I. Introduction to product submission Submission details Type of submission: Major variation (new indication) Decision: Approved Date of decision: 16 July 2015 Date of entry onto ARTG 23 July 2015 Active ingredient(s): Bevacizumab (rch) Product name(s): Avastin Sponsor’s name and address: Roche Products Pty Ltd PO Box 255 4-10 Innman Road Dee Why NSW 2099 Dose form: Injection, concentrated 100 mg/ 4 mL and 400 mg/ 16 mL Strengths: Container: vial Pack size: 1 vial Approved therapeutic use: In combination with paclitaxel and cisplatin is indicated for the treatment of persistent, recurrent or metastatic carcinoma of the cervix. In combination with paclitaxel and topotecan is an acceptable alternative where cisplatin is not tolerated or not indicated. Route of administration: intravenous Dosage: AVASTIN is administered in combination with paclitaxel and cisplatin or, if cisplatin is not tolerated or not indicated, paclitaxel and topotecan (see the Product Information for further details on the chemotherapy regimens). The recommended dose of AVASTIN is 15 mg/kg of body weight given once every 3 weeks as an intravenous (IV) infusion. ARTG numbers: 99756 and 99757 Product background This AusPAR describes the application by the sponsor to register Avastin bevacizumab (rch) for the following indication: AVASTIN (bevacizumab) in combination with paclitaxel and cisplatin or paclitaxel and topotecan is indicated for the treatment of persistent, recurrent or IV carcinoma of the cervix.
I. Introduction to product submission Submission details Type of submission: Major variation (new indication) Decision: Approved Date of decision: 16 July 2015 Date of entry onto ARTG 23 July 2015 Active ingredient(s): Bevacizumab (rch) Product name(s): Avastin Sponsor’s name and address: Roche Products Pty Ltd PO Box 255 4-10 Innman Road Dee Why NSW 2099 Dose form: Injection, concentrated Strengths: 100 mg/ 4 mL and 400 mg/ 16 mL Container: vial Pack size: 1 vial Approved therapeutic use: In combination with paclitaxel and cisplatin is indicated for the treatment of persistent, recurrent or metastatic carcinoma of the cervix. In combination with paclitaxel and topotecan is an acceptable alternative where cisplatin is not tolerated or not indicated. Route of administration: intravenous Dosage: AVASTIN is administered in combination with paclitaxel and cisplatin or, if cisplatin is not tolerated or not indicated, paclitaxel and topotecan (see the Product Information for further details on the chemotherapy regimens). The recommended dose of AVASTIN is 15 mg/kg of body weight given once every 3 weeks as an intravenous (IV) infusion. ARTG numbers: 99756 and 99757 Product background This AusPAR describes the application by the sponsor to register Avastin bevacizumab (rch) for the following indication: AVASTIN (bevacizumab) in combination with paclitaxel and cisplatin or paclitaxel and topotecan is indicated for the treatment of persistent, recurrent or IV carcinoma of the cervix.
auspar-bevacizumab-rch-170510.docx