Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: BONDRONAT
Active substances:
Ibandronic acid
Estonian, English, Latin
ATC code: M05BA06
Dosage form: concentrate for solution for infusion
Strength: 1mg 1ml
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Indication: Bondronat is indicated in adults for - Prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases. - Treatment of tumour-induced hypercalcaemia with or without metastases.
Safety features: Yes
Marketing authorization holder: Atnahs Pharma Netherlands B.V. 
Marketing authorization number: EU/1/96/012 
Marketing authorization issued on: August 27, 1997 
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
1173147  BONDRONAT  concentrate for solution for infusion  1mg 1ml 6ml 1TK  Prescription      08.01.2013     
1173158  BONDRONAT  concentrate for solution for infusion  1mg 1ml 6ml 5TK  Prescription           
1173169  BONDRONAT  concentrate for solution for infusion  1mg 1ml 6ml 10TK  Prescription           
1207987  BONDRONAT  concentrate for solution for infusion  1mg 1ml 2ml 1TK  Prescription           
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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