Authorisation For The Medicinal Product For Usoumano «Coxiben».

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

Read the untranslated law here:

Retrieved March 2, 2015 COXIBEN # 230/2015 determines the product:.
A.I.C. holder: S.F. Group S.r.l., via Beniamino Segre n. 59-00134 Rome.
Packaging: «100 mg capsule» 40 capsules in blister PVC/AL-A.I.C. # 043133014 (in base 10), 194B2Q (32);
«200 mg capsule» 20 capsules in blister PVC/AL-A.I.C. # 043133026 (10) 194B32 (based on 32).
Dosage form: capsules.
Composition: Each capsule contains: active ingredient: 100 mg of celecoxib, celecoxib 200 mg;
other ingredients: capsule contents: sodium lauryl sulphate, lactose monohydrate, crospovidone, povidone, magnesium stearate, K29-32;
the capsule shell: titanium dioxide (E171), gelatin, sodium lauryl sulphate;
printing ink for 100 mg hard capsules: blue ink TekPrint SB-6018 containing: shellac, Indigo Carmine (E132);
printing ink for 200 mg hard capsules: Golden TekPrint SB-3002 containing ink: shellac, iron oxide yellow (E172).
Production of active ingredient: Watson Pharma Private Limited-N-15, Additional Ambernath, MIDC Anand Nagar, Ambernath (East), Thane, Maharashtra, India;
Shasun Pharmaceuticals Ltd.-A-1/B, Sipcot Industrial Complex-Kudikadu Village, Cuddalore-607 005, India.
Batch release, batch control, primary packaging, secondary packaging: Balkanpharma – Dupnitza Samokovsko Shosse str. 3, Dupnitsa 2600 to Bulgaria.
Primary packaging, secondary packaging: Arrow Pharm (Malta) Limited-62 Hal Far BBG 3000-Malta, Birzebbuga Industrial Estate;
Actavis ehf. Reykjavikurvegur78, 220 Hafnarfjörður Iceland;
Actavis Ltd. BLB016, Bulebel Industrial estate Zejtun ZTN 3000 Malta.
Production: Watson Pharma Private Limited-Plot. No. A3 to A6, Phase 1-A, Verna Industrial Estate, Goa 403 722-Verna, Salcette, India-.
Medical indications: adults-symptomatic relief in the treatment of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.
The decision to prescribe a selective COX-2 inhibitor must be based on a patient's overall risk assessment.
Classification for the purposes of new listings ' box: "200 mg capsule» 20 capsules in blister PVC/AL-A.I.C. # 043133026 (10), 194B32 (32); new listings ' class ' in note 66 "; ex factory price (excluding VAT): €5.07; price (VAT included): €9.51.
The packs referred to in art. 1, which are not classified listings there band ' for the purposes of this article, are placed, by virtue of art. 12, paragraph 5, of Decree-Law No 158 September 13, 2012, converted, with amendments, by law November 8, 2012, # 189, in the section dedicated to drugs not yet evaluated for the purposes of new listings, the class of article. 8, paragraph 10) (c) of the Act December 24, 1993, # 537, and subsequent amendments, called class C (nn) ".
Classification for the purpose of the classification for the supply of the medicinal product «Coxiben» is the following: medicinal product subject to medical prescription (RR).
The holder of the patent protection A.I.C. the generic drug is exclusively responsible for the full respect for the rights of industrial property relative to the reference product and the patent regulations provisions in force.
The holder of the A.I.C. the generic drug and is also responsible for full compliance with the provisions of art. 14, paragraph 2 of Legislative Decree No. 219/2006 that forces do not include printed matter 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 the medicinal product.
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) 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.