Roflumilast
Active ingredient · 2 therapeutic classes
Sold as Libertek · Daliresp · DAXAS · ZORYVE
- Drug class
- Other Systemic Drugs For Obstructive Airway Diseases
- Availability
- See label
- Routes
- Topical, Oral
- Markets covered
- 3
- Products on record
- 12
Overview
Roflumilast is an active pharmaceutical ingredient in the Other Systemic Drugs For Obstructive Airway Diseases group (R03DX). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 7 | March 13, 2026 |
| CA Canada | Health Canada | 4 | December 1, 2025 |
| EU European Union | EMA | 1 | February 25, 2026 |
GBUnited Kingdom· MHRA
7 products
Uses
Daxas is indicated for maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (FEV1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add on to bronchodilator treatment.
How to take
CACanada· Health Canada
4 products
Uses
3%) is indicated for topical treatment of plaque psoriasis, including treatment of psoriasis in the intertriginous areas, in patients 12 years of age and older. 3%) is indicated for topical treatment of plaque psoriasis of the scalp and body in patients 12 years of age and older.
15%) is indicated for topical treatment of mild to moderate atopic dermatitis in patients 6 years of age and older. 3%) is indicated for topical treatment of seborrheic dermatitis in patients 9 years of age and older. 3% in patients 12 to 17 are very limited.
3 Pharmacokinetics). 3% in the treatment of plaque psoriasis for pediatric patients below the age of 12 years. 3 Pharmacokinetics). 15% in the treatment of atopic dermatitis for pediatric use in patients below the age of 6 years.
Seborrheic Dermatitis Pediatrics (9 to <18 years):
The safety and efficacy data submitted in patients 9 to 17 are limited. 3 Pharmacokinetics). 3% are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric patients below the age of 9 years.
EUEuropean Union· EMA
1 product
Uses
Daxas is indicated for maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (FEV1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add on to bronchodilator treatment.
How to take
Drug interactions
Known interactions involving Roflumilast. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 254. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PLGB179010318 · revised February 20, 2026
- [2]Health Canada (DPD) · 02537532 · revised December 1, 2025
- [3]European Medicines Agency · EMEA/H/C/001179 · revised February 25, 2026
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.