Authorisation For The Medicinal Product For Usoumano «Axxeron».

Original Language Title: Autorizzazione all'immissione in commercio del medicinale per usoumano «Axxeron».

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-02-13&atto.codiceRedazionale=15A00941&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Retrieved January 26, 2015 V&A # 101/2015 determines the description of medicine and assigning AIC is authorised the placing on the market of the medicinal product: AXXERON, shapes and packaging: "30 mg/1.5 ml solution 1 110 ml bottle ' skin in PP with dosing pump applicator dermal 1.5 mg/ml solution, «30» 3 110 ml bottle in PP with dosing pump with applicator under the conditions and with the specifications mentioned below: Mah: Eli Lilly Italy S.p.A., Via Gramsci, n. 731/733, chap. 50019-Sesto Fiorentino (FI), Italy, tax code 00426150488.
Package: «30 mg/1.5 ml solution 1 110 ml bottle ' skin in PP with dosing pump applicator;
A.I.C. # 041224015 (10) 17B1UH (based on 32).
Package: «30 mg/1.5 ml solution 3 110 ml bottles» skin in PP with dosing pump applicator;
A.I.C. # 041224027 (10) 17B1UV (based on 32).
Pharmaceutical form: skin solution.
Complete appliance validity: 2 years from date of manufacture.
Special storage conditions: this product is flammable and should be kept away from open flames and sources of ignition.
Composition: 1 ml of solution contains: active ingredient: 20 mg testosterone;
Other ingredients: octisalato cellulose, povidone, isopropyl alcohol, ethanol 96%.
Manufacturer of the active substance: N.V. Organon, Kloosterstraat 6, 5349 AB Oss, Netherlands;
Manufacturer of the finished product: Orion Corporation Orion Pharma Turku Site, Tengoströminkatu 8, FI-20360 Turku, Finland (production, control, primary and secondary packaging, batch release);
Orion Corporation Orion Pharma 1, FI-02200 Espoo Site, Orionintie, Espoo, Finland (batch release).
Medical indications: testosterone replacement therapy in Hypogonadal men if the testosterone deficiency has been confirmed by clinical symptoms and biochemical tests.
«Axxeron» it is suitable for adult men.
Classification for the purposes of new listings ' box: «30 mg/1.5 ml solution 1 110 ml bottle ' skin in PP with dosing pump applicator;
A.I.C. # 041224015.
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).
Package: «30 mg/1.5 ml solution 3 110 ml bottles» skin in PP with dosing pump applicator;
A.I.C. # 041224027.
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: "30 mg/1.5 ml solution 1 110 ml bottle ' skin in PP with dosing pump applicator;
A.I.C. # 041224015-RR: medicinal product subject to medical prescription.
Package: «30 mg/1.5 ml solution 3 110 ml bottles» skin in PP with dosing pump applicator;
A.I.C. # 041224027-RR: medicinal product subject to medical prescription.
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.