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

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

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-02-02&atto.codiceRedazionale=15A00585&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Retrieved January 13, 2015 9/2015 # PV of Medicine determines: 1 250 micrograms/packaging: 039465 012 "IPRAXA ml nebuliser solution" 20 vials 1 500 micrograms/ml LDPE 039465 024 "from 2 ml nebuliser solution" 20 vials 2 ml 250 micrograms/LDPE 039465 036 "from 1 ml nebuliser solution 1 ml 5 vials" LDPE from 1 ml 250 micrograms/039465 048 "nebuliser solution 1 ml 10 ampoules" LDPE 039465 051 1 250 micrograms/"from ml solution for 1 ml 15 vials "LDPE nebulizer from 1 250 micrograms/ml solution 039465 063" nebulizer "25 vials 1 250 micrograms/ml LDPE 039465 075 1" from ml nebuliser solution 1 ml LDPE ampoules from 039465 087 30 "" 250 micrograms/1 ml nebuliser solution 1 ml 40 "039465 099" LDPE ampoules from 1 250 micrograms/ml nebuliser solution 1 ml 50 ampoules "039465 101" LDPE from 1 250 micrograms/ml nebuliser solution "60 vials LDPE from 2 500 micrograms/ml 1 ml 039465 113 "solution for nebulizer 2 ml 5 vials" LDPE "500 micrograms/2 from 039465 125 ml nebuliser solution 2 ml vials 10" LDPE "500 micrograms/2 from 039465 137 ml nebuliser solution 2 ml 15 vials" LDPE from 500 micrograms/2 "039465 149 ml nebuliser solution 2 ml LDPE ampoules from 039465 152 25" "2 500 micrograms/ml nebuliser solution 2 ml LDPE ampoules from 039465 164 30" " 2 500 micrograms/ml nebuliser solution 2 ml LDPE ampoules from 039465 176 40 "" 2 500 micrograms/ml nebuliser solution 2 ml 50 ampoules "LDPE" 500 micrograms/2 from 039465 188 ml nebuliser solution 2 ml LDPE ampoules from 60 "Mah: TEVA ITALIA S.R.L. Mutual recognition procedure NL/H/001-001/002/R/1138 date May 31, 2013 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 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 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 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.