Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: AstraZeneca AB, SE-151 85 Södertälje, Sweden
Daxas 250 micrograms tablets.
| Pharmaceutical Form |
|---|
|
Tablet. White to off-white, round tablet, 5 mm in diameter, embossed with “D” on one side and “250” on the other side. |
Each tablet contains 250 micrograms of roflumilast.
Excipient with known effect: Each tablet contains 49.7 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| 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. |
| List of Excipients |
|---|
|
Lactose monohydrate |
PVC/PVDC aluminium blisters in packs of 28 tablets.
AstraZeneca AB, SE-151 85 Södertälje, Sweden
EU/1/10/636/008 28 tablets
Date of first authorisation: 05 July 2010
Date of latest renewal: 20 May 2020
| Drug | Countries | |
|---|---|---|
| DAXAS | Austria, Brazil, Canada, Estonia, Spain, Finland, Hong Kong, Croatia, Ireland, Lithuania, Netherlands, Poland, Romania, United Kingdom, South Africa |
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