Evotaz Unia Europejska - estoński - EMA (European Medicines Agency)

evotaz

bristol-myers squibb pharma eeig - cobicistat, atazanavir - hiv-nakkused - viirusevastased ravimid süsteemseks kasutamiseks - evotaz is indicated in combination with other antiretroviral medicinal products for the treatment of hiv-1 infected adults and adolescents (aged 12 years and older weighing at least 35 kg) without known mutations associated with resistance to atazanavir (see sections 4. 4 ja 5.

Forxiga Unia Europejska - estoński - EMA (European Medicines Agency)

forxiga

astrazeneca ab - dapaglifloksiinpropaandioolmonohüdraat - diabetes mellitus, type 2; heart failure, systolic; heart failure; renal insufficiency, chronic - diabeetis kasutatavad ravimid - 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. lisaks teiste ravimitega ravi 2. tüüpi diabeedi. 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 ja 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.

Glivec Unia Europejska - estoński - EMA (European Medicines Agency)

glivec

novartis europharm limited - imatiniib - precursor cell lymphoblastic leukemia-lymphoma; gastrointestinal stromal tumors; dermatofibrosarcoma; myelodysplastic-myeloproliferative diseases; leukemia, myelogenous, chronic, bcr-abl positive; hypereosinophilic syndrome - antineoplastilised ained - glivec is indicated for the treatment of , adult and paediatric patients with newly diagnosed philadelphia-chromosome (bcr-abl)-positive (ph+) chronic myeloid leukaemia (cml) for whom bone-marrow transplantation is not considered as the first line of treatment;, adult and paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis;, adult and paediatric patients with newly diagnosed philadelphia-chromosome-positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy;, adult patients with relapsed or refractory ph+ all as monotherapy;, adult patients with myelodysplastic / myeloproliferative diseases (mds / mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements;, adult patients with advanced hypereosinophilic syndrome (hes) and / or chronic eosinophilic leukaemia (cel) with fip1l1-pdgfra rearrangement. mõju glivec tulemuste kohta luu-üdi siirdamine ei ole kindlaks. glivec is indicated for: , the treatment of adult patients with kit (cd 117)-positive unresectable and / or metastatic malignant gastrointestinal stromal tumours (gist);, the adjuvant treatment of adult patients who are at significant risk of relapse following resection of kit (cd117)-positive gist. patsientidel, kellel on madal või väga madal risk kordumise ei tohiks saada abiaine ravi; ravi täiskasvanud patsientidel, kellel unresectable dermatofibrosarcoma protuberans (dfsp) ja täiskasvanud patsientidel korduva ja / või metastaatilise dfsp, kes ei ole abikõlblikud operatsioon. , täiskasvanud ja pediaatriliste patsientide, tõhususe glivec põhineb üldine hematoloogiline ja tsütogeneetiline ravivastus, ja progression-free survival in cml, hematoloogiline ja tsütogeneetiline ravivastus, ph+ all, mds / mpd, hematoloogiline ravivastus, in hes / cel ja objektiivne ravivastus, täiskasvanud patsientidel unresectable ja / või metastaatilise pÕhisisu ja dfsp ja kordumise-free survival in abiaine pÕhilised. kogemus glivec patsientidel mds / mpd seotud pdgfr geeni taas-kord on väga piiratud (vt lõik 5. välja arvatud äsja diagnoositud kroonilise faasi cml, ei ole kontrollitud uuringud, mis näitab kliiniline kasu või suurenenud ellujäämise eest need haigused.

Harvoni Unia Europejska - estoński - EMA (European Medicines Agency)

harvoni

gilead sciences ireland uc - ledipasvir, sofosbuvir - c-hepatiit, krooniline - viirusevastased ravimid süsteemseks kasutamiseks - harvoni is indicated for the treatment of chronic hepatitis c (chc) in adult and paediatric patients aged 3 years and above (see sections 4. 2, 4. 4 ja 5. c-hepatiidi viiruse (hcv) genotüüp-eriaktiivsus vt lõigud 4. 4 ja 5.

Hizentra Unia Europejska - estoński - EMA (European Medicines Agency)

hizentra

csl behring gmbh - inimese normaalne immunoglobuliin (scig) - immunoloogilise puudulikkuse sündroomid - suguhormoonid ja immunoglobuliinid, - replacement therapy in adults, children and adolescents (0-18 years) in:- primary immunodeficiency syndromes with impaired antibody production (see section 4. - secondary immunodeficiencies (sid) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (psaf)* or serum igg level of.

Icandra (previously Vildagliptin / metformin hydrochloride Novartis) Unia Europejska - estoński - EMA (European Medicines Agency)

icandra (previously vildagliptin / metformin hydrochloride novartis)

novartis europharm limited - vildagliptin, metformiin vesinikkloriid - suhkurtõbi, tüüp 2 - drugs used in diabetes, combinations of oral blood glucose lowering drugs - icandra is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus:in patients who are inadequately controlled with metformin hydrochloride alone. in patients who are already being treated with the combination of vildagliptin and metformin hydrochloride, as separate tablets. in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control (see sections 4. 4, 4. 5 ja 5. 1 erinevate kombinatsioonide kohta kättesaadavate andmete osas).

Imbruvica Unia Europejska - estoński - EMA (European Medicines Agency)

imbruvica

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.

Imvanex Unia Europejska - estoński - EMA (European Medicines Agency)

imvanex

bavarian nordic a/s - modifitseeritud vaktsiin ankara - baieri põhja (mva-bn) viirus - smallpox vaccine; monkeypox virus - muud viirusevaktsiinide - active immunisation against smallpox, monkeypox and disease caused by vaccinia virus in adults (see sections 4. 4 ja 5. kasutamist see vaktsiin peaks olema kooskõlas ametlike soovitustega.

Invokana Unia Europejska - estoński - EMA (European Medicines Agency)

invokana

janssen-cilag international nv - canagliflozin - suhkurtõbi, tüüp 2 - diabeetis kasutatavad ravimid - invokana is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise:as monotherapy when metformin is considered inappropriate due to intolerance or contraindicationsin addition to other medicinal products for the treatment of diabetes. 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 ja 5.

Jakavi Unia Europejska - estoński - EMA (European Medicines Agency)

jakavi

novartis europharm limited - ruxolitiniib (fosfaadina) - myeloproliferative disorders; polycythemia vera; graft vs host disease - antineoplastilised ained - 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. polycythaemia vera (pv)jakavi on näidustatud ravi täiskasvanud patsientidel, kellel polycythaemia vera, kes on resistentsed või sallimatu hydroxyurea. 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.