Daxas

AstraZeneca AB,SE-151 85 Södertälje,Sweden🇪🇺 European Union

EMA Page

Authorised Date: Jul 5, 2010
Approval ID: b6764f55d91c0e9e
Products: 1 listed
Opinion Adopted: N/A

Overview Summary

No summary available.

Therapeutic & Classification

Therapeutic Indication

### Therapeutic indication 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.

Therapeutic Area (MeSH)

N/A

ATC Code

R03DX07

ATC Item

roflumilast

Pharmacotherapeutic Group

Drugs for obstructive airway diseases

Active Substances

Active Substance (Summary)

roflumilast

INN / Common Names

N/A

Active Substance Details

Substance	CAS	Monograph
roflumilast	N/A	罗氟司特

Quick Info

Approval IDb6764f55d91c0e9e

Product NumberN/A

StatusAuthorised

Authorised DateJul 5, 2010

Opinion AdoptedN/A

Revision #N/A

Names & Aliases

EMA Name

Daxas

Medicine Name

Daxas

Aliases

N/A

Regulatory Flags

Orphan medicineUnknown

Generic medicineUnknown

BiosimilarUnknown

Conditional approvalUnknown

Exceptional circumstancesUnknown

Accelerated assessmentUnknown

Additional monitoringUnknown

Advanced therapyUnknown

Source Links

EMA Source

No risk management plan link.

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