Europese Unie - Nederlands - EMA (European Medicines Agency)

pfizer europe ma eeig - tofacitinib - artritis, reumatoïde - immunosuppressiva - rheumatoid arthritistofacitinib in combination with methotrexate (mtx) is indicated for the treatment of moderate to severe active rheumatoid arthritis (ra) in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying antirheumatic drugs (dmards) (see section 5. tofacitinib can be given as monotherapy in case of intolerance to mtx or when treatment with mtx is inappropriate (see sections 4. 4 en 4. psoriatic arthritistofacitinib in combination with mtx is indicated for the treatment of active psoriatic arthritis (psa) in adult patients who have had an inadequate response or who have been intolerant to a prior disease modifying antirheumatic drug (dmard) therapy (see section 5. ulcerative colitistofacitinib is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (uc) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent (see section 5. tofacitinib is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (rheumatoid factor positive [rf+] or negative [rf-] polyarthritis and extended oligoarthritis), and juvenile psoriatic arthritis (psa) in patients 2 years of age and older, who have responded inadequately to previous therapy with disease modifying antirheumatic drugs (dmards). tofacitinib can be given in combination with methotrexate (mtx) or as monotherapy in case of intolerance to mtx or where continued treatment with mtx is inappropriate. ankylosing spondylitistofacitinib is indicated for the treatment of adult patients with active ankylosing spondylitis (as) who have responded inadequately to conventional therapy.

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

medcor pharmaceuticals b.v. artemisweg 232 8239 de lelystad - rosuvastatine calcium 0-water 10,4 mg/stuk samenstelling overeenkomend met ; rosuvastatine 10 mg/stuk - filmomhulde tablet - cellulose, microkristallijn (e 460(i)) ; crospovidon (e 1202) ; glyceroltriacetaat (e 1518) ; hypromellose (e 464) ; ijzeroxide rood (e 172) ; lactose 1-water ; magnesiumstearaat (e 470b) ; titaandioxide (e 171) ; tricalciumfosfaat (e 341 (iii)), cellulose, microkristallijn (e 460) ; crospovidon (e 1202) ; glyceroltriacetaat (e 1518) ; hypromellose (e 464) ; ijzeroxide rood (e 172) ; lactose 1-water ; magnesiumstearaat (e 470b) ; titaandioxide (e 171) ; tricalciumfosfaat, - rosuvastatin

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

astrazeneca b.v prinses beatrixlaan 582 2595 bm den haag - rosuvastatine calcium 0-water 10,4 mg/stuk samenstelling overeenkomend met ; rosuvastatine 10 mg/stuk - filmomhulde tablet - cellulose, microkristallijn (e 460(i)) ; crospovidon (e 1202) ; glyceroltriacetaat (e 1518) ; hypromellose (e 464) ; ijzeroxide rood (e 172) ; lactose 1-water ; magnesiumstearaat (e 470b) ; titaandioxide (e 171) ; tricalciumfosfaat (e 341 (iii)), cellulose, microkristallijn (e 460) ; crospovidon (e 1202) ; glyceroltriacetaat (e 1518) ; hypromellose (e 464) ; ijzeroxide rood (e 172) ; lactose 1-water ; magnesiumstearaat (e 470b) ; titaandioxide (e 171) ; tricalciumfosfaat, - rosuvastatin

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

euro registratie collectief b.v. - rosuvastatine calcium 0-water samenstelling overeenkomend met; rosuvastatine; - filmomhulde tablet - rosuvastatin

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

euro registratie collectief b.v. van der giessenweg 5 2921 lp krimpen a/d ijssel - rosuvastatine calcium 0-water 10,4 mg/stuk samenstelling overeenkomend met ; rosuvastatine 10 mg/stuk - filmomhulde tablet - cellulose, microkristallijn (e 460(i)) ; crospovidon (e 1202) ; glyceroltriacetaat (e 1518) ; hypromellose (e 464) ; ijzeroxide rood (e 172) ; lactose 1-water ; magnesiumstearaat (e 470b) ; titaandioxide (e 171) ; tricalciumfosfaat (e 341 (iii)), cellulose, microkristallijn (e 460) ; crospovidon (e 1202) ; glyceroltriacetaat (e 1518) ; hypromellose (e 464) ; ijzeroxide rood (e 172) ; lactose 1-water ; magnesiumstearaat (e 470b) ; titaandioxide (e 171) ; tricalciumfosfaat, - rosuvastatin

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

delphi pharmaceuticals b.v. spoorhaven 39 2651 av berkel en rodenrijs - rosuvastatine calcium 0-water samenstelling overeenkomend met ; rosuvastatine - filmomhulde tablet - cellulose, microkristallijn (e 460) ; crospovidon (e 1202) ; glyceroltriacetaat (e 1518) ; hypromellose (e 464) ; ijzeroxide rood (e 172) ; lactose 1-water ; magnesiumstearaat (e 470b) ; titaandioxide (e 171) ; tricalciumfosfaat, - rosuvastatin

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

euro registratie collectief b.v. - rosuvastatine calcium 0-water samenstelling overeenkomend met; rosuvastatine; - filmomhulde tablet - rosuvastatin

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

dr. fisher farma b.v. - rosuvastatine calcium 0-water samenstelling overeenkomend met; rosuvastatine; - filmomhulde tablet - rosuvastatin

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

eu-pharma b.v. de steiger 41 1351 ac almere - rosuvastatine calcium 0-water 10,4 mg/stuk samenstelling overeenkomend met ; rosuvastatine 10 mg/stuk - filmomhulde tablet - cellulose, microkristallijn (e 460(i)) ; crospovidon (e 1202) ; glyceroltriacetaat (e 1518) ; hypromellose (e 464) ; ijzeroxide rood (e 172) ; lactose 1-water ; magnesiumstearaat (e 470b) ; titaandioxide (e 171) ; tricalciumfosfaat (e 341 (iii)), cellulose, microkristallijn (e 460) ; crospovidon (e 1202) ; glyceroltriacetaat (e 1518) ; hypromellose (e 464) ; ijzeroxide rood (e 172) ; lactose 1-water ; magnesiumstearaat (e 470b) ; titaandioxide (e 171) ; tricalciumfosfaat, - rosuvastatin

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

dr. fisher farma b.v. - rosuvastatine calcium 0-water samenstelling overeenkomend met; rosuvastatine; - filmomhulde tablet - rosuvastatin