Revised: 31 May 2019
Medicines
Medsafe Product Detail |   | |
|---|---|---|
| File ref: TT50-9751 |
| Trade Name | Dose Form | Strength | Identifier |
| Naglazyme | Concentrate for infusion | 1 mg/mL | |
| Sponsor | Application date | Registration situation | Classification |
| Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics P O Box 62027 Sylvia Park AUCKLAND 1644 | 24/4/2015 | Consent given Approval date: 24/3/2016 | Prescription |
Composition
| Component | Ingredient | Manufacturer |
| concentrate for infusion | Active | |
| Galsulfase 1 mg/mL | BioMarin Pharmaceutical Inc 46 Galli Drive Novato California 94949 UNITED STATES OF AMERICA | |
| Excipient | ||
| Polysorbate 80 | ||
| Sodium chloride | ||
| Sodium phosphate | ||
| Water for injection |
Production
| Manufacturing step | Manufacturer |
| Finished Product Testing | BioMarin International Ltd. Shanbally Ringaskiddy Co. Cork IRELAND |
| BioMarin Pharmaceutical Inc 300 Bel Marin Keys Novato CA 94949 UNITED STATES OF AMERICA | |
| Vetter Pharma-Fertigung GmbH & Co KG Eisenbahnstrasse 2-4 Langenargen D-88085 GERMANY | |
| Vetter Pharma-Fertigung GmbH & Co KG Mooswiesen 2 Ravensburg D-88214 GERMANY | |
| Vetter Pharma-Fertigung GmbH & Co KG Schuetzenstrasse 87, 99-101 Ravensburg D-88212 GERMANY | |
| Manufacture of Final Dose Form | Vetter Pharma-Fertigung GmbH & Co KG Eisenbahnstrasse 2-4 Langenargen D-88085 GERMANY |
| Packing | Vetter Pharma-Fertigung GmbH & Co KG Eisenbahnstrasse 2-4 Langenargen D-88085 GERMANY |
| Secondary Packaging | AndersonBrecon (UK) Limited Wye Valley Business Park Brecon Road, Hay-on-Wye Hereford HR3 5PG UNITED KINGDOM |
| BioMarin International Ltd. Shanbally Ringaskiddy Co. Cork 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, 5 cc, Type I borosilicate tubing glass | 5 mL | 3 years from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. Do not shake. 48 hours diluted stored at 2° to 8°C (Refrigerate, do not freeze) |
Indications
Naglazyme is indicated as long term enzyme replacement therapy in patients with Mucopolysaccharidosis VI (MPS VI, N-acetylgalactosamine 4-sulfatase deficiency, Maroteaux-Lamy syndrome).
Latest Regulatory Activity
| Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
| 25/1/2024 | Changed Medicine Notification | Active ingredient method of manufacture - G3 | Granted 14/3/2024 | 9/2/2024 | |
| 24/4/2015 | New Higher-risk Medicine Application | New higher-risk medicine containing one or more new active substances | Granted 24/3/2016 | 6/5/2015 | Y |
