Review Product Marketing Authorisation For Human Use «Clodeosten».

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

Read the untranslated law here:

Retrieved January 16, 2015 V&A # 292/2015 the determines 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 supporting a ASMF (Master File of the active substance), relative to medicine CLODEOSTEN, shapes and wrappings AIC # 035109014-"3.3 100 mg/ml solution for injection" 6 vials 100 mg: introduction of FARCHEMIA SRL as new producer for the active substance DISODIUM CLODRONATE, as follows: part of measure in graphic form the active ingredient is controlled according to the specifications of the European Pharmacopoeia current edition. Retest period: 4 years.
Mah: S.F. GROUP S.R.L. with registered office and tax domicile in Via Beniamino Segre, 59, 00134-Rome (RM) Italy, (tax 07599831000) 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.