Kesatuan Eropah - Sweden - EMA (European Medicines Agency)

teva pharma b.v. - budesonide, formoterol - astma - läkemedel mot obstruktiv lungsjukdom, - budesonid / formoterol teva pharma b. indikeras endast hos vuxna 18 år och äldre. asthmabudesonide/formoterol teva pharma b. is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate: orin patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β2 adrenoceptor agonists. in patients already adequately controlled on both inhaled corticosteroids and long-acting β2 adrenoceptor agonists.

Kesatuan Eropah - Sweden - EMA (European Medicines Agency)

ipsen pharma - cabozantinib (s)-malate - carcinoma, renal cell; carcinomas, hepatocellular - antineoplastiska medel - renal cell carcinoma (rcc)cabometyx is indicated as monotherapy for the treatment of advanced renal cell carcinoma (rcc):in treatment-naïve adults with intermediate or poor risk,in adults following prior vascular endothelial growth factor (vegf)-targeted therapy. cabometyx, in combination with nivolumab, is indicated for the first-line treatment of advanced renal cell carcinoma in adults. hepatocellular carcinoma (hcc)cabometyx is indicated as monotherapy for the treatment of hepatocellular carcinoma (hcc) in adults who have previously been treated with sorafenib.

Kesatuan Eropah - Sweden - EMA (European Medicines Agency)

merck sharp & dohme b.v. - caspofungin (as acetate) - candidiasis; aspergillosis - antimykotika för systemisk användning - treatment of invasive candidiasis in adult or paediatric patients;treatment of invasive aspergillosis in adult or paediatric patients who are refractory to or intolerant of amphotericin b, lipid formulations of amphotericin b and / or itraconazole. refractoriness is defined as progression of infection or failure to improve after a minimum of seven days of prior therapeutic doses of effective antifungal therapy;empirical therapy for presumed fungal infections (such as candida or aspergillus) in febrile, neutropaenic adult or paediatric patients.

Kesatuan Eropah - Sweden - EMA (European Medicines Agency)

laboratoires delbert - histamin dihydrochloride - leukemi, myeloid, akut - immunstimulatorer, - ceplene maintenance therapy is indicated for adult patients with acute myeloid leukaemia in first remission concomitantly treated with interleukin-2 (il-2). effekten av ceplene har inte visats fullständigt hos patienter som är äldre än 60 år.

Kesatuan Eropah - Sweden - EMA (European Medicines Agency)

menarini international operations luxembourg s.a. - pemetrexed dinatriumhemipentahydrat - carcinoma, non-small-cell lung; mesothelioma - antineoplastiska medel - malignant pleural mesothelioma ciambra in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. non-small cell lung cancer ciambra in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology. ciambra är indicerat som monoterapi för underhåll behandling av lokalt avancerad eller metastaserad icke-småcellig lungcancer andra än huvudsakligen skivepitelcancer histologi hos patienter vars sjukdom inte har gått omedelbart efter platinum-baserad kemoterapi. ciambra är indicerat som monoterapi för andra linjens behandling av patienter med lokalt avancerad eller metastaserad icke-småcellig lungcancer andra än huvudsakligen skivepitelcancer histologi.

Kesatuan Eropah - Sweden - EMA (European Medicines Agency)

bpl bioproducts laboratory gmbh - mänskliga koagulationsfaktorer x - faktor x brist - vitamin k and other hemostatics, antihemorrhagics, coagulation factor x - coagadex är indicerat för behandling och profylax av blödningsepisoder och för perioperativ hantering hos patienter med ärftlig faktor x-brist. coagadex anges i alla åldersgrupper.

Kesatuan Eropah - Sweden - EMA (European Medicines Agency)

cheplapharm arzneimittel gmbh - pioglitazon, metformin hydroklorid - diabetes mellitus, typ 2 - läkemedel som används vid diabetes - competact is indicated in the treatment of type 2 diabetes mellitus patients, particularly overweight patients, who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone.

Kesatuan Eropah - Sweden - EMA (European Medicines Agency)

novartis europharm limited - secukinumab - arthritis, psoriatic; psoriasis; spondylitis, ankylosing - immunsuppressiva - plaque psoriasiscosentyx is indicated for the treatment of moderate to severe plaque psoriasis in adults and children from the age of 6 years old who are candidates for systemic therapy. hidradenitis suppurativa (hs)cosentyx is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults with an inadequate response to conventional systemic hs therapy. psoriasisartrit arthritiscosentyx, ensamt eller i kombination med metotrexat (mtx), är indicerat för behandling av aktiv psoriasisartrit hos vuxna patienter, när svaret på tidigare sjukdomsmodifierande anti-reumatiska läkemedel (dmard) terapi har varit otillräcklig. axiell spondyloarthritis (axspa)ankyloserande spondylit (as, röntgen axiell spondyloarthritis)cosentyx är indicerat för behandling av aktiv ankyloserande spondylit hos vuxna som svarat otillräckligt för att konventionell terapi. non-radiographic axial spondyloarthritis (nr-axspa)cosentyx is indicated for the treatment of active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated c-reactive protein (crp) and/or magnetic resonance imaging (mri) evidence in adults who have responded inadequately to non steroidal anti inflammatory drugs (nsaids). juvenile idiopathic arthritis (jia)enthesitis-related arthritis (era)cosentyx, alone or in combination with methotrexate (mtx), is indicated for the treatment of active enthesitis-related arthritis in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy. juvenile psoriatic arthritis (jpsa)cosentyx, alone or in combination with methotrexate (mtx), is indicated for the treatment of active juvenile psoriatic arthritis in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy.

Kesatuan Eropah - Sweden - EMA (European Medicines Agency)

mylan pharmaceuticals limited - darunavir - hiv-infektioner - antivirala medel för systemisk användning - darunavir, co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv-1) infection (see section 4. darunavir mylan 75 mg, 150 mg, 300 mg and 600 mg tablets may be used to provide suitable dose regimens (see section 4. 2):för behandling av hiv-1-infektion antiretroviral behandling (art)-erfarna vuxna patienter, inklusive de som har varit mycket förbehandlade. för behandling av hiv-1-infektion hos pediatriska patienter från 3 års ålder och minst 15 kg kroppsvikt. när beslut fattas om att inleda behandlingen med darunavir samförvaltas med låg dos ritonavir, noggrann hänsyn bör tas till behandling historia av den enskilda patienten och de mönster av mutationer som förknippas med olika aktörer. genotypic or phenotypic testing (when available) and treatment history should guide the use of darunavir (see sections 4. 2, 4. 4 och 5. darunavir samförvaltas med låg dos ritonavir är indicerat i kombination med andra antiretrovirala läkemedel för behandling av patienter med humant immunbristvirus (hiv-1) infektion.  darunavir co-administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv-1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg) (see section 4.  darunavir mylan 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of hiv-1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are: antiretroviral therapy (art)-naïve (see section 4.  art-experienced with no darunavir resistance associated mutations (drv-rams) and who have plasma hiv-1 rna < 100,000 copies/ml and cd4+ cell count ≥ 100 cells x 10⁶/l. när beslut fattas om att inleda behandlingen med darunavir i sådan konst-erfarna patienter, genotypic testning bör styra användningen av darunavir (se avsnitt 4. 2, 4. 3, 4. 4 och 5.

Kesatuan Eropah - Sweden - EMA (European Medicines Agency)

janssen-cilag international n.v. - daratumumab - multipelt myelom - monoclonal antibodies and antibody drug conjugates, antineoplastic agents - multiple myelomadarzalex is indicated: in combination with lenalidomide and dexamethasone or with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. i kombination med bortezomib, talidomid och dexametason för behandling av vuxna patienter med nyligen fått diagnosen multipelt myelom som är berättigade till autolog stamcellstransplantation. i kombination med lenalidomid och dexametason, eller bortezomib och dexametason, för behandling av vuxna patienter med multipelt myelom som har fått minst en tidigare behandling. in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one prior therapy containing a proteasome inhibitor and lenalidomide and were lenalidomide refractory, or who have received at least two prior therapies that included lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or after the last therapy (see section 5. som monoterapi för behandling av vuxna patienter med återfall och eldfasta multipelt myelom, vars tidigare behandling ingår en proteasom-hämmare och en immunmodulerande substans avsedd att fungera som agent och som har visat att de försämras i sin sjukdom på den sista terapi. al amyloidosisdarzalex is indicated in combination with cyclophosphamide, bortezomib and dexamethasone for the treatment of adult patients with newly diagnosed systemic light chain (al) amyloidosis.