My HPRA: Register

The HPRA advises healthcare professionals not to retain printed versions of Summary of Product Characteristics (SPC) documents. As these documents are subject to frequent content updates, including changes to safety and dose related information, we recommend that you visit our website as necessary to access the most up-to-date versions. If you have any queries about specific SPCs on our website then please e-mail info@hpra.ie


Pirfenidone Viatris 801 mg film-coated tablets



Viatris LimitedEU/1/22/1707/011-015

Main Information

Trade NamePirfenidone Viatris 801 mg film-coated tablets
Active SubstancesPirfenidone
Dosage FormFilm-coated tablet
Licence HolderViatris Limited
Licence NumberEU/1/22/1707/011-015

Group Information

ATC CodeL04AX05 pirfenidone

Status

License statusAuthorised
Licence Issued10/01/2023
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

Documents

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

Generics Information

Interchangeable ListPirfenidone 801 mg Film-coated Tablets
Interchangeable List CodeIC0127-175-003
Interchangeable List DocumentPDF of Interchangeable List
« Back
Follow medicine

Print