País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
GRANISETRON
Actavis Group PTC ehf
GRANISETRON
3 Mg/Ml
Concentrate for Soln for Inf
Product subject to prescription which may not be renewed (A)
Withdrawn
2009-10-06
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA1380/001/002 Case No: 2057606 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to ACTAVIS GROUP PTC EHF REYKJAVIKURVEGI 76-78, 220 HAFNARFJORDUR, ICELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product GRANISETRON 3 MG/3 ML CONCENTRATE FOR SOLUTION FOR INFUSION OR INJECTION 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 20/01/2009 until 02/10/2013. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 20/01/2009_ _CRN 2057606_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Granisetron 3 mg/3 ml Concentrate For Solution For Infusion Or Injection. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml concentrate for solution for infusion or injection contains 1 mg granisetron (as granisetron hydrochloride). One 3 ml ampoule contains 3 mg granisetron (as granisetron hydrochloride). Excipient(s): Sodium chloride 9 mg/ml (equivalent to 3.54 mg sodium/ml) For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Concentrate for solution for infusion/injection Clear, colourless or slightly straw-coloured solution in a clear glass ampoul Leia o documento completo