Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
STANNOUS CHLORIDE DIHYDRATE TETRAKIS (2-METHOXY ISOBUTYL ISONITRILE) COPPER (I) TETRAFLUOROLBORATE CYSTEINE HYDROCHLORIDE MONOHYDRATE
Bristol-Myers Squibb Pharma Belgium SPRL
STANNOUS CHLORIDE DIHYDRATE TETRAKIS (2-METHOXY ISOBUTYL ISONITRILE) COPPER (I) TETRAFLUOROLBORATE CYSTEINE HYDROCHLORIDE MONO
%v/v
Kit for radiopharmaceutical preparation
Withdrawn
2008-12-31
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA1052/001/001 Case No: 2041882 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to BRISTOL-MYERS SQUIBB PHARMA CHAUSSEE DE LA HULPE 185, B-1170 BRUSSELS, BELGIUM an authorisation, subject to the provisions of the said Regulations, in respect of the product CARDIOLITE KIT FOR RADIOPHARMACEUTICAL PREPARATION 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 22/10/2007. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 23/10/2007_ _CRN 2041882_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cardiolite kit for radiopharmaceutical preparation 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Kit for radiopharmaceutical preparation of Technetium Tc-99m Sestamibi. Powder for solution for injection. Sterile non-pyrogenic lyophilized white powder for reconstitution with oxidant-free Sodium Pertechnetate Tc-99m Injection Ph. Eur. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For intravenous injection after reconstitution with Sodium pertechnetate [ 99m Tc] solution and may be used for: Adjunct for diagnosis of ischaemic heart disease. Adjunct for diagnosis and localisation of myocardia Lugege kogu dokumenti