ELIQUIS Film-coated tablet Ref.[6201] Active ingredients: Apixaban

Source: European Medicines Agency (EU)  Revision Year: 2018  Publisher: Bristol-Myers Squibb/Pfizer EEIG, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex, UB8 1DH, United Kingdom

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

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
ELIQUIS Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Ireland, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa

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