Belgium· BE-AMP-SAM185902-00

Aprovel 75 mg

A irbesartan product containing irbesartan, registered in Belgium by Sanofi Winthrop Industrie. The same ATC class is registered in 18 of our 19 countries.

ATC C09CA04

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedAprovel 75 mgATCC09CA04REGISTER NO.BE-AMP-SAM185902-00PACKS LISTED2CHECKEDSeptember 26, 2026

Where it is registered

Irbesartan is registered in 18 of 19 countries.

Countries holding a registration under ATC C09CA04 (irbesartan), each read from that country’s own register.

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

Irbesartan · ATC C09CA04

18 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Franceprice
  • Germany
  • Icelandprice
  • Ireland
  • Italyprice
  • Netherlands
  • Norwayprice
  • Polandprice
  • Spainprice
  • 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 irbesartan costs, country by country.

Normalised to the WHO defined daily dose (0.15 g), the median price runs from $0.14 in France to $0.68 in Switzerland — a ×4.7 gap.

  • 5 markets with a comparable price for this class
  • Public list prices, converted to USD at the rate date shown
  • US figures are pharmacy acquisition cost (CMS NADAC), not retail

Irbesartan · price per daily dose (0.15 g)

USD · FX 28 Sept 2026

  • CH Switzerland$0.68
  • ES Spain$0.31
  • IT Italy$0.26
  • US United States$0.16 (acquisition cost)
  • FR France$0.14
Median listed price per WHO defined daily dose, in each market that publishes a price. US = pharmacy acquisition cost (CMS NADAC), not a retail price. Open the full comparison

The record

At a glance

FAMHP / AFMPS (Belgium)
Active substance
Irbesartan
Manufacturer
Sanofi Winthrop Industrie
Country
Belgium (BE)
ATC code
C09CA04
ATC class
Irbesartan
Defined daily dose
0.15 g, O
Reimbursed
Not published by this register
Source register
FAMHP / AFMPS (Belgium)
Last checked
September 26, 2026

Packs & prices · 2

  • be_apb
    1685981
  • be_apb
    1356567

Regulatory notes

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

Interactions

371 interactions on record for irbesartan.

Graded by severity as the source publishes them — 7 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

Irbesartan · interactions on record

371 records

  • 7 severe
  • 128 moderate
  • 3 minor
  • 152 info

Most severe, free to view

  • Potassium chlorideA12BA01severe
  • Potassium citrateA12BA02severe
  • Potassium gluconateA12BA05severe
  • Potassium chlorideB05XA01severe

81 more interactions with mechanism and management, from a commercially licensed source.

Sign in to check
  • 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

Irbesartan in 17 other countries

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

All irbesartan products

Authorised across Europe · EMA

The same active substance is authorised in 23 EEA countries. Names it is sold under:

  • Austria · Irbepress, Irbesartan Hexal
  • Bulgaria · Ирбесан, Ирбесо
  • Cyprus · Converium, Irbesartan Vocate
  • Czechia · Isame
  • Germany · Irbepress, Irbesartan 1 A Pharma
  • Denmark · Irbesartan Accord, Irbesartan Jubilant
  • Spain · Irbesartán Almus, Irbesartán Alter
  • France · Irbesartan Accord, Irbesartan Arrow
  • United Kingdom (Northern Ireland) · Irbesartan, Irbesartan Accord
  • Greece · Besartan, Irbegen
  • Hungary · Irabel, Irbesartan Sandoz
  • Ireland · Irbesartan Clonmel, Irbesartan Rowa
  • Iceland · Aprovel, Ifirmasta
  • Italy · Abesart, Irbesartan Accord
  • Liechtenstein · Aprovel, Irbesartan Teva
  • Luxembourg · Irbesartan Eg, Irbesartan Viatris
  • Malta · Irbesartan Aurobindo Pharma (Malta)
  • Netherlands · Artibesan, Irbesartan Accord
  • Norway · Aprovel, Ifirmasta
  • Poland · Irbesartan Aurovitas
  • Portugal · Irbesartan Alter, Irbesartan Aurovitas
  • Romania · Irbesartan Terapia
  • Sweden · Irbesartan Accord, Irbesartan Actavis

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/af855fd7-ad60-4b08-9c37-fb20a7f568a2
GET /v1/drugs/af855fd7-ad60-4b08-9c37-fb20a7f568a2?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": "Tablet",
  "source": "afmps",
  "status": "AUTHORIZED",
  "name_en": "Aprovel 75 mg",
  "name_fr": "Aprovel 75 mg",
  "name_nl": "Aprovel 75 mg",
  "amp_code": "SAM185902-00",
  "strengths": [
    "75.0000",
    "75.0000",
    "75.0000"
  ],
  "pack_count": 5,
  "substances": [
    "Irbesartan",
    "Lactose Monohydrate"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Irbesartan",
  "authorisation_numbers": [
    "EU/1/97/046/003",
    "EU/1/97/046/002",
    "EU/1/97/046/001",
    "EU/1/97/046/010",
    "EU/1/97/046/013"
  ]
}

See everything about irbesartan.

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.