Delstrigo Europska Unija - hrvatski - EMA (European Medicines Agency)

delstrigo

merck sharp & dohme b.v. - doravirine, lamivudin, Тенофовир дизопроксил фумарат - hiv infekcije - antivirusni lijekovi za liječenje hiv infekcija, kombinacija - delstrigo indiciran za liječenje odraslih osoba zaraženih hiv-1, bez prošlosti ili ovih dokaza otpornost do klase ННИОТ, lamivudin ili Тенофовир. delstrigo is also indicated for the treatment of adolescents aged 12 years and older weighing at least 35 kg who are infected with hiv-1 without past or present evidence of resistance to the nnrti class, lamivudine, or tenofovir and who have experienced toxicities which preclude the use of other regimens that do not contain tenofovir disoproxil.

Varivax prašak i otapalo za suspenziju za injekciju u napunjenoj štrcaljki Hrvatska - hrvatski - HALMED (Agencija za lijekove i medicinske proizvode)

varivax prašak i otapalo za suspenziju za injekciju u napunjenoj štrcaljki

merck sharp & dohme d.o.o., ivana lučića 2a, zagreb, hrvatska - virus varičele, soj oka/merck (živi, atenuirani) - prašak i otapalo za suspenziju za injekciju - 1 doza (0,5 ml) - urbroj: nakon rekonstitucije, jedna doza (0,5 ml) sadrži: virus varičele soj oka/merck (živi, atenuirani) ≥1350 pfu, proizveden na ljudskim diploidnim (mrc-5) stanicama

Noxafil Europska Unija - hrvatski - EMA (European Medicines Agency)

noxafil

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.

Efficib Europska Unija - hrvatski - EMA (European Medicines Agency)

efficib

merck sharp and dohme b.v - ситаглиптин, metformin hidroklorid - dijabetes mellitus, tip 2 - lijekovi koji se koriste u dijabetesu - u bolesnika sa tip-2 dijabetesa:efficib prikazan kao dodatak prehrani i fizičke vježbe za poboljšanje glikemijski kontrole kod pacijenata, nedovoljno kontroliranim o njihovo maksimalno переносимой dozi samo метформина ili onih koji su već prolazi kroz tretman kombinacijom ситаглиптина i метформина. efficib drugačije u kombinaciji sa sulfonilurejom (ja. trostruka kombinirana terapija) kao dodatak prehrani i vježbe kod pacijenata, nedovoljno kontroliranim o njihovo maksimalno переносимой doze метформина i sulfonilurejom. efficib drugačije kao trostruki kombinirane terapije s агонистами rapp (ja. тиазолидиндионом) kao dodatak prehrani i vježbe kod pacijenata, nedovoljno kontroliranim o njihovo maksimalno переносимой doze метформина i ppur agonist. efficib također pokazuje kako dodati na inzulin (ja. trostruki kombinovanu terapiju) kao dodatak prehrani i fizičke vježbe za poboljšanje glikemijski kontrole kod bolesnika na stabilne doze inzulina i метформина sami ne pružaju adekvatnu glikemijski kontrole.

Segluromet Europska Unija - hrvatski - EMA (European Medicines Agency)

segluromet

merck sharp & dohme b.v. - ertugliflozin l-pyroglutamic acid, metformin hydrochloride - dijabetes mellitus, tip 2 - drugs used in diabetes, combinations of oral blood glucose lowering drugs - segluromet is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control:in patients not adequately controlled on their maximally tolerated dose of metformin alonein patients on their maximally tolerated doses of metformin in addition to other medicinal products for the treatment of diabetesin patients already being treated with the combination of ertugliflozin and metformin as separate tablets.

Pifeltro Europska Unija - hrvatski - EMA (European Medicines Agency)

pifeltro

merck sharp & dohme b.v. - doravirine - hiv infekcije - antivirusni lijekovi za sustavnu uporabu - pifeltro is indicated, in combination with other antiretroviral medicinal products, for the treatment of adults, and adolescents aged 12 years and older weighing at least 35 kg infected with hiv 1 without past or present evidence of resistance to the nnrti class.

TIENAM 500 mg/1 viala+ 500 mg/1 viala prašak za rastvor za infuziju Bosna i Hercegovina - hrvatski - Agencija za lijekove i medicinska sredstva Bosne i Hercegovine (Агенција за лијекове и медицинска средства Босне и Херцеговине)

tienam 500 mg/1 viala+ 500 mg/1 viala prašak za rastvor za infuziju

merck sharp & dohme bh d.o.o. - циластатин, Имипенем - prašak za rastvor za infuziju - 500 mg/1 viala+ 500 mg/1 viala - 1 bočica praška sadrži: 500 mg imipenema, bezvodnog (u obliku imipenemmonohidrata) 500 mg cilastatina (u obliku cilastatinnatrijuma)

GARDASIL 20 µg/0.5 mL+ 40 µg/0.5 mL+ 40 µg/0.5 mL+ 20 µg/0.5 mL suspenzija za injekciju Bosna i Hercegovina - hrvatski - Agencija za lijekove i medicinska sredstva Bosne i Hercegovine (Агенција за лијекове и медицинска средства Босне и Херцеговине)

gardasil 20 µg/0.5 ml+ 40 µg/0.5 ml+ 40 µg/0.5 ml+ 20 µg/0.5 ml suspenzija za injekciju

merck sharp & dohme bh d.o.o. - papilomavirus (humanitarne tipovi 6, 11, 16, 18) - suspenzija za injekciju - 20 µg/0.5 ml+ 40 µg/0.5 ml+ 40 µg/0.5 ml+ 20 µg/0.5 ml - 0,5 ml (1 doza) suspenzije za injekciju sadrži: 20 mcg humani papilomavirus tip 6 l1 protein 40 mcg humani papilomavirus tip 11 l1 protein 40 mcg humani papilomavirus tip 16 l1 protein 20 mcg humani papilomavirus tip 18 l1 protein

GARDASIL 20 µg/0.5 mL+ 40 µg/0.5 mL+ 40 µg/0.5 mL+ 20 µg/0.5 mL suspenzija za injekciju Bosna i Hercegovina - hrvatski - Agencija za lijekove i medicinska sredstva Bosne i Hercegovine (Агенција за лијекове и медицинска средства Босне и Херцеговине)

gardasil 20 µg/0.5 ml+ 40 µg/0.5 ml+ 40 µg/0.5 ml+ 20 µg/0.5 ml suspenzija za injekciju

merck sharp & dohme bh d.o.o. - papilomavirus (humanitarne tipovi 6, 11, 16, 18) - suspenzija za injekciju - 20 µg/0.5 ml+ 40 µg/0.5 ml+ 40 µg/0.5 ml+ 20 µg/0.5 ml - 0,5 ml (1 doza) suspenzije za injekciju sadrži: 20 mcg humani papilomavirus tip 6 l1 protein 40 mcg humani papilomavirus tip 11 l1 protein 40 mcg humani papilomavirus tip 16 l1 protein 20 mcg humani papilomavirus tip 18 l1 protein

GARDASIL 20 µg/0.5 mL+ 40 µg/0.5 mL+ 40 µg/0.5 mL+ 20 µg/0.5 mL suspenzija za injekciju u napunjenoj šprici Bosna i Hercegovina - hrvatski - Agencija za lijekove i medicinska sredstva Bosne i Hercegovine (Агенција за лијекове и медицинска средства Босне и Херцеговине)

gardasil 20 µg/0.5 ml+ 40 µg/0.5 ml+ 40 µg/0.5 ml+ 20 µg/0.5 ml suspenzija za injekciju u napunjenoj šprici

merck sharp & dohme bh d.o.o. - papilomavirus (humanitarne tipovi 6, 11, 16, 18) - suspenzija za injekciju u napunjenoj šprici - 20 µg/0.5 ml+ 40 µg/0.5 ml+ 40 µg/0.5 ml+ 20 µg/0.5 ml - 0,5 ml (1 doza) suspenzije za injekciju u napunjenoj šprici sadrži: 20 mcg humani papilomavirus tip 6 l1 protein 40 mcg humani papilomavirus tip 11 l1 protein 40 mcg humani papilomavirus tip 16 l1 protein 20 mcg humani papilomavirus tip 18 l1 protein