Review Product Marketing Authorisation For Human Use «Adenoscan»

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

Read the untranslated law here:

Retrieved V&A 2589/2014 December 9, 2014 # the determines are authorized the following variation: Review of the manufacturer of the active substance: from: s. 2.1 3.2. Manufacturer of the active substance: Adenosine, holder DMF: Pharma Waldhof GmbH, production site: Roche Diagnostic GmbH, Chemical Operation Mannheim (TW), 116, 68305 Mannheim Sandhofer Strasse (Germany);
in: s. 2.1 3.2. Manufacturer of the active substance: Adenosine, holder DMF: Pharma Waldhof GmbH, intermediate crude production sites: a) adenosine, Yamasa Corporation Choshi, Chiba, 2-10-I Araoicho 288-0056, Japan;
b Vlčinci 16/3 Na Klašterni, a.s.) adenosine Farmak Hradisko, 771 17 Olomouc, Czech Republic;
c) storage, (re) packaging and (re) labelling, Caesar 53227 Bonn GmbH, 46, Roehfeldstrasse & Loretz (Germany); Version November 2011 2014 DMFS: July with updates.
The active ingredient is controlled according to the current edition of the European Pharmacopoeia specifications, relative to medicine ADENOSCAN and authorised pack sizes the placing in Italy following the mutual recognition procedure.
How to: UK/H/0140/001/II/037.
Type of change: the B 1 Review of the manufacturer of a raw material, a reactive 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; b) introduction of a manufacturer of the active substance that has the support of a ASMF (Master File of the active substance).
MAh: Sanofi-Aventis 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.