Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Tybost   
Auth. number : EU/1/13/872
Active substance : cobicistat
ATC: Anatomical main group: V - Various
Therapeutic subgroup: V03 - All other therapeutic products
Pharmacological subgroup: V03A - All other therapeutic products
Chemical subgroup: V03AX - Other therapeutic products
Chemical substance: V03AX03 - Cobicistat
(See WHO ATC Index)
Indication: Indicated as a pharmacokinetic enhancer of atazanavir 300 mg once daily or darunavir 800 mg once daily as part of antiretroviral combination therapy in human immunodeficiency virus 1 (HIV 1) infected adults
Marketing Authorisation Holder: Gilead Sciences International Limited
Cambridge CB21 6GT, 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
23/09/2013 Centralised - Authorisation EMEA/H/C/2572 (2013)6210 of 19/09/2013
20/02/2014 Centralised - Variation EMEA/H/C/2572/WS/484/3
Updated with Decision(2015)812 of 10/02/2015
24/07/2014 Centralised - Variation EMEA/H/C/2572/II/4
Updated with Decision(2015)812 of 10/02/2015
23/10/2014 Centralised - Variation EMEA/H/C/2572/II/6
Updated with Decision(2015)812 of 10/02/2015
12/02/2015 Centralised - Yearly update (2015)812 of 10/02/2015
26/02/2015 Centralised - Variation EMEA/H/C/2572/IG/521
Updated with Decision(2016)941 of 11/02/2016
23/04/2015 Centralised - Variation EMEA/H/C/2572/II/12/G
Updated with Decision(2016)941 of 11/02/2016
05/05/2015 Centralised - Variation EMEA/H/C/2572/IB/16
Updated with Decision(2016)941 of 11/02/2016
07/03/2016 Centralised - Yearly update (2016)941 of 11/02/2016
01/04/2016 Centralised - Variation EMEA/H/C/2572/WS/837
26/01/2017 Centralised - Variation EMEA/H/C/2572/WS/1093