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

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

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-01-05&atto.codiceRedazionale=14A10042&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Retrieved determines the TECNIGEN # 1524/2014: Tecnigen: December 16, 2014 Medicine VALACICLOVIR Mah S.r.l. via Galileo Galilei, 40-20092 Cinisello Balsamo (MI) packaging: "250 mg film-coated tablets" 60 tablets in PVC/PE/PVDC/PE/PVC/AL-AIC # 042596015 (10) 18MXPH (based on 32);
"500 mg film-coated tablets" 42 tablets in PVC/PE/PVDC/PE/PVC/AL-AIC # 042596027 (10) 18MXPV (based on 32);
"1000 mg film-coated tablets" 21 tablets in PVC/PE/PVDC/PE/PVC/AL-AIC # 042596039 (10) 18MXQ7 (based on 32).
Pharmaceutical form: film-coated tablet.
Composition: each film-coated tablet contains: active substance: Valacyclovir TecniGen 250 mg film-coated tablets: each tablet contains 250 mg of valaciclovir hydrochloride equivalent to valaciclovir;
TecniGen valaciclovir 500 mg film-coated tablets: each tablet contains 500 mg of valaciclovir hydrochloride equivalent to valaciclovir;
Valaciclovir TecniGen 1000 mg film-coated tablets: each tablet contains valaciclovir hydrochloride equivalent to 1000 mg of valacyclovir.
Other ingredients: Tablet core: Povidone pregelatinised Crospovidone colloidal anhydrous magnesium stearate coating: Opadry OY-S-28861 [titanium dioxide (E171), hypromellose, Macrogol 400] production of the active ingredient (with possible signs of production): Assia Chemical Industries Ltd-Teva-Tech Site Neot-Eco-Hovav Industrial Park, Emek Sara, p. O Box 2049 Be'er Sheva Israel 8412316 Teva Pharmaceutical Fine Chemicals S.r.l.
Strada Statale Briantea KM 36 # 83, 23892 Bulciago (LC) Italy Aurobindo Pharma Limited Unit-XI, Survey No. 61-66, IDA, Pydibhimavaram, Ranasthalam Mandal, Srikakulam Dist, Andhra Pradesh, India, PIN: 532 409 primary secondary packaging production, packaging, batch control, batch release: West Pharma-Produções de Especialidades Farmacêuticas S.A.
Rua João de Deus, n. º 11, Venda Nova 2700-486 Amadora, Portugal primary packaging, secondary packaging, batch control, batch release: Atlantic Pharma-Produções Farmacêuticas, S.A.
Rua da Tapada Grande, n º 2, Abrunheira Sintra, Portugal 2710-089 medical indications: Varicella zoster virus (VZV) Infection-shingles TecniGen Valaciclovir is indicated for the treatment of herpes zoster and ophthalmic zoster in immunocompetent adults.
TecniGen valaciclovir is indicated for the treatment of herpes zoster in adults with mild to moderate entity immunosuppression.
Herpes simplex virus (HSV) TecniGen Valaciclovir is indicated for the treatment and suppression of HSV infections of the skin and mucous membranes that include: treatment of the first episode of genital herpes in adults and adolescents who are immunocompetent and immunocompromised adults treating recurrent infections of genital herpes in adults and adolescents who are immunocompetent and immunocompromised adults suppression of recurrent genital herpes in adults and adolescents who are immunocompetent and immunocompromised adults For the treatment and suppression of infections recurrent HSV ocular.
No clinical studies have been conducted in patients with immunocompromised HSV infection to other causes other than HIV infection.
Cytomegalovirus infections (CMV) TecniGen Valaciclovir is indicated for the prophylaxis of CMV infection and disease caused by solid organ transplantation in adults and adolescents.
New listings for the purposes of classification is packaging: "250 mg film-coated tablets" 60 tablets in PVC/PE/PVDC/PE/PVC/AL-AIC # 042596015 (10) 18MXPH (based on 32).
New listings ' class: c. packaging: "500 mg film-coated tablets" 42 tablets in PVC/PE/PVDC/PE/PVC/AL-AIC # 042596027 (10) 18MXPV (based on 32).
New listings class ': A Note 84 price ex factory (VAT): €35.34 retail price (VAT included): €66.28 packaging: "1000 mg film-coated tablets" 21 tablets in PVC/PE/PVDC/PE/PVC/AL-AIC # 042596039 (10) 18MXQ7 (based on 32).
New listings class ': A Note 84 price ex factory (VAT): €35.34 retail price (VAT included): €66.28 Classification for the purpose of the classification for the purposes of providing the medicine Valaciclovir Tecnigen is the following medicinal product subject to medical prescription (RR).
Terms and conditions of use only for prescription medicine packaging classified in 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.
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 application of the determination on the day following its publication in the official journal of the Italian Republic.