Retrieved January 14, 2015 V&A # 27/2015 of Procedure determines EU N°: UK/H/1478/001/II/007 type II variation: B.I. to z) are authorized the following variation: approval for updating the Drug Master File (DMF) added to the manufacturer of the active substance ' Neuland Laboratoies Limited.
The DMF has been updated from version «CTD-1/NPP/LF/AP/07.0 plus revision December 2008 plus Amendment DMF Revision 16.10.2010» than «NLL/LF/AP/001/07/Jan, 2013. " As a result it was updated the form of CTD s. 4.1 3.2 (specifications).
With respect to medicinal product: LEVIXIRAN and authorised pack sizes the placing in Italy following the mutual recognition procedure.
Mah: Chiesi Farmaceutici S.P.A.
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.