Ireland· IE-PA-EU/1/08/462/3,4,9,10
Ranexa 500 mg prolonged-release tablets
A other cardiac preparations product containing ranolazine, registered in Ireland by Menarini International Operations Luxembourg S.A.. The same ATC class is registered in 4 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
Where it is registered
Ranolazine is registered in 4 of 19 countries.
Countries holding a registration under ATC C01EB (other cardiac preparations), each read from that country’s own register.
- This record: Ireland, from HPRA (Ireland)
- 3 of them publish a price we can compare per daily dose
Ranolazine · ATC C01EB
4 / 19 countries
- Czechiaprice
- Ireland
- Polandprice
- United Statesprice
The record
At a glance
HPRA (Ireland)- Active substance
- Ranolazine
- Manufacturer
- Menarini International Operations Luxembourg S.A.
- Country
- Ireland (IE)
- ATC code
- C01EB
- ATC class
- Other cardiac preparations
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/08/462/3,4,9,10
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Ranolazine in 16 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- SpainLABIGAT 500 MG COMPRIMIDOS DE LIBERACION PROLONGADA EFGPharmathen S.A.
- United KingdomAnzipro 500mg modified-release tabletsRidge Pharma Ltd
- United StatesRanolazineZydus Lifesciences Limited
- CzechiaRANEXAMenarini International Operations Luxembourg S.A., Luxembourg
- NetherlandsLazela 500 mg, tabletten met verlengde afgifteDemo S.A. Pharmaceutical Industry
- ItalyRANEXAMENARINI INTERNAT. O.L.S.A
- PolandRalikFarmak International Sp. z o.o.
- NorwayRanexaBerlin-Chemie AG
Authorised across Europe · EMA
The same active substance is authorised in 23 EEA countries. Names it is sold under:
- Austria · Rande, Ranogelan
- Bulgaria · Равена
- Cyprus · Ranolazine Accord, Ranolazine Remedica
- Czechia · Ranolazine Umedica
- Germany · Halibrell, Labigat
- Denmark · Labigat
- Estonia · Halibrell, Ralik
- Spain · Labigat, Ranolazina Alter
- France · Ranolazine Micro Labs
- United Kingdom (Northern Ireland) · Ranolazine, Ranolazine Accord
- Greece · Labigat, Lakosun
- Croatia · Halibrell, Lasokun
- Iceland · Ranexa
- Italy · Labigat, Ranolazina Accord
- Liechtenstein · Ranexa
- Lithuania · Halibrell, Lasokun
- Latvia · Halibrell, Lasokun
- Netherlands · Lazela, Ranogelan
- Norway · Ranexa
- Poland · Ralik, Ranolazine Aurovitas
- Portugal · Ranolazina Adamed, Ranolazina Bluepharma
- Romania · Ranolazina Atb
- Slovenia · Halibrell, Ranolazin Stada
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/1bdea987-d01b-4157-bffd-1e2f0d2514f3 GET /v1/drugs/1bdea987-d01b-4157-bffd-1e2f0d2514f3?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": "Prolonged-release tablet",
"routes": [
"Oral use"
],
"source": "hpra",
"atc_all": [
"C01EB"
],
"strength": null,
"pa_number": "EU/1/08/462/3,4,9,10",
"substances": [
"Ranolazine"
],
"legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": null,
"dispensing_status": "Product subject to prescription which may be renewed (B)",
"registration_status": "AU",
"supply_legal_status": "Supply through pharmacies only",
"interchangeable_code": "IC0168-117-024"
}See everything about ranolazine.
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.