Authorisation For The Medicinal Product For Usoumano «Tecnigen» Escitalopram.

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

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-03-21&atto.codiceRedazionale=15A02045&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Retrieved March 2, 2015 2015 the resolution No. 215/Medicine: ESCITALOPRAM TECNIGEN.
MAh: Tecnigen S.r.l. Via Galileo Galilei, 40-20092 Cinisello Balsamo (Milan) «10 mg film-coated tablets» 28 tablets in PVC/PE/PVDC/PE/PVC + AL-AIC # 043497015 (10) 19HFKR (based on 32) «20 mg film-coated tablets» 28 tablets in PVC/PE/PVDC/PE/PVC + AL-AIC # 043497027 (10) 19HFL3 (based on 32) «20 mg/ml oral drops , 15 ml dropper bottle» 1 solution with child resistant closure-AIC # 043497039 (10) 19HFLH (based on 32) dosage form: film-coated tablet, oral drops, solution composition: Each film-coated tablet contains: active ingredient: 10 mg, 20 mg of escitalopram (such as oxalate).
Other ingredients: Tablet core microcrystalline croscarmellose sodium colloidal Talc magnesium stearate coating Hypromellose Macrogol titanium dioxide (E171) (Opadry OY-white S-28849) oral drops, solution: each ml of solution contains: active ingredient: 20 mg escitalopram (25.551 mg of escitalopram oxalate).
Excipients: citric acid anhydrous Ethanol 96% Propyl gallate, purified water sodium hydroxide Hydrochloric Acid Production active ingredient: film-coated tablets Zhejiang Huahai Pharmaceutical Co., Ltd.
Xunqiao, Linhai, Zhejiang Linhai 317,024 China Dr. Reddy's Laboratories Limited Chemical Technical Operations, Unit-IV, Plot No 9/A, Phase III, I.D.A. Jeedimetla, Hyderabad Andhra Pradesh India 500,055 oral drops, solution Zhejiang Huahai Pharmaceutical Co., Ltd.
Xunqiao, Linhai, Zhejiang Linhai 317,024 China manufacturing, primary and secondary packaging, control and batch release of finished product (tablets): Atlantic Pharma-Produções Farmacêuticas, S.A.
Rua da Tapada Grande, 2710-089, Abrunheira Sintra No 2, Portugal West Pharma-Produções de Especialidades Farmacêuticas S.A.
Rua João de Deus, # 11, 2700-Venda Nova 486 Amadora, Portugal production, primary and secondary packaging, control and batch release of finished product (oral drops, solution): Atlantic Pharma-Produções Farmacêuticas, S.A.
Rua da Tapada Grande, 2710-089, Abrunheira Sintra No 2, Portugal finished product inspection (oral drops, solution): Tecnimede-Sociedade technico-Medicinal S.A.
Quinta da Cerca, Caixaria, 2565-Dois Portos 187 Portugal medical indications: treatment of major depressive episodes.
Treatment of panic disorder with or without agoraphobia.
Treatment of social anxiety disorder (social phobia).
Treatment of generalized anxiety disorder.
Treatment of obsessive-compulsive disorder.
Classification for the purposes of new listings is 10 Confection «mg film-coated tablets» 28 tablets in PVC/PE/PVDC/PE/PVC + AL-AIC # 043497015 (10) 19HFKR (based on 32) new listings ' class «A» ex factory Price + VAT € 5.45.
Price (VAT included) € 10.22.
Package «20 mg film-coated tablets» 28 tablets in PVC/PE/PVDC/PE/PVC + AL-AIC # 043497027 (10) 19HFL3 (based on 32).
New listings ' class «A» ex factory Price + VAT € 10.75.
Price (VAT included) € 20.16.
Package «20 mg/ml oral drops, solution 15 ml dropper bottle» 1 with child resistant closure-AIC # 043497039 (10) 19HFLH (based on 32) new listings ' class «A» ex factory Price + VAT € 5.45 price (VAT included) € 10.22 Classification for the purpose of the classification for the purposes of providing the medicine ESCITALOPRAM TECNIGEN is as follows: medicinal product subject to medical prescription (RR).
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 co. 2 of legislative decree 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.