Authorisation For The Medicinal Product For Usoumano «Sodium Iodide (¹ ¹ ³ S) Mallinckrodt»

Original Language Title: Autorizzazione all'immissione in commercio del medicinale per usoumano «Sodio Ioduro (¹³¹I) Mallinckrodt»

Read the untranslated law here:

Retrieved January 14, 2015 V&A # 41/2015 determines the Description and attribution number A.I.C.
It is authorised for placing on the market of the medicinal product: sodium iodide (131 I) MALLINCKRODT, in the form and container: ' 74-740 MBq/ml solution for injection 10 ml 1 vial to 1 '; under the conditions and with the specifications below.
A.I.C. Owner: Mallinckrodt Medical Bv (Netherlands), having its registered office and address in Westerduinweg 3-1755 Le Petten (Netherlands).
Package: «74-740 MBq/ml solution for injection 10 ml 1 vial to 1 '-A.I.C. # 039088012 (10) 158VWD (based on 32).
Pharmaceutical form: solution for intravenous injection or oral sex.
Complete appliance validity: 45 days from the date of end of production. Validity after first opening: use within 8 hours.
Manufacturer of the active substance: IRE factory site in Zoning Industriel, Avenue de l'esperance-6220 Fleurus-Belgium; NTP Radioisotopes (SOC.) LTD factory site in Building P1700 and P1701 (Radiochemicals)-PO Box 582-Pretoria-South Africa.
Manufacturer of the finished product: GE Healthcare Buchler GmbH & co. KG Gieselweg 1-38110 Braunschweig-Germany site establishment (production, primary and secondary packaging, control);
Biochem GmbH factory site at 5b-D-76185 Karlsruhe-Germany Daimlerstraße (control);
Mallinckrodt Medical BV Westerduinweg 3-1755 ZG Petten-Netherlands site plant (secondary packaging and batch release).
Composition: each vial contains: active ingredient: sodium iodide (131I) 74-740 MBq at date and time of calibration;
excipients: sodium thiosulfate pentahydrate; disodium phosphate dodecahydrate; sodium dihydrogen phosphate dihydrate; sodium hydroxide; sodium chloride; water for injections.
Medical indications: therapeutic use.
Thyroid therapy with radioiodine is indicated for the treatment of Graves ' disease, toxic multinodular goiter, thyroid nodules functionally autonomous;
papillary and follicular thyroid cancer treatment including the metastatic form.
Therapy with sodium iodide (131 I) is often combined with surgery and antithyroid drugs; diagnostic use.
Sodium iodide can be used as a tracer to study the dose radioiodine «kinetic». Estimating reuptake and the effective half-life, achieved with a specific tracer dose can be used to calculate the activity required for radioiodine therapy.
In the treatment of thyroid carcinoma, sodium iodide (131I) is used to identify thyroid residues and metastasis (after surgical ablation).
Thyroid scintigraphy with sodium iodide (131I) for benign diseases only when there are no available radiopharmaceuticals with a most favorable dosimetry, eg. 99mtc or 123I.
Classification for the purposes of new listings ' box: A.I.C. # 039088012-«74-740 MBq/ml solution for injection 10 ml 1 vial to 1 '. New listings ' class: section of the class referred to in art. 8, paragraph 10) (c) of the Act December 24, 1993, no. 537 as amended, dedicated to drugs not yet evaluated for the purposes of new listings, called class C (nn).
Classification for the purposes of delivery set: A.I.C. # 039088012-«74-740 MBq/ml solution for injection 10 ml 1 vial 1 ' to-OSP: medicinal product subject to medical prescription, to be used only in hospitals or in similar structure to it.
Packaging of printed material should be marketed with labels and package leaflets comply with the attached text to the determination, under this extract.
It approved the summary of the product characteristics attached to the assessment, referred to in this excerpt.
In accordance with art. 80, paragraphs 1 and 3 of Legislative Decree No 219 April 24, 2006 and subsequent amendments and supplements to the package leaflet 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.
Periodic safety update reports PSUR-at the time of granting the authorisation, the submission of the periodic safety update reports not required for this product. However, the marketing authorisation holder shall submit periodic safety update reports for this product if the product is listed as reference dates (EURD list) under art. 107-quater, para. 7 of Directive 2010/84/EC and published on the web portal of the European Medicines Agency.
Date of determination: this determination takes effect from the day following that of its publication in the official journal of the Italian Republic, subject to a transitional period of ninety days, after that date, in order to provide for the adaptation of all packaging and preparation of printed materials. The same determination will be notified to the company holder of the marketing authorisation of the medicinal product.