Spain· ES:11740001
AMELUZ 78 MG/G GEL
A medicinal product containing ácido 5-aminolevulínico, registered in Spain by Biofrontera Bioscience Gmbh.
Checked against AEMPS CIMA (Spain) on
Informational only — not a medical device.
The record
At a glance
AEMPS CIMA (Spain)- Active substance
- ácido 5-aminolevulínico
- Manufacturer
- Biofrontera Bioscience Gmbh
- Country
- Spain (ES)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- AEMPS CIMA (Spain)
- Last checked
- September 12, 2026
Packs & prices · 1
1 priced- cima_codigo7006962EUR 203.75
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Ácido 5-aminolevulínico in 15 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- SwitzerlandAmeluz
- FinlandAmeluzBiofrontera Bioscience GmbH
- IrelandAmeluz 78 mg/g gelBiofrontera 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 18 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
- 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 AEMPS CIMA (Spain). 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/71dad5ca-b78e-4759-912b-1f1dab6a6930 GET /v1/drugs/71dad5ca-b78e-4759-912b-1f1dab6a6930?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.
{
"cpresc": "Medicamento Sujeto A Prescripción Médica",
"estado": "{\"aut\":1349679836000}",
"nregistro": "11740001",
"substance": "ácido 5-aminolevulínico"
}See everything about ácido 5-aminolevulínico.
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.