Review Of The Marketing Authorisation For Human Influenza Talunimedicinali

Original Language Title: Modifica dell'autorizzazione all'immissione in commercio di talunimedicinali per uso umano

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Retrieved determines the 2511/2014 December 2, 2014 n V & worksharing authorization on medicinal products: A.I.C. IMOVAX POLIO # 029310;
PENTAVAC A.I.C. # 034126 (SE/H/153/001/WS/98);
A.I.C. REVAXIS # 034457 (DE/H/193/001/WS/44);
A.I.C. TETRAVAC # 034127 (SE/H/154/001/WS/73), and authorised the placing packs in Italy as a result of national and mutual recognition procedure.
How EU n: DE/H/xxxx/WS/108.
The following variations are allowed: increasing the size of the batch crop of viral propagation at the building site production 15 Marcy l'Etoile: from: 1500 litres;
in: 3000 litres;
the Elimination of Streptomycin sulfate and polymyxin B sulfate by means of cultivation of Vero cells (333 L stairs process) at the building site production 15 Marcy l'Etoile;
the introduction of a new filtration system at the stage of "crude harvest» at the buildings 9 and 15 production Marcy l'Etoile site without the use of an adjuvant of filtration and prefiltration step-based (cellulose membrane with pores from 1.0 µm to 0.4 µm) and a final filtration (polyethersulfone membranes with pores from 0.65 µm to 0.2 µm and 0.2 µm pore membrane for the first to the second membrane);
the introduction of stainless steel tanks from 100 litres as alternative for the conservation of monovalent bulk containers;
the transfer of infertility tests: from: stage of «single harvest»;
to: stadio del «crude harvest».
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, paragraph 5 of the April 14, 2014 # 371 determines AIFA published in Official Gazette No 101 of May 3, 2014.
Date of determination: from the day following that of its publication, to decompress, in Gazzetta Ufficiale della Repubblica italiana.