Hrvatska - hrvatski - HALMED (Agencija za lijekove i medicinske proizvode)

as grindeks, krustpils iela 53, riga, latvija - sitagliptinklorid hidrat - filmom obložena tableta - urbroj: svaka filmom obložena tableta sadrži 50 mg sitagliptina u obliku sitagliptinklorid hidrata

Hrvatska - hrvatski - HALMED (Agencija za lijekove i medicinske proizvode)

as grindeks, krustpils iela 53, riga, latvija - sitagliptinklorid hidrat metforminklorid - filmom obložena tableta - urbroj: svaka filmom obložena tableta sadrži sitagliptinklorid hidrat što odgovara 50 mg sitagliptina i 1000 mg metformina

Hrvatska - hrvatski - HALMED (Agencija za lijekove i medicinske proizvode)

as grindeks, krustpils iela 53, riga, latvija - sitagliptinklorid hidrat metforminklorid - filmom obložena tableta - urbroj: svaka filmom obložena tableta sadrži sitagliptinklorid hidrat što odgovara 50 mg sitagliptina i 850 mg metforminklorida

Europska Unija - hrvatski - EMA (European Medicines Agency)

abbvie deutschland gmbh co. kg - glecaprevir, pibrentasvir - hepatitis c, kronični - antivirusni lijekovi za sustavnu uporabu - maviret is indicated for the treatment of chronic hepatitis c virus (hcv) infection in adults and children aged 3 years and older. maviret coated granules is indicated for the treatment of chronic hepatitis c virus (hcv) infection in children 3 years and older.

Europska Unija - hrvatski - EMA (European Medicines Agency)

daiichi sankyo europe gmbh - bempedoic kiseline - hypercholesterolemia; dyslipidemias - sredstva za modifikaciju lipida - nilemdo prikazan kod odraslih pacijenata s primarnim гиперхолестеринемии (гетерозиготная obiteljska i nije nasljedna) ili mješoviti dislipidemija kao dodatak prehrani u kombinaciji sa statinima ili statina s drugim гиполипидемической terapije kod bolesnika nisu uspjeli postići ldl s namjene s najviše переносимой doze statina (vidi 4. 2, 4. 3 i 4. 4) ili,zasebno ili u kombinaciji s drugim гиполипидемической terapije statinima u bolesnika нетолерантно, ili za koga statinima kontraindiciran.

Europska Unija - hrvatski - EMA (European Medicines Agency)

daiichi sankyo europe gmbh - bempedoic kiseline, эзетимиб - hypercholesterolemia; dyslipidemias - sredstva za modifikaciju lipida - nustendi prikazan kod odraslih pacijenata s primarnim гиперхолестеринемии (гетерозиготная obiteljska i nije nasljedna) ili mješoviti dislipidemija kao dodatak prehrani u kombinaciji sa statinima u bolesnika nisu uspjeli postići ldl kolesterol svrhu što переносимой dozi statina uz ezetimibealone kod pacijenata koji su ili statinima laktoza ili za koga statinima kontraindicirano, i ne možete postići ldl kolesterol cilj эзетимибом sami,kod bolesnika već tretiraju s kombinacijom bempedoic kiseline i эзетимиб kao pojedinačne tablete sa ili bez statina.

Europska Unija - hrvatski - EMA (European Medicines Agency)

merck sharp & dohme b.v. - индинавира sulfat ethanolate - hiv infekcije - antivirusni lijekovi za sustavnu uporabu - crixivan je indiciran u kombinaciji s antiretrovirusnim nukleozidnim analogom za liječenje hiv-1 inficiranih odraslih osoba.

Europska Unija - hrvatski - EMA (European Medicines Agency)

roche registration gmbh - sakvinavir - hiv infekcije - antivirusni lijekovi za sustavnu uporabu - invirase je indiciran za liječenje bolesnika odraslih inficiranih hiv-1. invirase treba dati samo u kombinaciji s ritonavirom i drugim antiretrovirusnim lijekovima.

Europska Unija - hrvatski - EMA (European Medicines Agency)

amryt pharmaceuticals dac - lomitapide - hiperkolesterolemija - sredstva za modifikaciju lipida - lojuxta je indicirana kao dodatak prehrani low‑fat i drugih lipid‑lowering lijekova s ili bez afereze najniža gustoće lipoproteina (ldl) u odraslih bolesnika s homozigotni obiteljska hiperkolesterolemija (hofh). genetičko potvrdu hofh mora biti ispitan na mogućnosti. drugi oblici primarne гиперлипопротейнемия i sekundarni uzroci гиперхолестеринемии (e. nephrotic sindrom, hipotireoza) moraju biti isključeni.

Europska Unija - hrvatski - 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.