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Product class:
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Authorized package
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Medicinal product class:
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For human use
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Package code:
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1299371
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Name of medicinal product:
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[18F]FDG-FR
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Active substances:
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ATC code:
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V09IX04
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Dosage form:
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solution for injection
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Route of administration:
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intravenous use
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Strengh:
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Amount in package:
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1TK
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Legal status for supply*:
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Subject to medicinal prescription
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Class of active substance:
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Additional information:
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Indication:
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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
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Safety features:
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No
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Summary of product characteristics (SPC):
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 (last updated July 1, 2020)
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Package information leaflet (PIL):
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EST (last updated March 23, 2022)
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Labelling:
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(last updated September 17, 2018)
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Last imported to Estonia:
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Never imported to Estonia
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Marketing authorization holder:
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Life Radiopharma Berlin GmbH
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Marketing authorization number:
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571108
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Marketing authorization issued on:
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February 8, 2008
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Marketing authorization expires on:
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Unlimited
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Marketing authorization procedure type:
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Mutual recognition
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Reference price:
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Under reference price:
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Reference price of daily dose:
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Description
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Additional condition
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Ei ole lubatud väljastada korduvretsepti
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Entry/Changing date:
March 22, 2022
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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