Retrieved December 2, 2014 A/V determines the Authorization of 2529 & variation: b. II. d. 1. and Review specification parameters and/or limits of the finished product-edit that is outside the bounds of the approved specification.
With respect to medicinal product: VALSARTAN EG European procedure: AT/0263/004/H/003-II/011 A.I.C. Holder: EG Spa, is hereby amended as follows: specific changes to Shelf Life: VALSARTAN 160 mg film-coated tablets 330 mg ± 3% by mass media (320-340 mg) to 330 mg ± 5% VALSARTAN 320 mg film-coated tablets 660 mg ± 3% by mass media (640-679 mg) to 660 mg ± 5% Changes of the specifications for the preservation and storage mass VALSARTAN 320 mg film-coated tablets 320 mg tablet core from 640 mg ± 3% 640 mg ± 5% 320 mg film-coated tablets (bulk) from 660 mg ± 3% 660 mg ± 5% with regard to marketing authorisations authorised pack sizes in Italy following the mutual recognition procedure.
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 14/04/2014 published in the Official Gazette No. 101 of 03/05/2014.
Date of determination: from the day following that of its publication, to decompress, in Gazzetta Ufficiale della Repubblica italiana.