Retrieved February 25, 2015 V&A # 377/2015 of authorization determines variation in relation to medicine MEROPENEM RANBAXY.
Are authorized the following variation: Add a batch size from 25,410 kg, equivalent to 37700 vials, the existing batch size to 4,381 kg, equivalent to 6500 ampoules with respect to medicinal product and authorisation authorised pack sizes in Italy following the mutual recognition procedure.
How to: IE/H/0204/001/II/008.
Types of variation: b. II b. 4 d.
A.I.C. holder: Ranbaxy Italy 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 paragraph 5 of the 14/04/2014 # 371 Determines AIFA published in the Official Journal No. 101 of 03/05/2014.
Date of determination: this determination is effective on the day following that of its publication, to decompress, in Gazzetta Ufficiale della Repubblica Italiana and company will be notified to the holder of the marketing authorisation for the medicinal product.