Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-03-04&atto.codiceRedazionale=15A01513&elenco30giorni=false&atto.tipoProvvedimento=DECRETO
Retrieved February 16, 2015 V&A # 285/2015 of description determines medicine and attribution Ma.
It is authorised for placing on the market of the medicinal product: MOMETASONE CIPLA, form and packaging: "50 micrograms/spray nasal spray suspension» 1 HDPE bottle from 18 g/140 disbursements with dosing pump and nasal adapter, under the conditions and with the specifications below.
MAh: Cipla (EU) Limited, Hillbrow House, Hillbrow Road, Esher, Surrey, KT10 9NW, United Kingdom box: «50 micrograms/spray nasal spray suspension» 1 HDPE bottle from 18 g/140 disbursements with dosing pump and nasal adapter-AIC # 043266016 (10) 198CZ0 (based on 32) dosage form: nasal spray suspension.
Validity complete appliance: 2 years. After first use: 2 months special precautions for storage: do not store above 25° c. Do not freeze. Store in the original package.
Composition: active ingredient: mometasone Furoate (as monohydrate).
Excipients: glycerol, microcrystalline cellulose, carmellose sodium, citric acid monohydrate, polysorbate 80, benzalkonium chloride, sodium citrate dihydrate, water for injections the active substance manufacturer: Cipla Limited, Manufacturing Division, Plot no. D-7, D-27, Kurkumbh MIDC Industrial Area, Village, Taluka-Daund, District-Pune, Maharashtra, India; (manufacturing, packaging, storage and control of the active substance).
Manufacturer of the finished product: Cipla Limited, Plot # 9 and 10, Indore Special Economic Zone, Phase II, Pitampur, Dhar, Madhya Pradesh, India 454775 District; (production and packaging of the finished product, quality control of the active substance and Excipients, controls "in process" and on the finished product, stability control and storage of the finished product);
Cipla (EU) Limited, 4th floor, 1 Kingdom Street, London, W2 6BY, United Kingdom (batch release of finished product);
& D Pharma CZ, spol. s r.o., Theodor 28, Pchery (Pharmos a.s. facility), Czech Republic, 273 08 (batch release of finished product);
Select Pharma Laboratories Limited, 55 Stirling Enterprise park, Stirling, FK7 7RP, United Kingdom (chemical and physical control of the finished product);
Select Bio Laboratories Limited, Biocity Scotland, Bo'Ness Road, Motherwell, Lanarkshire, ML1 5UH, United Kingdom (microbiological control of the finished product).
Medical indications: Mometasone furoate nasal spray suspension is indicated for treatment of the signs and seasonal or perennial allergic rhinitis, in adults and children over 12 years of age.
Mometasone furoate nasal spray suspension is also indicated for treatment of the signs and seasonal or perennial allergic rhinitis in children aged 6 to 11 years of age.
In patients with a history of seasonal allergic rhinitis symptoms of moderate to severe entity, prophylactic treatment with Mometasone furoate nasal spray, suspension, can be started up to four weeks before the scheduled start of the pollen season.
Mometasone furoate nasal spray suspension is indicated for the treatment of nasal polyps in patients adults from 18 years of age.
Classification for the purposes of new listings ' box: «50 micrograms/spray nasal spray suspension» 1 HDPE bottle from 18 g/140 disbursements with dosing pump and nasal adapter-AIC # 043266016 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: "50 micrograms/spray nasal spray suspension» 1 HDPE bottle from 18 g/140 disbursements with dosing pump and nasal adapter-AIC # 043266016-RR: medicinal product subject to medical prescription.
Packaging of printed material should be marketed with labels and package leaflets comply with the text annexed to this determination.
It approved the summary of the product characteristics attached to this determination.
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-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.
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