Renewal Of Marketing Authorisation, The Mutual Recognition Secondoprocedura, Of The Medicinal Product For Human Use "topiramate Eg», Resulting In A Review Printed.

Original Language Title: Rinnovo dell'autorizzazione all'immissione in commercio, secondoprocedura di mutuo riconoscimento, del medicinale per uso umano«Topiramato EG», con conseguente modifica stampati.

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-02-02&atto.codiceRedazionale=15A00582&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Retrieved 5 January 13, 2015 2015 # PV determines the/Medicine: TOPIRAMATE EG.
Packaging: 038314 011 "25 mg film-coated tablets" 10 tablets in al/al;
038314 023 "25 mg film-coated tablets" 28 tablets in al/al;
038314 035 "25 mg film-coated tablets" 50 tablets in al/al;
038314 047 "25 mg film-coated tablets" 60 tablets in al/al;
038314 050 "25 mg film-coated tablets" 100 tablets in al/al;
038314 062 "25 mg film-coated tablets" 200 tablets in al/al;
038314 074 "50 mg film-coated tablets" 10 tablets in al/al;
038314 086 "50 mg film-coated tablets" 28 tablets in al/al;
038314 098 "50 mg film-coated tablets" 50 tablets in al/al;
038314 100 "50 mg film-coated tablets" 60 tablets in al/al;
038314 112 "50 mg film-coated tablets" 100 tablets in al/al;
038314 124 "50 mg film-coated tablets" 200 tablets in al/al;
038314 136 ' 100 mg film-coated tablets "10 tablets in al/al;
038314 148 "100 mg film-coated tablets" 28 tablets in al/al;
038314 151 "100 mg film-coated tablets" 50 tablets in al/al;
038314 163 "100 mg film-coated tablets" 60 tablets in al/al;
038314 175 "100 mg film-coated tablets" 100 tablets in al/al;
038314 187 ' 100 mg film-coated tablets "120 tablets in al/al;
038314 199 "100 mg film-coated tablets" 200 tablets in al/al;
038314 201 "200 mg film-coated tablets" 10 tablets in al/al;
038314 213 "200 mg film-coated tablets" 28 tablets in al/al;
038314 225 "200 mg film-coated tablets" 60 tablets in al/al;
038314 237 "200 mg film-coated tablets" 100 tablets in al/al;
038314 249 "200 mg film-coated tablets" 200 tablets in al/al;
038314 252 "25 mg film-coated tablets" 14 tablets in al/al;
038314 264 "25 mg film-coated tablets" 20 tablets in al/al;
038314 276 "25 mg film-coated tablets" 90 tablets in al/al;
038314 288 "25 mg film-coated tablets" 120 tablets in al/al;
038314 290 "25 mg film-coated tablets" 150 tablets in al/al;
038314 302 "25 mg film-coated tablets" 180 tablets in al/al;
038314 314 "50 mg film-coated tablets" 14 tablets in al/al;
038314 338 "50 mg film-coated tablets" 90 tablets in al/al;
038314 340 "50 mg film-coated tablets" 120 tablets in al/al;
038314 353 "50 mg film-coated tablets" 150 tablets in al/al;
038314 365 "50 mg film-coated tablets" 180 tablets in al/al;
038314 377 "100 mg film-coated tablets" 90 tablets in al/al;
038314 391 "100 mg film-coated tablets" 150 tablets in al/al;
038314 403 "100 mg film-coated tablets" 180 tablets in al/al;
038314 415 "200 mg film-coated tablets" 90 tablets in al/al;
038314 427 "200 mg film-coated tablets" 120 tablets in al/al;
038314 439 "200 mg film-coated tablets" 150 tablets in al/al;
038314 441 "200 mg film-coated tablets" 180 tablets in al/al;
MAh: EG S.p.a.
Mutual recognition procedure 001-004/0889/DE/H/R/001.
Ending on September 30, 2012 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.
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.