Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Atnahs Pharma Netherlands B.V., Copenhagen Towers, Ørestads Boulevard 108, 5.tv, DK-2300 København S, Denmark
Bonviva 150 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. White to off white film-coated tablets, of oblong shape marked “BNVA” on one side, and “150” on the other side. |
Each film-coated tablet contains 150 mg ibandronic acid (as sodium monohydrate).
Excipients with known effect: Contains 154.6 mg anhydrous lactose (equivalent to 162.75 mg 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 |
Bonviva 150 mg film-coated tablets are supplied in blisters (PVC/PVDC, sealed with aluminium foil) containing 1 or 3 tablets.
Not all pack sizes may be marketed.
Atnahs Pharma Netherlands B.V., Copenhagen Towers, Ørestads Boulevard 108, 5.tv, DK-2300 København S, Denmark
EU/1/03/265/003
EU/1/03/265/004
Date of first authorisation: 23 February 2004
Date of latest renewal: 18 December 2013
| Drug | Countries | |
|---|---|---|
| BONVIVA | Austria, Brazil, Cyprus, Germany, Ecuador, Estonia, Spain, France, Hong Kong, Croatia, Ireland, Italy, Japan, Lithuania, Mexico, Netherlands, Poland, Romania, Singapore, Turkey, United Kingdom |
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