Revised: 31 May 2019

Medicines

 

Medsafe Product Detail

Data SheetCMI
File ref: TT50-9181
Trade NameDose FormStrengthIdentifier
PerjetaConcentrate for infusion420 mg/14mL
SponsorApplication dateRegistration situationClassification
Roche Products (NZ) Ltd
P O Box 109113
Newmarket
Auckland 1149
12/12/2012Consent given
Approval date: 18/7/2013
Prescription
 

Composition

ComponentIngredientManufacturer
concentrate for infusionActive 
 Pertuzumab 420mg equivalent to 30 mg/mLGenentech 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 stepManufacturer
Finished Product TestingGenentech Inc
4625 NE Brookwood Parkway
Hillsboro OR 97124-9332
United States of America
 Roche Diagnostics GmbH
Sandhofer Strasse 116
Mannheim D-68305
Germany
Manufacture of Final Dose FormGenentech Inc
4625 NE Brookwood Parkway
Hillsboro OR 97124-9332
United States of America
 Roche Diagnostics GmbH
Sandhofer Strasse 116
Mannheim D-68305
Germany
PackingGenentech Inc
4625 NE Brookwood Parkway
Hillsboro OR 97124-9332
United States of America
 Roche Diagnostics GmbH
Sandhofer Strasse 116
Mannheim D-68305
Germany
Secondary PackagingF Hoffmann-La Roche Ltd
Betriebsstatten Kaiseraugst
Wurmisweg
Kaiseraugst CH-4303
Switzerland
 Genentech Inc
4625 NE Brookwood Parkway
Hillsboro OR 97124-9332
United States of America
NZ Site of Product ReleaseRoche Products (NZ) Ltd
98 Carlton Gore Road
Newmarket
Auckland 1023

Packaging

PackageContentsShelf Life
Vial, glass, 14 mL24 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 DateApplication TypeChange(s)StatusPayment DatePriority
11/12/2021Changed Medicine NotificationFinished product testing site; Finished product manufacturing process - Grade 1; Test methods and specifications - Grade 4Granted 11/3/202220/12/2021 
12/12/2012New Higher-risk Medicine ApplicationNew higher-risk medicine containing one or more new active substancesGranted 18/7/201331/12/2012Y
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