Authorisation For The Medicinal Product For Usoumano «Risedronate Cipla».

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

Read the untranslated law here:

Retrieved March 2, 2015 # 218/2015 of Medicine determines: RISEDRONATE CIPLA.
MAh: Cipla Europe NV-Uitbreidingstraat 80-2600 Antwerp-Belgium.
Package «35 mg film-coated tablets» 4 tablets in PVC/AL-AIC # 043080011 (10) 192QBC (based on 32).
Package «35 mg film-coated tablets» 12 tablets in PVC/AL-AIC # 043080023 (10) 192QBR (based on 32).
Pharmaceutical form: film-coated tablets composition: each film-coated tablet contains: active ingredient: 35 mg Risedronate sodium (as hemipentahydrate) other ingredients: Tablet core: lactose anhydrous, microcrystalline croscarmellose sodium magnesium stearate film-coating: Hypromellose titanium dioxide (E171) Macrogol iron oxide yellow E172 red iron oxide (E172) batch release & D Pharma CZ spol. s r.o.-This Theodor 28, Pchery (Pharmos A.S. facility) 27308, Czech Republic Cipla (EU) Limited-4th floor, 1 Kingdom Street, London W2 United Kingdom 6 BY, Select batch control Pharma Laboratories Limited-55 Stirling Enterprise park, Stirling FK RP 77, United Kingdom Select Bio Laboratories Limited Biocity Scotland, Dumfries Road, Motherwell, Lanarkshire MI 1 5UH, United Kingdom production and packaging Cipla Ltd (Unit VII) Plot # S-M-l-62 139 103 & Verna Industrial Estate, Verna, Salcette Goa 403722, India Production active ingredient Cipla Lirnited-Plot D-7 D-22 D-27, IVIIDC Industrial Area, Kurkumbh, District-Pune, Maharashtra State, India 413802 medical indications: treatment of postmenopausal osteoporosis, to reduce the risk of vertebral fractures.
Treatment of postmenopausal osteoporosis ascertained, to reduce the risk of hip fractures.
Treatment of osteoporosis in men with high risk of fractures.
Classification for the purposes of rirnborsabilita ' Pack ' 35 mg film-coated tablets» 4 tablets in PVC/AL-AIC # 043080011 (10) 192QBC (based on 32) class of ' 79 Note new listings price ex factory (VAT) €8.21.
Price to the public (tax) €15.39.
Package «35 mg film-coated tablets» 12 tablets in PVC/AL-AIC # 043080023 (10) 192QBR (based on 32) rirnborsabilita ' class ' C '.
Classification for the purpose of the classification for the purposes of providing the medicine RISEDRONATE CIPLA 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-at the time of granting the authorisation, the submission of the periodic safety update reports not required for this product. However, the marketing authorisation holder shall submit periodic safety update reports for this product if the product is listed as reference dates (EURD list) referred to in article 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 its publication in the official journal of the Italian Republic.