Review Product Marketing Authorisation For Human Use "fleet Enema".

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

Read the untranslated law here:

Retrieved February 10, 2015 V&A # 225/2015 the determines are authorized the following variation: b. II. d. 1. and Review specification parameters and/or limits of the finished product Review outside the bounds of the approved specification, relative to medicine BARIUM FLEET, shapes and wrappings A.I.C. # 029319011-«ready to use» 133 ml bottle; A.I.C. n. 029319023-«ready to use» 133 ml bottles 4: enlargement of the specification limits, as follows: ' specific gravity at 25° C» release: from 1,121-1,128 g/ml at 1,118-1,130 g/ml; the shlef-life: from 1,121 1,116-1,132 1,128-g/ml in g/ml.
A.I.C. holder: Laboratorios Casen Fleet S.L.U. with registered office and tax domicile Autovia de Logrono km 13.300, 50180 Utebo (Zaragoza)-Spain-(Spain).
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 April 14, 2014 # 371 Determines 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.