Authorisation For The Medicinal Product For Usoumano «Travoprost Sandoz».

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

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-03-21&atto.codiceRedazionale=15A02052&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Retrieved March 2, 2015 # 241/2015 of Medicine determines: TRAVOPROST SANDOZ.
A.I.C. owner: Sandoz S.p.a., largo u. Boccioni n. 1-21040 Origgio (Varese).
Packaging: «40 micrograms/ml eye drops» 1 dropper bottle in pp from 2.5 ml-A.I.C. # 043373012 (10), 19CNGN (32);
«40 micrograms/ml eye drops» 3 2.5 ml pp dropper bottles-A.I.C. # 043373024 (10), 19CNH0 (32).
Pharmaceutical form: eyedrops, solution.
Composition: each ml of solution contains: active ingredient: 40 micrograms of travoprost;
other ingredients: benzalkonium chloride solution, macrogolglycerol Hydroxystearate thickening grease 40, trometamol, disodium Edetate, boric acid (E284), mannitol (E421), sodium hydroxide and/or hydrochloric acid (to adjust pH), purified water.
Validity complete appliance: before opening: 3 years;
After first opening: 4 months.
Producer active ingredient: Dr. Reddy's Laboratories Limited;
administrative site: 1/7/27, Ameerpet, Hyderabad 500 016, Andhra Pradesh;
production site: Steanard Lane, Mirfield, West Yorkshire, WF14 8 Hz, United Kingdom.
Batch release, batch control, production, primary and secondary packaging: Alcon-Couvreur n.v.-Rijksweg 14, B-2870 Puurs, Belgium;
Alcon Cusi ' s.a.-Camil Fabra 58, 08320 El Masnou, Barcelona, Spain.
Batch release, batch control and secondary packaging: Lek Pharmaceuticals d.d. -Verovškova 57, 1526 Ljubljana, Slovenia;
Salutas Pharma GmbH-Otto-von-Guericke-Allee 1, 39179 Barleben, Germany;
Aeropharm GmbH-Francois-mitterrand-allee 1, 07407 Rudolstadt, Germany.
Outer carton: UPS Healthcare Italy S.r.l., via Formellese 00060-Formello (Roma) Italy 4.300 km;
CRNA SA-Zoning Industriel d'heppignies 1, Fleurus, Hainaut, B-6220, Belgium.
Medical indications: reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.
Classification for the purposes of new listings ' box: «40 micrograms/ml eye drops» 1 dropper bottle in pp from 2.5 ml-A.I.C. # 043373012 (10), 19CNGN (32); new listings ' class «A»; ex factory price (excluding VAT): €6.69; price (VAT included): €12.55.
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 «Travoprost Sandoz» it is classified, in accordance with 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, 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 supply of the medicinal product ' Travoprost Sandoz» 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. generic drugs 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.