Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-03-02&atto.codiceRedazionale=15A01333&elenco30giorni=false&atto.tipoProvvedimento=DECRETO
Retrieved January 14, 2015 V&A # 49/2015 determines the description of medicine and assigning AIC is authorised the placing on the market of the medicinal product: "/-C, in the form and container: «0.5 ml suspension for injection prepriempita intramuscular syringe» 1 glass syringe with 1 needle in addition to packages already authorised, under the conditions and with the specifications mentioned below : Mah: Baxter S.p.a., with registered office and tax domicile in Rome (RM), Piazzale dell'industria, 20, 00144, Italy, social security CAP 00492340583;
Packaging: "0.5 ml suspension for injection prepriempita intramuscular syringe" 1 1 glass syringe with needle-AIC # 035602059 (10) 11YHNC (based on 32).
Pharmaceutical form: suspension for injection.
Composition: 1 dose (0.5 ml) suspension for injection contains: active ingredient: polysaccharide (de-O-ACETYLATED) Group C Neisseria meningitidis (strain C11): 10 mcg.
Classification for the purposes of new listings ' box: 035602059-"0.5 ml suspension for injection prepriempita intramuscular syringe" 1 1 glass syringe with needle.
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: 035602059-"0.5 ml suspension for injection prepriempita intramuscular syringe" 1 glass syringe with needle 1-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.
Adapt standard terms is changed, according to conforming to standards terms, the name of the Pack already authorised, as follows: from: AIC # 035602046-1 syringe 0.5 ml glass of susp. iniett. intram. with 2 needles: Pediatric and adults;
in: AIC # 035602046-1 syringe 0.5 ml glass of susp. iniett. intram. with 2 needles.
Review printed also authorized the review of printed materials, following the results of the study 670901 ' A Phase III, Randomized, Open Label b, Feasibility Study of a Single Priming Dose of Meningococcal Group C Conjugate Vaccine (/-C) in Infants», relatively evenly to the packaging: AIC # 035602010-1 syringe 0.5 ml intramuscular suspension for glass;
AIC # 035602022-10 syringes 0.5 ml intramuscular suspension for glass;
AIC # 035602034-20 glass 0.5 ml prefilled syringes of intramuscular suspension for injection;
AIC # 035602046-1 syringe 0.5 ml glass of susp. iniett. intram. with 2 needles.
Date of determination: from the day following that of its publication in the official journal of the Italian Republic.
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