Ritonavir Viatris (previously Ritonavir Mylan)
Authorised
This medicine is authorised for use in the European Union
ritonavir
MedicineHumanAuthorised
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- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Ritonavir Viatris is a medicine used to treat adults and children aged two years and older with human immunodeficiency virus type 1 (HIV-1) infection. HIV-1 is a virus that causes acquired immune deficiency syndrome (AIDS). Ritonavir Viatris is used to enhance the activity of other medicines called protease inhibitors, including atazanavir, fosamprenavir, lopinavir, tipranavir and darunavir.
Ritonavir Viatris contains the active substance ritonavir.
Ritonavir Viatris is a ‘generic medicine’. This means that it contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU. The reference medicine for Ritonavir Viatris is Norvir. For more information on generic medicines, see the question-and-answer document here.
Ritonavir Viatris can only be obtained with a prescription and treatment should be prescribed by a doctor who has experience in the treatment of HIV infection.
Ritonavir Viatris is available as tablets to be taken with food once or twice a day. The frequency depends on the protease inhibitor Ritonavir Viatris is given with.
For more information about using Ritonavir Viatris, see the package leaflet or contact your doctor or pharmacist.
The active substance in Ritonavir Viatris, ritonavir, enhances the activity of other HIV-1 medicines called protease inhibitors. These medicines block an enzyme (a type of protein) of HIV-1 called protease, which the virus needs to make new copies of itself.
When given together with protease inhibitors, ritonavir slows down the rate at which they are broken down in the body. This helps to keep their levels higher in the blood for longer, allowing them to work more effectively against the virus.
Ritonavir Viatris does not cure HIV-1 infections or AIDS. It delays the damage made by the virus to the immune system (the body’s natural defences) and the development of infections and diseases associated with AIDS.
Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Norvir, and do not need to be repeated for Ritonavir Viatris.
As for every medicine, the company provided studies on the quality of Ritonavir Viatris. The company also carried out a study that showed that it is ‘bioequivalent’ to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.
Because Ritonavir Viatris is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.
The European Medicines Agency concluded that, in accordance with EU requirements, Ritonavir Viatris has been shown to have comparable quality and to be bioequivalent to Norvir. Therefore, the Agency’s view was that, as for Norvir, the benefit outweighs the identified risk. The Agency recommended that Ritonavir Viatris be approved for use in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ritonavir Viatris have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Ritonavir Viatris are continuously monitored. Suspected side effects reported with Ritonavir Viatris are carefully evaluated and any necessary action taken to protect patients.
Ritonavir Viatris received a marketing authorisation valid throughout the EU on 10 November 2017.
The name of the medicine was changed to Ritonavir Viatris on 17 July 2024.
Product information
Latest procedure affecting product information:VR/0000325156
05/05/2026
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).
Product details
- Name of medicine
- Ritonavir Viatris (previously Ritonavir Mylan)
- Active substance
- ritonavir
- International non-proprietary name (INN) or common name
- ritonavir
- Therapeutic area (MeSH)
- HIV Infections
- Anatomical therapeutic chemical (ATC) code
- J05AE03
Pharmacotherapeutic group
Antivirals for systemic useTherapeutic indication
Ritonavir is indicated as a pharmacokinetic enhancer of co-administered protease inhibitors as part of antiretroviral combination therapy in human immunodeficiency virus-1 (HIV-1) infected patients (adults and children of 2 years of age and older).
News on Ritonavir Viatris (previously Ritonavir Mylan)
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