Retrieved 1 April V&A determines the 2015 # 609 authorization of change: C.I. 4) one or more amendments to the summary of product characteristics, labelling and package leaflet after new data on clinical or non-clinical, quality, pharmacovigilance, relatively to the medicine MACLADIN.
Authorized updating of the summary of product characteristics, package leaflet and labelling, relatively to the medicine Macladin, shapes and packages listed below: AIC # 027530043-500 mg/10 ml "powder and solvent for solution for infusion" 1 vial 10 ml powder + 1 solvent ampoule AIC # 027530056-"250 mg film-coated tablets" 12 tablets 125 mg/# 027530068-"AIC 5 ml granules for oral suspension 100 ml 1 bottle" AIC # 027530094-"250 mg granules for oral suspension" 14 sachets AIC # 027530106-"500 mg granules for oral suspension" 14 sachets AIC # 027530118-"500 mg film-coated tablets" 14 tablets 250 mg/# 027530120-"AIC 5 ml granules for oral suspension 100 ml 1 bottle" AIC # 027530144-"RM 500 mg modified-release tablets" 7 tablets handouts corrected and approved shall be annexed to the assessment, referred to in this excerpt.
MAh: Laboratori Guidotti S.p.a. (tax 00678100504) with registered office and tax domicile in via Livornese, 897, 56122 Pisa (PI) Italy-I-1 Printed. 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 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 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 art. 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 Mah makes accessible to pharmacist leaflet updated within the same timeframe.
Date of application of the determination on the day following that of its publication, to decompress, in Gazzetta Ufficiale della Repubblica italiana.