Renewal Of The Marketing Authorisation For The Medicinal Product For Human Use, National Secondoprocedura, «Erythromycin Ides» Resulting Review Boards.
Original Language Title: Rinnovo dell'autorizzazione all'immissione in commercio, secondoprocedura nazionale, del medicinale per uso umano «Eritromicina Idi»con conseguente modifica stampati.
Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-03-04&atto.codiceRedazionale=15A01486&elenco30giorni=false&atto.tipoProvvedimento=DECRETO
Retrieved February 11, 2015 2015 # 38/PV of determines the marketing authorisation of the medicinal product: ERYTHROMYCIN IDES.
Packaging: 029171 055-3% cream-tube 30 g;
029171 042-3% skin solution-40 ml bottle;
029171 016-3% gel-tube of 30 g.
MAh: Ethicon S.r.l.
Expiring on April 3, 2010 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 and the package leaflet and labelling within 180 days after the entry into force 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.
The packs already produced that does not bear the changes indicated by this determination can be dispensed to the public through the expiration date printed on the label.
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.
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