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ALDURAZYME

500 U unit(s)/millilitre Solution for infusion

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

Main Information

Trade NameALDURAZYME
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

Status

Authorised/WithdrawnAuthorised
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 StatusUnknown

Documents

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