Renewal Of Marketing Authorisation, The Mutual Recognition Secondoprocedura, Of The Medicinal Product For Human Use "mirtazapina Doc Generici», Resulting In A Review Printed.

Original Language Title: Rinnovo dell'autorizzazione all'immissione in commercio, secondoprocedura di mutuo riconoscimento, del medicinale per uso umano«Mirtazapina doc generici», 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=15A00586&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Retrieved January 13, 2015 10/2015 # PV of Medicine determines: MIRTAZAPINE 15 mg packaging: 038701 013 "DOC GENERICI orodispersible Tablet 6" PA/AL/PVC/paper/pet/AL 038701 025 "15 mg orodispersible tablets 18" PA/AL/PVC/paper/pet/AL 038701 037 "15 mg tablets 30 tablets" PA/AL/PVC/paper/pet/AL 038701 049 "15 mg orodispersible tablets 48" PA/AL/PVC/paper/pet/AL 038701 052 "15 mg tablets 90 tablets" PA/ Al/PVC/paper/pet/AL 038701 064 "15 mg orodispersible tablets 96" PA/AL/PVC/paper/pet/AL 038701 076 "30 mg orodispersible Tablet 6" PA/AL/PVC/paper/pet/AL 038701 088 30 mg orodispersible Tablet 18 "" PA/AL/PVC/paper/pet/AL 038701 090 "30 mg tablets 30 tablets" PA/AL/PVC/paper/pet/AL 038701 102 "30 mg orodispersible tablets 48" PA/AL/PVC/paper/pet/AL 038701 114 "30 mg tablets Oro-"90 tablets PA/AL/PVC/paper/pet/AL 038701 126 30 mg orodispersible tablets 96" "PA/AL/PVC/paper/pet/AL 038701 138" 45 mg orodispersible Tablet 6 "PA/AL/PVC/paper/pet/PER 038701 140" 45 mg orodispersible tablets 18 "PA/AL/PVC/paper/pet/AL 038701 153 45 mg orodispersible tablets 30" "PA/AL/PVC/paper/pet/038701 165 45 mg orodispersible tablet at 48" tablets "PA/AL/PVC/paper/pet/AL 038701 177 "45 mg orodispersible tablets 90" PA/AL/PVC/paper/pet/AL 038701 189 "45 mg orodispersible tablets" 96 tablets PA/AL/PVC/paper/pet/AL Mah: DOC GENERICI S.R.L. Mutual recognition procedure NL/H/1261/001-001 003/R/expiring on February 26, 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.