Svezia - svedese - Läkemedelsverket (Medical Products Agency)

steriscience b.v. - cilastatinnatrium; imipenemmonohydrat - pulver till infusionsvätska, lösning - 500 mg/500 mg - cilastatinnatrium 530,7 mg aktiv substans; imipenemmonohydrat 530,1 mg aktiv substans

Svezia - svedese - Läkemedelsverket (Medical Products Agency)

actavis group ptc ehf. - atorvastatinmagnesiumtrihydrat - filmdragerad tablett - 10 mg - mannitol hjälpämne; atorvastatinmagnesiumtrihydrat 10,7 mg aktiv substans - atorvastatin

Svezia - svedese - Läkemedelsverket (Medical Products Agency)

actavis group ptc ehf. - atorvastatinmagnesiumtrihydrat - filmdragerad tablett - 20 mg - atorvastatinmagnesiumtrihydrat 21,4 mg aktiv substans; mannitol hjälpämne - atorvastatin

Svezia - svedese - Läkemedelsverket (Medical Products Agency)

actavis group ptc ehf. - atorvastatinmagnesiumtrihydrat - filmdragerad tablett - 40 mg - atorvastatinmagnesiumtrihydrat 42,8 mg aktiv substans; mannitol hjälpämne - atorvastatin

Svezia - svedese - Läkemedelsverket (Medical Products Agency)

campus pharma ab - cilastatinnatrium; imipenemmonohydrat - pulver till infusionsvätska, lösning - 500 mg/500 mg - imipenemmonohydrat 530 mg aktiv substans; cilastatinnatrium 530,6 mg aktiv substans - imipenem med enzymhämmare

Svezia - svedese - Läkemedelsverket (Medical Products Agency)

medartuum ab - cilastatinnatrium; imipenemmonohydrat - pulver till infusionsvätska, lösning - cilastatinnatrium aktiv substans; imipenemmonohydrat aktiv substans - imipenem med enzymhämmare

Svezia - svedese - Läkemedelsverket (Medical Products Agency)

merck sharp & dohme bv - cilastatinnatrium; imipenemmonohydrat - pulver till infusionsvätska, lösning - 500 mg/500 mg - imipenemmonohydrat 530 mg aktiv substans; cilastatinnatrium 530 mg aktiv substans - imipenem med enzymhämmare

Unione Europea - svedese - EMA (European Medicines Agency)

seagen b.v. - tucatinib - breast neoplasms; neoplasm metastasis - antineoplastiska medel - tukysa is indicated in combination with trastuzumab and capecitabine for the treatment of adult patients with her2‑positive locally advanced or metastatic breast cancer who have received at least 2 prior anti‑her2 treatment regimens.

Unione Europea - svedese - EMA (European Medicines Agency)

roche registration gmbh - saquinavir - hiv-infektioner - antivirala medel för systemisk användning - invirase är indicerat för behandling av hiv-1-infekterade vuxna patienter. invirase ska endast ges i kombination med ritonavir och andra antiretrovirala läkemedel.

Unione Europea - svedese - EMA (European Medicines Agency)

merck sharp and dohme b.v - posakonazol - candidiasis; mycoses; coccidioidomycosis; aspergillosis - antimykotika för systemisk användning - noxafil gastro-resistant tablets are indicated for use in the treatment of the following fungal infections in adults (see sections 4. 2 och 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 och 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. refraktäritet definieras som utveckling av infektion eller utebliven förbättring efter en vistelse på minst 7 dagar före terapeutiska doser av effektiv antimykotisk 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 och 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 och 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 och 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. refraktäritet definieras som utveckling av infektion eller utebliven förbättring efter en vistelse på minst 7 dagar före terapeutiska doser av effektiv antimykotisk 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 och 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 och 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. refraktäritet definieras som utveckling av infektion eller utebliven förbättring efter en vistelse på minst 7 dagar före terapeutiska doser av effektiv antimykotisk 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 aspergillos hos patienter med sjukdom som är refraktära mot amfotericin b eller itrakonazol eller till patienter som är intoleranta mot dessa läkemedel, - fusariosis på patienter med den sjukdom som är refraktära mot amfotericin b eller till patienter som är intoleranta mot amfotericin b;- chromoblastomycosis och mycetoma på patienter med den sjukdom som är refraktära mot itrakonazol eller till patienter som är intoleranta mot itrakonazol;- coccidiomykos på patienter med den sjukdom som är refraktära mot amfotericin b, itrakonazol eller flukonazol eller till patienter som är intoleranta mot dessa läkemedel.- munhåla candidiasis: som första linjens behandling av patienter som har svår sjukdom eller nedsatt immunförsvar, i vilken respons till aktuell terapi väntas dålig. refraktäritet definieras som utveckling av infektion eller utebliven förbättring efter en vistelse på minst 7 dagar före terapeutiska doser av effektiv antimykotisk 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.