Apixaban

Active substance
Apixaban
Domain
Cardiovascular diseases
Reason of inclusion in Horizonscan Geneesmiddelen
Generic
Main indication
Antithrombotic medications
Extended indication
Pevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery. Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age ≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II). Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.

1. Product

Current proprietary name
Eliquis (BMS)
Proprietary name
Apixaban Accord
Manufacturer
Accord Healthcare
Mechanism of action
Anticoagulant

2. Registration

Registration route
Centralised (EMA)
Type of trajectory
Normal trajectory
Submission date
July 2019
Expected Registration
July 2020
Registration phase
Positive CHMP opinion
Additional comments
SPC Eliquis verloopt op 19-05-2026. Voor Eliquis loopt een financieel arrangement dat afloopt per december 2023. Positieve CHMP-opinie mei 2020.

3. Therapeutic value

Therapeutic value
Potential equal value
Duration of treatment
Not found

4. Expected patient volume per year

Patiëntvolume is niet van toepassing bij generieke geneesmiddelen of biosimilars.

5. Expected cost per patient per year

Horizonscan vermeldt geen prijsinformatie van generieke geneesmiddelen of biosimilars om het eventueel beïnvloeden van de markt te voorkomen.

6. Potential total cost per year

Horizonscan vermeldt geen prijsinformatie van generieke geneesmiddelen of biosimilars om het eventueel beïnvloeden van de markt te voorkomen.

7. Off label use

There is currently nothing known about off label use.

8. Indication extension

There is currently nothing known about indication extensions.

9. Other information

There is currently no futher information available.