Revised: 31 May 2019
Medicines
Medsafe Product Detail |   | |
|---|---|---|
| File ref: TT50-10027 |
| Trade Name | Dose Form | Strength | Identifier |
| Ocrevus | Concentrate for infusion | 300 mg/10mL | |
| Sponsor | Application date | Registration situation | Classification |
| Roche Products (NZ) Ltd P O Box 109113 Newmarket Auckland 1149 | 24/8/2016 | Consent given Approval date: 21/12/2017 | Prescription |
Composition
| Component | Ingredient | Manufacturer |
| concentrate for infusion | Active | |
| Ocrelizumab 300mg | Genentech 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 step | Manufacturer |
| Finished Product Testing | Roche Diagnostics GmbH Sandhofer Strasse 116 Mannheim D-68305 Germany |
| Manufacture of Final Dose Form | F. Hoffmann-La Roche AG Kaiseraugst - Herstellung Verpackung und Prufung Wurmisweg Kaiseraugst 4303 Switzerland |
| Roche Diagnostics GmbH Sandhofer Strasse 116 Mannheim D-68305 Germany | |
| Secondary Packaging | F Hoffmann-La Roche Ltd Betriebsstatten Kaiseraugst Wurmisweg Kaiseraugst CH-4303 Switzerland |
| NZ Site of Product Release | Roche Products (NZ) Ltd 98 Carlton Gore Road Newmarket Auckland 1023 |
Packaging
| Package | Contents | Shelf Life |
| Vial, glass, | 1 dose units | 24 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 Date | Application Type | Change(s) | Status | Payment Date | Priority |
| 24/4/2023 | Changed Medicine Notification | Active ingredient manufacturing site; Active ingredient testing site; Active ingredient method of manufacture - G2 | Initial evaluation | 2/5/2023 | |
| 24/8/2016 | New Higher-risk Medicine Application | New higher-risk medicine containing one or more new active substances | Granted 21/12/2017 | 9/9/2016 |
