Register of Medicinal Products

ACTIVELLE

Product class:	Authorized package
Medicinal product class:	For human use
Package code:	1880344
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 June 30, 2022)
Package information leaflet (PIL):	EST (last updated June 30, 2022)
Labelling:	(last updated June 30, 2022)
Last imported to Estonia:	Never imported to Estonia

Marketing authorization

Marketing authorization holder:	Ideal Trade Links UAB
Marketing authorization number:	1067622
Marketing authorization issued on:	June 30, 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
50	01.04.2023		Yes			No
100	01.04.2023		Yes			No	until 4 years

Reference price:	13,16 EUR
Under reference price:	Yes
Reference price of daily dose:	0,47 EUR

Entry/Changing date: June 30, 2022

Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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