Data from EMA (European Medicines Agency) - Curated by EPG Health - Last updated 15 August 2018

Indication(s)

- Darunavir Mylan 75 mg film-coated tablets
- Darunavir Mylan 150 mg film-coated tablets
- Darunavir Mylan 300 mg film-coated tablets
- Darunavir Mylan 600 mg film-coated tablets

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 Mylan  may be used to provide suitable dose regimens:
● 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.



- Darunavir Mylan 400 mg film-coated tablets
- Darunavir Mylan 800 mg film-coated tablets

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 adult patients.

Darunavir Mylan 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.
● 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 106/l. In deciding to initiate treatment with darunavir in such ART-experienced patients, genotypic testing should guide the use of darunavir.

Full Prescribing information

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More information

Category Value
Agency product number EMEA/H/C/004068
Orphan designation No
Date First Approved 04-01-2017
Type Medicinal product subject to restricted medical prescription
Marketing authorisation holder Mylan S.A.S.