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BETAHISTINE ACTAVIS
General data
Product class:
Authorized package
Medicinal product class:
For human use
Package code:
1236923
Name of medicinal product:
BETAHISTINE ACTAVIS
Active substances:
Betahistine
Estonian
,
English
,
Latin
ATC code:
N07CA01
Dosage form:
tablet
Route of administration:
oral use
Strengh:
16mg
Amount in package:
84TK
Legal status for supply*:
Subject to medicinal prescription
Class of active substance:
Additional information:
Indication:
Betahistine is indicated for: - Treatment of Ménieres syndrome, symptoms of which may include vertigo, tinnitus, hearing loss and nausea. - Symptomatic treatment of vertigo of vestibular origin.
Safety features:
Yes
Summary of product characteristics (SPC):
(last updated June 8, 2023)
Package information leaflet (PIL):
EST
(last updated June 29, 2023)
Labelling:
(last updated June 8, 2023)
Last imported to Estonia:
Never imported to Estonia
Marketing authorization
Marketing authorization holder:
Teva B.V.
Marketing authorization number:
518106
Marketing authorization issued on:
August 25, 2006
Marketing authorization expires on:
Unlimited
Marketing authorization procedure type:
Mutual recognition
Prices
Reference price:
Under reference price:
Reference price of daily dose:
Entry/Changing date: August 21, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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