Malta - English - Medicines Authority

mylan pharmaceuticals limited damastown industrial park mulhuddart dublin15 dublin, ireland - risperidone - orodispersible tablet - risperidone 0.5 mg - psycholeptics

Malta - English - Medicines Authority

mylan pharmaceuticals limited damastown industrial park mulhuddart dublin15 dublin, ireland - risperidone - orodispersible tablet - risperidone 1 mg - psycholeptics

Malta - English - Medicines Authority

mylan pharmaceuticals limited damastown industrial park mulhuddart dublin15 dublin, ireland - risperidone - orodispersible tablet - risperidone 2 mg - psycholeptics

Malta - English - Medicines Authority

mylan pharmaceuticals limited damastown industrial park mulhuddart dublin15 dublin, ireland - risperidone - orodispersible tablet - risperidone 3 mg - psycholeptics

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 ireland limited - abiraterone acetate - prostatic neoplasms - endocrine therapy, other hormone antagonists and related agents - abiraterone mylan is indicated with prednisone or prednisolone for:the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mhspc) in adult men in combination with androgen deprivation therapy (adt).the treatment of metastatic castration resistant prostate cancer (mcrpc) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated.the treatment of mcrpc in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen.

Malta - English - Medicines Authority

mylan pharmaceuticals limited damastown industrial park mulhuddart dublin15 dublin, ireland - piperacillin, tazobactam - powder for solution for infusion or injection - piperacillin 2 g tazobactam 0.25 g - antibacterials for systemic use

Malta - English - Medicines Authority

mylan pharmaceuticals limited damastown industrial park mulhuddart dublin15 dublin, ireland - piperacillin, tazobactam - powder for solution for infusion - piperacillin 4 g tazobactam 0.5 g - antibacterials for systemic use

European Union - English - EMA (European Medicines Agency)

mylan ireland limited - azacitidine - myelodysplastic syndromes; leukemia, myelomonocytic, chronic; leukemia, myeloid, acute - antineoplastic agents - azacitidine mylan is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (hsct) with:intermediate 2 and high risk myelodysplastic syndromes (mds) according to the international prognostic scoring system (ipss),chronic myelomonocytic leukaemia (cmml) with 10 29% marrow blasts without myeloproliferative disorder,acute myeloid leukaemia (aml) with 20 30% blasts and multi lineage dysplasia, according to world health organisation (who) classification,aml with > 30% marrow blasts according to the who classification.

European Union - English - EMA (European Medicines Agency)

mylan ireland limited - arsenic trioxide - leukemia, promyelocytic, acute - antineoplastic agents - arsenic trioxide mylan is indicated for induction of remission, and consolidation in adult patients with:- newly diagnosed low to intermediate risk acute promyelocytic leukaemia (apl) (white blood cell count, ≤ 10 x 103/μl) in combination with all trans retinoic acid (atra)- relapsed/refractory acute promyelocytic leukaemia (apl) (previous treatment should have included a retinoid and chemotherapy)characterised by the presence of the t(15;17) translocation and/or the presence of the promyelocytic leukaemia/retinoic acid receptor alpha (pml/rar alpha) gene.the response rate of other acute myelogenous leukaemia subtypes to arsenic trioxide has not beenexamined.