Revised: 31 May 2019
Medicines
Medsafe Product Detail | ||
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File ref: TT50-7065/1 |
Trade Name | Dose Form | Strength | Identifier |
Aldurazyme | Concentrate for infusion | 500 U/5mL | |
Sponsor | Application date | Registration situation | Classification |
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics P O Box 62027 Sylvia Park AUCKLAND 1644 | 30/6/2016 | Not available Approval date: 21/12/2017 Notification date: 21/1/2018 | Prescription |
Composition
Component | Ingredient | Manufacturer |
concentrate for infusion | Active | |
Laronidase 0.58 mg/mL (rch) | BioMarin Pharmaceutical Inc 46 Galli Drive Novato California 94949 UNITED STATES OF AMERICA | |
Excipient | ||
Dibasic sodium phosphate | ||
Monobasic sodium phosphate monohydrate | ||
Polysorbate 80 | ||
Sodium chloride | ||
Water for injection |
Production
Manufacturing step | Manufacturer |
Finished Product Testing | BioMarin Pharmaceutical Inc 300 Bel Marin Keys Novato CA 94949 UNITED STATES OF AMERICA |
BioMarin Pharmaceutical Inc 46 Galli Drive Novato California 94949 UNITED STATES OF AMERICA | |
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 | |
Finished Product Testing - Microbiological | Vetter Pharma-Fertigung GmbH & Co KG Eisenbahnstrasse 2-4 Langenargen D-88085 GERMANY |
Manufacture of Final Dose Form | Vetter Pharma-Fertigung GmbH & Co KG Eisenbahnstrasse 2-4 Langenargen D-88085 GERMANY |
Secondary Packaging | DHL Exel Supply Chain (Australia) Pty Ltd 16 Picrite Close Greystanes NSW 2145 AUSTRALIA |
DHL Exel Supply Chain (Australia) Pty Ltd 180 Parkwest Drive Derrimut VIC 3030 AUSTRALIA | |
Genzyme Corporation 11 Forbes Road Northborough Massachusetts 01523 UNITED STATES OF AMERICA | |
Linfox Australia 27-49 Lenore Drive Erskine Park New South Wales 2759 AUSTRALIA | |
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics 58 Richard Pearse Drive Airport Oaks Mangere AUCKLAND 2022 | |
NZ Site of Product Release | sanofi-aventis new zealand limited Level 8 56 Cawley Street Ellerslie AUCKLAND 1051 |
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 1 clear glass vial, Closure: chlorobutyl rubber stopper and al seal with a plastic cap | 1 dose units | 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 24 hours diluted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light |
Indications
ALDURAZYME is indicated as long-term enzyme replacement therapy in patients with Mucopolysaccharidosis I (MPS I; alpha-L-iduronidase deficiency) to treat the non-neurological manifestations of the disease.
Latest Regulatory Activity
Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
20/3/2023 | Changed Medicine Notification | Test methods and specifications - G3 | Granted 26/4/2023 | 28/3/2023 | |
30/6/2016 | New Higher-risk Medicine Application | New higher-risk medicine containing one or more new active substances | Granted 21/12/2017 | 15/7/2016 |