Germany· DE-A57-98f19e19ba4140e8
Radelumin
A medicinal product containing (3s,10s,14s)-1-[4-[[(2s)-4-carboxy-2-[(2s)-4-carboxy-2-(6-[18f] fluoropyridin-3-amido)butanamido]butanamido]methyl]phenyl]-3-[(naphthalen-2-yl)methyl]-1,4,12-trioxo-2,5,11,13-tetraazahexadecane-10,14,16-tricarboxylic acid, registered in Germany by Abx Advanced Biochemical Compounds Biomedizinische Forschungsreagenzien Gmbh.
Checked against EMA Article 57 (European Union) on
Informational only — not a medical device.
The record
At a glance
EMA Article 57 (European Union)- Active substance
- (3s,10s,14s)-1-[4-[[(2s)-4-Carboxy-2-[(2s)-4-Carboxy-2-(6-[18f] Fluoropyridin-3-Amido)butanamido]butanamido]methyl]phenyl]-3-[(Naphthalen-2-Yl)methyl]-1,4,12-Trioxo-2,5,11,13-Tetraazahexadecane-10,14,16-Tricarboxylic Acid
- Manufacturer
- Abx Advanced Biochemical Compounds Biomedizinische Forschungsreagenzien Gmbh
- Country
- Germany (DE)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- EMA Article 57 (European Union)
- Last checked
- September 30, 2026
Packs & prices · 0
No packs listed by the register for this record.
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
(3s,10s,14s)-1-[4-[[(2s)-4-carboxy-2-[(2s)-4-carboxy-2-(6-[18f] fluoropyridin-3-amido)butanamido]butanamido]methyl]phenyl]-3-[(naphthalen-2-yl)methyl]-1,4,12-trioxo-2,5,11,13-tetraazahexadecane-10,14,16-tricarboxylic acid in 10 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaAXUMINBlue Earth Diagnostics Ireland Ltd, Dublin
- BelgiumRadelumin 1300 MBq/mlAbx Advanced Biochemical Compounds - Biomedizinische Forschungsreagenzien
- FinlandAxuminBlue Earth Diagnostics Ireland Ltd
- FranceAXUMIN 1600 MBq/mL, solution injectableBLUE EARTH DIAGNOSTICS (ROYAUME UNI)
- IrelandAxumin 1,600 MBq/mL solution for injectionBlue Earth Diagnostics Ireland Ltd
- NetherlandsAxumin 1600 MBq/ml oplossing voor injectieBlue Earth Diagnostics Ireland Ltd
- SwedenAxumin 1600 MBq/ml Injektionsvätska, lösningBlue Earth Diagnostics Ireland Ltd
- NorwayAxuminBlue Earth Diagnostics Ireland Ltd
Authorised across Europe · EMA
The same active substance is authorised in 13 EEA countries. Names it is sold under:
- Austria · Radelumin
- Belgium · Radelumin
- Spain · Radelumin
- France · Radelumin
- Greece · Próstalumin
- Iceland · Axumin
- Italy · Radelumin
- Liechtenstein · Axumin
- Luxembourg · Radelumin
- Netherlands · Radelumin
- Norway · Axumin
- Poland · Radelumin
- Portugal · Radelumin
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 EMA Article 57 (European Union). 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/85d99384-7be2-43ac-ae82-64eacfa1497e GET /v1/drugs/85d99384-7be2-43ac-ae82-64eacfa1497e?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.
{
"pzn": null,
"route": "Intravenous Use",
"source": "ema_art57_de",
"ma_number": null,
"substance": "(3s,10s,14s)-1-[4-[[(2s)-4-Carboxy-2-[(2s)-4-Carboxy-2-(6-[18f] Fluoropyridin-3-Amido)butanamido]butanamido]methyl]phenyl]-3-[(Naphthalen-2-Yl)methyl]-1,4,12-Trioxo-2,5,11,13-Tetraazahexadecane-10,14,16-Tricarboxylic Acid",
"atc_from_source": null,
"authorisation_country": "Germany"
}See everything about (3s,10s,14s)-1-[4-[[(2s)-4-carboxy-2-[(2s)-4-carboxy-2-(6-[18f] fluoropyridin-3-amido)butanamido]butanamido]methyl]phenyl]-3-[(naphthalen-2-yl)methyl]-1,4,12-trioxo-2,5,11,13-tetraazahexadecane-10,14,16-tricarboxylic 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.