Authorisation For The Medicinal Product For Usoumano «Paracalcitolo Teva Italy».

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

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-01-09&atto.codiceRedazionale=15A00034&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Retrieved December 18, 2014 PARACALCITOLO # 1557/2014 determines the medication: TEVA ITALY Mah: Teva Italy S.r.l. via Messina 38-20154 Milan Italy.
Packaging: "1 microgram soft capsules" 7 capsules in blister PVC/ACLAR/AL-AIC # 043129016 (10) 19465S (based on 32);
"1 microgram soft capsules" 28 capsules in blister PVC/ACLAR/AL-AIC # 043129028 (in base 10) 194664 (32);
"1 microgram soft capsules" 30 capsules in blister PVC/ACLAR/AL-AIC # 043129030 (10) 194666 (based on 32);
"1 microgram soft capsules" 30 capsules in HDPE container-AIC # 043129042 (10) 19466L (based on 32);
"2 micrograms soft capsules" 7 capsules in blister PVC/ACLAR/AL-AIC # 043129055 (10) 19466Z (based on 32);
"2 micrograms soft capsules" 28 capsules in blister PVC/ACLAR/AL-AIC # 043129067 (10) 19467C (based on 32);
"2 micrograms soft capsules" 30 capsules in blister PVC/ACLAR/AL-AIC # 043129079 (10) 19467R (based on 32);
"2 micrograms soft capsules" 30 capsules in HDPE container-AIC # 043129081 (10) 19467T (based on 32);
"1 microgram soft capsules" 28 capsules in HDPE container-AIC # 043129093 (10) 194685 (based on 32);
"2 micrograms soft capsules" 28 capsules in HDPE container-AIC # 043129105 (10) 19468K (based on 32).
Pharmaceutical form: soft capsules.
Composition: each soft capsule contains: active ingredient: 1 microgram of paracalcitolo 2 micrograms of paracalcitolo Ingredients: medium-chain Triglycerides capsule contents: Ethanol, anhydrous Butylhydroxytoluene (E321) capsule shell: Gelatin, purified water Glycerol 1 microgram: titanium dioxide (E171) black iron oxide (E172) yellow iron oxide (E172) 2 micrograms: gelatin, purified water Glycerol titanium dioxide (E171) black iron oxide (E172) yellow iron oxide (E172) red iron oxide (E172) production active ingredient : Assia Chemical Industries Ltd., Teva-Tech site, Ramat Hovav, Emek Sara, P.O. Box 2049, Be'er Sheva, Israel Plantex Ltd., 1 84874-Hakadar Street, Industrial zone, P.O. Box 160, Netanya Israel 42101-Abic Ltd., New Industrial Zone, Kiryat Sapir, P.O. Box 8077, Netanya 42504 Teva API India Ltd.-Israel, A-2, A-2/1, A-2/2, UPSIDC Industrial Area, Bijnor Road Gajraula, Dist. J.p. Nagar (U.P.), Gajraula 244 235-India (API STABILITY TESTING) production: TEVA Gyogyszergyar Zrt. (TEVA Pharmaceutical Works Private, Limited Company, Debrecen, Pallagi ut 13 4042-Hungary, H-primary and secondary packaging: TEVA Gyogyszergyar Zrt. (TEVA Pharmaceutical Works Private, Limited Company, Debrecen, Pallagi ut 13 4042-Hungary, H-TEVA UK Ltd, Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG United Kingdom Pharmachemie B.V. Haarlem-5, 2031, Swensweg GA-Netherlands (secondary) Teva Czech Industries s.r.o., Ostravska 29, c.p. 305, Opava-Komarov 74770-Czech Republic Merckle GmbH, Graf-Arco-3, 89079 Ulm-Germany Neologistics str. S.r.l., Largo Boccioni 1, 21040 Origgio (VA), Italy (secondary) Transpharm Logistik GmbH, Einsteinstr. 2, gemäß den vorliegenden Grundrissplänen vom 10. März 1993, Germany 89179-1993, 89179 Beimerstetten Beimerstetten-(secondary) Transpharm Logistik GmbH, Nicolaus-Otto-89079 Ulm-Germany, 16 Str (secondary) quality control: Teva Gyogyszergyar Zrt. (TEVA Pharmaceutical Works Private Limited Company, Debrecen, Pallagi ut 13 4042-Pharmachemie B.V., H-Hungary, Swensweg 5, Haarlem 2031 GA-Holland Teva Czech Industries s.r.o., Ostravska 29, c.p. 305, Opava-Komarov 74770-Czech Republic batch release: Teva Gyogyszergyar Zrt. (TEVA Pharmaceutical Works Private, Limited Company, Debrecen, Pallagi ut 13 4042-Hungary, H-Teva UK Ltd, Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG United Kingdom Pharmachemie B.V. Haarlem-5, 2031, Swensweg GA-Holland Teva Czech Industries s.r.o., Ostravska 29, c.p. 305, Opava-Komarov 74770-Czech Republic Merckle GmbH, Ludwig-Straße 3, 89143 Blaubeuren-Merckle-Germany Teva Operations Poland Sp. z.o.o., ul. Mogilska 80 Paracalcitolo 31-546, Poland, Krakow therapeutic indication Teva Italy is indicated for the prevention and treatment of secondary hyperparathyroidism in patients with chronic renal failure (in stages 3 and 4) and in patients with chronic renal failure (5-stage) in hemodialysis or peritoneal dialysis.
New listings for the purposes of classification is packaging: "1 microgram soft capsules" 28 capsules in HDPE container-AIC # 043129093 (10) 194685 (based on 32).
New listings ' class: a. price ex factory (VAT): €47.56.
Price (VAT included): €89.19.
Packaging: "2 micrograms soft capsules" 28 capsules in HDPE container-AIC # 043129105 (10) 19468K (based on 32).
New listings ' class: a. price ex factory (VAT): €95.12.
Price (VAT included): €178.39.
Discount required to public facilities on the price ex factory as per contractual terms.
The classification of this determination takes effect, in accordance with art. 11, paragraph 1, last sentence, of Decree-Law No September 13, 2012. 158, converted, with amendments, by law November 8, 2012, n. 189, the day following the expiration of the patent or supplementary protection certificate, issued by the Ministry of economic development.
Until the expiry of the period referred to in the preceding paragraph, the medicine Paracalcitolo Teva Italy it is classified, in accordance with art. 12, paragraph 5, of Decree-Law No September 13, 2012. 158, converted, with amendments, by law November 8, 2012, n. 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, no. 537 as amended, called class C (nn).
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 as amended, called class C (nn).

Classification for the purpose of the classification for the purposes of the supply of the medicine Paracalcitolo Teva Italy is the following medicinal product subject to medical prescription (RR).
Terms and conditions of use of Prescription medicine subject to diagnosis-treatment plan and to the provisions of annex 2 as amended, October 29, 2004-PHT determination direct distribution Handbook, published in the ordinary supplement to the official journal # 259 of November 4, 2004.
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. 2 14 co. of d.lgs. 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-quater, para. 7 of Directive 2010/84/EC and published on the web portal of the European Medicines Agency.
Final provisions this determination takes effect on the day following its publication in the official journal of the Italian Republic, and will be notified to the company marketing authorisation holder.