BUDENOFALK

This brand name is authorized in Australia, Cyprus, Estonia, Finland, Hong Kong, Ireland, Lithuania, Netherlands, Poland, Romania, Singapore, Turkey, United Kingdom

Active ingredients

The drug BUDENOFALK contains one active pharmaceutical ingredient (API):

1 Budesonide
UNII Q3OKS62Q6X - BUDESONIDE

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.

Read about Budesonide

Medication package inserts

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

Medicine classification

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
Discover more medicines within A07EA06

Authorization and marketing

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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