Evropska unija - slovenščina - EMA (European Medicines Agency)

mylan pharmaceuticals limited - entekavir monohidrat - hepatitis b - antivirusi za sistemsko uporabo - 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 bolezen jeter. za obe nadomestilo in decompensated bolezni jeter, ta navedba temelji na kliničnem preskušanju podatkov v nucleoside naivnih bolnikov z hbeag pozitivnih in hbeag negativnih hbv okužbe. glede bolnikov z lamivudinom neodzivnega hepatitisa b. entecavir mylan je prav tako primerna za zdravljenje kronične hbv okužbe v nucleoside naivno pediatričnih bolnikih od 2 do.

Evropska unija - slovenščina - EMA (European Medicines Agency)

mylan pharmaceuticals limited - febuksostat - hyperuricemia; arthritis, gouty; gout - antigout pripravki - febuxostat mylan je indiciran za preprečevanje in zdravljenje hiperurikemija pri odraslih bolnikih, kemoterapijo za haematologic malignomi srednjim do visoko tveganje tumor lizo sindrom (tls). febuxostat mylan je indiciran za zdravljenje kronične hyperuricaemia v razmerah, v katerih urate nanašanja je že prišlo do (vključno z zgodovino, ali prisotnost, tophus in/ali uričnega artritisa). febuxostat mylan je navedeno v odrasli.

Evropska unija - slovenščina - EMA (European Medicines Agency)

mylan pharmaceuticals limited - fulvestrant - neoplazme dojke - endokrini terapija - fulvestrant je primerna za zdravljenje estrogen receptor pozitivno, lokalno napredno ali metastatskega raka dojke pri ženskah po menopavzi:ne prej, zdravljenih z endokrinih terapije, orwith ponovitve bolezni na ali po adjuvant anti-estrogen terapije, ali napredovanja bolezni na antiestrogen terapija.

Evropska unija - slovenščina - EMA (European Medicines Agency)

mylan s.a.s - ritonavir - okužbe z virusom hiv - antivirusi za sistemsko uporabo - ritonavir je indiciran v kombinaciji z drugimi protiretrovirusnimi zdravili za zdravljenje okuženih s hiv 1 (odrasli in otroci, stari 2 leti in starejši).

Evropska unija - slovenščina - EMA (European Medicines Agency)

mylan pharmaceuticals limited - prasugrel besilate - myocardial infarction; acute coronary syndrome; angina, unstable - antitrombotična sredstva - prasugrel mylan, co daje z acetilsalicilne kisline (asa), je označen za preprečevanje atherothrombotic dogodkov pri odraslih bolnikih s akutni koronarni sindrom (i. nestabilna angina pektoris, ki niso-st segmentu višinskih miokardni infarkt [ua/nstemi] ali st segmentu višinskih miokardni infarkt [stemi]) v procesu primarne zamudo ali perkutani koronarni intervenciji (pci).

Evropska unija - slovenščina - EMA (European Medicines Agency)

mylan pharmaceuticals limited - acetylsalicylic acid, clopidogrel hydrogen sulfate - acute coronary syndrome; myocardial infarction - antitrombotična sredstva - clopidogrel/acetilsalicilne kisline mylan je primerna za sekundarno preprečevanje atherothrombotic dogodkov pri odraslih bolnikih, ki že ob tako clopidogrel in acetilsalicilne kisline (asa). clopidogrel/acetilsalicilne kisline mylan je določen odmerek kombinacije zdravila za nadaljevanje terapije v:non-st segmentu višinskih akutni koronarni sindrom (nestabilna angina pektoris ali ne-q-val, miokardni infarkt), vključno z bolniki, ki opravljajo stent umestitev po perkutani koronarni interventionst segmentu višinskih akutni miokardni infarkt v medicinsko zdravljenih bolnikih, ki izpolnjujejo pogoje za thrombolytic terapija.

Evropska unija - slovenščina - EMA (European Medicines Agency)

mylan ireland limited - fingolimod hidroklorid - multiplo sklerozo, recidivno-nakazila - imunosupresivi - indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult and paediatric patients aged 10 years and older:patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (for exceptions and information about washout periods see sections 4. 4 in 5. 1)orpatients s hitro razvijajočimi se hudo recidivno nakazila multiplo sklerozo, opredeljeno z 2 ali več onemogočanje zagonov v enem letu, in z 1 ali več gadolinium krepitev poškodbe na možganih, mri ali znatno povečanje t2 lezije obremenitvi, kot je v primerjavi s predhodnim zadnjih mri.

Evropska unija - slovenščina - EMA (European Medicines Agency)

mylan ireland limited - rivaroksaban - venous thromboembolism; pulmonary embolism; acute coronary syndrome; stroke; coronary artery disease; peripheral arterial disease; atrial fibrillation - antitrombotična sredstva - 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.

Evropska unija - slovenščina - EMA (European Medicines Agency)

mylan ireland limited - sugammadex sodium - neuromuskularna blokada - vsi drugi terapevtski izdelki - 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.

Evropska unija - slovenščina - EMA (European Medicines Agency)

mylan ireland limited - fingolimod hidroklorid - multiplo sklerozo, recidivno-nakazila - imunosupresivi - indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult and paediatric patients aged 10 years and older: patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (for exceptions and information about washout periods see sections 4. 4 in 5. 1) or patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain mri or a significant increase in t2 lesion load as compared to a previous recent mri.