Revised: 31 May 2019
Medicines
Medsafe Product Detail |   | |
|---|---|---|
| File ref: TT50-10323 |
| Trade Name | Dose Form | Strength | Identifier |
| Spinraza | Solution for injection | 12 mg/5mL | Biogen |
| Sponsor | Application date | Registration situation | Classification |
| Biogen NZ Biopharma Ltd P O Box 62-027 Mt Wellington Auckland 1641 | 8/1/2018 | Consent given Approval date: 23/8/2018 Notification date: 18/11/2022 | Prescription |
Composition
| Component | Ingredient | Manufacturer |
| solution for injection | Active | |
| Nusinersen 12mg equivalent to equivalent to 12.6 mg nusinersen heptadecasodium | Ionis Pharmaceuticals Inc Building 2282-2292, Faraday Avenue Carlsbad Califronia 92008 United States of America | |
| Excipient | ||
| Calcium chloride dihydrate | ||
| Dibasic sodium phosphate | ||
| Hydrochloric acid | ||
| Magnesium chloride hexahydrate | ||
| Monobasic sodium phosphate dihydrate | ||
| Potassium chloride | ||
| Sodium chloride | ||
| Sodium hydroxide | ||
| Water for injection |
Production
| Manufacturing step | Manufacturer |
| Finished Product Testing | BioSpring GmbH Alt Fechenheim 34 Frankfurt am Main Hessen 60386 Germany |
| Manufacture of Final Dose Form | Patheon Italia S.p.A 2 Trav. SX, Via Morolense 5 Ferentino 03013 Italy |
| Vetter Pharma-Fertigung GmbH & Co KG Eisenbahnstrasse 2-4 Langenargen D-88085 Germany | |
| Secondary Packaging | FUJIFILM Diosynth Biotechnologies Denmark ApS Biotek Alle 1 Hillerod DK-3400 Denmark |
| NZ Site of Product Release | Biogen NZ Biopharma Ltd 188 Quay Street Auckland 1010 |
Packaging
| Package | Contents | Shelf Life |
| Vial, glass, Type I clear glass vial closed with Bromobutyl rubber stopper, Alu overseal and plastic cap | 1 dose units | 48 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 14 days unopened stored at or below 30°C protect from light 6 hours opened stored at or below 25°C |
Indications
SPINRAZA is indicated for the treatment of 5q Spinal Muscular Atrophy
Latest Regulatory Activity
| Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
| 19/11/2022 | Changed Medicine Notification | Indications/dosage - Grade 4 | Granted 20/12/2022 | 25/11/2022 | |
| 8/1/2018 | New Higher-risk Medicine Application | Abridged new higher-risk medicine containing one or more new active substance | Granted 23/8/2018 | 23/1/2018 | Y |
