Retrieved determines the 2673/2014 December 16, 2014 n V & Description and assigning AIC.
It is authorised for placing on the market of the medicinal product: «XYLOMETAZOLINA CARLO ERBA, in the form and container: «1 mg/ml nasal spray solution» 1 10 ml graduated from glass bottle with pump and regulator; under the conditions and with the specifications mentioned below: Mah: Carlo Erba O.T.C. S.r.l., with registered office and tax domicile in Pomezia (RM), via Ardeatina km 23.500-Fraction loc. Santa Palomba, Italy, tax code 08572280157;
Package: «1 mg/ml nasal spray solution» 1 10 ml graduated from glass bottle with pump and regulator-AIC # 043457011 (10) 19G6HM (based on 32).
Pharmaceutical form: nasal spray solution.
Complete appliance validity: 3 years from date of manufacture.
Manufacturer of the active substance: Basf Pharma Chemikalien GMBH & co. KG 15-39, 42-44, plant site in D-32423 Karlstrasse-Minden-Germany;
Finished product manufacturer: Famar Orleans establishment site at 5, Avenue de Concyr, 45071 Orleans Cedex 2-France (manufacturing, packaging, control and batch release);
Composition: each 140 's provision µ l of nasal spray solution contains: active ingredient: xylometazoline hydrochloride 140.0 µ g excipients: Edetate; sodium chloride; sodium dihydrogen phosphate dihydrate; disodium phosphate dihydrate; sorbitol (E420); purified water; benzalkonium chloride;
Medical indications: temporary relief of nasal congestion due to allergic rhinitis or sinusitis.
Classification for the purposes of new listings package: AIC # 043457011 «1 mg/ml nasal spray solution» 1 10 ml graduated from glass bottle with pump and regulator.
New listings class is: "C-bis '.
Classification for the purposes of delivery set: AIC # 043457011 «1 mg/ml nasal spray solution» 1 10 ml graduated from glass bottle with pump and regulator-OTC: medicinal product not subject to medical prescription over the counter.
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) referred to in article 107-quater, para. 2010/84/EC Directive 7) and published on the web portal of the European Medicines Agency.
Date of determination: from the day following that of its publication in the official journal of the Italian Republic.