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Product class:
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Authorized package
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Medicinal product class:
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For human use
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Package code:
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1265666
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Name of medicinal product:
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ACLASTA
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Active substances:
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ATC code:
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M05BA08
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Dosage form:
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solution for infusion
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Route of administration:
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intravenous use
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Strengh:
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0,05mg 1ml
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Amount in package:
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100ml 5TK
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Legal status for supply*:
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Subject to medicinal prescription
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Class of active substance:
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Additional information:
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Indication:
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Treatment of osteoporosis
- in post-menopausal women
- in adult men
at increased risk of fracture, including those with a recent low-trauma hip fracture.
Treatment of osteoporosis associated with long-term systemic glucocorticoid therapy
- in post-menopausal women
- in adult men
at increased risk of fracture.
Treatment of Paget¡¦s disease of the bone in adults.
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Safety features:
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Yes
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Summary of product characteristics (SPC):
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Package information leaflet (PIL):
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EST
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Labelling:
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Last imported to Estonia:
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Never imported to Estonia
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Marketing authorization holder:
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Sandoz Pharmaceuticals d.d.
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Marketing authorization number:
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EU/1/05/308
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Marketing authorization issued on:
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April 5, 2005
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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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Centralised
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Reference price:
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Under reference price:
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Reference price of daily dose:
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Entry/Changing date:
January 23, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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