Ireland· IE-PA-EU/1/11/740/001
Ameluz 78 mg/g gel
A aminolevulinic acid product containing 5-aminolevulinic acid hydrochloride, registered in Ireland by Biofrontera Bioscience GmbH. The same ATC class is registered in 14 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
Where it is registered
Aminolevulinic acid is registered in 14 of 19 countries.
Countries holding a registration under ATC L01XD04 (aminolevulinic acid), each read from that country’s own register.
- This record: Ireland, from HPRA (Ireland)
- 8 of them publish a price we can compare per daily dose
Aminolevulinic acid · ATC L01XD04
14 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Icelandprice
- Ireland
- Japan
- Netherlands
- Norwayprice
- Polandprice
- Switzerlandprice
- United Kingdom
- United Statesprice
The record
At a glance
HPRA (Ireland)- Active substance
- 5-aminolevulinic acid hydrochloride
- Manufacturer
- Biofrontera Bioscience GmbH
- Country
- Ireland (IE)
- ATC code
- L01XD04
- ATC class
- Aminolevulinic acid
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/11/740/001
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Interactions
121 interactions on record for aminolevulinic acid.
Graded by severity as the source publishes them — 120 severe. Severity grades are free for everyone; mechanism and management come with Growth.
- Severity for every pair — free, no plan needed
- The source, licence and sync date on every record
- Mechanism and what to do for each pair — Growth plan
Aminolevulinic acid · interactions on record
121 records
- 120 severe
- 1 moderate
Most severe, free to view
- MinocyclineA01AB23severe
- SulfasalazineA07EC01severe
- GlibenclamideA10BB01severe
- ChlorpropamideA10BB02severe
- Interaction severity from DDInter 2.0 (Xiong G. et al., Nucleic Acids Res.), licensed CC BY-NC 4.0 — free for non-commercial use only; not covered by the Drug Database commercial licence.
Same medicine, other countries
Aminolevulinic acid in 15 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- SwitzerlandAmeluz
- SpainAMELUZ 78 MG/G GELBiofrontera Bioscience Gmbh
- FinlandAmeluzBiofrontera Bioscience GmbH
- IcelandAmeluzBiofrontera Bioscience GmbH
- NetherlandsAmeluz 78 mg/g, gelBiofrontera Bioscience GmbH
- PolandAmeluzBiofrontera Bioscience GmbH
- SwedenAmeluz 78 mg/g GelBiofrontera Bioscience GmbH
- United StatesAMELUZBiofrontera Inc.
Authorised across Europe · EMA
The same active substance is authorised in 17 EEA countries. Names it is sold under:
- Austria · Alacare
- Belgium · Effala
- Czechia · Alacare
- Germany · Alacare
- Denmark · Alacare
- Finland · Alacare
- France · Effala
- United Kingdom (Northern Ireland) · Alacare
- Iceland · Ameluz, Gliolan
- Italy · Alacare
- Liechtenstein · Ameluz, Gliolan
- Netherlands · Alacare
- Norway · Alacare, Ameluz
- Poland · Alacare
- Portugal · Alacare
- Sweden · Alacare
- Slovakia · Alacare
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/ccd10b47-0a7f-43ba-8a56-df3516d8a092 GET /v1/drugs/ccd10b47-0a7f-43ba-8a56-df3516d8a092?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": "Gel",
"routes": [
"Cutaneous use"
],
"source": "hpra",
"atc_all": [
"L01XD",
"L01XD04"
],
"strength": null,
"pa_number": "EU/1/11/740/001",
"substances": [
"5-aminolevulinic acid hydrochloride"
],
"legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "14/12/2012",
"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 aminolevulinic acid.
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.