This brand name is authorized in Australia, Cyprus, Estonia, Finland, Hong Kong, Ireland, Lithuania, Netherlands, Poland, Romania, Singapore, Turkey, United Kingdom
The drug BUDENOFALK contains one active pharmaceutical ingredient (API):
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1
Budesonide
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. |
Below package inserts are available for further reading:
| Title | Information Source | Document Type | |
|---|---|---|---|
| BUDENOFALK Gastro-resistant capsule | Medicines & Healthcare Products Regulatory Agency (GB) | MPI, EU: SmPC | |
| BUDENOFALK Rectal foam | Medicines & Healthcare Products Regulatory Agency (GB) | MPI, EU: SmPC |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC code | Group title | 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) |
|---|---|---|
| Country: AU | Pharmaceutical Benefits Scheme | Identifier(s): 10034D |
| Country: EE | Ravimiamet | Identifier(s): 1359176, 1434080, 1723070, 1842735 |
| Country: FI | Lääkealan turvallisuus- ja kehittämiskeskus | Identifier(s): 006899, 006921, 062635 |
| Country: GB | Medicines & Healthcare Products Regulatory Agency | Identifier(s): 115510, 197385, 38080 |
| Country: HK | Department of Health Drug Office | Identifier(s): 58122, 61393 |
| Country: IE | Health Products Regulatory Authority | Identifier(s): 16007, 16072, 16080 |
| Country: LT | Valstybinė vaistų kontrolės tarnyba | Identifier(s): 1021269, 1021270, 1032085, 1038837, 1050860, 1068066, 1068067, 1068068, 1068069 |
| Country: NL | Z-Index G-Standaard, PRK | Identifier(s): 45489, 97373, 97713 |
| Country: PL | Rejestru Produktów Leczniczych | Identifier(s): 100202054, 100234522 |
| Country: RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | Identifier(s): W08631001, W54445001, W54445002, W54445003, W58169001, W58169002, W58169003, W58169004, W58169005 |
| Country: SG | Health Sciences Authority | Identifier(s): 11588P, 14115P |
| Country: TR | İlaç ve Tıbbi Cihaz Kurumu | Identifier(s): 8699543160016, 8699543160023 |
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