Review Product Marketing Authorisation For Human Use "engerix B».

Original Language Title: Modifica dell'autorizzazione all'immissione in commercio delmedicinale per uso umano «Engerix B».

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Retrieved February 23, 2015 V&A # 340/2015 of Procedure determines EU # EMA/H/xxxx/WS/610 type II variation: B.I.b. 2.
B.I.b. 1.
B. LL. b. 5.
Are authorized the following changes: the addition of nephelometry on bulk HBsAg prior adsorption with aluminum salts, in order to monitor the opalescence prior to formulation, and its acceptance criterion "no more than 1.18 NTU/20 µ g of protein" changing the "description" test performed on purified bulk by redefining acceptance criteria: from: "clear solution , from yellowish to colourless "in:" clear to opalescent and yellowish solution to colorless ".
With respect to medicinal product: ENGERIX B (BE/009 001-002 H///WS/068) and authorised pack sizes the placing in Italy following the mutual recognition procedure.
Mah: Glaxosmithkline Biologicals S.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 3/05/2014.
Date of application of the determination on the day following that of its publication, to decompress, in Gazzetta Ufficiale della Repubblica italiana.