Evropska unija - slovenščina - EMA (European Medicines Agency)

ascendis pharma endocrinology division a/s - lonapegsomatropin - growth and development - hipofize in hipotalamični hormoni in analogi - growth failure in children and adolescents aged from 3 years up to 18 years due to insufficient endogenous growth hormone secretion (growth hormone deficiency [ghd]),.

Slovenija - slovenščina - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

gsk d.o.o., ljubljana - virus mumpsa (sev jeryl lynn), živ, oslabljen; virus rdečk (sev wistar ra 27/3), živ, oslabljen; virus ošpic (sev schwarz), živ, oslabljen; virus noric (sev oka), živ, oslabljen - prašek in vehikel za raztopino za injiciranje - virus mumpsa (sev jeryl lynn), živ, oslabljen 25119 ccid50 / 0,5 ml  virus rdečk (sev wistar ra 27/3), živ, oslabljen1000 ccid50 / 0,5 ml  virus ošpic (sev schwarz), živ, oslabljen1000 ccid50 / 0,5 ml  virus noric (sev oka), živ, oslabljen1995 ccid50 / 0,5 ml; virus rdečk (sev wistar ra 27/3), živ, oslabljen 1000 ccid50 / 0,5 ml  virus ošpic (sev schwarz), živ, oslabljen1000 ccid50 / 0,5 ml  virus noric (sev oka), živ, oslabljen1995 ccid50 / 0,5 ml; virus ošpic (sev schwarz), živ, oslabljen 1000 ccid50 / 0,5 ml  virus noric (sev oka), živ, oslabljen1995 ccid50 / 0,5 ml; virus noric (sev oka), živ, oslabljen - mešano cepivo proti ošpicam, mumpsu, rdečkam in noricam z oslabljenimi virusi

Evropska unija - slovenščina - EMA (European Medicines Agency)

novartis europharm limited - canakinumab - cryopyrin-associated periodic syndromes; arthritis, juvenile rheumatoid; arthritis, gouty - interleukin inhibitorji, - redno vročina syndromesilaris je indicirano za zdravljenje naslednjih autoinflammatory redno vročina sindromov, pri odraslih, mladostnikih in otrocih, starih 2 leti in več:cryopyrin-associated periodic syndromesilaris je primerna za zdravljenje cryopyrin-associated periodic sindromov (caps), vključno z:muckle-sindrom wells (mws),novorojenčku-nastop multisystem vnetne bolezni (nomid) / kronične infantilne nevrološke, kožne, sklepni sindrom (cinca),hude oblike družinsko hladno autoinflammatory sindrom (fcas) / družinsko hladno urtikarija (fcu) predstavitev z znaki in simptomi, ki presegajo hladno-induced urticarial izpuščaj na koži,. tumor nekroze faktor receptor, povezanih redno sindrom (pasti)ilaris je primerna za zdravljenje tumor nekroze faktor (tnf), receptor, povezanih redno sindrom (pasti). hyperimmunoglobulin d sindrom (hids)/mevalonate kinaza pomanjkljivosti (mkd)ilaris je primerna za zdravljenje hyperimmunoglobulin d sindrom (hids)/mevalonate kinaza pomanjkljivosti (mkd). družinsko sredozemlju kuge (fmf)ilaris je primerna za zdravljenje družinsko sredozemlju kuge (fmf). ilaris je treba v kombinaciji z colchicine, če je primerno. ilaris je prikazano tudi za zdravljenje:še vedno je diseaseilaris je primerna za zdravljenje aktivnega še vedno je bolezen odraslih, vključno z nastopom še vedno je bolezen (aosd) in sistemsko mladoletnike idiopatsko artritis (sjia) pri bolnikih, starih 2 leti in več, ki so se odzvali neustrezno na prejšnje zdravljenje s nesteroidna protivnetna zdravila (nesteroidnih protivnetnih zdravil) in sistemski kortikosteroidi. ilaris lahko podana kot monotherapy ali v kombinaciji z metotreksatom. uričnim arthritisilaris je primerna za simptomatsko zdravljenje odraslih bolnikov s pogostimi uričnega artritisa napadov (vsaj za 3 napade v zadnjih 12 mesecih) pri katerih nesteroidna protivnetna zdravila (nesteroidnih protivnetnih zdravil) in colchicine so kontraindicirana, se ne prenaša ali ne zagotavlja ustreznega odgovora, in v kateri je ponovil tečaji kortikosteroidi niso primerne.

Evropska unija - slovenščina - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - diphtheria toxoid, tetanus toxoid, bordetella pertussis antigens (pertussis toxoid, filamentous haemagglutinin, pertactin), hepatitis b surface antigen, poliovirus (inactivated) (type-1 (mahoney strain), type-2 (mef-1 strain), type-3 (saukett strain)), haemophilus influenzae type b polysaccharide - hepatitis b; tetanus; immunization; meningitis, haemophilus; whooping cough; poliomyelitis; diphtheria - cepiva - infanrix hexa je indicirano za osnovno in obnovitveno cepljenje dojenčkov proti davici, tetanus, oslovski kašelj, hepatitis b, otroški ohromelosti in bolezen, ki povzroča haemophilus influenzae tipa b.

Evropska unija - slovenščina - EMA (European Medicines Agency)

pfizer limited - pneumococcal oligosaccharide serotype 18c, pneumococcal polysaccharide serotype 19f, pneumococcal polysaccharide serotype 23f, pneumococcal polysaccharide serotype 4, pneumococcal polysaccharide serotype 6b, pneumococcal polysaccharide serotype 9v, pneumococcal polysaccharide serotype 14 - pneumococcal infections; immunization - cepiva - aktivne imunizacije proti bolezni, ki povzroča streptococcus pneumoniae serotipe 4, 6b, iz 9v, 14, 18 c, 19f in 23f (vključno s sepso, meningitisom, pljučnica, bakteriemija in akutni otitis media) pri dojenčkih in otrocih od dveh mesecev do petih let starosti. uporaba prevenar je treba določiti na podlagi uradnih priporočil, ob upoštevanju vpliva invazivnih bolezni v različnih starostnih skupin, kot tudi variabilnost serotip epidemiologija v različnih geografskih področjih,.

Evropska unija - slovenščina - EMA (European Medicines Agency)

novartis europharm limited - secukinumab - arthritis, psoriatic; psoriasis; spondylitis, ankylosing - imunosupresivi - plaque psoriasiscosentyx is indicated for the treatment of moderate to severe plaque psoriasis in adults and children from the age of 6 years old who are candidates for systemic therapy. hidradenitis suppurativa (hs)cosentyx is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults with an inadequate response to conventional systemic hs therapy. psoriatični arthritiscosentyx, samostojno ali v kombinaciji z metotreksatom (mtx), je primerna za zdravljenje aktivnega psoriatičnega artritisa pri odraslih bolnikih, kadar je odgovor na prejšnje bolezni spreminjanje anti revmatičnih drog (dmard) terapija je bila neustrezna. aksialni spondyloarthritis (axspa)ankilozirajoči spondilitis (kot, radiografski osno spondyloarthritis)cosentyx je primerna za zdravljenje aktivnega ankilozirajoči spondilitis pri odraslih, ki so se odzvali neustrezno konvencionalne terapije. non-radiographic axial spondyloarthritis (nr-axspa)cosentyx is indicated for the treatment of active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated c-reactive protein (crp) and/or magnetic resonance imaging (mri) evidence in adults who have responded inadequately to non steroidal anti inflammatory drugs (nsaids). juvenile idiopathic arthritis (jia)enthesitis-related arthritis (era)cosentyx, alone or in combination with methotrexate (mtx), is indicated for the treatment of active enthesitis-related arthritis in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy. juvenile psoriatic arthritis (jpsa)cosentyx, alone or in combination with methotrexate (mtx), is indicated for the treatment of active juvenile psoriatic arthritis in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy.

Evropska unija - slovenščina - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - pneumococcal polysaccharide serotype 23f, pneumococcal polysaccharide serotype 4, pneumococcal polysaccharide serotype 5, pneumococcal polysaccharide serotype 6b, pneumococcal polysaccharide serotype 7f, pneumococcal polysaccharide serotype 9v, pneumococcal polysaccharide serotype 1, pneumococcal polysaccharide serotype 14, pneumococcal polysaccharide serotype 18c, pneumococcal polysaccharide serotype 19f - pneumococcal infections; immunization - cepiva - aktivne imunizacije proti invazivni bolezni in akutni otitis media, posledica streptococcus pneumoniae pri dojenčkih in otrocih od šest tednov do pet let. glej poglavja 4. 4 in 5. 1 v informacijah o izdelku za informacije o zaščiti proti specifičnim pnevmokoknim serotipom. uporaba synflorix je treba določiti na podlagi uradnih priporočil, ob upoštevanju vpliva invazivnih bolezni v različnih starostnih skupin, kot tudi variabilnost serotip epidemiologija v različnih geografskih področjih,.

Evropska unija - slovenščina - EMA (European Medicines Agency)

sanofi winthrop industrie - dupilumab - dermatitis, atopic; prurigo; esophageal diseases; asthma; sinusitis - sredstva za dermatitis, razen kortikosteroidov - atopic dermatitisadults and adolescentsdupixent is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy. children 6 months to 11 years of agedupixent is indicated for the treatment of severe atopic dermatitis in children 6 months to 11 years old who are candidates for systemic therapy. asthmaadults and adolescentsdupixent is indicated in adults and adolescents 12 years and older as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (feno), see section 5. 1, who are inadequately controlled with high dose inhaled corticosteroids (ics) plus another medicinal product for maintenance treatment. children 6 to 11 years of agedupixent is indicated in children 6 to 11 years old as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (feno), who are inadequately controlled with medium to high dose inhaled corticosteroids (ics) plus another medicinal product for maintenance treatment. chronic rhinosinusitis with nasal polyposis (crswnp)dupixent is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adults with severe crswnp for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control. prurigo nodularis (pn)dupixent is indicated for the treatment of adults with moderate-to-severe prurigo nodularis (pn) who are candidates for systemic therapy. eosinophilic esophagitis (eoe)dupixent is indicated for the treatment of eosinophilic esophagitis in adults and adolescents 12 years and older, weighing at least 40 kg, who are inadequately controlled by, are intolerant to, or who are not candidates for conventional medicinal therapy.

Evropska unija - slovenščina - EMA (European Medicines Agency)

leo pharma a/s - tralokinumab - dermatitis, atopic - drugi dermatološki preparati - adtralza is indicated for the treatment of moderate to severe atopic dermatitis in adult and adolescent patients 12 years and older who are candidates for systemic therapy.

Slovenija - slovenščina - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

sandoz gmbh - fenoksimetilpenicilin - peroralna suspenzija - fenoksimetilpenicilin 507,7 mg / 5 ml - benzatinijev fenoksimetilpenicilinat