In other countries
The same active substances on other registers, the same brand first.
- Auro-PirfenidoneCanada · 267 MG · Tablet · Auro Pharma INCSame form
- Auro-PirfenidoneCanada · 801 MG · Tablet · Auro Pharma INCSame form
- EsbrietCanada · 801 MG · Tablet · Hoffmann-LA Roche LimitedSame form
- Esbriet 267 MG Comprimidos Recubiertos con PeliculaSpain · 267 mg · comprimido recubierto con película · H.A.C. PharmaSame form
- Esbriet 801 MG Comprimidos Recubiertos con PelículaSpain · 801 mg · comprimido recubierto con película · H.A.C. PharmaSame form
- Pirfenidona Accord 267 MG Comprimidos Recubiertos con Pelicula EfgSpain · 267 mg · comprimido recubierto con película · Accord Healthcare S.L.U.Same form
- BlamonehelItaly · Compressa rivestita con film · S.F. Group S.R.L.Same form
- EsbrietItaly · Compressa rivestita con film · H.A.C. PharmaSame form
- Pirfenidone AccordItaly · Compressa rivestita con film · Accord Healthcare, S.L.U.Same form
- Esbriet 267 mg, filmomhulde tabletNetherlands · Filmomhulde tablet · H.A.C. PharmaSame form
- Esbriet 534 mg, filmomhulde tabletNetherlands · Filmomhulde tablet · H.A.C. PharmaSame form
- Esbriet 801 mg, filmomhulde tabletNetherlands · Filmomhulde tablet · H.A.C. PharmaSame form
- Pirfenidone SandozNew Zealand · Tab 267 mgSame form
- Pirfenidone SandozNew Zealand · Tab 801 mgSame form
- Esbriet®Serbia · 267mg · film tableta · Roche DOO BeogradSame form
- Esbriet®Serbia · 801mg · film tableta · Roche DOO BeogradSame form
- Pirfenidon HFSerbia · 267mg · film tableta · Hemofarm Ad VRŠAcSame form
- Esbriet 267 MG Film Coated TabletSaudi Arabia · Delpharm Milano SriSame form
- Esbriet 801 MG Film Coated TabletSaudi Arabia · Delpharm Milano SriSame form
- Esbriet Film Coated Tablet 267MGSingapore · 267.000 mg · tablet, film coated · Roche Singapore Pte. LTD.Same form
- Esbriet Film Coated Tablet 801MGSingapore · 801.000 mg · tablet, film coated · Roche Singapore Pte. LTD.Same form
- EsbrietUnited States · 267MG, 534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, 801MG · tablet · Legacy PharmaSame form
- PirfenidoneUnited States · 267MG, 534MG, 801MG · tablet · Aurobindo PharmaSame form
- EgurinelBrazil · Adium S.A.Same substance
- EsdonaBrazil · Teva Farmacêutica Ltda.Same substance
- pirfenidonaBrazil · Sandoz do Brasil Indústria Farmacêutica LtdaSame substance
- EsbrietEuropean Union · H.A.C. PharmaSame substance
- Pirfenidone axunio (previously Pirfenidone AET)European Union · Axunio Pharma GmbHSame substance
- Pirfenidone ViatrisEuropean Union · Viatris LimitedSame substance
- ESBRIET 267 mgRomania · 267mg · caps. · Roche Registration GMBHSame substance
- ESBRIET 801 mgRomania · 801mg · compr. film. · Roche Registration GMBHSame substance
- ESBRIET 267 mg HARD CAPSULESSaudi Arabia · Catalent Pharma SolutionsSame substance
- PirfenidoneUnited States · 267MG · capsule · AmnealSame substance
Packs
| Pack | Code | Status |
|---|---|---|
| 21 tableta u blisteru, u kutiji | HR-H-325579005-01 | nije stavljeno u promet |
| 42 tablete u blisteru, u kutiji | HR-H-325579005-02 | nije stavljeno u promet |
| 84 tablete u blisteru, u kutiji | HR-H-325579005-03 | nije stavljeno u promet |
| 168 tableta u blisteru, u kutiji | HR-H-325579005-04 | nije stavljeno u promet |
| 21 tableta u blisteru s jediničnom dozom, u kutiji | HR-H-325579005-05 | nije stavljeno u promet |
| 42 tablete u blisteru s jediničnom dozom, u kutiji | HR-H-325579005-06 | nije stavljeno u promet |
| 84 tablete u blisteru s jediničnom dozom, u kutiji | HR-H-325579005-07 | nije stavljeno u promet |
| 168 tablete u blisteru s jediničnom dozom, u kutiji | HR-H-325579005-08 | nije stavljeno u promet |
| 63 tablete (1 pakiranje s 21 tabletom i 1 pakiranje sa 42 tablete u blisteru), u kutiji | HR-H-325579005-09 | nije stavljeno u promet |
| 63 tablete (1 pakiranje s 21 tabletom u blisteru s jediničnom dozom i 1 pakiranje sa 42 tablete u blisteru s jediničnom dozom), u kutiji | HR-H-325579005-10 | nije stavljeno u promet |
| 252 tablete (3 pakiranja s 84 tablete u blisteru), u kutiji | HR-H-325579005-11 | nije stavljeno u promet |
| 252 tablete (3 pakiranja s 84 tablete u blisteru s jediničnom dozom), u kutiji | HR-H-325579005-12 | nije stavljeno u promet |
Sources and licences
Compiled by Prognia from the public register below; the register’s text is the official one.
HALMED — Agencija za lijekove i medicinske proizvode RH
HALMED, Baza lijekova, source export 08.10.2026., acquired 2026-10-08; factual structured adaptation; Otvorena dozvola RH, NN 67/2017.
Licence: Otvorena dozvola RH NN 67/2017 · Added 8 Oct 2026
Report an error or request removalCorrections from the holder or the register are welcome.
Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.
At a glance
- Active substance
- Pirfenidone
- Dosage form
- Filmom obložena tableta
- Register
- Croatia (HALMED)
- Status
- Not marketed
- Status in the register
- nije stavljeno u promet
- Authorised
- 16 Jun 2023
- Registration
- HR-H-325579005
- Marketing authorisation holder
- Accord Healthcare Polska Sp. z o.o., Ul. Tasmowa 7, Mazowieckie, Varšava, Poljska
- Manufacturer
- Accord Healthcare B.V., Utrecht, Nizozemska Pharmadox Healthcare Limited, Paola, Malta Laboratori Fundacio Dau, Barcelona, Španjolska Accord Healthcare Polska Sp. z o.o., Pabianice, Poljska Accord Healthcare Single Member S.A., Lamia, Grčka
- ATC code
- L04AX05
- Procedure
- National, MRP or DCP
- Supply
- na recept; u ljekarni