Evropska unija - slovenščina - EMA (European Medicines Agency)

novartis europharm limited  - pazopanib - karcinom, ledvična celica - antineoplastična sredstva - ledvična-cell carcinoma (rkc)votrient je navedeno v odraslih za prvo linijo zdravljenja naprednih ledvic-cell carcinoma (rkc) in pri bolnikih, ki so prejeli pred citokin terapije za napredno bolezni. mehka tkiva sarkom (sts)votrient je indiciran za zdravljenje odraslih bolnikov s selektivno podtipov naprednih mehka tkiva sarkom (sts), ki jih prejeli v pred kemoterapijo za metastatskim bolezni ali ki so napredovali v roku 12 mesecev po (neo)adjuvant therapy. učinkovitost in varnost so le bile ustanovljene v nekaterih sts tumorja, histološki podtipov.

Evropska unija - slovenščina - EMA (European Medicines Agency)

novartis europharm limited - ceritinib - karcinom, pljučni pljuč - antineoplastična sredstva - zdravilo zykadia je indicirano za zdravljenje odraslih bolnikov z anaplastičnim limfom-kinaznim (alk) pozitivnim napredovalim nedrobnoceličnim pljučnim rakom (nsclc), ki je bil predhodno zdravljen s krizotinibom.

Evropska unija - slovenščina - EMA (European Medicines Agency)

accord healthcare s.l.u. - doxorubicin hydrochloride, liposomal - ovarian neoplasms; sarcoma, kaposi; multiple myeloma - doxorubicin - zolsketil pegylated liposomal is a medicine used to treat the following types of cancer in adults:• breast cancer that has spread to other parts of the body in patients at risk of heart problems. zolsketil pegylated liposomal is used on its own for this disease;• advanced ovarian cancer in women whose previous treatment including a platinum-based cancer medicine has stopped working;• multiple myeloma (a cancer of the white blood cells in the bone marrow), in patients with progressive disease who have received at least one other treatment in the past and have already had, or are unsuitable for, a bone marrow transplantation. zolsketil pegylated liposomal is used in combination with bortezomib (another cancer medicine);• kaposi’s sarcoma in patients with aids who have a very damaged immune system. kaposi’s sarcoma is a cancer that causes abnormal tissue to grow under the skin, on moist body surfaces or on internal organs. zolsketil pegylated liposomal contains the active substance doxorubicin and is a ‘hybrid medicine’. this means that it is similar to a ‘reference medicine’ containing the same active substance called adriamycin. however, in zolsketil pegylated liposomal the active substance is enclosed in tiny fatty spheres called liposomes, whereas this is not the case for adriamycin.

Evropska unija - slovenščina - EMA (European Medicines Agency)

yes pharmaceutical development services gmbh - doksorubicinijev klorid - breast neoplasms; ovarian neoplasms; multiple myeloma; sarcoma, kaposi - antineoplastična sredstva - celdoxome pegylated liposomal is indicated in adults:as monotherapy for patients with metastatic breast cancer, where there is an increased cardiac risk. or treatment of advanced ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen. in combination with bortezomib for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplant. for treatment of aids-related kaposi’s sarcoma (ks) in patients with low cd4 counts (< 200 cd4 lymphocytes/mm3) and extensive mucocutaneous or visceral disease. celdoxome pegylated liposomal may be used as first-line systemic chemotherapy, or as second line chemotherapy in aids-ks patients with disease that has progressed with, or in patients intolerant to, prior combination systemic chemotherapy comprising at least two of the following agents: a vinca alkaloid, bleomycin and standard doxorubicin (or other anthracycline).

Evropska unija - slovenščina - EMA (European Medicines Agency)

akebia europe limited - vadadustat - renal insufficiency, chronic; anemia - antianemični preparati - vafseo is indicated for the treatment of symptomatic anaemia associated with chronic kidney disease (ckd) in adults on chronic maintenance dialysis.

Evropska unija - slovenščina - EMA (European Medicines Agency)

sanofi winthrop industrie - teriflunomide - multiple skleroza - selektivni imunosupresivi - aubagio is indicated for the treatment of adult patients and paediatric patients aged 10 years and older with relapsing remitting multiple sclerosis (ms) (please refer to section 5. 1 for important information on the population for which efficacy has been established).

Evropska unija - slovenščina - EMA (European Medicines Agency)

amryt pharmaceuticals dac - lomitapide - hiperholesterolemija - sredstva za spreminjanje lipidov - lojuxta je navedena kot dodatek k dieti low‑fat in drugimi lipid‑lowering zdravili z ali brez citofereza nizko gostoto lipoproteinov (ldl), pri odraslih bolnikih s homozigotno družinsko hiperholesterolemijo (hofh). genetske potrditev hofh, je treba pridobiti, kadar je to mogoče. druge oblike primarne hyperlipoproteinaemia in sekundarne vzroke hypercholesterolaemia (e. nephrotic sindrom, hipotiroidizem) mora biti izključena.

Evropska unija - slovenščina - EMA (European Medicines Agency)

roche registration gmbh - alectinib hidroklorid - karcinom, pljučni pljuč - antineoplastična sredstva - alecensa kot monotherapy je določen za prvo linijo zdravljenja odraslih bolnikih z anaplastični limfom kinaza (alk)-pozitivno napredno non-small cell lung cancer (nsclc). alecensa kot monotherapy je indiciran za zdravljenje odraslih bolnikov z alkalno‑pozitivno napredno nsclc predhodno zdravljenih z crizotinib.

Evropska unija - slovenščina - EMA (European Medicines Agency)

novartis europharm limited - lapatinib - neoplazme dojke - proteinska kinaza inhibitorji - tyverb je indiciran za zdravljenje bolnikov z rakom dojke, katerih tumorji, overexpress her2 (erbb2):v kombinaciji z capecitabine za bolnike z napredovalim ali metastatskim bolezni s napredovanje po predhodnem terapijo, ki mora biti vključeni anthracyclines in taxanes in terapija s trastuzumab v metastatskim nastavitev;v kombinaciji z trastuzumab za bolnike z hormon-receptor-negativne metastatskim bolezen, ki je napredovala na predhodno trastuzumab zdravljenja ali terapije v kombinaciji s kemoterapijo;v kombinaciji z zaviralec aromataze za ženske po menopavzi z hormon-receptor-pozitivno metastatskim bolezni, ki trenutno niso namenjene za kemoterapijo. bolniki v registraciji študija prej niso bili zdravljeni z trastuzumab ali zaviralec aromataze. ni na voljo so podatki o učinkovitosti te kombinacije glede na trastuzumab v kombinaciji z zaviralec aromataze v tem bolnik prebivalstva.

Evropska unija - slovenščina - EMA (European Medicines Agency)

roche registration gmbh  - entrectinib - cancer; carcinoma, non-small-cell lung - antineoplastična sredstva - rozlytrek as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age and older with solid tumours expressing a neurotrophic tyrosine receptor kinase (ntrk) gene fusion,who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, andwho have not received a prior ntrk inhibitorwho have no satisfactory treatment options. rozlytrek as monotherapy is indicated for the treatment of adult patients with ros1 positive, advanced non small cell lung cancer (nsclc) not previously treated with ros1 inhibitors.