Revised: 31 May 2019

Medicines

 

Medsafe Product Detail

File ref: TT50-7065/1
Trade NameDose FormStrengthIdentifier
AldurazymeConcentrate for infusion500 U/5mL
SponsorApplication dateRegistration situationClassification
sanofi-aventis new zealand limited
P O Box 12851
Penrose
AUCKLAND 1642
30/6/2016Not available
Approval date: 21/12/2017
Notification date: 21/1/2018
Prescription
 

Composition

ComponentIngredientManufacturer
concentrate for infusionActive 
 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 stepManufacturer
Finished Product TestingBioMarin 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
Finished Product Testing - MicrobiologicalJubilant HollisterStier LLC
3525 N Regal Street
Spokane
Washington 99207
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 FormJubilant HollisterStier LLC
3525 N Regal Street
Spokane
Washington 99207
United States of America
 Vetter Pharma-Fertigung GmbH & Co KG
Eisenbahnstrasse 2-4
Langenargen D-88085
Germany
Secondary PackagingCPSA
5 Eden Park Drive
North Ryde
NSW 2113
Australia
 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 ReleasePharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
58 Richard Pearse Drive
Airport Oaks
Mangere
AUCKLAND 2022

Packaging

PackageContentsShelf Life
Vial, glass, Type 1 clear glass vial, Closure: chlorobutyl rubber stopper and al seal with a plastic cap1 dose units36 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 DateApplication TypeChange(s)StatusPayment DatePriority
7/4/2021Changed Medicine NotificationActive ingredient method of manufacture - Grade 2; Test methods and specifications - Grade 4Granted 7/7/202112/4/2021 
30/6/2016New Higher-risk Medicine ApplicationNew higher-risk medicine containing one or more new active substancesGranted 21/12/201715/7/2016 
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