Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
CITALOPRAM
McDermott Laboratories Ltd t/a Gerard Laboratories
20 Milligram
Film Coated Tablet
2005-10-13
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0577/072/001 Case No: 2024541 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 CITALOPRAM 20MG FILM-COATED TABLETS The particulars of which are set out in Part I and Part II of 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 09/01/2007. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 22/09/2007_ _CRN 2024541_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Citalopram 20mg Film-Coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains citalopram hydrobromide equivalent to 20mg of citalopram. Excipient(s): 53.28 mg Lactose Monohydrate For a full list of excipients see section 6.1 3 PHARMACEUTICAL FORM Film coated tablet A white, oval film coated tablet marked with “CM scoreline 20” on one side and “G” on the other. The tablet can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Citalopram is indicated for the treatment of depressive illnesses in the initial stage and as Citiți documentul complet