Review Of The Marketing Authorisation For The Medicinal Product For Human Use, National Secondoprocedura, «Ebetametasone», Resulting In Generic Gentamicin Doc Review Boards.

Original Language Title: Modifica dell'autorizzazione all'immissione in commercio, secondoprocedura nazionale, del medicinale per uso umano «Gentamicina eBetametasone Doc Generici», con conseguente modifica stampati.

Read the untranslated law here:

Retrieved determines the 400/2014 December 10, 2014 The PV no authorisation for the medicinal product: GENTAMICIN SULFATE and BETAMETHASONE DOC GENERICI.
Packaging: 037891 013-0.1% + 0.1% cream-30 g tube.
A.I.C. holder: DOC Generici S.r.l.
National Procedure.
With the December 8, 2014 deadline 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 product characteristics while the package leaflet and labelling within 180 days after the date of publication 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 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 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.