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Esbriet 801 mg film-coated tablets



Roche Registration GmbHEU/1/11/667/011

Main Information

Trade NameEsbriet 801 mg film-coated tablets
Active SubstancesPirfenidone
Dosage FormFilm-coated tablet
Licence HolderRoche Registration GmbH
Licence NumberEU/1/11/667/011

Group Information

ATC CodeL04AX Other immunosuppressants
L04AX05 pirfenidone

Status

License statusAuthorised
Licence Issued
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

Educational Materials - HCP

Generics Information

Interchangeable List CodeIC0127-175-003
Interchangeable List DocumentPDF of Interchangeable List
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