Avrupa Birliği - Slovakça - EMA (European Medicines Agency)

neovii biotech gmbh - catumaxomab - ascites; cancer - iné antineoplastické látky - removab je indikovaný pri intraperitoneálnej liečbe malígneho ascitu u pacientov s epcam-pozitívnymi karcinómami kde štandardná liečba nie je k dispozícii alebo už nie je možné.

Avrupa Birliği - Slovakça - EMA (European Medicines Agency)

merck sharp & dohme b.v. - efavirenz - hiv infekcie - antivirotiká na systémové použitie - stocrin je indikovaný protivírusové kombinovanú liečbu ľudských-imunodeficiencie-virus-1 (hiv-1)-infikovaných dospelých, dospievajúcich a detí trojročné a staršie. stocrin nebola dostatočne preskúmaná 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 stocrin.

Avrupa Birliği - Slovakça - EMA (European Medicines Agency)

novartis europharm ltd. - aliskiren - vysoký tlak - Činidlá pôsobiace na systém renín-angiotenzín - liečba esenciálnej hypertenzie.

Avrupa Birliği - Slovakça - EMA (European Medicines Agency)

merck sharp & dohme b.v. - doravirine - hiv infekcie - antivirotiká na systémové použitie - pifeltro is indicated, in combination with other antiretroviral medicinal products, for the treatment of adults, and adolescents aged 12 years and older weighing at least 35 kg infected with hiv 1 without past or present evidence of resistance to the nnrti class.

Avrupa Birliği - Slovakça - EMA (European Medicines Agency)

bluebird bio (netherlands) b.v. - autológne cd34+ buniek obohatený obyvateľstva, ktorý obsahuje hematopoietic stem cells transduced s lentiglobin bb305 lentiviral vektor kódovanie beta-a-t87q-globínu gén - beta-thalassemia - other hematological agents - zynteglo je indikovaný na liečbu pacientov 12 rokov a starších s transfúziu-závislé β thalassaemia (tdt), ktorí nemajú β0/β0 genotyp, pre ktorých hematopoetickú kmeňových buniek (hsc) transplantácie je vhodné, ale človek, leukocytové antigénu (hla)-uzavreté súvisiace hsc darcu nie je k dispozícii.

Avrupa Birliği - Slovakça - 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.

Avrupa Birliği - Slovakça - EMA (European Medicines Agency)

gedeon richter ltd  - ulipristal acetát - leiomyóm - pohlavné hormóny a modulátory z genitálny systém, - ulipristal acetát je indikovaný na predoperačné liečenie stredne ťažkých až ťažkých symptómov maternicových fibroidov u dospelých žien v reprodukčnom veku. ulipristal acetát je určený pre občasné ošetrenie mierne až závažné príznaky maternice fibroids dospelých žien reprodukčného veku.

Avrupa Birliği - Slovakça - EMA (European Medicines Agency)

gedeon richter plc. - ulipristal acetát - leiomyóm - pohlavné hormóny a modulátory z genitálny systém, - ulipristal acetát je uvedená za jedno ošetrenie priebehu predoperačné liečbu stredne silnej až silnej príznaky maternice fibroids dospelých žien reprodukčného veku. ulipristal acetát je určený pre občasné ošetrenie mierne až závažné príznaky maternice fibroids dospelých žien reprodukčného veku, ktoré nie sú akceptovateľné pre operácie.

Avrupa Birliği - Slovakça - EMA (European Medicines Agency)

gedeon richter plc. - folitropín alfa - anovulácia - pohlavné hormóny a modulátory z genitálny systém, - in adult women:anovulation (including polycystic ovarian disease, pcod) in women who have been unresponsive to treatment with clomiphene citrate;stimulation of multifollicular development in patients undergoing superovulation for assisted reproductive technologies (art) such as in vitro fertilisation (ivf), gamete intra-fallopian transfer (gift) and zygote intra-fallopian transfer (zift);follitropin alfa in association with a luteinising hormone (lh) preparation is recommended for the stimulation of follicular development in women with severe lh and fsh deficiency. v klinických štúdiách týchto pacientov boli definované endogénny sérum lh < 1. 2 iu / l. in adult men:follitropin alfa is indicated for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotrophic hypogonadism with concomitant human chorionic gonadotrophin (hcg) therapy.

Avrupa Birliği - Slovakça - EMA (European Medicines Agency)

pfizer europe ma eeig - oestrogens konjugované, bazedoxifene - postmenopause - konjugované estrogény a bazedoxifene - duavive je indikovaný na:liečbu estrogénu, nedostatok príznaky u žien po menopauze s maternice (s najmenej 12 mesiacov od poslednej menštruácie), pre ktorých je liečba s progestin-obsahujúce terapia nie je vhodná. skúsenosti liečbe žien starších ako 65 rokov je obmedzený.