Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: ACTIVELLE
Active substances:
Norethisterone+Estradiol
Estonian, English, Latin
ATC code: G03FA01
Dosage form: film-coated tablet
Strength: 0,5mg+1mg
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):  (last updated September 11, 2023)
Package information leaflet (PIL): EST  (last updated September 11, 2023)
Labelling:  (last updated May 31, 2017)
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
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 
Assessment report:   
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported PƤritolumaa Additional information
1175464  ACTIVELLE  film-coated tablet  0,5mg +1mg 28TK  Prescription  50% 100%  13,16  16.05.2024     
1175475  ACTIVELLE  film-coated tablet  0,5mg +1mg 84TK  Prescription      13.10.2016     
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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