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 2510/2014 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/100);
A.I.C. REVAXIS # 034457 (DE/H/193/001/WS/45);
A.I.C. TETRAVAC # 034127 (SE/H/154/001/WS/74), and authorised the placing packages in Italy as a result of national and mutual recognition procedure.
How EU #: DE/H/xxxx/WS/110.
You authorize the following variation: the addition of the building 44 at the production site Val de Reuil for the formulation (step three monovalent bulk blending) and perform some quality control tests (bacterial endotoxins and sterility) of the active substance of victim of polio vaccine inactivated.
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.