Hollandia - holland - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

bioorganics bv microweg 22 6545 cm nijmegen - deferasirox 360 mg/stuk - filmomhulde tablet - cellulose, microkristallijn (e 460(i)) ; crospovidon (e 1202) ; glyceroltriacetaat (e 1518) ; hypromellose (e 464) ; indigokarmijn aluminiumlak (e 132) ; lactose 1-water ; magnesiumstearaat (e 470b) ; poloxameer 188 ; povidon k 30 (e 1201) ; siliciumdioxide (e 551) ; titaandioxide (e 171), cellulose, microkristallijn (e 460) ; crospovidon (e 1202) ; glyceroltriacetaat (e 1518) ; hypromellose (e 464) ; indigokarmijn aluminiumlak (e 132) ; lactose 1-water ; magnesiumstearaat (e 470b) ; poloxameer 188 ; povidon k 30 (e 1201) ; siliciumdioxide (e 551) ; titaandioxide (e 171) - deferasirox

Hollandia - holland - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

bioorganics bv microweg 22 6545 cm nijmegen - deferasirox 90 mg/stuk - filmomhulde tablet - cellulose, microkristallijn (e 460(i)) ; crospovidon (e 1202) ; glyceroltriacetaat (e 1518) ; hypromellose (e 464) ; indigokarmijn aluminiumlak (e 132) ; lactose 1-water ; magnesiumstearaat (e 470b) ; poloxameer 188 ; povidon k 30 (e 1201) ; siliciumdioxide (e 551) ; titaandioxide (e 171), cellulose, microkristallijn (e 460) ; crospovidon (e 1202) ; glyceroltriacetaat (e 1518) ; hypromellose (e 464) ; indigokarmijn aluminiumlak (e 132) ; lactose 1-water ; magnesiumstearaat (e 470b) ; poloxameer 188 ; povidon k 30 (e 1201) ; siliciumdioxide (e 551) ; titaandioxide (e 171) - deferasirox

Hollandia - holland - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

synthon b.v. microweg 22 6545 cm nijmegen - deferasirox - filmomhulde tablet - cellulose, microkristallijn (e 460) ; crospovidon (e 1202) ; glyceroltriacetaat (e 1518) ; hypromellose (e 464) ; indigokarmijn aluminiumlak (e 132) ; lactose 1-water ; magnesiumstearaat (e 470b) ; poloxameer 188 ; povidon k 30 (e 1201) ; siliciumdioxide (e 551) ; titaandioxide (e 171) - deferasirox

Hollandia - holland - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

synthon b.v. microweg 22 6545 cm nijmegen - deferasirox 180 mg/stuk - filmomhulde tablet - cellulose, microkristallijn (e 460(i)) ; crospovidon (e 1202) ; glyceroltriacetaat (e 1518) ; hypromellose (e 464) ; indigokarmijn aluminiumlak (e 132) ; lactose 1-water ; magnesiumstearaat (e 470b) ; poloxameer 188 ; povidon k 30 (e 1201) ; siliciumdioxide (e 551) ; titaandioxide (e 171), cellulose, microkristallijn (e 460) ; crospovidon (e 1202) ; glyceroltriacetaat (e 1518) ; hypromellose (e 464) ; indigokarmijn aluminiumlak (e 132) ; lactose 1-water ; magnesiumstearaat (e 470b) ; poloxameer 188 ; povidon k 30 (e 1201) ; siliciumdioxide (e 551) ; titaandioxide (e 171) - deferasirox

Hollandia - holland - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

synthon b.v. microweg 22 6545 cm nijmegen - deferasirox - filmomhulde tablet - cellulose, microkristallijn (e 460) ; crospovidon (e 1202) ; glyceroltriacetaat (e 1518) ; hypromellose (e 464) ; indigokarmijn aluminiumlak (e 132) ; lactose 1-water ; magnesiumstearaat (e 470b) ; poloxameer 188 ; povidon k 30 (e 1201) ; siliciumdioxide (e 551) ; titaandioxide (e 171) - deferasirox

Hollandia - holland - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

synthon b.v. microweg 22 6545 cm nijmegen - deferasirox 360 mg/stuk - filmomhulde tablet - cellulose, microkristallijn (e 460(i)) ; crospovidon (e 1202) ; glyceroltriacetaat (e 1518) ; hypromellose (e 464) ; indigokarmijn aluminiumlak (e 132) ; lactose 1-water ; magnesiumstearaat (e 470b) ; poloxameer 188 ; povidon k 30 (e 1201) ; siliciumdioxide (e 551) ; titaandioxide (e 171), cellulose, microkristallijn (e 460) ; crospovidon (e 1202) ; glyceroltriacetaat (e 1518) ; hypromellose (e 464) ; indigokarmijn aluminiumlak (e 132) ; lactose 1-water ; magnesiumstearaat (e 470b) ; poloxameer 188 ; povidon k 30 (e 1201) ; siliciumdioxide (e 551) ; titaandioxide (e 171) - deferasirox

Hollandia - holland - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

synthon b.v. microweg 22 6545 cm nijmegen - deferasirox - filmomhulde tablet - cellulose, microkristallijn (e 460) ; crospovidon (e 1202) ; glyceroltriacetaat (e 1518) ; hypromellose (e 464) ; indigokarmijn aluminiumlak (e 132) ; lactose 1-water ; magnesiumstearaat (e 470b) ; poloxameer 188 ; povidon k 30 (e 1201) ; siliciumdioxide (e 551) ; titaandioxide (e 171) - deferasirox

Hollandia - holland - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

synthon b.v. microweg 22 6545 cm nijmegen - deferasirox 90 mg/stuk - filmomhulde tablet - cellulose, microkristallijn (e 460(i)) ; crospovidon (e 1202) ; glyceroltriacetaat (e 1518) ; hypromellose (e 464) ; indigokarmijn aluminiumlak (e 132) ; lactose 1-water ; magnesiumstearaat (e 470b) ; poloxameer 188 ; povidon k 30 (e 1201) ; siliciumdioxide (e 551) ; titaandioxide (e 171), cellulose, microkristallijn (e 460) ; crospovidon (e 1202) ; glyceroltriacetaat (e 1518) ; hypromellose (e 464) ; indigokarmijn aluminiumlak (e 132) ; lactose 1-water ; magnesiumstearaat (e 470b) ; poloxameer 188 ; povidon k 30 (e 1201) ; siliciumdioxide (e 551) ; titaandioxide (e 171) - deferasirox

Hollandia - holland - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

mylan b.v. dieselweg 25 3752 lb bunschoten - doxazosinemesilaat 9,7 mg/stuk samenstelling overeenkomend met ; doxazosine 8 mg/stuk - tablet met verlengde afgifte - butylhydroxytolueen (e 321) ; cellulose, microkristallijn (e 460(i)) ; copolymeer van ethylacrylaat-methacrylzuur (1:1) ; macrogol 1500 ; natriumstearylfumaraat ; polyethyleenoxide ; povidon k 30 (e 1201) ; siliciumdioxide (e 551) ; siliciumdioxide, gehydrateerd (e 551) ; titaandioxide (e 171) ; tocoferol, dl-alfa (e 307), butylhydroxytolueen (e 321) ; cellulose, microkristallijn (e 460) ; copolymeer van ethylacrylaat-methacrylzuur (1:1) ; macrogol 1500 ; natriumstearylfumaraat ; polyethyleenoxide ; povidon k 30 (e 1201) ; siliciumdioxide (e 551) ; siliciumdioxide, gehydrateerd (e 551) ; titaandioxide (e 171) ; tocoferol, dl-alfa (e 307), butylhydroxytolueen (e 321) ; cellulose, microkristallijn (e 460) ; copolymeer van ethylacrylaat-methacrylzuur (1:1) ; macrogol 1500 ; natriumstearylfumaraat ; polyethyleenoxide ; povidon k 30 (e 1201) ; siliciumdioxide (e 551) ; titaandioxide (e 171) ; tocoferol, d-alfa (e 307), - doxazosin

Európai Unió - holland - EMA (European Medicines Agency)

alexion europe sas - ravulizumab - hemoglobinurie, paroxysmale - selectieve immunosuppressiva - paroxysmal nocturnal haemoglobinuria (pnh)ultomiris is indicated in the treatment of adult and paediatric patients with a body weight of 10 kg or above with pnh:- in patients with haemolysis with clinical symptom(s) indicative of high disease activity. - in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months (see section 5. atypical haemolytic uremic syndrome (ahus)ultomiris is indicated in the treatment of patients with a body weight of 10 kg or above with ahus who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab (see section 5. generalized myasthenia gravis (gmg)ultomiris is indicated as an add-on to standard therapy for the treatment of adult patients with gmg who are anti-acetylcholine receptor (achr) antibody-positive. neuromyelitis optica spectrum disorder (nmosd)ultomiris is indicated in the treatment of adult patients with nmosd who are anti-aquaporin 4 (aqp4) antibody-positive (see section 5. ultomiris is indicated in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (pnh):- in patients with haemolysis with clinical symptom(s) indicative of high disease activity. - in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months. ultomiris is indicated in the treatment of adult patients with atypical haemolytic uremic syndrome (ahus) who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab.