Drug Database
Back to search

Ireland· IE-PA-EU/1/09/574/25-36

Dafiro HCT 5 mg/160 mg/25 mg film-coated tablets

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

ATC C09DX01

Checked against HPRA (Ireland) on

Informational only — not a medical device.

SOURCE REGISTER · IEHPRA (Ireland)normalisedDafiro HCT 5 mg/160 mg/25 mg film-coa…ATCC09DX01REGISTER NO.IE-PA-EU/1/09/574/25-…PACKS LISTED1CHECKEDSeptember 28, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about amlodipine besilate + hydrochlorothiazide + valsartanAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

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: Ireland, from HPRA (Ireland)
  • 9 of them publish a price we can compare per daily dose
Search valsartan, amlodipine and hydrochlorothiazide products by name

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

HPRA (Ireland)
Active substance
Amlodipine besilate + Hydrochlorothiazide + Valsartan
Manufacturer
Novartis Europharm Limited
Country
Ireland (IE)
ATC code
C09DX01
ATC class
Valsartan, amlodipine and hydrochlorothiazide
Reimbursed
Not published by this register
Source register
HPRA (Ireland)
Last checked
September 28, 2026

Packs & prices · 1

  • ie_pa_number
    EU/1/09/574/25-36

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
Check valsartan, amlodipine and hydrochlorothiazide against other medicinesHow interaction checks work

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 11 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 26 EEA countries. Names it is sold under:

  • Austria · Amlodipin/Valsartan/Hct 1a Pharma, Amlodipin/Valsartan/Hct Sandoz
  • Belgium · Amlodipine/Valsartan/Hydrochlorothiazide Krka
  • Bulgaria · Aверкано, Аверкано
  • Cyprus · Amlodipine/Valsartan/Hydrochlorothiazide Elpen, Amlodipine+valsartan+hydrochlorothiazide Genepharm
  • Czechia · Valtricom
  • Germany · Amlodipin Plus Valsartan Hct Hexal, Amlodipin/Valsartan/Hct
  • Denmark · Amlodipin/Valsartan/Hydrochlorthiazid Elpen, Amlodipine/Valsartan/Hydrochlorothiazide Krka
  • Estonia · Valtricom
  • Spain · Amlodipino/Valsartán/Hidroclorotiazida Cinfa, Amlodipino/Valsartán/Hidroclorotiazida Combix
  • Finland · Amlodipin/Valsartan/Hydrochlorothiazide Orion, Amlodipine/Valsartan/Hydrochlorothiazide Krka
  • Greece · Amlodipine+valsartan+hydrochlorothiazide Genepharm, Amlodipine+valsartan+hydrochlorothiazide Tad
  • Croatia · Amlodipin/Valsartan/Hidroklorotiazid Genepharm, Awerkano
  • Hungary · Amlodipin/Valsartan/Hct Sandoz, Valtricom
  • Iceland · Copalia Hct, Dafiro Hct
  • Italy · Amlodipina / Valsartan / Idroclorotiazide Mylan Pharma, Dipperam Hct
  • Liechtenstein · Copalia Hct, Dafiro Hct
  • Lithuania · Valtricom
  • Latvia · Valtricom
  • Netherlands · Amlodipin/Valsartan/Hct Stada, Amlodipine/Valsartan/Hct Sandoz
  • Norway · Amlodipine/Valsartan/Hydrochlorothiazide Krka, Amlodipine/Valsartan/Hydrochlorothiazide Viatris
  • Poland · Dipperam Hct, Valtricom
  • Portugal · Amlodipina + Valsartan + Hidroclorotiazida Krka, Amlodipina + Valsartan + Hidroclorotiazida Macleods
  • Romania · Valtricom
  • Sweden · Amlodipin/Valsartan/Hydroklortiazid Teva, Trivals
  • Slovenia · Awerkano, Valtricom
  • Slovakia · Valtricom

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 HPRA (Ireland). 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/50291a7a-e5d1-4593-ba36-bda0c5fde87f
GET /v1/drugs/50291a7a-e5d1-4593-ba36-bda0c5fde87f?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",
  "routes": [
    "Oral use"
  ],
  "source": "hpra",
  "atc_all": [
    "C09DX",
    "C09DX01"
  ],
  "strength": null,
  "pa_number": "EU/1/09/574/25-36",
  "substances": [
    "Amlodipine besilate",
    "Hydrochlorothiazide",
    "Valsartan"
  ],
  "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)",
  "market_info": "Unknown",
  "authorised_at": "04/11/2009",
  "dispensing_status": "Product subject to prescription which may be renewed (B)",
  "registration_status": "AU",
  "supply_legal_status": "Supply through pharmacies only",
  "interchangeable_code": null
}
API referenceMCP serverPlans

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.

Try it freeOpen in the console