Medicine passport

M-PIRFENIDONE 801 mg

The same active substance, strength and form as listed by each country’s medicines regulator. For showing a pharmacist abroad.

Active substance
Pirfenidone
Strength
801 mg
Form
tablet
ATC code
L04AX05
Registered in
Canada · Mantra Pharma Inc
Prescription
Prescription only
DIN
02550652

Source: Drug Product Database · 2026-09-30

Not a prescription. Not a statement that these products are interchangeable. Products are matched on active substance, strength and kind of form only. Other ingredients, release, approved uses and the dose on the box can differ. A pharmacist or doctor decides whether one can replace another.

Listed in other countries

United States 23 matching products

Name on the boxStrength and formPrescriptionHolderOfficial record
Pirfenidone801 mg · Tablet, Film CoatedPrescription onlyTeva Pharmaceuticals, Inc. (+20)0480-3611
Esbriet801 mg · Tablet, CoatedPrescription onlyGenentech, Inc. (+1)50242-123

Source: NDC Directory (US Food and Drug Administration) · 2026-09-13 · Source: US Food and Drug Administration, NDC Directory.

Bulgaria 2 matching products

Name on the boxStrength and formPrescriptionHolderOfficial record
FREDALIXФРЕДАЛИКС801 mg · film-coated tabletsPrescription onlySandoz d.d., (+1)20220168

Source: Bulgarian Drug Agency register (Изпълнителна агенция по лекарствата (BDA)) · 2026-08-01

Spain 16 matching products

Name on the boxStrength and formPrescriptionHolderOfficial record
ESBRIET801 mg · comprimido recubierto con películaPrescription onlyH.A.C. Pharma111667018
PIRFENIDONA ACCORD801 mg · comprimido recubierto con películaPrescription onlyAccord Healthcare S.L.U.88261
PIRFENIDONA AUROVITAS801 mg · comprimidoPrescription onlyAurovitas Spain, S.A.U.89046
PIRFENIDONA AXUNIO801 MG · comprimido recubierto con películaPrescription onlyAxunio Pharma Gmbh1221655013
PIRFENIDONA CIPLA801 mg · comprimido recubierto con películaPrescription onlyCipla Europe N.V.89425
PIRFENIDONA DR. REDDYS801 mg · comprimido recubierto con películaPrescription onlyReddy Pharma Iberia S.A.87494

10 more names not shown. Source: CIMA — Centro de Información online de Medicamentos (Agencia Española de Medicamentos y Productos Sanitarios (AEMPS)) · 2026-09-30 · Fuente: Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), CIMA.

Netherlands 12 matching products

Name on the boxStrength and formPrescriptionHolderOfficial record
Esbriet 801 mg801 mg · filmomhulde tabletPrescription onlyH.A.C. PharmaEU/1/11/667
Pirfenidon Accord 801 mg801 mg · filmomhulde tabletPrescription onlyAccord Healthcare B.V.128234
Pirfenidon Amarox 801 mg filmomhulde tabletten801 mg · filmomhulde tabletPrescription onlyAmarox Pharma B.V.128610
Pirfenidon Aurobindo 801 mg801 mg · tabletPrescription onlyAurobindo Pharma B.V.130036
Pirfenidon Glenmark 801 mg filmomhulde tabletten801 mg · filmomhulde tabletPrescription onlyGlenmark Arzneimittel GmbH134944
Pirfenidon nio 801 mg filmomhulde tabletten801 mg · filmomhulde tabletPrescription onlyaxunio Pharma GmbH129152

6 more names not shown. Source: Geneesmiddeleninformatiebank (College ter Beoordeling van Geneesmiddelen (CBG-MEB)) · 2026-09-30 · Bron: College ter Beoordeling van Geneesmiddelen (CBG). De Rijksoverheid is het niet automatisch eens met de inhoud van deze site.

Same active substance, but no match for this strength and form

Countries covered: United States, Bulgaria, European Union, Spain, France, Netherlands, Canada, Switzerland. A country missing from the list may still sell this medicine: Mediclarum reads only these registers.

Register data as of 2026-09-30. Mediclarum stores nothing about you for this page. https://www.mediclarum.com/ca/en/medicines/m-pirfenidone-801-mg-tablet