Product class:
|
Authorized package
|
Medicinal product class:
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For human use
|
Package code:
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1397550
|
Name of medicinal product:
|
BETAFERON
|
Active substances:
|
|
ATC code:
|
L03AB08
|
Dosage form:
|
powder and solvent for solution for injection
|
Route of administration:
|
subcutaneous use
|
Strengh:
|
250mcg 1ml
|
Amount in package:
|
1.2ml 45TK
|
Legal status for supply*:
|
Subject to medicinal prescription
|
Class of active substance:
|
|
Additional information:
|
|
Indication:
|
Betaferon is indicated for the treatment of
-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).
- patients with relapsing-remitting multiple sclerosis and two or more relapses within the last two
years
- patients with secondary progressive multiple sclerosis with active disease, evidenced by
relapses.
|
Safety features:
|
Yes
|
Summary of product characteristics (SPC):
|
|
Package information leaflet (PIL):
|
EST
|
Labelling:
|
|
Last imported to Estonia:
|
Never imported to Estonia
|
Marketing authorization holder:
|
Bayer AG
|
Marketing authorization number:
|
EU/1/95/003
|
Marketing authorization issued on:
|
November 30, 1995
|
Marketing authorization expires on:
|
Unlimited
|
Marketing authorization procedure type:
|
Centralised
|
Reference price:
|
|
Under reference price:
|
|
Reference price of daily dose:
|
|
Entry/Changing date:
June 6, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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