Belgia - Belanda - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

pierre fabre benelux sa-nv - isotretinoïne 40 mg - capsule, zacht - 40 mg - isotretinoïne 40 mg - isotretinoin

Uni Eropa - Belanda - EMA (European Medicines Agency)

gedeon richter plc. - relugolix, norethisterone acetate, estradiol hemihydrate - leiomyoom - hypofyse en hypothalamische hormonen en analogen - ryeqo is indicated in adult women of reproductive age for:- treatment of moderate to severe symptoms of uterine fibroids,- symptomatic treatment of endometriosis in women with a history of previous medical or surgical treatment for their endometriosis.

Uni Eropa - Belanda - EMA (European Medicines Agency)

gedeon richter plc. - drospirenone, estetrol monohydrate - contraceptives, oral - geslachtshormonen en modulatoren van het genitale systeem, - oral contraceptive.

Uni Eropa - Belanda - EMA (European Medicines Agency)

estetra sprl - estetrol monohydrate, drospirenone - contraceptives, oral - geslachtshormonen en modulatoren van het genitale systeem, - orale anticonceptie. the decision to prescribe lydisilka should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (vte), and how the risk of vte with lydisilka compares with other combined hormonal contraceptives (chcs) (see sections 4. 3 and 4.

Uni Eropa - Belanda - EMA (European Medicines Agency)

fresenius kabi deutschland gmbh - tocilizumab - arthritis, rheumatoid; cytokine release syndrome; arthritis, juvenile rheumatoid; covid-19 virus infection; giant cell arteritis - immunosuppressiva - tyenne, in combination with methotrexate (mtx), is indicated for- the treatment of severe, active and progressive rheumatoid arthritis (ra) in adults not previously treated with mtx. - the treatment of moderate to severe active ra in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (dmards) or tumour necrosis factor (tnf) antagonists. in these patients, tyenne can be given as monotherapy in case of intolerance to mtx or where continued treatment with mtx is inappropriate. tocilizumab has been shown to reduce the rate of progression of joint damage as measured by x-ray and to improve physical function when given in combination with methotrexate. tyenne is indicated for the treatment of coronavirus disease 2019 (covid-19) in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. tyenne is indicated for the treatment of active systemic juvenile idiopathic arthritis (sjia) in patients 1 year of age and older, who have responded inadequately to previous therapy with nsaids and systemic corticosteroids. tyenne can be given as monotherapy (in case of intolerance to mtx or where treatment with mtx is inappropriate) or in combination with mtx. tyenne in combination with methotrexate (mtx) is indicated for the treatment of juvenile idiopathic polyarthritis (pjia; rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with mtx. tyenne can be given as monotherapy in case of intolerance to mtx or where continued treatment with mtx is inappropriate. tyenne is indicated for the treatment of chimeric antigen receptor (car) t cell-induced severe or life-threatening cytokine release syndrome (crs) in adults and paediatric patients 2 years of age and older. tyenne is indicated for the treatment of giant cell arteritis (gca) in adult patients.

Belanda - Belanda - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

grunenthal b.v. de corridor 21k 3621 za breukelen - tapentadolhydrochloride 4,7 mg/ml samenstelling overeenkomend met ; tapentadol 4 mg/ml - drank - citroenzuur 1-water (e 330) ; frambozensmaakstof ; natriumbenzoaat (e 211) ; propyleenglycol (e 1520) ; sucralose (e 955) ; water, gezuiverd, - tapentadol

Belanda - Belanda - 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

Belanda - Belanda - 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

Belanda - Belanda - 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

Belanda - Belanda - 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