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.