Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: N.V. Organon, Kloosterstraat 6, 5349 AB Oss, The Netherlands
FOSAVANCE 70 mg/2,800 IU tablets.
FOSAVANCE 70 mg/5,600 IU tablets.
| Pharmaceutical Form |
|---|
|
Tablet. FOSAVANCE 70 mg/2,800 IU tablets: Modified capsule-shaped, white to off-white tablets, marked with an outline of a bone image on one side, and ‘710’ on the other. FOSAVANCE 70 mg/5,600 IU tablets: Modified rectangle-shaped, white to off-white tablets, marked with an outline of a bone image on one side, and ‘270’ on the other. |
Each tablet contains 70 mg alendronic acid (as sodium trihydrate) and 70 micrograms (2,800 IU) colecalciferol (vitamin D3).
Excipients with known effect: Each tablet contains 62 mg lactose (as lactose anhydrous) and 8 mg sucrose.
Each tablet contains 70 mg alendronic acid (as sodium trihydrate) and 140 micrograms (5,600 IU) colecalciferol (vitamin D3).
Excipients with known effect: Each tablet contains 63 mg lactose (as lactose anhydrous) and 16 mg sucrose.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Alendronic acid |
Alendronic acid is a bisphosphonate that inhibits osteoclastic bone resorption with no direct effect on bone formation. The bone formed during treatment with alendronic acid is of normal quality. |
|
| Vitamin D3 |
In its biologically active form vitamin D3 stimulates intestinal calcium absorption, incorporation of calcium into the osteoid, and release of calcium from bone tissue. In the small intestine it promotes rapid and delayed calcium uptake. The passive and active transport of phosphate is also stimulated. |
| List of Excipients |
|---|
|
Microcrystalline cellulose (E460) |
FOSAVANCE 70 mg/2,800 IU tablets: Aluminium/aluminium blisters, in cartons containing 2, 4, 6 or 12 tablets.
FOSAVANCE 70 mg/5,600 IU tablets: Aluminium/aluminium blisters, in cartons containing 2, 4 or 12 tablets.
Not all pack sizes may be marketed.
N.V. Organon, Kloosterstraat 6, 5349 AB Oss, The Netherlands
FOSAVANCE 70 mg/2,800 IU tablets:
EU/1/05/310/001 – 2 tablets
EU/1/05/310/002 – 4 tablets
EU/1/05/310/003 – 6 tablets
EU/1/05/310/004 – 12 tablets
FOSAVANCE 70 mg/5,600 IU tablets:
EU/1/05/310/006 – 2 tablets
EU/1/05/310/007 – 4 tablets
EU/1/05/310/008 – 12 tablets
Date of first authorisation: 24 August 2005
Date of latest renewal: 24 April 2015
| Drug | Countries | |
|---|---|---|
| FOSAVANCE | Austria, Canada, Cyprus, Germany, Spain, Finland, France, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, Poland, Romania, Tunisia, Turkey, United Kingdom, South Africa |
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