ZYLLT Film-coated tablet Ref.[49899] Active ingredients: Clopidogrel

Source: European Medicines Agency (EU)  Revision Year: 2021  Publisher: KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Product name and form

Zyllt 75 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

Pink, round and slightly convex film-coated tablets.

Qualitative and quantitative composition

Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen sulphate).

Excipients with known effect: Each film-coated tablet contains 108.125 mg lactose.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Clopidogrel

Clopidogrel is a prodrug, one of whose metabolites is an inhibitor of platelet aggregation. Clopidogrel must be metabolised by CYP450 enzymes to produce the active metabolite that inhibits platelet aggregation.

List of Excipients

Tablet core:

Lactose
Cellulose, microcrystalline
Pregelatinised maize starch
Macrogol 6000
Hydrogenated castor oil

Film coating:

Hypromellose (E464)
Titanium dioxide (E171)
Red iron oxide (E172)
Talc
Propylene glycol

Pack sizes and marketing

Blister of OPA/Alu/PVC-Alu containing 7, 14, 28, 30, 50, 56, 60, 84, 90 and 100 film-coated tablets in the box.

Not all pack sizes may be marketed.

Marketing authorization holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Marketing authorization dates and numbers

7 film-coated tablets: EU/1/09/553/001
14 film-coated tablets: EU/1/09/553/002
28 film-coated tablets: EU/1/09/553/003
30 film-coated tablets: EU/1/09/553/004
50 film-coated tablets: EU/1/09/553/005
56 film-coated tablets: EU/1/09/553/006
60 film-coated tablets: EU/1/09/553/007
84 film-coated tablets: EU/1/09/553/008
90 film-coated tablets: EU/1/09/553/009
100 film-coated tablets: EU/1/09/553/010

Date of first authorisation: 28 September 2009
Date of latest renewal: 14 May 2014

Drugs

Drug Countries
ZYLLT Albania, Austria, Estonia, Croatia, Ireland, Italy, Lithuania, Poland, Romania

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