Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Triumeq   
Auth. number : EU/1/14/940
Active substance : dolutegravir / abacavir / lamivudine
ATC: Anatomical main group: J - General antiinfectives for systemic use
Therapeutic subgroup: J05 - Antivirals for systemic use
Pharmacological subgroup: J05A - Agents affecting the virus directly
Chemical subgroup: J05AR - Antivirals for treatment of hiv infections, combinations
Chemical substance: J05AR13 - Lamivudine, abacavir and dolutegravir
(See WHO ATC Index)
Indication: Triumeq is indicated for the treatment of Human Immunodeficiency Virus (HIV) infected adults and adolescents above 12 years of age weighing at least 40 kg (see sections 4.4 and 5.1).
Before initiating treatment with abacavir-containing products, screening for carriage of the HLA-B*5701 allele should be performed in any HIV-infected patient, irrespective of racial origin (see section 4.4). Abacavir should not be used in patients known to carry the HLA-B*5701 allele.
Marketing Authorisation Holder: ViiV Healthcare UK Limited
980 Great West Road, Brentford, Middlesex TW8 9GS, 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
03/09/2014 Centralised - Authorisation EMEA/H/C/2754 (2014)6266 of 01/09/2014
26/03/2015 Centralised - Variation EMEA/H/C/2754/II/4/G
Updated with Decision(2016)1524 of 07/03/2016
23/04/2015 Centralised - Variation EMEA/H/C/2754/WS/645
Updated with Decision(2016)1524 of 07/03/2016
17/06/2015 Centralised - Variation EMEA/H/C/2754/IB/12
Updated with Decision(2016)1524 of 07/03/2016
25/06/2015 Centralised - Variation EMEA/H/C/2754/II/7/G
Updated with Decision(2016)1524 of 07/03/2016
24/09/2015 Centralised - Variation EMEA/H/C/2754/II/15/G
Updated with Decision(2016)1524 of 07/03/2016
28/01/2016 Centralised - Variation EMEA/H/C/2754/WS/888/G
Updated with Decision(2016)1524 of 07/03/2016
09/03/2016 Centralised - Yearly update (2016)1524 of 07/03/2016
21/07/2016 Centralised - Variation EMEA/H/C/2754/WS/0948
Updated with Decision(2016)7469 of 14/11/2016
21/07/2016 Centralised - Variation EMEA/H/C/2754/II/0026/G
Updated with Decision(2016)7469 of 14/11/2016
21/09/2016 Centralised - Variation EMEA/H/C/2754/IB/0032
Updated with Decision(2016)7469 of 14/11/2016
16/11/2016 Centralised - 2-Monthly update EMEA/H/C/002754/II/0031 (2016)7469 of 14/11/2016
04/01/2017 Centralised - Variation EMEA/H/C/002754/IB/0038/G
19/01/2017 Centralised - Variation EMEA/H/C/002754/II/0037
19/01/2017 Centralised - Variation EMEA/H/C/002754/II/0035
19/01/2017 Centralised - Variation EMEA/H/C/002754/II/0036