Evropska unija - slovenščina - EMA (European Medicines Agency)

dompé biotec s.p.a. - cinakalcet - hypercalcemia; parathyroid neoplasms; hyperparathyroidism - kalcij homeostaza - zdravljenje sekundarnega hiperparatiroidizma (hpt) pri bolnikih s končno ledvično boleznijo (esrd) pri vzdrževalnem dializnem zdravljenju. mimpara se lahko uporablja kot del terapevtski režim, vključno z fosfat veziv in/ali vitamina d sterolov, kot je primerno (glej poglavje 5. zmanjšanje hypercalcaemia pri bolnikih z:-parathyroid karcinom. - primarni hpt, za katere parathyroidectomy bi se kazalo na osnovi seruma calciumlevels (kot je opredeljeno z ustreznimi smernicami za zdravljenje), ampak v katero parathyroidectomy ni klinično primerno ali je kontraindicirana.

Evropska unija - slovenščina - EMA (European Medicines Agency)

biopartners gmbh - somatropin - rast - pituitary and hypothalamic hormones and analogues, somatropin and somatropin agonists - somatropin biopartners je indiciran za nadomestno terapijo endogenega rastnega hormona pri odraslih s pomanjkanjem rastnega hormona (ghd). za odrasle, nastop: bolniki z sonČeve v odraslost so opredeljene kot bolnikih z znano hypothalamic-hipofiza patologija in vsaj eno dodatno znane pomanjkljivosti iz hipofize hormon, razen prolaktina. ti bolniki morajo opraviti eno dinamični test za diagnosticiranje ali izključi sonČeve. otroštvo-nastop: pri bolnikih z otroštvu-nastop izoliranih sonČeve (ni dokazov o hypothalamic-hipofiza bolezni ali lobanjski obsevanje), dve dinamične teste je treba opraviti po zaključku rasti, razen za tiste, ki imajo nizko insulin-like-rast-faktor i (igf-i) koncentracije (< -2 standardni odklon točk (sds)),, ki se lahko šteje za en test. cut-off point dinamični preskus je treba strogo.

Evropska unija - slovenščina - EMA (European Medicines Agency)

bluebird bio (netherlands) b.v. - elivaldogene autotemcel - adrenoleukodystrophy - druga zdravila na živčnem sistemu - treatment of early cerebral adrenoleukodystrophy in patients less than 18 years of age, with an abcd1 genetic mutation, and for whom a human leukocyte antigen (hla) matched sibling haematopoietic stem cell donor is not available.

Evropska unija - slovenščina - EMA (European Medicines Agency)

omrix biopharmaceuticals n. v. - humani fibrinogen, humani trombin - hemostaz, kirurški - antihemoragije - zdravilo evicel se uporablja kot podporno zdravljenje v kirurškem posegu, kjer standardne kirurške tehnike niso zadostne za izboljšanje hemostaze. evicel je prikazano tudi kot šivanje podporo za haemostasis v vaskularna kirurgija.

Evropska unija - slovenščina - EMA (European Medicines Agency)

aziende chimiche riunite angelini francesco s.p.a. - lurasidon - shizofrenija - psiholeptiki - zdravljenje shizofrenije pri odraslih, starejših od 18 let.

Evropska unija - slovenščina - EMA (European Medicines Agency)

sanofi belgium - alemtuzumab - multiple skleroza - selektivni imunosupresivi - lemtrada je indicirano za odraslih bolnikov z recidivno-remitentno multiple skleroze (rrms) z aktivno boleznijo določi kliničnih ali slikanje funkcije.

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

vetcare limited -

Evropska unija - slovenščina - EMA (European Medicines Agency)

daiichi sankyo europe gmbh - bempedoic kisline - hypercholesterolemia; dyslipidemias - sredstva za spreminjanje lipidov - nilemdo je indicirana pri odraslih z osnovnošolsko hypercholesterolaemia (heterozygous družinsko in ne družinsko) ali mešana dyslipidaemia, kot dodatek k prehrani:v kombinaciji z statin ali statin z drugimi lipidov-znižanje terapije pri bolnikih, ki ne more doseči ldl c ciljev z največjo prenaša odmerek statin (glej točki 4. 2, 4. 3 in 4. 4) ali samostojno ali v kombinaciji z drugimi lipidov-znižanje terapije pri bolnikih, ki so statin nestrpen ali, za katero statin je kontraindiciran.

Evropska unija - slovenščina - EMA (European Medicines Agency)

nova laboratories ireland limited - azathioprine - zavrnitev presadka - imunosupresivi - jayempi is indicated in combination with other immunosuppressive agents for the prophylaxis of transplant rejection in patients receiving allogenic kidney, liver, heart, lung or pancreas transplants. azathioprine is indicated in immunosuppressive regimens as an adjunct to immunosuppressive agents that form the mainstay of treatment (basis immunosuppression). jayempi is used as an immunosuppressant antimetabolite either alone or, more commonly, in combination with other agents (usually corticosteroids) and/ or procedures which influence the immune response. jayempi is indicated in patients who are intolerant to glucocorticosteroids or if the therapeutic response is inadequate despite treatment with high doses of glucocorticosteroids, in the following diseases:severe active rheumatoid arthritis (chronic polyarthritis) that cannot be kept under control by less toxic agents (disease-modifying anti-rheumatic -medicinal products – dmards)auto-immune hepatitis systemic lupus erythematosusdermatomyositispolyarteritis nodosapemphigus vulgaris and bullous pemphigoidbehçet’s diseaserefractory auto-immune haemolytic anaemia, caused by warm igg antibodieschronic refractory idiopathic thrombocytopenic purpurajayempi is used for the treatment of moderately severe to severe forms of chronic inflammatory bowel disease (ibd) (crohn’s disease or ulcerative colitis) in patients in whom glucocorticosteroid therapy is necessary, but where glucocorticosteroids are not tolerated, or in whom the disease is untreatable with other common means of first choice. it is also indicated in adult patients in relapsing multiple sclerosis, if an immunomodulatory therapy is indicated but beta interferon therapy is not possible, or a stable course has been achieved with previous treatment with azathioprine. 3jayempi is indicated for the treatment of generalised myasthenia gravis. depending on the severity of the disease, jayempi should be given in combination with glucocorticosteroids because of slow onset of action at the beginning of treatment and the glucocorticosteroid dose should be gradually reduced after several months of treatment.

Evropska unija - slovenščina - EMA (European Medicines Agency)

chanelle pharmaceuticals manufacturing ltd - imidacloprid, moxidectin - antiparasitic products, insecticides and repellents, macrocyclic lactones, milbemycins - cats; dogs; ferrets - for cats suffering from, or at risk from, mixed parasitic infections:• the treatment and prevention of flea infestation (ctenocephalides felis),• the treatment of ear mite infestation (otodectes cynotis),• the treatment of notoedric mange (notoedres cati),• the treatment of the lungworm eucoleus aerophilus (syn. capillaria aerophila) (adults),• the prevention of lungworm disease (l3/l4 larvae of aelurostrongylus abstrusus),• the treatment of the lungworm aelurostrongylus abstrusus (adults),• the treatment of the eye worm thelazia callipaeda (adults),• the prevention of heartworm disease (l3 and l4 larvae of dirofilaria immitis),• the treatment of infections with gastrointestinal nematodes (l4 larvae, immature adults and adults of toxocara cati and ancylostoma tubaeforme). zdravilo za uporabo v veterinarski medicini se lahko uporablja kot del strategije zdravljenja alergijskega dermatitisa bolh (fad).  for ferrets suffering from, or at risk from, mixed parasitic infections:• the treatment and prevention of flea infestation (ctenocephalides felis),• the prevention of heartworm disease (l3 and l4 larvae of dirofilaria immitis).  for dogs suffering from, or at risk from, mixed parasitic infections:• the treatment and prevention of flea infestation (ctenocephalides felis),• the treatment of biting lice (trichodectes canis),• the treatment of ear mite infestation (otodectes cynotis), sarcoptic mange (caused by sarcoptes scabiei var. canis), demodicosis (caused by demodex canis),• the prevention of heartworm disease (l3 and l4 larvae of dirofilaria immitis),• the treatment of circulating microfilariae (dirofilaria immitis),• the treatment of cutaneous dirofilariosis (adult stages of dirofilaria repens)• the prevention of cutaneous dirofilariosis (l3 larvae of dirofilaria repens),• the reduction of circulating microfilariae (dirofilaria repens),• the prevention of angiostrongylosis (l4 larvae and immature adults of angiostrongylus vasorum),• the treatment of angiostrongylus vasorum and crenosoma vulpis,• the prevention of spirocercosis (spirocerca lupi),• the treatment of eucoleus (syn. capillaria) boehmi (adults),• the treatment of the eye worm thelazia callipaeda (adults),• the treatment of infections with gastrointestinal nematodes (l4 larvae, immature adults and adults of toxocara canis, ancylostoma caninum and uncinaria stenocephala, adults of toxascaris leonina and trichuris vulpis). zdravilo za uporabo v veterinarski medicini se lahko uporablja kot del strategije zdravljenja alergijskega dermatitisa bolh (fad).