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.

Europese Unie - Nederlands - EMA (European Medicines Agency)

mylan ireland limited - dimethylfumaraat - multiple sclerose, relapsing-remitting - immunosuppressiva - dimethyl fumarate mylan is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis.

Europese Unie - Nederlands - EMA (European Medicines Agency)

biosimilar collaborations ireland limited - bevacizumab - colorectal neoplasms; breast neoplasms; ovarian neoplasms; fallopian tube neoplasms; peritoneal neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell; uterine cervical neoplasms - antineoplastische middelen - abevmy in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. abevmy in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. zie rubriek 5 voor meer informatie over de status van humane epidermale groeifactorreceptor 2 (her2). abevmy in combination with capecitabine is indicated for first-line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. patients who have received taxane and anthracycline containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with abevmy in combination with capecitabine. raadpleeg sectie 5 voor meer informatie over her2-status. abevmy, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology. abevmy, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with epidermal growth factor receptor (egfr) activating mutations (see section 5. abevmy in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. abevmy, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (international federation of gynecology and obstetrics [figo] stages iii b, iii c and iv) epithelial ovarian, fallopian tube, or primary peritoneal cancer (see section 5. abevmy, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor–targeted agents. abevmy in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor–targeted agents (see section 5. abevmy, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix (see section 5.

Europese Unie - Nederlands - EMA (European Medicines Agency)

nova laboratories ireland limited - spironolacton - edema; heart failure; liver cirrhosis; ascites; nephrotic syndrome; hyperaldosteronism; essential hypertension - antihypertensives and diuretics in combination - in the management of refractory oedema associated with congestive cardiac failure; hepatic cirrhosis with ascites and oedema, malignant ascites, nephrotic syndrome, diagnosis and treatment of primary aldosteronism, essential hypertension. neonates, children and adolescents should only be treated under guidance of a paediatric specialist (see sections 5. 1 en 5.

Europese Unie - Nederlands - EMA (European Medicines Agency)

biocryst ireland limited - berotralstat dihydrochloride - angioedemas, erfelijk - other hematological agents - orladeyo is indicated for routine prevention of recurrent attacks of hereditary angioedema (hae) in adult and adolescent patients aged 12 years and older.

Europese Unie - Nederlands - EMA (European Medicines Agency)

mylan ireland limited - abirateronacetaat - prostaatnoplasma - endocrine therapy, other hormone antagonists and related agents - abiraterone mylan is indicated with prednisone or prednisolone for:the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mhspc) in adult men in combination with androgen deprivation therapy (adt). the treatment of metastatic castration resistant prostate cancer (mcrpc) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated. the treatment of mcrpc in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen.

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

meda pharma b.v. - pantoprazol natrium 1,5-water samenstelling overeenkomend met; pantoprazol; - maagsapresistente tablet - pantoprazole

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

zr pharma& gmbh hietzinger hauptstrasse 37 1130 wenen (oostenrijk) - mesalazine 400 mg/stuk - maagsapresistente tablet - copolymeer van methacrylzuur-methylmethacrylaat (1:2)(e 1207) ; ijzeroxide geel (e 172) ; ijzeroxide rood (e 172) ; lactose 1-water ; macrogol 6000 ; magnesiumstearaat (e 470b) ; natriumzetmeelglycolaat ; povidon k 25 (e 1201) ; siliciumdioxide (e 551) ; talk (e 553 b) ; triethylcitraat (e 1505), copolymeer van methacrylzuur-methylmethacrylaat (1:2) ; ijzeroxide geel (e 172) ; ijzeroxide rood (e 172) ; lactose 1-water ; macrogol 6000 ; magnesiumstearaat (e 470b) ; natriumzetmeelglycolaat ; povidon k 25 (e 1201) ; siliciumdioxide (e 551) ; talk (e 553 b) ; triethylcitraat (e 1505), copolymeer van methacrylzuur-methylmethacrylaat (1:2) ; ijzeroxide geel (e 172) ; ijzeroxide rood (e 172) ; lactose 1-water ; macrogol 6000 ; magnesiumstearaat (e 470b) ; natriumzetmeelglycolaat ; povidon (e 1201) ; siliciumdioxide (e 551) ; talk (e 553 b) ; triethylcitraat (e 1505), copolymeer van methacrylzuur-methylmethacrylaat (1:2) ; ijzeroxide geel (e 172) ; ijzeroxide rood (e 172) ; lactose 1-water ; macrogol 6000 ; magnesiumstearaat (e 470b) ; natriumzetmeelglycolaat (e468) ; povidon (e 1201) ; siliciumdioxide (e 551) ; talk (e 553 b) ; triethylcitraat (e 1505), - mesalazine