Advanced Search

Review Agency For Marketing Authorisation For Human Use "pasteur Vaccine Vaxigrip" And "mutagrip".

Original Language Title: Modifica dell'autorizzazione all'immissione in commercio deimedicinali per uso umano «Vaxigrip» e «Vaccino Mutagrip Pasteur».

Subscribe to a Global-Regulation Premium Membership Today!

Key Benefits:

Subscribe Now for only USD$40 per month.
Retrieved January 14, 2015 V&A # 26/2015 of Procedure determines EU N°: FR/HR/XXXX/WS/025 type II variation: C.I. 11. b are authorized the following variation: introduction of the Risk Management Plan including the Enhanced Safety Plan Surveillance on medicinal products: Vaxigrip (FR/HR/0121/001/WS/0073) and (FR/HR/0139/001/WS/0047), Vaccine Mutagrip Pasteur (FR/HR/122/001/WS/0069) and authorised pack sizes the placing in Italy following of mutual recognition procedure.
MAh: Sanofi Pasteur MSD SNC Disposal stocks 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 April 14, 2014 # 371 of AIFA determines 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.