Revised: 31 May 2019
Medicines
Medsafe Product Detail | ![]() ![]() | |
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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 |