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Date: 2018-07-26

Type of information: Positive opinion for the granting of a Market Authorisation in the EU

Product name: Xarelto®

Compound: rivaroxaban

Therapeutic area: Cardiovascular diseases

Action mechanism: anticoagulant agent/oral direct Factor Xa inhibitor

Company: Bayer Healthcare (Germany)

Disease:

  • prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk of ischaemic event

Latest news:

  • • 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 Xarelto®. 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.” The full indications for Xarelto 2.5 mg tablets will be as follows: - 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. -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.

Patents:

Submission of marketing authorization application USA :

Submission of marketing authorization application UE:

Withdrawal of marketing authorization application USA:

Withdrawal of marketing authorization application UE:

US authorization:

UE authorization:

Favourable opinion UE: 2018-07-26

Favourable opinion USA:

Orphan status USA:

Orphan status UE:

Pediatric exclusivit _USA:

Pediatric exclusivity UE:

OTC status:

Other news:

Is general: Yes