Retrieved 14 January 14, 2015 V&A/variation of Authorization determines: 2 B, c) in relation to medicine: BCG MEDAC.
European procedure: DE/H/0212/001/II/027.
MAh: Medac Gesellschaft Fur Klinische Spezialpraparate MBH, is hereby amended as follows: the use of a new working seed lot (lot no. 11BCG417) to replace the currently used lotto (lot # 07BCG232) 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.