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 12/10/2022

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
13
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

22/08/2022 Ritonavir Mylan - EMEA/H/C/004549 - R/0015

Other EU languages available icon 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:

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

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

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