ACTIVELLE
General data
Product class:
Authorized package
Medicinal product class:
For human use
Package code:
1731013
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:
Poola 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 27 February 2023)
Package information leaflet (PIL):
EST
(last updated 27 February 2023)
Labelling:
(last updated 23 May 2022)
Last imported to Estonia:
11 July 2017
Marketing authorization
Marketing authorization holder:
First Pharma OÜ
Marketing authorization number:
926016
Marketing authorization issued on:
10 January 2017
Marketing authorization expires on:
Unlimited
Marketing authorization procedure type:
National
Secondary marketing authorization:
Yes
Prices
Reference price:
Under reference price:
Reference price of daily dose:
Entry/Changing date: 27 February 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription