Unione Europea - italiano - EMA (European Medicines Agency)

unigene uk ltd. - recombinant salmon calcitonin - hypercalcemia; osteitis deformans; bone resorption - omeostasi del calcio - la calcitonina è indicato per la prevenzione di acuta perdita ossea dovuta ad improvvisa immobilizzazione per esempio in pazienti con recentosteoporotic fracturespaget del diseasehypercalcaemia di malignità.

Svizzera - italiano - Swissmedic (Swiss Agency for Therapeutic Products)

novartis pharma schweiz ag - onasemnogenum abeparvovecum gentherapeutikum, das das humane survival-motoneuron- (smn) protein exprimiert. es handelt sich um einen nicht replizierenden rekombinanten adeno-assoziierten vektor auf der basis des virus-serotyp 9 (aav9), der die cdna des humanen smn-gens unter der kontrolle des cytomegalievirus-enhancers/hühner-β-aktin-hybrid-promotors enthält. onasemnogen-abeparvovec wird durch dns-rekombinationstechnologie in menschlichen embryonalen nierenzellen gebildet. besteht aus genetisch verändertem adeno-assoziiertem viralem vektor vom serotyp 9 (aav9) - solution for infusion, - lösung: onasemnogenum abeparvovecum gentherapeutikum, das das humane survival-motoneuron- (smn) protein exprimiert. es handelt sich um einen nicht replizierenden rekombinanten adeno-assoziierten vektor auf der basis des virus-serotyp 9 (aav9), der die cdna des humanen smn-gens unter der kontrolle des cytomegalievirus-enhancers/hühner-β-aktin-hybrid-promotors enthält. onasemnogen-abeparvovec wird durch dns-rekombinationstechnologie in menschlichen embryonalen nierenzellen gebildet. besteht aus genetisch verändertem adeno-assoziiertem viralem vektor vom serotyp 9 (aav9) 2×10e13 vektorgenomen (vg), trometamolum, magnesii chloridum 4.5-hydricum, natrii chloridum, poloxamerum 188, acidum hydrochloridum, aqua ad iniectabile, 1 ml corresp.. - zolgensma ist indiziert zur behandlung von: ; • patienten mit 5q-assoziierter spinaler muskelatrophie (sma) mit einer biallelischen mutation im smn1-gen und einer klinisch diagnostizierten typ-1-sma, oder; • patienten mit 5q-assoziierter sma mit einer biallelischen mutation im smn1-gen und bis zu 3 kopien des smn2-gens.; die therapie darf nur bis zum alter von zwei jahren verabreicht werden. - trapianto: gentherapieprodukt

Unione Europea - italiano - EMA (European Medicines Agency)

intervacc ab - recombinant streptococcus equi protein cce, recombinant streptococcus equi protein eq85, recombinant streptococcus equi protein idee - immunologici per equidi - cavalli - for the active immunisation to reduce clinical signs and the number of abscesses in acute stage of infection with s. equi.

Unione Europea - italiano - EMA (European Medicines Agency)

leti pharma, s.l.u. - recombinant protein q from leishmania infantum mon-1 - inattivato batterici vaccini (tra cui mycoplasma, tetanico e chlamydia) - cani - per l'immunizzazione attiva di cani a partire dai 6 mesi di età per ridurre il rischio di sviluppare un caso clinico di leishmaniosi.

Unione Europea - italiano - EMA (European Medicines Agency)

glaxosmithkline biologicals sa - recombinant varicella zoster virus glycoprotein e - herpes zoster - vaccini - shingrix is indicated for prevention of herpes zoster (hz) and post-herpetic neuralgia (phn), in:adults 50 years of age or older;adults 18 years of age or older at increased risk of hz. l'uso di shingrix dovrebbe essere in conformità con le raccomandazioni ufficiali.

Unione Europea - italiano - EMA (European Medicines Agency)

janssen-cilag international n.v.    - recombinant adenovirus type 26 (ad26) encoding the glycoprotein (gp) of the ebola virus zaire (zebov) mayinga strain - febbre emorragica di ebola - vaccini - active immunization for prevention of disease caused by ebola virus (zaire ebolavirus species) in individuals ≥ 1 year of age.

Unione Europea - italiano - EMA (European Medicines Agency)

janssen-cilag international n.v.    - recombinant modified vaccinia ankara bavarian nordic virus encoding the: ebola virus zaire (zebov) mayinga strain glycoprotein (gp); ebola virus sudan gulu strain gp; ebola virus taï forest strain nucleoprotein and the marburg virus musoke strain gp - febbre emorragica di ebola - vaccini - active immunization for prevention of disease caused by ebola virus (zaire ebolavirus species) in individuals ≥ 1 year of age.

Unione Europea - italiano - EMA (European Medicines Agency)

ceva-phylaxia co. ltd. - recombinant fowlpox virus expressing the membrane fusion protein and the encapsidation protein of avian infectious laryngotracheitis virus, live - pollo - for active immunisation of chickens from 8 weeks of age in order to reduce the skin lesions due to fowlpox and to reduce the clinical signs and tracheal lesions due to avian infectious laryngotracheitis.

Unione Europea - italiano - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a.  - respiratory syncytial virus recombinant glycoprotein f stabilised in the pre-fusion conformation (rsvpref3) produced in chinese hamster ovary (cho) cells by recombinant dna technology - infezioni da virus respiratorio sinciziale - vaccini - arexvy is indicated for active immunisation for the prevention of lower respiratory tract disease (lrtd) caused by respiratory syncytial virus in adults 60 years of age and older. l'uso di questo vaccino dovrebbe essere in conformità con le raccomandazioni ufficiali.

Unione Europea - italiano - EMA (European Medicines Agency)

sanofi pasteur - influenza a virus subtype h1n1 haemagglutinin, recombinant, influenza a virus subtype h3n2 haemagglutinin, recombinant, influenza b virus victoria lineage haemagglutinin, recombinant, influenza b virus yamagata lineage haemagglutinin, recombinant - influenza, umano - vaccini - supemtek is indicated for active immunization for the prevention of influenza disease in adults. supemtek should be used in accordance with official recommendations.