Belgium· BE-AMP-SAM426903-00
Irbesartan Zentiva 75 mg
A medicinal product containing irbesartan, registered in Belgium by Sanofi-Aventis Groupe.
Checked against FAMHP / AFMPS (Belgium) on
Informational only — not a medical device.
The record
At a glance
FAMHP / AFMPS (Belgium)- Active substance
- Irbesartan
- Manufacturer
- Sanofi-Aventis Groupe
- Country
- Belgium (BE)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- FAMHP / AFMPS (Belgium)
- Last checked
- September 26, 2026
Packs & prices · 0
No packs listed by the register for this record.
Regulatory notes
No shortage, Orange Book or US label notes for this record.
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.
- CzechiaAPROVELSanofi Winthrop Industrie, Gentilly
- SpainAPROVEL 75 mg COMPRIMIDOS RECUBIERTOS CON PELICULASanofi Winthrop Industrie
- FinlandAprovelSanofi Winthrop Industrie
- FranceAPROVEL 75 mg, comprimé pelliculéSANOFI WINTHROP INDUSTRIE
- NetherlandsAprovel 75 mg, filmomhulde tablettenSanofi Winthrop Industrie
- SwedenAprovel 75 mg Filmdragerad tablettSanofi Winthrop Industrie
- IrelandAprovel 75 mg film-coated tabletsSanofi Winthrop Industrie
- PolandAprovelSanofi Winthrop Industrie
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/faa7371c-88bd-4b91-8387-b8434693d517 GET /v1/drugs/faa7371c-88bd-4b91-8387-b8434693d517?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": "Irbesartan Zentiva 75 mg",
"name_fr": "Irbesartan Zentiva 75 mg",
"name_nl": "Irbesartan Zentiva 75 mg",
"amp_code": "SAM426903-00",
"strengths": [
"75.0000"
],
"pack_count": 0,
"substances": [
"Irbesartan"
],
"medicine_type": "ALLOPATHIC",
"atc_description": null,
"authorisation_numbers": null
}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.