Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Suboxone   
Auth. number : EU/1/06/359
Active substance : buprenorphine / naloxone
ATC: Anatomical main group: N - Nervous system
Therapeutic subgroup: N07 - Other nervous system drugs
Pharmacological subgroup: N07B - Drugs used in addictive disorders
Chemical subgroup: N07BC - Drugs used in opioid dependence
Chemical substance: N07BC51 - methadone
(See WHO ATC Index)
Indication: Substitution treatment for opioid drug dependence, within a framework of medical, social and
psychological treatment. The intention of the naloxone component is to deter intravenous misuse.
Treatment is intended for use in adults and adolescents over 15 years of age who have agreed to be
treated for addiction.
Marketing Authorisation Holder: Indivior UK Limited
103-105 Bath Road, Slough, Berkshire, SL1 3UH, 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
28/09/2006 Centralised - Authorisation EMEA/H/C/697 (2006)4344 of 26/09/2006
11/01/2007 Centralised - Notification EMEA/H/C/697/N/1
Updated with Decision(2007)3764 of 30/07/2007
27/04/2007 Centralised - Notification EMEA/H/C/697/N/2
Updated with Decision(2007)3764 of 30/07/2007
01/08/2007 Centralised - Variation EMEA/H/C/697/II/3 (2007)3764 of 30/07/2007
23/01/2008 Centralised - Notification EMEA/H/C/697/N/4
Updated with Decision(2010)5594 of 06/08/2010
10/03/2009 Centralised - Notification EMEA/H/C/697/N/5
Updated with Decision(2010)5594 of 06/08/2010
10/08/2010 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/697/T/6 (2010)5594 of 06/08/2010
20/09/2011 Centralised - Renewal EMEA/H/C/697/R/8 (2011)6594 of 16/09/2011
24/01/2012 Corrigendum (2011)6954 of 20/01/2012
19/09/2012 Centralised - Notification EMEA/H/C/697/N/11
Updated with Decision(2014)3621 of 23/05/2014
30/05/2013 Centralised - Variation EMEA/H/C/697/II/12/G
Updated with Decision(2014)3621 of 23/05/2014
03/09/2013 Centralised - Variation EMEA/H/C/697/IA/17
Updated with Decision(2014)3621 of 23/05/2014
27/05/2014 Centralised - Yearly update (2014)3621 of 23/05/2014
08/07/2014 Corrigendum (2014)4846 of 04/07/2014
01/04/2015 Centralised - 2-Monthly update EMEA/H/C/697/II/30/G (2015)2319 of 30/03/2015
12/08/2015 Centralised - Variation EMEA/H/C/697/IAin/32/G
Updated with Decision(2015)8131 of 16/11/2015
18/11/2015 Centralised - Variation EMEA/H/C/697/X/29 (2015)8131 of 16/11/2015