Extended indication Pevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or
Therapeutic value Possible equal value
Registration phase Positive CHMP opinion

Product

Active substance Apixaban
Domain Cardiovascular diseases
Reason of inclusion 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.
Current proprietary name Eliquis (BMS)
Proprietary name Apixaban Accord
Manufacturer Accord Healthcare
Mechanism of action Anticoagulant

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.

Therapeutic value

Therapeutic value Possible equal value

Expected patient volume per year

Patiëntvolume is niet van toepassing bij generieke geneesmiddelen of biosimilars.

Expected cost per patient per year

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

Potential total cost per year

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

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.