Belgium· BE-AMP-SAM521377-00

Esbriet 801 mg

A pirfenidone product containing pirfenidone, registered in Belgium by H.A.C. Pharma. The same ATC class is registered in 17 of our 19 countries.

ATC L04AX05

Checked against FAMHP / AFMPS (Belgium) on September 26, 2026

Informational only — not a medical device.

Compare price across countriesPer daily dose · free account Ask the assistant about pirfenidoneAnswers with sources · free account Check interactionsSeverity free · mechanism on Growth

Where it is registered

Pirfenidone is registered in 17 of 19 countries.

Countries holding a registration under ATC L04AX05 (pirfenidone), each read from that country’s own register.

This record: Belgium, from FAMHP / AFMPS (Belgium)
9 of them publish a price we can compare per daily dose

Search pirfenidone products by name

Pirfenidone · ATC L04AX05

17 / 19 countries

Belgiumprice
Canada
Czechiaprice
Denmark
Finlandprice
Franceprice
Germany
Icelandprice
Ireland
Japan
Netherlands
Norwayprice
Polandprice
Sweden
Switzerlandprice
United Kingdom
United Statesprice

Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

Price per daily dose

What a daily dose of pirfenidone costs, country by country.

Normalised to the WHO defined daily dose (2.4 g), the median price runs from $27.36 in France to $63.67 in Switzerland — a ×2.3 gap.

2 markets with a comparable price for this class
Public list prices, converted to USD at the rate date shown

Open the full comparison — free account Drug prices for market access

Pirfenidone · price per daily dose (2.4 g)

USD · FX 28 Sept 2026

CH Switzerland$63.67
FR France$27.36

Median listed price per WHO defined daily dose, in each market that publishes a price. Open the full comparison

The record

At a glance

FAMHP / AFMPS (Belgium)

Active substance: Pirfenidone
Manufacturer: H.A.C. Pharma
Country: Belgium (BE)
ATC code: L04AX05
ATC class: Pirfenidone
Defined daily dose: 2.4 g, O
Reimbursed: Not published by this register
Source register: FAMHP / AFMPS (Belgium)
Last checked: September 26, 2026

Packs & prices · 2

be_apb
7722663
be_apb
3623683

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Interactions

132 interactions on record for pirfenidone.

Graded by severity as the source publishes them — 20 severe. Severity grades are free for everyone; mechanism and management come with Growth.

Severity for every pair — free, no plan needed
The source, licence and sync date on every record
Mechanism and what to do for each pair — Growth plan

Check pirfenidone against other medicines How interaction checks work

Pirfenidone · interactions on record

132 records

20 severe
110 moderate
2 minor

Most severe, free to view

GivosiranA16AX16severe
AmiodaroneC01BD01severe
MipomersenC10AX11severe
LomitapideC10AX12severe

Interaction severity from DDInter 2.0 (Xiong G. et al., Nucleic Acids Res.), licensed CC BY-NC 4.0 — free for non-commercial use only; not covered by the Drug Database commercial licence.

Mechanism and what to do, in the interaction check

Source: DDInter 2.0 · synced 29 Sept 2026. Grades as the source publishes them.

Same medicine, other countries

Pirfenidone in 17 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All pirfenidone products

Authorised across Europe · EMA

The same active substance is authorised in 30 EEA countries. Names it is sold under:

Austria · Pirfenidon Accord, Pirfenidon Actavis
Bulgaria · Fredalix
Cyprus · Pirfenidone Accord, Pirfenidone Msn
Czechia · Fredalix, Pirfenidon Zentiva
Germany · Equitor, Pirfenair
Denmark · Fredalix, Pirfenair
Estonia · Pirfenidone Accord, Pirfenidone Msn
Spain · Pirfenidona Accord, Pirfenidona Aurovitas
Finland · Pirfenidon Cipla, Pirfenidone Accord
France · Pirfenidon Eg Labo - Laboratoireseurogenerics, Pirfenidone Accord
United Kingdom (Northern Ireland) · Pirfenidon Msn Laboratories Europe, Pirfenidone
Greece · Orepir, Pirfenidone Accord
Croatia · Pirfenidon Accord, Pirfenidon Sandoz
Hungary · Pirfenidon Zentiva
Ireland · Pirfenidone Accord, Pirfenidone Axunio
Iceland · Esbriet, Pirfenidon Medical Valley
Italy · Blamonehel, Pirfenidone Accord
Liechtenstein · Esbriet, Pirfenidone Viatris
Lithuania · Pirfenidone Accord, Pirfenidone Msn
Luxembourg · Pirfenidon Eg
Latvia · Pirfenidone Accord, Pirfenidone Msn
Malta · Pirfenidone Clonmel, Pirfenidone Msn
Netherlands · Pirfenidon Accord, Pirfenidon Amarox
Norway · Esbriet, Pirfenidon Cipla
Poland · Pirfenidon Cipla Europe, Pirfenidon Medical Valley
Portugal · Pirfenidona Accord, Pirfenidona Generis
Romania · Pirfenidon Msn
Sweden · Pirfenidon Cipla, Pirfenidon Medical Valley
Slovenia · Pirfenidon Accord, Pirfenidon Teva
Slovakia · Pirfenidón Accord, Pirfenidone Msn

Source: European Medicines Agency, Article 57 product data.

Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FAMHP / AFMPS (Belgium). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.

For developers

The same record over the API, and the raw payload

GET /v1/drugs/6f8555cf-e431-4a69-bd4e-d41af71c942f
GET /v1/drugs/6f8555cf-e431-4a69-bd4e-d41af71c942f?format=fhir

Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.

{
  "form": "Film-coated tablet",
  "source": "afmps",
  "status": "AUTHORIZED",
  "name_en": "Esbriet 801 mg",
  "name_fr": "Esbriet 801 mg",
  "name_nl": "Esbriet 801 mg",
  "amp_code": "SAM521377-00",
  "strengths": [
    "801.0000",
    "801.0000",
    "801.0000"
  ],
  "pack_count": 3,
  "substances": [
    "Pirfenidone"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Pirfenidone",
  "authorisation_numbers": [
    "EU/1/11/667/018",
    "EU/1/11/667/011",
    "EU/1/11/667/019"
  ]
}

API reference MCP server Plans

See everything about pirfenidone.

This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.

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