النرويج - النرويجية - Statens legemiddelverk

farmagon - mometasonfuroat - nesespray, suspensjon - 50 mikrog/ dose

الاتحاد الأوروبي - النرويجية - EMA (European Medicines Agency)

merck sharp and dohme b.v - posakonazol - candidiasis; mycoses; coccidioidomycosis; aspergillosis - antimykotika for systemisk bruk - 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. refraktivitet er definert som progresjon av infeksjon eller unnlatelse av å forbedre etter minimum 7 dager før terapeutiske doser av effektive soppdrepende behandling. 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. refraktivitet er definert som progresjon av infeksjon eller unnlatelse av å forbedre etter minimum 7 dager før terapeutiske doser av effektive soppdrepende behandling. 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. refraktivitet er definert som progresjon av infeksjon eller unnlatelse av å forbedre etter minimum 7 dager før terapeutiske doser av effektive soppdrepende behandling. 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. refraktivitet er definert som progresjon av infeksjon eller unnlatelse av å forbedre etter minimum 7 dager før terapeutiske doser av effektive soppdrepende behandling. 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.

الاتحاد الأوروبي - النرويجية - EMA (European Medicines Agency)

mylan pharmaceuticals limited - emtricitabine, tenofovir disoproxil maleate - hiv-infeksjoner - antivirale midler til systemisk bruk - treatment of hiv-1 infection:emtricitabine/tenofovir disoproxil mylan is indicated in antiretroviral combination therapy for the treatment of hiv-1 infected adults (see section 5. emtricitabine/tenofovir disoproxil mylan is also indicated for the treatment of hiv-1 infected adolescents, with nrti resistance or toxicities precluding the use of first line agents, (see sections 4. 2, 4. 4 og 5. pre-exposure prophylaxis (prep):emtricitabine/tenofovir disoproxil mylan is indicated in combination with safer sex practices for pre-exposure prophylaxis to reduce the risk of sexually acquired hiv-1 infection in adults and adolescents at high risk (see sections 4. 2, 4. 4 og 5.

الاتحاد الأوروبي - النرويجية - EMA (European Medicines Agency)

zentiva k.s. - emtricitabin, tenofovirdisoproksilfosfat - hiv-infeksjoner - antivirale midler til systemisk bruk - behandling av hiv-1 infectionemtricitabine/tenofovir disoproxil zentiva er angitt i antiretroviral kombinasjonsbehandling for behandling av hiv-1 infiserte voksne. emtricitabine/tenofovir disoproxil zentiva er også angitt for behandling av hiv-1 infiserte ungdom, med nrti motstand eller toxicities er til hinder for bruk av første linje agenter. pre-exposure prophylaxis (prep)emtricitabine/tenofovir disoproxil zentiva er indisert i kombinasjon med sikrere sex praksis for pre-exposure prophylaxis til å redusere risikoen for seksuelt kjøpt hiv-1-infeksjon hos voksne og ungdom med høy risiko.

الاتحاد الأوروبي - النرويجية - EMA (European Medicines Agency)

eco animal health europe limited - tylvalosin - antiinfectives for systemisk bruk, antibakterielle midler for systemisk bruk, makrolider - pheasants; chicken; turkeys; pigs - pigstreatment og methaphylaxis av svin enzootic lungebetennelse, behandling av svin proliferativ enteropati (ileitis);behandling og methaphylaxis av svin dysenteri. chickenstreatment og methaphylaxis av åndedretts sykdom forbundet med mycoplasma gallisepticum i kyllinger. pheasantstreatment av åndedretts sykdom forbundet med mycoplasma gallisepticum. turkeystreatment av åndedretts sykdom forbundet med tylvalosin følsomme stammer av ornithobacterium rhinotracheale i kalkuner.

الاتحاد الأوروبي - النرويجية - EMA (European Medicines Agency)

zoetis belgium sa - toceranib - antineoplastiske midler - hunder - behandling av ikke-resekterbare patnaik grade ii (mellomstore) eller -iii (høyverdige), tilbakevendende, kutane mastcelletumorer hos hunder.

الاتحاد الأوروبي - النرويجية - EMA (European Medicines Agency)

krka, d.d., novo mesto - emtricitabine, tenofovir disoproxil succinate - hiv-infeksjoner - antivirale midler til systemisk bruk - behandling av hiv-1 infectionemtricitabine/tenofovir disoproxil krka er angitt i antiretroviral kombinasjonsbehandling for behandling av hiv-1 infiserte voksne. emtricitabine/tenofovir disoproxil krka er også angitt for behandling av hiv-1 infiserte ungdom, med nrti motstand eller toxicities er til hinder for bruk av første linje agenter, i alderen 12 til < 18 år (se punkt 5.. 1pre-exposure prophylaxis (prep)emtricitabine/tenofovir disoproxil krka er indisert i kombinasjon med sikrere sex praksis for pre-exposure prophylaxis til å redusere risikoen for seksuelt kjøpt hiv-1-infeksjon hos voksne med høy risiko.

الاتحاد الأوروبي - النرويجية - EMA (European Medicines Agency)

celgene europe ltd. - lepirudin - thromboembolism; thrombocytopenia - antithrombotic agents - antikoagulering hos voksne pasienter med heparininducert trombocytopeni type ii og tromboembolisk sykdom som mandater parenteral antitrombotisk terapi. diagnosen bør bekreftes av heparin-indusert aktivering av blodplater analysen, eller en tilsvarende test.

الاتحاد الأوروبي - النرويجية - EMA (European Medicines Agency)

gilead sciences ireland uc - emtricitabine, tenofovir disoproxil fumarate - hiv-infeksjoner - antivirale midler til systemisk bruk - treatment of hiv-1 infection: , truvada is indicated in antiretroviral combination therapy for the treatment of hiv-1 infected adults. , truvada er også angitt for behandling av hiv-1 infiserte ungdom, med nrti motstand eller toxicities er til hinder for bruk av første linje agenter, i alderen 12 til < 18 år. , pre-exposure prophylaxis (prep): , truvada is indicated in combination with safer sex practices for pre-exposure prophylaxis to reduce the risk of sexually acquired hiv-1 infection in adults at high risk.

الاتحاد الأوروبي - النرويجية - EMA (European Medicines Agency)

csl behring gmbh - menneskelige koagulering faktor viii, human von willebrand faktor - hemophilia a; von willebrand diseases - blood coagulation factors, von willebrand factor and coagulation factor viii in combination, antihemorrhagics - von willebrand sykdom (vwd)prophylaxis og behandling av blødning eller kirurgisk blødning hos pasienter med vwd, når desmopressin (ddavp) behandling alene er ineffektiv eller kontraindisert. haemophilia a (medfødt faktor-viii-mangel)prophylaxis og behandling av blødninger hos pasienter med haemophilia en.