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MYOZYME

5 Mg/Ml Pdr/Conc/Soln for Infus

Genzyme Europe B.V.EU/1/06/333/1-3

Main Information

Trade NameMYOZYME
Active SubstancesALGLUCOSIDASE ALFA
Strength5 Mg/Ml
Dosage FormPdr/Conc/Soln for Infus
Licence HolderGenzyme Europe B.V.
Licence NumberEU/1/06/333/1-3

Group Information

ATC CodeA16AB07 Enzymes

Status

Authorised/WithdrawnAuthorised
Licence Issued29/03/2006
Supply StatusSupply through pharmacies only
Dispensing StatusProduct subject to prescription which may not be renewed (A)
Marketing Status--Unknown--
Promotion StatusPromotion to Healthcare Professionals only
Conditions of LicenceMedicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2)

Documents

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

Educational Materials - HCP

Safety Information Packet
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