Europeiska unionen - kroatiska - EMA (European Medicines Agency)

pierre fabre medicament - vinorelbin - carcinoma, transitional cell; urologic neoplasms - antineoplastična sredstva - javlor je indiciran u monoterapiji za liječenje odraslih bolesnika s naprednim ili metastatskim karcinomom prijelazne stanice urotelijalnog trakta nakon neuspjeha prethodnog režima koji sadrži platinu. učinkovitost i sigurnost винфлунин nije studirao kod pacijenata s pokazateljima stanja ≥ 2.

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.

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

bayer d.o.o., radnička cesta 80, zagreb - moxifloxacinum - filmom obložena tableta - 400 mg - urbroj: jedna filmom obložena tableta sadrži 400 mg moksifloksacina u obliku moksifloksacinklorida

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

bayer d.o.o., radnička cesta 80, zagreb - moxifloxacinum - otopina za infuziju - 400 mg/250 ml - urbroj: 1 ml otopine za infuziju sadržava 1,6 mg moksifloksacina u obliku moksifloksacinklorida

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

pliva hrvatska d.o.o., prilaz baruna filipovića 25, zagreb - perindoprilum, indapamidum - filmom obložena tableta - 2,5 mg + 0,625 mg - urbroj: jedna filmom obložena tableta sadrži 2,5 mg perindopriltosilata i 0,625 mg indapamida

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

krka - farma d.o.o., radnička cesta 48, zagreb, hrvatska - miconazolum - oralni gel - 20 mg/g - urbroj: 1 g oralnog gela sadrži 20 mg mikonazola

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

mibe pharmaceuticals d.o.o., zavrtnica 17, zagreb, hrvatska - indapamid - tableta s produljenim oslobađanjem - 1,5 mg - urbroj: jedna tableta s produljenim oslobađanjem sadrži 1,5 mg indapamida

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

stada d.o.o., hercegovačka 14, zagreb, hrvatska - domperidon - raspadljiva tableta za usta - 10 mg - urbroj: svaka raspadljiva tableta za usta sadrži 10 mg domperidona

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

jadran galenski laboratorij d.d., svilno 20, rijeka - flukonazol - kapsula, tvrda - 50 mg - urbroj: 1 kapsula sadržava 50 mg flukonazola

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

belupo lijekovi i kozmetika d.d., ulica danica 5, koprivnica, hrvatska - indapamid - tableta s produljenim oslobađanjem - 1,5 mg - urbroj: jedna tableta s produljenim oslobađanjem sadrži 1,5 mg indapamida