Европска Унија - Словеначки - EMA (European Medicines Agency)

eli lilly nederland b.v. - teriparatid - osteoporosis; osteoporosis, postmenopausal - kalcij homeostaza - zdravljenje osteoporoze pri ženskah po menopavzi in pri moških z večjim tveganjem zloma. pri ženskah v postmenopavzi je bilo dokazano znatno zmanjšanje pojavnosti vretenc in nevretenčnih zlomov, ne pa zlomov kolka. zdravljenje osteoporoze, povezane s trajno sistemsko glukokortikoidnih terapija pri ženskah in moških na povečano tveganje za zlom.

Европска Унија - Словеначки - EMA (European Medicines Agency)

abbvie deutschland gmbh co. kg - adalimumab - spondylitis, ankylosing; arthritis, juvenile rheumatoid; uveitis; colitis, ulcerative; psoriasis; arthritis, psoriatic; crohn disease; arthritis, rheumatoid - imunosupresivi - prosimo, glejte dokument o izdelku.

Европска Унија - Словеначки - EMA (European Medicines Agency)

eco animal health europe limited - tilvalozin - antiinfectives za sistemsko uporabo, antibacterials za sistemsko uporabo, macrolides - pheasants; chicken; turkeys; pigs - pigstreatment in methaphylaxis prašičev enzootske pljučnica;zdravljenje prašičev proliferative enteropatija (ileitis);zdravljenje in methaphylaxis prašičev driske. chickenstreatment in methaphylaxis dihal bolezni, povezanih z mikroplazma gallisepticum v piščancev. pheasantstreatment dihal bolezni, povezanih z mikroplazma gallisepticum. turkeystreatment dihal bolezni, povezanih z tylvalosin občutljivih sevov ornithobacterium rhinotracheale v puranov.

Европска Унија - Словеначки - EMA (European Medicines Agency)

elanco gmbh - pegbovigrastim - colony stimulating factors, immunostimulants, zdravila z delovanjem na novotvorbe agenti - cattle (cows and heifers); cattle - kot pomoč v programu za črede zmanjšati tveganje za klinični mastitis v perifernih mlečnih kravah in telicah v 30 dneh po telitvi.

Европска Унија - Словеначки - EMA (European Medicines Agency)

intervet international bv - živi oslabljen različni sev virusa bronhitisa ptic 4-91 - imunologija za aves - piščanec - aktivna imunizacija piščancev za zmanjšanje dihalnih znakov infekcijskega bronhitisa, ki jih povzroča variantni sev ib 4-91.

Европска Унија - Словеначки - EMA (European Medicines Agency)

boehringer ingelheim vetmedica gmbh - virus vcp1338 - immunostimulants, zdravila z delovanjem na novotvorbe in imunomodulatorji agenti, immunostimulants, - mačke - immunotherapy, da se uporablja v povezavi z kirurgijo in radioterapijo pri mačkah z fibrosarcoma (2-5 cm premer) brez metastaze ali limfnih vozlišč vključenost, zmanjšanje tveganja za ponovitev bolezni in poveča čas do ponovitve (lokalne ponovitve ali metastaze).

Европска Унија - Словеначки - EMA (European Medicines Agency)

boehringer ingelheim vetmedica gmbh - mačji levkemijo virus rekombinantne canarypox virus (vcp97) - immunologicals za skupin felidae, - mačke - aktivna imunizacija mačk, starih 8 tednov ali več, proti mačji levkemiji za preprečevanje vztrajne viremije in kliničnih znakov s tem povezane bolezni. začetek imunosti je bil dokazan 2 tedna po osnovnem cepljenju. trajanje imunitete je eno leto po zadnjem cepljenju.

Европска Унија - Словеначки - EMA (European Medicines Agency)

intervet international bv - tildipirozin - antiinfectives za sistemsko zdravljenje - pigs; cattle - 40-mg/ml raztopina za injiciranje za pigstreatment in metaphylaxis prašičje bolezni dihal (srd), ki je povezana z actinobacillus pleuropneumoniae, pasteurella multocida, bordetella bronchiseptica in haemophilus parasuis občutljivi na tildipirosin. prisotnost bolezni v čredi je treba potrditi, preden se izvaja metafilaksa. 180-mg/ml raztopina za injiciranje za cattlefor zdravljenje in preprečevanje govedi, bolezni dihal (brd), ki je povezana z mannheimia haemolytica, pasteurella multocida in histophilus somni občutljivi na tildipirosin. prisotnost bolezni v čredi je treba potrditi pred preventivno zdravljenjem.

Европска Унија - Словеначки - EMA (European Medicines Agency)

biomarin international limited - sapropterin dihydrochloride - fenilketonurije - drugi zdravljene bolezni prebavil in presnove izdelki, - kuvan je indiciran za zdravljenje hiperfenilalaninemije (hpa) pri odraslih in pediatričnih bolnikih vseh starosti s fenilketonurijo (pku), za katere se je izkazalo, da so odzivne na takšno zdravljenje. kuvan je tudi primerna za zdravljenje hyperphenylalaninaemia (hpa) pri odraslih in pediatričnih bolnikih vseh starosti z tetrahydrobiopterin (bh4) pomanjkljivosti, ki so pokazale, da se je treba odzivati na tako zdravljenje.

Европска Унија - Словеначки - EMA (European Medicines Agency)

merck sharp and dohme b.v - posakonazol - candidiasis; mycoses; coccidioidomycosis; aspergillosis - antimikotiki za sistemsko uporabo - noxafil gastro-resistant tablets are indicated for use in the treatment of the following fungal infections in adults (see sections 4. 2 in 5. 1):- invasive aspergillosisnoxafil gastro-resistant tablets are indicated for use in the treatment of the following fungal infections in paediatric patients from 2 years of age weighing more than 40 kg and adults (see sections  4. 2 in 5. 1):- invasive aspergillosis in patients with disease that is refractory to amphotericin b or itraconazole or in patients who are intolerant of these medicinal products;- fusariosis in patients with disease that is refractory to amphotericin b or in patients who are intolerant of amphotericin b;- chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- coccidioidomycosis in patients with disease that is refractory to amphotericin b, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. refractoriness je opredeljena kot napredovanje okužbe ali neuspeh za izboljšanje po najmanj 7 dni pred terapevtskih odmerkih učinkovito protiglivično zdravljenje. noxafil gastro-resistant tablets are also indicated for prophylaxis of invasive fungal infections in the following paediatric patients from 2 years of age weighing more than 40 kg and adults (see sections 4. 2 in 5. 1):- patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;- hematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections. please refer to the summary of product characteristics of noxafil oral suspension for use in oropharyngeal candidiasis.  noxafil concentrate for solution for infusion is indicated for use in the treatment of the following fungal infections in adults (see sections 4. 2 in 5. 1):- invasive aspergillosisnoxafil concentrate for solution for infusion is indicated for use in the treatment of the following fungal infections in adult and paediatric patients from 2 years of age (see sections 4. 2 in 5. 1):- invasive aspergillosis in patients with disease that is refractory to amphotericin b or itraconazole or in patients who are intolerant of these medicinal products;- fusariosis in patients with disease that is refractory to amphotericin b or in patients who are intolerant of amphotericin b;- chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- coccidioidomycosis in patients with disease that is refractory to amphotericin b, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. refractoriness je opredeljena kot napredovanje okužbe ali neuspeh za izboljšanje po najmanj 7 dni pred terapevtskih odmerkih učinkovito protiglivično zdravljenje. noxafil concentrate for solution for infusion is also indicated for prophylaxis of invasive fungal infections in the following adult and paediatric patients from 2 years of age (see sections 4. 2 in 5. 1):- patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;- hematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease (gvhd) and who are at high risk of developing invasive fungal infections. please refer to the summary of product characteristics of noxafil oral suspension for use in oropharyngeal candidiasis.  noxafil gastro resistant powder and solvent for oral suspension is indicated for use in the treatment of the following fungal infections in paediatric patients from 2 years of age (see sections 4. 2 in 5. 1):- invasive aspergillosis in patients with disease that is refractory to amphotericin b or itraconazole or in patients who are intolerant of these medicinal products;- fusariosis in patients with disease that is refractory to amphotericin b or in patients who are intolerant of amphotericin b;- chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- coccidioidomycosis in patients with disease that is refractory to amphotericin b, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. refractoriness je opredeljena kot napredovanje okužbe ali neuspeh za izboljšanje po najmanj 7 dni pred terapevtskih odmerkih učinkovito protiglivično zdravljenje. noxafil gastro-resistant powder and solvent for oral suspension is indicated for prophylaxis of invasive fungal infections in the following paediatric patients from 2  years of age:- patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who are at high  risk of developing invasive fungal infections;- haematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high  risk of developing invasive fungal infections. please refer to the summary of product characteristics of noxafil concentrate for solution for infusion and the gastro-resistant tablets for use in primary treatment of invasive aspergillosis. please refer to the summary of product characteristics of noxafil oral suspension for use in oropharyngeal candidiasis.  noxafil oral suspension is indicated for use in the treatment of the following fungal infections in adults (see section 5. 1):- invazivne aspergillosis pri bolnikih z boleznijo, ki je neodzivna, da amphotericin b ali itraconazole ali pri bolnikih, ki ne prenašajo teh zdravil;- fusariosis pri bolnikih z boleznijo, ki je neodzivna, da amphotericin b ali pri bolnikih, ki so nestrpne amphotericin b;- chromoblastomycosis in mycetoma pri bolnikih z boleznijo, ki je neodzivna, da itraconazole ali pri bolnikih, ki so nestrpne itraconazole;- coccidioidomycosis pri bolnikih z boleznijo, ki je neodzivna, da amphotericin b, itraconazole ali fluconazole ali pri bolnikih, ki ne prenašajo teh zdravil;- Žrela kandidoza: kot prvo linijo zdravljenja pri bolnikih, ki imajo hude bolezni ali so immunocompromised, v kateri je odziv na aktualne terapija je pričakovati, da bo slaba. refractoriness je opredeljena kot napredovanje okužbe ali neuspeh za izboljšanje po najmanj 7 dni pred terapevtskih odmerkih učinkovito protiglivično zdravljenje. noxafil oral suspension is also indicated for prophylaxis of invasive fungal infections in the following patients:- patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;- hematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections. please refer to the summary of product characteristics of noxafil concentrate for solution for infusion and the gastro-resistant tablets for use in primary treatment of invasive aspergillosis.