Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-04-20&atto.codiceRedazionale=15A02804&elenco30giorni=false&atto.tipoProvvedimento=DECRETO
Retrieved 1 April V&A determines the 2015 # 603 authorization of change: C.I. z) several changes with respect to the medicine MEDIPO.
Authorized updating of the summary of product characteristics 4.4, 4.5 and 5.2 sections and corresponding paragraphs of leaflet in relation to medicine «Medipo», in the forms and packages listed below: A.I.C. # 028370017-' 10 mg film-coated tablets» 20 tablets;
A.I.C. # 028370029-«20 mg film-coated tablets» 10 tablets;
A.I.C. # 028370043-' 40 mg film-coated tablets» 10 tablets;
A.I.C. # 028370106-«20 mg film-coated tablets» 28 tablets;
A.I.C. # 028370118-' 40 mg film-coated tablets» 28 tablets.
Handouts are fixed and approved shall be annexed to the assessment, referred to in this excerpt.
A.I.C. holder: Mediolanum Farmaceutici S.p.a. (tax ID # 01689550158), registered office and tax domicile in via San g. Cottolengo # 15-20143 Milano (Italy).
Printed 1. The marketing authorisation holder should make the changes, after the date of entry into force of this determination, 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 subsequent modifications and integrations, leaflet and labels must be written in Italian and, limited to medicinal products marketed in the province of Bolzano, in German. The holder of the A.I.C. 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.
Date of determination: from the day following that of its publication, to decompress, in Gazzetta Ufficiale della Repubblica italiana.
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