Retrieved determines the 2549/2014 December 2, 2014 n V & Authorize the variation in relation to medicine INFLUPOZZI VACCINE.
Are authorized the following variation: 2 B. c) Changes in the manufacturing process of the active substance. The change relates to a biological/immunological substance or use of a substance derived chemically different in manufacture of a biological/immunological substance, that have a significant impact on the quality, safety and efficacy of the medicinal product and which is not linked to a Protocol regarding the medicine Influpozzi Adjuvanted, shapes and packaging and A.I.C.: A.I.C. # 034377010-"suspension for injection for intramuscular use" 1 0.5 ml prefilled syringe;
A.I.C. # 034377022-"suspension for injection for intramuscular use" 10 0.5 ml prefilled syringes: introduction of pre-conditioning with PBS 5 mm and 1.2 mm filters, used for clarification after diafiltration virus pool at NVD.
A.I.C. holder: Novartis Vaccines and Diagnostics S.r.l. with registered office and tax domicile in Florentine Street # 1-53100 Siena (SI)-Italy; (tax ID # 01392770465).
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 causes of the April 14, 2014 # 371 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.