Europäische Union - Kroatisch - EMA (European Medicines Agency)

merck sharp & dohme b.v. - danas tvrtka otvara, razvija, grazoprevir - hepatitis c, kronični - direct acting antivirals, antivirals for systemic use, antivirals for treatment of hcv infections - zepatier is indicated for the treatment of chronic hepatitis c (chc) in adult and paediatric patients 12 years of age and older who weigh at least 30 kg (see sections 4. 2, 4. 4 i 5. virus hepatitisa c (hcv) genotip-specifične aktivnosti vidi 4. 4 i 5.

Europäische Union - Kroatisch - EMA (European Medicines Agency)

dendreon uk ltd - autologne mononuklearne stanice periferne krvi, uključujući najmanje 50 milijuna autolognih cd54 + stanica koje su aktivirane s fosfatazom prostate kiseline granulocitno-makrofagskog faktora koji stimulira kolonije - prostatske neoplazme - ostali imunostimulanti - provenge je indiciran za liječenje asimptomatski ili minimalno simptomatsko metastatski (sobe-visceralni) kastrirati otporna karcinoma prostate u odraslih muškaraca u kojih kemoterapija nije još klinički indiciran.

Europäische Union - Kroatisch - EMA (European Medicines Agency)

merck sharp dohme ltd - tip papilloma virus 6 Л1 sirutke papilloma virus tipa 11 Л1 sirutke papilloma virus tipa 16 Л1 sirutke papilloma virus tipa 18 Л1 proteina - papillomavirus infections; uterine cervical dysplasia; condylomata acuminata; immunization - cjepiva - Силгард cjepivo za korištenje u dobi od 9 godina za upozorenje:prekanceroznih lezija genitalnih organa (vrata maternice, vulve i vagine), prekanceroznih lezija analnom području, raka grlića materice i analnog raka, uzročno povezane s određenim онкогенным virusom hpv čovjeka (hpv); genitalne bradavice (acuminata acuminata), uzročno povezane s određenim hpv-a. pogledajte odjeljke 4. 4 i 5. 1 za važne informacije o podacima koji podržavaju ovu oznaku. korištenje Силгард moraju biti u skladu sa službenim preporukama.

Europäische Union - Kroatisch - EMA (European Medicines Agency)

alexion europe sas - Экулизумаб - hemoglobinuria, paroxysmal - imunosupresivi - Солирис indiciran za odrasle i djecu, za liječenje:пароксизмальная noćni гемоглобинурия (apg). dokaza klinički učinak očituje se u bolesnika s гемолизом s klinički simptom(ova), ukazuje na visoke aktivnosti bolesti, bez obzira na priče transfuziju (vidi odjeljak 5. Атипичный гемолитико-уремический (agus). Солирис prikazan kod odraslih za liječenje:vatrostalne postati generalizirani миастенией gravis (ГГМ) u bolesnika s anti-ацетилхолиновому рецептору (АЧР) antitijela (vidi odjeljak 5. poremećaj neuromyelitis vidnog spektra (nmosd) kod pacijenata koji su anti-aquaporin-4 (aqp4) antitijela s recidivom tijekom bolesti.

Europäische Union - Kroatisch - EMA (European Medicines Agency)

blue earth diagnostics ireland ltd - fluciclovine (18f) - prostatic neoplasms; radionuclide imaging - dijagnostički radiofarmaceutici - ovaj je lijek samo za dijagnostičku uporabu. axumin indiciran za pozitronska emisijska tomografija (pet) ct za otkrivanje recidiva raka prostate kod odraslih muškaraca sumnja na recidiv, na temelju povišeni krvni razine specifičnog antigena prostate (psa) nakon primarnog liječenja.

Europäische Union - Kroatisch - EMA (European Medicines Agency)

xbiotech germany gmbh - ljudskog igg1 monoklonskog protutijela specifična za ljudski interleukina-1 alfa - kolorektalne neoplazme - antineoplastična sredstva - liječenje метастатического raka debelog crijeva .

Europäische Union - Kroatisch - EMA (European Medicines Agency)

zoetis belgium sa - frunevetmab - analgetici - mačke - for the alleviation of pain associated with osteoarthritis in cats.

Europäische Union - Kroatisch - EMA (European Medicines Agency)

chanelle pharmaceuticals manufacturing ltd - имидаклоприд, моксидектин - 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). the veterinary medicinal product can be used as part of a treatment strategy for flea allergy dermatitis (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). the veterinary medicinal product can be used as part of a treatment strategy for flea allergy dermatitis (fad).

Europäische Union - Kroatisch - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - nivolumab, relatlimab - melanoma - antineoplastic agents, monoclonal antibodies - opdualag is indicated for the first line treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older with tumour cell pd l1 expression < 1%.

Kroatien - Kroatisch - HALMED (Agencija za lijekove i medicinske proizvode)

octapharma (ip) sprl, allee de la recherche 65, anderlecht, belgija - ljudska plazma - prašak i otapalo za otopinu za infuziju - urbroj: jedna bočica s praškom sadrži 9 - 14 g proteina ljudske plazme specifičnih za krvne grupe ab0. nakon rekonstitucije sa 190 ml otapala, otopina sadrži 45-70 mg/ml proteina ljudske plazme specifičnih za krvne grupe ab0