Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Zyprexa Velotab   
Auth. number : EU/1/99/125
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: Eli Lilly Nederland B.V.
Grootslag 1-5, NL-3991 RA Houten, 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
12/04/2000 Centralised - Variation EMEA/H/C/287/I/1
02/01/2001 Centralised - Variation EMEA/H/C/287/II/2 (2000)4278 of 27/12/2000
06/02/2001 Centralised - Variation EMEA/H/C/287/I/3
15/06/2001 Centralised - Variation EMEA/H/C/287/I/5 (2001)1320 of 14/06/2001
15/06/2001 Centralised - Variation EMEA/H/C/287/II/4 (2001)1320 of 14/06/2001
21/11/2001 Centralised - Variation EMEA/H/C/287/II/7 (2001)3577 of 20/11/2001
19/04/2002 Centralised - Variation EMEA/H/C/287/I/9
06/06/2002 Centralised - Variation EMEA/H/C/287/II/6 (2002)2086 of 04/06/2002
12/09/2002 Centralised - Variation EMEA/H/C/287/II/8 (2002)3384 of 10/09/2002
21/11/2002 Centralised - Variation EMEA/H/C/287/N/10 (2002)4587 of 20/11/2002
16/05/2003 Centralised - Variation EMEA/H/C/287/I/13
10/10/2003 Centralised - Variation EMEA/H/C/287/II/12 (2003)3742 of 08/10/2003
28/10/2003 Centralised - Variation EMEA/H/C/287/II/11 (2003)4015 of 24/10/2003
12/01/2004 Centralised - Variation EMEA/H/C/287/IB/15
09/02/2004 Centralised - Variation EMEA/H/C/287/IA/16
26/05/2004 Centralised - Variation EMEA/H/C/287/IA/20
28/05/2004 Centralised - Variation EMEA/H/C/287/IA/21
04/06/2004 Centralised - Variation EMEA/H/C/287/IB/18
Updated with Decision(2004)4344 of 04/11/2004
15/07/2004 Centralised - Variation EMEA/H/C/287/II/17 (2004)2812 of 13/07/2004
30/07/2004 Centralised - Variation EMEA/H/C/287/IA/23
26/10/2004 Centralised - Variation EMEA/H/C/287/IA/26
08/11/2004 Centralised - Variation EMEA/H/C/287/II/9 (2004)4345 of 04/11/2004
08/11/2004 Centralised - Renewal EMEA/H/C/287/R/22 (2004)4344 of 04/11/2004
20/12/2004 Centralised - Variation EMEA/H/C/287/II/24
09/02/2005 Centralised - Authorisation EMEA/H/C/287 (2000)171 of 03/02/2000
11/02/2005 Centralised - Variation EMEA/H/C/287/II/25 (2005)361 of 09/02/2005
18/03/2005 Centralised - Variation EMEA/H/C/287/IB/28
31/03/2005 Centralised - Variation EMEA/H/C/287/IA/29
30/06/2005 Centralised - Variation EMEA/H/C/287/IB/30
Updated with Decision(2005)3403 of 31/08/2005
02/09/2005 Centralised - Variation EMEA/H/C/287/II/27 (2005)3403 of 31/08/2005
16/11/2005 Centralised - Variation EMEA/H/C/287/IB/32
16/11/2005 Centralised - Variation EMEA/H/C/287/IA/34
16/11/2005 Centralised - Variation EMEA/H/C/287/IB/31
16/11/2005 Centralised - Variation EMEA/H/C/287/IA/33
20/12/2005 Centralised - Variation EMEA/H/C/287/II/35
13/06/2006 Centralised - Variation EMEA/H/C/287/IA/38
14/09/2006 Centralised - Renewal EMEA/H/C/287/R/36 (2006)4166 of 12/09/2006
15/09/2006 Centralised - Variation EMEA/H/C/287/II/37 (2006)4175 of 13/09/2006
17/11/2006 Centralised - Variation EMEA/H/C/287/IA/41
17/11/2006 Centralised - Variation EMEA/H/C/287/IA/42
Updated with Decision(2007)3078 of 19/06/2007
12/12/2006 Centralised - Variation EMEA/H/C/287/IA/45
Updated with Decision(2007)3078 of 19/06/2007
15/12/2006 Centralised - Variation EMEA/H/C/287/IB/50
Updated with Decision(2007)3078 of 19/06/2007
15/12/2006 Centralised - Variation EMEA/H/C/287/IB/49
Updated with Decision(2007)3078 of 19/06/2007
15/12/2006 Centralised - Variation EMEA/H/C/287/IB/47
Updated with Decision(2007)3078 of 19/06/2007
15/12/2006 Centralised - Variation EMEA/H/C/287/IA/46
Updated with Decision(2007)3078 of 19/06/2007
15/12/2006 Centralised - Variation EMEA/H/C/287/IA/44
Updated with Decision(2007)3078 of 19/06/2007
15/12/2006 Centralised - Variation EMEA/H/C/287/IA/43
Updated with Decision(2007)3078 of 19/06/2007
15/12/2006 Centralised - Variation EMEA/H/C/287/IB/48
Updated with Decision(2007)3078 of 19/06/2007
07/02/2007 Centralised - Variation EMEA/H/C/287/N/51
Updated with Decision(2007)3078 of 19/06/2007
11/05/2007 Centralised - Variation EMEA/H/C/287/IA/55
11/05/2007 Centralised - Variation EMEA/H/C/287/IA/56
21/06/2007 Centralised - Variation (2007)3078 of 19/06/2007
29/06/2007 Centralised - Variation EMEA/H/C/287/IB/57
05/09/2007 Centralised - Variation EMEA/H/C/287/II/53 (2007)4175 of 30/08/2007
06/09/2007 Centralised - Variation EMEA/H/C/287/IA/59
23/11/2007 Centralised - Variation EMEA/H/C/287/II/58 (2007)5743 of 21/11/2007
21/01/2008 Centralised - Variation EMEA/H/C/287/II/60 (2008)288 of 17/01/2008
16/04/2008 Centralised - Variation EMEA/H/C/287/IA/63
17/04/2008 Centralised - Variation EMEA/H/C/287/IA/62
Updated with Decision(2008)4112 of 28/07/2008
25/04/2008 Centralised - Variation EMEA/H/C/287/II/52 (2008)1702 of 23/04/2008
30/04/2008 Centralised - Variation EMEA/H/C/287/IA/64
03/06/2008 Centralised - Variation EMEA/H/C/287/IB/65
23/07/2008 Centralised - Variation EMEA/H/C/287/IA/67
30/07/2008 Centralised - Variation EMEA/H/C/287/II/61 (2008)4112 of 28/07/2008
06/01/2009 Centralised - Variation EMEA/H/C/287/IB/69
27/03/2009 Centralised - Variation EMEA/H/C/287/II/68 (2009)2294 of 25/03/2009
09/07/2009 Centralised - Variation EMEA/H/C/287/II/70 (2009)5593 of 07/07/2009
20/07/2009 Centralised - Variation EMEA/H/C/287/IA/71
23/12/2009 Centralised - Variation EMEA/H/C/287/II/72 (2009)10695 of 21/12/2009
08/09/2010 Centralised - Variation EMEA/H/C/287/WS/21 (2010)6229 of 06/09/2010
17/12/2010 Centralised - Variation EMEA/H/C/287/IG/30
23/12/2010 Centralised - Variation EMEA/H/C/287/WS/65 (2010)9631 of 20/12/2010
28/10/2011 Centralised - Variation EMEA/H/C/287/WS/182 (2011)7676 of 20/10/2011
28/11/2011 Centralised - Variation EMEA/H/C/287/WS/127 (2011)8841 of 24/11/2011
29/06/2012 Centralised - Variation EMEA/H/C/287/WS/215 (2012)4483 of 27/06/2012
29/05/2013 Centralised - Variation EMEA/H/C/287/WS/337 (2013)3230 of 27/05/2013
25/04/2014 Centralised - Variation EMEA/H/C/287/WS/485