Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Tybost   
Auth. number : EU/1/13/872
INN : 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