Authorisation For The Medicinal Product For Usoumano «Pantoprazolo Aurobindo. '

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

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-03-30&atto.codiceRedazionale=15A02261&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Retrieved March 13, 2015 # 290/2015 of Medicine determines: PANTOPRAZOLE AUROBINDO.
MAh: Aurobindo Pharma (Italy) s.r.l., Vicolo San Giovanni Sul Muro, 9-20121 Milan, Italy.
Package: «7» 20 mg gastro-resistant tablets in PA/AL/PVC/AL;
A.I.C. # 043494018 (10) 19HBN2 (based on 32).
Package: «14» 20 mg gastro-resistant tablets in PA/AL/PVC/AL;
A.I.C. # 043494020 (10) 19HBN4 (based on 32).
Package: «15» 20 mg gastro-resistant tablets in PA/AL/PVC/AL;
A.I.C. # 043494032 (10) 19HBNJ (based on 32).
Package: «20 mg gastro-resistant» 28 tablets in PA/AL/PVC/AL;
A.I.C. # 043494044 (10) 19HBNW (based on 32).
Package: «20 mg gastro-resistant» 30 tablets in PA/AL/PVC/AL;
A.I.C. # 043494057 (10) 19HBP9 (based on 32).
Package: «20 mg gastro-resistant» 56 tablets in PA/AL/PVC/AL;
A.I.C. # 043494069 (10) 19HBPP (based on 32).
Package: «20 mg gastro-resistant» 60 tablets in PA/AL/PVC/AL;
A.I.C. # 043494071 (10) 19HBPR (based on 32).
Package: ' 98 ' 20 mg gastro-resistant tablets in PA/AL/PVC/AL;
A.I.C. # 043494083 (10) 19HBQ3 (based on 32).
Package: «100» 20 mg gastro-resistant tablets in PA/AL/PVC/AL;
A.I.C. # 043494095 (10) 19HBQH (based on 32).
Package: «500» 20 mg gastro-resistant tablets in PA/AL/PVC/AL;
A.I.C. # 043494107 (10) 19HBQV (based on 32).
Package: «» 7 40 mg gastro-resistant tablets in PA/AL/PVC/AL;
A.I.C. # 043494119 (10) 19HBR7 (based on 32).
Package: «14» 40 mg gastro-resistant tablets in PA/AL/PVC/AL;
A.I.C. # 043494121 (10) 19HBR9 (based on 32).
Package: «15» 40 mg gastro-resistant tablets in PA/AL/PVC/AL;
A.I.C. # 043494133 (10) 19HBRP (based on 32).
Package: «40 mg gastro-resistant» 28 tablets in PA/AL/PVC/AL;
A.I.C. # 043494145 (10) 19HBS1 (based on 32).
Package: «40» 30 mg gastro-resistant tablets in PA/AL/PVC/AL;
A.I.C. # 043494158 (10) 19HBSG (based on 32).
Package: ' 56 ' 40 mg gastro-resistant tablets in PA/AL/PVC/AL;
A.I.C. # 043494160 (10) 19HBSJ (based on 32).
Package: «60» 40 mg gastro-resistant tablets in PA/AL/PVC/AL;
A.I.C. # 043494172 (10) 19HBSW (based on 32).
Package: ' 98 ' 40 mg gastro-resistant tablets in PA/AL/PVC/AL;
A.I.C. # 043494184 (10) 19HBT8 (based on 32).
Package: «100» 40 mg gastro-resistant tablets in PA/AL/PVC/AL;
A.I.C. # 043494196 (10) 19HBTN (based on 32).
Package: «500» 40 mg gastro-resistant tablets in PA/AL/PVC/AL;
A.I.C. # 043494208 (10) 19HBU0 (based on 32).
Pharmaceutical form: gastro-resistant tablet.
Composition: each gastro-resistant Tablet contains: active ingredient: 20 mg, 40 mg pantoprazole (pantoprazole sodium sesquiidrato as).
Other ingredients: Tablet core: sodium carbonate (anhydrous) Mannitol Crospovidone (type B) Hydroxypropyl Cellulose calcium stearate coating: hypromellose yellow iron oxide (E172) methacrylic Acid-ethyl acrylate copolymer (1:1) dispersion 30% Polysorbate 80 will trigger it triethyl citrate printing ink: Shellac red iron oxide (E172) black iron oxide (E172) yellow iron oxide (E172) propylene glycol solution of ammonia, concentrated Production active ingredient: Aurobindo Pharma Limited , Unit I-Survey Nos. 388 389, Borpatla Village, Hatnoora & Mandal, Medak District, Andhra Pradesh-India.
Production, primary and secondary packaging: Aurobindo Pharma Limited-UNIT VII (SEZ) APIIC SEZ, Plot No. S1 (Part), Survey ". Nos. 411, 425, 434, 435, 458, Green Industrial Park, Polepally village, Jedcherla Mandal, Mahaboob Nagar District, Andhra Pradesh, India 509302, secondary packaging: APL Swift Services (Malta) Limited, HF26, Hal Far Industrial Estate, Hal Far, Birżebbuġa, BBG 3000, Malta;
Silvano Gordon Logistics s.p.a.-via delle Industrie snc, 26814 Livraga, Lodi-Italy;
Next Pharma Logistics GmbH-Reichenberger Straße 43, 33605 Bielefeld, North Rhine-Westphalia-Germany 33605;
Prestige Promotion Verkaufsförderung & Werbeservice GmbH-Lindigstr. 6, 63801 Kleinostheim-63801 Germany;
Segetra Pharma s.r. l-Via Milano, 85-20078 San Colombano AL Lambro, Milan-Italy.
Quality control: APL Swift Services (Malta) Limited, HF26, Hal Far Industrial Estate, Hal Far, Birżebbuġa, BBG 3000, Malta.
Batch release: APL Swift Services (Malta) Limited, HF26, Hal Far Industrial Estate, Hal Far, Birżebbuġa, BBG 3000, Malta;
Milpharm Limited-Ares Block, Odyssey Business Park, West End Road, Ruislip HA4 6QD-United Kingdom;
Medical indications: 20 mg: adults and adolescents 12 years and older: symptomatic gastroesophageal reflux disease.
For long term treatment and prevention of recurrence of reflux esophagitis.
Adults: prevention of gastroduodenal ulcers induced by non-steroidal anti-inflammatory drugs (NSAIDs) NSAIDs in patients at risk who require continuous treatment with NSAIDs (see section 4.4).
40 mg: adults and adolescents 12 years and older: reflux oesophagitis.
Adults: eradication of Helicobacter pylori (H. pylori) in conjunction with appropriate antibiotic therapy in patients with ulcers associated h. pylori.
Gastric and duodenal ulcer.
Zollinger-Ellison syndrome and other pathological conditions characterised by acid hypersecretion.
Classification for the purposes of new listings ' box: «20 mg gastro-resistant» 14 tablets in PA/AL/PVC/AL;
A.I.C. # 043494020 (10) 19HBN4 (based on 32);
New listings: class A (Note 1-48);
Ex factory price (excluding VAT): €2.83;
Price (VAT included): €5.30.
Package: «14» 40 mg gastro-resistant tablets in PA/AL/PVC/AL;
A.I.C. # 043494121 (10) 19HBR9 (based on 32);
New listings: class A (Note 1-48);
Ex factory price (excluding VAT): €5.11;
Price (VAT included): €9.59.

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 supply of the medicinal product ' Pantoprazolo Aurobindo» is the following: the presentations of 7, 14, 15, 28, 30, 56, 60, 98 and 100 gastro-resistant: medicinal product subject to medical prescription (RR).
For Pack of 500 gastro-resistant: medicinal product subject to medical prescription, to be used only in hospitals or in similar structure to it (OSP).
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.
Date of determination: from the day following its publication in the official journal of the Italian Republic.