Review Product Marketing Authorisation For Human Use «Umanifresenius» T Cell Immunoglobulin.

Original Language Title: Modifica dell'autorizzazione all'immissione in commercio delmedicinale per uso umano «Immunoglobuline Anti-Linfociti T umaniFresenius».

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Retrieved V&A 2653/2014 December 16, 2014 # the determines (authorization of the change relatively ala medicinal product immunoglobulin human T lymphocytes Fresenius) authorization of change: change the manufacturer of a raw material of a reagent or an intermediate product used in the manufacturing process of the active substance or changing the manufacturer from: S&K-LAP KFT (Sandor Ferenc), Office : Vöroshadsereg ut 135, 2173 Kartal, (H), rabbit housing site: Soroksar-.1239 Tanyaközpont Budapest (H) represented by: Tamas Kertai, Sales Bernaystr. 10, 80937 Munich (DE): S&K-LAP KFT (Sandor Ferenc), Office: Csaszar u. 135 * 2173 Kartal (H), rabbit housing site: Hovirag u. 1579, 2173 Kartal (H) represented by: Tamas Kertai, Sales, Bernaystr. 10, 80937 Munich (DE) concerning the medicinal product and authorisation authorised pack sizes in Italy following the mutual recognition procedure.
How: AT/H/0478/001/II/002 nature of change: the B 1. e) Mah: NEOVII BIOTECH GMBH 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: this determination is effective on the day following that of its publication, to decompress, in Gazzetta Ufficiale della Repubblica Italiana and company will be notified to the holder of the marketing authorisation for the medicinal product.