Tybost

RSS

cobicistat

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 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
13
Date of issue of marketing authorisation valid throughout the European Union
19/09/2013
Contact address

Carrigtohill
County Cork T45 DP77
Ireland

Product information

20/05/2020 Tybost - EMEA/H/C/002572 - PSUSA/00010081/201908

Contents

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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.

Assessment history

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