Retrieved February 24, 2015 V&A # 367/2015 of authorization determines variation in relation to medicine PRAZEPAM EG are authorized the following variation: update of the DMF of manufacturer of the active substance (Prazepam) with ASMF Prodrug Milan S.r. l concerning the medicinal product and authorisation authorised pack sizes in Italy following the mutual recognition procedure.
Procedures: BE/H/0143/001-003/II/007 type of variation: b. 1. z) Mah: EG 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 determines AIFA n. 371 of 14/04/2014 published in the Official Journal No. 101 of 03/05/2014.
Date of application of determining 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.