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

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

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-03-19&atto.codiceRedazionale=15A01892&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Retrieved February 18, 2015 2015 of # 51/PV determines Medicine: MONTELUKAST TEVA Italy.
Packaging: 040672 014 «7» 4 mg chewable tablets in AL/AL;
«14» 040672 026 4 mg chewable tablets in AL/AL;
040672 038 «4 mg chewable» 15 tablets in AL/AL;
«4» 040672 040 20 mg chewable tablets in AL/AL;
040672 053 «4 mg chewable» 28 tablets in AL/AL;
«040672 065 4 mg chewable» 30 tablets in AL/AL;
040672 077 «4 mg chewable» 50 tablets in AL/AL;
040672 089 «4 mg chewable» 56 tablets in AL/AL;
040672 091 «4 mg chewable» 60 tablets in AL/AL;
040672 103 «4 mg chewable» 90 tablets in AL/AL;
040672 115 «4 mg chewable» 98 tablets in AL/AL;
040672 127 «4 mg chewable» 100 tablets in AL/AL;
«040672 139 5 mg chewable» 7 tablets in AL/AL;
040672 141 «5 mg chewable» 14 tablets in AL/AL;
040672 154 «» 15 5 mg chewable tablets in AL/AL;
«040672 166 5 mg chewable» 20 tablets in AL/AL;
040672 178 «5 mg chewable» 28 tablets in AL/AL;
«040672 180 5 mg chewable» 30 tablets in AL/AL;
040672 192 «5 mg chewable» 50 tablets in AL/AL;
040672 204 ' 56 ' 5 mg chewable tablets in AL/AL;
040672 216 «5 mg chewable» 60 tablets in AL/AL;
040672 228 «5 mg chewable» 90 tablets in AL/AL;
040672 230 «» 98 5 mg chewable tablets in AL/AL;
040672 242 «5 mg chewable» 100 tablets in AL/AL;
«040672 255 4 mg chewable» 7 tablets in AL/AL calendar Pack;
14 040672 267 «» 4 mg chewable tablets in AL/AL calendar Pack;
040672 279 «4 mg chewable» 28 tablets in AL/AL calendar Pack;
040672 281 «4 mg chewable» 56 tablets in AL/AL calendar Pack;
040672 293 «4 mg chewable» 98 tablets in AL/AL calendar Pack;
040672 305 «5 mg chewable» 7 tablets in AL/AL calendar Pack;
040672 317 «5 mg chewable» 14 tablets in AL/AL calendar Pack;
040672 329 «5 mg chewable» 28 tablets in AL/AL calendar Pack;
040672 331 «5 mg chewable» 56 tablets in AL/AL calendar Pack;
040672 343 «5 mg chewable» 98 tablets in AL/AL calendar Pack.
A.I.C. holder: Teva Italy S.r.l.
How to: 1331/001 DK/H/mutual recognition-002/R/001 date of 9/24/2013 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.
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 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 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 A.I.C. holder 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.