This brand name is authorized in Austria, Canada, Cyprus, Germany, Spain, Finland, France, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, Poland, Romania, Tunisia, Turkey, United Kingdom, South Africa
The drug FOSAVANCE contains a combination of these active pharmaceutical ingredients (APIs):
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1
Alendronate sodium trihydrate
UNII 2UY4M2U3RA - ALENDRONATE SODIUM
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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. |
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2
Vitamin D3
UNII 1C6V77QF41 - CHOLECALCIFEROL
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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. |
Below package inserts are available for further reading:
| Title | Information Source | Document Type | |
|---|---|---|---|
| FOSAVANCE Tablet | European Medicines Agency (EU) | MPI, EU: SmPC |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC code | Group title | Classification |
|---|---|---|
| M05BB03 | Alendronic acid and colecalciferol | M Musculo-skeletal system → M05 Drugs for treatment of bone diseases → M05B Drugs affecting bone structure and mineralization → M05BB Bisphosphonates, combinations |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| Country: CA | Health Products and Food Branch | Identifier(s): 02276429, 02314940 |
| Country: DE | Bundesinstitut für Arzneimittel und Medizinprodukte | Identifier(s): 00968730, 00968747, 03420286, 05703143, 14340745, 15241442, 17531032 |
| Country: EE | Ravimiamet | Identifier(s): 1213344, 1213355, 1213366, 1213377, 1339130, 1339141, 1339152 |
| Country: ES | Centro de información online de medicamentos de la AEMPS | Identifier(s): 05310002, 05310002IP, 05310007, 05310007IP, 05310007IP1 |
| Country: FI | Lääkealan turvallisuus- ja kehittämiskeskus | Identifier(s): 025306, 112368 |
| Country: FR | Base de données publique des médicaments | Identifier(s): 63591602, 68300050 |
| Country: GB | Medicines & Healthcare Products Regulatory Agency | Identifier(s): 142406, 161821, 374381, 95239 |
| Country: IE | Health Products Regulatory Authority | Identifier(s): 26112, 37152, 75212, 75251, 75279, 75315, 75318, 75323, 75333, 75382 |
| Country: IL | מִשְׂרַד הַבְּרִיאוּת | Identifier(s): 6305 |
| Country: IT | Agenzia del Farmaco | Identifier(s): 036845028, 036845079 |
| Country: LT | Valstybinė vaistų kontrolės tarnyba | Identifier(s): 1004487, 1004488, 1004806, 1005111, 1028603, 1028604, 1028606, 1028607 |
| Country: NL | Z-Index G-Standaard, PRK | Identifier(s): 122424, 122432 |
| Country: PL | Rejestru Produktów Leczniczych | Identifier(s): 100143587, 100309770 |
| Country: RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | Identifier(s): W67694001, W67694002, W67694003, W67694004, W67697001, W67697002, W67697003 |
| Country: TN | Direction de la Pharmacie et du Médicament | Identifier(s): 3443032 |
| Country: TR | İlaç ve Tıbbi Cihaz Kurumu | Identifier(s): 8683280337190, 8683280337206 |
| Country: ZA | Health Products Regulatory Authority | Identifier(s): 44/3.2/0350, A40/3.2/0259 |
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