Roctavian Unia Europejska - polski - EMA (European Medicines Agency)

roctavian

biomarin international limited - valoctocogene roxaparvovec - antykrościeryczne - treatment of severe haemophilia a (congenital factor viii deficiency) in adult patients without a history of factor viii inhibitors and without detectable antibodies to adeno-associated virus serotype 5 (aav5).

Voxzogo Unia Europejska - polski - EMA (European Medicines Agency)

voxzogo

biomarin international limited - vosoritide - achondroplasia - leki stosowane w leczeniu chorób kości - voxzogo is indicated for the treatment of achondroplasia in patients 4 months of age and older whose epiphyses are not closed. the diagnosis of achondroplasia should be confirmed by appropriate genetic testing.

Naglazyme Unia Europejska - polski - EMA (European Medicines Agency)

naglazyme

biomarin international limited - galsulfaza - mukopolisacharydoza vi - inne przewodu pokarmowego i przemianę materii narzędzia, - preparat naglazyme jest wskazany w długotrwałej terapii zastąpienia enzymu u pacjentów z potwierdzonym rozpoznaniem mukopolisacharydoza vi (mps vi; niedoborem sulfatazy n-acetylogalaktozaminy-4; maroteaux-lamy'ego zespół) (patrz punkt 5. jak i dla wszystkich lizosomalnych zaburzeniami genetycznymi, ma ogromne znaczenie, szczególnie w ciężkich postaciach, należy rozpocząć leczenie jak najszybciej, do momentu pojawienia się nieodwracalnych objawów klinicznych choroby. kluczową kwestią jest w leczeniu młodych pacjentów w wieku.

Vimizim Unia Europejska - polski - EMA (European Medicines Agency)

vimizim

biomarin international limited - recombinant human n-acetylgalactosamine-6-sulfatase - mukopolisacharydoza iv - inne przewodu pokarmowego i przemianę materii narzędzia, - vimizim jest wskazany w leczeniu mukopolisacharydozy typu iva (zespół morquio a, mps iva) u pacjentów w każdym wieku.

Rivaroxaban Viatris (previously Rivaroxaban Mylan) Unia Europejska - polski - EMA (European Medicines Agency)

rivaroxaban viatris (previously rivaroxaban mylan)

mylan ireland limited - rywaroksaban - venous thromboembolism; pulmonary embolism; acute coronary syndrome; stroke; coronary artery disease; peripheral arterial disease; atrial fibrillation - Środki przeciwzakrzepowe - 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.