Modification Of The Marketing Authorization For Human Use Delmedicinale "activelle."

Original Language Title: Modifica dell'autorizzazione all'immissione in commercio delmedicinale per uso umano «Activelle».

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Extract determines V & A no. 392 of March 4, 2015 Authorization of variation: CI z) Other changes ;, Activelle for the medicinal product; Procedure number: n. SE / H / 0150/002 / II / 060. E 'approved the update of the Summary of Product Characteristics, Package Leaflet and Tags, for the medicinal Activelle, forms and packages listed below: 034117034 - "0.5 mg / 0.1 mg film-coated tablets" 1x28 tablets packed calendar pp / polystyrene / polystyrene 034117046 - "0.5 mg / 0.1 mg film-coated tablets" 3x28 tablets packed calendar pp / polystyrene / polystyrene The printed corrected and approved are attached to the determination, under this extract. MAH: Novo Nordisk SPA, with registered office and tax domicile in Rome (RM), VIA Elio Vittorini, 129, CAP 00144, Italy, Fiscal Code 03918040589 Printed 1. The marketing authorization holder must make changes authorized, the date of entry into force of this Determination to the Summary of Product Characteristics; no later than six months from that date to the package leaflet and to 'labeling. 2. In accordance with art. 80, paragraphs 1 and 3, of Legislative Decree 24 April 2006, no. 219, as amended, the leaflet and labels must be written in Italian and, for medicinal products marketed in the province of Bolzano, also in German. The MAH that it intends to use the additional foreign language, must give prior notice to AIFA and make available to the official translation of texts in German and / or another foreign language. In case of non-compliance with labeling and package leaflet shall be penalized in art. 82 of this decree. Destocking Both lots already 'products at the date of entry into force of this Determination that all items produced in the period referred to in Article 2, paragraph 1, of the present, not bearing the authorized changes, can remain on sale until the date expiration of the medicine on the label. Pharmacists are required to deliver the Information Leaflet updated users, from the time limit of 30 days from the date of publication in the Official Gazette of the Italian Republic in this determination. The marketing authorization holder shall make the pharmacist leaflet updated within the same period. Effective date of determination, from the day following that of its publication, to extract, in the Official Gazette of the Italian Republic.