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Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: [18F]FDG-FR
Active substances:
Fludeoxyglucose (18F)
Estonian, English, Latin
ATC code: V09IX04
Dosage form: solution for injection
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):  (last updated July 1, 2020)
Package information leaflet (PIL): EST  (last updated March 23, 2022)
Labelling:  (last updated September 17, 2018)
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
Marketing authorization holder: Life Radiopharma Berlin GmbH 
Marketing authorization number: 571108 
Marketing authorization issued on: February 8, 2008 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Mutual recognition 
Assessment report:   
Description Additional condition
Ei ole lubatud väljastada korduvretsepti
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported Additional information
1299371  [18F]FDG-FR  solution for injection  1TK  Prescription         
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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