Retrieved February 24, 2015 V&A # 362/2015 of authorization determines variation in relation to medicine FLUCONAZOLE b. BRAUN is authorized the following variation: ASMF update (QS1-Ed2 version; February 2014) PA Vendor Quimica Synthetic s.a., C/Dulcinea s/n, E-28805 Alcala de Henares, Madrid Spain, concerning the active substance Fluconazole. Consequently, even updated its section 3.2. S concerning the medicinal product and authorisation authorised pack sizes in Italy following the mutual recognition procedure.
Procedures: DE/H/1055/001/II/005 type of variation: B.I. to z) Mah: b. BRAUN MELSUNGEN AG stock 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 subparagraph 5 of Determines AIFA n. 371 of 14/04/2014 published in the Official Gazette No. 101 of 03/05/2014.
Date of determination: this determination is effective on the day following that of its publication, to decompress, in Gazzetta Ufficiale della Repubblica italiana and company will be notified to the holder of the marketing authorisation for the medicinal product.