Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1731013
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:  
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 December 7, 2020)
Package information leaflet (PIL): EST  (last updated May 23, 2022)
Labelling:  (last updated May 23, 2022)
Last imported to Estonia: July 11, 2017
Marketing authorization holder: First Pharma OÜ 
Marketing authorization number: 926016 
Marketing authorization issued on: January 10, 2017 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: National 
Secondary marketing authorization: Yes 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: May 23, 2022
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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