Idefirix European Union - Slovak - EMA (European Medicines Agency)

idefirix

hansa biopharma ab - imlifidase - desensitization, immunologic; kidney transplantation - imunosupresíva - idefirix is indicated for desensitisation treatment of highly sensitised adult kidney transplant patients with positive crossmatch against an available deceased donor. the use of idefirix should be reserved for patients unlikely to be transplanted under the available kidney allocation system including prioritisation programmes for highly sensitised patients.

Comirnaty European Union - Slovak - EMA (European Medicines Agency)

comirnaty

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.

Grafalon Slovakia - Slovak - ŠÚKL (Štátny ústav pre kontrolu liečiv)

grafalon

neovii biotech gmbh, nemecko - antitymocytový imunoglobulín (králičí) - 59 - immunopraeparata

Blitzima European Union - Slovak - EMA (European Medicines Agency)

blitzima

celltrion healthcare hungary kft. - rituximab - lymphoma, non-hodgkin; leukemia, lymphocytic, chronic, b-cell - antineoplastické činidlá - blitzima je indikovaný u dospelých na nasledujúcich označení:non-hodgkin je lymfóm (nhl)blitzima je indikovaný na liečbu doteraz neliečených pacientov s fáza iii-iv follicular lymfóm v kombinácii s chemoterapiou. blitzima údržba terapia je indikovaná na liečbu follicular lymfóm, pacienti odpovedajúci na indukčná terapia. blitzima monotherapy je indikovaný na liečbu pacientov s fáza iii-iv follicular lymfóm, ktorí sú chemo-odolný, alebo sú v ich druhom a ďalších relapsu po chemoterapii. blitzima je indikovaný na liečbu pacientov s cd20 pozitívne plošných veľké b bunky non-hodgkin je lymfóm v kombinácii s chop (cyklofosfamidom, doxorubicin, vincristine, prednisolone) chemoterapia. chronic lymphocytic leukémia (cll)blitzima v kombinácii s chemoterapiou je indikovaný na liečbu pacientov s predtým neliečených a relapsed/žiaruvzdorné cll. len obmedzené údaje o účinnosti a bezpečnosti pacientov v minulosti liečených monoklonálne protilátky, vrátane blitzima alebo pacientov, žiaruvzdorné na predchádzajúcu blitzima plus chemoterapia.

Ritemvia European Union - Slovak - EMA (European Medicines Agency)

ritemvia

celltrion healthcare hungary kft. - rituximab - lymphoma, non-hodgkin; microscopic polyangiitis; wegener granulomatosis - antineoplastické činidlá - ritemvia je indikovaný u dospelých na nasledujúcich označení:non-hodgkin je lymfóm (nhl) ritemvia je indikovaný na liečbu doteraz neliečených pacientov s štádium iii, iv follicular lymfóm v kombinácii s chemoterapiou. ritemvia údržba terapia je indikovaná na liečbu follicular lymfóm, pacienti odpovedajúci na indukčná terapia. ritemvia monotherapy je indikovaný na liečbu pacientov s štádium iii, iv follicular lymfóm, ktorí sú odolné voči chemoterapii alebo sú v ich druhom a ďalších relapsu po chemoterapii. ritemvia je indikovaný na liečbu pacientov s cd20 pozitívne plošných veľké b bunky non hodgkin je lymfóm v kombinácii s chop (cyklofosfamidom, doxorubicin, vincristine, prednisolone) chemoterapia. granulomatosis s polyangiitis a mikroskopické polyangiitis. ritemvia, v kombinácii s glucocorticoids, je indikovaný na indukciu odpustenie u dospelých pacientov s ťažkou, aktívne granulomatosis s polyangiitis (wegener) (gpa) a mikroskopické polyangiitis (mpa).

Blincyto European Union - Slovak - EMA (European Medicines Agency)

blincyto

amgen europe b.v. - blinatumomab - prekurzorová bunková lymfoblastická leukémia-lymfóm - antineoplastické činidlá - blincyto is indicated as monotherapy for the treatment of adults with cd19 positive relapsed or refractory b precursor acute lymphoblastic leukaemia (all). patients with philadelphia chromosome positive b-precursor all should have failed treatment with at least 2 tyrosine kinase inhibitors (tkis) and have no alternative treatment options. blincyto is indicated as monotherapy for the treatment of adults with philadelphia chromosome negative cd19 positive b-precursor all in first or second complete remission with minimal residual disease (mrd) greater than or equal to 0. blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with philadelphia chromosome negative cd19 positive b precursor all which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic haematopoietic stem cell transplantation. blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with high-risk first relapsed philadelphia chromosome negative cd19 positive b-precursor all as part of the consolidation therapy (see section 4.

Kesimpta European Union - Slovak - EMA (European Medicines Agency)

kesimpta

novartis ireland ltd - ofatumumab - roztrúsená skleróza, recidivujúce-odosielajúcej - immunosuppressant - kesimpta is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (rms) with active disease defined by clinical or imaging features (see section 5.

Ambirix European Union - Slovak - EMA (European Medicines Agency)

ambirix

glaxosmithkline biologicals s.a. - hepatitis a virus (inactivated), hepatitis b surface antigen - hepatitis b; hepatitis a; immunization - vakcíny - ambirix je určený na použitie u neimunitných osôb od jedného roka do veku 15 rokov vrátane na ochranu pred infekciou vírusom hepatitídy a a hepatitídy b. ochrana proti hepatitíde b infekcie môže možné získať až po druhej dávke. preto:ambirix by mali byť použité iba vtedy, keď existuje relatívne nízke riziko hepatitída-b infekcie počas očkovania samozrejme;odporúča sa, aby ambirix by mali byť podávané v prostredí, kde dokončenie z dvoch dávok očkovania samozrejme môžete byť istí,.

Kyntheum European Union - Slovak - EMA (European Medicines Agency)

kyntheum

leo pharma a/s - brodalumab - svrab - imunosupresíva - kyntheum je indikovaný na liečbu stredne ťažkej až ťažkej psoriázy plakov u dospelých pacientov, ktorí sú kandidátmi na systémovú terapiu.

Qdenga European Union - Slovak - EMA (European Medicines Agency)

qdenga

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 - tropická horúčka - 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.