Tybost
cobicistat
Table of contents
Overview
Tybost is a medicine for treating adults and adolescents from 12 years of age (and over a certain weight) who are infected with HIV-1, a virus that causes acquired immune deficiency syndrome (AIDS).
Tybost does not treat HIV directly but is given to boost the effects of atazanavir or darunavir, which are used with other standard medicines to treat HIV-1.
It contains the active substance cobicistat.
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List item
Tybost : EPAR - Medicine overview (PDF/121.03 KB)
First published: 24/10/2013
Last updated: 29/07/2020
EMA/78905/2020 -
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List item
Tybost : EPAR - Risk-management-plan summary (PDF/84.43 KB)
First published: 29/07/2020
Authorisation details
Product details | |
---|---|
Name |
Tybost
|
Agency product number |
EMEA/H/C/002572
|
Active substance |
cobicistat
|
International non-proprietary name (INN) or common name |
cobicistat
|
Therapeutic area (MeSH) |
HIV Infections
|
Anatomical therapeutic chemical (ATC) code |
V03AX03
|
Publication details | |
---|---|
Marketing-authorisation holder |
Gilead Sciences Ireland UC
|
Revision |
15
|
Date of issue of marketing authorisation valid throughout the European Union |
19/09/2013
|
Contact address |
Carrigtohill |
Product information
13/02/2023 Tybost - EMEA/H/C/002572 - IB/0064
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Antivirals for systemic use
Therapeutic indication
Tybost is 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 and adolescents aged 12 years and older:
- weighing at least 35 kg co‑administered with atazanavir or
- weighing at least 40 kg co‑administered with darunavir.