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

amgen australia pty ltd - trastuzumab, quantity: 440 mg - injection, powder for - excipient ingredients: histidine hydrochloride monohydrate; polysorbate 20; histidine; trehalose dihydrate - early breast cancer,kanjinti 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,kanjinti is indicated for the treatment of her2-positive locally advanced breast cancer in combination with neoadjuvant chemotherapy followed by adjuvant kanjinti.,metastatic breast cancer,kanjinti 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,kanjinti 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)

amgen australia pty ltd - trastuzumab, quantity: 156 mg - injection, powder for - excipient ingredients: polysorbate 20; histidine hydrochloride monohydrate; histidine; trehalose dihydrate - early breast cancer,kanjinti 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,kanjinti is indicated for the treatment of her2-positive locally advanced breast cancer in combination with neoadjuvant chemotherapy followed by adjuvant kanjinti.,metastatic breast cancer,kanjinti 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,kanjinti 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.

Israel - English - Ministry of Health

astrazeneca (israel) ltd - trastuzumab deruxtecan - powder for concentrate for solution for infusion - trastuzumab deruxtecan 100 mg - trastuzumab - her2-positive metastatic breast cancerenhertu is indicated for the treatment of adult patients with unresectable or metastatic her2-positive breast cancer who have received a prior anti-her2-based regimen either:• in the metastatic setting, or• in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy.her2-low metastatic breast cancerenhertu is indicated for the treatment of adult patients with unresectable or metastatic her2-low (ihc 1+ orihc 2+/ish-) breast cancer who have received a prior chemotherapy in the metastatic setting or developed diseaserecurrence during or within 6 months of completing adjuvant chemotherapyunresectable or metastatic her2-mutant non-small cell lung cancerenhertu is indicated for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (nsclc) whose tumors have activating her2 (erbb2) mutations, as detected by an approved test, and who have received a prior systemic therapy. locally advanced or metastatic gastric cancerenhertu is indicated for the treatment of adult patients with locally advanced or metastatic her2-positive gastric or gastroesophageal junction (gej) adenocarcinoma who have received a prior trastuzumab-based regimen.

Singapore - English - HSA (Health Sciences Authority)

innogene kalbiotech pte. ltd. - trastuzumab - injection, powder, lyophilized, for solution - trastuzumab 150mg per vial

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

celltrion healthcare malaysia sdn. bhd. - trastuzumab -

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

celltrion healthcare malaysia sdn. bhd. - trastuzumab -

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

biocon sdn bhd - trastuzumab -

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

biocon sdn bhd - trastuzumab -

European Union - English - EMA (European Medicines Agency)

sandoz gmbh - trastuzumab - breast neoplasms; stomach neoplasms - antineoplastic agents - treatment of metastatic and early breast cancer and metastatic gastric cancer (mgc).

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

celltrion healthcare australia pty ltd - trastuzumab, quantity: 440 mg - injection, powder for - excipient ingredients: histidine hydrochloride; histidine; polysorbate 20; trehalose dihydrate - early breast cancer hertuzu? 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 hertuzu? is indicated for the treatment of her2-positive locally advanced breast cancer in combination with neoadjuvant chemotherapy followed by adjuvant hertuzu?.,metastatic breast cancer hertuzu? 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 postmenopausal patients with hormonereceptor positive metastatic breast cancer.,advanced gastric cancer hertuzu? is indicated in combination with cisplatin a