ZIREX Film-coated tablet Ref.[28273] Active ingredients: Cetirizine

Source: Υπουργείο Υγείας (CY)  Publisher: Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus

Product name and form

Zirex 10 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

White, capsule shaped, film-coated tablets, scored and embossed with R/R on the same side.

The tablet can be divided into equal doses.

Qualitative and quantitative composition

Each film-coated tablet contains 10 mg cetirizine dihydrochloride.

Excipient with known effect: This product contains 85.2 mg lactose.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Cetirizine

Cetirizine, a human metabolite of hydroxyzine, is a potent and selective antagonist of peripheral H1-receptors. In vitro receptor binding studies have shown no measurable affinity for other than Η1-receptors.

List of Excipients

Core:

Lactose monohydrate
Maize starch
Povidone
Magnesium stearate

Film-coating:

Hypromellose
Macrogol 400
Titanium dioxide
Talc

Pack sizes and marketing

PVC/Aluminium blisters Pack-sizes of 10, 30, 100 and 1000 film-coated tablets.
PP containers with PE closure. Pack-size of 1000 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus

Marketing authorization dates and numbers

20193

Date of first authorization: 28 February 2007
Date of latest renewal: 20 February 2013

Drugs

Drug Countries
ZIREX Albania, Cyprus, Hong Kong

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