Europese Unie - Nederlands - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - ivacaftor - taaislijmziekte - andere producten van het ademhalingssysteem - kalydeco tablets are indicated:as monotherapy for the treatment of adults, adolescents, and children aged 6 years and older and weighing 25 kg or more with cystic fibrosis (cf) who have an r117h cftr mutation or one of the following gating (class iii) mutations in the cystic fibrosis transmembrane conductance regulator (cftr) gene: g551d, g1244e, g1349d, g178r, g551s, s1251n, s1255p, s549n or s549r (see sections 4. 4 en 5. in a combination regimen with tezacaftor/ivacaftor tablets for the treatment of adults, adolescents, and children aged 6 years and older with cystic fibrosis (cf) who are homozygous for the f508del mutation or who are heterozygous for the f508del mutation and have one of the following mutations in the cftr gene: p67l, r117c, l206w, r352q, a455e, d579g, 711+3a→g, s945l, s977f, r1070w, d1152h, 2789+5g→a, 3272 26a→g, and 3849+10kbc→t. in a combination regimen with ivacaftor/tezacaftor/elexacaftor tablets for the treatment of adults, adolescents, and children aged 6 years and older with cystic fibrosis (cf) who have at least one f508del mutation in the cftr gene (see section 5. kalydeco granules are indicated for the treatment of infants aged at least 4 months, toddlers and children weighing 5 kg to less than 25 kg with cystic fibrosis (cf) who have an r117h cftr mutation or one of the following gating (class iii) mutations in the cftr gene: g551d, g1244e, g1349d, g178r, g551s, s1251n, s1255p, s549n or s549r (see sections 4. 4 en 5. in a combination regimen with ivacaftor/tezacaftor/elexacaftor for the treatment of cystic fibrosis (cf) in paediatric patients aged 2 to less than 6 years who have at least one f508del mutation in the cftr gene.

Europese Unie - Nederlands - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - lumacaftor, ivacaftor - taaislijmziekte - andere producten van het ademhalingssysteem - orkambi tabletten zijn geïndiceerd voor de behandeling van cystic fibrosis (cf) patiënten in de leeftijd van 6 jaar en ouder, die homozygoot is voor de f508del mutatie in het cftr-gen. orkambi granules are indicated for the treatment of cystic fibrosis (cf) in children aged 1 year and older who are homozygous for the f508del mutation in the cftr gene.

Europese Unie - Nederlands - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - ivacaftor, tezacaftor, elexacaftor - taaislijmziekte - andere producten van het ademhalingssysteem - kaftrio is indicated in a combination regimen with ivacaftor for the treatment of cystic fibrosis (cf) in patients aged 6 years and older who have at least one f508del mutation in the cystic fibrosis transmembrane conductance regulator (cftr) gene.

Europese Unie - Nederlands - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - tezacaftor, ivacaftor - taaislijmziekte - andere producten van het ademhalingssysteem - symkevi is indicated in a combination regimen with ivacaftor tablets for the treatment of patients with cystic fibrosis (cf) aged 6 years and older who are homozygous for the f508del mutation or who are heterozygous for the f508del mutation and have one of the following mutations in the cystic fibrosis transmembrane conductance regulator (cftr) gene: p67l, r117c, l206w, r352q, a455e, d579g, 711+3a→g, s945l, s977f, r1070w, d1152h, 2789+5g→a, 3272 26a→g, and 3849+10kbc→t.

België - Nederlands - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

pfizer sa-nv - dinoproston 0,5 mg - tablet - 0,5 mg - dinoproston 0.5 mg - dinoprostone

België - Nederlands - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

pfizer sa-nv - dinoproston 3 mg - tablet voor vaginaal gebruik - 3 mg - dinoproston 3.15 mg - dinoprostone

België - Nederlands - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

pfizer sa-nv - dinoproston 2 mg - gel voor vaginaal gebruik - 2 mg - dinoproston 2 mg - dinoprostone

België - Nederlands - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

pfizer sa-nv - dinoproston 1 mg - gel voor vaginaal gebruik - 1 mg - dinoproston 1 mg - dinoprostone

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

aurobindo pharma b.v. baarnsche dijk 1 3741 ln baarn - finasteride 1 mg/stuk - filmomhulde tablet - cellulose, microkristallijn (e 460) ; docusaat natrium ; hyprolose (e 463) ; hypromellose, type 2910 (3 - 15 mpa.s) (e 464) ; ijzeroxide geel (e 172) ; ijzeroxide rood (e 172) ; lactose 1-water ; magnesiumstearaat (e 470b) ; maÏszetmeel, gepregelatineerd ; natriumzetmeelglycolaat ; talk (e 553 b) ; titaandioxide (e 171), cellulose, microkristallijn (e 460) ; docusaat natrium ; hyprolose (e 463) ; hypromellose, type 2910 (3 - 15 mpa.s) (e 464) ; ijzeroxide geel (e 172) ; ijzeroxide rood (e 172) ; lactose 1-water ; magnesiumstearaat (e 470b) ; maÏszetmeel, gepregelatineerd ; natriumzetmeelglycolaat (e468) ; talk (e 553 b) ; titaandioxide (e 171), - finasteride

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

teva nederland b.v. swensweg 5 2031 ga haarlem - finasteride 1 mg/stuk - filmomhulde tablet - cellulose, microkristallijn (e 460) ; hypromellose (e 464) ; ijzeroxide geel (e 172) ; ijzeroxide rood (e 172) ; lactose 1-water ; macrogol 400 ; macrogol 6000 ; magnesiumstearaat (e 470b) ; maÏszetmeel, gepregelatineerd ; natriumlaurilsulfaat (e 487) ; natriumzetmeelglycolaat ; povidon k 30 (e 1201) ; titaandioxide (e 171), cellulose, microkristallijn (e 460) ; hypromellose (e 464) ; ijzeroxide geel (e 172) ; ijzeroxide rood (e 172) ; lactose 1-water ; macrogol 400 ; macrogol 6000 ; magnesiumstearaat (e 470b) ; maÏszetmeel, gepregelatineerd ; natriumlaurilsulfaat (e 487) ; natriumzetmeelglycolaat (e468) ; povidon k 30 (e 1201) ; titaandioxide (e 171), - finasteride