Review Product Marketing Authorisation For Human Use «Pentavac».

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

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Retrieved February 25, 2015 V&A # 376/2015 of authorization determines variation in relation to medicine PENTAVAC.
Review of the production process of the finished product: next PRP-T freezing and thawing for the formulation of the final bulk product in relation to the medicinal product and authorisation authorised pack sizes in Italy following the mutual recognition procedure, to complement the V&A 2323 November 4, 2014 determination concerning the medicinal product ACTHIB whose retrieved it is published in the official journal of the Italian Republic , General series # 277 of 28/11/2014.
How to: SE/H/XXXX/WS/043.
Types of variation: b. II. b. 3. c Holder A.I.C.: Sanofi Pasteur MSD S.n.c.
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.