Retrieved December 2, 2014 A/2533 V determines the Authorization of change &: b. II. b. 4 changing the size of the lot (including the classes of lot size) of the finished product d) the change relates to all other pharmaceutical forms manufactured according to complex manufacturing processes in relation to medicine: CARBOPLATIN AHCL European procedure: UK/H/1126/001/II/024 Mah: ACCORD HEALTHCARE LIMITED is hereby amended as follows Lot size: from 600 l 45 and 60 ml fill volumes 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 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.