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Neoclarityn 5 mg film-coated tablets (2011)

Active ingredients: Desloratadine

Product Name and Form

Neoclarityn 5 mg film-coated tablets.

Pharmaceutical form

Film-coated tablets.

Qualitative and Quantitative Composition

Each tablet contains 5 mg desloratadine.

For a full list of excipients, see section 6.1.

Chemical substance
Description
Desloratadine

Desloratadine is a non-sedating, long-acting histamine antagonist with selective peripheral H1-receptor antagonist activity. After oral administration, desloratadine selectively blocks peripheral histamine H1-receptors because the substance is excluded from entry to the central nervous system.

List of excipients

Tablet core:

Calcium hydrogen phosphate dihydrate
Microcrystalline cellulose
Maize starch
Talc

Tablet coating:

Film coat (containing lactose monohydrate, hypromellose, titanium dioxide, macrogol 400, indigotin (E132))
Clear coat (containing hypromellose, macrogol 400)
Carnauba wax
White wax

Pack sizes and Marketing

Neoclarityn is supplied in unit dose blisters comprised of laminant blister film with foil lidding.

The materials of the blister consist of a polychlorotrifluoroethylene (PCTFE)/Polyvinyl Chloride (PVC) film (product contact surface) with an aluminium foil lidding coated with a vinyl heat seal coat (product contact surface) which is heat sealed.

Packs of 1, 2, 3, 5, 7, 10, 14, 15, 20, 21, 30, 50, 100 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder
Authorization dates

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

Date of first authorisation: 15 January 2001

Date of last renewal: 15 January 2006

Marketing authorization number:

EU/1/00/161/001-013