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Belgium· BE-AMP-SAM412745-00

Ameluz 78 mg/g

A aminolevulinic acid product containing aminolevulinic acid hydrochloride, registered in Belgium by Biofrontera Bioscience. The same ATC class is registered in 14 of our 19 countries.

ATC L01XD04

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedAmeluz 78 mg/gATCL01XD04REGISTER NO.BE-AMP-SAM412745-00PACKS LISTED2CHECKEDSeptember 26, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about aminolevulinic acid hydrochlorideAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

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: Belgium, from FAMHP / AFMPS (Belgium)
  • 8 of them publish a price we can compare per daily dose
Search aminolevulinic acid products by name

Aminolevulinic acid · ATC L01XD04

14 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Icelandprice
  • Ireland
  • Japan
  • Netherlands
  • Norwayprice
  • Polandprice
  • Switzerlandprice
  • United Kingdom
  • United Statesprice
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

FAMHP / AFMPS (Belgium)
Active substance
Aminolevulinic Acid Hydrochloride
Manufacturer
Biofrontera Bioscience
Country
Belgium (BE)
ATC code
L01XD04
ATC class
Aminolevulinic acid
Reimbursed
Not published by this register
Source register
FAMHP / AFMPS (Belgium)
Last checked
September 26, 2026

Packs & prices · 2

  • be_apb
    3188455
  • be_apb
    7708654

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
Check aminolevulinic acid against other medicinesHow interaction checks work

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.
Mechanism and what to do, in the interaction check
Source: DDInter 2.0 · synced 29 Sept 2026. Grades as the source publishes them.

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.

All aminolevulinic acid products

Authorised across Europe · EMA

The same active substance is authorised in 17 EEA countries. Names it is sold under:

  • Austria · Alacare
  • Czechia · Alacare
  • Germany · Alacare
  • Denmark · Alacare
  • Finland · Alacare
  • France · Effala
  • United Kingdom (Northern Ireland) · Alacare
  • 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 FAMHP / AFMPS (Belgium). 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/c0e3c99e-f575-4f50-99d4-7bcec6b49f4d
GET /v1/drugs/c0e3c99e-f575-4f50-99d4-7bcec6b49f4d?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",
  "source": "afmps",
  "status": "AUTHORIZED",
  "name_en": "Ameluz 78 mg/g",
  "name_fr": "Ameluz 78 mg/g",
  "name_nl": "Ameluz 78 mg/g",
  "amp_code": "SAM412745-00",
  "strengths": [
    "78.0000",
    "10.0000",
    "2.4000"
  ],
  "pack_count": 1,
  "substances": [
    "Aminolevulinic Acid Hydrochloride",
    "Aminolevulinic Acid",
    "Disodium Hydrogen Phosphate Dihydrate",
    "Propylene Glycol",
    "Sodium Benzoate",
    "Sodium Dihydrogen Phosphate Dihydrate",
    "Polysorbate 80"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Aminolevulinic Acid",
  "authorisation_numbers": [
    "EU/1/11/740/001"
  ]
}
API referenceMCP serverPlans

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.

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