Európai Unió - magyar - EMA (European Medicines Agency)

gilead sciences ireland uc - sacituzumab govitecan - breast neoplasms; triple negative breast neoplasms - daganatellenes szerek - trodelvy as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (mtnbc) who have received two or more prior systemic therapies, including at least one of them for advanced disease.

Európai Unió - magyar - EMA (European Medicines Agency)

amgen europe b.v. - blinatumomab - prekurzorsejt limfoblasztikus leukémia-limfóma - daganatellenes szerek - blincyto is indicated as monotherapy for the treatment of adults with cd19 positive relapsed or refractory b precursor acute lymphoblastic leukaemia (all). patients with philadelphia chromosome positive b-precursor all should have failed treatment with at least 2 tyrosine kinase inhibitors (tkis) and have no alternative treatment options. blincyto is indicated as monotherapy for the treatment of adults with philadelphia chromosome negative cd19 positive b-precursor all in first or second complete remission with minimal residual disease (mrd) greater than or equal to 0. blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with philadelphia chromosome negative cd19 positive b precursor all which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic haematopoietic stem cell transplantation. blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with high-risk first relapsed philadelphia chromosome negative cd19 positive b-precursor all as part of the consolidation therapy (see section 4.

Európai Unió - magyar - EMA (European Medicines Agency)

janssen-cilag international nv - ciltacabtagene autoleucel - myeloma multiplex - carvykti is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-cd38 antibody and have demonstrated disease progression on the last therapy.

Európai Unió - magyar - EMA (European Medicines Agency)

janssen-cilag international n.v. - talquetamab - myeloma multiplex - daganatellenes szerek - talvey is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least 3 prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti cd38 antibody and have demonstrated disease progression on the last therapy.

Európai Unió - magyar - EMA (European Medicines Agency)

novartis europharm limited - inclisiran - hypercholesterolemia; dyslipidemias - lipid módosító szerek - leqvio is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach ldl-c goals with the maximum tolerated dose of a statin, oralone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.

Európai Unió - magyar - EMA (European Medicines Agency)

les laboratoires servier - trifluridine, tipiracil-hidroklorid - colorectalis daganatok - daganatellenes szerek - colorectal cancerlonsurf is indicated in combination with bevacizumab for the treatment of adult patients with metastatic colorectal cancer (crc) who have received two prior anticancer treatment regimens including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-vegf agents, and/or anti-egfr agents. lonsurf is indicated as monotherapy for the treatment of adult patients with metastatic colorectal cancer (crc) who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-vegf agents, and anti egfr agentsgastric cancerlonsurf is indicated as monotherapy for the treatment of adult patients with metastatic gastric cancer including adenocarcinoma of the gastroesophageal junction, who have been previously treated with at least two prior systemic treatment regimens for advanced disease.

Európai Unió - magyar - EMA (European Medicines Agency)

astrazeneca ab - saxagliptin - diabetes mellitus, 2. típus - cukorbetegségben szedett gyógyszerek - add-on combination therapyonglyza is indicated in adult patients aged 18 years and older with type-2 diabetes mellitus to improve glycaemic control:as monotherapy:in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance;as dual oral therapy:in combination with metformin, when metformin alone, with diet and exercise, does not provide adequate glycaemic control;in combination with a sulphonylurea, when the sulphonylurea alone, with diet and exercise, does not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate;in combination with a thiazolidinedione, when the thiazolidinedione alone with diet and exercise, does not provide adequate glycaemic control in patients for whom use of a thiazolidinedione is considered appropriate;as triple oral therapy:in combination with metformin plus a sulphonylurea when this regimen alone, with diet and exercise, does not provide adequate glycaemic control;as combination therapy with insulin (with or without metformin), when this regimen alone, with diet and exercise, does not provide adequate glycaemic control.

Európai Unió - magyar - EMA (European Medicines Agency)

janssen-cilag international nv - rilpivirine - hiv fertőzések - vírusellenes szerek szisztémás alkalmazásra - rekambys is indicated, in combination with cabotegravir injection, for the treatment of human immunodeficiency virus type 1 (hiv 1) infection in adults who are virologically suppressed (hiv-1 rna < 50 copies/ml) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with, agents of the nnrti and ini class.

Európai Unió - magyar - EMA (European Medicines Agency)

viiv healthcare bv - lamivudin - hiv fertőzések - vírusellenes szerek szisztémás alkalmazásra - az epivir az antiretrovirális kombinációs terápia részeként említi az emberi immunhiány-vírus (hiv) fertőzött felnőttek és gyermekek.

Európai Unió - magyar - EMA (European Medicines Agency)

kite pharma eu b.v. - axicabtagene ciloleucel - lymphoma, follicular; lymphoma, large b-cell, diffuse - daganatellenes szerek - yescarta is indicated for the treatment of adult patients with diffuse large b cell lymphoma (dlbcl) and high-grade b-cell lymphoma (hgbl) that relapses within 12 months from completion of, or is refractory to, first-line chemoimmunotherapy. yescarta is indicated for the treatment of adult patients with relapsed or refractory (r/r) dlbcl and primary mediastinal large b cell lymphoma (pmbcl), after two or more lines of systemic therapy. yescarta is indicated for the treatment of adult patients with r/r follicular lymphoma (fl) after three or more lines of systemic therapy.