Retrieved determines the Permission to March 4, 2015 # 391 V & variations: C.I. 4) one or more amendments to the summary of product characteristics, labelling and package leaflet after new data on quality, preclinical, and clinical or pharmacovigilance type IB variation with respect to the medicine SPIRIVA RESPIMAT.
Procedure numbers: # NL/H/0718/001/II/011;
# NL/H/0718/001/IB/013.
Authorized updating of the summary of product characteristics, package leaflet, relatively to the medicine SPIRIVA RESPIMAT, shapes and packages listed below: A.I.C. # 038880011-«2.5 mcg Inhalation Solution» respimat inhaler 1 + 1 pe/pp cartridge from 60 deliveries;
A.I.C. # 038880023-«2.5 mcg Inhalation Solution» respimat inhaler 2 + 2 pe/pp cartridges from 60 deliveries;
A.I.C. # 038880035-«2.5 mcg Inhalation Solution» respimat inhaler 3 + pe/pp cartridges 3 from 60 deliveries;
A.I.C. # 038880047-«2.5 mcg Inhalation Solution» respimat inhaler 8 + 8 pe/pp cartridges from 60 deliveries.
Handouts are fixed and approved shall be annexed to the assessment, referred to in this excerpt.
A.I.C. holder: Boehringer Ingelheim International GMBH, with registered office and tax domicile in Ingelheim Am Rhein, Binger Strasse 173, CAP D55216, Germany (DE).
Printed 1. The marketing authorisation holder should make the changes, after the date of entry into force of this determination to the summary of product characteristics; no later than six months from the same date the package leaflet and labelling.
2. 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 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 aforementioned legislative decree.
Inventory disposal Both lots already products on the date of entry into force of this determination that the batches produced during the period referred to in paragraph 1 of the preceding paragraph, of this, not bearing approved changes 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 A.I.C. Holder makes accessible to pharmacist leaflet updated within the same timeframe.
Date of determination: from the day following that of its publication, to decompress, in Gazzetta Ufficiale della Repubblica italiana.