Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Invega   
Auth. number : EU/1/07/395
INN : paliperidone
ATC: Anatomical main group: N - Nervous system
Therapeutic subgroup: N05 - Psycholeptics
Pharmacological subgroup: N05A - Antipsychotics
Chemical subgroup: N05AX - Other antipsychotics
Chemical substance: N05AX13 - Paliperidone
(See WHO ATC Index)
Indication: INVEGA is indicated for the treatment of schizophrenia in adults and in adolescents 15 years and older.
INVEGA is indicated for the treatment of schizophrenia in adults.
INVEGA is indicated for the treatment of psychotic or manic symptoms of schizoaffective disorder in adults. Effect on depressive symptoms has not been demonstrated.
Marketing Authorisation Holder: Janssen-Cilag International NV
Turnhoutseweg 30, B-2340 Beerse, België

  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
27/06/2007 Centralised - Authorisation EMEA/H/C/746 (2007)3175 of 25/06/2007
24/04/2008 Centralised - Variation EMEA/H/C/746/II/2 (2008)1679 of 22/04/2008
19/05/2008 Centralised - Variation EMEA/H/C/746/IB/9
Updated with Decision(2009)120 of 12/01/2009
19/05/2008 Centralised - Variation EMEA/H/C/746/IB/10
Updated with Decision(2009)120 of 12/01/2009
19/05/2008 Centralised - Variation EMEA/H/C/746/IB/11
Updated with Decision(2009)120 of 12/01/2009
19/05/2008 Centralised - Variation EMEA/H/C/746/IB/12
Updated with Decision(2009)120 of 12/01/2009
19/05/2008 Centralised - Variation EMEA/H/C/746/IB/13
Updated with Decision(2009)120 of 12/01/2009
19/05/2008 Centralised - Variation EMEA/H/C/746/IB/14
Updated with Decision(2009)120 of 12/01/2009
19/05/2008 Centralised - Variation EMEA/H/C/746/IB/15
Updated with Decision(2009)120 of 12/01/2009
19/05/2008 Centralised - Variation EMEA/H/C/746/IB/16
Updated with Decision(2009)120 of 12/01/2009
19/05/2008 Centralised - Variation EMEA/H/C/746/IB/17
Updated with Decision(2009)120 of 12/01/2009
19/05/2008 Centralised - Variation EMEA/H/C/746/IB/8
Updated with Decision(2009)120 of 12/01/2009
19/05/2008 Centralised - Variation EMEA/H/C/746/IB/6
Updated with Decision(2009)120 of 12/01/2009
19/05/2008 Centralised - Variation EMEA/H/C/746/IB/7
Updated with Decision(2009)120 of 12/01/2009
14/01/2009 Centralised - Variation EMEA/H/C/746/II/18 (2009)120 of 12/01/2009
14/01/2009 Centralised - Variation EMEA/H/C/746/X/3 (2009)120 of 12/01/2009
09/07/2009 Centralised - Variation EMEA/H/C/746/II/20 (2009)5601 of 07/07/2009
09/11/2009 Centralised - Variation EMEA/H/C/746/II/22 (2009)8715 of 05/11/2009
25/11/2009 Centralised - Variation EMEA/H/C/746/II/21 (2009)9453 of 23/11/2009
29/03/2010 Centralised - Variation EMEA/H/C/746/II/24 (2010)2191 of 26/03/2010
15/06/2010 Centralised - Variation EMEA/H/C/746/IAin/7/G
Updated with Decision(2011)2625 of 08/04/2011
06/07/2010 Centralised - Variation EMEA/H/C/746/II/25 (2010)4678 of 01/07/2010
22/09/2010 Centralised - Variation EMEA/H/C/746/IG/23/G
Updated with Decision(2011)2625 of 08/04/2011
30/09/2010 Centralised - Variation EMEA/H/C/746/II/26/G
15/12/2010 Centralised - Variation EMEA/H/C/746/II/23 (2010)9302 of 13/12/2010
12/04/2011 Centralised - Variation EMEA/H/C/746/II/23 (2011)2625 of 08/04/2011
05/05/2011 Centralised - Variation EMEA/H/C/746/N/27
Updated with Decision(2011)7391 of 12/10/2011
14/10/2011 Centralised - Variation EMEA/H/C/746/II/28 (2011)7391 of 12/10/2011
16/05/2012 Centralised - Renewal EMEA/H/C/746/R/34 (2012)3293 of 14/05/2012
02/07/2012 Centralised - Variation EMEA/H/C/746/II/32 (2012)4515 of 27/06/2012
25/07/2013 Centralised - Variation EMEA/H/C/746/II/38
Updated with Decision(2013)5598 of 26/08/2013
28/08/2013 Centralised - Variation EMEA/H/C/746/WS/403/39 (2013)5598 of 26/08/2013
27/05/2014 Centralised - Variation EMEA/H/C/746/II/37 (2014)3619 of 23/05/2014