Европска Унија - Холандски - EMA (European Medicines Agency)

accord healthcare s.l.u. - trastuzumab - breast neoplasms; stomach neoplasms - antineoplastische middelen - breast cancermetastatic breast cancer zercepac is indicated for the treatment of adult patients with her2 positive metastatic breast cancer (mbc):as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease. voorafgaande chemotherapie moet bevat ten minste een anthracycline en een taxane tenzij patiënten zijn niet geschikt voor deze behandelingen. hormoon-receptor-positieve patiënten moeten ook gefaald hebben op hormonale therapie, tenzij patiënten zijn niet geschikt voor deze behandelingen.                      in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable. in combinatie met docetaxel voor de behandeling van de patiënten die geen chemotherapie voor hun gemetastaseerde ziekte. in combinatie met een aromatase remmer voor de behandeling van postmenopauzale patiënten met een hormoon-receptor positieve mbc, die niet eerder zijn behandeld met trastuzumab. early breast cancer zercepac is indicated for the treatment of adult patients with her2 positive early breast cancer (ebc). na de operatie, chemotherapie (neoadjuvant of adjuvant) en radiotherapie (indien van toepassing). volgende adjuvante chemotherapie in combinatie met doxorubicine en cyclofosfamide, in combinatie met paclitaxel of docetaxel. in combinatie met adjuvante chemotherapie, bestaande uit docetaxel en carboplatine. in combination with neoadjuvant chemotherapy followed by adjuvant zercepac therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter. zercepac should only be used in patients with metastatic or early breast cancer whose tumours have either her2 overexpression or her2 gene amplification as determined by an accurate and validated assay. metastatic gastric cancer zercepac in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of adult patients with her2 positive metastatic adenocarcinoma of the stomach or gastro-oesophageal junction who have not received prior anti-cancer treatment for their metastatic disease. zercepac should only be used in patients with metastatic gastric cancer (mgc) whose tumours have her2 overexpression as defined by ihc2+ and a confirmatory sish or fish result, or by an ihc 3+ result. accuraat en gevalideerd gehalte methoden moeten worden gebruikt.

Европска Унија - Холандски - EMA (European Medicines Agency)

celltrion healthcare hungary kft. - 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 - vegzelma in combination with fluoropyrimidine based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. vegzelma 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). vegzelma 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 vegzelma in combination with capecitabine. raadpleeg sectie 5 voor meer informatie over her2-status. vegzelma, 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 (nsclc) other than predominantly squamous cell histology. vegzelma, in combination with erlotinib, is indicated for first line treatment of adult patients with unresectable advanced, metastatic or recurrent nsclc with epidermal growth factor receptor (egfr) activating mutations (see section 5. vegzelma, in combination with interferon alfa 2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. vegzelma, 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. vegzelma, 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 vascular endothelial growth factor (vegf) inhibitors or vegf receptor–targeted agents. vegzelma 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. vegzelma, 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.

Европска Унија - Холандски - EMA (European Medicines Agency)

baxter holding b.v. - pemetrexed disodium heptahydrate - carcinoma, non-small-cell lung; mesothelioma - antineoplastische middelen - malignant pleural mesotheliomapemetrexed baxter in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. non-small cell lung cancerpemetrexed baxter in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see section 5. pemetrexed baxter is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy (see section 5. pemetrexed baxter is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see section 5.

Холандија - Холандски - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

ebewe pharma ges.m.b.h. nfg. kg - gemcitabinehydrochloride samenstelling overeenkomend met ; gemcitabine - poeder voor oplossing voor infusie - mannitol (d-) (e 421) ; natriumacetaat 3-water (e 262) ; natriumhydroxide (e 524) ; stikstof (head space) (e 941), - gemcitabine

Холандија - Холандски - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

ebewe pharma ges.m.b.h. nfg. kg - gemcitabinehydrochloride samenstelling overeenkomend met ; gemcitabine - poeder voor oplossing voor infusie - mannitol (d-) (e 421) ; natriumacetaat 3-water (e 262) ; natriumhydroxide (e 524) ; stikstof (head space) (e 941), - gemcitabine

Холандија - Холандски - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

aurobindo pharma b.v. - gemcitabinehydrochloride samenstelling overeenkomend met ; ; gemcitabine - poeder voor oplossing voor infusie - mannitol (d-) (e 421) ; natriumacetaat 3-water (e 262) ; natriumhydroxide (e 524) ; stikstof (head space) (e 941), - gemcitabine

Холандија - Холандски - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

aurobindo pharma b.v. - gemcitabinehydrochloride samenstelling overeenkomend met ; ; gemcitabine - poeder voor oplossing voor infusie - mannitol (d-) (e 421) ; natriumacetaat 3-water (e 262) ; natriumhydroxide (e 524) ; stikstof (head space) (e 941), - gemcitabine

Холандија - Холандски - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

aurobindo pharma b.v. baarnsche dijk 1 3741 ln baarn - gemcitabinehydrochloride 45,6 mg/ml samenstelling overeenkomend met ; gemcitabine 40 mg/ml - concentraat voor oplossing voor infusie - stikstof (head space) (e 941) ; water voor injectie ; zoutzuur (e 507), - gemcitabine

Холандија - Холандски - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

hikma farmaceutica (portugal), s.a. estrada do rio da mó, 8, 8a e 8b fervenca 2705-906 terrugem snt (portugal) - gemcitabinehydrochloride 1140 mg/stuk samenstelling overeenkomend met ; gemcitabine 1000 mg/stuk - poeder voor oplossing voor infusie - mannitol (d-) (e 421) ; natriumacetaat 0-water (e 262) ; natriumhydroxide (e 524) ; stikstof (head space) (e 941) ; zoutzuur (e 507), - gemcitabine

Холандија - Холандски - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

hikma farmaceutica (portugal), s.a. estrada do rio da mó, 8, 8a e 8b fervenca 2705-906 terrugem snt (portugal) - gemcitabinehydrochloride 228 mg/stuk samenstelling overeenkomend met ; gemcitabine 200 mg/stuk - poeder voor oplossing voor infusie - mannitol (d-) (e 421) ; natriumacetaat 0-water (e 262) ; natriumhydroxide (e 524) ; stikstof (head space) (e 941) ; zoutzuur (e 507), - gemcitabine