Revised: 31 May 2019

Medicines

 

Medsafe Product Detail

File ref: TT50-11104
Trade NameDose FormStrengthIdentifier
NexviazymePowder for infusion concentrate100 mg
SponsorApplication dateRegistration situationClassification
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
P O Box 62027
Sylvia Park
AUCKLAND 1644
21/11/2022Pending

Prescription
 

Composition

ComponentIngredientManufacturer
powder for infusionActive 
 Avalglucosidase alfa 100mgGenzyme Flanders
Cipalstraat 8
Geel
Antwerpen B-2440
BELGIUM
 Excipient 
 Glycine
 Histidine
 Histidine hydrochloride monohydrate
 Mannitol
 Polysorbate 80

Production

Manufacturing stepManufacturer
Finished Product TestingEurofins Biopharma Product Testing Ireland Limited
Clogherane
Dungarvan
County Waterford X35 T628
IRELAND
 Genzyme Flanders
Cipalstraat 8
Geel
Antwerpen B-2440
BELGIUM
 Genzyme Ireland Ltd
Old Kilmeadon Road
Waterford
IRELAND
Manufacture of Final Dose FormGenzyme Ireland Ltd
Old Kilmeadon Road
Waterford
IRELAND
PackingGenzyme Ireland Ltd
Old Kilmeadon Road
Waterford
IRELAND
Secondary PackagingGenzyme Ireland Ltd
Old Kilmeadon Road
Waterford
IRELAND
NZ Site of Product ReleasePharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
58 Richard Pearse Drive
Airport Oaks
Mangere
AUCKLAND 2022

Packaging

PackageContentsShelf Life
Vial, glass, (Type I), closed with siliconised elastomeric stopper, aluminium seal and flip-off button1 vials36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)
24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze)
24 hours diluted stored at 2° to 8°C (Refrigerate, do not freeze). Can also be stored up to 9 hours (including infusion time) at room temperature (up to 25°C)

Indications

Latest Regulatory Activity

Application DateApplication TypeChange(s)StatusPayment DatePriority
21/11/2022New Higher-risk Medicine ApplicationAbridged new higher-risk medicine containing one or more new active substanceAdditional evaluation started 06/05/202422/12/2022 
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