Slovenia - sloveeni - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

sandoz d.d. - razagilin - tableta - razagilin 1 mg / 1 tableta - razagilin

Euroopan unioni - sloveeni - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - dabigatran etexilate mesilate - arthroplasty, replacement; venous thromboembolism - antitrombotična sredstva - pradaxa 75 mgprimary preprečevanje venske thromboembolic dogodkov pri odraslih bolnikih, ki so bili izbirni skupaj operacijo zamenjave kolka ali skupaj kirurški zamenjavi kolena. pradaxa 110 mgprimary preprečevanje venske thromboembolic dogodkov pri odraslih bolnikih, ki so bili izbirni skupaj operacijo zamenjave kolka ali skupaj kirurški zamenjavi kolena. preprečevanje kapi in sistemska embolija pri odraslih bolnikih z ne-valvular atrijsko fibrilacijo (nvaf), z eno ali več dejavnikov tveganja, kot so pred možgansko kap ali prehodni ischemic attack (tia); starost ≥ 75 let; srčno popuščanje (nyha razred ≥ ii); sladkorna bolezen; povišan krvni tlak. zdravljenje globoke venske tromboze (dvt) in pljučna embolija (pe), in preprečevanje ponavljajočih se dvt in pe pri odraslih. pradaxa 150 mgprevention kap in sistemska embolija pri odraslih bolnikih z ne-valvular atrijsko fibrilacijo (nvaf), z eno ali več dejavnikov tveganja, kot so pred možgansko kap ali prehodni ischemic attack (tia); starost ≥ 75 let; srčno popuščanje (nyha razred ≥ ii); sladkorna bolezen; povišan krvni tlak. zdravljenje globoke venske tromboze (dvt) in pljučna embolija (pe), in preprečevanje ponavljajočih se dvt in pe pri odraslih.

Euroopan unioni - sloveeni - EMA (European Medicines Agency)

leadiant gmbh - chenodeoxycholic kisline - xanthomatosis, cerebrotendinous; metabolism, inborn errors - terapija z jetri in jeter - chenodeoxycholic kislina je indiciran za zdravljenje prirojenih napak primarni žolčnih kislin sinteze zaradi sterola 27 hidroksilaza pomanjkljivosti (predstavlja kot cerebrotendinous xanthomatosis (ctx)) pri dojenčkih, otrocih in mladostnikih, starih od 1 mesec do 18 let in odrasli.

Slovenia - sloveeni - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

gambro lundia ab - raztopina za hemodializo/hemofiltracijo - zdravila za filtracijo krvi

Euroopan unioni - sloveeni - 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).

Slovenia - sloveeni - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

novartis pharma gmbh - oktreotid - raztopina za injiciranje/infundiranje - oktreotid 0,05 mg / 1 ml - oktreotid

Euroopan unioni - sloveeni - EMA (European Medicines Agency)

mirum pharmaceuticals international b.v. - maralixibat chloride - alagille syndrome - other drugs for bile therapy - livmarli is indicated for the treatment of cholestatic pruritus in patients with alagille syndrome (algs) 2 months of age and older.

Euroopan unioni - sloveeni - EMA (European Medicines Agency)

aop orphan pharmaceuticals gmbh - sugammadex sodium - neuromuskularna blokada - vsi drugi terapevtski izdelki - zavrnitev nevromuskularne blokade, ki jo inducira rocuronium ali vecuronium. for the paediatric population: sugammadex is only recommended for routine reversal of rocuronium induced blockade in children and adolescents aged 2 to 17 years.

Euroopan unioni - sloveeni - EMA (European Medicines Agency)

sandoz gmbh - pegfilgrastim - nevtropenija - immunostimulants, - skrajšanje trajanja nevtropenija in pojavnost vročinskih nevtropenija pri odraslih bolnikih, zdravljenih s citotoksično kemoterapijo za malignosti (razen kronično mieloično levkemijo in mielodisplastični sindrom).

Euroopan unioni - sloveeni - EMA (European Medicines Agency)

mylan pharmaceuticals limited - teriflunomide - multiplo sklerozo, recidivno-nakazila - imunosupresivi - teriflunomide mylan is indicated for the treatment of adult patients and paediatric patients aged 10 years and older (body weight > 40 kg) with relapsing remitting multiple sclerosis (ms) (please refer to section 5. 1 of the smpc for important information on the population for which efficacy has been established).