Revised: 31 May 2019
Medicines
Medsafe Product Detail | ||
---|---|---|
File ref: TT50-11104 |
Trade Name | Dose Form | Strength | Identifier |
Nexviazyme | Powder for infusion concentrate | 100 mg | |
Sponsor | Application date | Registration situation | Classification |
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics P O Box 62027 Sylvia Park AUCKLAND 1644 | 21/11/2022 | Pending | Prescription |
Composition
Component | Ingredient | Manufacturer |
powder for infusion | Active | |
Avalglucosidase alfa 100mg | Genzyme Flanders Cipalstraat 8 Geel Antwerpen B-2440 BELGIUM | |
Excipient | ||
Glycine | ||
Histidine | ||
Histidine hydrochloride monohydrate | ||
Mannitol | ||
Polysorbate 80 |
Production
Manufacturing step | Manufacturer |
Finished Product Testing | Eurofins 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 Form | Genzyme Ireland Ltd Old Kilmeadon Road Waterford IRELAND |
Packing | Genzyme Ireland Ltd Old Kilmeadon Road Waterford IRELAND |
Secondary Packaging | Genzyme Ireland Ltd Old Kilmeadon Road Waterford IRELAND |
NZ Site of Product Release | Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics 58 Richard Pearse Drive Airport Oaks Mangere AUCKLAND 2022 |
Packaging
Package | Contents | Shelf Life |
Vial, glass, (Type I), closed with siliconised elastomeric stopper, aluminium seal and flip-off button | 1 vials | 36 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 Date | Application Type | Change(s) | Status | Payment Date | Priority |
21/11/2022 | New Higher-risk Medicine Application | Abridged new higher-risk medicine containing one or more new active substance | Information requested 17/10/2023 | 22/12/2022 |