Ireland· IE-PA-PA22992/025/001
Mildronate 500 mg hard capsules
A meldonium product containing meldonium dihydrate, registered in Ireland by AS Grindeks. 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
Meldonium is registered in 4 of 19 countries.
Countries holding a registration under ATC C01EB22 (meldonium), 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
Meldonium · ATC C01EB22
4 / 19 countries
- Finlandprice
- Ireland
- Norwayprice
- Polandprice
The record
At a glance
HPRA (Ireland)- Active substance
- Meldonium dihydrate
- Manufacturer
- AS Grindeks
- Country
- Ireland (IE)
- ATC code
- C01EB22
- ATC class
- Meldonium
- Defined daily dose
- 0.75 g, O
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberPA22992/025/001
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Meldonium in 3 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- PolandMeldokarAflofarm Farmacja Polska Sp. z o.o.
- FinlandMyldroxGrindeks AS
- NorwayMildronateGrindeks AS
Authorised across Europe · EMA
The same active substance is authorised in 15 EEA countries. Names it is sold under:
- Austria · Mildronate
- Bulgaria · Mildronate, Милдронат
- Cyprus · Mildronate
- Finland · Myldrox
- Croatia · Myldrox, Myldroх
- Italy · Mildronate
- Lithuania · Mildronate, Zovanat
- Luxembourg · Mildronate
- Latvia · Meldonium Olpha, Mildronats
- Malta · Meldonium, Meldopharm
- Norway · Mildronate
- Poland · Meldokar, Mildronate
- Romania · Mildronate
- Slovenia · Mildronate
- Slovakia · Mildronate
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/5bdb5d34-a93c-44cb-a53a-0a0efc38fa72 GET /v1/drugs/5bdb5d34-a93c-44cb-a53a-0a0efc38fa72?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": "Capsule, hard",
"routes": [
"Oral use"
],
"source": "hpra",
"atc_all": [
"C01EB22"
],
"strength": null,
"pa_number": "PA22992/025/001",
"substances": [
"Meldonium dihydrate"
],
"legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)",
"market_info": "Not marketed",
"authorised_at": "13/10/2023",
"dispensing_status": "Product subject to prescription which may not be renewed (A)",
"registration_status": "AU",
"supply_legal_status": "Supply through pharmacies only",
"interchangeable_code": null
}See everything about meldonium.
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.