Daxas

Unknown🇪🇺 European Union

EMA Page

Authorised Date: N/A
Approval ID: 94958707a96976bb
Products: 1 listed
Opinion Adopted: N/A

Overview Summary

No summary available.

Therapeutic & Classification

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)

Pulmonary Disease, Chronic Obstructive

ATC Code

R03DX07

ATC Item

N/A

Pharmacotherapeutic Group

Drugs for obstructive airway diseases

Active Substances

Active Substance (Summary)

roflumilast

INN / Common Names

roflumilast

Active Substance Details

Active substance details are not yet available.

Quick Info

Approval ID94958707a96976bb

Product NumberN/A

StatusAuthorised

Authorised DateN/A

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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