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VAGIFEM
General data
Product class:
Authorized package
Medicinal product class:
For human use
Package code:
1380721
Name of medicinal product:
VAGIFEM
Active substances:
Estradiol
Estonian
,
English
,
Latin
ATC code:
G03CA03
Dosage form:
vaginal tablet
Route of administration:
vaginal use
Strengh:
10mcg
Amount in package:
18TK
Legal status for supply*:
Subject to medicinal prescription
Class of active substance:
Additional information:
Indication:
Treatment of vaginal atrophy due to oestrogen deficiency in postmenopausal women (see section 5.1). The experience treating women older than 65 years is limited.
Safety features:
Yes
Summary of product characteristics (SPC):
(last updated September 26, 2022)
Package information leaflet (PIL):
EST
(last updated March 20, 2024)
Labelling:
(last updated March 20, 2024)
Last imported to Estonia:
March 21, 2024
Marketing authorization
Marketing authorization holder:
Novo Nordisk A/S
Marketing authorization number:
676710
Marketing authorization issued on:
March 3, 2010
Marketing authorization expires on:
Unlimited
Marketing authorization procedure type:
Decentralised
Reimbursements
Percent
Valid from
Valid until
Valid
Diagnosis
Doctor's speciality
Primary
Age
Other
50
01.01.2024
01.04.2024
Yes
No
100
01.01.2024
01.04.2024
Yes
No
until 4 years
Prices
Reference price:
14,58 EUR
Under reference price:
Yes
Reference price of daily dose:
0,81 EUR
Entry/Changing date: March 20, 2024
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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