Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: ACLASTA
Active substances:
Zoledronic acid
Estonian, English, Latin
ATC code: M05BA08
Dosage form: solution for infusion
Strength: 0,05mg 1ml
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
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
Marketing authorization holder: Sandoz Pharmaceuticals d.d. 
Marketing authorization number: EU/1/05/308 
Marketing authorization issued on: April 5, 2005 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Centralised 
Assessment report:   
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported PƤritolumaa Additional information
1201712  ACLASTA  solution for infusion  0,05mg 1ml 100ml 1TK  Prescription      12.06.2024     
1265666  ACLASTA  solution for infusion  0,05mg 1ml 100ml 5TK  Prescription           
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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