Tybost

RSS

cobicistat

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

Overview

This is a summary of the European public assessment report (EPAR) for Tybost. It explains how the European Medicines Agency assessed the medicine to recommend its authorisation in the European Union (EU) and its conditions of use. It is not intended to provide practical advice on how to use Tybost.

For practical information about using Tybost, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 13/08/2018

Authorisation details

Product details
Name
Tybost
Agency product number
EMEA/H/C/002572
Active substance
cobicistat on silicon dioxide
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
11
Date of issue of marketing authorisation valid throughout the European Union
19/09/2013
Contact address
Carrigtohill
Cork T45 DP77
Ireland

Product information

26/07/2018 Tybost - EMEA/H/C/002572 - R/0041

Contents

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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.

Assessment history

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