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 December 21, 2023)
Package information leaflet (PIL): EST  (last updated December 21, 2023)
Labelling:  (last updated December 21, 2023)
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: 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 
Assessment report:   
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported PƤritolumaa Additional information
1887992  ACTIVELLE  film-coated tablet  0,5mg +1mg 28TK  Prescription  100% 50%  13,16  22.05.2024  Itaalia  Itaalia pakend 
1888005  ACTIVELLE  film-coated tablet  0,5mg +1mg 84TK  Prescription        Itaalia  Itaalia pakend 
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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