Renewal Of The Marketing Authorisation For The Medicinal Product For Human Use Decentralized Secondoprocedura «Pressloval», Fill Review Boards.

Original Language Title: Rinnovo dell'autorizzazione all'immissione in commercio secondoprocedura decentrata del medicinale per uso umano «Pressloval», conconseguente modifica stampati.

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-01-27&atto.codiceRedazionale=15A00407&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Retrieved determines the December 16, 2014 PRESSLOVAL # PV 408/2014:041168016 40 "Medicine packs mg film-coated tablets in PVC/PVDC/aluminium Blister" 041168028 "40 mg film-coated tablets in PVC/PVDC/aluminium Blister" 041168030 "40 mg film-coated tablets in PVC/PVDC/aluminium Blister" 041168042 "40 mg film-coated tablets in PVC/PVDC/aluminium Blister" 041168055 "80 mg film-coated tablets in PVC/PVDC/aluminium Blister" 041168067 "80 mg film-coated tablets" PVC/PVDC/aluminum 041168079 "80 mg film-coated tablets in PVC/PVDC/aluminium Blister" 041168081 "80 mg film-coated tablets in PVC/PVDC/aluminium Blister" 041168093 "160 mg film-coated tablets in PVC/PVDC/aluminium Blister" 041168105 "160 mg film-coated tablets in PVC/PVDC/aluminium Blister" 041168117 "160 mg film-coated tablets in PVC/PVDC/aluminium Blister" 041168129 "160 mg film-coated tablets in PVC/PVDC/aluminium Blister" Mah : SO.SE. PHARM S.R.L.
Decentralized procedure IT/H/001-001/003/R/0326 expiring on 31/12/2014 is renewed, with unlimited validity, the marketing authorisation subject to amendment of the summary of product characteristics, package leaflet and labelling and on condition that, on the date of entry into force of this determination, the requirements of quality, safety and efficacy are still present.
It also approved the variation C1B/2014/2727 updating of the summary of product characteristics/leaflet.
Changes must be made immediately to the summary of the product characteristics as per the package leaflet and labelling no later than six months after its publication in the Official Gazette of the Italian Republic of this determination.
In accordance with art. 80, paragraphs 1 and 3, of Legislative Decree No 219 April 24, 2006 and s leaflet and labels must be written in Italian and, limited to medicinal products marketed in the province of Bolzano, in German. The mAh avails itself of the complementary use of foreign languages, must give prior notice to the AIFA and keep available the certified translation of German texts and/or in another foreign language. In case of non-compliance with the provisions on the labelling and package leaflet shall apply sanctions under art. 82 of the Decree.
Both lots already products as of the date of publication in the official journal of the Italian Republic of this determination that the batches produced during the period referred to in article 2, paragraph 2, of the aforementioned determination, which did not indicate the changes authorized, can be kept on the market until the expiration date printed on the label of the medicine. Pharmacists are required to deliver the package leaflet updated users as from the end of 30 days from the date of publication in the Official Gazette of the Italian Republic of this determination. The mAh makes accessible to pharmacist leaflet updated within the same timeframe.
This determination takes effect from the day following that of its publication in the official journal of the Italian Republic and will be notified to the company holder of the marketing authorisation of the medicinal product.