Register of Medicinal Products

ACTIVELLE

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:	May 24, 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

Percent	Valid from	Valid until	Valid	Diagnosis	Doctor's speciality	Primary	Age	Other
100	01.04.2023		Yes			No	until 4 years
50	01.04.2023		Yes			No

Reference price:	13,16 EUR
Under reference price:	Yes
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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