Review Product Marketing Authorisation For Human Use «Gemcitabine Actavis».

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

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-01-20&atto.codiceRedazionale=15A00239&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Retrieved V&A 2593/2014 December 9, 2014 # the determines are authorized the following variation: change in the manufacturing process of the finished product. Changing the batch size of the finished product. The change relates to all other pharmaceutical forms manufactured according to complex manufacturing processes. relatively to the drug GEMCITABINE ACTAVIS and authorised pack sizes the placing in Italy following the mutual recognition procedure.
How to: NL/H/1236/001/II/017/G type of variation: b. II. b. 3. z Change in the manufacturing process of the finished product.
B. II. b. 4. d changing the batch size of the finished product. The change relates to all other pharmaceutical forms manufactured according to complex manufacturing processes.
Mah: Actavis Italy S.P.A.
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: 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.