New Zealand - English - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - trastuzumab 440mg;  ;   - powder for infusion concentrate - 440 mg - active: trastuzumab 440mg     excipient: histidine histidine hydrochloride polysorbate 20 trehalose benzyl alcohol water for injection - herceptin is indicated for the treatment of patients with metastatic breast cancer who have tumours that overexpress her2: a) as monotherapy for the treatment of those patients who have received one or more chemotherapy regimens for their metastatic disease; or b) in combination with taxanes for the treatment of those patients who have not received chemotherapy for their metastatic disease; or c) in combination with an aromatase inhibitor for the treatment of post-menopausal patients with hormone-receptor positive metastatic breast cancer.

Australia - English - Department of Health (Therapeutic Goods Administration)

maxx pharma pty ltd - trastuzumab, quantity: 150 mg - powder - excipient ingredients: histidine; sorbitol; histidine hydrochloride monohydrate; macrogol 3350; sodium hydroxide; hydrochloric acid - ? early breast cancer,ogivri is indicated for the treatment of her2-positive early breast cancer following surgery, and in association with chemotherapy and, if applicable, radiotherapy.,? locally advanced breast cancer,ogivri is indicated for the treatment of her2-positive locally advanced breast cancer in combination with neoadjuvant chemotherapy followed by adjuvant ogivri.,? metastatic breast cancer,ogivri is indicated for the treatment of patients with metastatic breast cancer who have tumours that overexpress her2:,a) as monotherapy for the treatment of those patients who have received one or more chemotherapy regimens for their metastatic disease;,b) in combination with taxanes for the treatment of those patients who have not received chemotherapy for their metastatic disease; or,c) in combination with an aromatase inhibitor for the treatment of post-menopausal patients with hormone-receptor positive metastatic breast cancer.,? advanced gastric cancer,ogivri is indicated in combination with cisplatin and either capecitabine or 5-fu for the treatment of patients with her2 positive advanced adenocarcinoma of the stomach or gastro-oesophageal junction who have not received prior anti-cancer treatment for their metastatic disease.

Australia - English - Department of Health (Therapeutic Goods Administration)

celltrion healthcare australia pty ltd - trastuzumab, quantity: 150 mg - injection, powder for - excipient ingredients: histidine hydrochloride; polysorbate 20; histidine; trehalose dihydrate - early breast cancer,indicated for the treatment of her2-positive early breast cancer following surgery, and in association with chemotherapy and, if applicable, radiotherapy.,locally advanced breast cancer,indicated for the treatment of her2-positive locally advanced breast cancer in combination with neoadjuvant chemotherapy followed by adjuvant therapy.,metastatic breast cancer,indicated for the treatment of patients with metastatic breast cancer who have tumours that overexpress her2:,a) as monotherapy for the treatment of those patients who have received one or more chemotherapy regimens for their metastatic disease;,b) in combination with taxanes for the treatment of those patients who have not received chemotherapy for their metastatic disease; or,c) in combination with an aromatase inhibitor for the treatment of post-menopausal patients with hormone-receptor positive metastatic breast cancer.,advanced gastric cancer,indicated in combination with cisplatin and either capecitabine or 5-fu for the treatmen

Australia - English - Department of Health (Therapeutic Goods Administration)

celltrion healthcare australia pty ltd - trastuzumab, quantity: 150 mg - injection, powder for - excipient ingredients: histidine hydrochloride; polysorbate 20; histidine; trehalose dihydrate - early breast cancer,indicated for the treatment of her2-positive early breast cancer following surgery, and in association with chemotherapy and, if applicable, radiotherapy.,locally advanced breast cancer,indicated for the treatment of her2-positive locally advanced breast cancer in combination with neoadjuvant chemotherapy followed by adjuvant therapy.,metastatic breast cancer,indicated for the treatment of patients with metastatic breast cancer who have tumours that overexpress her2:,a) as monotherapy for the treatment of those patients who have received one or more chemotherapy regimens for their metastatic disease;,b) in combination with taxanes for the treatment of those patients who have not received chemotherapy for their metastatic disease; or,c) in combination with an aromatase inhibitor for the treatment of post-menopausal patients with hormone-receptor positive metastatic breast cancer.,advanced gastric cancer,indicated in combination with cisplatin and either capecitabine or 5-fu for the treatment of patients with her2 positive advanced adenocarcinoma of the stomach or gastrooesophageal junction who have not received prior anti-cancer treatment for their metastatic disease.

Australia - English - Department of Health (Therapeutic Goods Administration)

celltrion healthcare australia pty ltd - trastuzumab, quantity: 150 mg - injection, powder for - excipient ingredients: histidine hydrochloride; polysorbate 20; histidine; trehalose dihydrate - early breast cancer,indicated for the treatment of her2-positive early breast cancer following surgery, and in association with chemotherapy and, if applicable, radiotherapy.,locally advanced breast cancer,indicated for the treatment of her2-positive locally advanced breast cancer in combination with neoadjuvant chemotherapy followed by adjuvant therapy.,metastatic breast cancer,indicated for the treatment of patients with metastatic breast cancer who have tumours that overexpress her2:,a) as monotherapy for the treatment of those patients who have received one or more chemotherapy regimens for their metastatic disease;,b) in combination with taxanes for the treatment of those patients who have not received chemotherapy for their metastatic disease; or,c) in combination with an aromatase inhibitor for the treatment of post-menopausal patients with hormone-receptor positive metastatic breast cancer.,advanced gastric cancer,indicated in combination with cisplatin and either capecitabine or 5-fu for the treatmen

Israel - English - Ministry of Health

roche pharmaceuticals (israel) ltd - trastuzumab - solution for infusion - trastuzumab 440 mg/ml - trastuzumab - trastuzumab - herceptin is indicated for the treatment of patients with metastatic breast cancer who have tumours that overexpress her2: 1. as a single agent for the treatment of those patients who have received one or more chemotherapy regiments for their metastatic disease. 2. in combination with paclitaxel or docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease. 3. herceptin in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive metastatic breast cancer. early breast cancer (ebc) :herceptin is indicated to treat patients with her2-positive early breast cancer following surgery and chemotherapy (neoadjuvant or adjuvant) either alone or in combination with chemotherapy excluding anthracyclines. herceptin should only be used in patients whose tumors have either her2 overexpression or her2 gene amplification as determined by an accurate and validated assay.her2 metastatic gastric cancer (mgc)herceptin in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of patients with her2 positive metastatic adenocarcinoma of the stomach or gastro-esophageal junction who have not received prior anti-cancer treatment for their metastatic disease.herceptin should only be used in patients with metastatic gastric cancer whose tumours have her2 overexpression as defined by ihc2+ and a confirmatory fish+ result, or ihc 3+, as determined by an accurate and validated assay

New Zealand - English - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - trastuzumab 440mg (no overfill, only 420 mg deliverable);   - powder for infusion concentrate - 440 mg - active: trastuzumab 440mg (no overfill, only 420 mg deliverable)   excipient: histidine histidine hydrochloride monohydrate polysorbate 20 sucrose benzyl alcohol water for injection - metastatic breast cancer trazimera is indicated for the treatment of patients with metastatic breast cancer who have tumours that overexpress her2: - as monotherapy for the treatment of those patients who have received one or more chemotherapy regimens for their metastatic disease; or - in combination with taxanes for the treatment of those patients who have not received chemotherapy for their metastatic disease; or - in combination with an aromatase inhibitor for the treatment of post-menopausal patients with hormone-receptor positive metastatic breast cancer.

Singapore - English - HSA (Health Sciences Authority)

roche singapore pte. ltd. - trastuzumab - injection, powder, for solution - 440 mg/vial - trastuzumab 440 mg/vial

New Zealand - English - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - trastuzumab 150mg (excludes 4% overage);  ;  ;   - powder for infusion concentrate - 150 mg - active: trastuzumab 150mg (excludes 4% overage)       excipient: histidine histidine hydrochloride monohydrate polysorbate 20 trehalose - herceptin is indicated for the treatment of patients with metastatic breast cancer who have tumours that overexpress her2: a) as monotherapy for the treatment of those patients who have received one or more chemotherapy regimens for their metastatic disease; or b) in combination with taxanes for the treatment of those patients who have not received chemotherapy for their metastatic disease; or c) in combination with an aromatase inhibitor for the treatment of post-menopausal patients with hormone-receptor positive metastatic breast cancer.

New Zealand - English - Medsafe (Medicines Safety Authority)

celltrion healthcare new zealand limited - trastuzumab 440mg - powder for infusion concentrate - 440 mg - active: trastuzumab 440mg excipient: histidine histidine hydrochloride polysorbate 20 trehalose dihydrate benzyl alcohol water for injection - herzuma is indicated for patients with metastatic breast cancer who have tumours that overexpress her2: - as monotherapy for the treatment of those patients who have received one or more chemotherapy regimens for their metastatic disease; or - in combination with taxanes for the treatment of those patients who have not received chemotherapyfor their metastatic disease; or - in combination with a aromatase inhibitor for the treatment of post-menopausal patients with hormone-receptor positive metastatic breast cancer.