Authorisation For The Medicinal Product For Usoumano «Ticerin».

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

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-03-02&atto.codiceRedazionale=15A01354&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Retrieved January 14, 2015 V&A # 52/2015 determines the Description and attribution MA is authorized the placing on the market of the medicinal product: "TICERIN", also in shapes and packaging: "10 mg film-coated tablets" 100 tablets in Pvc/Pvdc/Al and "10 mg film-coated tablets" 10 tablets in Pvc/Pvdc/Al, under the conditions and with the specifications below.
MAh: Teva Italy S.r.l., with registered office and tax domicile in Milano, via Messina, 38, 20154, Italy, social security cap 11654150157.
Packaging: "10 mg film-coated tablets" 100 tablets in Pvc/Pvdc/Al-AIC # 042053088 (10) 183CH0 (based on 32).
Packaging: "10 mg film-coated tablets" 10 tablets in Pvc/Pvdc/Al-AIC # 042053090 (10) 183CH2 (based on 32).
Dosage form: tablets.
Composition: 10 mg film-coated tablet contains: active ingredient: Citirizina dicloroidrato 10 mg.
Classification for the purposes of new listings package: AIC # 042053088-"10 mg film-coated tablets" 100 tablets in Pvc/Pvdc/aluminium.
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: AIC # 042053090-"10 mg film-coated tablets" 10 tablets in Pvc/Pvdc/aluminium.
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: AIC # 042053088-"10 mg film-coated tablets" 100 tablets in Pvc/Pvdc/Al-RR: medicinal product subject to medical prescription.
Package: AIC # 042053090-"10 mg film-coated tablets" 10 tablets in Pvc/Pvdc/Al-SOP: medicinal product not subject to medical prescription, but not over the counter.
Packaging of printed material should be placed on the market with handouts, as previously approved by this administration, with the only changes necessary to adapt 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.
Dcorrenza of efficacy of determination from the day following that of its publication in the official journal of the Italian Republic