Renewal Of Marketing Authorisation, The Mutual Recognition Secondoprocedura, Of The Medicinal Product For Human Use "topiramate Zentiva», 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 Zentiva», 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=15A00584&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Retrieved January 13, 2015 8/2015 # PV of Medicine determines: TOPIRAMATE ZENTIVA packaging: 038475 012 "25 mg film-coated tablets" 14 tablets in AL/AL 038475 024 "25 mg film-coated tablets" 20 tablets in AL/AL 038475 036 "25 mg film-coated tablets" 28 tablets in AL/AL 038475 048 "25 mg film-coated tablets" 50 tablets in AL/AL 038475 051 "25 mg film-coated tablets 60 tablets" AL/AL blister 038475 063 "25 mg film-coated tablets" 100 tablets in AL/AL 038475 075 "25 mg film-coated tablets 200 tablets in" AL/AL 038475 087 "25 mg film-coated tablets" 14 tablets in HDPE 038475 099 "25 mg film-coated tablets" 60 tablets in HDPE 038475 101 "25 mg film-coated tablets 200 tablets" in HDPE 038475 113 "50 mg film-coated tablets" 14 tablets AL/AL blister 038475 125 "50 mg film-coated tablets" 20 tablets in AL/AL 038475 137 "50 mg film-coated tablets" 28 tablets in AL/AL 038475 149 "50 mg film-coated tablets" 50 tablets in AL/AL 038475 152 "50 mg film-coated tablets" 60 tablets in AL/AL 038475 164 "50 mg film-coated tablets" 100 tablets in AL/AL 038475 176 "50 mg film-coated tablets with the movie "200 tablets in AL/AL 038475 188" 50 mg film-coated tablets "14 tablets in HDPE 038475 190" 50 mg film-coated tablets "60 tablets in HDPE 038475 202" 50 mg film-coated tablets 200 tablets "in HDPE 038475 214" 100 mg film-coated tablets "14 tablets in AL/AL 038475 226" 100 mg film-coated tablets "20 tablets in AL/AL 038475 238" 100 mg tablets 28 "film-coated tablets in AL/AL 038475 240" 100 mg film-coated tablets "50 tablets in AL/AL 038475 253" 100 mg film-coated tablets "60 tablets in AL/AL 038475 265" 100 mg film-coated tablets "100 tablets in AL/AL 038475 277" 100 mg film-coated tablets 200 tablets in "AL/AL 038475 289" 100 mg film-coated tablets "14 tablets in HDPE 038475 291" 100 mg film-coated tablets "60 tablets in HDPE 038475 303" 100 mg film-coated tablets 200 tablets "in HDPE 038475 315" 200 mg film-coated tablets "14 tablets in AL/AL 038475 327" 200 mg film-coated tablets "20 tablets in AL/AL 038475 339" 200 mg film-coated tablets "28 tablets in AL/AL 038475 341" 200 mg film-coated tablets "50 tablets in AL/AL
038475 354 "200 mg film-coated tablets" 60 tablets in AL/AL 038475 366 "200 mg film-coated tablets" 100 tablets in AL/AL 038475 378 "200 mg film-coated tablets 200 tablets in" AL/AL 038475 380 "200 mg film-coated tablets" 14 tablets in HDPE 038475 392 "200 mg film-coated tablets" 60 tablets in HDPE 038475 404 "200 mg film-coated tablets 200 tablets in a bottle" HDPE Mah: ZENTIVA ITALIA S.R.L. Mutual recognition procedure DE/H/004/001-001/R/1031 expiring on February 12, 2013 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 DE/H/1031/001-004/IB/015-C1B/2012/1016, updating of the summary of product characteristics.
It also approved the variation DE/H/1031/001-004/IB/016-C1B/2013/337, updating of the summary of product characteristics and package 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 art. 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.