Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1173147
Name of medicinal product: BONDRONAT
Active substances:
Ibandronic acid
Estonian, English, Latin
ATC code: M05BA06
Dosage form: concentrate for solution for infusion
Route of administration: intravenous use
Strengh: 1mg 1ml
Amount in package: 6ml 1TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
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
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Last imported to Estonia: January 8, 2013
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 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: May 30, 2019
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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