Product class: Authorized package
Medicinal product class: For human use
Package code: 1299371
Name of medicinal product: [18F]FDG-FR
Active substances:
Fludeoxyglucose (18F)
Estonian, English, Latin
ATC code: V09IX04
Dosage form: solution for injection
Route of administration: intravenous use
Strengh:  
Amount in package: 1TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: This medicinal product is for diagnostic use only. Fludeoxyglucose (18F) is indicated for use with positron emission tomography (PET) in adults and paediatric population. Oncology [18F]FDG-FR is indicated for imaging in patients undergoing oncologic diagnostic procedures describing function or diseases where enhanced glucose influx of specific organs or tissues is the diagnostic target. The following indications are sufficiently documented (see section 4.4): Diagnosis: " Characterisation of solitary pulmonary nodule " Detection of cancer of unknown origin, revealed for example by cervical adenopathy, liver or bones metastases " Characterisation of a pancreatic mass Staging: " Head and neck cancers including assistance in guiding biopsy " Primary lung cancer " Oesophageal cancer " Colorectal cancer particularly in restaging recurrences " Malignant lymphoma " Malignant melanoma, Breslow >1.5 mm or lymph node metastasis at first diagnosis Monitoring of therapeutic response: " Malignant lymphoma " Head and neck cancers Detection in case of reasonable suspicion of recurrences: " Glioma with high grade of malignancy (III or IV) " Head and neck cancers " Primary lung cancer (see section 4.4) " Colorectal cancer " Malignant lymphoma Cardiology In the cardiologic indication, the diagnostic target is viable myocardial tissue that takes-up glucose but is hypo-perfused, as it must be assessed beforehand using appropriate blood-flow imaging techniques. " Evaluation of myocardial viability in patients with severe impaired left ventricular function who are candidates for revascularisation when conventional imaging modalities are not contributive. Neurology In the neurologic indication the interictal glucose hypometabolism is the diagnostic target. " Localisation of epileptogenic foci in the presurgical evaluation of partial temporal epilepsy
Safety features: No
Summary of product characteristics (SPC):  (last updated 01 July 2020)
Package information leaflet (PIL): EST  (last updated 23 March 2022)
Labelling:  (last updated 17 September 2018)
Last imported to Estonia: Never imported to Estonia
Marketing authorization holder: Life Radiopharma Berlin GmbH 
Marketing authorization number: 571108 
Marketing authorization issued on: 08 February 2008 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Mutual recognition 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Description Additional condition
Ei ole lubatud väljastada korduvretsepti
Entry/Changing date: 22 March 2022
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription