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

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

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-03-02&atto.codiceRedazionale=15A01353&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Retrieved January 14, 2015 V&A # 51/2015 determines the Description and attribution MA is authorized the placing on the market of the medicinal product: "SODIUM iodide (131 I) GE", in both shape and packaging: "74 MBq/ml oral solution 10 ml vial of 0.5 to 1" and "925 MBq/ml oral solution 1 vial of 10 ml to 1.0", under the conditions and with the specifications mentioned below as long as they are effective on the date of entry into force of this determination.
MAh: GE Healthcare S.r.l. with registered office and tax domicile in via Galeno, 36, 20126 Milan-Italy-fiscal code 01778520302.
Packaging: "74 MBq/ml oral solution" 1 vial of 0.5 to 10 ml-AIC # 041793011 (10) 17VFHM (based on 32).
Dosage form: oral solution.
Validity complete appliance: 39 days from the date of end of production and 31 days from the date and time of calibration on the label.
Manufacturer of the active substance: NTP Radioisotope Pty Ltd; Building P1700 and P1701 (Radiochemicals) PO Box 582 Pretoria 0001, South Africa (all phases) and IRE (Institut National des Radioelements), Zonig Industriel, Avenue de l'esperance, 6220 Fleurus-Belgium (all phases).
Manufacturer of the finished product: GE Healthcare Buchler GmbH & co. KG Gieselweg 1-38110 Braunschweig-Germany plant site (full production, primary and secondary packaging, control and batch release).
Composition: 1 ml oral solution contains: active ingredient: sodium iodide (131 I) 74 MBq at date and time of calibration.
Excipients: sodium thiosulfate pentahydrate; Disodium hydrogen phosphate dodecahydrate; Sodium dihydrogen phosphate dihydrate; Sodium hydroxide; Sodium chloride; Water for injections.
Packaging: "925 MBq/ml oral solution" 1 vial of 10 ml to 1.0-AIC # 041793023 (10) 17VFHZ (based on 32).
Pharmaceutical form: solution for injection.
Validity complete appliance: 39 days from the date of end of production and 31 days from the date and time of calibration on the label.
Manufacturer of the active substance: NTP Radioisotope Pty Ltd; Building P1700 and P1701 (Radiochemicals) PO Box 582 Pretoria 0001, South Africa (all phases) and IRE (Institut National des Radioelements), Zonig Industriel, Avenue de l'esperance, 6220 Fleurus-Belgium (all phases).
Manufacturer of the finished product: GE Healthcare Buchler GmbH & co. KG Gieselweg 1-38110 Braunschweig-Germany plant site (full production, primary and secondary packaging, control and batch release).
Composition: 1 ml oral solution contains: active ingredient: sodium iodide (131 I) 925 MBq at date and time of calibration.
Excipients: sodium thiosulfate pentahydrate; Disodium hydrogen phosphate dodecahydrate; Sodium dihydrogen phosphate dihydrate; Sodium hydroxide; Sodium chloride; Water for injections.
Therapeutic indication 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 of sodium iodide can be given as a dose "tracer" to study the kinetics of radioiodine. 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 (131 I) it is used to identify thyroid residues and metastasis (after surgical ablation).
Thyroid scintigraphy with sodium iodide (131 I) for benign diseases only when there are no available radiopharmaceuticals with a most favorable dosimetry eg. 99 m Tc o123 I.
Classification for the purposes of new listings package: AIC # 041793011-' 74 MBq/ml oral solution "1 vial of 0.5 to 10 ml listings there's class: the class section under art. 8, paragraph 10) (c) of the Act No 537 as amended December 24, 1993, dedicated to drugs not yet evaluated for the purposes of new listings, called class C (nn).
Package: AIC # 041793023-"925 MBq/ml oral solution" 1 vial of 10 ml 1.0 in new listings ' class: section of the class referred to in art. 8, paragraph 10) (c) of the Act No 537 as amended December 24, 1993, dedicated to drugs not yet evaluated for the purposes of new listings, called class C (nn).
Classification for the purposes of delivery set: AIC # 041793011-' 74 MBq/ml oral solution "1 vial of 0.5 to 10 ml-OSP: medicinal product subject to medical prescription, to be used only in hospitals or in similar structure to it.
Package: AIC # 041793023-"925 MBq/ml oral solution" 1 vial of 10 ml to 1.0-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 the Legislative Decree of April 24, 2006, # 219 s and the package 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.
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 from the day following that of its publication, to decompress, in Gazzetta Ufficiale della Repubblica italiana.