Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Tivicay   
Auth. number : EU/1/13/892
Active substance : dolutegravir
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: J05AX - Other antivirals
Chemical substance: J05AX12 - Dolutegravir
(See WHO ATC Index)
Indication: Tivicay is indicated in combination with other anti-retroviral medicinal products for the treatment of Human Immunodeficiency Virus (HIV) infected adults, adolescents and children above 6 years of age.
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
21/01/2014 Centralised - Authorisation EMEA/H/C/2753 (2014)305 of 16/01/2014
25/04/2014 Centralised - Variation EMEA/H/C/2753/WS/544
Updated with Decision(2015)2929 of 24/04/2015
26/06/2014 Centralised - Variation EMEA/H/C/2753/II/3
Updated with Decision(2015)2929 of 24/04/2015
24/07/2014 Centralised - Variation EMEA/H/C/2753/II/1
Updated with Decision(2015)2929 of 24/04/2015
25/09/2014 Centralised - Variation EMEA/H/C/2753/II/5
Updated with Decision(2015)2929 of 24/04/2015
23/04/2015 Centralised - Variation EMEA/H/C/2753/WS/645
Updated with Decision(2015)5465 of 28/07/2015
28/04/2015 PSUSA - Modification EMEA/H/C/2753/PSUSA/10075 (2015)2929 of 24/04/2015
25/06/2015 Centralised - Variation EMEA/H/C/2753/II/12
Updated with Decision(2015)5465 of 28/07/2015
30/07/2015 Centralised - 2-Monthly update EMEA/H/C/2753/II/8 (2015)5465 of 28/07/2015
24/09/2015 Centralised - Variation EMEA/H/C/2753/II/14
Updated with Decision(2016)6295 of 26/09/2016
23/11/2015 Centralised - Notification EMEA/H/C/2753/N/16
Updated with Decision(2016)6295 of 26/09/2016
06/09/2016 Centralised - Variation EMEA/H/C/2753/IB/23
Updated with Decision(2017)1406 of 23/02/2017
28/09/2016 Centralised - Yearly update (2016)6295 of 26/09/2016
19/01/2017 Centralised - Variation EMEA/H/C/2753/II/27
27/02/2017 Centralised - Variation EMEA/H/C/2753/X/18 (2017)1406 of 23/02/2017
04/07/2017 Centralised - Variation EMEA/H/C/2753/IB/29