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

Original Language Title: Rinnovo dell'autorizzazione all'immissione in commercio, secondoprocedura di mutuo riconoscimento, del medicinale per uso umano«Meropur», 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=15A02310&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Retrieved February 26, 2015 63/2015 # PV of Medicine determines: DIVERT.
Packaging: A.I.C. # 036749 036 «600 IU powder and solvent for solution for injection syringe 1 1 vial powder + 1 ' ml solvent + Aug + 9 + 9 alcohol swabs disposable syringes;
A.I.C. # 048 036749 «1200 IU powder and solvent for solution for injection 2 1 1 vial syringes» dust + ml solvent + needle + 18 + 18 alcohol swabs disposable syringes.
A.I.C. holder: Ferring S.p.a.
How to: mutual recognition DK/H/0606/002-003/R/002, expiring on January 13, 2015 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 A.I.F.A. 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.