Extended indication extension to the existing indication to include treatment of venous thromboembolism (VTE) and preven
Therapeutic value No estimate possible yet
Registration phase Positive CHMP opinion

Product

Active substance Apixaban
Domain Cardiovascular diseases
Reason of inclusion Indication extension
Main indication Antithrombotic medications
Extended indication extension to the existing indication to include treatment of venous thromboembolism (VTE) and prevention of recurrent VTE in children, associated with the addition of new pharmaceutical forms and new strengths (0.15 mg granules in capsules for opening, as well as 0.5, 1.5 and 2 mg coated granules in sachet).
Proprietary name Eliquis
Manufacturer BMS
Mechanism of action Anticoagulant
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Extramural (GVS)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP Yes
Submission date August 2023
Expected Registration August 2024
Orphan drug No
Registration phase Positive CHMP opinion
Additional remarks Positieve CHMP-opinie mei 2024

Therapeutic value

Therapeutic value No estimate possible yet

Expected patient volume per year

There is currently nothing known about the expected patient volume.

Expected cost per patient per year

There is currently nothing known about the expected cost.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.