Euroopa Liit - eesti - EMA (European Medicines Agency)

eisai gmbh - lenvatinibmesülaat - kartsinoom, neerurakk - antineoplastilised ained - kisplyx is indicated for the treatment of adults with advanced renal cell carcinoma (rcc):in combination with pembrolizumab, as first-line treatment (see section 5. in combination with everolimus, following one prior vascular endothelial growth factor (vegf)-targeted therapy.

Euroopa Liit - eesti - EMA (European Medicines Agency)

novartis europharm limited - trametiniib - melanoom - antineoplastilised ained - melanomatrametinib as monotherapy or in combination with dabrafenib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a braf v600 mutation (see sections 4. 4 ja 5. trametinib monotherapy has not demonstrated clinical activity in patients who have progressed on a prior braf inhibitor therapy (see section 5. adjuvant treatment of melanomatrametinib in combination with dabrafenib is indicated for the adjuvant treatment of adult patients with stage iii melanoma with a braf v600 mutation, following complete resection. mitteväikerakk-kopsuvähk (mitteväikerakk-kopsuvähi)trametinib koos dabrafenib on näidustatud ravi täiskasvanud patsientidel, kaugelearenenud mitteväikerakk-kopsuvähi, mille braf v600 mutatsioon.

Euroopa Liit - eesti - EMA (European Medicines Agency)

roche registration gmbh - metoksü polüetüleenglükool-epoetin beta - anemia; kidney failure, chronic - antianemilised preparaadid - treatment of symptomatic anaemia associated with chronic kidney disease (ckd) in adult patients (see section 5. treatment of symptomatic anaemia associated with chronic kidney disease (ckd) in paediatric patients from 3 months to less than 18 years of age who are converting from another erythropoiesis stimulating agent (esa) after their haemoglobin level was stabilised with the previous esa (see section 5.

Euroopa Liit - eesti - EMA (European Medicines Agency)

janssen-cilag international nv - darunaviiri - hiv-nakkused - viirusevastased ravimid süsteemseks kasutamiseks - prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adult and paediatric patients from the age of 3 years and at least 15 kg body weight. prezista, co administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg). in deciding to initiate treatment with prezista co administered with cobicistat or low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. genotypic or phenotypic testing (when available) and treatment history should guide the use of prezista. prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv 1) infection. prezista 75 mg, 150 mg, and 600 mg tablets may be used to provide suitable dose regimens:for the treatment of hiv 1 infection in antiretroviral treatment (art) experienced adult patients, including those that have been highly pre treated. for the treatment of hiv 1 infection in paediatric patients from the age of 3 years and at least 15 kg body weight. in deciding to initiate treatment with prezista co administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. genotypic or phenotypic testing (when available) and treatment history should guide the use of prezista. prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv 1) infection. prezista, co administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg). prezista 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of hiv 1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are:antiretroviral therapy (art) naïve. art experienced with no darunavir resistance associated mutations (drv rams) and who have plasma hiv 1 rna < 100,000 copies/ml and cd4+ cell count ≥ 100 cells x 106/l. in deciding to initiate treatment with prezista in such art experienced patients, genotypic testing should guide the use of prezista.

Euroopa Liit - eesti - EMA (European Medicines Agency)

takeda gmbh - pantoprasool - gastroösofageaalne refluks - prootonpumba inhibiitorid - refluksümptomite lühiajaline ravi (nt. kõrvetised, happe regurgitatsioon) täiskasvanutel.

Euroopa Liit - eesti - EMA (European Medicines Agency)

takeda gmbh - pantoprasool - gastroösofageaalne refluks - prootonpumba inhibiitorid - refluksümptomite lühiajaline ravi (nt. kõrvetised, happe regurgitatsioon) täiskasvanutel.

Euroopa Liit - eesti - EMA (European Medicines Agency)

biogen netherlands b.v. - dimetüülfumaraat - hulgiskleroos - immunosupressandid - tecfidera is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (rrms).

Euroopa Liit - eesti - EMA (European Medicines Agency)

takeda gmbh - pantoprasool - gastroösofageaalne refluks - prootonpumba inhibiitorid - refluksümptomite lühiajaline ravi (nt. kõrvetised, happe regurgitatsioon) täiskasvanutel.

Euroopa Liit - eesti - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - ipilimumab - melanoma; carcinoma, renal cell; carcinoma, non-small-cell lung; mesothelioma, malignant; colorectal neoplasms - antineoplastilised ained - 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 ja 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%.

Euroopa Liit - eesti - EMA (European Medicines Agency)

gilead sciences ireland uc - tenofoviiralafenamiidi fumaraat - b-hepatiit - viirusevastased ravimid süsteemseks kasutamiseks - vemlidy is indicated for the treatment of chronic hepatitis b (chb) in adults and paediatric patients 6 years of age and older weighing at least 25 kg (see section 5.