Libmeldy Evropska unija - slovenščina - EMA (European Medicines Agency)

libmeldy

orchard therapeutics (netherlands) bv - atidarsagene autotemcel - leukodystrophy, metachromatic - druga zdravila na živčnem sistemu - 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.

Vumerity Evropska unija - slovenščina - EMA (European Medicines Agency)

vumerity

biogen netherlands b.v. - diroximel fumarate (biib098) - multiplo sklerozo, recidivno-nakazila - imunosupresivi - vumerity is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (see section 5. 1 for important information on the populations for which efficacy has been established).

Tecovirimat SIGA Evropska unija - slovenščina - EMA (European Medicines Agency)

tecovirimat siga

siga technologies netherlands b.v. - tecovirimat - poxviridae infections; cowpox; monkeypox; vaccinia; smallpox - antivirusi za sistemsko uporabo - tecovirimat siga is indicated for the treatment of the following viral infections in adults and children with body weight at least 13 kg:- smallpox- monkeypox- cowpoxtecovirimat siga is also indicated to treat complications due to replication of vaccinia virus following vaccination against smallpox in adults and children with body weight at least 13 kg (see sections 4. 4 in 5. tecovirimat siga should be used in accordance with official recommendations.

Breyanzi Evropska unija - slovenščina - 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 - antineoplastična sredstva - 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.

Lupkynis Evropska unija - slovenščina - EMA (European Medicines Agency)

lupkynis

otsuka pharmaceutical netherlands b.v. - voclosporin - lupus nephritis - imunosupresivi - lupkynis is indicated in combination with mycophenolate mofetil for the treatment of adult patients with active class iii, iv or v (including mixed class iii/v and iv/v) lupus nephritis (ln).

Sunosi Evropska unija - slovenščina - EMA (European Medicines Agency)

sunosi

atnahs pharma netherlands b.v. - solriamfetol hidroklorid - narcolepsy; sleep apnea, obstructive - psychoanaleptics, - sunosi je pokazala, da izboljšanje budnosti in zmanjšati prekomerno dnevno zaspanost, pri odraslih bolnikih z narcolepsy (z ali brez cataplexy). sunosi je pokazala, da izboljšanje budnosti in zmanjšati prekomerno dnevno zaspanost (eds) pri odraslih bolnikih z obstruktivno spalno apnoea (osa), katerih eds ni bila zadovoljivo zdravljenih s primarno osa terapije, kot so stalno pozitiven tlak v dihalnih poteh (cpap).

EPREX 30.000 i.e./0,75 ml raztopina za injiciranje v napolnjenih injekcijskih brizgah Slovenija - slovenščina - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

eprex 30.000 i.e./0,75 ml raztopina za injiciranje v napolnjenih injekcijskih brizgah

johnson & johnson d.o.o. - epoetin alfa - raztopina za injiciranje v napolnjeni injekcijski brizgi - epoetin alfa 30000 i.e. / 0,75 ml - eritropoetin

EPREX 40.000 i.e./1,0 ml raztopina za injiciranje v napolnjenih injekcijskih brizgah Slovenija - slovenščina - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

eprex 40.000 i.e./1,0 ml raztopina za injiciranje v napolnjenih injekcijskih brizgah

johnson & johnson d.o.o. - epoetin alfa - raztopina za injiciranje - epoetin alfa 40000 i.e. / 1 ml - eritropoetin

EPREX 8000 i.e./0,8 ml raztopina za injiciranje v napolnjenih injekcijskih brizgah Slovenija - slovenščina - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

eprex 8000 i.e./0,8 ml raztopina za injiciranje v napolnjenih injekcijskih brizgah

johnson & johnson d.o.o. - epoetin alfa - raztopina za injiciranje - epoetin alfa 8000 i.e. / 0,8 ml - eritropoetin

EPREX 3000 i.e./0,3 ml raztopina za injiciranje v napolnjenih injekcijskih brizgah Slovenija - slovenščina - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

eprex 3000 i.e./0,3 ml raztopina za injiciranje v napolnjenih injekcijskih brizgah

johnson & johnson d.o.o. - epoetin alfa - raztopina za injiciranje - epoetin alfa 3000 i.e. / 0,3 ml - eritropoetin