Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-05-05&atto.codiceRedazionale=15A03264&elenco30giorni=false&atto.tipoProvvedimento=DECRETO
Retrieved April 14, 2015 V&A # 723 of authorization determines variation: C.I. 4) one or more amendments to the summary of product characteristics, labelling and package leaflet after new data on quality, pharmacovigilance, preclinical, clinical or relatively to medicines, ZETIA, ABSORCOL, EMETIB EZETROL;
Number of steps: no DE/H/xxxx/WS/058 authorized updating of the summary of product characteristics to sections 4.2, 4.4, 4.8, 5.1 and 5.2, EZETROL, ZETIA, EMETIB, on medicinal products ABSORCOL in form and authorised pack sizes;
The authorization of the European procedure DE/H/xxxx/WS/058 EZETROL, ZETIA, EMETIB, medicinal products ABSORCOL has complied with all the measures included in the agreed paediatric investigation plan. For the purposes of article 8 and 28 (3) of the paediatric regulation, the results obtained from the study PO5522 pediatric studies were conducted in accordance to the PIP (P/0061/2012). The conformity to the PIP was confirmed by (EMA/C/PIP01/07/M02/000007 on January 11, 2013).
Handouts are fixed and approved shall be annexed to the assessment, referred to in this excerpt.
MA holders: MERCK SHARP & DOHME LIMITED with registered office and address in HERTFORD ROAD-HODDESDON-HERTFORDSHIRE, EN11 9BU, UK NEOPHARMED GENTILI S.R.L., with registered office and tax domicile in MILANO (MI), Via San Giuseppe Cottolengo, 15, CAP 20143, Italy, Codice Fiscale 06647900965 ADDENDA PHARMA S.R.L., with registered office and tax domicile in Rome (RM), VIALE SHAKESPEARE 00144, Italy, 47, CAP, tax code 05643891004 1 Handouts. 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.
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 art. 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.
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