Den Europæiske Union - dansk - EMA (European Medicines Agency)

merck sharp and dohme b.v - posaconazol - candidiasis; mycoses; coccidioidomycosis; aspergillosis - antimykotika til systemisk brug - noxafil gastro-resistant tablets are indicated for use in the treatment of the following fungal infections in adults (see sections 4. 2 og 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 og 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. uimodtagelighed over er defineret som progression af infektion eller manglende bedring efter minimum 7 dage før terapeutiske doser af effektiv svampedræbende terapi. 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 og 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 og 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 og 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. uimodtagelighed over er defineret som progression af infektion eller manglende bedring efter minimum 7 dage før terapeutiske doser af effektiv svampedræbende terapi. 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 og 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 og 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. uimodtagelighed over er defineret som progression af infektion eller manglende bedring efter minimum 7 dage før terapeutiske doser af effektiv svampedræbende terapi. 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):- invasiv aspergillose hos patienter med sygdom, der er refraktære over for amphotericin b eller itraconazol eller patienter, der ikke tåler disse lægemidler;- fusariosis hos patienter med sygdom, der er refraktære over for amphotericin b eller patienter, der er intolerante over for amphotericin b;- chromoblastomycosis og mycetoma hos patienter med sygdom, der er refraktære over for itraconazol eller patienter, der er intolerante over for itraconazol;- coccidioidomycosis hos patienter med sygdom, der er refraktære over for amphotericin b, itraconazol eller fluconazol eller patienter, der ikke tåler disse lægemidler.- oropharyngeale candidiasis: som første linje behandling til patienter, som har svær sygdom eller er immunsvækkede, i, som reaktion på aktuelle behandling forventes at være fattig. uimodtagelighed over er defineret som progression af infektion eller manglende bedring efter minimum 7 dage før terapeutiske doser af effektiv svampedræbende terapi. 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.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

noden pharma dac - aliskiren - forhøjet blodtryk - agenter, der virker på renin-angiotensinsystemet - behandling af essentiel hypertension.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

merck sharp & dohme b.v. - bezlotoxumab - enterocolitis, pseudomembranøs - immune sera og immunoglobuliner, - zinplava er indiceret til forebyggelse af tilbagefald af clostridium difficile infektion (cdi) hos voksne med høj risiko for gentagelse af cdi.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

merck sharp & dohme b.v. - sitagliptin, metformin-hydrochlorid - diabetes mellitus, type 2 - narkotika anvendt i diabetes - for patienter med type-2-diabetes mellitus:ristfor er indiceret som et supplement til kost og motion til forbedring af glykæmisk kontrol hos patienter, der ikke er tilstrækkeligt kontrolleret på deres maksimal tolereret dosis af metformin alene, eller dem, der allerede er i behandling med kombinationen af sitagliptin og metformin. ristfor er indiceret i kombination med sulphonylurea (jeg. triple kombinationsbehandling) som supplement til diæt og motion hos patienter, der ikke er tilstrækkeligt kontrolleret på deres maksimal tolereret dosis af metformin og et sulphonylurea. ristfor er angivet som tredobbelt kombinationsbehandling med en peroxisome proliferator-activated-receptor-gamma (ppary) agonist (jeg. en thiazolidinedione) som et supplement til diæt og motion hos patienter, der ikke er tilstrækkeligt kontrolleret på deres maksimal tolereret dosis af metformin og et ppary agonist. ristfor er også indiceret som supplement til insulin (jeg. triple kombinationsbehandling) som supplement til diæt og motion til forbedring af glykæmisk kontrol hos patienter, når stabil dosering af insulin og metformin alene ikke giver tilstrækkelig glykæmisk kontrol.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

merck sharp & dohme b.v. - tedizolid phosphat - soft tissue infections; skin diseases, bacterial - antibacterials for systemic use, , other antibacterials - sivextro is indicated for the treatment of acute bacterial skin and skin structure infections (absssi) in adults and adolescents 12 years of age and older.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

eli lilly and company (ireland) limited - ixekizumab - psoriasis - immunosuppressiva - plak psoriasistaltz er indiceret til behandling af moderat til svær plaque psoriasis hos voksne, der er kandidater til systemisk terapi. psoriasis arthritistaltz, alene eller i kombination med methotrexat, er indiceret til behandling af aktiv psoriasis artrit hos voksne patienter, der har svaret, ikke er tilstrækkeligt til, eller der er intolerante over for et eller flere sygdomsmodificerende anti-reumatiske lægemidler (dmard) behandlinger.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

recordati netherlands b.v. - siltuximab - giant lymfeknudehyperplasi - immunosuppressiva - sylvant er indiceret til behandling af voksne patienter med polycentrisk castleman sygdom (mcd, der er human immundefekt virus (hiv) negative og humant herpesvirus-8 (hhv-8) negative.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

merck sharp and dohme b.v - ribavirin - hepatitis c kronisk - antivirals for systemic use, antivirals for treatment of hcv infections - rebetol er indiceret i kombination med andre lægemidler til behandling af kronisk hepatitis c (chc) hos voksne. rebetol er indiceret i kombination med andre lægemidler til behandling af kronisk hepatitis c (chc) for pædiatriske patienter (børn fra 3 år og ældre og unge), der ikke tidligere er behandlet, og uden leveren dekompensation.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

regeneron uk limited - rilonacept - cryopyrin-associerede periodiske syndromer - immunosuppressiva - rilonacept regeneron er indiceret til behandling af cryopyrin-associerede periodiske syndromer (caps) med svære symptomer, herunder familiær kolde auto-inflammatoriske syndrom (fcas) og muckle-wells syndrom (mws), hos voksne og børn i alderen 12 år og ældre.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

novartis europharm ltd. - aliskiren - forhøjet blodtryk - agenter, der virker på renin-angiotensinsystemet - behandling af essentiel hypertension.