Review Product Marketing Authorisation For Human Use «Gluscan».

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

Read the untranslated law here:

Retrieved February 25, 2015 2015 V&A # 379/determines the permission of variation in relation to medicine GLUSCAN.
Are authorized the following variation: ASMF update for manufacturer ABX Advanced Biochemical: from: 101/05 the Applicant Part EDMF TATM and EDMF TATM 102/05;
a: Applicant Part of the 101/06 and EDMF TATM TATM 102/06 regarding QOS EDMF medicinal product and authorisation authorised pack sizes in Italy following the mutual recognition procedure.
How to: FR/HR/0286/001/II/051.
Types of variation: B.I. b z.
A.I.C. Holder: Advanced Accelerator Applications.
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 subparagraph 5 of Determines AIFA n. 371 of 4/14/2014 published in the Official Journal No. 101 of 5/3/2014.
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.