Revised: 31 May 2019
Medicines
Medsafe Product Detail |   | |
|---|---|---|
| File ref: TT50-9713 |
| Trade Name | Dose Form | Strength | Identifier |
| VIMIZIM | Concentrate for injection | 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 | 19/2/2015 | Consent given Approval date: 20/8/2015 Notification date: 28/6/2016 | Prescription |
Composition
| Component | Ingredient | Manufacturer |
| concentrate for injection | Active | |
| Elosulfase alfa 1 mg/mL | BioMarin International Ltd. Shanbally Ringaskiddy Co. Cork IRELAND | |
| BioMarin Pharmaceutical Inc 46 Galli Drive Novato California 94949 UNITED STATES OF AMERICA | ||
| Excipient | ||
| Arginine hydrochloride | ||
| Monobasic sodium phosphate monohydrate | ||
| Polysorbate 20 | ||
| Sodium acetate trihydrate | ||
| Sorbitol | ||
| 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 Helmut-Vetter-Str. 10 Ravensburg Baden Wurttemberg 88213 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 |
| Vetter Pharma-Fertigung GmbH & Co KG Mooswiesen 2 Ravensburg D-88214 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 mL | 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light |
Indications
Treatment of mucopolysaccharidosis type IVA (MPS IVA; Morquio A syndrome) in children and adults of all ages.
Latest Regulatory Activity
| Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
| 6/12/2023 | Changed Medicine Notification | Active ingredient testing site; Active ingredient method of manufacture - G1 | Granted 15/1/2024 | 19/12/2023 | |
| 17/11/2023 | Self-Assessable Change Notification | Test methods and specifications - G1 (Self assessable) | Notified | 27/11/2023 | |
| 19/2/2015 | New Higher-risk Medicine Application | Abridged new higher-risk medicine containing one or more new active substance | Granted 20/8/2015 | 4/3/2015 | Y |
