Rumānija - rumāņu - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

pharmadox healthcare limited - malta - moxifloxacinum - compr. film. - 400mg - chinolone antibacteriene fluorochinolone

Eiropas Savienība - rumāņu - EMA (European Medicines Agency)

novartis europharm limited - secukinumab - arthritis, psoriatic; psoriasis; spondylitis, ankylosing - imunosupresoare - plaque psoriasiscosentyx is indicated for the treatment of moderate to severe plaque psoriasis in adults and children from the age of 6 years old who are candidates for systemic therapy. hidradenitis suppurativa (hs)cosentyx is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults with an inadequate response to conventional systemic hs therapy. psoriazică arthritiscosentyx, singur sau în asociere cu metotrexat (mtx), este indicat pentru tratamentul artritei psoriazice active la pacienții adulți, atunci când răspunsul la precedenta modificare a bolii anti-reumatice droguri (marmb) a fost terapia inadecvată. spondilartrită axială (axspa)spondilita anchilozantă (ca, radiografic spondilartrită axială)cosentyx este indicat pentru tratamentul de spondilită anchilozantă activă la adulți care au răspuns inadecvat la terapia convențională. non-radiographic axial spondyloarthritis (nr-axspa)cosentyx is indicated for the treatment of active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated c-reactive protein (crp) and/or magnetic resonance imaging (mri) evidence in adults who have responded inadequately to non steroidal anti inflammatory drugs (nsaids). juvenile idiopathic arthritis (jia)enthesitis-related arthritis (era)cosentyx, alone or in combination with methotrexate (mtx), is indicated for the treatment of active enthesitis-related arthritis in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy. juvenile psoriatic arthritis (jpsa)cosentyx, alone or in combination with methotrexate (mtx), is indicated for the treatment of active juvenile psoriatic arthritis in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy.

Eiropas Savienība - rumāņu - EMA (European Medicines Agency)

novartis europharm limited - sacubitril, valsartan - insuficienta cardiaca - antagoniști ai angiotensinei ii, alte combinații, agenți care acționează asupra sistemului renină-angiotensină - paediatric heart failureentresto is indicated in children and adolescents aged one year or older for treatment of symptomatic chronic heart failure with left ventricular systolic dysfunction. adult heart failureentresto is indicated in adult patients for treatment of symptomatic chronic heart failure with reduced ejection fraction.

Eiropas Savienība - rumāņu - EMA (European Medicines Agency)

novartis europharm limited - ruxolitinib (sub formă de fosfat) - myeloproliferative disorders; polycythemia vera; graft vs host disease - agenți antineoplazici - myelofibrosis (mf)jakavi is indicated for the treatment of disease related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis. policitemie vera (pv)jakavi este indicat pentru tratamentul pacienților adulți cu policitemie vera, care sunt rezistente la sau intoleranță la hidroxiuree. graft versus host disease (gvhd)jakavi is indicated for the treatment of patients aged 12 years and older with acute graft versus host disease or chronic graft versus host disease who have inadequate response to corticosteroids or other systemic therapies (see section 5.

Eiropas Savienība - rumāņu - EMA (European Medicines Agency)

novartis europharm limited - sacubitril, valsartan - insuficienta cardiaca - agenți care acționează asupra sistemului renină-angiotensină - paediatric heart failureneparvis is indicated in children and adolescents aged one year or older for treatment of symptomatic chronic heart failure with left ventricular systolic dysfunction (see section 5. adult heart failureneparvis is indicated in adult patients for treatment of symptomatic chronic heart failure with reduced ejection fraction (see section 5.

Eiropas Savienība - rumāņu - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - lumacaftor, ivacaftor - fibroză chistică - alte produse ale sistemului respirator - orkambi comprimate este indicat pentru tratamentul fibrozei chistice (fc) la pacienții cu vârsta de 6 ani și peste, care sunt homozigoți pentru mutația f508del în gena cftr. orkambi granules are indicated for the treatment of cystic fibrosis (cf) in children aged 1 year and older who are homozygous for the f508del mutation in the cftr gene.

Eiropas Savienība - rumāņu - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - tezacaftor, ivacaftor - fibroză chistică - alte produse ale sistemului respirator - symkevi is indicated in a combination regimen with ivacaftor tablets for the treatment of patients with cystic fibrosis (cf) aged 6 years and older who are homozygous for the f508del mutation or who are heterozygous for the f508del mutation and have one of the following mutations in the cystic fibrosis transmembrane conductance regulator (cftr) gene: p67l, r117c, l206w, r352q, a455e, d579g, 711+3a→g, s945l, s977f, r1070w, d1152h, 2789+5g→a, 3272 26a→g, and 3849+10kbc→t.

Eiropas Savienība - rumāņu - EMA (European Medicines Agency)

novartis europharm limited  - indacaterol, mometasone furoate - astm - medicamente pentru afecțiuni obstructive ale căilor respiratorii, - bemrist breezhaler is indicated as a maintenance   treatment of asthma in adults and adolescents 12 years of age and older not adequately controlled with inhaled corticosteroids and inhaled short acting beta2-agonists.

Eiropas Savienība - rumāņu - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - ivacaftor, tezacaftor, elexacaftor - fibroză chistică - alte produse ale sistemului respirator - kaftrio is indicated in a combination regimen with ivacaftor for the treatment of cystic fibrosis (cf) in patients aged 6 years and older who have at least one f508del mutation in the cystic fibrosis transmembrane conductance regulator (cftr) gene.

Eiropas Savienība - rumāņu - EMA (European Medicines Agency)

novartis europharm limited - crizanlizumab - anemie, sickle cell - other hematological agents - adakveo is indicated for the prevention of recurrent vaso occlusive crises (vocs) in sickle cell disease patients aged 16 years and older. it can be given as an add on therapy to hydroxyurea/hydroxycarbamide (hu/hc) or as monotherapy in patients for whom hu/hc is inappropriate or inadequate.