Regkirona Európska únia - slovenčina - EMA (European Medicines Agency)

regkirona

celltrion healthcare hungary kft. - regdanvimab - covid-19 virus infection - imunitný séra a imunoglobulíny, - regdanvimab is indicated for the treatment of adults with coronavirus disease 2019 (covid-19) who do not require supplemental oxygen and who are at increased risk of progressing to severe covid-19.

Beyfortus Európska únia - slovenčina - EMA (European Medicines Agency)

beyfortus

astrazeneca ab - nirsevimab - imunitný séra a imunoglobulíny, - beyfortus is indicated for the prevention of respiratory syncytial virus (rsv) lower respiratory tract disease in neonates and infants during their first rsv season. beyfortus should be used in accordance with official recommendations.

Libmeldy Európska únia - slovenčina - EMA (European Medicines Agency)

libmeldy

orchard therapeutics (netherlands) bv - atidarsagene autotemcel - leukodystrophy, metachromatic - Ďalšie lieky na nervový systém - libmeldy is indicated for the treatment of metachromatic leukodystrophy (mld) characterized by biallelic mutations in the arysulfatase a (arsa) gene leading to a reduction of the arsa enzymatic activity:in children with late infantile or early juvenile forms, without clinical manifestations of the disease,in children with the early juvenile form, with early clinical manifestations of the disease, who still  have the ability to walk independently and before the onset of cognitive decline.

Nyxthracis (previously Obiltoxaximab SFL) Európska únia - slovenčina - EMA (European Medicines Agency)

nyxthracis (previously obiltoxaximab sfl)

sfl pharmaceuticals deutschland gmbh - nyxthracis - anthrax - imunitný séra a imunoglobulíny, - obiltoxaximab sfl is indicated in combination with appropriate antibacterial drugs in all age groups for treatment of inhalational anthrax due to bacillus anthracis (see section 5. obiltoxaximab sfl is indicated in all age groups for post-exposure prophylaxis of inhalational anthrax when alternative therapies are not appropriate or are not available (see section 5.

AVAXIM 160 U Slovensko - slovenčina - ŠÚKL (Štátny ústav pre kontrolu liečiv)

avaxim 160 u

sanofi pasteur , francúzsko - očkovacia látka proti hepatitíde a, inaktivovaná, neporušený vírus - 59 - immunopraeparata

Ambirix Európska únia - slovenčina - 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,.

Blincyto Európska únia - slovenčina - 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.

Octaplasma Slovensko - slovenčina - ŠÚKL (Štátny ústav pre kontrolu liečiv)

octaplasma

octapharma (ip) sprl, belgicko - náhrady krvi a plazmatické bielkoviny - 75 - substitutio sanguinis (a krvnÉ derivÁty)

Breyanzi Európska únia - slovenčina - EMA (European Medicines Agency)

breyanzi

bristol-myers squibb pharma eeig - cd19-directed genetically modified autologous cell-based product consisting of purified cd8+ t-cells (cd8+ cells), cd19-directed genetically modified autologous cell-based product consisting of purified cd4+ t cells (cd4+ cells) - lymphoma, large b-cell, diffuse; lymphoma, follicular; mediastinal neoplasms - antineoplastické činidlá - breyanzi is indicated for the treatment of adult patients with diffuse large b-cell lymphoma (dlbcl), high grade b-cell lymphoma (hgbcl), primary mediastinal large b-cell lymphoma (pmbcl) and follicular lymphoma grade 3b (fl3b), who relapsed within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy.

Gardasil 9 Európska únia - slovenčina - EMA (European Medicines Agency)

gardasil 9

merck sharp & dohme b.v. - vakcína proti ľudskému papilomavírusu [typy 6, 11, 16, 18, 31, 33, 45, 52, 58] (rekombinantná, adsorbovaná) - condylomata acuminata; papillomavirus infections; immunization; uterine cervical dysplasia - papilomavírus vakcín - gardasil 9 je indikovaný na aktívnej imunizácie jednotlivcov od veku 9 rokov proti týmto hpv choroby:premalignant lézie a rakoviny postihujúcich maternice, ženské ohanbie, pošvy a konečníka spôsobené hpv vakcíny typesgenital bradavice (condyloma acuminata) spôsobené osobitné typy hpv. pozri časti 4. 4 a 5. 1 dôležité informácie o údajoch, ktoré podporujú tieto označenia. použitie gardasil 9 by mali byť v súlade s oficiálne odporúčania.