralised - Variation | - | (2012)771 of 06/02/2012 | |||
| 24/09/2012 | Centralised - Variation | - | (2012)6711 of 20/09/2012 | |||
| 10/10/2012 | Centralised - Variation | EMEA/H/C/1178/IB/12 | ||||
| Updated with Decision(2012)8701 of 22/11/2012 | ||||||
| 26/11/2012 | Centralised - Variation | - | (2012)8701 of 22/11/2012 |