Evropska unija - slovenščina - EMA (European Medicines Agency)

laboratoire francais du fractionnement et des biotechnologies - eptacog beta (activated) - hemophilia a; hemophilia b - antihemoragije - cevenfacta is indicated in adults and adolescents (12 years of age and older) for the treatment of bleeding episodes and for the prevention of bleeding in those undergoing surgery or invasive procedures in the following patient groups:in patients with congenital haemophilia with high-responding inhibitors to coagulation factors viii or ix (i. ≥5 bethesda units (bu)); in patients with congenital haemophilia with low titre inhibitors (bu.

Evropska unija - slovenščina - EMA (European Medicines Agency)

bayer animal health gmbh - imidacloprid, moxidectin - antiparazitni izdelki, insekticidi in repelenti - dogs; cats; ferrets - dogsfor psi, ki trpijo ali na tveganje, mešani parazitske okužbe:zdravljenje in preprečevanje bolh okužbe (ctenocephalides felis),zdravljenje grize lice (trichodectes canis),zdravljenje uho tropilaelaps okužbe (otodectes cynotis), sarcoptic mange (zaradi sarcoptes scabiei var. canis), demodicosis (zaradi demodex canis),preprečevanje heartworm bolezni (l3 in l4 ličinke dirofilaria immitis),zdravljenje, ki kroži microfilariae (dirofilaria immitis),zdravljenje kožne dirofilariosis (za odrasle faze dirofilaria repens)preprečevanje kožne dirofilariosis (l3 ličinke dirofilaria repens),zmanjšanje obtoku microfilariae (dirofilaria repens),preprečevanje angiostrongylosis (l4 ličinke in nezreli odraslimi angiostrongylus vasorum),zdravljenje angiostrongylus vasorum in crenosoma vulpis,preprečevanje spirocercosis (spirocerca lupi),zdravljenje eucoleus (syn. capillaria) boehmi (odrasli),zdravljenje oči črv thelazia callipaeda (odrasli),zdravljenje okužb z prebavil nematodes (l4 ličinke, nezreli odraslih od toxocara canis, ancylostoma caninum in uncinaria stenocephala, odraslimi toxascaris leonina in trichuris vulpis). izdelek se lahko uporablja kot del strategije zdravljenja alergijskega dermatitisa bolh (fad). catsfor mačke, ki trpijo ali na tveganje, mešani parazitske okužbe:zdravljenje in preprečevanje bolh okužbe (ctenocephalides felis),zdravljenje uho tropilaelaps okužbe (otodectes cynotis),zdravljenje notoedric mange (notoedres cati),zdravljenje lungworm eucoleus aerophilus (syn. capillaria aerophila) (odrasli),preprečevanje lungworm bolezni (l3/l4 ličinke aelurostrongylus abstrusus),zdravljenje lungworm aelurostrongylus abstrusus (odrasli),zdravljenje oči črv thelazia callipaeda (odrasli),preprečevanje heartworm bolezni (l3 in l4 ličinke dirofilaria immitis),zdravljenje okužb z prebavil nematodes (l4 ličinke, nezreli odraslih od toxocara cati in ancylostoma tubaeforme). izdelek se lahko uporablja kot del strategije zdravljenja alergijskega dermatitisa bolh (fad). ferretsfor bele dihurje, ki trpijo ali na tveganje, mešani parazitske okužbe:zdravljenje in preprečevanje bolh okužbe (ctenocephalides felis),preprečevanje heartworm bolezni (l3 in l4 ličinke dirofilaria immitis).

Evropska unija - slovenščina - EMA (European Medicines Agency)

laboratorios hipra, s.a. - v živo vidni nalezljive bursal bolezni virus (ibdv), sev 1052 - immunologicals za aves, domačo kokošjo, Živo virusna cepiva, ptic nalezljive bursal bolezni virus (bolezni gumboro) - chicken; embryonated chicken eggs - za aktivno imunizacijo 1-dan-stare pitovnih piščancev in embryonated pitovnih kokošja jajca za zmanjšanje kliničnih znakov bolezni in poškodb od bursa od fabricius, ki jih povzročajo zelo virulentni aviarne nalezljive bursal bolezni, okužbe z virusom.

Evropska unija - slovenščina - EMA (European Medicines Agency)

orion corporation - tasipimidine sulfate - other hypnotics and sedatives - psi - alleviation of situational anxiety and fear in dogs triggered by e. travel, noise, owner departure, veterinary visits.

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)

novartis europharm limited - sacubitril, valsartan - odpoved srca - angiotensin ii antagonisti, druge kombinacije, agente, ki delujejo na renin-angiotensin sistem - paediatric heart failureentresto is indicated in children and adolescents aged one year or older for treatment of symptomatic chronic heart failure with left ventricular systolic dysfunction. adult heart failureentresto is indicated in adult patients for treatment of symptomatic chronic heart failure with reduced ejection fraction.

Evropska unija - slovenščina - EMA (European Medicines Agency)

chiesi farmaceutici s.p.a. - deferiprone - beta-thalassemia; iron overload - vsi drugi terapevtski izdelki - monoterapija ferriprox je indicirana za zdravljenje preobremenjenosti železa pri bolnikih s talasemijo, ko je sedanja kelacijska terapija kontraindicirana ali nezadostna. ferriprox v kombinaciji z drugo chelator je indicirana pri bolnikih z talasemija major, ko monotherapy z vsemi železa chelator je neučinkovita, ali ko je preprečevanje ali zdravljenje življenjsko nevarne posledice železa preobremenitve (predvsem srčno preobremenitve) utemeljuje hitro ali intenzivno popravek.

Evropska unija - slovenščina - EMA (European Medicines Agency)

daiichi sankyo europe gmbh - edoxaban tosilate - stroke; venous thromboembolism - antitrombotična sredstva - preprečevanje možgansko kap in sistemsko embolijo pri odraslih bolnikih z nonvalvular atrijsko fibrilacijo (nvaf) z eno ali več dejavniki tveganja, kot so kongestivno srčno popuščanje, hipertenzijo, starost ≥ 75 let, sladkorna bolezen, predhodna kap ali prehodnih ishemičnih napad ( tia). zdravljenje globoke venske tromboze (dvt) in pljučna embolija (pe), in preprečevanje ponavljajočih se dvt in pe pri odraslih.

Evropska unija - slovenščina - EMA (European Medicines Agency)

teva b.v. - doksorubicinijev klorid - neoplazme dojke - antineoplastična sredstva - myocet liposomal, v kombinaciji z ciklofosfamid, je označen za prvo linijo zdravljenja metastatskega raka dojk pri odraslih žensk.

Evropska unija - slovenščina - EMA (European Medicines Agency)

novartis europharm limited - sacubitril, valsartan - odpoved srca - sredstva, ki delujejo na sistem renin-angiotenzin - paediatric heart failureneparvis is indicated in children and adolescents aged one year or older for treatment of symptomatic chronic heart failure with left ventricular systolic dysfunction (see section 5. adult heart failureneparvis is indicated in adult patients for treatment of symptomatic chronic heart failure with reduced ejection fraction (see section 5.