Radelumin®
[¹⁸F]PSMA-1007

Advanced Diagnostics of Prostate Cancer

Radelumin® [¹⁸F]PSMA-1007

Radelumin® is indicated for the detection of prostate-specific membrane antigen (PSMA)-positive lesions with positron emission tomography (PET) in adults with prostate cancer (PCa) in the following clinical settings:

• Primary staging of patients with high-risk PCa prior to primary curative therapy,
• Suspected PCa recurrence in patients with increasing levels of serum prostate-specific antigen (PSA) after primary curative therapy.

 

Radelumin® is a fluorine-based prostate-specific membrane antigen -PET/CT-tracer. 
ABX received a marketing authorisation for Radelumin® ([¹⁸F]PSMA-1007) in Austria, Belgium, France, Germany, Italy, Luxembourg, Poland, Portugal, Spain, The Netherlands and United Kingdom.

Find your Distribution Partner

The world map provides an overview of the countries where ABX is represented as a Marketing Authorization Holder (MAH), as well as markets with authorisations by our partners. Relevant contact details are provided for all the countries shown to facilitate direct inquiries regarding product availability, authorization status, or further information.

  • MAH ABX - CMO Partner
  • MAH Local Partner

ABX advanced biochemical compounds GmbH

Radeberg, Germany; Contact: Dr. Tony Köhler

Universitätsklinikum Leipzig

Leipzig; Contact: Dr. Tony Köhler

Advanced Accelerator Applications Deutschland GmbH

Bonn; Contact: Dominik Buss

Advanced Accelerator Applications Deutschland GmbH

München; Contact: Dominik Buss

Advanced Accelerator Applications Deutschland GmbH

München; Contact: Dominik Buss

Alliance Medical RP GmbH

Bonn; Contact: Kristina Hartmann

Alliance Medical RP Berlin GmbH

Berlin ; Contact: Kristina Hartmann

Diagnostisch Therapeutisches Zentrum am Frankfurter Tor

Berlin; Contact: Dr. Tony Köhler

Alliance Medical f-con GmbH

Holzhausen Germany; Contact: Marcel Grootens

Alliance Medical RP B.V.

Holzhausen Germany; Contact: Marcel Grootens

Alliance Medical Radiopharmacy Limited

Warwick CV34 6DA, United Kingdom

A.C.O.M. – ADVANCED CENTER ONCOLOGY MACERATA – S.R.L.

Lecce, Italy

Advanced Accelerator Applications Molecular Imaging Italy s.r.l.

Pozzilli (IS), Italy

Advanced Accelerator Applications Molecular Imaging Italy s.r.l.

Meldola, Italy

ITEL Telecomunicazioni S.r.l.

Ruvo di Puglia (BA), Italy

IRCCS

Negrar di Valpolicella, Italy

PETNET Solutions Inc.

Lisses, France; Contact: Cédric Bouteiller

Advanced Accelerator Applications Molecular Imaging

Béthune, France; Contact: Cédric Bouteiller

Advanced Accelerator Applications Molecular Imaging

Rosières Près Troyes, France; Contact: Cédric Bouteiller

Advanced Accelerator Applications Molecular Imaging

Marseille, France; Contact: Cédric Bouteiller

Newcure M Inc.

Seodaemun-gu Seoul, Republic of Korea; Contact: Mr. Minho Jung

SWAN Isotopen AG

Bern, Schweiz; Contact: Giovanni Roncolato

UniversitätsSpital Zürich

Zürich; Contact: Dr. Anass Johayem

EuroPET GmbH

Freiburg; Contact: Dr. Gabriel Fischer

EuroPET GmbH

Freiburg; Contact: Dr. Gabriel Fischer

Herz und Diabeteszentrum NRW

Bad Oeynhausen; Contact: Dr. Harald Henneken

Alliance Medical RP GmbH

Bonn, Germany

EuroPET GmbH

Freiburg, Germany

Universitätsklinikum Tübingen – Radiopharmazie

Tübingen; Contact: Prof. Gerald Reischl

Universitätsklinikum Würzburg - Interdisziplinäres PET-Zentrum (IPZ)

Würzburg; Contact: Katrin Höpfl

Synektik Pharma Sp. z o.o.

Warszawa, Poland

Synektik Pharma Sp. z o.o.

Kielce, Poland

Synektik Pharma Sp. z o.o.

Mszczonów, Poland

Alliance Medical RP sp. z.o.o.

Szeligi, Poland

Advanced Accelerator Applications Molecular Imaging S.L.U. Oporto

Senhora da Hora Matosinhos, Portugal

Advanced Accelerator Applications Molecular Imaging S.L.U. Barcelona

Esplugues de Llobregat, Barcelona, Spain

Advanced Accelerator Applications Molecular Imaging S.L.U. Murcia

Murcia, Spain

IRAB – Institut de Radiofarmàcia Aplicada de Barcelona

Barcelona, Spain

BIOKOSMOS S.A.

Greece; Contact: Yannis Emmanouilidis

BIOKOSMOS S.A.

Lakkoma Chalkidiki, Greece; Contact: Yannis Emmanouilidis

SISORA Société Isotope Radioactif

ZI Kheireddine Kram Tunis, Tunisia; Contact: Ramzi Frifita

SISORA Société Isotope Radioactif

ZI Kheireddine Kram Tunis, Tunisia; Contact: Ramzi Frifita
  • MAH ABX - CMO Partner
  • MAH Local Partner

Download SmPC and Educational Material

Austria
Summary of product characteristics (SmPC):
↓ 1300 MBq/ml solution for injection
↓ 2000 MBq/ml solution for injection

↓ Educational Material for Healthcare Professionals

Package leaflet:
↓ 1300 MBq/ml solution for injection
↓ 2000 MBq/ml solution for injection
Belgium
Summary of product characteristics (SmPC):
↓ 1300 MBq/ml solution for injection
↓ 2000 MBq/ml solution for injection

↓ Educational Material for Healthcare Professionals

Package leaflet:
↓ 1300 MBq/ml solution for injection
↓ 2000 MBq/ml solution for injection
France
Summary of product characteristics (SmPC):
↓ 1300 MBq/ml solution for injection
↓ 2000 MBq/ml solution for injection

Package leaflet:
↓ 1300 MBq/ml solution for injection
↓ 2000 MBq/ml solution for injection
Germany
Summary of product characteristics (SmPC):
↓ 1300 MBq/ml solution for injection
↓ 2000 MBq/ml solution for injection

↓ Educational Material for Healthcare Professionals

Package leaflet:
↓ 1300 MBq/ml solution for injection
↓ 2000 MBq/ml solution for injection
Italy
Summary of product characteristics (SmPC):
↓ 1300 MBq/ml solution for injection
↓ 2000 MBq/ml solution for injection

↓ Educational Material for Healthcare Professionals

Package leaflet:
↓ 1300 MBq/ml solution for injection
↓ 2000 MBq/ml solution for injection
Luxembourg
Summary of product characteristics (SmPC):
↓ 1300 MBq/ml solution for injection
↓ 2000 MBq/ml solution for injection

↓ Educational Material for Healthcare Professionals

Package leaflet:
↓ 1300 MBq/ml solution for injection
↓ 2000 MBq/ml solution for injection
Poland
Summary of product characteristics (SmPC):
↓ 1300 MBq/ml solution for injection
↓ 2000 MBq/ml solution for injection

↓ Educational Material for Healthcare Professionals

Package leaflet:
↓ 1300 MBq/ml solution for injection
↓ 2000 MBq/ml solution for injection
Portugal
Summary of product characteristics (SmPC)
↓ 1300 MBq/ml solution for injection
↓ 2000 MBq/ml solution for injection

↓ Educational Material for Healthcare Professionals (available on the INFOMED website)

Package leaflet:
↓ 1300 MBq/ml solution for injection
↓ 2000 MBq/ml solution for injection
Spain
Summary of product characteristics (SmPC)

 
▼ Radelumin (PSMA-1007 (¹⁸F)):

↓ 1300 MBq/ml solution for injection and/ or
↓ 2000 MBq/ml solution for injection
↓ Educational Material for Healthcare Professionals

Consult this material alongside the medicinal product's summary of product characteristics, available via the AEMPS online medicines information center (CIMA). https://cima.aemps.es/

It is important to remember to report suspected adverse reactions through the corresponding Regional Pharmacovigilance Centre or the electronic form available at https://www.notificaRAM.es

Risk prevention information agreed upon with the Spanish Agency of Medicines and Medical Devices (AEMPS). April 2024.

▼ This medicinal product is subject to additional monitoring; reporting suspected adverse reactions associated with this medicinal product is a priority.

Package leaflet:
↓ 1300 MBq/ml solution for injection
↓ 2000 MBq/ml solution for injection
Netherlands
Summary of product characteristics (SmPC):
↓ 1300 MBq/ml solution for injection
↓ 2000 MBq/ml solution for injection

↓ Educational Material for Healthcare Professionals

Package leaflet:
↓ 1300 MBq/ml solution for injection
↓ 2000 MBq/ml solution for injection
United Kingdom
Summary of product characteristics (SmPC):
↓ 2000 MBq/ml solution for injection

↓ Educational Material for Healthcare Professionals

Package leaflet:
↓ 2000 MBq/ml solution for injection