Ülke: İrlanda
Dil: İngilizce
Kaynak: HPRA (Health Products Regulatory Authority)
CETIRIZINE DIHYDROCHLORIDE
McDermott Laboratories Ltd t/a Gerard Laboratories
CETIRIZINE DIHYDROCHLORIDE
10 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Withdrawn
2013-04-30
IRISH MEDICINES BOARD ACT 1995, AS AMENDED MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED PA0577/085/001 Case No: 2085502 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to MCDERMOTT LABORATORIES LTD T/A GERARD LABORATORIES 35-36 BALDOYLE INDUSTRIAL ESTATE, GRANGE ROAD, DUBLIN 13, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product CETIRIZINE 10 MG 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 30/07/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 30/07/2010_ _CRN 2085502_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cetirizine 10 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One film-coated tablet contains 10mg cetirizine dihydrochloride. Excipients: one film-coated tablet contains 74.3mg lactose-monohydrate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablets. White, capsule shaped, film coated tablet with breakline and marked ‘CZ’ and ‘10’ on one side and marked ‘G’ on the reverse. The breakline is to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In adults and pae Belgenin tamamını okuyun