Authorisation For The Medicinal Product For Usoumano «Zoledronic Acid Fair-Med».

Original Language Title: Autorizzazione all'immissione in commercio del medicinale per usoumano «Acido zoledronico Fair-Med».

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-01-09&atto.codiceRedazionale=14A10115&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Retrieved December 16, 2014 2014 # 1495/determines the Medicine: ZOLEDRONIC ACID FAIR-MED.
MAh: Fair-Med Healthcare GmbH Planckstrasse 13, 22765 Hamburg-Germany.
Package: «5 mg/100 ml solution for infusion 100 ml glass vial-1» AIC # 043125018 (10) 19428U (based on 32).
Package: «5 mg/100 ml solution for infusion 100 ml glass vials» 4-AIC # 043125020 (10) 19428W (based on 32).
Package: «5 mg/100 ml solution for infusion 100 ml glass vials» 10-AIC # 043125032 (10) 194,292 (based on 32).
Pharmaceutical form: solution for infusion.
Composition: each vial with 100 ml of solution contains: active ingredient: 5 mg zoledronic acid (as monohydrate).
Each ml of solution contains 0.05 mg zoledronic acid anhydrous (as monohydrate).
Excipients: mannitol (E421);
Sodium citrate (E331);
Water for injections.
Production active ingredient: Jubilant Lifesciences Limited Plot No. 18, 56, 57 and 58 KIADB Industrial Area, Nanjangud-571 302, Mysore District, Karnataka-India;
Assia Chemical Industries Ltd., Teva-Tech site Neot-P.O. Box 2049, Emek Sara Hovav, Beer-Sheva 8,412,316-Israel.
Production, primary and secondary packaging, control and batch release: Agila Specialties Polska Sp. Zo. o. 10, Warsaw 03-230-Daniszewska, Poland.
Sanochemia Pharmazeutika AG control and batch release: Landeggerstrasse 7, 2491 Neufeld an der Leitha, Austria.
Sanochemia Pharmazeutika AG Werk 2 secondary packaging: 33 Landeggerstrasse, 2491-Neufeld an der Leitha Austria.
Medical indications: treatment of osteoporosis in postmenopausal women;
in adult men, at increased risk of fractures, including those with a recent hip fracture by mild trauma.
Treatment of osteoporosis associated with long-term systemic glucocorticoid therapy: in postmenopausal women;
in adult men, at increased risk of fracture.
Treatment of Paget's disease of bone in adults. Conditions or restrictions with regard to the safe and effective use of the medicinal product.
The marketing authorisation holder shall provide the educational material aimed at all doctors who supposedly can prescribe zoledronic acid 5 mg/100 ml in Fair-Med medical indications authorised for the treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture, including those with a recent hip fracture by mild trauma and treating osteoporosis associated with long-term systemic glucocorticoid therapy in postmenopausal women and in men at increased risk of fracture.
Before the distribution of educational material for the prescriber in each Member State, the authorisation holder must agree the content and size, together with a communication plan, with the competent national authorities.
The educational material to the physician should include: the summary of the product characteristics;
Reminder card;
Educational material for the patient.
The reminder card should highlight the following key points: need to calculate creatinine clearance according to body weight using the Cockcroft-Gault before each treatment with Zoledronic Acid 5 mg/100 ml Fair-Med;
Contraindication in patients with creatinine < 35 ml/min;
Contraindicated during pregnancy and in lactating women due to the potential teratogenicita ';
Need to ensure adequate hydration to patients, especially those in old age and those in diuretic therapy;
Need to give zoledronic acid 5 mg/100 ml Fair-Med slowly over a period of time of not less than 15 minutes;
Annual administration scheme;
Recommendation to prescribe in association with zoledronic acid 5 mg/100 ml Fair-Med adequate support of calcium and vitamin D;
Need to perform appropriate physical activity, not to smoke and to follow a healthy diet.
The educational material for the patient must contain: leaflet;
Educational materials including the following key messages: contraindication in patients with severe kidney problems;
Contraindicated during pregnancy and in lactating women;
Need for adequate calcium and vitamin D, attivitafisica appropriate, no smoking and healthy diet.
Key signs and symptoms of serious adverse events;
When to seek medical attention from the staff.
Risk management plan (Risk Management Plan, RMP).
The marketing authorisation holder shall perform the activities and interventions required and detailed pharmacovigilance in the RMP agreed and presented in module 1.8.2 authorisation and any subsequent updates of the RMP.
An RMP should be submitted upon request of the European Medicines Agency (EMA);
whenever the risk management system is modified, especially upon receipt of new information which may lead to a significant change to the benefit/risk profile or the result of achieving an important goal (pharmacovigilance or to minimize the risk).
When the dates for the submission of a periodic safety update report (PSUR) and updating the RMP coincide, they can be presented simultaneously.
Classification for the purposes of new listings ' box: 100 mg/ml solution for infusion «5» 1 glass vial 100 ml-AIC # 043125018 (10) 19428U (based on 32).
New listings ' class: h. ex factory Price (excluding VAT): £ 127.97.
Price (VAT included): € 211.21.
Package: «5 mg/100 ml solution for infusion 100 ml glass vials» 4-AIC # 043125020 (10) 19428W (based on 32).
New listings ' class: c. packaging: «5 mg/100 ml solution for infusion 100 ml glass vials» 10-AIC # 043125032 (10) 194,292 (based on 32).
New listings ' class: c. Classification for the purpose of the classification for the purposes of the supply of the drug ZOLEDRONIC ACID FAIR-MED is the following: medicinal product subject to medical prescription, to be renewed from time to time, be sold to the public on prescription of hospitals or specialist (internist, rheumatologist, geriatrician, endocrinologist)-RNRL.
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 d.lgs. # 219/2006 imposing certain not to 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) 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.