Review Product Marketing Authorisation For Human Use "fluodeossiglucosio [18 F] Iba."

Original Language Title: Modifica dell'autorizzazione all'immissione in commercio delmedicinale per uso umano «Fluodeossiglucosio [18 F] IBA».

Read the untranslated law here:

Retrieved 15 January 14, 2015 V&A determines the variation # Authorization: 1. g. B.I.b.
With respect to medicinal product: FLUODEOSSIGLUCOSIO [18 F] IBA.
European procedure: FR/HR/0229/001/II/040.
A.I.C. Holder: CHARLAX Pharma S.A.
Is amended as follows: authorisation of the use of water enriched in O-18 for the production of the active substance Fludeoxyglucose (18F) with a low level of enrichment than is currently used (by 95% to greater than greater than or equal to 87%).
With regard to marketing authorisations authorised pack sizes in Italy following the mutual recognition procedure.
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.