Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-01-21&atto.codiceRedazionale=15A00340&elenco30giorni=false&atto.tipoProvvedimento=DECRETO
Retrieved V&A 2588/2014 December 9, 2014 # the determines are authorized the following variation: introduction of the Risk Management Plan, in relation to the drug LATANOPROST and TIMOLOL ZENTIVA and authorised pack sizes the placing in Italy following the mutual recognition procedure.
How to: IE/H/0234/002/II/003.
Types of variation: C.I. 11. b) Changes relating to the safety, efficacy and pharmacovigilance. Medicinal products for human and veterinary use. Introduction of obligations and conditions relating to a marketing authorisation, or modifications thereto.
MAh: Zentiva Italy S.r.l.
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, comma 5 della determines AIFA n. 371 of 14/04/2014 published in the 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.
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