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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1212893
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Name of medicinal product:
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AVONEX
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Active substances:
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|
ATC code:
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L03AB07
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Dosage form:
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solution for injection
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Route of administration:
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intramuscular use
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Strengh:
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30mcg 0.5ml
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Amount in package:
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0.5ml 4TK
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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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süstel
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Indication:
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AVONEX is indicated in adults for the treatment of
- Patients diagnosed with relapsing multiple sclerosis (MS). In clinical trials, this was
characterised by two or more acute exacerbations (relapses) in the previous three-years without
evidence of continuous progression between relapses; AVONEX slows the progression of
disability and decreases the frequency of relapses.
- Patients with a single demyelinating event with an active inflammatory process, if it is severe
enough to warrant treatment with intravenous corticosteroids, if alternative diagnoses have been
excluded, and if they are determined to be at high risk of developing clinically definite multiple
sclerosis (see section 5.1).
AVONEX should be discontinued in patients who develop progressive MS.
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Safety features:
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Yes
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Summary of product characteristics (SPC):
|
|
Package information leaflet (PIL):
|
EST
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Labelling:
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|
Last imported to Estonia:
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March 31, 2016
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Marketing authorization holder:
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Biogen Netherlands B.V.
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Marketing authorization number:
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EU/1/97/033
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Marketing authorization issued on:
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June 24, 2003
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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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Centralised
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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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|
Entry/Changing date:
October 18, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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