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Naglazyme

1 milligram(s)/millilitre Concentrate for solution for infusion

BioMarin International LimitedEU/1/05/324/001

Main Information

Trade NameNaglazyme
Active SubstancesGalsulfase
Strength1 milligram(s)/millilitre
Dosage FormConcentrate for solution for infusion
Licence HolderBioMarin International Limited
Licence NumberEU/1/05/324/001

Group Information

ATC CodeA16AB08 galsulfase

Status

Authorised/WithdrawnAuthorised
Licence Issued24/01/2006
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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