Revised: 31 May 2019
Medicines
Medsafe Product Detail | ![]() ![]() | |
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File ref: TT50-9181 |
Trade Name | Dose Form | Strength | Identifier |
Perjeta | Concentrate for infusion | 420 mg/14mL | |
Sponsor | Application date | Registration situation | Classification |
Roche Products (NZ) Ltd P O Box 109113 Newmarket Auckland 1149 | 12/12/2012 | Consent given Approval date: 18/7/2013 | Prescription |
Composition
Component | Ingredient | Manufacturer |
concentrate for infusion | Active | |
Pertuzumab 420mg equivalent to 30 mg/mL | Genentech Inc 1000 New Horizons Way Vacaville California 95688 United States of America | |
Excipient | ||
Glacial acetic acid | ||
Histidine | ||
Polysorbate 20 | ||
Sucrose | ||
Water for injection |
Production
Manufacturing step | Manufacturer |
Finished Product Testing | Genentech Inc 1000 New Horizons Way Vacaville California 95688 United States of America |
Genentech Inc 4625 NE Brookwood Parkway Hillsboro Oregon 97124-9332 United States of America | |
Roche Diagnostics GmbH Sandhofer Strasse 116 Mannheim D-68305 Germany | |
Manufacture of Final Dose Form | Genentech Inc 4625 NE Brookwood Parkway Hillsboro Oregon 97124-9332 United States of America |
Roche Diagnostics GmbH Sandhofer Strasse 116 Mannheim D-68305 Germany | |
Packing | Genentech Inc 4625 NE Brookwood Parkway Hillsboro Oregon 97124-9332 United States of America |
Roche Diagnostics GmbH Sandhofer Strasse 116 Mannheim D-68305 Germany | |
Secondary Packaging | F Hoffmann-La Roche Ltd Betriebsstatten Kaiseraugst Wurmisweg Kaiseraugst CH-4303 Switzerland |
Genentech Inc 4625 NE Brookwood Parkway Hillsboro Oregon 97124-9332 United States of America | |
NZ Site of Product Release | Roche Products (NZ) Ltd 98 Carlton Gore Road Newmarket Auckland 1023 |
Packaging
Package | Contents | Shelf Life |
Vial, glass, | 14 mL | 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light |
Indications
Metastatic Breast Cancer
Perjeta is indicated in combination with trastuzumab and docetaxel for patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for their metastatic disease.
Early Breast Cancer
Perjeta is indicated in combination with trastuzumab and chemotherapy for the:
· neoadjuvant treatment of patients with HER2-positive, early stage (either > 2 cm in diameter or node positive), inflammatory or locally advanced breast cancer as part of a complete treatment regimen for early breast cancer
· adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence.
Latest Regulatory Activity
Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
6/11/2023 | Changed Medicine Notification | Active ingredient method of manufacture - G2; Test methods and specifications - G1; Test methods and specifications - G2; Test methods and specifications - G3; Shelf life/storage conditions - G1 | Initial evaluation | 13/11/2023 | |
12/12/2012 | New Higher-risk Medicine Application | New higher-risk medicine containing one or more new active substances | Granted 18/7/2013 | 31/12/2012 | Y |