Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1175475
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: 84TK
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 August 26, 2022)
Package information leaflet (PIL): EST  (last updated August 26, 2022)
Labelling:  (last updated May 31, 2017)
Last imported to Estonia: October 13, 2016
Marketing authorization holder: Novo Nordisk A/S 
Marketing authorization number: 291799 
Marketing authorization issued on: August 26, 2005 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Mutual recognition 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: August 26, 2022
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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