Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
CINNARIZINE
McDermott Laboratories Ltd t/a Gerard Laboratories
15 Milligram
Tablets
2005-09-23
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0577/070/001 Case No: 2042448 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 NAGERINE 15 MG 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 12/12/2007 until 22/09/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 04/01/2008_ _CRN 2042448_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nagerine 15mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Cinnarizine 15mg. For excipients see Section 6.1. 3 PHARMACEUTICAL FORM Tablet White, flat bevel edged tablets marked 'G' on both sides. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cinnarizine is effective in the control of motion sickness. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Cinnarizine is for oral administration to both adults and children according to the following dosage regime. Tablets may be sucked, chewed or swallowed whole with water. Motion sickness: _Adults, elderly an Read the complete document