Eiropas Savienība - slovāku - EMA (European Medicines Agency)

biontech manufacturing gmbh - single-stranded, 5’-capped messenger rna 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 - vakcíny - comirnaty 30 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in individuals 12 years of age and older.  comirnaty 30 micrograms/dose dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in individuals 12 years of age and older.  comirnaty 10 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in children aged 5 to 11 years.  comirnaty 3 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in infants and children aged 6 months to 4 years.  comirnaty original/omicron ba. 1 (15/15 micrograms)/dose dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in individuals 12 years of age and older who have previously received at least a primary vaccination course against covid-19. comirnaty original/omicron ba. 4-5 (15/15 micrograms)/dose dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in individuals 12 years of age and older. comirnaty original/omicron ba. 4-5 (5/5 micrograms)/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in children aged 5 to 11 years. comirnaty original/omicron ba. 4-5 (5/5 micrograms)/dose dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in children aged 5 to 11 years.  comirnaty original/omicron ba. 4-5 (1. 5/1. 5 micrograms)/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in infants and children aged 6 months to 4 years.  comirnaty omicron xbb. 5 30 micrograms/dose dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in individuals 12 years of age and older. comirnaty omicron xbb. 5 10 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in children aged 5 to 11 years. comirnaty omicron xbb. 5 10 micrograms/dose dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in children aged 5 to 11 years. comirnaty omicron xbb. 5 3 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in infants and children aged 6 months to 4 years. použitie tejto vakcíny by mali byť v súlade s oficiálne odporúčania.

Eiropas Savienība - slovāku - EMA (European Medicines Agency)

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 - vakcíny - 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.

Slovākija - slovāku - ŠÚKL (Štátny ústav pre kontrolu liečiv)

genesis diagnostics ltd eden research park, henry crabb road littleort, cambridgeshire spojené kráľovstvo veľkej británie a severného Írska -

Slovākija - slovāku - ŠÚKL (Štátny ústav pre kontrolu liečiv)

cambridge nutritional sciences ltd. eden reasearch par, henry crabb road cb6 1se littleport, cambridgeshire spojené kráľovstvo veľkej británie a severného Írska -

Slovākija - slovāku - ŠÚKL (Štátny ústav pre kontrolu liečiv)

cambridge nutritional sciences ltd. eden reasearch par, henry crabb road cb6 1se littleport, cambridgeshire spojené kráľovstvo veľkej británie a severného Írska -

Slovākija - slovāku - ŠÚKL (Štátny ústav pre kontrolu liečiv)

cambridge nutritional sciences ltd. eden reasearch par, henry crabb road cb6 1se littleport, cambridgeshire spojené kráľovstvo veľkej británie a severného Írska -

Eiropas Savienība - slovāku - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - pomalidomide - viacnásobný myelóm - imunosupresíva - imnovid v kombinácii s bortezomib a dexamethasone je indikovaný na liečbu dospelých pacientov s mnohopočetným myelómom, ktorí dostali aspoň jeden pred liečebného režimu vrátane lenalidomide. imnovid v kombinácii s dexametazónom je indikovaný na liečbu dospelých pacientov s relabujúcim a refraktérnym mnohopočetným myelómom, ktorí dostali najmenej dve predchádzajúce liečebných režimov, vrátane lenalidomid a bortezomib, a preukázali progresie ochorenia po poslednej liečby.

Eiropas Savienība - slovāku - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - lenalidomid - multiple myeloma; lymphoma, mantle-cell; myelodysplastic syndromes - imunosupresíva - viac myelomarevlimid ako monotherapy je indikovaný na udržiavaciu liečbu dospelých pacientov s novo diagnostikovanou myelómom je mladších, ktorí prešli autológne transplantácie kmeňových buniek. revlimid ako kombinovaná liečba s dexamethasone, alebo bortezomib a dexamethasone, alebo melphalan a prednizón (pozri časť 4. 2) je indikovaný na liečbu dospelých predtým neliečených pacientov s myelómom je mladších, ktorí nie sú spôsobilí na transplantáciu. revlimid v kombinácii s dexamethasone je indikovaný na liečbu myelómom je mladších dospelých pacientov, ktorí dostali aspoň jeden pred terapia. myelodysplastic syndromesrevlimid ako monotherapy je indikovaný na liečbu dospelých pacientov s transfúziu-závislé anémia kvôli nízkym alebo stredne-1-riziko myelodysplastic syndrómy spojené s izolovaný výmaz 5q cytogenetic abnormality, keď iné terapeutické možnosti sú nedostatočná alebo neprimeraná. plášť bunky lymphomarevlimid ako monotherapy je indikovaný na liečbu dospelých pacientov s relapsed alebo žiaruvzdorné plášť bunky lymfómu. follicular lymphomarevlimid v kombinácii s rituximabom (anti-cd20 protilátok) je indikovaný na liečbu dospelých pacientov s predtým ošetrené follicular lymfóm (trieda 1 – 3a).

Eiropas Savienība - slovāku - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - efavirenz - hiv infekcie - antivirotiká na systémové použitie - sustiva je indikovaná v antivírusovej kombinovanej liečbe dospelých, dospievajúcich a detí vo veku od troch rokov, ktoré sú infikované vírusom 1 (hiv-1) ľudskou imunitnou nedostatočnosťou. sustiva nebol dostatočne študoval u pacientov s pokročilou hiv ochorenia, a to u pacientov s počtom cd4 < 50 buniek/mm3, alebo po poruche proteináz-inhibítor (pi)-obsahujúce režimy. hoci krížovej rezistencie efavirenz s inhibítormi proteinázy hiv nebola preukázaná, tam sú v súčasnosti nedostatočné údaje o účinnosti následné použitie pi-založené kombinovaná liečba po zlyhaní režimy obsahujúce sustiva.

Eiropas Savienība - slovāku - 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%.