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.

Europska Unija - hrvatski - EMA (European Medicines Agency)

viiv healthcare bv - fosamprenavir kalcij - hiv infekcije - antivirusni lijekovi za sustavnu uporabu - telzir u kombinaciji s niske doze ritonavira je indiciran za liječenje human-immunodeficiency-virus-type-1-infected odraslih, adolescenata i djece u dobi od šest godina i više u kombinaciji s drugim bosentana i antiretrovirusnih lijekova. u umjereno arv-iskusni odrasli, Телзир u kombinaciji s niskom dozom ritonavir nije bilo prikazano, da bude jednako učinkovit kao i лопинавир / ritonavir. komparativna istraživanja su provedena u djece i adolescenata. u velikoj mjeri prethodno tretiranih pacijenata, korištenje Телзир u kombinaciji s niskom dozom ritonavir je još uvijek nedovoljno istražena. u протеаза-inhibitor-iskusan pacijenata, izbor Телзир mora se temeljiti na individualnoj virusne rezistencije ispitivanje i povijesti liječenje .

Europska Unija - hrvatski - EMA (European Medicines Agency)

merck sharp & dohme b.v. - letermovir - infekcije citomegalovirusa - antivirusni lijekovi za sustavnu uporabu - prevymis je indiciran za profilaksu citomegalovirus (cmv) reaktivacije i bolesti u odraslih cmv seropozitivne primatelja [r +] transplantacija alogenih krvotvornih matičnih stanica (hsct). treba uzeti u obzir formalne preporuke za odgovarajuće korištenje antivirusnih lijekova.

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

mylan hrvatska d.o.o., koranska 2, zagreb, hrvatska - rosuvastatinkalcij ezetimib - filmom obložena tableta - 10 mg + 10 mg - urbroj: jedna filmom obložena tableta sadrži 10 mg rosuvastatina (u obliku kalcija) i 10 mg ezetimiba

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

mylan hrvatska d.o.o., koranska 2, zagreb, hrvatska - rosuvastatinkalcij ezetimib - filmom obložena tableta - 20 mg + 10 mg - urbroj: jedna filmom obložena tableta sadrži 20 mg rosuvastatina (u obliku kalcija) i 10 mg ezetimiba

Europska Unija - hrvatski - EMA (European Medicines Agency)

merck sharp & dohme b.v. - efavirenz - hiv infekcije - antivirusni lijekovi za sustavnu uporabu - stocrin je indiciran u antivirusnom kombiniranom tretmanu odraslih, adolescenata i djece starijih od tri godine starijih od ljudske imunodeficijencije-1 (hiv-1). Стокрин nisu bili pravilno istražena u bolesnika s uznapredovalom faze infekcije hiv-om, a upravo je u bolesnika s razinom cd4 < 50 ćelija/mm3, ili nakon neuspjeha протеаза-inhibitora (pi)-sadrže sheme. iako je cross-otpornost эфавиренза sa ip nije bio registriran, trenutno nema dovoljno podataka o efikasnosti kasniju upotrebu pi na temelju kombinirane terapije neučinkovitosti sheme sadrže Стокрин.

Europska Unija - hrvatski - EMA (European Medicines Agency)

sanofi winthrop industrie - dronedaron - fibrilacija atrija - srčana terapija - multaq je indiciran za održavanje sinusnog ritma nakon uspješne kardioversije kod odraslih klinički stabilnih bolesnika s paroksizmom ili trajnom atrijskom fibrilacijom (af). zbog sigurnosnog profila, multaq bi trebao biti propisan samo nakon što se razmotre mogućnosti alternativnih liječenja. multaq ne moraju dolaziti bolestan od систолической disfunkcija lijeve klijetke ili u bolesnika s trenutnim ili prethodnim epizodama zatajenja srca.

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

pliva hrvatska d.o.o., prilaz baruna filipovića 25, zagreb, hrvatska - dronedaronklorid - filmom obložena tableta - 400 mg - urbroj: jedna tableta sadrži 400 mg dronedarona (u obliku dronedaronklorida)

Bosna i Hercegovina - hrvatski - Agencija za lijekove i medicinska sredstva Bosne i Hercegovine (Агенција за лијекове и медицинска средства Босне и Херцеговине)

merck sharp & dohme bh d.o.o. - efavirenz - filmom obložena tableta - 50 mg/1 tableta - 1 filmom obložena tableta sadrži: 50 mg efavirenza

Bosna i Hercegovina - hrvatski - Agencija za lijekove i medicinska sredstva Bosne i Hercegovine (Агенција за лијекове и медицинска средства Босне и Херцеговине)

merck sharp & dohme bh d.o.o. - efavirenz - filmom obložena tableta - 600 mg/1 tableta - 1 filmom obložena tableta sadrži: 600 mg efavirenza