COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso umano «Novadien». (13A04209)
Estratto determinazione V &
A n. 582 del 16 aprile 2013 Descrizione del medicinale e attribuzione n. AIC E' autorizzata l'immissione in commercio del medicinale: «NOVADIEN», nella forma e confezione: "2 mg/0,03 mg compresse rivestite con film" 21 compresse, alle condizioni e con le specificazioni di seguito indicate, purche' siano efficaci alla data di entrata in vigore della presente determinazione: Titolare AIC: Farmitalia Industria Chimico Farmaceutica S.r.l. con sede legale e domicilio fiscale in Viale Alcide De Gasperi, 165/B, 95127 - Catania, Codice Fiscale 03115090874. Confezione: "2 mg/ 0,03 mg compresse rivestite con film" 21 compresse - AIC n. 041390016 (in base 10) 17H3Y0 (in base 32). Forma Farmaceutica: Compressa rivestita con film Validita' Prodotto Integro: 3 anni dalla data di fabbricazione Produttori dei principi attivi: Dienogest: Crystal Pharma S.A.U., Parque Tecnologico De Boecillo - Valladolid, 47151- Spagna;
Industriale Chimica S.r.l., stabilimento sito in 21047 - Saronno (Varese), Via E. H. Grieg 13;
Etinilestradiolo: Organon NV, Kloosterstraat 6, 5349 AB 0SS - Olanda;
Organon NV, Veersemeer 4, 5347 JN 0SS - Olanda;
Produttore del prodotto finito: Haupt Pharma Munster GMBH stabilimento sito in Munster - Germania, Schleebruggenkamp 15 (produzione, confezionamento e controlli);
Helm AG, Nordkanalstrasse 28 20097 - Hamburg, Germania (rilascio dei lotti);
Composizione: Una compressa rivestita con film contiene: Principi Attivi: Dienogest 2 mg;
Etinilestradiolo 0,03 mg Eccipienti: Nucleo della compressa: Lattosio monoidrato 57,17 mg;
Amido di mais 12 mg;
Povidone K 30 3 mg;
Amido di sodio glicolato 5 mg;
...
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