Poland· PL-100452220

Mildronate

A meldonium product containing meldonium dihydratum, registered in Poland by AS Grindeks. The same ATC class is registered in 4 of our 19 countries.

ATC C01EB22

Checked against URPL (Poland) on

Informational only — not a medical device.

SOURCE REGISTER · PLURPL (Poland)normalisedMildronateATCC01EB22REGISTER NO.PL-100452220PACKS LISTED4CHECKEDSeptember 27, 2026

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: Poland, from URPL (Poland)
  • 3 of them publish a price we can compare per daily dose

Meldonium · ATC C01EB22

4 / 19 countries

  • Finlandprice
  • Ireland
  • Norwayprice
  • 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

URPL (Poland)
Active substance
Meldonium dihydratum
Manufacturer
AS Grindeks
Country
Poland (PL)
ATC code
C01EB22
ATC class
Meldonium
Defined daily dose
0.75 g, O
Reimbursed
Not published by this register
Source register
URPL (Poland)
Last checked
September 27, 2026

Packs & prices · 4

  • gtin
    05909991497224
  • gtin
    05909991497231
  • gtin
    04750232019429
  • gtin
    04750232019412

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.

All meldonium products

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
  • Ireland · Mildronate
  • Italy · Mildronate
  • Lithuania · Mildronate, Zovanat
  • Luxembourg · Mildronate
  • Latvia · Meldonium Olpha, Mildronats
  • Malta · Meldonium, Meldopharm
  • Norway · 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 URPL (Poland). 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/5b77c31b-ccd0-40f2-aa15-39425761b0ad
GET /v1/drugs/5b77c31b-ccd0-40f2-aa15-39425761b0ad?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": "Kapsułki twarde",
  "source": "urpl",
  "strength": "500 mg",
  "packaging": "05909991497224 ¦ Rp ¦ Skasowane ¦ 147014\n20 kaps.\n05909991497231 ¦ Rp ¦ Skasowane ¦ 147015\n60 kaps.\n04750232019429 ¦ Rp ¦ 152776\n60 kaps.\n04750232019412 ¦ Rp ¦ 152777\n20 kaps.",
  "substance": "Meldonium dihydratum 500 mg",
  "common_name": "Meldonium dihydratum",
  "pl_product_id": "100452220",
  "pozwolenie_nr": "27385",
  "auth_procedure": "DCP",
  "authorisation_validity": "2027-10-07"
}

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.