ZOBRAL Film-coated tablet Ref.[51108] Active ingredients: Levocetirizine

Source: Υπουργείο Υγείας (CY)  Revision Year: 2020  Publisher: Delorbis Pharmaceuticals Ltd., 17 Athinon Street, Ergates Industrial Area, 2643 Ergates, P.O. Box 28629, 2081 Lefkosia, Cyprus, European Union

Product name and form

Zobral 5 mg Film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

White, round, biconvex, film-coated tablets.

Qualitative and quantitative composition

Each film-coated tablet contains 5 mg of levocetirizine dihydrochloride.

Excipient(s) with known effect: 79.00 mg lactose monohydrate/tablet.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Levocetirizine

Levocetirizine, the ® enantiomer of cetirizine, is a potent and selective antagonist of peripheral H1-receptors. Pharmacodynamic studies in healthy volunteers demonstrate that, at half the dose, levocetirizine has comparable activity to cetirizine, both in the skin and in the nose.

List of Excipients

Tablet core:

Lactose monohydrate
Magnesium stearate and prosolv SMCC 90 (consisting of: cellulose microcrystalline and colloidal silica anhydrous).

Film-coating:

Opadry Y-1-7000 or AquaPolish 010 white [hypromellose, titanium dioxide (E171), macrogol 400]

Pack sizes and marketing

Ζobral 5 mg film-coated tablets are supplied in blister packs of Aluminium/Aluminium containing 1, 2, 4, 5, 7, 10, 14, 15, 28, 30 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Delorbis Pharmaceuticals Ltd., 17 Athinon Street, Ergates Industrial Area, 2643 Ergates, P.O. Box 28629, 2081 Lefkosia, Cyprus, European Union

Marketing authorization dates and numbers

Zobral 5 mg film-coated tablets: 021149

Date of first authorisation: 16 December 2011

Drugs

Drug Countries
ZOBRAL Cyprus, Malta

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