Retrieved 12 January 14, 2015 V&A/variation of Authorization determines: b. II. b. 4 d) concerning medicine: GLICLAZIDE SANDOZ GMBH European procedure: PT/H/0534/001/II/003 Mah: SANDOZ GMBH is hereby amended as follows: increased lot size: 42.5 Kg (250.000 tablets) in 170Kg (1.000 .000 tablets) 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, paragraph 5, of the causes of the April 14, 2014 # 371 AIFA published in Official Gazette No 101 of May 3, 2014.
Date of determination: from the day following that of its publication, to decompress, in Gazzetta Ufficiale della Repubblica Italiana.