Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1887992
Name of medicinal product: ACTIVELLE
Active substances:
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 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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