Review Product Marketing Authorisation For Human Use "vancomycin Mylan»

Original Language Title: Modifica dell'autorizzazione all'immissione in commercio delmedicinale per uso umano «Vancomicina Mylan»

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Retrieved November 20, 2014 at the # 2425/2014 V & determines are authorized the following variation: changes applied to the site of production of the finished product «Vianex S.A. plant C (Greece) ' means adding a new lot of 194.0 size L (equivalent to 47,549 vials) for 500 mg Vancomycina Mylan.; increasing the size of the lot involving some minor modifications of the production process: using water for injections at 80% rather than at 90%, for the dissolution phase; changing the parameters of the sterilization process of glass vials, relatively to the drug VANCOMYCIN MYLAN and authorised pack sizes the placing in Italy following the mutual recognition procedure.
How to: CZ/H/0351/001/II/005/G.
Types of variation: b. II. b. 4. d changing the size of the lot (including the classes of lot size) of the finished product-The amendment concerns all other pharmaceutical forms manufactured according to complex manufacturing processes-b. II. b. 3. a) quality changes finished product-Production-importer level change of method of batch release and quality control tests on the finished product-Change in the manufacturing process of the finished product.
A.I.C. holder: Mylan S.p.a.
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: this determination is effective on the day following that of its publication, to decompress, in Gazzetta Ufficiale della Repubblica italiana and company will be notified to the holder of the marketing authorisation for the medicinal product.