Liên Minh Châu Âu - Tiếng Hà Lan - EMA (European Medicines Agency)

astrazeneca ab - osimertinib mesilate - carcinoom, niet-kleincellige long - andere antineoplastische middelen, proteïne kinase remmers - tagrisso as monotherapy is indicated for:- the adjuvant treatment after complete tumour resection in adult patients with stage ib-iiia non-small cell lung cancer (nsclc) whose tumours have epidermal growth factor receptor (egfr) exon 19 deletions or exon 21 (l858r) substitution mutations- the first-line treatment of adult patients nsclc with activating egfr mutations. - the treatment of adult patients with locally advanced or metastatic egfr t790m mutation-positive nsclc. tagrisso as monotherapy is indicated for:- the adjuvant treatment after complete tumour resection in adult patients with stage ib-iiia non-small cell lung cancer (nsclc) whose tumours have epidermal growth factor receptor (egfr) exon 19 deletions or exon 21 (l858r) substitution mutations. - the first-line treatment of adult patients with locally advanced or metastatic nsclc with activating egfr mutations. - the treatment of adult patients with locally advanced or metastatic egfr t790m mutation-positive nsclc.

Liên Minh Châu Âu - Tiếng Hà Lan - EMA (European Medicines Agency)

astrazeneca ab - saxagliptin - diabetes mellitus, type 2 - geneesmiddelen die worden gebruikt bij diabetes - add-on combination therapyonglyza is indicated in adult patients aged 18 years and older with type-2 diabetes mellitus to improve glycaemic control:as monotherapy:in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance;as dual oral therapy:in combination with metformin, when metformin alone, with diet and exercise, does not provide adequate glycaemic control;in combination with a sulphonylurea, when the sulphonylurea alone, with diet and exercise, does not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate;in combination with a thiazolidinedione, when the thiazolidinedione alone with diet and exercise, does not provide adequate glycaemic control in patients for whom use of a thiazolidinedione is considered appropriate;as triple oral therapy:in combination with metformin plus a sulphonylurea when this regimen alone, with diet and exercise, does not provide adequate glycaemic control;as combination therapy with insulin (with or without metformin), when this regimen alone, with diet and exercise, does not provide adequate glycaemic control.

Hà Lan - Tiếng Hà Lan - 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

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

astrazeneca b.v prinses beatrixlaan 582 2595 bm den haag - rosuvastatine calcium 0-water 20,8 mg/stuk samenstelling overeenkomend met ; rosuvastatine 20 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

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

astrazeneca b.v prinses beatrixlaan 582 2595 bm den haag - rosuvastatine calcium 0-water 41,6 mg/stuk samenstelling overeenkomend met ; rosuvastatine 40 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

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

astrazeneca b.v prinses beatrixlaan 582 2595 bm den haag - rosuvastatine calcium 0-water 5,2 mg/stuk samenstelling overeenkomend met ; rosuvastatine 5 mg/stuk - filmomhulde tablet - cellulose, microkristallijn (e 460(i)) ; crospovidon (e 1202) ; glyceroltriacetaat (e 1518) ; hypromellose (e 464) ; ijzeroxide geel (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 geel (e 172) ; lactose 1-water ; magnesiumstearaat (e 470b) ; titaandioxide (e 171) ; tricalciumfosfaat, - rosuvastatin

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

astrazeneca b.v prinses beatrixlaan 582 2595 bm den haag - felodipine 2,5 mg/stuk - tablet met verlengde afgifte - carnaubawas (e 903) ; cellulose, microkristallijn (e 460(i)) ; hyprolose (e 463) ; hypromellose (e 464) ; hypromellose (release controlling polymer)(e 464) ; hypromellose, type 2910 (3 - 15 mpa.s) (e 464) ; ijzeroxide geel (e 172) ; lactose 0-water ; macrogol 6000 ; macrogolglycerolhydroxystearaat ; natriumaluminiumsilicaat (e 554) ; natriumstearylfumaraat ; propylgallaat (e 310) ; titaandioxide (e 171), carnaubawas (e 903) ; cellulose, microkristallijn (e 460) ; hyprolose (e 463) ; hypromellose (e 464) ; hypromellose (release controlling polymer)(e 464) ; hypromellose, type 2910 (3 - 15 mpa.s) (e 464) ; ijzeroxide geel (e 172) ; lactose 0-water ; macrogol 6000 ; macrogolglycerolhydroxystearaat ; natriumaluminiumsilicaat (e 554) ; natriumstearylfumaraat ; propylgallaat (e 310) ; titaandioxide (e 171), - felodipine

Hà Lan - Tiếng Hà Lan - 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

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

astrazeneca b.v prinses beatrixlaan 582 2595 bm den haag - rosuvastatine calcium 0-water 20,8 mg/stuk samenstelling overeenkomend met ; rosuvastatine 20 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

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

astrazeneca b.v prinses beatrixlaan 582 2595 bm den haag - rosuvastatine calcium 0-water 41,6 mg/stuk samenstelling overeenkomend met ; rosuvastatine 40 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