Revised: 31 May 2019

Medicines

 

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
8/1/2018Not available
Approval date: 23/8/2018
Notification date: 16/10/2018
Prescription
 

Composition

ComponentIngredientManufacturer
solution for injectionActive 
 Nusinersen 12 mg equivalent to equivalent to 12.6 mg nusinersen heptadecasodiumIonis 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 stepManufacturer
Finished Product TestingBioSpring GmbH
Alt Fechenheim 34
Frankfurt am Main
Hessen 60386
Germany
Manufacture of Final Dose FormPatheon Italia SpA
2 Trav. SX Via Morolense 5
Ferentino
Frosinone I-03013
Italy
 Vetter Pharma-Fertigung GmbH & Co KG
Eisenbahnstrasse 2-4
Langenargen D-88085
Germany
Secondary PackagingBiogen Denmark Manufacturing ApS
Biogen Alle 1
Hillerod DK-3400
Denmark
NZ Site of Product ReleaseBiogen NZ Biopharma Ltd
188 Quay Street
Auckland 1010

Packaging

PackageContentsShelf Life
Vial, glass, Type I clear glass vial closed with Bromobutyl rubber stopper, Alu overseal and plastic cap1 dose units36 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 DateApplication TypeChange(s)StatusPayment DatePriority
17/7/2020Self-Assessable Change NotificationData sheet - miscellaneous changes (Self assessable)Notified30/7/2020 
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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