Review Of The Marketing Authorisation Of Talunimedicinali For Human Use.

Original Language Title: Modifica dell'autorizzazione all'immissione in commercio di talunimedicinali per uso umano.

Read the untranslated law here:

Retrieved 1 April # 612 V&A determines the 2015 Authorize variations: variations: C.I. 4).
Authorization renewal: C.I. 3. b;
C.i. 1. a;
C.I.. z) Plaunazide Plaunac, Olprezide, on medicinal products ..., Olpress, Giant, Bivis.
Variations: C.I. 4).
Authorization renewal: C.I. 3. b;
C.i. 1. a;
C.I.. z). On medicinal products Sevikar, Olmetec, Olmegan.
Numbers of procedure: DE/H/xxxx/WS/068/G, DE/H/xxxx/WS/Plaunac Olprezide, 097, on medicinal products Plaunazide, Olpress, Olmegan, Sevikar, Olmetec, Giant, Bivis;
DE/H/0385/001-003/IB/045 in relation to medicine Plaunac;
DE/H/0524/003-004/IB/043, DE/H/0524/001-004/IB/055 relatively to the medicine Plaunazide;
DE/H/0386/001-003/IB/039 with regard to medicine Olpress;
DE/H/004/003-0525/IB/041, DE/H/0525/001-004/IB/053 relatively to the medicine Olprezide;
NL/H/001-003/IB/1115/021, NL/H/03/01-1115/R/01 concerning the medicine Bivis;
NL/H/1114/001-003/R/001, 001-1114/NL/H/003/IB/023 relatively to the drug Giant;
NL/H/001-001/003/R/1113, NL/H/003 001-021/IB/1113/relation to medicine Sevikar;
DE/H/0384/001-003/IB/043 relatively to the medicine Olmetec;
DE/H/0523/003-004/IB/043, DE/H/0523/001-004/IB/048, DE/H/0523/001-004/IB/052 relatively to the medicine Olmegan;
Authorized updating of the summary of product characteristics and package leaflet and labels; additional changes to the procedures of renewal.
Plaunac, Olprezide, Plaunazide on medicinal products, Olpress, Olmegan, Sevikar, Olmetec, Giant, Bivis shapes and packagings authorized;
Handouts are fixed and approved shall be annexed to the assessment, referred to in this excerpt.
A.I.C. holders: Menarini International Operations Luxembourg S.A. with registered office and tax domicile in 1, Avenue de la Gare, L-1611 Luxembourg, (LU).
Daiichi Sankyo Italy S.P.A., with registered office and tax domicile in Rome (RM), via Paolo di Dono, 73, 00142 00468270582, Italy, social security Cap.
Printed 1. The marketing authorisation holder should make the changes, after the date of entry into force of this determination, 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 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 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 article 2, paragraph 1, of the present, 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 it 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.