Darunavir Viatris (previously Darunavir Mylan)
Authorised
This medicine is authorised for use in the European Union
darunavir
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Darunavir Viatris is an antiviral medicine used with other HIV medicines to treat patients with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS). It is given with low-dose ritonavir or, in adults, with cobicistat. Darunavir Viatris may be given to adults or children from 3 years of age and weighing at least 15 kg.
Darunavir Viatris contains the active substance darunavir and is a ‘generic medicine’. This means that Darunavir Viatris contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU. The reference medicine for Darunavir Viatris is Prezista. For more information on generic medicines, see the question-and-answer document here.
Darunavir Viatris can only be obtained with a prescription and treatment should be started by a healthcare professional who has experience in the management of HIV infection.
Darunavir Viatris is available as tablets. The medicine is always taken either with cobicistat (in adults) or with low-dose ritonavir (in adults and children) and with other HIV medicines, and should be taken with food.
For more information about using Darunavir Viatris, see the package leaflet or contact your doctor or pharmacist
The active substance in Darunavir Viatris, darunavir, is a protease inhibitor. It blocks protease, an enzyme involved in the reproduction of HIV. When the enzyme is blocked, the virus does not reproduce normally, slowing down its multiplication in the body. Darunavir Viatris is always given with ritonavir or cobicistat. Ritonavir and cobicistat reduce the breakdown of darunavir, increasing the levels of darunavir in the blood. This allows effective treatment while avoiding a higher dose of darunavir.
Darunavir Viatris, taken in combination with other HIV medicines, reduces the amount of HIV in the blood and keeps it at a low level. Darunavir Viatris does not cure HIV infection or AIDS, but HIV treatment may hold off the damage to the immune system and the development of infections and diseases associated with AIDS.
Studies on the benefits and risks of the active substance in the approved use have already been carried out with the reference medicine, Prezista, and do not need to be repeated for Darunavir Viatris.
As for every medicine, the company provided studies on the quality of Darunavir Viatris. The company also carried out studies 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 Darunavir 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, Darunavir Viatris has been shown to have comparable quality and to be bioequivalent to Prezista. Therefore, the Agency’s view was that, as for Prezista, the benefit outweighs the identified risk and it can be authorised for use in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Darunavir Viatris have been included in the summary of product characteristics and the package leaflet. Any additional measures in place for Prezista also apply to Duranavir Viatris where appropriate.
As for all medicines, data on the use of Duranavir Viatris are continuously monitored. Suspected side effects reported with Duranavir Viatris are carefully evaluated and any necessary action taken to protect patients.
The European Commission granted a marketing authorisation valid throughout the European Union for Darunavir Mylan on 4 January 2017.
The name of the medicine was changed to Duranavir Viatris on 5 July 2024.
Product information
Latest procedure affecting product information:
T/0000178554
05/07/2024
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
- Darunavir Viatris (previously Darunavir Mylan)
- Active substance
- darunavir
- International non-proprietary name (INN) or common name
- darunavir
- Therapeutic area (MeSH)
- HIV Infections
- Anatomical therapeutic chemical (ATC) code
- J05AE10
Pharmacotherapeutic group
Antivirals for systemic useTherapeutic indication
Darunavir, co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (HIV-1) infection (see section 4.2).
Darunavir Viatris 75 mg, 150 mg, 300 mg and 600 mg tablets may be used to provide suitable dose regimens (see section 4.2):
- For the treatment of HIV-1 infection in antiretroviral treatment (ART)-experienced adult patients, including those that have been highly pre-treated.
- For the treatment of HIV-1 infection in paediatric patients from the age of 3 years and at least 15 kg body weight.
In deciding to initiate treatment with darunavir co-administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. Genotypic or phenotypic testing (when available) and treatment history should guide the use of darunavir (see sections 4.2, 4.4 and 5.1).
Darunavir co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (HIV-1) infection.
Darunavir co-administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg) (see section 4.2).
Darunavir Viatris 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of HIV-1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are:
- antiretroviral therapy (ART)-naïve (see section 4.2).
- ART-experienced with no darunavir resistance associated mutations (DRV-RAMs) and who have plasma HIV-1 RNA < 100,000 copies/ml and CD4+ cell count ? 100 cells x 10?/L. In deciding to initiate treatment with darunavir in such ART-experienced patients, genotypic testing should guide the use of darunavir (see sections 4.2, 4.3, 4.4 and 5.1).
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