FREDALIX 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
- film-coated tablets
- ATC code
- L04AX05
- Registered in
- Bulgaria · Sandoz d.d.,
- Prescription
- Prescription only
- Reg. no.
- 20220168
Source: Bulgarian Drug Agency register · 2026-08-01
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 box | Strength and form | Prescription | Holder | Official record |
|---|---|---|---|---|
| Pirfenidone | 801 mg · Tablet, Film Coated | Prescription only | Teva Pharmaceuticals, Inc. (+20) | 0480-3611 |
| Esbriet | 801 mg · Tablet, Coated | Prescription only | Genentech, Inc. (+1) | 50242-123 |
Source: NDC Directory (US Food and Drug Administration) · 2026-09-13 · Source: US Food and Drug Administration, NDC Directory.
Spain 16 matching products
| Name on the box | Strength and form | Prescription | Holder | Official record |
|---|---|---|---|---|
| ESBRIET | 801 mg · comprimido recubierto con película | Prescription only | H.A.C. Pharma | 111667018 |
| PIRFENIDONA ACCORD | 801 mg · comprimido recubierto con película | Prescription only | Accord Healthcare S.L.U. | 88261 |
| PIRFENIDONA AUROVITAS | 801 mg · comprimido | Prescription only | Aurovitas Spain, S.A.U. | 89046 |
| PIRFENIDONA AXUNIO | 801 MG · comprimido recubierto con película | Prescription only | Axunio Pharma Gmbh | 1221655013 |
| PIRFENIDONA CIPLA | 801 mg · comprimido recubierto con película | Prescription only | Cipla Europe N.V. | 89425 |
| PIRFENIDONA DR. REDDYS | 801 mg · comprimido recubierto con película | Prescription only | Reddy 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.
Canada 7 matching products
| Name on the box | Strength and form | Prescription | Holder | Official record |
|---|---|---|---|---|
| AURO-PIRFENIDONE | 801 mg · tablet | Prescription only | Auro Pharma Inc | 02537761 |
| ESBRIET | 801 mg · tablet | Prescription only | Hoffmann-La Roche Limited | 02464500 |
| JAMP PIRFENIDONE | 801 mg · tablet | Prescription only | Jamp Pharma Corporation | 02514710 |
| M-PIRFENIDONE | 801 mg · tablet | Prescription only | Mantra Pharma Inc | 02550652 |
| MAR-PIRFENIDONE | 801 mg · tablet | Prescription only | Marcan Pharmaceuticals Inc | 02549263 |
| PMS-PIRFENIDONE | 801 mg · tablet | Prescription only | Pharmascience Inc | 02531534 |
1 more names not shown. Source: Drug Product Database (Health Canada) · 2026-09-30 · Contains information licensed under the Open Government Licence – Canada.
Netherlands 12 matching products
| Name on the box | Strength and form | Prescription | Holder | Official record |
|---|---|---|---|---|
| Esbriet 801 mg | 801 mg · filmomhulde tablet | Prescription only | H.A.C. Pharma | EU/1/11/667 |
| Pirfenidon Accord 801 mg | 801 mg · filmomhulde tablet | Prescription only | Accord Healthcare B.V. | 128234 |
| Pirfenidon Amarox 801 mg filmomhulde tabletten | 801 mg · filmomhulde tablet | Prescription only | Amarox Pharma B.V. | 128610 |
| Pirfenidon Aurobindo 801 mg | 801 mg · tablet | Prescription only | Aurobindo Pharma B.V. | 130036 |
| Pirfenidon Glenmark 801 mg filmomhulde tabletten | 801 mg · filmomhulde tablet | Prescription only | Glenmark Arzneimittel GmbH | 134944 |
| Pirfenidon nio 801 mg filmomhulde tabletten | 801 mg · filmomhulde tablet | Prescription only | axunio Pharma GmbH | 129152 |
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
- European Union: 3 products · Every strength and form
- Switzerland: 8 products · Every strength and form