Retrieved February 16, 2015 V&A # 283/2015 of description determines medicine and assigning AIC is authorised the placing on the market of the medicinal product: ELLEPALMIRON, shapes and packaging: "5 mg/ml oral solution 1 vial 100 ml glass", "5 mg/ml oral solution 500 ml glass bottle, 1" "5 mg/ml oral solution 100 ml glass vials 3" under the conditions and with the specifications mentioned below: Mah: l. Molteni & c. the operating company F.lli Alitti near S.p.A., Strada Statale 67 Tosco Romagnola-Fraz. Grenadiers-50018 Scandicci (Florence) Italy, tax code 01286700487 packaging: "5 mg/ml oral solution 1 vial 100 ml glass" AIC # 043711011 (10) 19PYK3 (based on 32) packaging: "5 mg/ml oral solution 500 ml glass bottle 1" AIC # 043711023 (10) 19PYKH (based on 32) packaging: "5 mg/ml oral solution 100 ml glass vials 3" AIC # 043711035 (10) 19PYKV (based on 32) pharmaceutical form : complete appliance: 3 years validity oral solution. The solution should be used within 12 weeks of first opening.
Special storage conditions: store at room temperature below 25° c.
Composition: 1 ml oral solution contains: active ingredient: excipients: methyl parahydroxybenzoate hydrochloride 5 mg levomethadone (E218), betaine hydrochloride, glycerol, purified water Producer of the finished product: l. Molteni & c. of operating company F.lli Alitti near S.p.A., Strada Statale 67 Tosco Romagnola-Fraz. Grenadiers-50018 Scandicci (Florence) Italy (production, primary and secondary packaging, quality control, batch release) medical indications: maintenance replacement therapy in opioid addiction in adults, in association with medical, social and psychological support.
New listings for the purposes of classification is packaging: "5 mg/ml oral solution" 1 vial 100 ml glass AIC # 043711011 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).
Packaging: "5 mg/ml oral solution" 1 500 ml glass bottle AIC # 043711023 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).
Packaging: "5 mg/ml oral solution" 100 ml glass vials 3 AIC # 043711035 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: "5 mg/ml oral solution" 1 vial 100 ml glass.
AIC # 043711011-OSP: medicinal products subject to medical prescription, for use exclusively in hospitals or in similar structure to it.
Packaging: "5 mg/ml oral solution" 1 500 ml glass bottle.
AIC # 043711023-OSP: medicinal products subject to medical prescription, for use exclusively in hospitals or in similar structure to it.
Packaging: "5 mg/ml oral solution" 3 100 ml glass bottles.
AIC # 043711035-OSP: medicinal products subject to medical prescription, for use exclusively 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.
Generic drug patent protection the mAh is responsible of full respect for the rights of industrial property relative to the reference product and the patent regulations provisions in force.
The mAh of the generic drug and is also responsible for full compliance with the provisions of art. 14, paragraph 2 of Legislative Decree No 219 April 24, 2006 and s, in virtue of which are not included in the printed those parts of the summary of product characteristics of the reference medicinal product referring to indications or dosages still covered by a patent at the time of placing on the market of generic medicine.
Periodic safety update reports PSUR-The marketing authorisation holder shall provide periodic safety update reports for this product in accordance with the requirements set out in the list of dates of reference (EURD list) under art. 107 c, paragraph 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.