This brand name is authorized in Australia, Cyprus, Estonia, Finland, Hong Kong SAR China, Ireland, Lithuania, Netherlands, Poland, Romania, Singapore, Turkey, UK.
The drug BUDENOFALK contains one active pharmaceutical ingredient (API):
1
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UNII
Q3OKS62Q6X - BUDESONIDE
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Budesonide is a glucocorticosteroid with a high local anti-inflammatory effect. At doses clinically equivalent to systemically acting glucocorticosteroids, budesonide gives significantly less HPA axis suppression and has a lower impact on inflammatory markers. |
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Below package inserts are available for further reading:
| Document | Type | Information Source | |
|---|---|---|---|
| BUDENOFALK Rectal foam | MPI, EU: SmPC | Medicines & Healthcare Products Regulatory Agency (GB) | |
| BUDENOFALK Gastro-resistant capsule | 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 | |
|---|---|---|
| A07EA06 | Budesonide | A Alimentary tract and metabolism → A07 Antidiarrheals, intestinal antiinflammatory/antiinfective agents → A07E Intestinal antiinflammatory agents → A07EA Corticosteroids acting locally |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| AU | Pharmaceutical Benefits Scheme | 10034D |
| EE | Ravimiamet | 1359176, 1434080, 1723070, 1842735 |
| FI | Lääkealan turvallisuus- ja kehittämiskeskus | 006899, 006921, 062635 |
| GB | Medicines & Healthcare Products Regulatory Agency | 115510, 197385, 38080 |
| HK | Department of Health Drug Office | 58122, 61393 |
| IE | Health Products Regulatory Authority | 16007, 16072, 16080 |
| LT | Valstybinė vaistų kontrolės tarnyba | 1021269, 1021270, 1032085, 1038837, 1050860, 1068066, 1068067, 1068068, 1068069 |
| NL | Z-Index G-Standaard, PRK | 45489, 97373, 97713 |
| PL | Rejestru Produktów Leczniczych | 100202054, 100234522 |
| RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | W08631001, W54445001, W54445002, W54445003, W58169001, W58169002, W58169003, W58169004, W58169005 |
| SG | Health Sciences Authority | 11588P, 14115P |
| TR | İlaç ve Tıbbi Cihaz Kurumu | 8699543160016, 8699543160023 |
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