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Chiesi Farmaceutici S.p.A.EU/1/23/1724/001-003

Main Information

Trade NameElfabrio
Active SubstancesPegunigalsidase Alfa
Dosage FormConcentrate for solution for infusion
Licence HolderChiesi Farmaceutici S.p.A.
Licence NumberEU/1/23/1724/001-003

Group Information

ATC CodeA16AB Enzymes
A16AB20 pegunigalsidase alfa


License statusAuthorised
Licence Issued04/05/2023
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


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

Educational Materials - HCP

Educational Materials - Patient

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