Revised: 31 May 2019
Medicines
Medsafe Product Detail |   | |
|---|---|---|
| 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 |
| 26/1/2024 | Self-Assessable Change Notification | Labelling - G1 (Self assessable) | Notified | 8/2/2024 | |
| 17/1/2024 | CMN 24(5) | Active ingredient method of manufacture - G1; Active ingredient method of manufacture - G2; Active ingredient method of manufacture - G3; Test methods and specifications - G1; Test methods and specifications - G2 | Initial evaluation | 8/2/2024 | |
| 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 |
