Review Product Marketing Authorisation For Human Use «Curosurf».

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

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-03-02&atto.codiceRedazionale=15A01401&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Retrieved February 16, 2015 2015 # 300/V&A of determines are authorized the following variation: 1. b B.I.b. Review specification parameters and/or limits of the active ingredient, a raw material, intermediate, or reagent used in the manufacturing process of the active substance tightening of specification limits, b. II. d. 1. a change in the specification parameters and/or limits of the finished tightening of specification limits , B. II. d. 1. f Review specification parameters and/or limits specific deletion of a finished product is liable to have a significant effect on the overall quality of the finished product, CUROSURF, shapes and medicine packaging ICA n. 028221012-"80 mg/ml suspension endotracheobronchiale instillation" 2 1.5 ml vials, AIC # 028221024-"80 mg/ml suspension endotracheobronchiale instillation" 1 3 ml vial, AIC # 028221036-"80 mg/ml suspension endotracheobronchiale instillation" 1.5 ml vial 1: Elimination of in vivo tests for biological activity and consequent tightening of specification limits of the active substance and the finished product Mah: CHIESI FARMACEUTICI S.P.A. with registered office and tax domicile in Via Palermo, 26/A, 43122 Parma (PR), Italy (tax 01513360345) 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.