مالطا - الإنجليزية - 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

مالطا - الإنجليزية - Malta Medicines Authority

mylan ireland limited unit 35/36, grange parade, baldoyle industrial estate, dublin 13, ireland - imatinib - film-coated tablet - imatinib 100 mg - antineoplastic agents

مالطا - الإنجليزية - Malta Medicines Authority

mylan ireland limited unit 35/36, grange parade, baldoyle industrial estate, dublin 13, ireland - sunitinib - hard capsule - sunitinib 12.5 mg - antineoplastic agents

مالطا - الإنجليزية - Malta Medicines Authority

mylan ireland limited unit 35/36, grange parade, baldoyle industrial estate, dublin 13, ireland - sunitinib - hard capsule - sunitinib 25 mg - antineoplastic agents

مالطا - الإنجليزية - Malta Medicines Authority

mylan ireland limited unit 35/36, grange parade, baldoyle industrial estate, dublin 13, ireland - sunitinib - hard capsule - sunitinib 37.5 mg - antineoplastic agents

مالطا - الإنجليزية - Malta Medicines Authority

mylan ireland limited unit 35/36, grange parade, baldoyle industrial estate, dublin 13, ireland - sunitinib - hard capsule - sunitinib 50 mg - antineoplastic agents

الاتحاد الأوروبي - الإنجليزية - EMA (European Medicines Agency)

mylan pharmaceuticals limited - teriflunomide - multiple sclerosis, relapsing-remitting - immunosuppressants - teriflunomide mylan is indicated for the treatment of adult patients and paediatric patients aged 10 years and older (body weight > 40 kg) with relapsing remitting multiple sclerosis (ms) (please refer to section 5.1 of the smpc for important information on the population for which efficacy has been established). 

الاتحاد الأوروبي - الإنجليزية - EMA (European Medicines Agency)

mylan s.a.s. - docetaxel - head and neck neoplasms; carcinoma, non-small-cell lung; adenocarcinoma; prostatic neoplasms; breast neoplasms - antineoplastic agents - treatment of breast cancer, special forms of lung cancer (non-small-cell lung cancer), prostate cancer, gastric cancer, or head and neck cancer.

الاتحاد الأوروبي - الإنجليزية - EMA (European Medicines Agency)

mylan pharmaceuticals limited - tenofovir disoproxil - hiv infections - antivirals for systemic use - hiv-1 infectiontenofovir disoproxil 245 mg film-coated tablets are indicated in combination with other antiretroviral medicinal products for the treatment of hiv-1 infected adults.in adults, the demonstration of the benefit of tenofovir disoproxil in hiv-1 infection is based on results of one study in treatment-naïve patients, including patients with a high viral load (> 100,000 copies/ml) and studies in which tenofovir disoproxil was added to stable background therapy (mainly tritherapy) in antiretroviral pre-treated patients experiencing early virological failure (< 10,000 copies/ml, with the majority of patients having < 5,000 copies/ml).tenofovir disoproxil 245 mg film-coated tablets are also indicated for the treatment of hiv-1 infected adolescents, with nrti resistance or toxicities precluding the use of first line agents, aged 12 to < 18 years.the choice of tenofovir disoproxil to treat antiretroviral-experienced patients with hiv-1 infection should be based on individual viral resistance testing and/or treatment history of patients.hepatitis b infectiontenofovir disoproxil 245 mg film-coated tablets are indicated for the treatment of chronic hepatitis b in adults with:compensated liver disease, with evidence of active viral replication, persistently elevated serum alanine aminotransferase (alt) levels and histological evidence of active inflammation and/or fibrosis.evidence of lamivudine-resistant hepatitis b virus.decompensated liver disease.tenofovir disoproxil 245 mg film-coated tablets are indicated for the treatment of chronic hepatitis b in adolescents 12 to < 18 years of age with:compensated liver disease and evidence of immune active disease, i.e. active viral replication, persistently elevated serum alt levels and histological evidence of active inflammation and/or fibrosis.

الاتحاد الأوروبي - الإنجليزية - EMA (European Medicines Agency)

mylan pharmaceuticals limited - zoledronic acid - fractures, bone - drugs for treatment of bone diseases - prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone;treatment of adult patients with tumour-induced hypercalcaemia (tih).