Review Product Marketing Authorisation For Human Use "lipitor".

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

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-04-27&atto.codiceRedazionale=15A02998&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Retrieved April 7, 2015 V&A # 694/2015 of authorization determines variation: C.I. 4) concerning medicine LIPITOR (3882/01-08/DE/H/WS/005) procedure number: DE/H/XXXX/WS/087 amendment of the summary of product characteristics and package leaflet according to the Core Data Sheet (CDS) to atorvastatin.
Adaptation of texts to new QRD Template.
In form and packs listed below: 033008018-033008020-10 10 Mg Tablets "10" "10" 10 Mg Tablets 30 20 10 20 Mg Tablets 033008032-"033008044"-"033008057-20 Mg Tablets 30" 20 "40 10 40 Mg Tablets 033008069"-"40" 40 Mg Tablets 30 033008071-"10 Mg Film-coated tablets" 90 tablets In Hdpe 033008083-"20 Mg Film-coated tablets" 90 tablets In Hdpe 033008095-"40 Mg Film-coated tablets" 90 tablets In Hdpe 033008246-"80 Mg Film-coated tablets "4 tablets In Pa/Al/Pvc-Al/vinyl 033008259-" 80 Mg Film-coated tablets "7 tablets In Pa/Al/Pvc-Al/vinyl 033008261-" 80 Mg Film-coated tablets "10 tablets In Pa/Al/Pvc-Al/vinyl 033008273-" 80 Mg Film-coated tablets "14 tablets In Pa/Al/Pvc-Al/vinyl 033008285-" 80 Mg Film-coated tablets "20 tablets In Pa/Al/Pvc-Al/vinyl 033008297-" 80 Mg Film-coated tablets "28 Tablets In Pa/Al/Pvc-Al/vinyl 033008309-"80 Mg Film-coated tablets" 30 tablets In Pa/Al/Pvc-Al/vinyl 033008311-"80 Mg Film-coated tablets" 50 tablets In Pa/Al/Pvc-Al/vinyl 033008323-"80 Mg Film-coated tablets" 56 tablets In Pa/Al/Pvc-Al/vinyl 033008335-"80 Mg Film-coated tablets" 84 tablets In Pa/Al/Pvc-Al/vinyl 033008347-"80 Mg Film-coated tablets" 98 tablets In Pa/Al/ PVC-Al/vinyl 033008350-"80 Mg Film-coated tablets" 100 tablets In Pa/Al/Pvc-Al/vinyl 033008362-"80 Mg Film-coated tablets" 200 (10x20) tablets In Pa/Al/Pvc-Al/vinyl 033008374-"80 Mg Film-coated tablets" 500 tablets In Pa/Al/Pvc-Al/vinyl 033008386-"80 Mg Film-coated tablets" 90 tablets In Hdpe 033008398-"30" 5 Mg chewable tablets In Pa/Al/Pvc-Al 033008400-"10 Mg chewable tablets 30 Tablets" Blister Pa/Al/Pvc-Al 033008412-"20 Mg chewable tablets 30 tablets In" Pa/Al/Pvc-Al 033008424-"30" 40 Mg chewable tablets In Pa/Al/Pvc-Al handouts corrected and approved are attached to this determination.
MAh: PFIZER LIMITED (SIS 1533) printed 1. The marketing authorisation holder should make the changes, after the date of entry into force of this Determination to the summary of product characteristics; no later than six months from the same date the package leaflet and labelling.
2. 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 aforementioned legislative decree.
Generic drug patent protection the mAh is responsible of full respect for the rights of industrial property relative to the reference product and the patent regulations provisions in force.
The mAh of the generic drug and is also responsible for full compliance with the provisions of art. 14, paragraph 2, of Legislative Decree No 219 April 24, 2006 and s, in virtue of which are not included in the printed those parts of the summary of product characteristics of the reference medicinal product referring to indications or dosages still covered by a patent at the time of placing on the market of generic medicine.
Inventory disposal Both lots already products on the date of entry into force of this determination that the batches produced during the period referred to in article 2, paragraph 1, of the present, not bearing approved changes 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.
Date of determination: from the day following that of its publication, to decompress, in Gazzetta Ufficiale della Repubblica italiana.