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Belgium· BE-AMP-SAM355293-00

Dafiro HCT 10 mg - 160 mg - 25 mg

A valsartan, amlodipine and hydrochlorothiazide product containing hydrochlorothiazide, registered in Belgium by Novartis Europharm. The same ATC class is registered in 12 of our 19 countries.

ATC C09DX01

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedDafiro HCT 10 mg - 160 mg - 25 mgATCC09DX01REGISTER NO.BE-AMP-SAM355293-00PACKS LISTED0CHECKEDSeptember 26, 2026

Where it is registered

Valsartan, amlodipine and hydrochlorothiazide is registered in 12 of 19 countries.

Countries holding a registration under ATC C09DX01 (valsartan, amlodipine and hydrochlorothiazide), each read from that country’s own register.

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

Valsartan, amlodipine and hydrochlorothiazide · ATC C09DX01

12 / 19 countries

  • Belgiumprice
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Icelandprice
  • Ireland
  • Italyprice
  • Netherlands
  • Norwayprice
  • Polandprice
  • Switzerlandprice
  • 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
Hydrochlorothiazide
Manufacturer
Novartis Europharm
Country
Belgium (BE)
ATC code
C09DX01
ATC class
Valsartan, amlodipine and hydrochlorothiazide
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

48 interactions on record for valsartan, amlodipine and hydrochlorothiazide.

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, amlodipine and hydrochlorothiazide · interactions on record

48 records

48 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, amlodipine and hydrochlorothiazide in 14 other countries

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

All valsartan, amlodipine and hydrochlorothiazide products

Authorised across Europe · EMA

The same active substance is authorised in 24 EEA countries. Names it is sold under:

  • Austria · Hct G.L.
  • Bulgaria · Hypodehydra, Дехидразид
  • Cyprus · Didralin, Hydrochlorothiazide Remedica
  • Czechia · Hydrochlorothiazid Léčiva
  • Germany · Hct 089pharm, Hct 1 A Pharma
  • Denmark · Hydrochlorothiazide Orifarm, Hydromed
  • Estonia · Hypothiazid
  • Spain · Drine, Esidrex
  • Finland · Hydrex, Hydrex Semi
  • France · Esidrex, Hydrochlorothiazide Arrow
  • United Kingdom (Northern Ireland) · Hydrochlorothiazide Aspire Pharma
  • Greece · Diuren, Losazide
  • Hungary · Hypothiazid
  • Iceland · Hydromed
  • Italy · Esidrex, Idroclorotiazide Aurobindo
  • Lithuania · Hypothiazid
  • Latvia · Hypothiazid
  • Netherlands · Hydrochloorthiazide 1a Pharma, Hydrochloorthiazide Aurobindo
  • Norway · Esidrex, Hydrochlorothiazide Orifarm
  • Poland · Hydrochlorothiazide Aurovitas, Hydrochlorothiazidum Polpharma
  • Portugal · Hidroclorotiazida Bluefish, Hidroclorotiazida Generis
  • Romania · Nefrix
  • Sweden · Esidrex, Hydrochlorothiazide Bluefish
  • Slovakia · Hydrochlorothiazid Léčiva

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/ca464f78-0e6f-4d7f-a19f-42cc373c5a94
GET /v1/drugs/ca464f78-0e6f-4d7f-a19f-42cc373c5a94?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 HCT 10 mg - 160 mg - 25 mg",
  "name_fr": "Dafiro HCT 10 mg - 160 mg - 25 mg",
  "name_nl": "Dafiro HCT 10 mg - 160 mg - 25 mg",
  "amp_code": "SAM355293-00",
  "strengths": [
    "25.0000",
    "160.0000",
    "10.0000"
  ],
  "pack_count": 12,
  "substances": [
    "Hydrochlorothiazide",
    "Valsartan",
    "Amlodipine Besilate",
    "Amlodipine"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Valsartan, amlodipine and hydrochlorothiazide",
  "authorisation_numbers": [
    "EU/1/09/574/037",
    "EU/1/09/574/038",
    "EU/1/09/574/039",
    "EU/1/09/574/040",
    "EU/1/09/574/041",
    "EU/1/09/574/042",
    "EU/1/09/574/043",
    "EU/1/09/574/044",
    "EU/1/09/574/045",
    "EU/1/09/574/046",
    "EU/1/09/574/047",
    "EU/1/09/574/048"
  ]
}

See everything about valsartan, amlodipine and hydrochlorothiazide.

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.