Revised: 31 May 2019



Medsafe Product Detail

Data SheetCMI
File ref: TT50-10323
Trade NameDose FormStrengthIdentifier
SpinrazaSolution for injection12 mg/5mLBiogen
SponsorApplication dateRegistration situationClassification
Biogen NZ Biopharma Ltd
P O Box 62-027
Mt Wellington
Auckland 1641
8/1/2018Consent given
Approval date: 23/8/2018
Notification date: 18/11/2022


solution for injectionActive 
 Nusinersen 12mg equivalent to equivalent to 12.6 mg nusinersen heptadecasodiumIonis Pharmaceuticals Inc
Building 2282-2292, Faraday Avenue
Califronia 92008
United States of America
 Calcium chloride dihydrate
 Dibasic sodium phosphate
 Hydrochloric acid
 Magnesium chloride hexahydrate
 Monobasic sodium phosphate dihydrate
 Potassium chloride
 Sodium chloride
 Sodium hydroxide
 Water for injection


Manufacturing stepManufacturer
Finished Product TestingBioSpring GmbH
Alt Fechenheim 34
Frankfurt am Main
Hessen 60386
Manufacture of Final Dose FormPatheon Italia S.p.A
2 Trav. SX, Via Morolense 5
Ferentino 03013
 Vetter Pharma-Fertigung GmbH & Co KG
Eisenbahnstrasse 2-4
Langenargen D-88085
Secondary PackagingFUJIFILM Diosynth Biotechnologies Denmark ApS
Biotek Alle 1
Hillerod DK-3400
NZ Site of Product ReleaseBiogen NZ Biopharma Ltd
188 Quay Street
Auckland 1010


PackageContentsShelf Life
Vial, glass, Type I clear glass vial closed with Bromobutyl rubber stopper, Alu overseal and plastic cap1 dose units48 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


SPINRAZA is indicated for the treatment of 5q Spinal Muscular Atrophy

Latest Regulatory Activity

Application DateApplication TypeChange(s)StatusPayment DatePriority
19/11/2022Changed Medicine NotificationIndications/dosage - Grade 4Granted 20/12/202225/11/2022 
8/1/2018New Higher-risk Medicine ApplicationAbridged new higher-risk medicine containing one or more new active substanceGranted 23/8/201823/1/2018Y
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