Revised: 31 May 2019

Medicines

 

Medsafe Product Detail

Data SheetCMI
File ref: TT50-10027
Trade NameDose FormStrengthIdentifier
OcrevusConcentrate for infusion300 mg/10mL
SponsorApplication dateRegistration situationClassification
Roche Products (NZ) Ltd
P O Box 109113
Newmarket
Auckland 1149
24/8/2016Consent given
Approval date: 21/12/2017
Prescription
 

Composition

ComponentIngredientManufacturer
concentrate for infusionActive 
 Ocrelizumab 300 mgGenentech Inc
1000 New Horizons Way
Vacaville
California 95688
United States of America
 Excipient 
 Glacial acetic acid
 Polysorbate 20
 Sodium acetate trihydrate
 Trehalose dihydrate
 Water for injection

Production

Manufacturing stepManufacturer
Finished Product TestingGenentech Inc
1 DNA Way
South San Francisco
California 94080-4990
United States of America
 Roche Diagnostics GmbH
Sandhofer Strasse 116
Mannheim D-68305
Germany
Manufacture of Final Dose FormRoche Diagnostics GmbH
Sandhofer Strasse 116
Mannheim D-68305
Germany
Secondary PackagingF Hoffmann-La Roche Ltd
Betriebsstatten Kaiseraugst
Wurmisweg
Kaiseraugst CH-4303
Switzerland
NZ Site of Product ReleaseRoche Products (NZ) Ltd
98 Carlton Gore Road
Newmarket
Auckland 1023

Packaging

PackageContentsShelf Life
Vial, glass, 1 dose units24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light
24 hours diluted stored at 2° to 8°C (Refrigerate, do not freeze)
8 hours diluted stored at or below 30°C

Indications

OCREVUS is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) to suppress relapses and disease progression (clinical and subclinical disease activity).
OCREVUS is indicated for the treatment of adult patients with primary progressive multiple sclerosis (PPMS) to delay disease progression and reduce deterioration in walking speed.

Latest Regulatory Activity

Application DateApplication TypeChange(s)StatusPayment DatePriority
24/6/2020Changed Medicine NotificationFinished product manufacturing siteInitial evaluation1/7/2020 
29/4/2020CMN 24(5)Indications/dosage - Grade 3Initial evaluation6/5/2020 
24/8/2016New Higher-risk Medicine ApplicationNew higher-risk medicine containing one or more new active substancesGranted 21/12/20179/9/2016 
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