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

zentiva pharma d.o.o. - диосмин - film tableta - 500 mg/1 tableta - 1 film tableta sadrži: 500 mg diosmina

Montenegro - croat - CInMED-Institut za ljekove i medicinska sredstva Crne Gore

druŠtvo sa ograniČenom odgovornoŠĆu "nobel" podgorica - azitromicin - film tableta - 500mg

Croàcia - croat - HALMED (Agencija za lijekove i medicinske proizvode)

pliva hrvatska d.o.o., prilaz baruna filipovića 25, zagreb - gestoden etinilestradiol - filmom obložena tableta - 0,06 mg/0,015 mg - urbroj: jedna blijedožuta filmom obložena tableta sadrži 0,060 mg gestodena i 0,015 mg etinilestradiola; bijele tablete ne sadrže djelatne tvari (tablete s placebom)

Unió Europea - croat - EMA (European Medicines Agency)

les laboratoires servier - ivabradin hidroklorid - angina pectoris; heart failure - srČani terapija - simptomatsko liječenje kronične stabilne angine pectorisivabradine indiciran za simptomatsko liječenje kronične stabilne angine pri kbs odrasla osoba s normalnim синусовым ritam i definiranju ≥ 70 уд.. Ивабрадин prikazan:u odraslih, ne uvažavaju tolerirati ili s противопоказанием za primjenu beta-blockersor u kombinaciji s beta-адреноблокаторами kod pacijenata sa adekvatno kontrolirani optimalan beta-blokator doze. liječenje kroničnog zatajenja failureivabradine prikazan kod kroničnog zatajenja srca u nyha od ii do iv klase s систолической disfunkcije kod pacijenata s синусовым ritam i čija definiranju ≥ 75 otkucaja / min, u kombinaciji sa standardnom terapijom, uključujući beta-blokatori ili kada su beta-blokatori kontraindiciran ili ne migriraju.

Unió Europea - croat - EMA (European Medicines Agency)

gilead sciences ireland uc - Софосбувир, velpatasvir - hepatitis c, kronični - antivirusni lijekovi za sustavnu uporabu - epclusa is indicated for the treatment of chronic hepatitis c virus (hcv) infection in patients 3 years of age and older (see sections 4. 2, 4. 4 i 5.

Unió Europea - croat - EMA (European Medicines Agency)

gilead sciences ireland uc - ледипасвир, софосбувир - hepatitis c, kronični - antivirusni lijekovi za sustavnu uporabu - harvoni is indicated for the treatment of chronic hepatitis c (chc) in adult and paediatric patients aged 3 years and above (see sections 4. 2, 4. 4 i 5. virus hepatitisa c (hcv) genotip-specifične aktivnosti vidi 4. 4 i 5.

Unió Europea - croat - EMA (European Medicines Agency)

takeda pharma a/s - alogliptin, pioglitazone - dijabetes mellitus, tip 2 - drugs used in diabetes, combinations of oral blood glucose lowering drugs - incresync is indicated as a second- or third-line treatment in adult patients aged 18 years and older with type-2 diabetes mellitus: , as an adjunct to diet and exercise to improve glycaemic control in adult patients (particularly overweight patients) inadequately controlled on pioglitazone alone, and for whom metformin is inappropriate due to contraindications or intolerance;, in combination with metformin (i. trostruka kombinirana terapija) kao dodatak prehrani i fizičke vježbe za poboljšanje glikemijski kontrole kod odraslih pacijenata (posebno u pacijenata s viškom težine) neadekvatna na njihovu maksimalnu переносимой doze метформина i пиоглитазона. osim toga , incresync može se koristiti kako bi zamijeniti pojedine tablete alogliptin i pioglitazone u onih odraslih pacijenata u dobi od 18 godina i stariji sa dm-2 već šećerna bolest liječi sa ovom kombinacijom. nakon početka terapije s incresync, pacijenti moraju biti revidiran nakon tri do šest mjeseci, za procjenu adekvatnosti odgovora na liječenje (e. smanjenje pokazatelja hba1c). kod bolesnika koji ne pokazuju adekvatan odgovor, incresync treba prestati. u svjetlu potencijalnih rizika kod duljeg pioglitazone terapija, propisane lijekove treba potvrditi u kasnijim rutinske inspekcije da dobro incresync sprema (vidi odjeljak 4.

Unió Europea - croat - EMA (European Medicines Agency)

novartis europharm limited - ruxolitinib (kao fosfat) - myeloproliferative disorders; polycythemia vera; graft vs host disease - antineoplastična sredstva - myelofibrosis (mf)jakavi is indicated for the treatment of disease related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis. Полицитемия vjera (mf)jakavi indiciran za liječenje odraslih bolesnika s полицитемия vjera, koje su otporne na ili netoleranciju hidroksiurea. graft versus host disease (gvhd)jakavi is indicated for the treatment of patients aged 12 years and older with acute graft versus host disease or chronic graft versus host disease who have inadequate response to corticosteroids or other systemic therapies (see section 5.

Unió Europea - croat - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - empagliflozin - diabetes mellitus, type 2; heart failure; renal insufficiency, chronic - lijekovi koji se koriste u dijabetesu - type 2 diabetes mellitusjardiance is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exerciseas monotherapy when metformin is considered in addition to other medicinal products for the treatment of diabetesfor study results with respect to combinations of therapies, effects on glycaemic control, and cardiovascular and renal events, and the populations studied, see sections 4. 4, 4. 5 i 5. of the annex. heart failurejardiance is indicated in adults for the treatment of symptomatic chronic heart failure.  chronic kidney diseasejardiance is indicated in adults for the treatment of chronic kidney disease.

Unió Europea - croat - 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.