Product class:
|
Authorized package
|
Medicinal product class:
|
For human use
|
Package code:
|
1684111
|
Name of medicinal product:
|
ESTROFEM
|
Active substances:
|
|
ATC code:
|
G03CA03
|
Dosage form:
|
film-coated tablet
|
Route of administration:
|
oral use
|
Strengh:
|
2mg
|
Amount in package:
|
28TK
|
Legal status for supply*:
|
Subject to medicinal prescription
|
Class of active substance:
|
|
Additional information:
|
Tšehhi pakend
|
Indication:
|
Hormone replacement therapy for oestrogen deficiency symptoms in postmenopausal women.
Prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of osteoporosis.
Note. Estrofem is mainly suitable for women without uterus and who do not therefore need estrogen/progestagen combined treatment.
Experience of treating women older than 65 years is limited.
|
Safety features:
|
Yes
|
Summary of product characteristics (SPC):
|
(last updated September 11, 2023)
|
Package information leaflet (PIL):
|
EST (last updated September 11, 2023)
|
Labelling:
|
(last updated December 7, 2020)
|
Last imported to Estonia:
|
January 21, 2019
|
Marketing authorization holder:
|
First Pharma OÜ
|
Marketing authorization number:
|
881015
|
Marketing authorization issued on:
|
September 16, 2015
|
Marketing authorization expires on:
|
Unlimited
|
Marketing authorization procedure type:
|
National
|
Secondary marketing authorization:
|
Yes
|
Percent
|
Valid from
|
Valid until
|
Valid
|
Diagnosis
|
Doctor's speciality
|
Primary
|
Age
|
Other
|
100
|
01.01.2024
|
01.04.2024
|
Yes
|
E89.4-E89.4; E28.3-E28.3; E23.0-E23.0; Q96-Q97
|
Günekoloog, Endokrinoloog
|
Yes
|
until 50 years
|
haigus on diagnoositud enne 40. eluaastat ning patsient on alla 50. eluaasta vana
|
100
|
01.01.2024
|
01.04.2024
|
Yes
|
|
|
No
|
until 4 years
|
|
50
|
01.01.2024
|
01.04.2024
|
Yes
|
|
|
No
|
|
|
100
|
01.01.2024
|
01.04.2024
|
Yes
|
E89.4-E89.4; E28.3-E28.3; E23.0-E23.0; Q96-Q97
|
Endokrinoloog, Günekoloog
|
Yes
|
until 4 years
|
haigus on diagnoositud enne 40. eluaastat ning patsient on alla 50. eluaasta vana
|
Reference price:
|
8,96 EUR
|
Under reference price:
|
No
|
Reference price of daily dose:
|
0,32 EUR
|
Entry/Changing date:
September 11, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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