Eiropas Savienība - čehu - EMA (European Medicines Agency)

novartis europharm limited - vildagliptin, metformin hydrochloridu - diabetes mellitus, typ 2 - drugs used in diabetes, combinations of oral blood glucose lowering drugs - eucreas is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus:in patients who are inadequately controlled with metformin hydrochloride alone. in patients who are already being treated with the combination of vildagliptin and metformin hydrochloride, as separate tablets. in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control.

Eiropas Savienība - čehu - EMA (European Medicines Agency)

novartis europharm limited - vildagliptin, metformin hydrochloridu - diabetes mellitus, typ 2 - drugs used in diabetes, combinations of oral blood glucose lowering drugs - icandra is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus:in patients who are inadequately controlled with metformin hydrochloride alone. in patients who are already being treated with the combination of vildagliptin and metformin hydrochloride, as separate tablets. in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control (see sections 4. 4, 4. 5 a 5. 1 pro dostupné údaje o různých kombinacích).

Eiropas Savienība - čehu - 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 - antineoplastická činidla - 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 pacientů s egfr nebo alk pozitivních nádorů mutace, měly by rovněž absolvovat cílené terapie před užívajících 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.

Eiropas Savienība - čehu - EMA (European Medicines Agency)

sanofi winthrop industrie - alirocumab - dyslipidémie - Činidla modifikující lipidy - primární hypercholesterolemie a smíšená dyslipidaemiapraluent je indikován u dospělých pacientů s primární hypercholesterolémií (heterozygotní familiární a nefamiliární) nebo se smíšenou dyslipidemií, jako doplněk k dietním opatřením:v kombinaci se statinem nebo statinu s další hypolipidemické léčby terapie u pacientů, kteří nemohou dosáhnout ldl-c cíle s maximální tolerovaná dávka statinu nebo,samostatně nebo v kombinaci s další hypolipidemickou terapií u pacientů, kteří jsou statin-intolerantních, nebo pro koho statinem je kontraindikováno. založena aterosklerotických kardiovaskulárních onemocnění praluent je indikován u dospělých se zavedenými aterosklerotických kardiovaskulárních onemocnění snížit kardiovaskulární riziko snížení hladin ldl-c, jako doplněk ke korekci jiných rizikových faktorů:v kombinaci s maximální tolerovaná dávka statinu s nebo bez jiné hypolipidemické léčby nebo v monoterapii nebo v kombinaci s další hypolipidemickou terapií u pacientů, kteří jsou statin-intolerantních, nebo pro koho statinem je kontraindikováno. pro výsledky studií s ohledem na účinky na ldl-c, kardiovaskulárních příhod a zkoumané populaci viz bod 5.

Eiropas Savienība - čehu - EMA (European Medicines Agency)

novartis europharm limited  - vildagliptin, metformin hydrochloridu - diabetes mellitus, typ 2 - léky užívané při diabetu - zomarist is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus:in patients who are inadequately controlled with metformin hydrochloride alone. in patients who are already being treated with the combination of vildagliptin and metformin hydrochloride, as separate tablets. in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate.

Eiropas Savienība - čehu - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - dostarlimab - endometrial neoplasms - antineoplastic agents and antibody drug conjugates - jemparli is indicated as monotherapy for the treatment of adult patients with mismatch repair deficient (dmmr)/microsatellite instability-high (msi h) recurrent or advanced endometrial cancer (ec) that has progressed on or following prior treatment with a platinum-containing regimen.

Eiropas Savienība - čehu - EMA (European Medicines Agency)

accord healthcare s.l.u. - sunitinib - gastrointestinal stromal tumors; carcinoma, renal cell; neuroendocrine tumors - antineoplastická činidla - gastrointestinal stromal tumour (gist)sunitinib accord is indicated for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (gist) in adults after failure of imatinib treatment due to resistance or intolerance. metastatic renal cell carcinoma (mrcc)sunitinib accord is indicated for the treatment of advanced/metastatic renal cell carcinoma (mrcc) in adults. pancreatic neuroendocrine tumours (pnet)sunitinib accord is indicated for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours (pnet) with disease progression in adults.

Eiropas Savienība - čehu - EMA (European Medicines Agency)

pfizer europe ma eeig - somatrogon - growth and development - hypofyzÁrnÍ a hypotalamickÉ hormony a analogy - indicated for the long-term treatment of paediatric patients with growth disturbance due to insufficient secretion of growth hormone.

Eiropas Savienība - čehu - EMA (European Medicines Agency)

takeda gmbh - dengue virus, serotype 2, expressing dengue virus, serotype 1, surface proteins, live, attenuated, dengue virus, serotype 2, expressing dengue virus, serotype 3, surface proteins, live, attenuated, dengue virus, serotype 2, expressing dengue virus, serotype 4, surface proteins, live, attenuated, dengue virus, serotype 2, live, attenuated - dengue - vakcíny - qdenga is indicated for the prevention of dengue disease in individuals from 4 years of age. the use of qdenga should be in accordance with official recommendations.

Eiropas Savienība - čehu - EMA (European Medicines Agency)

novartis europharm limited - sacubitril, valsartan - srdeční selhání - antagonisté angiotensinu ii, jiné kombinace, látky působící na renin-angiotensinový systém - paediatric heart failureentresto is indicated in children and adolescents aged one year or older for treatment of symptomatic chronic heart failure with left ventricular systolic dysfunction. adult heart failureentresto is indicated in adult patients for treatment of symptomatic chronic heart failure with reduced ejection fraction.