Review Product Marketing Authorisation For Human Use «Zestril».

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

Read the untranslated law here:

Retrieved February 25, 2015 V&A # 374/2015 of authorization determines variation in relation to medicine ZESTRIL.
Are authorized the following variation: harmonisation of quality form the dossier following Referral under article. 30 with regard to the medicinal product and authorisation authorised pack sizes in Italy following the mutual recognition procedure.
How to: SE/004 002-0527/H//II/054.
Type of change: B 1 b).
A.I.C. holder: Astrazeneca 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 subparagraph 5 of Determines AIFA n. 371 of 14/04/2014 published in the Official Journal 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.