ELIQUIS Film-coated tablets

Active ingredients: Apixaban

Product name and form

Eliquis 2.5 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet (tablet).

Yellow, round tablets debossed with 893 on one side and 2 1⁄2 on the other side.

Qualitative and quantitative composition

Each film-coated tablet contains 2.5 mg apixaban.

Excipients with known effect: Each 2.5 mg film-coated tablet contains 51.43 mg lactose (see section 4.4).

For the full list of excipients, see section 6.1.

Active Ingredient
Description

Apixaban is a potent, oral, reversible, direct and highly selective active site inhibitor of factor Xa. It does not require antithrombin III for antithrombotic activity. Apixaban inhibits free and clot-bound factor Xa, and prothrombinase activity. By inhibiting factor Xa, apixaban prevents thrombin generation and thrombus development.

List of Excipients

Tablet core:

Anhydrous lactose
Microcrystalline cellulose (E460)
Croscarmellose sodium
Sodium laurilsulfate
Magnesium stearate (E470b)

Film coat:

Lactose monohydrate
Hypromellose (E464)
Titanium dioxide (E171)
Triacetin (E1518)
Yellow iron oxide (E172)

Pack sizes and marketing

Alu-PVC/PVdC blisters. Cartons of 10, 20, 60, 168 and 200 film-coated tablets.

Alu PVC/PVdC perforated unit dose blisters of 60x1 and 100x1 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Bristol-Myers Squibb/Pfizer EEIG, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex, UB8 1DH, United Kingdom

Marketing authorization dates and numbers

EU/1/11/691/001
EU/1/11/691/002
EU/1/11/691/003
EU/1/11/691/004
EU/1/11/691/005
EU/1/11/691/013
EU/1/11/691/015

Date of first authorisation: 18 May 2011

Date of latest renewal: 14 January 2016

Drugs

Drug
Countries
Austria, Australia, Brazil, Canada, Cyprus, Spain, France, Hong Kong, Ireland, Lithuania, Netherlands, Singapore, United Kingdom, United States