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

Malta - English - Medicines Authority

mylan ireland limited unit 35/36, grange parade, baldoyle industrial estate, dublin 13, ireland - aripiprazole - tablet - aripiprazole 30 mg - psycholeptics

Malta - English - Medicines Authority

mylan ire healthcare limited unit 35/36, grange parade, baldoyle industrial estate, dublin 13, ireland - mebeverine hydrochloride - prolonged-release capsule - mebeverine hydrochloride 200 mg - drugs for functional gastrointestinal disorders

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.

Malta - English - Medicines Authority

mylan ire healthcare limited unit 35/36, grange parade, baldoyle industrial estate, dublin 13, ireland - nitroglycerin - transdermal patch - nitroglycerin 10 mg/24 h - cardiac therapy

Malta - English - Medicines Authority

mylan ire healthcare limited unit 35/36, grange parade, baldoyle industrial estate, dublin 13, ireland - influenza vaccine, split virion, inactivated - suspension for injection in pre-filled syringe - influenza vaccine (split virion, inactivated) 15 µg - vaccines

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.