欧州連合 - スウェーデン語 - EMA (European Medicines Agency)

accord healthcare s.l.u. - trastuzumab - breast neoplasms; stomach neoplasms - antineoplastiska medel - 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. tidigare kemoterapi måste ha inkluderat åtminstone ett anthracycline och en taxane om patienter som är olämpliga för dessa behandlingar. hormon receptor-positiva patienter måste också ha misslyckats med hormonell behandling, om inte patienter som är olämpliga för dessa behandlingar.                      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. i kombination med docetaxel för behandling av de patienter som inte fått kemoterapi mot sin metastatiska sjukdom. i kombination med en aromatashämmare för behandling av postmenopausala patienter med hormonreceptorpositiv mbc, inte tidigare behandlats med trastuzumab. early breast cancer zercepac is indicated for the treatment of adult patients with her2 positive early breast cancer (ebc). efter kirurgi, kemoterapi (neoadjuvant eller adjuvant) och strålbehandling (om tillämpbart). efter adjuvant kemoterapi med doxorubicin och cyklofosfamid, i kombination med paklitaxel eller docetaxel. i kombination med adjuvant kemoterapi som utgörs av docetaxel och karboplatin. 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. korrekt och validerat analysen metoder som ska användas.

欧州連合 - スウェーデン語 - 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 - antineoplastiska medel - 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. för vidare information om human epidermal growth factor receptor 2 (her2) status, se avsnitt 5. 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. för ytterligare information om her2-status, se avsnitt 5. 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.

スウェーデン - スウェーデン語 - Läkemedelsverket (Medical Products Agency)

sun pharmaceutical industries europe b.v. - oxaliplatin - koncentrat till infusionsvätska, lösning - 5 mg/ml - oxaliplatin 5 mg aktiv substans; laktosmonohydrat hjälpämne - oxaliplatin

スウェーデン - スウェーデン語 - Läkemedelsverket (Medical Products Agency)

mylan hospital as - docetaxel (vattenfri) - koncentrat och vätska till infusionsvätska, lösning - 40 mg/ml - docetaxel (vattenfri) 40 mg aktiv substans; etanol, vattenfri hjälpämne - docetaxel

スウェーデン - スウェーデン語 - Läkemedelsverket (Medical Products Agency)

esteve pharmaceuticals s.a.s - streptozocin - pulver till koncentrat till infusionsvätska, lösning - 1 g - streptozocin 1 g aktiv substans

スウェーデン - スウェーデン語 - Läkemedelsverket (Medical Products Agency)

hexal a/s - pemetrexeddinatrium-2,5-hydrat - koncentrat till infusionsvätska, lösning - 25 mg/ml - pemetrexeddinatrium-2,5-hydrat 30,2 mg aktiv substans; propylenglykol hjälpämne

スウェーデン - スウェーデン語 - Läkemedelsverket (Medical Products Agency)

ever valinject gmbh - pemetrexeddinatrium-2,5-hydrat; pemetrexeddinatriumheptahydrat - koncentrat till infusionsvätska, lösning - 25 mg/ml - pemetrexeddinatrium-2,5-hydrat 30,4 mg aktiv substans; pemetrexeddinatriumheptahydrat 34,9 mg aktiv substans

スウェーデン - スウェーデン語 - Läkemedelsverket (Medical Products Agency)

zentiva k.s. - pemetrexeddinatrium-2,5-hydrat - infusionsvätska, lösning - 10 mg/ml - mannitol hjälpämne; pemetrexeddinatrium-2,5-hydrat 12,08 mg aktiv substans

スウェーデン - スウェーデン語 - Läkemedelsverket (Medical Products Agency)

accord healthcare b.v. - topotekanhydroklorid - koncentrat till infusionsvätska, lösning - 1 mg/ml - topotekanhydroklorid 1,087 mg aktiv substans - topotekan

スウェーデン - スウェーデン語 - Läkemedelsverket (Medical Products Agency)

accord healthcare ltd. - topotekanhydroklorid - pulver till koncentrat till infusionsvätska, lösning - 4 mg - mannitol hjälpämne; topotekanhydroklorid 4,346 mg aktiv substans - topotekan