Mircera Evropska unija - slovenščina - EMA (European Medicines Agency)

mircera

roche registration gmbh - metoksi polietilen glikol-epoetin beta - anemia; kidney failure, chronic - antianemični preparati - 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.

Plegridy Evropska unija - slovenščina - EMA (European Medicines Agency)

plegridy

biogen netherlands b.v. - peginterferon beta-1a - multiple skleroza - immunostimulants, - zdravljenje ponavljajoče se remitirne multiple skleroze pri odraslih bolnikih.

Evrenzo Evropska unija - slovenščina - EMA (European Medicines Agency)

evrenzo

astellas pharma europe b.v. - roxadustat - anemia; kidney failure, chronic - antianemični preparati - evrenzo is indicated for treatment of adult patients with symptomatic anaemia associated with chronic kidney disease (ckd).

Besremi Evropska unija - slovenščina - EMA (European Medicines Agency)

besremi

aop orphan pharmaceuticals gmbh - ropeginterferon alfa-2b - polycythemia vera - immunostimulants, - besremi je označen kot monotherapy pri odraslih za zdravljenje polycythaemia vera brez simptomatsko splenomegaly.

Celdoxome pegylated liposomal Evropska unija - slovenščina - EMA (European Medicines Agency)

celdoxome pegylated liposomal

yes pharmaceutical development services gmbh - doksorubicinijev klorid - breast neoplasms; ovarian neoplasms; multiple myeloma; sarcoma, kaposi - antineoplastična sredstva - celdoxome pegylated liposomal is indicated in adults:as monotherapy for patients with metastatic breast cancer, where there is an increased cardiac risk. or treatment of advanced ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen. in combination with bortezomib for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplant. for treatment of aids-related kaposi’s sarcoma (ks) in patients with low cd4 counts (< 200 cd4 lymphocytes/mm3) and extensive mucocutaneous or visceral disease. celdoxome pegylated liposomal may be used as first-line systemic chemotherapy, or as second line chemotherapy in aids-ks patients with disease that has progressed with, or in patients intolerant to, prior combination systemic chemotherapy comprising at least two of the following agents: a vinca alkaloid, bleomycin and standard doxorubicin (or other anthracycline).

Skytrofa (previously Lonapegsomatropin Ascendis Pharma) Evropska unija - slovenščina - EMA (European Medicines Agency)

skytrofa (previously lonapegsomatropin ascendis pharma)

ascendis pharma endocrinology division a/s - lonapegsomatropin - growth and development - hipofize in hipotalamični hormoni in analogi - growth failure in children and adolescents aged from 3 years up to 18 years due to insufficient endogenous growth hormone secretion (growth hormone deficiency [ghd]),.

Lonquex Evropska unija - slovenščina - EMA (European Medicines Agency)

lonquex

teva b.v. - lipegfilgrastim - nevtropenija - immunostimulants, , colony stimulating factors - lonquex is indicated in adults and in children 2 years of age and older for reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).

Spikevax (previously COVID-19 Vaccine Moderna) Evropska unija - slovenščina - EMA (European Medicines Agency)

spikevax (previously covid-19 vaccine moderna)

moderna biotech spain, s.l. - single-stranded, 5’-capped messenger rna (mrna) produced using a cell-free in vitro transcription from the corresponding dna templates, encoding the viral spike (s) protein of sars-cov-2 - covid-19 virus infection - cepiva - spikevax is indicated for active immunisation to prevent covid-19 caused by sars-cov-2 in individuals 6 months of age and older. spikevax bivalent original/omicron ba. 1 is indicated for active immunisation to prevent covid-19 caused by sars-cov-2 in individuals 6 years of age and older who have previously received at least a primary vaccination course against covid-19. spikevax bivalent original/omicron ba. 4-5 is indicated for active immunisation to prevent covid-19 caused by sars-cov-2 in individuals 6 months of age and older.  spikevax xbb. 5 is indicated for active immunisation to prevent covid 19 caused by sars-cov-2 in individuals 6 months of age and older. the use of this vaccine should be in accordance with official recommendations.

Onivyde pegylated liposomal (previously known as Onivyde) Evropska unija - slovenščina - EMA (European Medicines Agency)

onivyde pegylated liposomal (previously known as onivyde)

les laboratoires servier - irinotecan anhydrous free-base - pankreatične neoplazme - antineoplastična sredstva - zdravljenje metastatskega adenokarcinoma trebušne slinavke, v kombinaciji z 5 flúorouracíl (5-fu) in leucovorin (lv), pri odraslih bolnikih, ki so napredovali po gemcitabin na zdravljenje.

Caelyx pegylated liposomal Evropska unija - slovenščina - EMA (European Medicines Agency)

caelyx pegylated liposomal

baxter holding b.v. - doksorubicinijev klorid - sarcoma, kaposi; multiple myeloma; ovarian neoplasms; breast neoplasms - antineoplastična sredstva - caelyx pegylated liposomal je navedeno:kot monotherapy za bolnike z metastatskim rakom dojke, kjer je povečana srčna tveganja;za zdravljenje advanced rak na jajčnikih pri ženskah, ki niso uspeli v prvi vrstici platinum, ki temelji kemoterapijo režim;v kombinaciji z bortezomib za zdravljenje postopno več plazmocitom pri bolnikih, ki so prejeli vsaj en pred terapijo in ki so že obdelani ali ki so neprimerni za presaditev kostnega mozga;za zdravljenje hiv kaposi ' s sarkom (ks) pri bolnikih z nizko cd4 šteje (.