Table of contents
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.
Ritonavir Mylan : EPAR - Summary for the public (PDF/92.32 KB)
First published: 20/11/2017
Last updated: 20/11/2017
Ritonavir Mylan : EPAR - Risk Management Plan summary (PDF/139.51 KB)
First published: 12/10/2022
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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.
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117 Allée des Parcs
69800 Saint Priest
22/08/2022 Ritonavir Mylan - EMEA/H/C/004549 - R/0015
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.
Antivirals for systemic use
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).