Sweden· SE-20101022000062
Ameluz 78 mg/g Gel
A medicinal product containing 5-aminolevulinic acid, registered in Sweden by Biofrontera Bioscience GmbH.
Checked against Swedish Medical Products Agency (Sweden) on
Informational only — not a medical device.
The record
At a glance
Swedish Medical Products Agency (Sweden)- Active substance
- 5-Aminolevulinic Acid
- Manufacturer
- Biofrontera Bioscience GmbH
- Country
- Sweden (SE)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- Swedish Medical Products Agency (Sweden)
- Last checked
- October 1, 2026
Packs & prices · 1
- se_varunummer20101022000062
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
5-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
- IrelandAmeluz 78 mg/g gelBiofrontera Bioscience GmbH
- IcelandAmeluzBiofrontera Bioscience GmbH
- NetherlandsAmeluz 78 mg/g, gelBiofrontera Bioscience GmbH
- PolandAmeluzBiofrontera 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
- Ireland · Alacare
- Iceland · Ameluz, Gliolan
- Italy · Alacare
- Liechtenstein · Ameluz, Gliolan
- Netherlands · Alacare
- Norway · Alacare, Ameluz
- Poland · Alacare
- Portugal · 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 Swedish Medical Products Agency (Sweden). 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/5f94e53c-65b4-45ad-b189-02e0dc48767f GET /v1/drugs/5f94e53c-65b4-45ad-b189-02e0dc48767f?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.
{
"source": "lakemedelsverket",
"doc_types": [
"EPAR",
"EMA"
],
"se_npl_id": "20101022000062",
"product_page": "https://www.lakemedelsverket.se/sv/sok-lakemedelsfakta/lakemedel?id=20101022000062",
"product_doc_link": "https://www.ema.europa.eu/sv/documents/product-information/ameluz-epar-product-information_sv.pdf"
}See everything about 5-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.