Retrieved February 10, 2015 V&A # 214/2015 determines the authorized the following variation: b. II. b. 5. and Review of evidence being manufactured or limits applied during the manufacture of the finished product the IPC approved limits, Enlargement is likely to have a significant effect on the overall quality of the finished product, b. II. d. 1. and change in the specification parameters and/or finished product limits change outside of the approved specification limits with respect to the ABDOMINAL WALL, shapes and AIC packs no medicine. 026608075-"330 mg effervescent tablets with vitamin C" 20 tablets: enlargement of the IPC and of the IPC, as follows: "specific tensile strength": 80N-160N ≥ 80N;
Specifies "tensile strength" to shelf-life: a ≥ ≤ 177N 80N;
specify "time of disintegration" on release: from 1 ' 00 ' -1 ' 35 "at ≤ 95 sec.
Mah: BRISTOL-MYERS SQUIBB S.A.R.L. with registered office and tax domicile in 3 RUE JOSEPH MONIER-92500 RUEIL MALMAISON (FRANCE) disposal stocks 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 April 14, 2014 # 371 of AIFA determines 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.