Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1618657
Name of medicinal product: AMYVID
Active substances:
Florbetapir (18F)
Estonian, English, Latin
ATC code: V09AX05
Dosage form: solution for injection
Route of administration: intravenous use
Strengh: 800MBq 1ml
Amount in package: 10ml 1TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: This medicinal product is for diagnostic use only. Amyvid is a radiopharmaceutical indicated for Positron Emission Tomography (PET) imaging of â-amyloid neuritic plaque density in the brains of adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease (AD) and other causes of cognitive impairment. Amyvid should be used in conjunction with a clinical evaluation. A negative scan indicates sparse or no plaques, which is not consistent with a diagnosis of AD. For the limitations in the interpretation of a positive scan, see sections 4.4 and 5.1.
Safety features: No
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Last imported to Estonia: Never imported to Estonia
Marketing authorization holder: Eli Lilly Nederland B.V. 
Marketing authorization number: EU/1/12/805 
Marketing authorization issued on: January 17, 2013 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Centralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Description Additional condition
Ei ole lubatud väljastada korduvretsepti
Entry/Changing date: October 2, 2017
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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