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Belgium· BE-AMP-SAM564631-00

Aprexevo 150 mg - 10 mg

A irbesartan und amlodipin product containing amlodipine besilate, registered in Belgium by Sanofi Belgium.

ATC C09DB05

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedAprexevo 150 mg - 10 mgATCC09DB05REGISTER NO.BE-AMP-SAM564631-00PACKS LISTED0CHECKEDSeptember 26, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about amlodipine besilateAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

The record

At a glance

FAMHP / AFMPS (Belgium)
Active substance
Amlodipine Besilate
Manufacturer
Sanofi Belgium
Country
Belgium (BE)
ATC code
C09DB05
ATC class
Irbesartan und Amlodipin
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.

Interactions

14 interactions on record for irbesartan und amlodipin.

Mechanism, severity and management for each pair, from a commercially licensed source — included 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 irbesartan und amlodipin against other medicinesHow interaction checks work

Irbesartan und amlodipin · interactions on record

14 records

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

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Mechanism and what to do, in the interaction check
Interaction register. Grades as the source publishes them.

Same medicine, other countries

Irbesartan und amlodipin in 16 other countries

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

All irbesartan und amlodipin products

Authorised across Europe · EMA

The same active substance is authorised in 29 EEA countries. Names it is sold under:

  • Austria · Amlodibene Teva, Amlodilan
  • Bulgaria · Nordipin 10 Mg, Nordipin 5 Mg
  • Cyprus · Afiten, Amlobe
  • Czechia · Agen, Amlodipin Teva
  • Germany · Amlo Besilat Tad, Amlodipin (Besilat) Dexcel
  • Denmark · Adipine, Amlodipin 1a Farma
  • Estonia · Agen, Amlocard
  • Spain · Amlodipino Almus, Amlodipino Alter
  • Finland · Amlodipin Accord, Amlodipin Krka
  • France · Amlodipine Almus, Amlodipine Arrow
  • United Kingdom (Northern Ireland) · Amlodipine, Amlodipine Accord Healthcare
  • Greece · Abesyl, Amilopid
  • Croatia · Amlodipin Genericon, Amlodipin Pharmas
  • Hungary · Amlobesyl, Amlodipin Sandoz
  • Ireland · Amlode, Amlodipine 10 Mg
  • Iceland · Amló, Amlodipin Bluefish
  • Italy · Abis, Almidis
  • Lithuania · Agen, Alneta
  • Luxembourg · Amlodipin Besilaat Sandoz, Amlodipine Amlodipine Taw Pharma 1 mg/Ml Suspension Buvable
  • Latvia · Agen, Amlodipine Vitabalans
  • Malta · Amlodipina Ipca, Amlodipine Accord Healthcare
  • Netherlands · Amlober, Amlodipine (Als Besilaat) Accord
  • Norway · Amlodipin Accord, Amlodipin Sandoz
  • Poland · Adipine, Agen
  • Portugal · Amlocor, Amlodipina Accord
  • Romania · Almacor, Amlodipină Arena
  • Sweden · Amlodipin, Amlodipin Accord
  • Slovenia · Amlodipin Alkaloid-Int, Amlodipin Krka D.D.
  • Slovakia · Agen, Amlodipin Ratiopharm

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/c054429f-c484-41a4-800b-e0ff80f5245f
GET /v1/drugs/c054429f-c484-41a4-800b-e0ff80f5245f?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": "REVOKED",
  "name_en": "Aprexevo 150 mg - 10 mg",
  "name_fr": "Aprexevo 150 mg - 10 mg",
  "name_nl": "Aprexevo 150 mg - 10 mg",
  "amp_code": "SAM564631-00",
  "strengths": [
    "14.0000",
    "150.0000",
    "10.0000",
    "150.0000",
    "14.0000",
    "10.0000"
  ],
  "pack_count": 5,
  "substances": [
    "Amlodipine Besilate",
    "Irbesartan",
    "Amlodipine"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Irbesartan and Amlodipine",
  "authorisation_numbers": [
    "BE564631"
  ]
}
API referenceMCP serverPlans

See everything about irbesartan und amlodipin.

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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