Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
IOPAMIDOL
Bracco UK Limited
300 Milligram
Solution for Injection
1998-03-10
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA1022/010/002 Case No: 2041084 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to BRACCO UK LIMITED BRACCO HOUSE, MERCURY PARK, WYCOMBE LANE, WOOBURN GREEN, HIGH WYCOMBE, BUCKS HP10 OHH, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product NIOPAM 300, SOLUTION FOR INJECTION, GLASS BOTTLES 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 08/03/2008. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 21/05/2008_ _CRN 2041084_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Niopam 300, Solution for injection, glass bottles 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The solution contains 61.2%w/v Iopamidol, equivalent to 300mg iodine/ml Each ml contains 612mg Iopamidol. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. A clear aqueous solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS X-ray contrast medium for use in thoraco-lumbar and cervical myelography and in computer tomography enhancement. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Method of administration Intrathecal. Intravent Read the complete document