Review Product Marketing Authorisation For Human Use "topamax".

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

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-01-05&atto.codiceRedazionale=14A10041&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Retrieved December 16, 2014 # 2612 V determines the Authorization of & variation: C.I. 4) one or more amendments to the summary of product characteristics, labelling and package leaflet after new data on quality, preclinical, clinical or pharmacovigilance medicine TOPAMAX.
Procedure number: 001-004/0110/SE/H .007-009/II/067.
Authorized updating of the summary of product characteristics, package leaflet, in relation to the drug TOPAMAX, shapes and packagings listed below: 032023020-«50 mg film-coated tablets» 60 tablets;
032023032-«100 mg film-coated tablets» 60 tablets;
032023044-' 200 mg film-coated tablets» 60 tablets;
032023071-' 25 mg film-coated tablets» 60 tablets;
032023083-«15 mg capsule» 60 capsules;
032023095-' 25 mg capsule» 60 capsules;
032023119-' 25 mg film-coated tablets» 20 tablets in plastic container;
032023121-' 25 mg film-coated tablets» 28 tablets in plastic container;
032023133-' 25 mg film-coated tablets» 30 tablets in plastic container;
032023145-' 25 mg film-coated tablets» 50 tablets in plastic container;
032023158-' 25 mg film-coated tablets» 56 tablets in plastic container;
032023160-' 25 mg film-coated tablets» 100 tablets in plastic container;
032023172-' 50 mg film-coated tablets» 20 tablets in plastic container;
032023184-' 50 mg film-coated tablets» 28 tablets in plastic container;
032023196-' 50 mg film-coated tablets» 30 tablets in plastic container;
032023208-' 50 mg film-coated tablets» 50 tablets in plastic container;
032023210-' 50 mg film-coated tablets» 56 tablets in plastic container;
032023222-' 50 mg film-coated tablets» 100 tablets in plastic container;
032023234-«100 mg film-coated tablets» 20 tablets in plastic container;
032023246-«100 mg film-coated tablets» 28 tablets in plastic container;
032023259-«100 mg film-coated tablets» 30 tablets in plastic container;
032023261-«100 mg film-coated tablets» 50 tablets in plastic container;
032023273-«100 mg film-coated tablets» 56 tablets in plastic container;
032023285-«100 mg film-coated tablets» 100 tablets in plastic container;
032023297-' 200 mg film-coated tablets» 20 tablets in plastic container;
032023309-' 200 mg film-coated tablets» 28 tablets in plastic container;
032023311-' 200 mg film-coated tablets» 30 tablets in plastic container;
032023323-' 200 mg film-coated tablets» 50 tablets in plastic container;
032023335-' 200 mg film-coated tablets» 56 tablets in plastic container;
032023347-' 200 mg film-coated tablets» 100 tablets in plastic container;
032023350-' 25 mg film-coated tablets» 10 tablets in Al/Al;
032023362-' 25 mg film-coated tablets» 20 tablets in Al/Al;
032023374-' 25 mg film-coated tablets» 28 tablets in Al/Al;
032023386-' 25 mg film-coated tablets» 30 tablets in Al/Al;
032023398-' 25 mg film-coated tablets» 50 tablets in Al/Al;
032023400-' 25 mg film-coated tablets» 56 tablets in Al/Al;
032023412-' 25 mg film-coated tablets» 100 tablets in Al/Al;
032023424-' 50 mg film-coated tablets» 10 tablets in Al/Al;
032023436-' 50 mg film-coated tablets» 20 tablets in Al/Al;
032023448-' 50 mg film-coated tablets» 30 tablets in Al/Al;
032023451-' 50 mg film-coated tablets» 50 tablets in Al/Al;
032023463-' 50 mg film-coated tablets» 56 tablets in Al/Al;
032023475-' 50 mg film-coated tablets» 100 tablets in Al/Al;
032023487-' 50 mg film-coated tablets» 28 tablets in Al/Al;
032023499-«100 mg film-coated tablets» 10 tablets in Al/Al;
032023501-«100 mg film-coated tablets» 20 tablets in Al/Al;
032023513-«100 mg film-coated tablets» 28 tablets in Al/Al;
032023525-«100 mg film-coated tablets» 30 tablets in Al/Al;
032023537-«100 mg film-coated tablets» 50 tablets in Al/Al;
032023549-«100 mg film-coated tablets» 56 tablets in Al/Al;
032023552-«100 mg film-coated tablets» 100 tablets in Al/Al;
032023564-' 200 mg film-coated tablets» 10 tablets in Al/Al;
032023576-' 200 mg film-coated tablets» 20 tablets in Al/Al;
032023588-' 200 mg film-coated tablets» 28 tablets in Al/Al;
032023590-' 200 mg film-coated tablets» 30 tablets in Al/Al;
032023602-' 200 mg film-coated tablets» 50 tablets in Al/Al;
032023614-' 200 mg film-coated tablets» 56 tablets in Al/Al;
032023626-' 200 mg film-coated tablets» 100 tablets in Al/Al;
032023638-«15 mg capsule» 20 capsules in Hdpe container;
032023640-«15 mg capsule» 28 capsules in Hdpe container;
032023653-«15 mg capsule» 100 capsules in Hdpe container;
032023665-' 25 mg capsule» 20 capsules in Hdpe container;
032023677-' 25 mg capsule» 28 capsules in Hdpe container;
032023689-' 25 mg capsule» 100 capsules in Hdpe container;
032023691-' 50 mg hard capsules» 20 capsules in Hdpe container;
032023703-' 50 mg hard capsules» 28 capsules in Hdpe container;
032023715-' 50 mg hard capsules» 100 capsules in Hdpe container;
032023727-' 25 mg film-coated tablets» 200 tablets in plastic container;
032023739-' 50 mg film-coated tablets» 200 tablets in plastic container;
032023741-«100 mg film-coated tablets» 200 tablets in plastic container;
032023754-' 200 mg film-coated tablets» 200 tablets in plastic container;
032023766-' 25 mg film-coated tablets» 200 tablets in Al/Al;
032023778-' 50 mg film-coated tablets» 200 tablets in Al/Al;
032023780-«100 mg film-coated tablets» 200 tablets in Al/Al;
032023792-' 200 mg film-coated tablets» 200 tablets in Al/Al;

032023804-' 25 mg film-coated tablets» 60 tablets in Al/Al;
032023816-' 50 mg film-coated tablets» 60 tablets in Al/Al;
032023828-«100 mg film-coated tablets» 60 tablets in Al/Al;
032023830-' 200 mg film-coated tablets» 60 tablets in Al/Al.
Handouts are fixed and approved shall be annexed to the assessment, referred to in this excerpt.
A.I.C. holder: Janssen Cilag S.p.A., with registered office and tax domicile in Cologno Monzese (Milan), via Michelangelo Buonarroti, 20093 (Italy), 23-Chapter tax code 00962280590.
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 April 24, 2006. 219 and subsequent amendments and additions, the 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. Pharmacists are required to deliver the package leaflet updated users, from period of thirty days from the date of publication in the Official Gazette of the Italian Republic of this determination. The A.I.C. holder makes it 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.