Hà Lan - Tiếng Hà Lan - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

accord healthcare b.v. winthontlaan 200 3526 kv utrecht - hydrochloorthiazide 12,5 mg/stuk ; olmesartanmedoxomil 40 mg/stuk - filmomhulde tablet - cellulose, microkristallijn (e 460(i)) ; hydroxypropylcellulose, laag gesubstitueerd (e 463a) ; hyprolose (e 463) ; hypromellose, type 2910 (3 - 15 mpa.s) (e 464) ; ijzeroxide geel (e 172) ; ijzeroxide rood (e 172) ; lactose 1-water ; macrogol 3000 ; magnesiumstearaat (e 470b) ; talk (e 553 b) ; titaandioxide (e 171), cellulose, microkristallijn (e 460) ; hydroxypropylcellulose, laag gesubstitueerd (e 463) ; hyprolose (e 463) ; hypromellose, type 2910 (3 - 15 mpa.s) (e 464) ; ijzeroxide geel (e 172) ; ijzeroxide rood (e 172) ; lactose 1-water ; macrogol 3000 ; magnesiumstearaat (e 470b) ; talk (e 553 b) ; titaandioxide (e 171), - olmesartan medoxomil and diuretics

Hà Lan - Tiếng Hà Lan - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

accord healthcare b.v. winthontlaan 200 3526 kv utrecht - hydrochloorthiazide 25 mg/stuk ; olmesartanmedoxomil 40 mg/stuk - filmomhulde tablet - cellulose, microkristallijn (e 460(i)) ; hydroxypropylcellulose, laag gesubstitueerd (e 463a) ; hyprolose (e 463) ; hypromellose, type 2910 (3 - 15 mpa.s) (e 464) ; ijzeroxide geel (e 172) ; ijzeroxide rood (e 172) ; lactose 1-water ; macrogol 3000 ; magnesiumstearaat (e 470b) ; talk (e 553 b) ; titaandioxide (e 171), cellulose, microkristallijn (e 460) ; hydroxypropylcellulose, laag gesubstitueerd (e 463) ; hyprolose (e 463) ; hypromellose, type 2910 (3 - 15 mpa.s) (e 464) ; ijzeroxide geel (e 172) ; ijzeroxide rood (e 172) ; lactose 1-water ; macrogol 3000 ; magnesiumstearaat (e 470b) ; talk (e 553 b) ; titaandioxide (e 171), - olmesartan medoxomil and diuretics

Hà Lan - Tiếng Hà Lan - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

pharmachemie b.v. swensweg 5 2031 ga haarlem - tacrolimus 1-water 0,51 mg/stuk samenstelling overeenkomend met ; tacrolimus 0-water 0,5 mg/stuk - capsule, hard - croscarmellose natrium (e 468) ; gelatine (e 441) ; ijzeroxide geel (e 172) ; lactose 0-water ; magnesiumstearaat (e 470b) ; povidon k 30 (e 1201) ; titaandioxide (e 171), - tacrolimus

Hà Lan - Tiếng Hà Lan - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

pharmachemie b.v. swensweg 5 2031 ga haarlem - tacrolimus 1-water 1,02 mg/stuk samenstelling overeenkomend met ; tacrolimus 0-water 1 mg/stuk - capsule, hard - croscarmellose natrium (e 468) ; gelatine (e 441) ; lactose 0-water ; magnesiumstearaat (e 470b) ; povidon k 30 (e 1201) ; titaandioxide (e 171), - tacrolimus

Hà Lan - Tiếng Hà Lan - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

pharmachemie b.v. swensweg 5 2031 ga haarlem - tacrolimus 1-water 5,12 mg/stuk samenstelling overeenkomend met ; tacrolimus 0-water 5 mg/stuk - capsule, hard - croscarmellose natrium (e 468) ; gelatine (e 441) ; ijzeroxide rood (e 172) ; lactose 0-water ; magnesiumstearaat (e 470b) ; povidon k 30 (e 1201) ; titaandioxide (e 171), - tacrolimus

Hà Lan - Tiếng Hà Lan - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

dr. fisher farma b.v. - tacrolimus 1-water samenstelling overeenkomend met ; tacrolimus 0-water - capsule, hard - croscarmellose natrium (e 468) ; gelatine (e 441) ; hyprolose (e 463) ; hypromellose (e 464) ; ijzeroxide rood (e 172) ; lactose 1-water ; lecithine, soya (e 322) ; magnesiumstearaat (e 470b) ; rode inkt ; schellak (e 904) ; simeticon ; titaandioxide (e 171), - tacrolimus

Hà Lan - Tiếng Hà Lan - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

euro registratie collectief b.v. - tacrolimus 1-water samenstelling overeenkomend met ; tacrolimus 0-water - capsule, hard - croscarmellose natrium (e 468) ; gelatine (e 441) ; hypromellose, type 2910 (3 - 15 mpa.s) (e 464) ; ijzeroxide rood (e 172) ; lactose 1-water ; magnesiumstearaat (e 470b) ; propyleenglycol (e 1520) ; schellak (e 904) ; titaandioxide (e 171) ; witte inkt, - tacrolimus

Hà Lan - Tiếng Hà Lan - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

bmodesto b.v. - tacrolimus 1-water samenstelling overeenkomend met ; tacrolimus 0-water - capsule, hard - carmellose natrium (e 466) ; gelatine (e 441) ; hyprolose (e 463) ; hypromellose, type 2910 (3 - 15 mpa.s) (e 464) ; ijzeroxide geel (e 172) ; ijzeroxide rood (e 172) ; lactose 1-water ; lecithine, soya (e 322) ; magnesiumstearaat (e 470b) ; rode inkt ; schellak glaze, gedeeltelijk veresterd ; simeticon ; titaandioxide (e 171), - tacrolimus

Hà Lan - Tiếng Hà Lan - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

bmodesto b.v. - tacrolimus 1-water samenstelling overeenkomend met ; tacrolimus 0-water - capsule, hard - croscarmellose natrium (e 468) ; gelatine (e 441) ; hyprolose (e 463) ; hypromellose, type 2910 (3 - 15 mpa.s) (e 464) ; ijzeroxide rood (e 172) ; lactose 1-water ; lecithine, soya (e 322) ; magnesiumstearaat (e 470b) ; rode inkt ; schellak (e 904) ; simeticon ; titaandioxide (e 171), - tacrolimus

Liên Minh Châu Âu - Tiếng Hà Lan - 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.