Secondoprocedura Renewal Of Marketing Authorisation For The Medicinal Product For Human Use Mutual Recognition, "esomeprazole Sun», Resulting In A Review Printed.
Original Language Title: Rinnovo dell'autorizzazione all'immissione in commercio, secondoprocedura di mutuo riconoscimento, del medicinale per uso umano«Esomeprazolo Sun», con conseguente modifica stampati.
Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-03-31&atto.codiceRedazionale=15A02333&elenco30giorni=false&atto.tipoProvvedimento=DECRETO
Retrieved February 26, 2015 58/2015 # PV of Medicine determines: ESOMEPRAZOLE SUN.
Packaging: A.I.C. # 040438 018 «40 mg powder for solution for injection/infusion 5 ml vial for 1 ";
A.I.C. # 040438 020 «40 mg powder for solution for injection/infusion 5 ml vials to 10 ".
A.I.C. Holder: Sun Pharmaceutical Industries (Europe) B.V.
Mutual recognition procedure NL/H/2156/001/R/001, maturing on November 19, 2014 it 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 subsequent amendments and supplements 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 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 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 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.
Search Translated Laws of Italy