Uni Eropa - Slovak - EMA (European Medicines Agency)

warner chilcott uk ltd. - testosterón - sexuálne dysfunkcie, psychologické - pohlavné hormóny a modulátory z genitálny systém, - intrinsa je indikovaný na liečbu hypoactive sexuálnou túžbou ochorenia (hsdd) u dvojstranne oophorectomised a po hysterektómii (chirurgicky vyvolaná menopauza) žien súbežné estrogén terapia.

Uni Eropa - Slovak - EMA (European Medicines Agency)

warner chilcott  deutschland gmbh - testosterón - sexuálne dysfunkcie, psychologické - pohlavné hormóny a modulátory z genitálny systém, - livensa je indikovaný na liečbu hypoactive sexuálnou túžbou ochorenia (hsdd) u dvojstranne oophorectomised a po hysterektómii (chirurgicky vyvolaná menopauza) žien súbežné estrogén terapia.

Uni Eropa - Slovak - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - ipilimumab - melanoma; carcinoma, renal cell; carcinoma, non-small-cell lung; mesothelioma, malignant; colorectal neoplasms - antineoplastické činidlá - melanomayervoy as monotherapy or combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older (see section 4.  yervoy in combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults. relative to nivolumab monotherapy, an increase in progression-free survival (pfs) and overall survival (os) for the combination of nivolumab with ipilimumab is established only in patients with low tumour pd-l1 expression (see sections 4. 4 a 5. renal cell carcinoma (rcc)yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma (see section 5. non-small cell lung cancer (nsclc)yervoy in combination with nivolumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising egfr mutation or alk translocation. malignant pleural mesothelioma (mpm)yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. mismatch repair deficient (dmmr) or microsatellite instability-high (msi-h) colorectal cancer (crc)yervoy in combination with nivolumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer after prior fluoropyrimidine based combination chemotherapy (see section 5. oesophageal squamous cell carcinoma (oscc)yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%.

Uni Eropa - Slovak - EMA (European Medicines Agency)

ratiopharm gmbh - paclitaxel - neoplazmy prsníkov - antineoplastické činidlá - pazenir 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. pazenir 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.

Uni Eropa - Slovak - EMA (European Medicines Agency)

merck sharp & dohme b.v. - pembrolizumab - melanoma; hodgkin disease; carcinoma, renal cell; carcinoma, non-small-cell lung; carcinoma, transitional cell; squamous cell carcinoma of head and neck; urologic neoplasms; endometrial neoplasms - antineoplastické činidlá - melanomakeytruda as monotherapy is indicated for the treatment of adults and adolescents aged 12 years and older with advanced (unresectable or metastatic) melanoma. keytruda as monotherapy is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older with stage iib, iic, or with stage iii melanoma and lymph node involvement who have undergone complete resection. non small cell lung carcinoma (nsclc)keytruda as monotherapy is indicated for the adjuvant treatment of adults with non-small cell lung carcinoma who are at high risk of recurrence following complete resection and platinum based chemotherapy (for selection criteria, see section 5. keytruda as monotherapy is indicated for the first line treatment of metastatic non small cell lung carcinoma in adults whose tumours express pd l1 with a ≥ 50% tumour proportion score (tps) with no egfr or alk positive tumour mutations. keytruda, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of metastatic non squamous non small cell lung carcinoma in adults whose tumours have no egfr or alk positive mutations. keytruda, in combination with carboplatin and either paclitaxel or nab paclitaxel, is indicated for the first line treatment of metastatic squamous non small cell lung carcinoma in adults. keytruda  as monotherapy is indicated for the treatment of locally advanced or metastatic non small cell lung carcinoma in adults whose tumours express pd l1 with a ≥ 1% tps and who have received at least one prior chemotherapy regimen. u pacientov s egfr alebo alkalickÝm pozitívne nádor mutácie by tiež dostali cielenú liečbu pred prijatím keytruda. classical hodgkin lymphoma (chl)keytruda as monotherapy is indicated for the treatment of adult and paediatric patients aged 3 years and older with relapsed or refractory classical hodgkin lymphoma who have failed autologous stem cell transplant (asct) or following at least two prior therapies when asct is not a treatment option. urothelial carcinomakeytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum containing chemotherapy. keytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin containing chemotherapy and whose tumours express pd l1 with a combined positive score (cps) ≥ 10. head and neck squamous cell carcinoma (hnscc)keytruda, as monotherapy or in combination with platinum and 5 fluorouracil (5 fu) chemotherapy, is indicated for the first line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma in adults whose tumours express pd l1 with a cps ≥ 1. keytruda as monotherapy is indicated for the treatment of recurrent or metastatic head and neck squamous cell carcinoma in adults whose tumours express pd l1 with a ≥ 50% tps and progressing on or after platinum containing chemotherapy. renal cell carcinoma (rcc)keytruda, in combination with axitinib, is indicated for the first line treatment of advanced renal cell carcinoma in adults. keytruda  as monotherapy is indicated for the adjuvant treatment of adults with renal cell carcinoma at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions (for selection criteria, please see section 5. microsatellite instability high (msi-h) or mismatch repair deficient (dmmr) cancerscolorectal cancer (crc)keytruda as monotherapy is indicated for theadults with msi-h or dmmr colorectal cancer in the following settings:first line treatment of metastatic microsatellite instability high (msi h) or mismatch repair deficient (dmmr) colorectal cancer in adults;treatment of unresectable or metastatic colorectal cancer after previous fluoropyrimidine based combination therapy.  non-colorectal cancerskeytruda as monotherapy is indicated for the treatment of the following msi h or dmmr tumours in adults with:advanced or recurrent endometrial carcinoma, who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation;unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy. oesophageal carcinomakeytruda, in combination with platinum and fluoropyrimidine based chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic carcinoma of the oesophagus or her-2 negative gastroesophageal junction adenocarcinoma, in adults whose tumours express pd l1 with a cps ≥ 10. triple negative breast cancer (tnbc)keytruda, in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery, is indicated for the treatment of adults with locally advanced, or early stage triple negative breast cancer at high risk of recurrence. keytruda, in combination with chemotherapy, is indicated for the treatment of locally recurrent unresectable or metastatic triple negative breast cancer in adults whose tumours express pd l1 with a cps ≥ 10 and who have not received prior chemotherapy for metastatic disease. endometrial carcinoma (ec)keytruda, in combination with lenvatinib, is indicated for the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation. cervical cancerkeytruda, in combination with chemotherapy with or without bevacizumab, is indicated for the treatment of persistent, recurrent, or metastatic cervical cancer in adults whose tumours express pd l1 with a cps ≥ 1. gastric or gastro-oesophageal junction (gej) adenocarcinomakeytruda, in combination with trastuzumab, fluoropyrimidine and platinum-containing chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic her2-positive gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express pd-l1 with a cps ≥ 1.

Uni Eropa - Slovak - EMA (European Medicines Agency)

pfizer europe ma eeig - pemetrexed disodium, pemetrexed disodium hemipentahydrate - carcinoma, non-small-cell lung; mesothelioma - antineoplastické činidlá - malignant pleural mesotheliomapemetrexed pfizer in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. non-small cell lung cancerpemetrexed pfizer in combination with cisplatin is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology. pemetrexed pfizer is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy. pemetrexed pfizer is indicated as monotherapy for the second-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.

Uni Eropa - Slovak - EMA (European Medicines Agency)

astrazeneca ab - gefitinib - karcinóm, pľúc bez malých buniek - antineoplastické činidlá - iressa je indikovaný na liečbu dospelých pacientov s lokálne pokročilým alebo metastatickým non-small cell lung cancer s aktiváciou mutácie pokožky-rastový faktor-receptor tyrozín kinase.

Uni Eropa - Slovak - EMA (European Medicines Agency)

norton healthcare ltd. - paclitaxel - sarcoma, kaposi; carcinoma, non-small-cell lung; ovarian neoplasms; breast neoplasms - antineoplastické činidlá - paxene je indikovaný na liečbu pacientov s:• rozšírené pomÔcky súvisiace s kaposiho sarkóm (aids-ks), ktorý sa nepodarilo pred liposomal anthracycline terapie;• metastatickým karcinóm prsníka (mbc), ktorí zlyhali, alebo nie sú kandidátmi pre štandardné anthracycline-obsahujúce terapie;• pokročilý karcinóm vaječníka (aoc) alebo s reziduálnej choroby (> 1 cm) po prvotnom laparotomy, v kombinácii s cisplatin ako v prvej línii liečby;• metastatickým karcinóm vaječníka (moc) po neúspechu platinum-obsahujúce zmes terapia bez taxanes ako druhú líniu liečby;• non-small cell karcinómu pľúc (nsclc), ktorí nie sú kandidátmi na potenciálne liečebné zákroky a/alebo rádioterapia v kombinácii s cisplatin. obmedzené údaje o účinnosti podporujú túto indikáciu (pozri časť 5.

Uni Eropa - Slovak - EMA (European Medicines Agency)

eli lilly nederland b.v. - necitumumab - karcinóm, pľúc bez malých buniek - antineoplastické činidlá - portrazza v kombinácii s chemoterapiou gemcitabínu a cisplatiny je indikovaný na liečbu dospelých pacientov s lokálne pokročilým alebo metastázujúcim receptor epidermálneho rastového (faktora egfr) vyjadrenie dlaždicové non-malá bunka rakovina pľúca ktorí predtým nedostávali chemoterapiu pre túto podmienku.

Uni Eropa - Slovak - EMA (European Medicines Agency)

pfizer limited - celecoxib - adenomatózna polypóza coli - antineoplastické činidlá - onsenal je indikovaný na zníženie počtu adenomatóznej Črevné polypy v familiárnej adenomatóznej polypózy (fap), ako doplnok chirurgia a ďalšie endoskopické sledovanie (pozri časť 4. Účinok onsenal vyvolaných zníženie polyp záťaž na riziko črevnej rakovina nebola preukázaná (pozri časť 4. 4 a 5.