Unión Europea - estonio - EMA (European Medicines Agency)

mylan s.a.s - ambrisentaan - hüpertensioon, kopsuvähk - antihypertensives, - ambrisentan mylan on näidustatud ravi pulmonaalse arteriaalse hüpertensiooni (pah) täiskasvanud patsientidel, kes funktsionaalne klass (fc) ii-iii, sealhulgas kasutada kombineeritud ravi. efektiivsus on näidustatud idiopaatiliste pah-de (ipah) ja sidekoehaigusega seotud pah-de puhul. ambrisentan mylan on näidustatud ravi pulmonaalse arteriaalse hüpertensiooni (pah) täiskasvanud patsientidel, kes funktsionaalne klass (fc) ii-iii, sealhulgas kasutada kombineeritud ravi. efektiivsus on näidustatud idiopaatiliste pah-de (ipah) ja sidekoehaigusega seotud pah-de puhul.

Unión Europea - estonio - EMA (European Medicines Agency)

mylan pharmaceuticals limited - deferasiroks - iron overload; beta-thalassemia - raua kelaativad ained - deferasirox mylan on märgitud forthe ravi kroonilise raua ülekoormuse tõttu sagedasi vereülekandeid (≥7 ml/kg/kuus pakitud vere punaliblede) patsientidel beeta thalassaemia suur vanuses 6 aastat ja olderthe ravi kroonilise raua ülekoormuse tõttu vereülekandeid, kui deferoksamiini ravi on vastunäidustatud või ebapiisav järgmised patsientide grupid:lastel patsientidel beeta thalassaemia suur raua ülekoormuse tõttu sagedasi vereülekandeid (≥7 ml/kg/kuus pakitud vere punaliblede), vanuses 2 kuni 5 aastat,täiskasvanud ja pediaatriliste patsientide beeta thalassaemia suur raua ülekoormuse tõttu harvad vereülekandeid (.

Unión Europea - estonio - EMA (European Medicines Agency)

mylan ireland limited - asatsitidiin - myelodysplastic syndromes; leukemia, myelomonocytic, chronic; leukemia, myeloid, acute - antineoplastilised ained - 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.

Unión Europea - estonio - EMA (European Medicines Agency)

mylan pharmaceuticals limited - acetylsalicylic acid, clopidogrel hydrogen sulfate - acute coronary syndrome; myocardial infarction - antitrombootilised ained - clopidogrel/atsetüülsalitsüülhape mylan on näidustatud sekundaarseks ennetamiseks atherothrombotic sündmuste täiskasvanud patsientidel, arvestades juba nii clopidogrel ja atsetüülsalitsüülhape (asa). clopidogrel/atsetüülsalitsüülhape mylan on fikseeritud annuse kombinatsioon ravimi jätkamine ravi:non-st segmendi elevatsiooniga äge koronaarsündroom (ebastabiilne stenokardia või mitte-q-wave müokardiinfarkt), k.a patsiendid toimumas stent paigutuse pärast perkutaanne südame interventionst segmendi elevatsiooniga ägeda müokardiinfarkti meditsiiniliselt ravitud patsientide abikõlblikud trombolüütiline ravi.

Unión Europea - estonio - EMA (European Medicines Agency)

mylan ireland limited - arseentrioksiid - leukeemia, promüelotsüütne, äge - antineoplastilised ained - arseentrioksiid mylan on näidustatud remissiooni induktsioon, ja konsolideerimise täiskasvanud patsientidel, kellel on:- hiljuti diagnoositud madala kuni keskmise riski ägeda promyelocytic leukeemia (avp) (valgete vereliblede arv, ≤ 10 x 103/µl) koos kõik-trans-retinoolhappe (atra)- taastekkinud/tulekindlad äge promyelocytic leukeemia (avp) (varasem ravi peab olema lisatud retinoid ja keemiaravi), mida iseloomustab juuresolekul, t(15;17) translokatsioon ja/või olemasolu promyelocytic leukeemia/retinoolhappe retseptori α (pml/rar alfa) geen. vastuse määr muude ägeda müeloidse leukeemia alatüüpi, et arseentrioksiid ei ole beenexamined.

Unión Europea - estonio - EMA (European Medicines Agency)

mylan ire healthcare limited - pretomanid - tuberkuloos, multidrug-resistentne - antimükobakterid - dovprela is indicated in combination with bedaquiline and linezolid, in adults, for the treatment of pulmonary extensively drug resistant (xdr), or treatment-intolerant or nonresponsive multidrug-resistant (mdr) tuberculosis (tb). tuleks arvesse võtta ametlikke juhiseid sobiva kasutada antibakteriaalseid aineid.

Unión Europea - estonio - EMA (European Medicines Agency)

mylan ireland limited - abirateroonatsetaat - eesnäärmevähk - 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.

Unión Europea - estonio - EMA (European Medicines Agency)

mylan ireland limited - rivaroksabaan - venous thromboembolism; pulmonary embolism; acute coronary syndrome; stroke; coronary artery disease; peripheral arterial disease; atrial fibrillation - antitrombootilised ained - rivaroxaban mylan co-administered with acetylsalicylic acid (asa) alone or with asa plus clopidogrel or ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (acs) with elevated cardiac biomarkers.  rivaroxaban mylan co-administered with acetylsalicylic acid (asa), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (cad) or symptomatic peripheral artery disease (pad) at high risk of ischaemic events.  ------prevention of venous thromboembolism (vte) in adult patients undergoing elective hip or knee replacement surgery.  treatment of deep vein thrombosis (dvt) and pulmonary embolism (pe), and prevention of recurrent dvt and pe in adults. -------adults prevention of stroke and systemic embolism in adult   patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. paediatric population treatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment. paediatric population treatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing more than 50 kg after at least 5 days of initial parenteral anticoagulation treatment.

Unión Europea - estonio - EMA (European Medicines Agency)

mylan ireland limited - sugammadex sodium - neuromuskulaarne blokaad - kõik muud ravitoimingud - reversal of neuromuscular blockade induced by   rocuronium or vecuronium in adults. for the paediatric population: sugammadex is only recommended for routine reversal of rocuronium induced blockade in children and adolescents aged 2 to 17 years.

Unión Europea - estonio - EMA (European Medicines Agency)

mylan ire healthcare limited - bevatsizumab - colorectal neoplasms; breast neoplasms; ovarian neoplasms; fallopian tube neoplasms; peritoneal neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell; uterine cervical neoplasms - antineoplastilised ained - treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix.