Drug Database
Back to search

Ireland· IE-PA-PA1347/055/001

Amlodipine/Valsartan Krka 5 mg/ 80 mg film-coated tablets

A rosuvastatin und amlodipin product containing amlodipine + valsartan, registered in Ireland by KRKA, d.d., Novo mesto. The same ATC class is registered in 5 of our 19 countries.

ATC C10BX09

Checked against HPRA (Ireland) on

Informational only — not a medical device.

SOURCE REGISTER · IEHPRA (Ireland)normalisedAmlodipine/Valsartan Krka 5 mg/ 80 mg…ATCC10BX09REGISTER NO.IE-PA-PA1347/055/001PACKS LISTED1CHECKEDSeptember 28, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about amlodipine + valsartanAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

Where it is registered

Rosuvastatin und amlodipin is registered in 5 of 19 countries.

Countries holding a registration under ATC C10BX09 (rosuvastatin und amlodipin), each read from that country’s own register.

  • This record: Ireland, from HPRA (Ireland)
  • 4 of them publish a price we can compare per daily dose
Search rosuvastatin und amlodipin products by name

Rosuvastatin und amlodipin · ATC C10BX09

5 / 19 countries

  • Belgiumprice
  • Finlandprice
  • Ireland
  • Italyprice
  • Polandprice
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 + Valsartan
Manufacturer
KRKA, d.d., Novo mesto
Country
Ireland (IE)
ATC code
C10BX09
ATC class
Rosuvastatin und Amlodipin
Reimbursed
Not published by this register
Source register
HPRA (Ireland)
Last checked
September 28, 2026

Packs & prices · 1

  • ie_pa_number
    PA1347/055/001

Regulatory notes

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

Same medicine, other countries

Rosuvastatin und amlodipin in 14 other countries

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

All rosuvastatin und amlodipin products

Authorised across Europe · EMA

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

  • Austria · Amlodipin/Valsartan +pharma, Amlodipin/Valsartan 1a Pharma
  • Belgium · Amlodipine/Valsartan Eg, Amlodipine/Valsartan Krka
  • Bulgaria · Aзбима, Валдипин Дуо
  • Cyprus · Valsimia
  • Czechia · Asbima, Wamlox
  • Germany · Amlo-Valsacor, Amlodipin Hexal Plus Valsartan Hexal
  • Denmark · Amlodipin/Valsartan Stada
  • Estonia · Wamlox
  • Spain · Amlodipino/Valsartán Aurovitas, Amlodipino/Valsartán Cinfamed
  • Finland · Amlodipin/Valsartan Krka, Amlodipin/Valsartan Orion
  • France · Amlodipine/Valsartan Accord, Amlodipine/Valsartan Arrow
  • United Kingdom (Northern Ireland) · Amlodipine / Valsartan Zentiva Pharma
  • Greece · Alvoda, Amlodipine+valsartan Tad
  • Croatia · Dipperam, Vainas
  • Hungary · Amlodipin/Valsartan Krka Pharma, Amlodipin/Valsartan Sandoz
  • Iceland · Amlodipine/Valsartan Mylan, Copalia
  • Italy · Amlodipina E Valsartan Doc, Amlodipina E Valsartan Krka Pharma
  • Liechtenstein · Amlodipine/Valsartan Mylan, Copalia
  • Lithuania · Amlodipine/Valsartan Ingen Pharma, Dipperam
  • Luxembourg · Amlodipine/Valsartan Eg
  • Latvia · Wamlox
  • Netherlands · Amlodipine Besylate/Valsartan Aurobindo, Amlodipine/Valsartan Sandoz
  • Norway · Amlodipin/Valsartan Krka, Amlodipine/Valsartan Mylan
  • Poland · Avasart Plus, Dipperam
  • Portugal · Amlodipina / Valsartan Macleods, Amlodipina + Valsartan Alter
  • Romania · Amlodipină/Valsartan Stada, Bevacomb
  • Sweden · Amlodipin/Valsartan Actavis, Amlodipin/Valsartan Denk
  • Slovenia · Wamlox
  • Slovakia · Amlodipín/Valsartan Sandoz, Wamlox

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/4cfade49-0cee-462b-bf79-947d9e22c059
GET /v1/drugs/4cfade49-0cee-462b-bf79-947d9e22c059?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": [
    "C10BX",
    "C10BX09"
  ],
  "strength": null,
  "pa_number": "PA1347/055/001",
  "substances": [
    "Amlodipine",
    "Valsartan"
  ],
  "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)",
  "market_info": "Marketed",
  "authorised_at": "05/02/2016",
  "dispensing_status": "Product subject to prescription which may be renewed (B)",
  "registration_status": "AU",
  "supply_legal_status": "Supply through pharmacies only",
  "interchangeable_code": "IC0042-087-003"
}
API referenceMCP serverPlans

See everything about rosuvastatin 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.

Try it freeOpen in the console