Review Product Marketing Authorisation For Human Use «Nutrispecial Lipidsenza Nutrispecial Lipid And Electrolytes».

Original Language Title: Modifica dell'autorizzazione all'immissione in commercio delmedicinale per uso umano «Nutrispecial Lipid e Nutrispecial Lipidsenza elettroliti».

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Retrieved November 20, 2014 at the # 2423/2014 V & determines are authorized the following variation: introduction to the new active ingredient valine producer Amino Gmbh (site: An der Zucker-9/10, D-38373 Refineries Frellstedt-Germany) supported by Asmf «June 03, 2008-version Applicant Part» «June 4, 2008, Restricted Parts» version on medicinal products NUTRISPECIAL LIPID and LIPID NUTRISPECIAL without electrolytes and at authorised pack sizes the placing in Italy following the mutual recognition procedure.
Procedures: DE/H/0165/001/II/015 and DE/H/0167/001/II/013.
Type of change: 1. b B) quality changes active ingredient-manufacture "changing of the manufacturer of a raw material, a reactive or an intermediate product used in the manufacturing process of the active substance '.
A.I.C. Holder: B. Braun Melsungen AG.
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 extract, in the Official Gazette of the Italian Republic and will be notified to the company holder of the marketing authorisation of medicinal products.