Product Dossier
TUZUCIP
Product Dossier for TUZUCIP (Trastuzumab, Cipla). ARTG record, PBS listing, PBAC outcomes, AusPAR — compiled by arcimedes.
- Sponsor: Cipla
- Active ingredient: Trastuzumab
- Therapeutic area: Oncology
- Related brand: OGIVRI
- Related brand: HERCEPTIN
- Related brand: TRASTUCIP
- Same area: TALZENNA
- Same area: ZARZIO
What it is
TUZUCIP is trastuzumab 150 mg powder for injection supplied in vials.
Approved indications
— Treatment of HER2-positive early breast cancer following surgery, and in association with chemotherapy and, if applicable, radiotherapy. — Treatment of HER2-positive locally advanced breast cancer in combination with neoadjuvant chemotherapy followed by adjuvant TUZUCIP. — Treatment of patients with metastatic breast cancer who have tumours that overexpress HER2 as monotherapy for those who have received one or more chemotherapy regimens for their metastatic disease. — Treatment of patients with metastatic breast cancer who have tumours that overexpress HER2 in combination with taxanes for those who have not received chemotherapy for their metastatic disease. — Treatment of post-menopausal patients with hormone-receptor positive metastatic breast cancer in combination with an aromatase inhibitor. — 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, in combination with cisplatin and either capecitabine or 5-FU.
Regulatory history
TUZUCIP received ARTG registration on 18 July 2022. The AusPAR approval date was 7 July 2022.