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

sandoz b.v. veluwezoom 22 1327 ah almere - methotrexaat - oplossing voor injectie - natriumchloride ; natriumhydroxide (e 524) ; stikstof (head space) (e 941) ; water voor injectie, - methotrexate

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

sandoz b.v. veluwezoom 22 1327 ah almere - methotrexaat - oplossing voor injectie - natriumchloride ; natriumhydroxide (e 524) ; stikstof (head space) (e 941) ; water voor injectie, - methotrexate

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

sandoz b.v. veluwezoom 22 1327 ah almere - methotrexaat - oplossing voor injectie - natriumchloride ; natriumhydroxide (e 524) ; stikstof (head space) (e 941) ; water voor injectie, - methotrexate

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

sandoz b.v. veluwezoom 22 1327 ah almere - methotrexaat - oplossing voor injectie - natriumchloride ; natriumhydroxide (e 524) ; stikstof (head space) (e 941) ; water voor injectie, - methotrexate

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

sandoz b.v. veluwezoom 22 1327 ah almere - lansoprazol - maagsapresistente capsule, hard - carrageenan (e 407) ; copolymeer van ethylacrylaat-methacrylzuur (1:1) ; hypromellose (e 464) ; kaliumchloride ; macrogol 400 ; magnesiumcarbonaat, licht (e 504 (ii)) ; maÏszetmeel ; natriumlaurilsulfaat (e 487) ; polysorbaat 80 (e 433) ; saccharose ; siliciumdioxide (e 551) ; sugar spheres ; talk (e 553 b) ; titaandioxide (e 171), - lansoprazole

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

sandoz b.v. veluwezoom 22 1327 ah almere - lansoprazol - maagsapresistente capsule, hard - carrageenan (e 407) ; copolymeer van ethylacrylaat-methacrylzuur (1:1) ; hypromellose (e 464) ; kaliumchloride ; macrogol 400 ; magnesiumcarbonaat, licht (e 504 (ii)) ; maÏszetmeel ; natriumlaurilsulfaat (e 487) ; polysorbaat 80 (e 433) ; saccharose ; siliciumdioxide (e 551) ; sugar spheres ; talk (e 553 b) ; titaandioxide (e 171), - lansoprazole

Europese Unie - Nederlands - EMA (European Medicines Agency)

celltrion healthcare hungary kft. - adalimumab - arthritis, rheumatoid; arthritis, psoriatic; psoriasis; spondylitis, ankylosing; uveitis; hidradenitis suppurativa; colitis, ulcerative; crohn disease; arthritis, juvenile rheumatoid - immunosuppressiva - rheumatoid arthritisyuflyma 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. yuflyma can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. 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 arthritispolyarticular juvenile idiopathic arthritisyuflyma 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). yuflyma can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5. adalimumab is niet onderzocht bij patiënten jonger dan 2 jaar. enthesitis-related arthritisyuflyma 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 (see section 5. axial spondyloarthritisankylosing spondylitis (as)yuflyma 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 asyuflyma 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 non-steroidal anti-inflammatory drugs (nsaids). psoriatic arthritisyuflyma 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 (zie hoofdstuk 5. 1) en aan het verbeteren van de fysieke functie. psoriasisyuflyma is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. paediatric plaque psoriasisyuflyma 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)yuflyma 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 (see sections 5. 1 en 5. crohn’s diseaseyuflyma 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 diseaseyuflyma 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. ulcerative colitisyuflyma 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. paediatric ulcerative colitisyuflyma 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. uveitisyuflyma 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 uveitisyuflyma 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.

Europese Unie - Nederlands - EMA (European Medicines Agency)

cangene europe limited - humaan hepatitis b-immunoglobuline - immunization, passive; hepatitis b - specifieke immunoglobulinen - immunoprofylaxe van hepatitis b - in geval van accidentele blootstelling in niet-geïmmuniseerde personen (inclusief personen van wie de vaccinatie isincomplete of status onbekend). - in haemodialysed patiënten, tot vaccinatie van kracht is geworden. - in de pasgeborene van een hepatitis-b-virus drager-moeder. - in onderwerpen die niet een immuunrespons (geen meetbare hepatitis b-antistoffen) na de vaccinatie en voor wie een continue preventie is nodig vanwege de voortdurende risico van besmetting met hepatitis b. er moet ook aandacht worden gegeven aan andere officiële richtlijnen betreffende het juiste gebruik van het menselijk hepatitis b-immunoglobuline voor intramusculair gebruik.

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

dr. fisher farma b.v. - dydrogesteron; estradiol 0,5-water samenstelling overeenkomend met; estradiol; - filmomhulde tablet - dydrogesterone and estrogen

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

bmodesto b.v. - dydrogesteron; estradiol 0,5-water samenstelling overeenkomend met; estradiol; - filmomhulde tablet - dydrogesterone and estrogen