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

Shire Human Genetic Therapies ABEU/1/01/189/001

Main Information

Active SubstancesAgalsidase alfa
Strength1mg/ml milligram(s)/millilitre
Dosage FormConcentrate for solution for infusion
Licence HolderShire Human Genetic Therapies AB
Licence NumberEU/1/01/189/001

Group Information

ATC CodeA16AB Enzymes
A16AB03 agalsidase alfa


Licence Issued03/08/2001
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
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