Europese Unie - Nederlands - EMA (European Medicines Agency)

sandoz gmbh - adalimumab - arthritis, rheumatoid; arthritis, psoriatic; spondylitis, ankylosing; uveitis; hidradenitis suppurativa; colitis, ulcerative; arthritis, juvenile rheumatoid; crohn disease; skin diseases, papulosquamous - immunosuppressiva - rheumatoid arthritishyrimoz in combination with methotrexate, is indicated for:- the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate. - the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. hyrimoz kan worden gegeven als monotherapie in geval van intolerantie voor methotrexaat of wanneer voortgezette behandeling met methotrexaat als ongepast. adalimumab is aangetoond dat het verminderen van de snelheid van progressie van gewrichtsschade, zoals gemeten door de x-ray en verbetering van fysiek functioneren, indien gegeven in combinatie met methotrexaat. juvenile idiopathic arthritis- polyarticular juvenile idiopathic arthritishyrimoz in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (dmards). hyrimoz kan worden gegeven als monotherapie in geval van intolerantie voor methotrexaat of wanneer voortgezette behandeling met methotrexaat als ongepast. adalimumab is niet onderzocht bij patiënten jonger dan 2 jaar. - enthesitis-related arthritishyrimoz is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy. axial spondyloarthritis- ankylosing spondylitis (as)hyrimoz is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. - axial spondyloarthritis without radiographic evidence of ashyrimoz is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of as but with objective signs of inflammation by elevated crp and / or mri, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs. psoriatic arthritishyrimoz is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. adalimumab is aangetoond dat het verminderen van de snelheid van progressie van perifere gewrichtsschade, zoals gemeten door de x-ray bij patiënten met polyarticulaire symmetrische subtypen van de ziekte en het verbeteren van fysieke functie. psoriasishyrimoz is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. paediatric plaque psoriasishyrimoz is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies. hidradenitis suppurativa (hs)hyrimoz is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic hs therapy. crohn’s diseasehyrimoz is indicated for treatment of moderately to severely active crohn’s disease in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and / or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. paediatric crohn's diseasehyrimoz is indicated for the treatment of moderately to severely active crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and / or an immunomodulator, or who are intolerant to or have contraindications for such therapies.  paediatric ulcerative colitishyrimoz is indicated for the treatment of moderately to severely active ulcerative colitis in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including corticosteroids and/or 6-mercaptopurine (6-mp) or azathioprine (aza), or who are intolerant to or have medical contraindications for such therapies. ulcerative colitishyrimoz is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-mp) or azathioprine (aza), or who are intolerant to or have medical contraindications for such therapies. uveitishyrimoz is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate. paediatric uveitishyrimoz is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.

Nederland - Nederlands - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

pharos pharmaceutical oriented services ltd - abacavir ; lamivudine 0-water - filmomhulde tablet - cellulose, microkristallijn (e 460) ; hypromellose, type 2910 (3 - 15 mpa.s) (e 464) ; macrogol 400 ; magnesiumstearaat (e 470b) ; natriumzetmeelglycolaat ; povidon k 90 (e 1201) ; titaandioxide (e 171) ; zonnegeel fcf aluminiumlak (e 110), cellulose, microkristallijn (e 460) ; hypromellose, type 2910 (3 - 15 mpa.s) (e 464) ; macrogol 400 ; magnesiumstearaat (e 470b) ; natriumzetmeelglycolaat (e468) ; povidon k 90 (e 1201) ; titaandioxide (e 171) ; zonnegeel fcf aluminiumlak (e 110), - lamivudine and abacavir

Nederland - Nederlands - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

teva nederland b.v. swensweg 5 2031 ga haarlem - efavirenz 600 mg/stuk ; emtricitabine 200 mg/stuk ; tenofovirdisoproxilfosfaat 291,2 mg/stuk samenstelling overeenkomend met ; tenofovirdisoproxil 245 mg/stuk - filmomhulde tablet - cellulose, microkristallijn (e 460(i)) ; croscarmellose natrium (e 468) ; crospovidon (e 1202) ; hydroxypropylcellulose, laag gesubstitueerd (e 463a) ; hyprolose (e 463) ; hypromellose, type 2910 (3 - 15 mpa.s) (e 464) ; karmijn (e120) ; macrogol 3350 ; mannitol (d-) (e 421) ; natriumstearylfumaraat ; plantaardige olie, gehydreerd ; poloxameer 407 ; polyvinylalcohol, gedeeltelijk gehydrolyseerd (e1203) ; talk (e 553 b) ; titaandioxide (e 171), cellulose, microkristallijn (e 460) ; croscarmellose natrium (e 468) ; crospovidon (e 1202) ; hydroxypropylcellulose, laag gesubstitueerd (e 463) ; hyprolose (e 463) ; hypromellose, type 2910 (3 - 15 mpa.s) (e 464) ; karmijn (e120) ; macrogol 3350 ; mannitol (d-) (e 421) ; natriumstearylfumaraat ; plantaardige olie, gehydreerd ; poloxameer 407 ; polyvinylalcohol, gedeeltelijk gehydrolyseerd (e1203) ; talk (e 553 b) ; titaandioxide (e 171), - emtricitabine, tenofovir disoproxil and efavirenz

Nederland - Nederlands - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

teva nederland b.v. swensweg 5 2031 ga haarlem - desogestrel 150 µg/stuk ; ethinylestradiol 20 µg/stuk - tablet - aardappelzetmeel ; lactose 0-water ; povidon k 30 (e 1201) ; siliciumdioxide (e 551) ; stearinezuur (e 570) ; tocoferol, dl-alfa (e 307), - desogestrel and ethinylestradiol

Nederland - Nederlands - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

teva nederland b.v. swensweg 5 2031 ga haarlem - desogestrel 150 µg/stuk ; ethinylestradiol 30 µg/stuk - tablet - aardappelzetmeel ; lactose 0-water ; povidon k 30 (e 1201) ; siliciumdioxide (e 551) ; stearinezuur (e 570) ; tocoferol, dl-alfa (e 307), - desogestrel and ethinylestradiol

Nederland - Nederlands - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

hexal ag industriestrasse 25 d-83607 holzkirchen (duitsland) - carbidopa 1-water 25 samenstelling overeenkomend met ; carbidopa 0-water mg/stuk ; levodopa 100 mg/stuk - tablet met verlengde afgifte - chinolinegeel (e 104) ; fumaarzuur (e 297) ; hypromellose (e 464) ; ijzeroxide geel (e 172) ; ijzeroxide rood (e 172) ; natriumstearylfumaraat ; polyethyleenglycol (e 1521) ; siliciumdioxide (e 551) ; titaandioxide (e 171), - levodopa and decarboxylase inhibitor

Nederland - Nederlands - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

hexal ag industriestrasse 25 d-83607 holzkirchen (duitsland) - carbidopa 1-water 50 samenstelling overeenkomend met ; carbidopa 0-water mg/stuk ; levodopa 200 mg/stuk - tablet met verlengde afgifte - chinolinegeel (e 104) ; fumaarzuur (e 297) ; hypromellose (e 464) ; ijzeroxide geel (e 172) ; ijzeroxide rood (e 172) ; natriumstearylfumaraat ; polyethyleenglycol (e 1521) ; siliciumdioxide (e 551) ; titaandioxide (e 171), - levodopa and decarboxylase inhibitor

Nederland - Nederlands - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

hetero europe s.l. - abacavirsulfaat samenstelling overeenkomend met ; abacavir ; lamivudine 0-water - filmomhulde tablet - cellulose, microkristallijn (e 460) ; hypromellose, type 2910 (3 - 15 mpa.s) (e 464) ; macrogol 400 ; magnesiumstearaat (e 470b) ; natriumzetmeelglycolaat ; polysorbaat 80 (e 433) ; siliciumdioxide (e 551) ; titaandioxide (e 171) ; zonnegeel fcf aluminiumlak (e 110), cellulose, microkristallijn (e 460) ; hypromellose, type 2910 (3 - 15 mpa.s) (e 464) ; macrogol 400 ; magnesiumstearaat (e 470b) ; natriumzetmeelglycolaat (e468) ; polysorbaat 80 (e 433) ; siliciumdioxide (e 551) ; titaandioxide (e 171) ; zonnegeel fcf aluminiumlak (e 110), - lamivudine and abacavir

Nederland - Nederlands - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

ratiopharm gmbh graf-arco-strasse 3 89079 ulm (duitsland) - ezetimib 10 mg/stuk ; simvastatine 20 mg/stuk - tablet - ascorbinezuur (l-) (e 300) ; butylhydroxyanisol (e 320) ; cellulose, microkristallijn (e 460(i)) ; citroenzuur 0-water (e 330) ; croscarmellose natrium (e 468) ; hypromellose, type 2910 (3 - 15 mpa.s) (e 464) ; ijzeroxide geel (e 172) ; ijzeroxide rood (e 172) ; ijzeroxide zwart (e 172) ; lactose 1-water ; magnesiumstearaat (e 470b) ; propylgallaat (e 310), ascorbinezuur (l-) (e 300) ; butylhydroxyanisol (e 320) ; cellulose, microkristallijn (e 460) ; citroenzuur 0-water (e 330) ; croscarmellose natrium (e 468) ; hypromellose, type 2910 (3 - 15 mpa.s) (e 464) ; ijzeroxide geel (e 172) ; ijzeroxide rood (e 172) ; ijzeroxide zwart (e 172) ; lactose 1-water ; magnesiumstearaat (e 470b) ; propylgallaat (e 310), - simvastatin and ezetimibe

Nederland - Nederlands - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

ratiopharm gmbh graf-arco-strasse 3 89079 ulm (duitsland) - ezetimib 10 mg/stuk ; simvastatine 40 mg/stuk - tablet - ascorbinezuur (l-) (e 300) ; butylhydroxyanisol (e 320) ; cellulose, microkristallijn (e 460(i)) ; citroenzuur 0-water (e 330) ; croscarmellose natrium (e 468) ; hypromellose, type 2910 (3 - 15 mpa.s) (e 464) ; ijzeroxide geel (e 172) ; ijzeroxide rood (e 172) ; ijzeroxide zwart (e 172) ; lactose 1-water ; magnesiumstearaat (e 470b) ; propylgallaat (e 310), ascorbinezuur (l-) (e 300) ; butylhydroxyanisol (e 320) ; cellulose, microkristallijn (e 460) ; citroenzuur 0-water (e 330) ; croscarmellose natrium (e 468) ; hypromellose, type 2910 (3 - 15 mpa.s) (e 464) ; ijzeroxide geel (e 172) ; ijzeroxide rood (e 172) ; ijzeroxide zwart (e 172) ; lactose 1-water ; magnesiumstearaat (e 470b) ; propylgallaat (e 310), - simvastatin and ezetimibe