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.

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.

European Union - English - EMA (European Medicines Agency)

mylan ireland limited - dimethyl fumarate - multiple sclerosis, relapsing-remitting - immunosuppressants - dimethyl fumarate mylan is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis.

European Union - English - EMA (European Medicines Agency)

mylan pharmaceuticals limited - cinacalcet hydrochloride - hyperparathyroidism, secondary; hypercalcemia - calcium homeostasis - treatment of secondary hyperparathyroidism (hpt) in patients with end-stage renal disease (esrd) on maintenance dialysis therapy.cinacalcet mylan may be used as part of a therapeutic regimen including phosphate binders and/or vitamin d sterols, as appropriate.reduction of hypercalcaemia in patients with:parathyroid carcinomaprimary hpt for whom parathyroidectomywould be indicated on the basis of serum calcium levels (as defined by relevant treatment guidelines), but in whom parathyroidectomy is not clinically appropriate or is contraindicated. 

Malta - English - Medicines Authority

mylan ireland limited unit 35/36, grange parade, baldoyle industrial estate, dublin 13, ireland - pantoprazole - gastro-resistant tablet - pantoprazole 20 mg - drugs for acid related disorders

Malta - English - Medicines Authority

mylan ireland limited unit 35/36, grange parade, baldoyle industrial estate, dublin 13, ireland - tigecycline - powder for solution for infusion - tigecycline 50 mg - antibacterials for systemic use

Malta - English - Medicines Authority

mylan ireland limited unit 35/36, grange parade, baldoyle industrial estate, dublin 13, ireland - aripiprazole - tablet - aripiprazole 5 mg - psycholeptics

Malta - English - Medicines Authority

mylan ireland limited unit 35/36, grange parade, baldoyle industrial estate, dublin 13, ireland - aripiprazole - tablet - aripiprazole 10 mg - psycholeptics

Malta - English - Medicines Authority

mylan ireland limited unit 35/36, grange parade, baldoyle industrial estate, dublin 13, ireland - aripiprazole - tablet - aripiprazole 15 mg - psycholeptics