Authorisation For The Medicinal Product For Usoumano «Valganciclovir Teva».

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

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-01-09&atto.codiceRedazionale=14A10114&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Retrieved determines the December 16, 2014 1496/2014 # Medicine: VALGANCICLOVIR TEVA.
MAh: Teva Italy S.r.l. Via Messina, 38-20154-Milan.
Package: "450 mg film-coated tablets» 60 tablets in PVC/ACLAR/PVC/AL-AIC # 042545018 (10) 18LCVU (based on 32).
Package: "450 mg film-coated tablets» 30 tablets in HDPE bottle with child resistant closure-AIC # 042545020 (10) 18LCVW (based on 32).
Package: "450 mg film-coated tablets» 60 tablets in HDPE bottle with child resistant closure-AIC # 042545032 (10) 18LCW8 (based on 32).
Package: "450 mg film-coated tablets» 30 tablets in PVC/ACLAR/PVC/AL-AIC # 042545044 (10) 18LCWN (based on 32).
Dosage form: tablets.
Composition: each tablet contains: active ingredient: valganciclovir hydrochloride 496.3 mg corresponding to 450 mg of valganciclovir.
Other ingredients: Tablet core: microcrystalline cellulose (E460 (i));
Mannitol (E421);
Magnesium stearate (E572);
Colloidal silicon dioxide (E551);
Crospovidone (E1202), grade A; Film coating: Opadry II 32K54870 pink containing: hypromellose (E464);
Titanium dioxide (E171);
Lactose monohydrate;
(E1518);
Red iron oxide (E172);
Production of active ingredient: Mylan Laboratories Limited (Unit-1) 10/42, Gaddapotharam-Kazipally, Survey no Industrial Area, Medak District 502319 Andhra Pradesh, India.
Packaging, control, batch release: Teva Operations Poland SP. z.o. or Ul. Sienkiewicza 25, 99-300 Kutno-Poland;
TEVA Gyogyszergyar Zrt. (TEVA Pharmaceutical Works Private Limited Company) Pallagi ut 13-4042 Debrecen-Hungary;
Teva Pharma S.L.U. C/C, # 4, Poligono Industrial Malpica-50016 Zaragoza-Spain;
TEVA Operations Poland SP. z o.o. UL. Mogilska 80. 31-546, Krakow-Poland;
TEVA 89100 Sens-France Bellocier Sante ' Rue;
Ludwig Merckle GmbH-Merckle-Germany 3, 89143 Blaubeuren-Straße.
Packaging, batch release: Teva UK Ltd Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG-United Kingdom.
Packaging (secondary only), control, batch release: Pharmachemie B.V. Haarlem-Netherlands 5 2031 Swensweg GA.
Manufacturing, packaging, testing, batch release: Teva Czech Industries s.r.o. Ostravska 29, c.p. 305, 74770 Opava-Komarov-Czech Republic;
PLIVA Hrvatska d.o.o (PLIVA Croatia Ltd.) Filipovica 25, 10000 Zagreb-Croatia prilaz baruna.
Batch control, batch release: HBM Pharma s or 30 Sklabinska, SK-03680 Martin-Slovak Republic.
Packaging (secondary only): Silvano Gordon Logistics S.p.a. Via Delle Industrie SNC-26814 Livraga (LO)-Italy;
Neologistic S.r.l. Largo Boccioni, 1 21040-Origgio (VA)-Italy;
CIT S.r.l. Via Primo Villa, 17-20040 Burago di Molgora (MB)-Italy;
Mono chem-pharm. Produkte GmbH Lagerbereiche 102-112, 129, 1200 Wien Handelskai Weather: Lokal 2b, 4, Austria 6-Lokal Lokal;
Etnovia Oy, Teollisuustie 16 60100 Seinajoki-Finland;
Farmagon AS Karihaugveien 22, 1086 Oslo-Norway;
Scanpharm A/s. Topstykket 12, DK-3460 Birkerød-Denmark.
Batch release: Teva Pharma B.V. Swensweg 5, 2003 RN Haarlem-Netherlands.
Packaging (primary and secondary): MPF bv Appelhof 13, 8465 RX Oudehaske-Holland;
Tjoapack B.V. Columbusstraat 4, 7825 VR Emmen-Netherlands;
MPF bv Neptunus 12, 8448 CN Heerenveen-Netherlands.
Medical indications: Valganciclovir Teva is indicated for the treatment of induction and maintenance of Cytomegalovirus (CMV) retinitis in patients with acquired immune deficiency syndrome (AIDS).
Valganciclovir Teva is indicated for the prevention of CMV disease in CMV-negative patients who received a solid organ transplantation from a donor CMV-positive.
Classification for the purposes of new listings ' box: "450 mg film-coated tablets» 60 tablets in PVC/ACLAR/PVC/AL-AIC # 042545018 (10) 18LCVU (based on 32).
New listings ' class: a. price ex factory (VAT): €610.12.
Price (VAT included): €1,144.28.
Package: "450 mg film-coated tablets» 60 tablets in HDPE bottle with child resistant closure-AIC # 042545032 (10) 18LCW8 (based on 32).
New listings ' class: a. price ex factory (VAT): €610.12.
Price (VAT included): €1,144.28.
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 drug VALGANCICLOVIR TEVA is as follows: 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-Guide, 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) 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.