Liên Minh Châu Âu - Tiếng Anh - EMA (European Medicines Agency)

mylan pharmaceuticals limited - zonisamide - epilepsy - antiepileptics, - monotherapy in the treatment of partial seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy;adjunctive therapy in the treatment of partial seizures, with or without secondary generalisation, in adults, adolescents, and children aged 6 years and above.

Liên Minh Châu Âu - Tiếng Anh - EMA (European Medicines Agency)

mylan pharmaceuticals limited - entecavir monohydrate - hepatitis b - antivirals for systemic use - entecavir mylan is indicated for the treatment of chronic hepatitis b virus (hbv) infection in adults with:compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (alt) levels and histological evidence of active inflammation and/or fibrosis.decompensated liver disease.for both compensated and decompensated liver disease, this indication is based on clinical trial data in nucleoside naive patients with hbeag positive and hbeag negative hbv infection. with respect to patients with lamivudine-refractory hepatitis b.entecavir mylan is also indicated for the treatment of chronic hbv infection in nucleoside naive paediatric patients from 2 to

Liên Minh Châu Âu - Tiếng Anh - EMA (European Medicines Agency)

mylan pharmaceuticals limited - fulvestrant - breast neoplasms - endocrine therapy - fulvestrant is indicated for the treatment of estrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women:not previously treated with endocrine therapy, orwith disease relapse on or after adjuvant anti-estrogen therapy, or disease progression on antiestrogen therapy.

Malta - Tiếng Anh - Malta Medicines Authority

mylan ireland limited unit 35/36, grange parade, baldoyle industrial estate, dublin 13, ireland - lansoprazole - orodispersible tablet - lansoprazole 15 mg - drugs for acid related disorders

Malta - Tiếng Anh - Malta Medicines Authority

mylan ireland limited unit 35/36, grange parade, baldoyle industrial estate, dublin 13, ireland - lansoprazole - orodispersible tablet - lansoprazole 30 mg - drugs for acid related disorders

Malta - Tiếng Anh - Malta Medicines Authority

mylan ireland limited unit 35/36, grange parade, baldoyle industrial estate, dublin 13, ireland - dutasteride - soft capsule - dutasteride 0.5 mg - urologicals

Malta - Tiếng Anh - Malta Medicines Authority

mylan ireland limited unit 35/36, grange parade, baldoyle industrial estate, dublin 13, ireland - imatinib - film-coated tablet - imatinib 400 mg - antineoplastic agents

Malta - Tiếng Anh - Malta Medicines Authority

mylan ireland limited unit 35/36, grange parade, baldoyle industrial estate, dublin 13, ireland - ibandronic acid - film-coated tablet - ibandronic acid 150 mg - drugs for treatment of bone diseases

Malta - Tiếng Anh - Malta Medicines Authority

mylan ireland limited unit 35/36, grange parade, baldoyle industrial estate, dublin 13, ireland - montelukast - chewable tablet - montelukast 4 mg - drugs for obstructive airway diseases

Malta - Tiếng Anh - Malta Medicines Authority

mylan ireland limited unit 35/36, grange parade, baldoyle industrial estate, dublin 13, ireland - montelukast - chewable tablet - montelukast 5 mg - drugs for obstructive airway diseases