Malta - English - Medicines Authority

mylan s.a.s. 117 allee des parcs, 69800 saint priest, france - risperidone - orodispersible tablet - risperidone 2 milligram(s) - psycholeptics

Malta - English - Medicines Authority

mylan s.a.s. 117 allee des parcs, 69800 saint priest, france - risperidone - orodispersible tablet - risperidone 3 milligram(s) - psycholeptics

Malta - English - Medicines Authority

mylan s.a.s. 117 allee des parcs, 69800 saint priest, france - risperidone - orodispersible tablet - risperidone 4 milligram(s) - psycholeptics

European Union - English - EMA (European Medicines Agency)

mylan pharmaceuticals limited - darunavir - hiv infections - antivirals for systemic use - 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 adults and adolescents (aged 12 years and older, weighing at least 40 kg) (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 10⁶/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).

European Union - English - EMA (European Medicines Agency)

mylan pharmaceuticals limited - emtricitabine, tenofovir disoproxil maleate - hiv infections - antivirals for systemic use - treatment of hiv-1 infection:emtricitabine/tenofovir disoproxil mylan is indicated in antiretroviral combination therapy for the treatment of hiv-1 infected adults (see section 5.1).emtricitabine/tenofovir disoproxil mylan is also indicated for the treatment of hiv-1 infected adolescents, with nrti resistance or toxicities precluding the use of first line agents, (see sections 4.2, 4.4 and 5.1).pre-exposure prophylaxis (prep):emtricitabine/tenofovir disoproxil mylan is indicated in combination with safer sex practices for pre-exposure prophylaxis to reduce the risk of sexually acquired hiv-1 infection in adults and adolescents at high risk (see sections 4.2, 4.4 and 5.1).

European Union - English - EMA (European Medicines Agency)

mylan pharmaceuticals limited - pregabalin - anxiety disorders; epilepsy - antiepileptics, - neuropathic painpregabalin mylan is indicated for the treatment of peripheral and central neuropathic pain in adults.epilepsypregabalin mylan is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.generalised anxiety disorderpregabalin mylan is indicated for the treatment of generalised anxiety disorder (gad) in adults.

European Union - English - EMA (European Medicines Agency)

mylan s.a.s. - pregabalin - anxiety disorders; neuralgia; epilepsy - antiepileptics, - epilepsypregabalin mylan pharma is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.generalised anxiety disorderpregabalin mylan pharma is indicated for the treatment of generalised anxiety disorder (gad) in adults.

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 pharmaceuticals limited - anagrelide hydrochloride - thrombocythemia, essential - antineoplastic agents - anagrelide is indicated for the reduction of elevated platelet counts in at risk essential thrombocythaemia (et) patients who are intolerant to their current therapy or whose elevated platelet counts are not reduced to an acceptable level by their current therapy.an at-risk patientan at-risk essential thrombocythaemia patient is defined by one or more of the following features:>60 years of age ora platelet count >1,000 x 10⁹/l ora history of thrombo-haemorrhagic events. 

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

mylan healthcare sdn. bhd. - epirubicin hydrochloride -