Review Of The Marketing Authorisation, The Mutual Recognition Secondoprocedura, Of The Medicinal Product For Human Use «Fentalgon», Resulting In A Review Printed.
Original Language Title: Modifica dell'autorizzazione all'immissione in commercio, secondoprocedura di mutuo riconoscimento, del medicinale per uso umano«Fentalgon», con conseguente modifica stampati.
Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-01-12&atto.codiceRedazionale=15A00090&elenco30giorni=false&atto.tipoProvvedimento=DECRETO
Retrieved determines the December 16, 2014 FENTALGON # PV 402/2014: Medicine.
Packaging: 039359 017-"25 mcg/h transdermal patches» patches in sachet 3 PET/AL/PP;
039359 029-«50 mcg/h transdermal patches» patches in sachet 3 PET/AL/PP;
039359 031-' 75 mcg/h transdermal patches» patches in sachet 3 PET/AL/PP;
039359 043-«100 mcg/h transdermal patches» patches in sachet 3 PET/AL/PP.
A.I.C. Holder: ITALFARMACO S.P.A.
Mutual recognition procedure IT/H/0345/001-004/R/001.
Expiring on February 10, 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 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.
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