ZONTIVITY Film-coated tablet Ref.[9380] Active ingredients: Vorapaxar

Source: European Medicines Agency (EU)  Revision Year: 2017  Publisher: Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

Product name and form

Zontivity 2 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

The film-coated tablets are yellow, oval-shaped, size 8.48 mm x 4.76 mm, with “351” on one side and the MSD logo on the other side.

Qualitative and quantitative composition

Each film-coated tablet contains 2.08 mg of vorapaxar (as vorapaxar sulfate).

Excipient(s) with known effect: Each film-coated tablet contains 66.12 mg of lactose (as monohydrate).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Vorapaxar

Vorapaxar is a selective and reversible inhibitor of the PAR-1 receptors on platelets that are activated by thrombin.

List of Excipients

Tablet core:

Lactose monohydrate
Cellulose, microcrystalline (E460)
Croscarmellose sodium (E468)
Povidone (E1201)
Magnesium stearate (E572)

Film coating:

Lactose monohydrate
Hypromellose (E464)
Titanium dioxide (E171)
Triacetin (E1518)
Iron oxide yellow (E172)

Pack sizes and marketing

Packs of 7, 28, 30 and 100 film-coated tablets in aluminium/aluminium blister cards.

Packs of 10 and 50 film-coated tablets in aluminium/aluminium unit-dose blister cards.

Not all pack sizes may be marketed.

Marketing authorization holder

Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

Marketing authorization dates and numbers

EU/1/14/976/001
EU/1/14/976/002
EU/1/14/976/003
EU/1/14/976/004
EU/1/14/976/005
EU/1/14/976/006

Date of first authorisation:19 January 2015

Drugs

Drug Countries
ZONTIVITY Estonia, Lithuania, Romania, United States

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