Ritonavir Mylan

RSS

ritonavir

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

Overview

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

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

This EPAR was last updated on 27/09/2019

Authorisation details

Product details
Name
Ritonavir Mylan
Agency product number
EMEA/H/C/004549
Active substance
ritonavir
International non-proprietary name (INN) or common name
ritonavir
Therapeutic area (MeSH)
HIV Infections
Anatomical therapeutic chemical (ATC) code
J05AE03
GenericGeneric

This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

Publication details
Marketing-authorisation holder
Mylan S.A.S
Revision
4
Date of issue of marketing authorisation valid throughout the European Union
09/11/2017
Contact address
117 Allée des Parcs
69800 Saint Priest
France

Product information

06/05/2019 Ritonavir Mylan - EMEA/H/C/004549 - N/0004

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

Ritonavir is indicated in combination with other antiretroviral agents for the treatment of HIV 1 infected patients (adults and children of 2 years of age and older).

Assessment history

How useful was this page?

Add your rating