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

Heinrich-Gläser-Straße 10-14, D-01454 Radeberg, Germany; Contact: Dr. Tony Köhler

Universitätsklinikum Leipzig

Liebigstr. 18, 04103 Leipzig; Contact: Dr. Tony Köhler

Advanced Accelerator Applications Deutschland GmbH

Saime-Genc-Ring 18 D-53121 Bonn; Contact: Dominik Buss

Advanced Accelerator Applications Deutschland GmbH

Im Klinikum der Universität München Marchioninistraße 15 D-81377 München; Contact: Dominik Buss

Advanced Accelerator Applications Deutschland GmbH

Im Klinikum der Universität München Marchioninistraße 15 D-81377 München; Contact: Dominik Buss

Alliance Medical RP GmbH

Spessartstraße 9 D-53119 Bonn; Contact: Kristina Hartmann

Alliance Medical RP Berlin GmbH

Max-Planck-Straße 4 D-12489 Berlin ; Contact: Kristina Hartmann

Diagnostisch Therapeutisches Zentrum am Frankfurter Tor

Kadiner Straße 23, 10243 Berlin; Contact: Dr. Tony Köhler

Alliance Medical f-con GmbH

Nic.-Aug.-Otto-Str. 7a 56357 Holzhausen Germany; Contact: Marcel Grootens

Alliance Medical f-con GmbH

Nic.-Aug.-Otto-Str. 7a 56357 Holzhausen Germany; Contact: Marcel Grootens

Alliance Medical Radiopharmacy Limited

Iceni Centre, Warwick Technology Park Warwick CV34 6DA, United Kingdom

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

Località Cavallino 39/A-B 62010 Montecosaro (MC), Italy

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

Via dell’Industria, Prima Traversa 86077, Pozzilli (IS), Italy

ITEL Telecomunicazioni S.r.l.

Via Labriola Z.I. snc 70037 Ruvo di Puglia (BA) Italy

Advanced Accelerator Applications Molecular Imaging

20 rue Diesel, 01630 Saint-Genis-Pouilly, France

Newcure M Inc.

Cancer Hospital Basement, 5th floor, 50-01, Yonsei-ro, Seodaemun-gu Seoul, Republic of Korea; Contact: Mr. Minho Jung

SWAN Isotopen AG

SWAN-Haus, Inselspital, CH-3010 Bern, Schweiz; Contact: Giovanni Roncolato

EuroPET GmbH

Im Universitätsklinikum Freiburg Hugstetter Str. 55 D-79106 Freiburg; Contact: Dr. Gabriel Fischer

EuroPET GmbH

Im Universitätsklinikum Freiburg Hugstetter Str. 55 D-79106 Freiburg; Contact: Dr. Gabriel Fischer

Herz und Diabeteszentrum NRW

Radiopharmazie Georgstr. 11 D-32545 Bad Oeynhausen; Contact: Dr. Harald Henneken

Alliance Medical RP GmbH

Spessartstraße 9 D-53119 Bonn, Germany

EuroPET GmbH

Im Universitätsklinikum Freiburg Hugstetter Str. 55 D-79106 Freiburg, Germany

Universitätsklinikum Tübingen – Radiopharmazie

Röntgenweg 15 D-72076 Tübingen; Contact: Dr. Gerald Reischl

Universitätsklinikum Würzburg - Interdisziplinäres PET-Zentrum (IPZ)

Oberdürrbacher Straße 6 D-97080 Würzburg; Contact: Katrin Höpfl

Synektik Pharma Sp. z o.0.

ul. Jozefa Piusa Dziekoniskiego 3 00-728 Warszawa, Poland

Alliance Medical RP sp. z.o.o.

ul. Szeligowska 3 05-850 Szeligi, Poland

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

Instituto CUF Rua da Fonte das Sete Bicas nº 170. 4460-283 Senhora da Hora Matosinhos, Portugal

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

Josep Anselm Clavé, 100 08950 Esplugues de Llobregat, Barcelona, Spain

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

Hospital Universitario Virgen de La Arrixaca Carretera Madrid-Cartagena S/N 30120 El Palmar, Murcia, Spain

IRAB – Institut de Radiofarmàcia Aplicada de Barcelona

C. Doctor Aiguader, 88, Planta -1 08003 Barcelona, Spain

BIOKOSMOS S.A.

Panormos Area, 19500 Lavrio, Greece; Contact: Yannis Emmanouilidis

SISORA Société Isotope Radioactif

43 rue Socrate ZI Kheireddine Kram Tunis, Tunisia; Contact: Ramzi Frifita

SISORA Société Isotope Radioactif

43 rue Socrate 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