Land: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
LEVOCETIRIZINE DIHYDROCHLORIDE
Profind Wholesale Ltd
LEVOCETIRIZINE DIHYDROCHLORIDE
5 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Withdrawn
2013-01-29
IRISH MEDICINES BOARD ACT 1995, AS AMENDED MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED PPA1500/055/001 Case No: 2083448 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to PROFIND WHOLESALE LTD. UNIT 625, KILSHANE AVENUE, NORTHWEST BUSINESS PARK, DUBLIN 15, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product XYZAL 5MG FILM-COATED TABLETS the particulars of which are set out in the attached Schedule. The authorisation is also subject to the general conditions as may be specified in the said Regulations as listed on the reverse of this document. This authorisation, unless previously revoked, shall continue in force from 28/07/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 28/07/2010_ _CRN 2083448_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Xyzal 5mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 5mg levocetirizine dihydrochloride. Excipients: contains lactose monohydrate (63.5mg per tablet) For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated Tablet _Product imported from the UK:_ White to off-white, oval, film-coated tablet with a Y logo on one side 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic treatment of allergic rhinitis (including persistent allergic rhinitis) and chronic idiopathic urticaria. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The film-coated tablet must be taken or Lestu allt skjalið