Europeiska unionen - kroatiska - EMA (European Medicines Agency)

crealta pharmaceuticals ireland limited - pegloticase - giht - antigadni pripravci - krystexxa je indiciran za liječenje teškog oslabiti kronične tophaceous gihta u odraslih bolesnika koji može imati erozivni zajednički angažman i koji nisu uspjeli normalizirati serumske mokraćne kiseline s ksantin oksidaza inhibitori maksimalno medicinski odgovarajuće doze ili kojima ovi lijekovi su kontraindicirani.

Europeiska unionen - kroatiska - EMA (European Medicines Agency)

eli lilly nederland b.v. - olaratumab - sarkom - antineoplastična sredstva - lartruvo je indiciran u kombinaciji s doksorubicinom za liječenje odraslih bolesnika s uznapredovalim sarkomom mekih tkiva koji su podvrgnuti liječenju uz operaciju ili radioterapiju i koji nisu bili prethodno tretirani s doksorubicinom (vidjeti odjeljak 5.

Europeiska unionen - kroatiska - EMA (European Medicines Agency)

sloan pharma s.a.r.l - botulinum toksin tip b - krivošija - mišićni relaksanti - neurobloc je indiciran za liječenje cervikalne distonije (torticollis). cm. odjeljak 5. 1 podaci o učinkovitosti u bolesnika pristupačnost / otporan na botulinum toksin tipa a.

Europeiska unionen - kroatiska - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - nivolumab - karcinom, ne-malih stanica pluća - Антинеопластические i иммуномодулирующие agenti, monoklonsko antitijelo - nivolumab bms je indiciran za liječenje lokalno avanziranog ili metastatskog skvamoznog ne-malih stanica raka pluća (nsclc) nakon prethodne kemoterapije kod odraslih.

Europeiska unionen - kroatiska - EMA (European Medicines Agency)

merck sharp and dohme b.v - posakonazol - candidiasis; mycoses; coccidioidomycosis; aspergillosis - antimikotika za sustavnu uporabu - noxafil gastro-resistant tablets are indicated for use in the treatment of the following fungal infections in adults (see sections 4. 2 i 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 i 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. Огнеупорность definira kao progresiju infekcije ili nedostatak poboljšanja nakon što je minimum 7 dana do terapijske doze učinkovit antifungalna terapija. 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 i 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 i 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 i 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. Огнеупорность definira kao progresiju infekcije ili nedostatak poboljšanja nakon što je minimum 7 dana do terapijske doze učinkovit antifungalna terapija. 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 i 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 i 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. Огнеупорность definira kao progresiju infekcije ili nedostatak poboljšanja nakon što je minimum 7 dana do terapijske doze učinkovit antifungalna terapija. 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):- 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;- oropharyngeal candidiasis: as first-line therapy in patients who have severe disease or are immunocompromised, in whom response to topical therapy is expected to be poor. Огнеупорность definira kao progresiju infekcije ili nedostatak poboljšanja nakon što je minimum 7 dana do terapijske doze učinkovit antifungalna terapija. 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.

Europeiska unionen - kroatiska - EMA (European Medicines Agency)

ipsen pharma - somatropin - turner syndrome; dwarfism, pituitary - hipofiza i hipotalamusni hormoni i analozi - dugoročno liječenje djece s neuspjehom rasta zbog neadekvatne endogene sekrecije hormona rasta. dugotrajno liječenje zatajenja rasta povezane s turnerovim sindromom. liječenje kod djece u препубертатном dobi s povećanjem srca, povezana s kroničnom bubrežnom insuficijencijom do transplantacije bubrega. zamjena endogenog hormona rasta kod odraslih osoba s nedostatkom hormona rasta ili dječjoj ili odrasloj dobi etiologije. nedostatak hormona rasta mora biti na odgovarajući način potvrđena prije početka liječenja.

Europeiska unionen - kroatiska - EMA (European Medicines Agency)

bracco international b.v. - sumpornog heksafluorida - ultrasonography; echocardiography - kontrastni medij - ovaj je lijek samo za dijagnostičku uporabu. sonovue je dizajniran za korištenje s ultrazvučna vizualizacija za pojačanje эхогенности krvi ili tekućine u urinarnom, što dovodi do poboljšanja odnosa signal-šum . sonovue treba koristiti samo u bolesnika u kojih je studija bez kontrasta pojačanje je неокончательным. echocardiographysonovue je транспульмональная эхокардиографическое kontrastno supstance za upotrebu kod odraslih pacijenata s potencijalnim ili instaliran srčanih i krvožilnih bolesti, kako bi se osiguralo контрастирование kamere srca i povećavaju эндокарда lijeve klijetke razgraničenje granice. Допплер macrovasculaturesonovue poboljšava točnost otkrivanja ili iznimke patologije церебральных arterija i ekstrakranijskom сонных ili perifernih arterija kod odraslih pacijenata poboljšanjem dopler signala na buku . sonovue poboljšava kvalitetu slike dopler toka i trajanja klinički korisno pojačanje signala u procjeni portalna vena kod odraslih pacijenata. Допплер microvasculaturesonovue poboljšava prikaz dotok krvi u jetri i lezija dojke u roku od допплерография kod odraslih pacijenata dovodi do više specifičnim poraz karakteristike. ultrazvuk, экскреторной mokraćnog tractsonovue je dizajniran za korištenje u usi izlaznih puteva u pedijatrijskoj oboljelih od novorođenčadi do 18 godina za identifikaciju пузырно-мочеточникового refluks. ograničenja u interpretaciji negativnih urosonography.

Europeiska unionen - kroatiska - EMA (European Medicines Agency)

janssen-cilag international nv - paliperidon palmitata - shizofrenija - psycholeptics - treviska, 3-mjesečna injekcija, indicirana je za liječenje shizofrenije u odraslih bolesnika koji su klinički stabilni na 1 mjesečni paliperidon palmitatni injekcijski proizvod.

Europeiska unionen - kroatiska - EMA (European Medicines Agency)

glaxosmithkline trading services limited - umeclidinium bromid - plućna bolest, kronična opstruktivna - lijekovi za opstruktivne plućne bolesti dišnih putova, - rolufta je indicirana kao liječenje bronhodilatatora za održavanje radi ublažavanja simptoma u odraslih bolesnika s kroničnom opstruktivnom plućnom bolesti (copd).

Europeiska unionen - kroatiska - EMA (European Medicines Agency)

ology bioservices ireland ltd - virusi influence (cijeli virion, inaktivirani), koji sadrže antigen od: a / vietnam / 1203/2004 (h5n1) - influenza, human; immunization; disease outbreaks - cjepiva protiv gripe - aktivna imunizacija protiv h5n1 podtipa virusa influence a. ovaj prikaz se temelji na imunogenosti podataka od ispitanika u dobi od 6 mjeseci i dalje nakon uvođenja dvije doze cjepiva, kuhani s podtipa h5n1 sojeva . vepacel mora se koristiti u skladu sa službenim vodstvom.