This brand name is authorized in United States. It is also authorized in Austria, Brazil, Canada, Croatia, France, Germany, Hong Kong SAR China, Ireland, Italy, Mexico, Netherlands, New Zealand, Romania, Singapore, South Africa, Spain, Turkey, UK.
The drug FOSAMAX contains one active pharmaceutical ingredient (API):
1
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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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Below package inserts are available for further reading:
| Document | Type | Information Source | |
|---|---|---|---|
| Fosamax | MPI, EU: SmPC | Medicines & Healthcare Products Regulatory Agency (GB) | |
| FOSAMAX Once Weekly Tablets | MPI, EU: SmPC | Medicines & Healthcare Products Regulatory Agency (GB) |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC Group | Classification | |
|---|---|---|
| M05BA04 | Alendronic acid | M Musculo-skeletal system → M05 Drugs for treatment of bone diseases → M05B Drugs affecting bone structure and mineralization → M05BA Bisphosphonates |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| BR | Câmara de Regulação do Mercado de Medicamentos | 525501103111314 |
| CA | Health Products and Food Branch | 02245329 |
| DE | Bundesinstitut für Arzneimittel und Medizinprodukte | 00070182, 00461793, 01453666, 03221368, 03368829, 06435696, 07765088, 07765094, 07778547, 13248977, 16834724, 16834730 |
| ES | Centro de información online de medicamentos de la AEMPS | 63955 |
| FR | Base de données publique des médicaments | 62158815 |
| GB | Medicines & Healthcare Products Regulatory Agency | 138810, 142401, 161819, 17233, 391355 |
| HK | Department of Health Drug Office | 49103 |
| HR | Agencija za lijekove i medicinske proizvode | HR-H-982508386 |
| IE | Health Products Regulatory Authority | 25828, 75210, 75219 |
| IT | Agenzia del Farmaco | 029052077 |
| MX | Comisión Federal para la Protección contra Riesgos Sanitarios | 279M94 |
| NL | Z-Index G-Standaard, PRK | 122416 |
| NZ | Medicines and Medical Devices Safety Authority | 9634 |
| RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | W68213001, W68213002, W68213003, W68213004 |
| SG | Health Sciences Authority | 11446P |
| TR | İlaç ve Tıbbi Cihaz Kurumu | 8683280337176, 8683280337183 |
| US | FDA, National Drug Code | 0006-0031 |
| ZA | Health Products Regulatory Authority | 29/3.2/0668, 35/3.2/0371 |
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