Review Product Marketing Authorisation For Human Use "typhim Vi '.

Original Language Title: Modifica dell'autorizzazione all'immissione in commercio delmedicinale per uso umano «Typhim VI».

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Retrieved V&A 16/02/2015 289/2015 of authorization determines no variation in relation to medicine WS UK/European procedure TYPHIM VI H/xxxx/WS/098 are authorized the following variation: b. II. b. 5. a Review of in-process tests or limits applied during the manufacture of the finished product enhancement of in-process limits, b. LL. b. 5. b Review of in-process tests or limits applied during the manufacture of the finished product Addition new evidence and new limits, b. II. d. 1. c Review specification parameters and/or limits of the finished adding a new parameter to the specification with the corresponding test method, b. II. d. 2. Change in test procedure for the finished product minor changes to a test procedure approved, b. II. f. 1. e) modification of storage time and conditions of storage of the finished product Review of an approved stability Protocol , B. II. b. 3 c) change in the manufacturing process of the finished product, including an intermediate product used in the manufacture of the finished product the product is a biological/immunological medicinal product and the change requires an assessment of comparability, relative to medicine TYPHIM VI, in shapes and packagings AIC # 029153018-"Solution for intramuscular injection" 1 syringe with attached needle from 0.5 ml , AIC # 029153020-"solution for intramuscular injection" 1 0.5 ml syringe without needle with 2 separate needles: upgrading forms 3.2 3.2. P and a. the registration dossier Mah: SANOFI PASTEUR MSD SNC with registered office and tax domicile in 8, RUE JONAS SALK, 69367-LYON CEDEX 07 (France) 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 paragraph 5 of the AIFA 14/04/2014 # 371 of Determines published in the Official Gazette No. 101 of 03/05/2014.
Date of determination: from the day following that of its publication, to decompress, in Gazzetta Ufficiale della Repubblica Italiana.