Uniunea Europeană - română - EMA (European Medicines Agency)

alnylam netherlands b.v. - vutrisiran sodium - amyloid neuropathies, familial - alte medicamente pentru sistemul nervos - treatment of hereditary transthyretin-mediated amyloidosis (hattr amyloidosis) in adult patients with stage 1 or stage 2 polyneuropathy.

Uniunea Europeană - română - EMA (European Medicines Agency)

viiv healthcare bv - dolutegravir - infecții cu hiv - antivirale pentru uz sistemic - tivicay is indicated in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (hiv) infected adults, adolescents and children of at least 6 years of age or older and weighing at least 14 kg. tivicay is indicated in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (hiv) infected adults, adolescents and children of at least 4 weeks of age or older and weighing at least 3 kg.

Uniunea Europeană - română - EMA (European Medicines Agency)

kyowa kirin holdings b.v. - burosumab - hypophosphatemia, familial; hypophosphatemic rickets, x-linked dominant; osteomalacia - medicamente pentru tratamentul bolilor osoase - crysvita is indicated for the treatment of x-linked hypophosphataemia, in children and adolescents aged 1 to 17 years with radiographic evidence of bone disease, and in adults. crysvita is indicated for the treatment of fgf23-related hypophosphataemia in tumour-induced osteomalacia associated with phosphaturic mesenchymal tumours that cannot be curatively resected or localised in children and adolescents aged 1 to 17 years and in adults.

Uniunea Europeană - română - EMA (European Medicines Agency)

akcea therapeutics ireland limited - inotersen de sodiu - amiloidoza - alte medicamente pentru sistemul nervos - tratamentul etapa 1 sau 2 polineuropatie la pacienți adulți cu afecțiuni ereditare transthyretin amiloidoza (hattr).

Uniunea Europeană - română - EMA (European Medicines Agency)

plethora pharma solutions limited - lidocaina, prilocaina - ejacularea prematura - anestezice - senstend este indicat pentru tratamentul primar ejaculare precoce la bărbați adulți.

Uniunea Europeană - română - EMA (European Medicines Agency)

sandoz pharmaceuticals d.d. - acid zoledronic - osteoporosis; osteitis deformans; osteoporosis, postmenopausal - medicamente pentru tratamentul bolilor osoase - treatment of osteoporosis: , in post-menopausal women;, in men; , at increased risk of fracture, including those with a recent low-trauma hip fracture. tratamentul osteoporozei asociate cu termen lung sistemice terapia cu glucocorticoizi în post-menopauză și la bărbați cu risc crescut de fracturi. tratamentul de boala paget a osului.

Uniunea Europeană - română - EMA (European Medicines Agency)

astrazeneca ab - dapagliflozin propandiol monohidrat - diabetes mellitus, type 2; heart failure, systolic; heart failure; renal insufficiency, chronic - medicamente utilizate în diabet - type 2 diabetes mellitusedistride is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exerciseas monotherapy when metformin is considered inappropriate due to intolerance. în plus față de alte medicamente pentru tratamentul diabetului zaharat de tip 2. for study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4. 4, 4. 5 și 5. heart failureedistride is indicated in adults for the treatment of symptomatic chronic heart failure. chronic kidney diseaseedistride is indicated in adults for the treatment of chronic kidney disease.

Uniunea Europeană - română - EMA (European Medicines Agency)

astrazeneca ab - dapagliflozin propandiol monohidrat - diabetes mellitus, type 2; heart failure, systolic; heart failure; renal insufficiency, chronic - medicamente utilizate în diabet - type 2 diabetes mellitusforxiga is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exerciseas monotherapy when metformin is considered inappropriate due to intolerance. în plus față de alte medicamente pentru tratamentul diabetului zaharat de tip 2. for study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4. 4, 4. 5 și 5. heart failureforxiga is indicated in adults for the treatment of symptomatic chronic heart failure. chronic kidney diseaseforxiga is indicated in adults for the treatment of chronic kidney disease.

Uniunea Europeană - română - EMA (European Medicines Agency)

janssen-cilag international nv - ibrutinib - lymphoma, mantle-cell; leukemia, lymphocytic, chronic, b-cell - antineoplastic agents, protein kinase inhibitors - imbruvica as a single agent is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (mcl). imbruvica as a single agent or in combination with rituximab or obinutuzumab or venetoclax is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (cll) (see section 5. imbruvica as a single agent or in combination with bendamustine and rituximab (br) is indicated for the treatment of adult patients with cll who have received at least one prior therapy. imbruvica as a single agent is indicated for the treatment of adult patients with waldenström’s macroglobulinaemia (wm) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo immunotherapy. imbruvica in combination with rituximab is indicated for the treatment of adult patients with wm.

Uniunea Europeană - română - EMA (European Medicines Agency)

gilead sciences ireland uc - elvitegravir, cobicistat, emtricitabină, tenofovir disoproxil fumarat - infecții cu hiv - antivirals for treatment of hiv infections, combinations, antivirals for systemic use - tratament de virusul imunodeficienţei umane (hiv 1) 1 infecţie la adulţi în vârstă de 18 ani şi peste care sunt antiretrovirale netrataţi sau sunt infectate cu hiv 1 fără mutaţii cunoscute asociate cu rezistenta la oricare trei agenţi de antiretrovirale în stribild.