This brand name is authorized in Austria, Brazil, Canada, Estonia, Spain, Finland, Hong Kong, Croatia, Ireland, Lithuania, Netherlands, Poland, Romania, United Kingdom, South Africa
The drug DAXAS contains one active pharmaceutical ingredient (API):
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1
Roflumilast
UNII 0P6C6ZOP5U - ROFLUMILAST
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Roflumilast is a PDE4 inhibitor, a non-steroid, anti-inflammatory active substance designed to target both the systemic and pulmonary inflammation associated with COPD. |
Below package inserts are available for further reading:
| Title | Information Source | Document Type | |
|---|---|---|---|
| DAXAS Tablet | European Medicines Agency (EU) | MPI, EU: SmPC |
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 |
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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