Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Atnahs Pharma Netherlands B.V., Strawinskylaan 3127, 1077 ZX Amsterdam, Netherlands
Bondronat 50 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablets. White to off-white film-coated tablets, of oblong shape engraved “L2” on one side and “IT” on the other side. |
Each film-coated tablet contains 50 mg of ibandronic acid (as sodium monohydrate).
Excipients with known effect: Contains 88.1 mg lactose (as lactose monohydrate).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Ibandronic acid |
Ibandronic acid belongs to the bisphosphonate group of compounds which act specifically on bone. Their selective action on bone tissue is based on the high affinity of bisphosphonates for bone mineral. Bisphosphonates act by inhibiting osteoclast activity, although the precise mechanism is still not clear. In vivo, ibandronic acid prevents experimentally-induced bone destruction caused by cessation of gonadal function, retinoids, tumours or tumour extracts. |
| List of Excipients |
|---|
|
Tablet core: Lactose monohydrate Tablet coat: Hypromellose |
Bondronat 50 mg film coated tablets are supplied in blisters (aluminium) containing 7 tablets, which are presented as packs containing 28 or 84 tablets.
Not all pack sizes may be marketed.
Atnahs Pharma Netherlands B.V., Strawinskylaan 3127, 1077 ZX Amsterdam, Netherlands
EU/1/96/012/009
EU/1/96/012/010
Date of first authorisation: 25 June 1996
Date of latest renewal: 25 June 2006
| Drug | Countries | |
|---|---|---|
| BONDRONAT | Austria, Australia, Germany, Ecuador, Estonia, Spain, France, Hong Kong, Croatia, Ireland, Lithuania, Netherlands, Poland, Singapore, Turkey, United Kingdom, South Africa |
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