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Palynziq



BioMarin International LimitedEU/1/19/1362/002

Main Information

Trade NamePalynziq
Active SubstancesPEGVALIASE
Dosage FormSolution for injection in pre-filled syringe
Licence HolderBioMarin International Limited
Licence NumberEU/1/19/1362/002

Group Information

ATC CodeA16A OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
A16AB19 pegvaliase

Status

License statusAuthorised
Licence Issued03/05/2019
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 to 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

Educational Materials - HCP

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