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Irish Medicines Database · HPRA register

Aldurazyme 100 U/ml concentrate for solution for infusion

Authorisation EU/1/03/253/01-3 · Sanofi B.V.

← All medicines

Aldurazyme 100 U/ml concentrate for solution for infusion

Licence EU/1/03/253/01-3 · Unknown

Licence holder: Sanofi B.V. (all products →)
Active substance: Laronidase
Dosage form: Concentrate for solution for infusion
Route of administration: Intravenous use
ATC codes: A16AB, A16AB05
First authorised: 10/06/2003
Prescription status: Product subject to prescription which may not be renewed (A)
Supply: Supply through pharmacies only
Legal basis: New active substance (Article 8(3) of Directive No 2001/83/EC)

Data: Health Products Regulatory Authority (HPRA) open dataset, licensed CC BY 4.0, published 04 Jul 2026. This listing is regulatory information, not medical advice — consult the package leaflet, SPC, or a healthcare professional. For the authoritative record see the HPRA register.