Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Olanzapine Teva   
Auth. number : EU/1/07/427
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: Adults
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 (see section 5.1).
Marketing Authorisation Holder: Teva Pharma B.V.
Computerweg 10, NL-3542 DR Utrecht, Nederland

  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
14/12/2007 Centralised - Authorisation EMEA/H/C/810 (2007)6454 of 12/12/2007
29/01/2008 Centralised - Variation EMEA/H/C/810/IA/4
Updated with Decision(2008)2735 of 10/06/2008
29/01/2008 Centralised - Variation EMEA/H/C/810/IA/5
Updated with Decision(2008)2735 of 10/06/2008
29/01/2008 Centralised - Variation EMEA/H/C/810/IA/6
Updated with Decision(2008)2735 of 10/06/2008
29/01/2008 Centralised - Variation EMEA/H/C/810/IA/7
Updated with Decision(2008)2735 of 10/06/2008
29/01/2008 Centralised - Variation EMEA/H/C/810/IA/8
Updated with Decision(2008)2735 of 10/06/2008
29/01/2008 Centralised - Variation EMEA/H/C/810/IA/9
Updated with Decision(2008)2735 of 10/06/2008
29/01/2008 Centralised - Variation EMEA/H/C/810/IA/10
Updated with Decision(2008)2735 of 10/06/2008
29/01/2008 Centralised - Variation EMEA/H/C/810/IA/11
Updated with Decision(2008)2735 of 10/06/2008
29/01/2008 Centralised - Variation EMEA/H/C/810/IA/2
Updated with Decision(2008)2735 of 10/06/2008
29/01/2008 Centralised - Variation EMEA/H/C/810/IA/3
Updated with Decision(2008)2735 of 10/06/2008
08/02/2008 Centralised - Variation EMEA/H/C/810/IB/13
Updated with Decision(2008)2735 of 10/06/2008
08/02/2008 Centralised - Variation EMEA/H/C/810/IB/14
Updated with Decision(2008)2735 of 10/06/2008
08/02/2008 Centralised - Variation EMEA/H/C/810/IB/15
Updated with Decision(2008)2735 of 10/06/2008
08/02/2008 Centralised - Variation EMEA/H/C/810/IB/16
Updated with Decision(2008)2735 of 10/06/2008
08/02/2008 Centralised - Variation EMEA/H/C/810/IB/12
Updated with Decision(2008)2735 of 10/06/2008
08/02/2008 Centralised - Variation EMEA/H/C/810/IB/18
Updated with Decision(2008)2735 of 10/06/2008
08/02/2008 Centralised - Variation EMEA/H/C/810/IB/19
Updated with Decision(2008)2735 of 10/06/2008
08/02/2008 Centralised - Variation EMEA/H/C/810/IB/20
Updated with Decision(2008)2735 of 10/06/2008
08/02/2008 Centralised - Variation EMEA/H/C/810/IB/21
Updated with Decision(2008)2735 of 10/06/2008
08/02/2008 Centralised - Variation EMEA/H/C/810/IB/17
Updated with Decision(2008)2735 of 10/06/2008
03/03/2008 Centralised - Variation EMEA/H/C/810/IB/23
Updated with Decision(2008)2735 of 10/06/2008
11/03/2008 Centralised - Variation EMEA/H/C/810/N/1
Updated with Decision(2008)2735 of 10/06/2008
29/05/2008 Centralised - Variation EMEA/H/C/810/IA/29
10/06/2008 Centralised - Variation EMEA/H/C/810/IB/27
11/06/2008 Centralised - Variation EMEA/H/C/810/IA/30
Updated with Decision(2008)4959 of 02/09/2008
11/06/2008 Centralised - Variation EMEA/H/C/810/IA/31
Updated with Decision(2008)4959 of 02/09/2008
12/06/2008 Centralised - Variation EMEA/H/C/810/IB/28
Updated with Decision(2008)4959 of 02/09/2008
12/06/2008 Centralised - Variation EMEA/H/C/810/II/24 (2008)2735 of 10/06/2008
07/08/2008 Centralised - Variation EMEA/H/C/810/IB/33
04/09/2008 Centralised - Variation EMEA/H/C/810/II/32 (2008)4959 of 02/09/2008
23/09/2008 Centralised - Variation EMEA/H/C/810/IB/35
Updated with Decision(2008)7467 of 21/11/2008
25/11/2008 Centralised - Variation EMEA/H/C/810/II/34 (2008)7467 of 21/11/2008
23/07/2009 Centralised - Variation EMEA/H/C/810/II/36 (2009)5902 of 20/07/2009
21/10/2009 Centralised - Variation EMEA/H/C/810/II/37 (2009)8265 of 19/10/2009
31/03/2010 Centralised - Variation EMEA/H/C/810/IB/38
Updated with Decision(2010)7617 of 28/10/2010
19/08/2010 Centralised - Variation EMEA/H/C/810/IA/39
Updated with Decision(2010)7617 of 28/10/2010
01/11/2010 Centralised - Variation (2010)7617 of 28/10/2010
12/11/2010 Centralised - Variation EMEA/H/C/810/IB/40
Updated with Decision(2011)4300 of 14/06/2011
16/06/2011 Centralised - Variation (2011)4300 of 14/06/2011
11/11/2011 Centralised - Variation EMEA/H/C/810/IA/42/G
Updated with Decision(2012)1186 of 17/02/2012
21/12/2011 Centralised - Variation EMEA/H/C/810/810/IA/43
Updated with Decision(2012)1186 of 17/02/2012
18/01/2012 Centralised - Variation EMEA/H/C/810/IB/44
Updated with Decision(2012)5760 of 08/08/2012
21/02/2012 Centralised - Variation (2012)1186 of 17/02/2012
13/04/2012 Corrigendum
10/08/2012 Centralised - Variation (2012)5760 of 08/08/2012
25/09/2012 Centralised - Variation EMEA/H/C/810/IB/49
Updated with Decision(2012)8371 of 12/11/2012
14/11/2012 Centralised - Renewal EMEA/H/C/810/R/48 (2012)8371 of 12/11/2012
01/03/2013 Centralised - Variation EMEA/H/C/810/IB/50/G
Updated with Decision(2014)1470 of 28/02/2014
22/08/2013 Centralised - Variation EMEA/H/C/810/IB/52
Updated with Decision(2014)1470 of 28/02/2014
23/09/2013 Centralised - Variation EMEA/H/C/810/IB/53
Updated with Decision(2014)1470 of 28/02/2014
05/03/2014 Centralised - Variation (2014)1470 of 28/02/2014