Authorisation For The Medicinal Product For Usoumano «Alendronic Acid Tecnigen».

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

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-03-21&atto.codiceRedazionale=15A02049&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Retrieved determines the March 2, 2015 225/2015 # Medicine: alendronic acid TECNIGEN.
A.I.C. owner: Tecnigen S.r.l., via Galileo Galilei n. 40-20092 Cinisello Balsamo (Milan).
Package: «70 mg film-coated tablets» 4 tablets in PVC/PVDC/AL-A.I.C. # 043119015 (10), 193WF7 (32).
Pharmaceutical form: film-coated tablet.
Composition: each film-coated tablet contains: active ingredient: 70 mg alendronic acid as 91.35 mg of Alendronate Sodium trihydrate;
excipients: microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, sodium Stearyl fumarate, opadry 20A28569 (hydroxypropyl methylcellulose 2910 and TALC).
The active substance manufacturer (with possible signs of production): Pharmaceutical Works Polpharma S.A.-Synthesis Section PS III-19 Pelplinska str., Pomorskie, Poland, 83-200 ni 27b-Building.
Production, batch control, batch release, primary and secondary packaging: West Pharma-Produções de Especialidades Farmacêuticas S.A. -Rua João de Deus, n. º 11, Venda Nova-Amadora, Portugal 2700-486;
Atlantic Pharma-Produções Farmacêuticas, S.A.-Rua da Tapada Grande, n º 2, Abrunheira Sintra, Portugal--2710-089.
Medical indications: treatment of postmenopausal osteoporosis. Alendronic Acid «TecniGen» reduces the risk of vertebral fractures and hip.
Classification for the purposes of new listings ' box: «70 mg film-coated tablets» 4 tablets in PVC/PVDC/AL-A.I.C. # 043119015 (10), 193WF7 (32); new listings ' class ' in note 79 '; ex factory price (excluding VAT): €9.58; price (VAT included): €17.97.
Classification for the purpose of the classification for the supply of the medicinal product ' Alendronic acid Tecnigen» is as follows: medicinal product subject to medical prescription (RR).
Printed packaging of the medicinal product 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.
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-c, paragraph 7) of Directive 2010/84/EC and published on the web portal of the European Medicines Agency.
Date of determination: from the day following its publication in the official journal of the Italian Republic.