Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Zyprexa   
Auth. number : EU/1/96/022
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: AdultsOlanzapine 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: 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 continues to be 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
27/09/1996 Centralised - Authorisation EMEA/H/C/115 (96)2643 of 27/09/1996
04/03/1998 Centralised - Variation EMEA/H/C/115/N/5 (1998)528 of 03/03/1998
27/03/1998 Centralised - Variation EMEA/H/C/115/II/1 (1998)750 of 26/03/1998
26/10/1998 Centralised - Variation EMEA/H/C/115/II/7 (1998)3186 of 22/10/1998
24/12/1998 Centralised - Variation EMEA/H/C/115/I/8 (1998)4497 of 17/12/1998
10/06/1999 Centralised - Variation EMEA/H/C/115/I/12
21/07/1999 Centralised - Variation EMEA/H/C/115/I/13
29/07/1999 Centralised - Variation EMEA/H/C/115/II/11 (1999)2222 of 19/07/1999
05/10/1999 Centralised - Variation EMEA/H/C/115/I/14
12/04/2000 Centralised - Variation EMEA/H/C/115/I/19
13/04/2000 Centralised - Variation EMEA/H/C/115/N/18 (2000)967 of 12/04/2000
16/05/2000 Centralised - Variation EMEA/H/C/115/I/20
20/07/2000 Centralised - Variation EMEA/H/C/115/I/22 (2000)1796 of 11/07/2000
26/09/2000 Centralised - Variation EMEA/H/C/115/II/17 (2000)2600 of 25/09/2000
02/01/2001 Centralised - Authorisation EMEA/H/C/115/X/16 (2000)4279 of 27/12/2000
02/01/2001 Centralised - Variation EMEA/H/C/115/II/23 (2000)4288 of 28/12/2000
15/02/2001 Centralised - Variation EMEA/H/C/115/I/25
28/02/2001 Centralised - Variation EMEA/H/C/115/I/26
15/06/2001 Centralised - Variation EMEA/H/C/115/I/27 (2001)1316 of 14/06/2001
15/06/2001 Centralised - Variation EMEA/H/C/115/II/24 (2001)1316 of 14/06/2001
04/07/2001 Centralised - Authorisation EMEA/H/C/115/X/21 (2001)1382 of 02/07/2001
12/09/2001 Centralised - Variation EMEA/H/C/115/II/32 (2002)3368 of 09/09/2002
22/10/2001 Centralised - Variation EMEA/H/C/115/I/30 (2001)2873 of 19/10/2001
21/11/2001 Centralised - Renewal EMEA/H/C/115/R/29 (2001)3579 of 20/11/2001
04/02/2002 Centralised - Variation EMEA/H/C/115/I/31
19/04/2002 Centralised - Variation EMEA/H/C/115/I/33
06/06/2002 Centralised - Variation EMEA/H/C/115/II/28 (2002)2085 of 04/06/2002
22/10/2002 Centralised - Variation EMEA/H/C/115/II/34 (2002)4082 of 18/10/2002
21/11/2002 Centralised - Variation EMEA/H/C/115/N/35 (2002)4581 of 20/11/2002
10/04/2003 Centralised - Variation EMEA/H/C/115/I/38
06/10/2003 Centralised - Variation EMEA/H/C/115/I/40
06/10/2003 Centralised - Variation EMEA/H/C/115/I/40
10/10/2003 Centralised - Variation EMEA/H/C/115/II/37 (2003)3743 of 08/10/2003
28/10/2003 Centralised - Variation EMEA/H/C/115/II/36 (2003)4031 of 24/10/2003
26/02/2004 Centralised - Variation EMEA/H/C/115/IA/42
Updated with Decision(2004)2810 of 13/07/2004
26/02/2004 Centralised - Variation EMEA/H/C/115/IA/43
Updated with Decision(2004)2810 of 13/07/2004
27/02/2004 Centralised - Variation EMEA/H/C/115/IA/45
04/05/2004 Centralised - Variation EMEA/H/C/115/IA/47
04/05/2004 Centralised - Variation EMEA/H/C/115/IA/46
26/05/2004 Centralised - Variation EMEA/H/C/115/IA/48
15/07/2004 Centralised - Variation EMEA/H/C/115/II/44 (2004)2810 of 13/07/2004
27/07/2004 Centralised - Variation EMEA/H/C/115/IA/50
08/11/2004 Centralised - Variation EMEA/H/C/115/II/49 (2004)4337 of 04/11/2004
15/12/2004 Centralised - Variation EMEA/H/C/115/IA/57
15/12/2004 Centralised - Variation EMEA/H/C/115/IB/55
15/12/2004 Centralised - Variation EMEA/H/C/115/IB/54
20/12/2004 Centralised - Variation EMEA/H/C/115/II/51
04/02/2005 Centralised - Variation EMEA/H/C/115/IA/58
11/02/2005 Centralised - Variation EMEA/H/C/115/II/52 (2005)360 of 09/02/2005
11/02/2005 Centralised - Variation EMEA/H/C/115/II/53 (2005)359 of 09/02/2005
31/03/2005 Centralised - Variation EMEA/H/C/115/IA/60
26/08/2005 Centralised - Variation EMEA/H/C/115/IB/61
Updated with Decision(2006)959 of 20/03/2006
02/09/2005 Centralised - Variation EMEA/H/C/115/II/59 (2005)3402 of 31/08/2005
16/11/2005 Centralised - Variation EMEA/H/C/115/IB/62
22/03/2006 Centralised - Variation (2006)959 of 20/03/2006
16/05/2006 Centralised - Variation EMEA/H/C/115/IA/66
Updated with Decision(2006)4167 of 12/09/2006
14/09/2006 Centralised - Renewal EMEA/H/C/115/R/64 (2006)4167 of 12/09/2006
15/09/2006 Centralised - Variation EMEA/H/C/115/II/65 (2006)4176 of 13/09/2006
08/12/2006 Centralised - Variation EMEA/H/C/115/IA/69
Updated with Decision(2007)3399 of 09/07/2007
08/12/2006 Centralised - Variation EMEA/H/C/115/IA/74
Updated with Decision(2007)3399 of 09/07/2007
08/12/2006 Centralised - Variation EMEA/H/C/115/IA/73
Updated with Decision(2007)3399 of 09/07/2007
08/12/2006 Centralised - Variation EMEA/H/C/115/IA/70
Updated with Decision(2007)3399 of 09/07/2007
08/12/2006 Centralised - Variation EMEA/H/C/115/IA/71
Updated with Decision(2007)3399 of 09/07/2007
08/12/2006 Centralised - Variation EMEA/H/C/115/IA/72
Updated with Decision(2007)3399 of 09/07/2007
19/12/2006 Centralised - Variation EMEA/H/C/115/IA/82
20/12/2006 Centralised - Variation EMEA/H/C/115/IB/78
Updated with Decision(2007)3399 of 09/07/2007
20/12/2006 Centralised - Variation EMEA/H/C/115/IB/79
Updated with Decision(2007)3399 of 09/07/2007
20/12/2006 Centralised - Variation EMEA/H/C/115/IB/80
Updated with Decision(2007)3399 of 09/07/2007
20/12/2006 Centralised - Variation EMEA/H/C/115/IB/77
Updated with Decision(2007)3399 of 09/07/2007
20/12/2006 Centralised - Variation EMEA/H/C/115/IB/75
Updated with Decision(2007)3399 of 09/07/2007
20/12/2006 Centralised - Variation EMEA/H/C/115/IB/76
Updated with Decision(2007)3399 of 09/07/2007
07/02/2007 Centralised - Variation EMEA/H/C/115/N/81
Updated with Decision(2007)3399 of 09/07/2007
11/05/2007 Centralised - Variation EMEA/H/C/115/IA/85
11/07/2007 Centralised - Variation (2007)3399 of 09/07/2007
24/08/2007 Centralised - Variation EMEA/H/C/115/IA/87
05/09/2007 Centralised - Variation EMEA/H/C/115/II/84 (2007)4173 of 30/08/2007
16/10/2007 Centralised - Variation EMEA/H/C/115/IA/89
23/11/2007 Centralised - Variation EMEA/H/C/115/II/86 (2007)5782 of 21/11/2007
21/01/2008 Centralised - Variation EMEA/H/C/115/II/88 (2008)287 of 17/01/2008
26/02/2008 Centralised - Variation EMEA/H/C/115/II/90
24/04/2008 Centralised - Variation EMEA/H/C/115/II/83 (2008)1688 of 22/04/2008
30/06/2008 Centralised - Variation EMEA/H/C/115/II/91
30/07/2008 Centralised - Variation EMEA/H/C/115/II/92 (2008)4113 of 28/07/2008
27/08/2008 Centralised - Variation EMEA/H/C/115/IA/93
17/10/2008 Centralised - Variation EMEA/H/C/115/IA/94
03/12/2008 Centralised - Variation EMEA/H/C/115/IA/95
Updated with Decision(2009)2299 of 25/03/2009
09/12/2008 Centralised - Variation EMEA/H/C/115/IA/97
09/12/2008 Centralised - Variation EMEA/H/C/115/IA/98
27/03/2009 Centralised - Variation EMEA/H/C/115/II/96 (2009)2299 of 25/03/2009
07/07/2009 Centralised - Variation EMEA/H/C/115/II/99 (2009)5511 of 03/07/2009
25/09/2009 Centralised - Variation EMEA/H/C/115/IA/101
Updated with Decision(2009)10692 of 21/12/2009
23/12/2009 Centralised - Variation EMEA/H/C/115/II/100 (2009)10692 of 21/12/2009
08/09/2010 Centralised - Variation EMEA/H/C/115/WS/21 (2010)6225 of 06/09/2010
25/11/2010 Centralised - Variation EMEA/H/C/115/IB/103/G
Updated with Decision(2010)9629 of 20/12/2010
17/12/2010 Centralised - Variation EMEA/H/C/115/IG/30
23/12/2010 Centralised - Variation EMEA/H/C/115/WS/65 (2010)9629 of 20/12/2010
23/02/2011 Centralised - Variation EMEA/H/C/115/II/102 (2011)1189 of 21/02/2011
28/10/2011 Centralised - Variation EMEA/H/C/115/WS/182 (2011)7677 of 20/10/2011
28/11/2011 Centralised - Variation EMEA/H/C/115/WS/127 (2011)8842 of 24/11/2011
29/06/2012 Centralised - Variation EMEA/H/C/115/WS/215 (2012)4484 of 27/06/2012
29/05/2013 Centralised - Variation EMEA/H/C/115/WS/337 (2013)3231 of 27/05/2013