Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Abilify   
Auth. number : EU/1/04/276
INN : aripiprazole
ATC: Anatomical main group: N - Nervous system
Therapeutic subgroup: N05 - Psycholeptics
Pharmacological subgroup: N05A - Antipsychotics
Chemical subgroup: N05AX - Other antipsychotics
Chemical substance: N05AX12 - Aripiprazole
(See WHO ATC Index)
Indication: ABILIFY is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older.
ABILIFY is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment.
ABILIFY is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older.
Marketing Authorisation Holder: Otsuka Pharmaceutical Europe Ltd.
Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom

  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
08/06/2004 Centralised - Authorisation EMEA/H/C/471 (2004)2063 of 04/06/2004
21/01/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/471/II/2
24/03/2005 Centralised - Variation EMEA/H/C/471/IB/5
Updated with Decision(2005)4344 of 28/10/2005
01/04/2005 Centralised - Variation EMEA/H/C/471/II/3 (2005)1090 of 30/03/2005
22/06/2005 Centralised - Variation EMEA/H/C/471/X/1 (2005)1909 of 20/06/2005
11/07/2005 Centralised - Notification EMEA/H/C/471/N/6
Updated with Decision(2005)4344 of 28/10/2005
02/08/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/471/IA/9
02/08/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/471/IA/10
09/08/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/471/IA/12
23/08/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/471/IB/11
04/11/2005 Centralised - Variation EMEA/H/C/471/X/4 (2005)4344 of 28/10/2005
09/11/2005 Centralised - Variation EMEA/H/C/471/II/7, 8 (2005)4386 of 07/11/2005
16/01/2006 Centralised - Variation EMEA/H/C/471/IB/14
Updated with Decision(2006)1815 of 27/04/2006
22/02/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/471/IB/18
02/05/2006 Centralised - Variation EMEA/H/C/471/II/17 (2006)1815 of 27/04/2006
04/05/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/471/IA/20
01/06/2006 Centralised - Variation EMEA/H/C/471/IA/21
Updated with Decision(2006)4122 of 07/09/2006
02/06/2006 Centralised - Variation EMEA/H/C/471/II/19 (2006)2230 of 31/05/2006
17/08/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/471/IA/25
12/09/2006 Centralised - Variation EMEA/H/C/471/II/22, EMEA/H/C/II/23 (2006)4122 of 07/09/2006
19/09/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/471/IA/26
06/10/2006 Centralised - Variation EMEA/H/C/471/X/16 (2006)4799 of 04/10/2006
06/10/2006 Centralised - Variation EMEA/H/C/471/II/15 (2006)4800 of 04/10/2006
01/12/2006 Centralised - Variation EMEA/H/C/471/II/24 (2006)5925 of 28/11/2006
13/12/2006 Centralised - Notification EMEA/H/C/471/N/27
Updated with Decision(2007)2490 of 05/06/2007
11/01/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/471/IB/28
18/01/2007 Centralised - Notification EMEA/H/C/471/N/31
Updated with Decision(2007)2490 of 05/06/2007
01/02/2007 Centralised - Variation EMEA/H/C/471/IA/34
Updated with Decision(2007)2490 of 05/06/2007
02/02/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/471/IB/32
07/02/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/471/IA/35
09/02/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/471/IB/33
16/02/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/471/IA/29
16/02/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/471/IA/30
19/04/2007 Centralised - Notification EMEA/H/C/471/N/36
Updated with Decision(2007)2490 of 05/06/2007
07/06/2007 Centralised - Variation EMEA/H/C/471/II/37 (2007)2490 of 05/06/2007
27/06/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/471/IA/38
31/10/2007 Centralised - Variation EMEA/H/C/471/II/40 (2007)5366 of 29/10/2007
26/11/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/471/IA/45
29/11/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/471/IB/43
13/12/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/471/IA/47
13/12/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/471/IB/44
25/02/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/471/II/46
04/03/2008 Centralised - Variation EMEA/H/C/471/II/42 (2008)863 of 29/02/2008
02/04/2008 Centralised - Variation EMEA/H/C/471/II/39 (2008)1280 of 31/03/2008
15/04/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/471/IA/50
17/04/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/471/IA/53
17/04/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/471/IA/52
07/05/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/471/IB/49
14/05/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/471/IB/54
24/06/2008 Centralised - Variation EMEA/H/C/471/II/41 (2008)3200 of 20/06/2008
27/08/2008 Centralised - Variation EMEA/H/C/471/II/55 (2008)4675 of 25/08/2008
02/10/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/471/IA/58
17/10/2008 Centralised - Notification EMEA/H/C/471/N/57
Updated with Decision(2009)1352 of 24/02/2009
10/12/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/471/IA/62
17/12/2008 Centralised - Variation EMEA/H/C/471/IA/61
Updated with Decision(2009)1352 of 24/02/2009
11/02/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/471/II/56
25/02/2009 Centralised - Variation EMEA/H/C/471/II/60 (2009)1352 of 24/02/2009
04/03/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/471/IA/66
23/04/2009 Centralised - Renewal EMEA/H/C/471/R/59 (2009)3131 of 21/04/2009
10/06/2009 Centralised - Variation EMEA/H/C/471/II/64, 65 (2009)4580 of 08/06/2009
09/07/2009 Centralised - Variation EMEA/H/C/471/II/67 (2009)5598 of 07/07/2009
25/08/2009 Centralised - Variation EMEA/H/C/471/II/48 (2009)6620 of 21/08/2009
10/11/2009 Centralised - Variation EMEA/H/C/471/II/68 (2009)8718 of 05/11/2009
11/03/2010 Centralised - Notification EMEA/H/C/471/N/70
Updated with Decision(2010)5621 of 06/08/2010
11/03/2010 Centralised - Variation EMEA/H/C/471/IA/71/G
Updated with Decision(2010)5621 of 06/08/2010
25/03/2010 Centralised - Variation EMEA/H/C/471/II/69 (2010)2019 of 23/03/2010
07/05/2010 Corrigendum EMEA/H/C/471/II/68 (2009)8718 corr of 05/05/2010
04/08/2010 Centralised - Variation EMEA/H/C/471/IA/75
Updated with Decision(2010)7830 of 05/11/2010
12/08/2010 Centralised - Variation (2010)5621 of 06/08/2010
09/11/2010 Centralised - Variation EMEA/H/C/471/II/72, 73 (2010)7830 of 05/11/2010
14/12/2010 Centralised - Notification EMEA/H/C/471/N/76
Updated with Decision(2011)395 of 21/01/2011
11/01/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/471/IA/77
25/01/2011 Centralised - Variation EMEA/H/C/471/II/74 (2011)395 of 21/01/2011
22/03/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/471/IA/78
28/09/2011 Centralised - Variation EMEA/H/C/471/IB/81
Updated with Decision(2012)3209 of 10/05/2012
04/04/2012 Centralised - Variation EMEA/H/C/471/IAin/83/G
Updated with Decision(2012)3209 of 10/05/2012
14/05/2012 Centralised - Variation (2012)3209 of 10/05/2012
22/11/2012 Centralised - Variation EMEA/H/C/471/II/86 (2012)8579 of 19/11/2012
29/01/2013 Centralised - 2-Monthly update EMEA/H/C/471/II/82 (2013)490 of 24/01/2013
01/02/2013 Centralised - Variation EMEA/H/C/471/IAin/91
Updated with Decision(2013)3816 of 13/06/2013
14/03/2013 Centralised - Notification EMEA/H/C/471/N/90
Updated with Decision(2013)3816 of 13/06/2013
15/03/2013 Centralised - Notification EMEA/H/C/471/N/92
Updated with Decision(2013)3816 of 13/06/2013
25/04/2013 Centralised - Variation EMEA/H/C/471/II/84
Updated with Decision(2014)2588 of 10/04/2014
17/06/2013 Centralised - Modification EMEA/H/C/471/PSU/63 (2013)3816 of 13/06/2013
27/06/2013 Centralised - Variation EMEA/H/C/471/IAin/94
Updated with Decision(2014)2588 of 10/04/2014
31/07/2013 Centralised - Variation EMEA/H/C/471/IB/95
Updated with Decision(2014)2588 of 10/04/2014
21/11/2013 Centralised - Variation EMEA/H/C/471/IB/97/G
Updated with Decision(2014)2588 of 10/04/2014
16/01/2014 Centralised - Variation EMEA/H/C/471/IAin/99/G
Updated with Decision(2014)2588 of 10/04/2014
20/03/2014 Centralised - Variation EMEA/H/C/471/II/96/G
27/03/2014 Centralised - Notification EMEA/H/C/471/N/102
27/03/2014 Centralised - Notification EMEA/H/C/471/N/100
14/04/2014 Centralised - Yearly update (2014)2588 of 10/04/2014
24/07/2014 Centralised - Variation EMEA/H/C/471/II/101
04/08/2014 Centralised - Variation EMEA/H/C/471/IA/104
25/09/2014 Centralised - Variation EMEA/H/C/471/II/103