Európska únia - slovenčina - EMA (European Medicines Agency)

centus biotherapeutics europe limited - bevacizumab - colorectal neoplasms; breast neoplasms; ovarian neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell - antineoplastické činidlá - bevacizumab v kombinácii s chemoterapiou na báze fluoropyrimidínu je indikovaný na liečbu dospelých pacientov s metastatickým karcinómom hrubého čreva alebo konečníka. bevacizumab v kombinácii s paclitaxel je uvedené v prvej línii liečby dospelých pacientov s metastatického karcinómu prsníka. Ďalšie informácie o stave receptora ľudského epidermálneho rastového faktora 2 (her2) nájdete v časti 5. bevacizumab v kombinácii s capecitabine je uvedené v prvej línii liečby dospelých pacientov s metastatického karcinómu prsníka, u ktorých liečba s inými chemoterapia možností, vrátane taxanes alebo anthracyclines nie je považované za vhodné. patients who have received taxane and anthracycline- containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with equidacent in combination with capecitabine. Ďalšie informácie o stave her2 nájdete v časti 5. bevacizumab, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology. bevacizumab v kombinácii s erlotinib je uvedený na prvej línie liečby dospelých pacientov s unresectable pokročilým, metastatickým alebo recidivujúcim non-karcinómom non-small cell lung cancer s epidermálnych growth factor receptor (egfr) aktivácia mutácie. bevacizumab in combination with interferon alfa-2a is indicated for first-line treatment of adult patients with advanced and/or metastatic renal cell cancer. bevacizumab, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (international federation of gynecology and obstetrics (figo) stages iiib, iiic and iv) epithelial ovarian, fallopian tube, or primary peritoneal cancer (see section 5. bevacizumab, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor-targeted agents. bevacizumab v kombinácii s paclitaxel a cisplatin, alebo, alternatívne, paclitaxel a topotecan v pacienti, ktorí nemôžu dostávať platinum terapia, je indikovaný na liečbu dospelých pacientov s perzistentné, opakujúce, alebo metastatickým karcinóm krčka maternice.

Európska únia - slovenčina - EMA (European Medicines Agency)

mylan ire healthcare limited - bevacizumab - colorectal neoplasms; breast neoplasms; ovarian neoplasms; fallopian tube neoplasms; peritoneal neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell; uterine cervical neoplasms - antineoplastické činidlá - treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix.

Európska únia - slovenčina - EMA (European Medicines Agency)

fresenius kabi deutschland gmbh - tocilizumab - arthritis, rheumatoid; cytokine release syndrome; arthritis, juvenile rheumatoid; covid-19 virus infection; giant cell arteritis - imunosupresíva - tyenne, in combination with methotrexate (mtx), is indicated for- the treatment of severe, active and progressive rheumatoid arthritis (ra) in adults not previously treated with mtx. - the treatment of moderate to severe active ra in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (dmards) or tumour necrosis factor (tnf) antagonists. in these patients, tyenne can be given as monotherapy in case of intolerance to mtx or where continued treatment with mtx is inappropriate. tocilizumab has been shown to reduce the rate of progression of joint damage as measured by x-ray and to improve physical function when given in combination with methotrexate. tyenne is indicated for the treatment of coronavirus disease 2019 (covid-19) in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. tyenne is indicated for the treatment of active systemic juvenile idiopathic arthritis (sjia) in patients 1 year of age and older, who have responded inadequately to previous therapy with nsaids and systemic corticosteroids. tyenne can be given as monotherapy (in case of intolerance to mtx or where treatment with mtx is inappropriate) or in combination with mtx. tyenne in combination with methotrexate (mtx) is indicated for the treatment of juvenile idiopathic polyarthritis (pjia; rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with mtx. tyenne can be given as monotherapy in case of intolerance to mtx or where continued treatment with mtx is inappropriate. tyenne is indicated for the treatment of chimeric antigen receptor (car) t cell-induced severe or life-threatening cytokine release syndrome (crs) in adults and paediatric patients 2 years of age and older. tyenne is indicated for the treatment of giant cell arteritis (gca) in adult patients.

Európska únia - slovenčina - EMA (European Medicines Agency)

otsuka pharmaceutical netherlands b.v. - aripiprazol - schizofrénie - psycholeptika - udržiavacia liečba schizofrénie u dospelých pacientov stabilizovaná perorálnym aripiprazolom.

Európska únia - slovenčina - EMA (European Medicines Agency)

tmc pharma services ltd. - gadofosveset trisodný - magnetická rezonančná angiografia - kontrastné médiá - tento liek je určený len na diagnostické účely. ablavar je indikovaný na kontrast-enhanced magnetickej rezonancie angiografia (ce-mra bola zabezpečená) na vizualizáciu brucha alebo končatín ciev u dospelých, len s podozrením alebo známe cievne ochorenia.

Európska únia - slovenčina - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - paclitaxel - breast neoplasms; pancreatic neoplasms; carcinoma, non-small-cell lung - antineoplastické činidlá - abraxane monotherapy je indikovaný na liečbu metastatického karcinómu prsníka u dospelých pacientov, ktorí zlyhali v prvej línii liečby pre metastatické ochorenie a pre koho štandard, anthracycline obsahujúce terapia nie je uvedené. abraxane v kombinácii s gemcitabine je uvedené, za prvé-line liečbu dospelých pacientov s metastatickým adenocarcinoma slinivky brušnej. abraxane v kombinácii s carboplatin je uvedené, za prvé-line liečba non-small cell lung cancer u dospelých pacientov, ktorí nie sú kandidátmi na potenciálne liečebné zákroky a/alebo rádioterapia.

Európska únia - slovenčina - EMA (European Medicines Agency)

sandoz pharmaceuticals d.d. - kyselina zoledrónová - osteoporosis; osteitis deformans; osteoporosis, postmenopausal - lieky na liečbu chorôb kostí - treatment of osteoporosis: , in post-menopausal women;, in men; , at increased risk of fracture, including those with a recent low-trauma hip fracture. liečba osteoporózy priradené dlhodobé systémové glukokortikoidy terapia v post-menopauzálnych žien a u mužov zvýšené riziko zlomeniny. liečba paget je ochorenie kostí.

Európska únia - slovenčina - EMA (European Medicines Agency)

takeda pharma a/s - brentuximab vedotin - lymphoma, non-hodgkin; hodgkin disease - antineoplastické činidlá - hodgkin lymphomaadcetris is indicated for adult patients with previously untreated cd30+ stage iv hodgkin lymphoma (hl) in combination with doxorubicin, vinblastine and dacarbazine (avd). adcetris is indicated for the treatment of adult patients with cd30+ hl at increased risk of relapse or progression following autologous stem cell transplant (asct). adcetris je indikovaný na liečbu dospelých pacientov s relapsed alebo žiaruvzdorné cd30+ hodgkinovým lymfómom (hl):v nadväznosti na asct, orfollowing aspoň dve predchádzajúce terapie pri asct alebo multi-agent chemoterapia nie je možnosť liečby. systemic anaplastic large cell lymphomaadcetris in combination with cyclophosphamide, doxorubicin and prednisone (chp) is indicated for adult patients with previously untreated systemic anaplastic large cell lymphoma (salcl). adcetris is indicated for the treatment of adult patients with relapsed or refractory salcl. cutaneous t cell lymphomaadcetris is indicated for the treatment of adult patients with cd30+ cutaneous t cell lymphoma (ctcl) after at least 1 prior systemic therapy.

Európska únia - slovenčina - EMA (European Medicines Agency)

n.v. organon - colecalciferol, alendronic acid (as sodium trihydrate) - osteoporóza, postmenopauza - lieky na liečbu chorôb kostí - liečba postmenopauzálnej osteoporózy u pacientov s rizikom nedostatku vitamínu d. adrovance znižuje riziko vertebrálnych a zlomenín bedra.

Európska únia - slovenčina - EMA (European Medicines Agency)

astellas pharma europe bv - tacrolimus - odmietnutie štepu - imunosupresíva - profylaxia odmietnutia transplantátu u dospelých príjemcov obličiek alebo pečeňových aloimplantátov. liečba rejekcie aloštepu rezistentnej na liečbu inými imunosupresívnymi liekmi u dospelých pacientov.