Review Product Marketing Authorisation For Human Use "kelis".

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

Read the untranslated law here:

Retrieved determines V December 2, 2014 2014 of the 2557/& as no Authorization of the change relatively to the medicine KELIS.
Are authorized the following variation: 1. b B) change in the manufacturer of a raw material of a reagent or an intermediate product used in the manufacturing process of the active substance or review of the manufacturer of the active substance (possibly including the sites of quality control), for which you do not have a certificate of conformity to European Pharmacopoeia-introduction of a manufacturer of the active substance that has the support of a ASMF (Master File of the active substance) with respect to the medicine Kelis, shapes and packaging and A.I.C.: A.I.C. n. 038723019-"80 mg powder for oral solution" bipartite 30 sachets: adding the manufacturer of active ingredient ketoprofen lysine salt: Clarochem 15, Damastown, Mulhuddart, Dublin Ireland Limited-Ireland.
A.I.C. owner: Epifarma S.r.l. with registered office and tax domicile in via San Rocco # 6-85033 Episcopia-Potenza (PZ) Italy; (tax ID # 01135800769).
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 causes of the April 14, 2014 # 371 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.