Ireland· IE-PA-EU/1/20/1470/001
Lumeblue 25 mg prolonged-release tablets
A other diagnostic agents product containing methylthioninium chloride, registered in Ireland by Alfasigma S.p.A. The same ATC class is registered in 11 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
Where it is registered
Methylthioninium chloride is registered in 11 of 19 countries.
Countries holding a registration under ATC V04CX (other diagnostic agents), each read from that country’s own register.
- This record: Ireland, from HPRA (Ireland)
- 7 of them publish a price we can compare per daily dose
Methylthioninium chloride · ATC V04CX
11 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Icelandprice
- Ireland
- Netherlands
- Norwayprice
- Polandprice
- Switzerlandprice
The record
At a glance
HPRA (Ireland)- Active substance
- Methylthioninium chloride
- Manufacturer
- Alfasigma S.p.A
- Country
- Ireland (IE)
- ATC code
- V04CX
- ATC class
- Other diagnostic agents
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/20/1470/001
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Methylthioninium chloride in 8 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- BelgiumLumeblue 25 mgCosmo Technologies
- FinlandLumeblueCosmo Technologies Limited
- United StatesArthcal 1% METHYLENE BLUEBeijing JUNGE Technology Co., Ltd.
- United KingdomMethylthioninium chloride (methylene blue) 100mg/10ml solution for injection ampoulesMartindale Pharmaceuticals Ltd
- CanadaMETHYLENE BLEU LIQ 1%LABORATOIRE ATLAS INC
- CzechiaMETHYLTHIONINIUMCHLORID PROVEBLUEPROVEPHARM SAS, Marseille
- NorwayMetibloSterop
- SwedenMethylthioninium chloride Proveblue 5 mg/ml Injektionsvätska, lösningProvepharm SAS
Authorised across Europe · EMA
The same active substance is authorised in 6 EEA countries. Names it is sold under:
- Belgium · Metiblo
- United Kingdom (Northern Ireland) · Methylthioninium Chloride Phebra Limited
- Iceland · Proveblue
- Italy · Metiltioninio Cloruro Bioindustria L.I.M., Metiltioninio Cloruro Monico
- Liechtenstein · Proveblue
- Norway · Proveblue
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/df4d9335-f9a6-4281-ab6c-adec90d54c1b GET /v1/drugs/df4d9335-f9a6-4281-ab6c-adec90d54c1b?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": [
"V04CX"
],
"strength": null,
"pa_number": "EU/1/20/1470/001",
"substances": [
"Methylthioninium chloride"
],
"legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "19/08/2020",
"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 methylthioninium chloride.
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.