Xarelto

rivaroxaban

Opinion

On 26 July 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Xarelto. The marketing authorisation holder for this medicinal product is Bayer AG.

The CHMP adopted a new indication for Xarelto 2.5 mg tablets as follows:

“Xarelto, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk of ischaemic events.”

For information, the full indications for Xarelto 2.5 mg tablets will be as follows1:

“Xarelto, co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers (see sections 4.3, 4.4 and 5.1).

Xarelto, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk of ischaemic events.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.


1 New text is in bold.

Key facts

Name
Xarelto
Agency product number
EMEA/H/C/000944
International non-proprietary name (INN) or common name
  • rivaroxaban
Active substance
  • rivaroxaban
Therapeutic area
Arthroplasty, Replacement
Venous Thromboembolism
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Date opinion adopted
26/07/2018
Company name
Bayer AG
Status
Positive
Application type
Post-authorisation

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