Canada - English - Health Canada

mylan pharmaceuticals ulc - pantoprazole (pantoprazole sodium sesquihydrate) - tablet (delayed-release) - 40mg - pantoprazole (pantoprazole sodium sesquihydrate) 40mg - proton-pump inhibitors

European Union - English - EMA (European Medicines Agency)

mylan pharmaceuticals limited - efavirenz, emtricitabine, tenofovir disoproxil maleate - hiv infections - antivirals for systemic use - efavirenz/emtricitabine/tenofovir disoproxil mylan is a fixed-dose combination of efavirenz, emtricitabine and tenofovir disoproxil. it is indicated for the treatment of human immunodeficiency virus-1 (hiv-1) infection in adults aged 18 years and over with virologic suppression to hiv-1 rna levels of < 50 copies/ml on their current combination antiretroviral therapy for more than three months. patients must not have experienced virological failure on any prior antiretroviral therapy and must be known not to have harboured virus strains with mutations conferring significant resistance to any of the three components contained in efavirenz/emtricitabine/tenofovir disoproxil mylan prior to initiation of their first antiretroviral treatment regimen.the demonstration of the benefit of efavirenz/emtricitabine/tenofovir disoproxil is primarily based on 48-week data from a clinical study in which patients with stable virologic suppression on a combination antiretroviral therapy changed to efavirenz/emtricitabine/tenofovir disoproxil (see section 5.1). no data are currently available from clinical studies with efavirenz/emtricitabine/tenofovir disoproxil in treatment-naïve or in heavily pretreated patients.no data are available to support the combination of efavirenz/emtricitabine/tenofovir disoproxil and other antiretroviral agents.

European Union - English - EMA (European Medicines Agency)

mylan s.a.s - ritonavir - hiv infections - 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).

European Union - English - EMA (European Medicines Agency)

mylan pharmaceuticals limited - gefitinib - carcinoma, non-small-cell lung - antineoplastic agents, protein kinase inhibitors - gefitinib mylan is indicated as monotherapy for the treatment of adult patients with locally advanced or metastatic non‑small cell lung cancer (nsclc) with activating mutations of egfr‑tk.

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

mylan healthcare sdn. bhd. - epirubicin hydrochloride -

Malta - English - Malta Medicines Authority

mylan ireland limited unit 35/36, grange parade, baldoyle industrial estate, dublin 13, ireland - pantoprazole - gastro-resistant tablet - pantoprazole 40 mg - drugs for acid related disorders

Malta - English - Malta Medicines Authority

mylan ireland limited unit 35/36, grange parade, baldoyle industrial estate, dublin 13, ireland - lamivudine - film-coated tablet - lamivudine 150 mg - antivirals for systemic use

Malta - English - Malta Medicines Authority

mylan ireland limited unit 35/36, grange parade, baldoyle industrial estate, dublin 13, ireland - lamivudine - film-coated tablet - lamivudine 300 mg - antivirals for systemic use

Malta - English - Malta Medicines Authority

mylan ireland limited unit 35/36, grange parade, baldoyle industrial estate, dublin 13, ireland - sildenafil citrate - film-coated tablet - sildenafil citrate 25 mg - urologicals

Malta - English - Malta Medicines Authority

mylan ireland limited unit 35/36, grange parade, baldoyle industrial estate, dublin 13, ireland - sildenafil citrate - film-coated tablet - sildenafil citrate 50 mg - urologicals