Renewal Of Marketing Authorisation, The Mutual Recognition Secondoprocedura, Of The Medicinal Product For Human Use "ebastine Teva ', Resulting In A Review Printed.

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

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-03-31&atto.codiceRedazionale=15A02311&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Retrieved February 26, 2015 2015 # 64/PV determines the Medicine: EBASTINE TEVA.
Container size: 10 mg orodispersible 040840 011 '» 10 tablets in opa/al/pvc/al;
040840 023 «10 mg orodispersible» 20 tablets in opa/al/pvc/al;
040840 035 «10 mg orodispersible» 30 tablets in opa/al/pvc/al;
040840 047 «10 mg orodispersible» 40 tablets in opa/al/pvc/al;
040840 050 «10 mg orodispersible» 50 tablets in opa/al/pvc/al;
040840 062 «10 mg orodispersible» 90 tablets in opa/al/pvc/al;
040840 074 «10 mg orodispersible» 98 tablets in opa/al/pvc/al;
040840 086 "10 mg orodispersible» 100 tablets in opa/al/pvc/al;
040840 098 «20 mg orodispersible» 10 tablets in opa/al/pvc/al;
040840 100 ' 20 mg orodispersible» 15 tablets in opa/al/pvc/al;
040840 112 ' 20 mg orodispersible» 20 tablets in opa/al/pvc/al;
040840 124 «20 mg orodispersible» 30 tablets in opa/al/pvc/al;
040840 136 «20 mg orodispersible» 40 tablets in opa/al/pvc/al;
«040840 148 20 mg orodispersible» 50 tablets in opa/al/pvc/al;
040840 151 «20 mg orodispersible» 98 tablets in opa/al/pvc/al;
040840 163 «20 mg orodispersible» 100 tablets in opa/al/pvc/al.
A.I.C. holder: Teva Italy s.r.l.
Mutual recognition procedure IF/H/001-001/002/R/0955, expiring on January 31, 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 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.
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.