Review Product Marketing Authorisation For Human Use «Rhophylac»

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

Read the untranslated law here:

Retrieved December 16, 2014 2014 # 2658/V&A determines the permission of variation in relation to medicine: RHOPHYLAC.
Are authorized the following variation: introduction of CSL Behring GmbH, Marburg as alternate site of aseptic filling of bulk solution Rhophylac in addition to Vetter Pharma-Fertigung GmbH Ravensburg. Consequential amendments to the lot size and the packing materials. Change in the composition of immediate packaging. Consequent changes in some sections of modules 2 and 3, in relation to medicine and 036161014-«RHOPHYLAC only 200 micrograms/Pack: 2 Ml injection» 1 syringe, authorized the placing in Italy following the mutual recognition procedure.
How to: DE/H/0211/001/II/092/G.
Types of variation: b. II. e. 1. a. 3) quality changes finished product ' Review of the immediate packaging of the finished product;
B. II. b. 1 c) quality changes finished product «replacement or addition of a manufacturing site for part or the entirety of the manufacturing process of the finished product;
B. II. b. 4 c) quality changes finished product batch size of the finished product "changing".
A.I.C. Holder: CSL Behring GmbH.
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 April 14, 2014 # 371 determines AIFA published in Official Gazette No 101 of May 3, 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.