Renewal Of The Marketing Authorisation For The Medicinal Product For Human Use Mutual Recognition Secondoprocedura «Acarphage», Resulting In A Review Printed.

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

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-01-27&atto.codiceRedazionale=15A00410&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Retrieved determines the December 10, 2014 ACARPHAGE # PV 398/2014 038835 017 50 MG medication: pack size: 20 "" compressed tablets in 50 MG AL/AL 038835 029 "tablets" 21 tablets in 50 MG AL/AL 038835 031 "tablets" 30 tablets in 50 MG AL/AL 038835 043 "tablets" 40 tablets in 50 MG AL/AL 038835 056 "tablets" 50 tablets in 50 MG AL/AL 038835 068 "tablets" 90 tablets in AL/AL 038835 070 "50 MG tablets" 100 tablets in 50 MG AL/AL 038835 082 "tablets" 105 tablets in 50 MG AL/AL 038835 094 "tablets" 120 tablets in AL/AL 038835 106 "50 MG tablets" 180 tablets in AL/AL 038835 118 "100 MG tablets" 20 tablets in AL/AL 038835 120 "100 MG tablets" 21 tablets in AL/AL 038835 132 "100 MG tablets" 30 tablets in AL/AL 038835 144 "100 MG tablets "40 tablets in AL/AL 038835 157" 100 MG tablets "50 tablets in AL/AL 038835 169" 100 MG tablets "90 tablets in AL/AL 038835 171" 100 MG tablets "100 tablets in AL/AL 038835 183" 100 MG tablets "105 tablets in AL/AL 038835 195" 100 MG tablets "120 tablets in AL/AL 038835 207" 100 MG tablets "180 tablets in AL/AL Mah : MERCK SERONO S.P.A.
Mutual recognition procedure 0869/001-002/DE/H/R/001 date of 31/05/2012 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.
It also approved the variation DE/H/0869/001-002/IB/012-C1B/2013/2821 concerning the update of the summary of product characteristics and package leaflet.
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 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.
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 mAh 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.