Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
HUMAN ALBUMIN MACRO AGGREGATED
Amersham Health Srl
HUMAN ALBUMIN MACRO AGGREGATED
Unknown
Product subject to prescription which may not be renewed (A)
Withdrawn
2010-01-22
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0401/003/001 Case No: 1010602 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to AMERSHAM HEALTH SRL VIA CRESCENTINO, 13040 SALUGGIA (VERCELLI), ITALY an authorisation, subject to the provisions of the said Regulations, in respect of the product MACROTEC 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 23/11/2007 until 22/11/2012. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 29/11/2007_ _CRN 1010602_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Macrotec Powder for suspension for injection Kit for radiopharmaceutical preparation 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Human albumin macroaggregates (MAA) 2.0mg Each vial contains 4.5 x 10 6 MAA particles. The size range is 10-90µm. The product is prepared from batches of human albumin. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Kit for the preparation of Technetium ( 99m Tc) Macrosalb Injection PhEur. The product comprises five vials each containing a sterile white to off-white solid deposit. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medical product is for diagnostic use only After la Lue koko asiakirja