COMUNICATO - Autorizzazione all''immissione in commercio del medicinale per uso umano «Etinilestradiolo e Gestodene Alfra» (12A11623)
Estratto determinazione V & A n. 1601 del 19 ottobre 2012
Descrizione del medicinale e attribuzione n. A.I.C.
E' autorizzata l'immissione in commercio del medicinale: «ETINILESTRADIOLO E GESTODENE ALFRA» nella forma e confezione: «15 microgrammi/60 microgrammi compresse rivestite con film» 28 compresse con le specificazioni di seguito indicate, a condizione che siano efficaci alla data di entrata in vigore della presente determinazione:
titolare A.I.C.: Alfra di anselmo leonarda & C. SNC-Societa' in nome collettivo con sede legale e domicilio fiscale in 00185 - Roma, viale Manzoni, 59, codice fiscale 03935261002.
Confezione: «15 microgrammi/60 microgrammi compresse rivestite con film» 28 compresse - A.I.C. n. 039525011 (in base 10) 15Q6NM (in base 32).
Forma farmaceutica: compressa rivestita con film.
Validita' prodotto integro: 3 anni dalla data di fabbricazione.
Produttori del principio attivo: N.V. Organon, Kloosterstraat 6, NL-5349 AB OSS OR Veersemeer 4, NL-5347 JN OSS - Olanda; Libbs Farmoquimica LTDA, Rua Dona Cesaria Camargo De Oliveira 240, Jardim Vista Alegre - 06807 320 - EMBU- San Paolo - Brasile; Industriale chimica S.r.l., stabilimento sito in 21047 - Saronno (VA), Via E. H. Grieg 13 - Italia.
Produttore del prodotto finito: Haupt Pharma Münster GMBH stabilimento sito in Münster - Germania, Scleebrüggenkamp 15 (produzione, confezionamento, controllo); Helm AG, stabilimento sito in Germania, Nordkanalstrasse 28, 20097 Amburgo (rilascio dei lotti).
Composizione: una compressa rivestita con film.
Principio attivo:
Gestodene 60 mcg;
Etinilestradiolo 15 mcg.
Eccipienti: Compressa gialla (attiva): Lattosio monoidrato 46.725 mg; cellulosa microcristallina 20 mg; Distearato glicerolo 0.350 mg; Polacrilin...
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