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 Mylan 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 adult patients (see section 4.2). Darunavir Mylan 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 6 /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).
The FDA has approved Prezcobix (darunavir 800 mg/cobicistat 150 mg) tablets, from Janssen Therapuetics, for the treatment of Human Immunodeficiency...
Teva Pharmaceutical Industries announced that it has withdrawn its cash and stock proposal to acquire all of the outstanding ordinary...
Mylan N.V. announced that it has officially commenced its formal offer to acquire all outstanding ordinary shares of Perrigo Company...
Teva Pharmaceutical Industries Ltd. announced a proposal to acquire all of the outstanding shares of Mylan N.V. in a transaction...
Mylan N.V. and Biocon Ltd. announced that the FDA has accepted Mylan's biologics license application (BLA) for MYL 1401O, (Hertraz)...
Mylan N.V. announced that Mylan has made a proposal to acquire Perrigo Company plc in a cash-and-stock transaction that would...
The Board of Directors of Meda AB hereby confirms that it has been contacted by Mylan, Inc.regarding an indicative proposal...
Mylan N.V. announced that the FDA has approved Mylan's Abbreviated New Drug Applications (ANDAs) for Glatiramer Acetate Injection 40 mg/mL...