BRILIQUE Film-coated tablet Ref.[7362] Active ingredients: Ticagrelor

Source: European Medicines Agency (EU)  Revision Year: 2019  Publisher: AstraZeneca AB, SE-151 85 Södertälje, Sweden

Product name and form

Brilique 90 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet (tablet).

Round, biconvex, yellow tablets marked with ‘90’ above ‘T’ on one side and plain on the other.

Qualitative and quantitative composition

Each film-coated tablet contains 90 mg ticagrelor.

Brilique contains less than 1 mmol sodium (23 mg) per dose, i.e. is essentially ‘sodium-free’.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Ticagrelor

Ticagrelor is an oral, direct acting, selective and reversibly binding P2Y12 receptor antagonist that prevents ADP-mediated P2Y12 dependent platelet activation and aggregation. Since platelets participate in the initiation and/or evolution of thrombotic complications of atherosclerotic disease, inhibition of platelet function has been shown to reduce the risk of CV events such as death, MI or stroke.
List of Excipients

Tablet core:

Mannitol (E421)
Calcium hydrogen phosphate dihydrate
Magnesium stearate (E470b)
Sodium starch glycolate type A
Hydroxypropylcellulose (E463)

Tablet coating:

Titanium dioxide (E171)
Iron oxide black (E172)
Iron oxide red (E172)
Macrogol 400
Hypromellose (E464)

Pack sizes and marketing

  • PVC-PVDC/Al transparent blister (with sun/moon symbols) of 10 tablets; cartons of 60 tablets (6 blisters) and 180 tablets (18 blisters).
  • PVC-PVDC/Al transparent calendar blister (with sun/moon symbols) of 14 tablets; cartons of 14 tablets (1 blister), 56 tablets (4 blisters) and 168 tablets (12 blisters).

Not all pack sizes may be marketed.

Marketing authorization holder

AstraZeneca AB, SE-151 85 Södertälje, Sweden

Marketing authorization dates and numbers

EU/1/10/655/007-011

Date of first authorisation: 03 December 2010
Date of latest renewal: 17 July 2015

Drugs

Drug Countries
BRILIQUE Austria, Cyprus, Estonia, Spain, Finland, France, Croatia, Ireland, Lithuania, Netherlands, Poland, Romania, Tunisia, United Kingdom
 
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