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Review Product Marketing Authorisation For Human Use «Unifol».

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

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Retrieved January 14, 2015 V&A # 24/2015 of Procedure determines EU N°: NL/H/1268/001/II/004 type II variation: b. II. b). 3. b) are authorized the following variation: addition of new production line (PFE line 2).
With respect to medicinal product: UNIFOL and authorised pack sizes the placing in Italy following the mutual recognition procedure.
MAh: Claris Lifesciences (UK) Limited 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 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.