Product class: Authorized package
Medicinal product class: For human use
Package code: 1175464
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:  
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 11 September 2023)
Package information leaflet (PIL): EST  (last updated 11 September 2023)
Labelling:  (last updated 31 May 2017)
Last imported to Estonia: 16 May 2024
Marketing authorization holder: Novo Nordisk A/S 
Marketing authorization number: 291799 
Marketing authorization issued on: 26 August 2005 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Mutual recognition 
Percent Valid from Valid until Valid Diagnosis Doctor's speciality Primary Age Other
50  05/04/2024     Yes      No      
100  05/04/2024     Yes      No  until 4 years   
Reference price: 13.16 EUR 
Under reference price: No 
Reference price of daily dose: 0.47 EUR 
Entry/Changing date: 03 May 2024
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription