Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
ERYTHROMYCIN LACTOBIONIC ACID
HOSPIRA UK Ltd
1 Grams
Pdr for Soln for Infusion
1992-04-17
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0437/025/001 Case No: 2055150 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to HOSPIRA UK LTD QUEENSWAY, ROYAL LEAMINGTON SPA, WARWICKSHIRE CV31 3RW, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product ERYTHROMYCIN 1G POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 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 17/09/2008. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 29/09/2008_ _CRN 2055150_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Erythromycin 1g Powder for Concentrate for Solution for Infusion. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial, before reconstitution contains: Erythromycin 1 g (as lactobionate) When reconstituted as directed in section 6.6 (_Special precautions for disposal of a used medicinal product or waste_ _materials derived from such medicinal product and other handling of the product_), each vial provides a concentrate for solution for infusion containing 50 mg/ml erythromycin (as lactobionate). For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for conc Read the complete document