Review Agency For Marketing Authorisation For Human Use «Acthib» And «Pentavac».

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

Read the untranslated law here:

Retrieved February 25, 2015 V&A # 375/2015 of change determines membrane used for filtering the formulation of final bulk of finished product (Haemophilus Influenzae conjugate Polysaccharide): from: 0.22 µm pore membrane of polyvinylidene fluoride (PVDF);
a: 0.22 µm pore membrane of polyvinylidene fluoride (PVDF) with a prefilter embedded asymmetric Polysulfone (PES).
Adding a sterilisation step online (filter with pores from 0.22 µm) as near as possible to the filling of vials. Change in specifications concerning the end of the period of validity of the finished product (Haemophilus Influenzae conjugate Polysaccharide) pertaining to specialty medicine ACTHIB and PENTAVAC and authorised pack sizes the placing in Italy.
How to: SE/H/XXXX/WS/066.
Types of variation: b. II. d. 1 z), b. II. b. 3 c).
A.I.C. holder: 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 subparagraph 5 of Determines AIFA n. 371 of 14/04/2014 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.