Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
ALBUMIN HUMAN
Octapharma Limited
50 g/l
Solution for Infusion
1993-07-14
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0521/002/001 Case No: 2045324 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to OCTAPHARMA LIMITED THE ZENITH BUILDING, 26 SPRING GARDENS, MANCHESTER, M2 1AB, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product ALBUMIN HUMAN 50G/L OCTAPHARMA, 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 14/07/2008. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 30/09/2008_ _CRN 2045324_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Albumin Human 50g/l Octapharma, solution for infusion. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Human albumin from human plasma source. Solution containing 5% of protein of which at least 96% is human albumin. Each 100ml contains 5g human albumin. Albumin Human 50 g/l is a mildly hypooncotic pasteurized solution. Excipients: also includes sodium 157.5mmol/litre For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for infusion. A clear, slightly viscous liquid; it is almost colourless, yellow, amber or green supplied in Type II (Ph. Eur.) glass infusio Lue koko asiakirja