Authorisation For The Medicinal Product For Usoumano «Coripren»

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

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-03-26&atto.codiceRedazionale=15A02212&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Retrieved March 11, 2015 V&A # 457/2015 of description determines medicine and allocation number A.I.C.
It is authorised for placing on the market of the medicinal product: CORIPREN, shapes and packaging: «20 mg/20 mg film-coated tablets» 7 tablets in PA/AL/PVC/AL, «20 mg/20 mg film-coated tablets» 14 tablets in PA/AL/PVC/AL, «20 mg/20 mg film-coated tablets» 28 tablets in PA/AL/PVC/AL, «20 mg/20 mg film-coated tablets» 30 tablets in PA/AL/PVC/AL «20 mg/20 mg film-coated tablets» 35 tablets in PA/AL/PVC/AL, «20 mg/20 mg film-coated tablets» 42 tablets in PA/AL/PVC/AL, «20 mg/20 mg film-coated tablets» 50 tablets in PA/AL/PVC/AL, «20 mg/20 mg film-coated tablets» 56 tablets in PA/AL/PVC/AL «20 mg/20 mg film-coated tablets» 90 tablets in PA/AL/PVC/AL, «20 mg/20 mg film-coated tablets» 98 tablets in PA/AL/PVC/AL, «20 mg/20 mg film-coated tablets» 100 tablets in PA/AL/PVC/AL, under the conditions and with the specifications below.
A.I.C. holder: chemical and pharmaceutical company Recordati S.p.A., via Civitali n. 1-c.a.p. 20148 Milan (Italy), tax code 00748210150.
Packaging: «20 mg/20 mg film-coated tablets» 7 tablets in PA/AL/PVC/AL-A.I.C. # 038568236 (10) 14T09D (based on 32);
«20 mg/20 mg film-coated tablets» 14 tablets in PA/AL/PVC/AL-A.I.C. # 038568248 (10) 14T09S (based on 32);
«20 mg/20 mg film-coated tablets» 28 tablets in PA/AL/PVC/AL-A.I.C. # 038568251 (10) 14T09V (based on 32);
«20 mg/20 mg film-coated tablets» 30 tablets in PA/AL/PVC/AL-A.I.C. # 038568263 (10) 14T0B7 (based on 32);
«20 mg/20 mg film-coated tablets» 35 tablets in PA/AL/PVC/AL-A.I.C. # 038568275 (10) 14T0BM (based on 32);
«20 mg/20 mg film-coated tablets» 42 tablets in PA/AL/PVC/AL-A.I.C. # 038568287 (10) 14T0BZ (based on 32);
«20 mg/20 mg film-coated tablets» 50 tablets in PA/AL/PVC/AL-A.I.C. # 038568299 (10) 14T0CC (based on 32);
«20 mg/20 mg film-coated tablets» 56 tablets in PA/AL/PVC/AL-A.I.C. # 038568301 (10) 14T0CF (based on 32);
«20 mg/20 mg film-coated tablets» 90 tablets in PA/AL/PVC/AL-A.I.C. # 038568313 (10) 14T0CT (based on 32);
«20 mg/20 mg film-coated tablets» 98 tablets in PA/AL/PVC/AL-A.I.C. # 038568325 (10) 14T0D5 (based on 32);
«20 mg/20 mg film-coated tablets» 100 tablets in PA/AL/PVC/AL-A.I.C. # 038568337 (10) 14T0DK (based on 32).
Pharmaceutical form: film-coated tablet.
Complete appliance validity: 2 years from date of manufacture.
Special precautions for storage: store in the original package in order to protect from light and moisture. Do not store above 25° c.
Composition: each film-coated tablet contains: active ingredient: 20 mg enalapril maleate (15.29 mg of enalapril) and 20 mg of lercanidipine hydrochloride (equivalent to 18.88 mg of lercanidipine);
excipients: core: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate (type A), povidone K30, sodium hydrogen carbonate, magnesium stearate;
film coating: hypromellose 5 cP, titanium dioxide (E171), macrogol 6000, yellow iron oxide (E172), talc, red iron oxide (E172).
Manufacturer of the active substance: Zhejiang Huahai Pharmaceutical Co. Ltd., Xunqiao, 317 024 Linhai City, Zhejiang Province, China (enalapril maleate);
Dr Reddy's Laboratories Ltd, Plot # 116, Sri Venkateswara Co-operative Industrial Estate, I.D.A. Bolarum, Jinnaram Mandal, Medak District, Andhra Pradesh, India 502 325 (enalapril maleate);
Dr Reddy's Laboratories Ltd, Peddadevulapalli, Miryalguda Mandal Nalgonda District, Tripuraram Taluk, 508 207 Andhra Pradesh-India (enalapril maleate);
Recordati pharmaceutical and chemical industries S.p.A., via Median 4-04011 Aprilia # Cistern Campoverde (Latina)-Italy (lercanidipine hydrochloride);
Recordati Ireland Limited, Raheens East, Ringaskiddy, co. Cork-Ireland (lercanidipine hydrochloride).
Manufacturer of the finished product: Recordati pharmaceutical and chemical industries S.p.A., via m. Civitali # 1-20148 Milano (Italy) (production, primary and secondary packaging, quality control and batch release).
Indications treatment of essential hypertension as replacement therapy in adult patients whose blood pressure is adequately controlled with 20 mg of enalapril and lercanidipine 20 mg administered concurrently in separate tablets.
Classification for the purposes of new listings is 20 mg/20 mg packaging: «tablets» 7 tablets in PA/AL/PVC/AL-A.I.C. # 038568236. 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);
«20 mg/20 mg film-coated tablets» 14 tablets in PA/AL/PVC/AL-A.I.C. # 038568248. 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);
«20 mg/20 mg film-coated tablets» 28 tablets in PA/AL/PVC/AL-A.I.C. # 038568251. 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);
«20 mg/20 mg film-coated tablets» 30 tablets in PA/AL/PVC/AL-A.I.C. # 038568263. 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);

«20 mg/20 mg film-coated tablets» 35 tablets in PA/AL/PVC/AL-A.I.C. # 038568275. 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);
«20 mg/20 mg film-coated tablets» 42 tablets in PA/AL/PVC/AL-A.I.C. # 038568287. 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);
«20 mg/20 mg film-coated tablets» 50 tablets in PA/AL/PVC/AL-A.I.C. # 038568299. 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);
«20 mg/20 mg film-coated tablets» 56 tablets in PA/AL/PVC/AL-A.I.C. # 038568301. 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);
«20 mg/20 mg film-coated tablets» 90 tablets in PA/AL/PVC/AL-A.I.C. # 038568313. 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);
«20 mg/20 mg film-coated tablets» 98 tablets in PA/AL/PVC/AL-A.I.C. # 038568325. 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);
«20 mg/20 mg film-coated tablets» 100 tablets in PA/AL/PVC/AL-A.I.C. # 038568337. 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 purpose of packaging: «20 mg/20 mg film-coated tablets» 7 tablets in PA/AL/PVC/AL-A.I.C. # 038568236-RR: medicinal product subject to medical prescription;
«20 mg/20 mg film-coated tablets» 14 tablets in PA/AL/PVC/AL-A.I.C. # 038568248-RR: medicinal product subject to medical prescription;
«20 mg/20 mg film-coated tablets» 28 tablets in PA/AL/PVC/AL-A.I.C. # 038568251-RR: medicinal product subject to medical prescription;
«20 mg/20 mg film-coated tablets» 30 tablets in PA/AL/PVC/AL-A.I.C. # 038568263-RR: medicinal product subject to medical prescription;
«20 mg/20 mg film-coated tablets» 35 tablets in PA/AL/PVC/AL-A.I.C. # 038568275-RR: medicinal product subject to medical prescription;
«20 mg/20 mg film-coated tablets» 42 tablets in PA/AL/PVC/AL-A.I.C. # 038568287-RR: medicinal product subject to medical prescription;
«20 mg/20 mg film-coated tablets» 50 tablets in PA/AL/PVC/AL-A.I.C. # 038568299-RR: medicinal product subject to medical prescription;
«20 mg/20 mg film-coated tablets» 56 tablets in PA/AL/PVC/AL-A.I.C. # 038568301-RR: medicinal product subject to medical prescription;
«20 mg/20 mg film-coated tablets» 90 tablets in PA/AL/PVC/AL-A.I.C. # 038568313-RR: medicinal product subject to medical prescription;
«20 mg/20 mg film-coated tablets» 98 tablets in PA/AL/PVC/AL-A.I.C. # 038568325-RR: medicinal product subject to medical prescription;
«20 mg/20 mg film-coated tablets» 100 tablets in PA/AL/PVC/AL-A.I.C. # 038568337-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 Legislative Decree No 219 April 24, 2006 and subsequent modifications and integrations, leaflet and labels must be written in Italian and, limited to medicinal products marketed in the province of Bolzano, in German. The holder of the A.I.C. 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-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.