Európska únia - slovenčina - EMA (European Medicines Agency)

accord healthcare s.l.u. - lakosamid - epilepsie - antiepileptiká, - lacosamide accord is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy. lacosamide accord is indicated as adjunctive therapy•         in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy. •         in the treatment of primary generalised tonic-clonic seizures in adults, adolescents and children from 4 years of age with idiopathic generalised epilepsy.

Európska únia - slovenčina - EMA (European Medicines Agency)

amryt pharmaceuticals dac - metreleptin - lipodystrofiou, rodinné Čiastočné - iné alimentárny trakt a metabolizmus výrobky, - myalepta je uvedené ako doplnok k strave ako substitučná terapia na liečbu komplikácií nedostatok leptínu v lipodystrofiou (ld) pacientov:s potvrdil vrodené všeobecných ld (berardinelli-seip syndróm) alebo získala všeobecný ld (lawrence syndróm) u dospelých a detí od 2 rokov veku a abovewith potvrdil, rodinné čiastočné ld alebo získané čiastočným ld (barraquer-simons syndróm), u dospelých a deti 12 rokov a vyššie, pre ktorých štandardné liečby sa nepodarilo dosiahnuť adekvátne metabolickej kontroly.

Európska únia - slovenčina - EMA (European Medicines Agency)

lupin europe gmbh - mexiletine hydrochloride - myotonická poruchy - kardioterapia - namuscla je indikovaný na liečbu symptomatických myotonia u dospelých pacientov s non-dystrofické myotonická poruchy.

Európska únia - slovenčina - EMA (European Medicines Agency)

medac gesellschaft für klinische spezialpräparate mbh - treosulfan - transplantácia hematopoetických kmeňových buniek - antineoplastické činidlá - treosulfan in combination with fludarabine is indicated as part of conditioning treatment prior to allogeneic haematopoietic stem cell transplantation (allohsct) in adult patients and in paediatric patients older than one month with malignant and non-malignant diseases.

Európska únia - slovenčina - EMA (European Medicines Agency)

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.

Európska únia - slovenčina - EMA (European Medicines Agency)

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.

Európska únia - slovenčina - EMA (European Medicines Agency)

novartis europharm limited - crizanlizumab - anémia, kosáčiková bunka - other hematological agents - adakveo is indicated for the prevention of recurrent vaso occlusive crises (vocs) in sickle cell disease patients aged 16 years and older. it can be given as an add on therapy to hydroxyurea/hydroxycarbamide (hu/hc) or as monotherapy in patients for whom hu/hc is inappropriate or inadequate.

Európska únia - slovenčina - EMA (European Medicines Agency)

insmed netherlands b.v. - amikacin sulfate - infekcie dýchacích ciest - antibakteriálne pre systémové použitie, - arikayce liposomal is indicated for the treatment of non-tuberculous mycobacterial (ntm) lung infections caused by mycobacterium avium complex (mac) in adults with limited treatment options who do not have cystic fibrosis.

Európska únia - slovenčina - EMA (European Medicines Agency)

stemline therapeutics b.v. - tagraxofusp - lymphoma - antineoplastické činidlá - elzonris is indicated as monotherapy for the first-line treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm (bpdcn).

Európska únia - slovenčina - EMA (European Medicines Agency)

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.