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Product class:
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Medicinal product with marketing authorization
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Medicinal product class:
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Human medicine
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Name of medicinal product:
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ACTIVELLE
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Active substances:
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ATC code:
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G03FA01
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Dosage form:
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film-coated tablet
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Strength:
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0,5mg+1mg
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Legal status for supply*:
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Subject to medicinal prescription
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Summary of product characteristics (SPC):
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 (last updated February 27, 2023)
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Package information leaflet (PIL):
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EST (last updated February 27, 2023)
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Labelling:
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(last updated May 23, 2022)
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Indication:
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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.
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Safety features:
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Yes
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Marketing authorization holder:
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First Pharma OÜ
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Marketing authorization number:
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926016
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Marketing authorization issued on:
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January 10, 2017
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Marketing authorization expires on:
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Unlimited
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Marketing authorization procedure type:
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National
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Secondary marketing authorization:
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Yes
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Assessment report:
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Package code
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Name of medicinal product
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Dosage form
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Package
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Legal status
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Reimbursements
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Reference price
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Last imported
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PƤritolumaa
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Additional information
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1731013
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ACTIVELLE
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film-coated tablet
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0,5mg +1mg 28TK
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Prescription
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11.07.2017
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Poola
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Poola pakend
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Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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