Hemlibra Европейский союз - словацкий - EMA (European Medicines Agency)

hemlibra

roche registration limited - emicizumab - hemofília a - antihemoragiká - hemlibra is indicated for routine prophylaxis of bleeding episodes in patients with haemophilia a (congenital factor viii deficiency):with factor viii inhibitorswithout factor viii inhibitors who have:severe disease (fviii < 1%)moderate disease (fviii ≥ 1% and ≤ 5%) with severe bleeding phenotype. hemlibra môžu byť použité vo všetkých vekových skupinách.

Keytruda Европейский союз - словацкий - EMA (European Medicines Agency)

keytruda

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.

Stribild Европейский союз - словацкий - EMA (European Medicines Agency)

stribild

gilead sciences ireland uc - elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate - hiv infekcie - antivirals for treatment of hiv infections, combinations, antivirals for systemic use - liečbu vírusu ľudskej imunodeficiencie 1 (hiv-1) infekcie u dospelých vo veku 18 rokov a nad antiretrovírusovej liečby alebo ktorí sú infikovaní vírusom hiv 1 bez známe mutácie spojené s rezistenciou voči ktorejkoľvek z troch antiretrovírusovými látkami v lieku stribild.

Wilate 500 Словакия - словацкий - ŠÚKL (Štátny ústav pre kontrolu liečiv)

wilate 500

octapharma (ip) sprl, belgicko - koagulačný faktor viii a von willebrandov faktor v kombinácii - 16 - anticoagulantia (fibrinolytica, antifibrinol.)

Wilate 1000 Словакия - словацкий - ŠÚKL (Štátny ústav pre kontrolu liečiv)

wilate 1000

octapharma (ip) sprl, belgicko - koagulačný faktor viii a von willebrandov faktor v kombinácii - 16 - anticoagulantia (fibrinolytica, antifibrinol.)

Capecitabine SUN Европейский союз - словацкий - EMA (European Medicines Agency)

capecitabine sun

sun pharmaceutical industries europe b.v. - kapecitabín - stomach neoplasms; breast neoplasms; colonic neoplasms; colorectal neoplasms - kapecitabín - capecitabín je indikovaný na adjuvantnú liečbu pacientov po operácii štádia iii (dukesov štádia-c) rakoviny hrubého čreva. capecitabine je indikovaný na liečbu metastatickým kolorektálnym. capecitabine je uvedené v prvej línii liečby pokročilého karcinómu v kombinácii s platinum-na základe denného režimu. capecitabine v kombinácii s docetaxel je indikovaný na liečbu pacientov s lokálne pokročilého alebo metastatického karcinómu prsníka po zlyhaní cytotoxické chemoterapia. predchádzajúca liečba mala zahŕňať antracyklín. capecitabine je tiež uvedené, ako monotherapy pre liečbu pacientov s lokálne pokročilého alebo metastatického karcinómu prsníka po zlyhaní taxanes a anthracycline-obsahujúce chemoterapia režimu alebo pre koho ďalej anthracycline terapia nie je uvedené.

Truberzi Европейский союз - словацкий - EMA (European Medicines Agency)

truberzi

allergan pharmaceuticals international limited - eluxadoline - irritable bowel syndrome; diarrhea - antidiarrheals, črevné protizápalové / antiinfective agentov - truberzi je indikovaný u dospelých na liečbu syndrómu dráždivého čreva s hnačkou (ibs d).

ReFacto AF Европейский союз - словацкий - EMA (European Medicines Agency)

refacto af

pfizer europe ma eeig - moroktokogu alfa - hemofília a - antihemoragiká - liečba a profylaxia krvácania u pacientov s hemofíliou a (vrodená deficiencia faktora viii). refacto af je vhodný na použitie u dospelých a deti všetkých vekových skupín vrátane novorodencov. refacto af neobsahuje von-willebrand faktor, a preto nie je uvedené v von-willebrand choroba.

Afstyla Европейский союз - словацкий - EMA (European Medicines Agency)

afstyla

csl behring gmbh - lonoktokog alfa - hemofília a - antihemoragiká - liečba a profylaxia krvácania u pacientov s hemofíliou a (vrodená deficiencia faktora viii). afstyla môžu byť použité pre všetky vekové skupiny.

Advate Европейский союз - словацкий - EMA (European Medicines Agency)

advate

takeda manufacturing austria ag - octocog alfa - hemofília a - antihemoragiká - liečba a profylaxia krvácania u pacientov s hemofíliou a (vrodená deficiencia faktora viii). advate neobsahuje von willebrand faktor v farmakologicky účinných množstvách, a preto nie je uvedené v von willebrand ochorenia.