Register of
Medicinal Products

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 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
100  05.04.2024     Yes      No  until 4 years   
50  05.04.2024     Yes      No      
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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