DAXAS

This brand name is authorized in Austria, Brazil, Canada, Estonia, Spain, Finland, Hong Kong, Croatia, Ireland, Lithuania, Netherlands, Poland, Romania, United Kingdom, South Africa

Active ingredients

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

1 Roflumilast
UNII 0P6C6ZOP5U - ROFLUMILAST

Roflumilast is a PDE4 inhibitor, a non-steroid, anti-inflammatory active substance designed to target both the systemic and pulmonary inflammation associated with COPD.

Read about Roflumilast

Medication package inserts

Below package inserts are available for further reading:

Title Information Source Document Type  
DAXAS Tablet European Medicines Agency (EU) 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
R03DX07 Roflumilast R Respiratory system → R03 Drugs for obstructive airway diseases → R03D Other systemic drugs for obstructive airway diseases → R03DX Other systemic drugs for obstructive airway diseases
Discover more medicines within R03DX07

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country Identification scheme Identifier(s)
Country: BR Câmara de Regulação do Mercado de Medicamentos Identifier(s): 502317120033217, 502317120033317
Country: CA Health Products and Food Branch Identifier(s): 02359456
Country: EE Ravimiamet Identifier(s): 1484670, 1484681, 1484692, 1544408, 1544419, 1544420, 1544431, 1770106
Country: ES Centro de información online de medicamentos de la AEMPS Identifier(s): 10636002, 110636008
Country: FI Lääkealan turvallisuus- ja kehittämiskeskus Identifier(s): 091356, 091367, 540167
Country: GB Medicines & Healthcare Products Regulatory Agency Identifier(s): 176695, 357546
Country: HK Department of Health Drug Office Identifier(s): 60596
Country: LT Valstybinė vaistų kontrolės tarnyba Identifier(s): 1055979, 1055980, 1055981, 1063655, 1063656, 1063657, 1063658, 1085389
Country: NL Z-Index G-Standaard, PRK Identifier(s): 101818, 200158
Country: PL Rejestru Produktów Leczniczych Identifier(s): 100227338, 100417406
Country: RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale Identifier(s): W63472001, W63472002, W63472003
Country: ZA Health Products Regulatory Authority Identifier(s): 44/10.3/0670

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