Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1265666
Name of medicinal product: ACLASTA
Active substances:
Zoledronic acid
Estonian, English, Latin
ATC code: M05BA08
Dosage form: solution for infusion
Route of administration: intravenous use
Strengh: 0,05mg 1ml
Amount in package: 100ml 5TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: 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.
Safety features: Yes
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Last imported to Estonia: Never imported to Estonia
Marketing authorization holder: Novartis Europharm Limited 
Marketing authorization number: EU/1/05/308 
Marketing authorization issued on: April 5, 2005 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Centralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: May 2, 2018
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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