COMUNICATO - Autorizzazione all''immissione in commercio del medicinale «Venoruton» (11A09006)
Estratto determinazione V & A.N/ n. 883 del 16 giugno 2011
Descrizione del medicinale e attribuzione numero A.I.C.: e' autorizzata l'immissione in commercio del medicinale: VENORUTON, anche nella forma e confezione: «500 mg compresse rivestite con film» 30 compresse alle condizioni e con le specificazioni di seguito indicate, a condizione che siano efficaci alla data di entrata in vigore della presente determinazione.
Titolare A.I.C.: Novartis Consumer Health S.P.A. con sede legale e domicilio fiscale in Largo Umberto Boccioni n. 1 - 21040 - Origgio (Varese) - codice fiscale 00687350124.
Confezione: «500 mg compresse rivestite con film» 30 compresse - A.I.C. n. 017076148 (in base 10) 0J93XN (in base 32).
Forma farmaceutica: compressa rivestita con film.
Validita' prodotto integro: 5 anni dalla data di fabbricazione.
Produttore del principio attivo: Novartis Consumer Health S.A. stabilimento sito in Route de L'etraz - Case Postale 269, 1260 Nyon - Canton Vaud (Svizzera).
Produttore del prodotto finito:
Novartis Farma S.P.A. stabilimento sito in via Provinciale Schito n. 131 - 80058 Torre Annunziata - Napoli (produzione confezionamento completo, controlli di qualita' sul prodotto finito e rilascio del lotto);
Kemwell PVT, LTD stabilimento sito in 34th Km, Tumkur Road, T-Begur, 562123 Nelamangala, Bangalore (India), (produzione, confezionamento completo, controlli di qualita');
Kemwell AB stabilimento sito in Svezia, 75182 Uppsala...
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