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Belgium· BE-AMP-SAM297656-00

Exforge 5 mg - 80 mg

A valsartan and amlodipine product containing amlodipine besilate, registered in Belgium by Novartis Europharm. The same ATC class is registered in 14 of our 19 countries.

ATC C09DB01

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedExforge 5 mg - 80 mgATCC09DB01REGISTER NO.BE-AMP-SAM297656-00PACKS LISTED2CHECKEDSeptember 26, 2026

Where it is registered

Valsartan and amlodipine is registered in 14 of 19 countries.

Countries holding a registration under ATC C09DB01 (valsartan and amlodipine), each read from that country’s own register.

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

Valsartan and amlodipine · ATC C09DB01

14 / 19 countries

  • Belgiumprice
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Icelandprice
  • Ireland
  • Italyprice
  • Netherlands
  • Norwayprice
  • Polandprice
  • Spainprice
  • 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.

The record

At a glance

FAMHP / AFMPS (Belgium)
Active substance
Amlodipine Besilate
Manufacturer
Novartis Europharm
Country
Belgium (BE)
ATC code
C09DB01
ATC class
Valsartan and amlodipine
Reimbursed
Not published by this register
Source register
FAMHP / AFMPS (Belgium)
Last checked
September 26, 2026

Packs & prices · 2

1 priced
  • be_apb
    2388551
    EUR 34.57
  • be_apb
    0786533

Regulatory notes

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

Interactions

81 interactions on record for valsartan and amlodipine.

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

Valsartan and amlodipine · interactions on record

81 records

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

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

Same medicine, other countries

Valsartan and amlodipine in 16 other countries

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

All valsartan and amlodipine 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/b0d2e80a-51d9-4096-b9bf-30a59a827dc4
GET /v1/drugs/b0d2e80a-51d9-4096-b9bf-30a59a827dc4?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": "Exforge 5 mg - 80 mg",
  "name_fr": "Exforge 5 mg - 80 mg",
  "name_nl": "Exforge 5 mg - 80 mg",
  "amp_code": "SAM297656-00",
  "strengths": [
    "5.0000",
    "5.0000",
    "80.0000",
    "80.0000"
  ],
  "pack_count": 13,
  "substances": [
    "Amlodipine Besilate",
    "Amlodipine",
    "Valsartan"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Valsartan and Amlodipine",
  "authorisation_numbers": [
    "EU/1/06/370/001",
    "EU/1/06/370/002",
    "EU/1/06/370/003",
    "EU/1/06/370/004",
    "EU/1/06/370/005",
    "EU/1/06/370/006",
    "EU/1/06/370/007",
    "EU/1/06/370/008",
    "EU/1/06/370/025",
    "EU/1/06/370/026",
    "EU/1/06/370/027",
    "EU/1/06/370/034",
    "EU/1/06/370/037"
  ]
}

See everything about valsartan and amlodipine.

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.