Review Product Marketing Authorisation For Human Use «Omegaven»

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

Read the untranslated law here:

Retrieved V&A 2656/2014 December 16, 2014 's authorization determines no variation in relation to medicine: OMEGAVEN.
Are authorized the following variation: lot size: from 2000L in 2000-6000L. Changes to the manufacturing process of the finished product for: filtration excipients and final preparation of emulsion rubber Stoppers (ready to use). Control changes in course of process phases: preparation of the emulsion (pH oxygen degree of dispersion in sodium); filling (pH extractable volume of microbial load); sterilization (sterilization cycle and temperature control); inspection of filled containers (Visual inspection); labelling and packaging), with regard to the medicinal product authorisations authorised pack sizes and OMEGAVEN in Italy following the mutual recognition procedure.
How to: DE/H/0139/001/II/020/G.
Types of variation: b. II. b. 4 d; B. LL. b. 5. b; B. II. b. 5 c; B. II. b. 32; B. II. b. 52.
A.I.C. Holder: Fresenius Kabi Deutschland Gmbh.
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.