The HPRA advises healthcare professionals not to retain printed versions of Summary of Product Characteristics (SPC) documents. As these documents are subject to frequent content updates, including changes to safety and dose related information, we recommend that you visit our website as necessary to access the most up-to-date versions. If you have any queries about specific SPCs on our website then please e-mail


500 U unit(s)/millilitre Solution for infusion

Genzyme Europe B.V.EU/1/03/253/01-3

Main Information

Active SubstancesLaronidase
Strength500 U unit(s)/millilitre
Dosage FormSolution for infusion
Licence HolderGenzyme Europe B.V.
Licence NumberEU/1/03/253/01-3

Group Information

ATC CodeA16AB Enzymes
A16AB05 laronidase


Licence Issued10/06/2003
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceMedicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2)
Marketing Status


Summary of Product CharacteristicsSearch EMA website
Package LeafletSearch EMA website
Public Assessment ReportSearch EMA website
« Back