Nederländerna - nederländska - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

krka d.d., novo mesto smarjeska cesta 6 8501 novo mesto (sloveniË) - fingolimodhydrochloride 0,56 mg/stuk samenstelling overeenkomend met ; fingolimod 0,5 mg/stuk - capsule, hard - ammonia (e 527) ; carrageenan (e 407) ; cellulose, microkristallijn (e 460(i)) ; hypromellose (e 464) ; ijzeroxide geel (e 172) ; ijzeroxide zwart (e 172) ; kaliumchloride (e 508) ; kaliumhydroxide (e 525) ; magnesiumstearaat (e 470b) ; povidon k 30 (e 1201) ; propyleenglycol (e 1520) ; schellak (e 904) ; titaandioxide (e 171) ; zwarte inkt, ammonia (e 527) ; carrageenan (e 407) ; cellulose, microkristallijn (e 460) ; hypromellose (e 464) ; ijzeroxide geel (e 172) ; ijzeroxide zwart (e 172) ; kaliumchloride ; kaliumhydroxide (e 525) ; magnesiumstearaat (e 470b) ; povidon k 30 (e 1201) ; propyleenglycol (e 1520) ; schellak (e 904) ; titaandioxide (e 171) ; zwarte inkt, ammonia (e 527) ; cellulose, microkristallijn (e 460) ; gelatine (e 441) ; ijzeroxide geel (e 172) ; ijzeroxide zwart (e 172) ; magnesiumstearaat (e 470b) ; povidon k 30 (e 1201) ; propyleenglycol (e 1520) ; schellak (e 904) ; titaandioxide (e 171) ; zwarte inkt

Europeiska unionen - nederländska - EMA (European Medicines Agency)

samsung bioepis nl b.v. - 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 - onbevzi in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. onbevzi 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). onbevzi 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 onbevzi in combination with capecitabine. raadpleeg sectie 5 voor meer informatie over her2-status. onbevzi, 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. onbevzi, 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. onbevzi in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. onbevzi, 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. onbevzi, 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. onbevzi, in combination with 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. onbevzi, 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.

Nederländerna - nederländska - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

denk pharma gmbh & co. kg prinzregentenstrasse 79 81675 mÜnchen (duitsland) - fingolimodhydrochloride 0,56 mmol/stuk samenstelling overeenkomend met ; fingolimod 0,5 mg/stuk - capsule, hard - ammonia (e 527) ; calciumwaterstoffosfaat 2-water (e 341) ; croscarmellose natrium (e 468) ; gelatine (e 441) ; hyprolose (e 463) ; ijzeroxide geel (e 172) ; ijzeroxide zwart (e 172) ; kaliumhydroxide (e 525) ; magnesiumstearaat (e 470b) ; propyleenglycol (e 1520) ; schellak (e 904) ; titaandioxide (e 171) ; zwarte inkt

Nederländerna - nederländska - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

glenmark arzneimittel gmbh industriestrasse 31 82194 grobenzell (duitsland) - fingolimodhydrochloride 0,56 mg/stuk samenstelling overeenkomend met ; fingolimod 0,5 mg/stuk - capsule, hard - ammonia (e 527) ; gelatine (e 441) ; ijzeroxide geel (e 172) ; ijzeroxide zwart (e 172) ; propyleenglycol (e 1520) ; schellak glaze, gedeeltelijk veresterd ; stearinezuur (e 570) ; titaandioxide (e 171) ; tricalciumfosfaat (e 341 (iii)) ; zwarte inkt, ammonia (e 527) ; gelatine (e 441) ; ijzeroxide geel (e 172) ; ijzeroxide zwart (e 172) ; propyleenglycol (e 1520) ; schellak glaze, gedeeltelijk veresterd ; stearinezuur (e 570) ; titaandioxide (e 171) ; tricalciumfosfaat ; zwarte inkt, ammonia (e 527) ; blauwe inkt ; gelatine (e 441) ; gele inkt ; ijzeroxide geel (e 172) ; ijzeroxide zwart (e 172) ; propyleenglycol (e 1520) ; schellak glaze, gedeeltelijk veresterd ; stearinezuur (e 570) ; titaandioxide (e 171) ; tricalciumfosfaat

Nederländerna - nederländska - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

synthon b.v. microweg 22 6545 cm nijmegen - fingolimodhydrochloride 0,56 mg/stuk samenstelling overeenkomend met ; fingolimod 0,5 mg/stuk - capsule, hard - gelatine (e 441) ; ijzeroxide geel (e 172) ; magnesiumstearaat (e 470b) ; siliciumdioxide (e 551) ; titaandioxide (e 171) ; trikaliumcitraat 1-water (e 332), gelatine (e 441) ; ijzeroxide geel (e 172) ; magnesiumstearaat (e 470b) ; siliciumdioxide (e 551) ; titaandioxide (e 171) ; trikaliumcitraat 1-water

Europeiska unionen - nederländska - EMA (European Medicines Agency)

mabxience research sl - bevacizumab - colorectal neoplasms; breast neoplasms; ovarian neoplasms; peritoneal neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell; uterine cervical neoplasms - antineoplastische middelen - alymsys in combination with fluoropyrimidine based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. alymsys in combination with paclitaxel is indicated for first line treatment of adult patients with metastatic breast cancer. alymsys 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 alymsys in combination with capecitabine. alymsys, 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. alymsys, 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. alymsys in combination with interferon alfa 2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. alymsys, 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. alymsys, 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. alymsys, in combination with 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. alymsys, 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.

Europeiska unionen - nederländska - EMA (European Medicines Agency)

stada arzneimittel ag - 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 - oyavas in combination with fluoropyrimidine based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. oyavas 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). oyavas 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 oyavas in combination with capecitabine. raadpleeg sectie 5 voor meer informatie over her2-status. oyavas, 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. oyavas, 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. oyavas in combination with interferon alfa 2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. oyavas, 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. oyavas, 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. oyavas, in combination with 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. oyavas, 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.

Belgien - nederländska - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

sandoz sa-nv - fingolimodhydrochloride 0,56 mg - eq. fingolimod 0,5 mg - capsule, hard - 0,5 mg - fingolimodhydrochloride 0.56 mg - fingolimod

Europeiska unionen - nederländska - 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.

Nederländerna - nederländska - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

fingolimodhydrochloride 0,56 mg/stuk samenstelling overeenkomend met ; fingolimod 0,5 mg/stuk - capsule, hard - gelatine (e 441) ; ijzeroxide geel (e 172) ; ijzeroxide zwart (e 172) ; kaliumhydroxide (e 525) ; maltodextrine ; natriumstearylfumaraat ; propyleenglycol (e 1520) ; schellak (e 904) ; talk (e 553 b) ; titaandioxide (e 171) ; zwarte inkt