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ACTIVELLE
General data
Product class:
Authorized package
Medicinal product class:
For human use
Package code:
1887992
Name of medicinal product:
ACTIVELLE
Active substances:
Norethisterone+Estradiol
Estonian
,
English
,
Latin
ATC code:
G03FA01
Dosage form:
film-coated tablet
Route of administration:
oral use
Strengh:
0,5mg+1mg
Amount in package:
28TK
Legal status for supply*:
Subject to medicinal prescription
Class of active substance:
Additional information:
Itaalia pakend
Indication:
Hormone Replacement Therapy (HRT) for oestrogen deficiency symptoms in postmenopausal women with more than 1 year since last menses. 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. The experience treating women older than 65 years is limited.
Safety features:
Yes
Summary of product characteristics (SPC):
(last updated September 29, 2022)
Package information leaflet (PIL):
EST
(last updated September 29, 2022)
Labelling:
(last updated September 29, 2022)
Last imported to Estonia:
November 30, 2023
Marketing authorization
Marketing authorization holder:
Lex Ano UAB
Marketing authorization number:
1072622
Marketing authorization issued on:
September 29, 2022
Marketing authorization expires on:
Unlimited
Marketing authorization procedure type:
National
Secondary marketing authorization:
Yes
Reimbursements
Percent
Valid from
Valid until
Valid
Diagnosis
Doctor's speciality
Primary
Age
Other
50
24.10.2023
Yes
No
100
24.10.2023
Yes
No
until 4 years
Prices
Reference price:
13,16 EUR
Under reference price:
No
Reference price of daily dose:
0,47 EUR
Entry/Changing date: September 29, 2022
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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