Product class:
|
Authorized package
|
Medicinal product class:
|
For human use
|
Package code:
|
1604337
|
Name of medicinal product:
|
BETMIGA
|
Active substances:
|
|
ATC code:
|
G04BD12
|
Dosage form:
|
prolonged-release tablet
|
Route of administration:
|
oral use
|
Strengh:
|
50mg
|
Amount in package:
|
30TK
|
Legal status for supply*:
|
Subject to medicinal prescription
|
Class of active substance:
|
|
Additional information:
|
|
Indication:
|
Symptomatic treatment of urgency, increased micturition frequency and/or urgency incontinence as may occur in adult patients with overactive bladder (OAB) syndrome.
|
Safety features:
|
Yes
|
Summary of product characteristics (SPC):
|
|
Package information leaflet (PIL):
|
EST
|
Labelling:
|
|
Last imported to Estonia:
|
March 21, 2024
|
Marketing authorization holder:
|
Astellas Pharma Europe B.V.
|
Marketing authorization number:
|
EU/1/12/809
|
Marketing authorization issued on:
|
January 7, 2013
|
Marketing authorization expires on:
|
Unlimited
|
Marketing authorization procedure type:
|
Centralised
|
Percent
|
Valid from
|
Valid until
|
Valid
|
Diagnosis
|
Doctor's speciality
|
Primary
|
Age
|
Other
|
100
|
01.01.2024
|
01.04.2024
|
Yes
|
|
|
No
|
until 4 years
|
|
50
|
01.01.2024
|
01.04.2024
|
Yes
|
|
|
No
|
|
|
Reference price:
|
|
Under reference price:
|
|
Reference price of daily dose:
|
|
Entry/Changing date:
September 25, 2017
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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