DAXAS

This brand name is authorized in Austria, Brazil, Canada, Croatia, Estonia, Finland, Hong Kong SAR China, Ireland, Lithuania, Netherlands, Poland, Romania, South Africa, Spain, UK.

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 more about Roflumilast

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
DAXAS Tablet	MPI, EU: SmPC	European Medicines Agency (EU)

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

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