Review Product Marketing Authorisation For Human Use «Antithrombin Iii Immuno».

Original Language Title: Modifica dell'autorizzazione all'immissione in commercio delmedicinale per uso umano «Antitrombina III immuno».

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Retrieved February 10, 2015 V&A # 212/2015 the determines are authorized the following variation: b. II. d. 2 BC) change in test procedure of the finished material modification or replacement of a biological/immunological test method or a method using a biological reagent, or replacement of a biological reference preparation not covered by an approved Protocol with respect to medicine packaging, shapes and Antithrombin III Immuno A.I.C. # 027113012-' 500 IU/10 ml powder and solvent for solution for infusion» 1 vial 1 vial 10 ml powder 500 IU + solvent + set of reconstitution and infusion, A.I.C. # 027113024-«1000UI/20 ml powder and solvent for solution for infusion» 1 vial 20 ml + +1 1000UI powder solvent vial reconstitution and infusion sets :
===================================================================== |  Da |  A | +=================================+=================================+ | | Finished product specification: | | Finished product specification: | Test method: test for | Test method: Test of pyrogens | bacterial endotoxins: method | | about rabbits: test procedure chromogenic, kinetic procedure | | | Or-13-00041 specification: absence of tet OR-13-00043 | Specifies: ≤ || pyrogens | 2 EU/ml | +----------------------------------+----------------------------------+ Holder A.I.C.: Baxter AG with registered office and tax domicile Industriestrasse 67, 1220 Vienna (Austria).
Inventory disposal lots already products can be kept on the market until the expiration date printed on the label of the medicinal product in accordance with art. 1 paragraph 5 of the April 14, 2014 # 371 determines AIFA published in Official Gazette No 101 of May 3, 2014.
Date of determination: from the day following that of its publication, to decompress, in Gazzetta Ufficiale della Repubblica italiana.