Unione Europea - rumeno - 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.

Unione Europea - rumeno - EMA (European Medicines Agency)

accord healthcare s.l.u. - lacosamid - epilepsie - antiepileptice, - lacosamide accord is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy. lacosamide accord is indicated as adjunctive therapy•         in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy. •         in the treatment of primary generalised tonic-clonic seizures in adults, adolescents and children from 4 years of age with idiopathic generalised epilepsy.

Unione Europea - rumeno - EMA (European Medicines Agency)

novartis europharm limited - eltrombopag - purpură, trombocitopenică, idiopatică - other systemic hemostatics, antihemorrhagics - revolade is indicated for the treatment of adult patients with primary immune thrombocytopenia (itp) who are refractory to other treatments (e. corticosteroids, immunoglobulins) (see sections 4. 2 și 5. revolade is indicated for the treatment of paediatric patients aged 1 year and above with primary immune thrombocytopenia (itp) lasting 6 months or longer from diagnosis and who are refractory to other treatments (e. corticosteroids, immunoglobulins) (see sections 4. 2 și 5. revolade is indicated in adult patients with chronic hepatitis c virus (hcv) infection for the treatment of thrombocytopenia, where the degree of thrombocytopenia is the main factor preventing the initiation or limiting the ability to maintain optimal interferon-based therapy (see sections 4. 4 and 5. revolade is indicated in adult patients with acquired severe aplastic anaemia (saa) who were either refractory to prior immunosuppressive therapy or heavily pretreated and are unsuitable for haematopoietic stem cell transplantation (see section 5.

Unione Europea - rumeno - EMA (European Medicines Agency)

mylan ireland limited - rivaroxaban - venous thromboembolism; pulmonary embolism; acute coronary syndrome; stroke; coronary artery disease; peripheral arterial disease; atrial fibrillation - agenți antitrombotici - 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.

Unione Europea - rumeno - EMA (European Medicines Agency)

biogen netherlands b.v.  - fampridine - scleroză multiplă - alte medicamente pentru sistemul nervos - fampyra este indicat pentru ameliorarea mersului pe jos la pacienții adulți cu scleroză multiplă cu handicap de mers pe jos (starea de invaliditate la scară extinsă 4-7).

Unione Europea - rumeno - EMA (European Medicines Agency)

csl behring gmbh - albutrepenonacog alfa - hemofilia b - hemostatice - tratamentul și profilaxia hemoragiilor la pacienții cu hemofilie b (deficit congenital de factor ix).

Unione Europea - rumeno - EMA (European Medicines Agency)

takeda pharmaceuticals international ag ireland branch - teduglutide - sindroamele de malabsorbție - alte medicamente pentru tractul digestiv și metabolism, - revestive este indicat pentru tratamentul pacienților în vârstă de 1 an și mai mult cu sindromul bowelului scurt (sbs). pacienții trebuie să fie stabili după o perioadă de adaptare intestinală după o intervenție chirurgicală. revestive este indicat pentru tratamentul pacienților cu vârsta cuprinsă între 1 an și mai sus, cu sindrom de intestin scurt. pacienții trebuie să fie stabili după o perioadă de adaptare intestinală după o intervenție chirurgicală.

Unione Europea - rumeno - EMA (European Medicines Agency)

csl behring gmbh - lioctocog alfa - hemofilia a - hemostatice - tratamentul și profilaxia hemoragiilor la pacienții cu hemofilie a (deficit congenital de factor viii). afstyla poate fi utilizat pentru toate grupele de vârstă.

Unione Europea - rumeno - EMA (European Medicines Agency)

pfizer europe ma eeig - dacomitinib monohidrat - carcinom, pulmonar non-celulă mică - agenți antineoplazici - vizimpro, ca monoterapie, este indicat pentru tratamentul de primă linie al pacienților adulți cu avansat local sau metastatic, cancer pulmonar fără celule mici (nsclc) cu receptorul factorului de creștere epidermal (egfr) activarea mutații.

Unione Europea - rumeno - EMA (European Medicines Agency)

eli lilly nederland b.v. - selpercatinib - carcinoma, non-small-cell lung; thyroid neoplasms - agenți antineoplazici - retsevmo as monotherapy is indicated for the treatment of adults and adolescents 12 years and older with advanced ret-mutant medullary thyroid cancer (mtc)advanced ret fusion-positive non-small cell lung cancer (nsclc) not previously treated with a ret inhibitoradvanced ret fusion-positive thyroid cancer who require systematic therapy following prior treatment.