Belgium· BE-AMP-SAM297412-00

Dafiro 5 mg - 160 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 September 26, 2026

Informational only — not a medical device.

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

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

Search valsartan and amlodipine products by name

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 · 0

No packs listed by the register for this record.

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

Check valsartan and amlodipine against other medicines How interaction checks work

Valsartan and amlodipine · interactions on record

81 records

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

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/f463cd9f-bb8c-4f68-8d13-a3148082fded
GET /v1/drugs/f463cd9f-bb8c-4f68-8d13-a3148082fded?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": "Dafiro 5 mg - 160 mg",
  "name_fr": "Dafiro 5 mg - 160 mg",
  "name_nl": "Dafiro 5 mg - 160 mg",
  "amp_code": "SAM297412-00",
  "strengths": [
    "5.0000",
    "5.0000",
    "160.0000",
    "160.0000",
    "5.0000"
  ],
  "pack_count": 13,
  "substances": [
    "Amlodipine Besilate",
    "Amlodipine",
    "Valsartan"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Valsartan and Amlodipine",
  "authorisation_numbers": [
    "EU/1/06/371/009",
    "EU/1/06/371/010",
    "EU/1/06/371/011",
    "EU/1/06/371/012",
    "EU/1/06/371/013",
    "EU/1/06/371/014",
    "EU/1/06/371/015",
    "EU/1/06/371/016",
    "EU/1/06/371/028",
    "EU/1/06/371/029",
    "EU/1/06/371/030",
    "EU/1/06/371/035",
    "EU/1/06/371/038"
  ]
}

API reference MCP server Plans

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.

Try it free Open in the console