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)

dany bienenwohl gmbh - oxalic acid dihidrat - ectoparasiticides za lokalno uporabo, vključno. insekticidi - Čebele - za zdravljenje varroosis (varroa destructor) medu čebele (apis mellifera) v zaroda-brezplačno kolonije.

Evropska unija - slovenščina - EMA (European Medicines Agency)

dany bienenwohl gmbh - oxalic acid dihidrat - ectoparasiticides for topical use, incl. insecticides, ectoparaciticides, insecticides and repellents - honey bees - za zdravljenje varroosis (varroa destructor) medu čebele (apis mellifera) v zaroda-brezplačno kolonije.

Evropska unija - slovenščina - EMA (European Medicines Agency)

alexion europe sas - ravulizumab - hemoglobinurija, paroksizmal - selektivni imunosupresivi - paroxysmal nocturnal haemoglobinuria (pnh)ultomiris is indicated in the treatment of adult and paediatric patients with a body weight of 10 kg or above with pnh:- in patients with haemolysis with clinical symptom(s) indicative of high disease activity. - in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months (see section 5. atypical haemolytic uremic syndrome (ahus)ultomiris is indicated in the treatment of patients with a body weight of 10 kg or above with ahus who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab (see section 5. generalized myasthenia gravis (gmg)ultomiris is indicated as an add-on to standard therapy for the treatment of adult patients with gmg who are anti-acetylcholine receptor (achr) antibody-positive. neuromyelitis optica spectrum disorder (nmosd)ultomiris is indicated in the treatment of adult patients with nmosd who are anti-aquaporin 4 (aqp4) antibody-positive (see section 5. ultomiris is indicated in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (pnh):- in patients with haemolysis with clinical symptom(s) indicative of high disease activity. - in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months. ultomiris is indicated in the treatment of adult patients with atypical haemolytic uremic syndrome (ahus) who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab.

Evropska unija - slovenščina - EMA (European Medicines Agency)

boehringer ingelheim vetmedica gmbh - afoxolaner - ektoparaziticidi za sistemsko uporabo - psi - zdravljenje bolh (ctenocephalides felis in c. canis) infestations. izdelek se lahko uporablja kot del strategije zdravljenja za nadzor alergijskega dermatitisa bolha (fad). zdravljenje klopi (dermacentor reticulatus, ixodes ricinus, rhipicephalus sanguineus) infestations. zdravljenje demodicosis (zaradi demodex canis). zdravljenje sarcoptic mange (zaradi sarcoptes scabiei var. canis).

Evropska unija - slovenščina - EMA (European Medicines Agency)

cis bio international - ioflupan (123l) - radionuclide imaging; dementia; movement disorders - diagnostični radiofarmacevtiki - to zdravilo je samo za diagnostično uporabo. striascan je označen za odkrivanje izguba funkcionalne dopaminergičnih nevronov terminalov v striatum:pri odraslih bolnikih s klinično negotova parkinsonian sindromov, na primer tistih z zgodnji simptomi, da bi razlikuje bistveno, tremor iz parkinsonian sindromov, povezanih z idiopatsko parkinsonovo boleznijo, bolezni, multiple sistemske atrofije in postopno supranuclear palsy. striascan, ne more razlikovati med parkinsonove bolezni, multiple sistemske atrofije in postopno supranuclear palsy. pri odraslih bolnikih, za pomoč pri razlikovanju verjetno, demenco z lewy organe, od alzheimerjeve bolezni. striascan, ne more razlikovati med demenco z lewy organov in parkinsonova bolezen, demenca.

Evropska unija - slovenščina - EMA (European Medicines Agency)

laboratorios hipra s.a. - v živo vidni goveja dihal syncytial virus (brsv), sev lym-56 - immunologicals za bovidae, govedo, Živo, virusna cepiva, goveje dihal syncytial virus (brsv) - govedo - aktivno imunizacijo goveda (za zmanjšanje virus prelivanje in dihal, klinične znake, ki jih povzročajo goveja dihal syncytial virus okužbe.

Evropska unija - slovenščina - EMA (European Medicines Agency)

intervet international b.v. - v živo myxoma vectored rhd virus sev 009, Živo myxoma vectored rhd virus sev mk1899 - immunologicals za leporidae - kunci - za aktivno imunizacijo kuncev od 5. tedna starosti dalje za zmanjšanje umrljivosti in kliničnih znakov miksomatoze in zajec hemoragične bolezni (rhd), ki jih povzročajo klasični rhd virus (rhdv1) in rhd tipa 2 virus (rhdv2).

Evropska unija - slovenščina - EMA (European Medicines Agency)

qbiotics netherlands b.v. - tigilanol tiglate - tigilanol tiglate - psi - za zdravljenje ne-resectable, non-metastatskim (ki uprizoritev) podkožnega jambor celice tumorji, ki se nahajajo na ali v distalni komolca ali hock, in non-resectable, ne metastatskim kožne jambor celice tumorjev pri psih.

Evropska unija - slovenščina - EMA (European Medicines Agency)

dechra regulatory b.v. - mirtazapine - psychoanaleptics, antidepressants in combination with psycholeptics - mačke - za pridobivanje telesne teže pri mačkah slaba apetita in izguba teže, ki je posledica kroničnih obolenj.