Organon Italia - S.p.a.
Modifica secondaria di un'autorizzazione all'immissione
in commercio di specialita' medicinale per uso umano
Titolare: N.V. Organon, Kloosterstraat n. 6, 5349 AB, Oss (Olanda). Rappresentante in Italia: Organon Italia S.p.a., via Ostilia n. 15, 00184 Roma.
Comunicazioni Agenzia italiana del farmaco del 30 agosto 2007.
Specialita' medicinale: PRACTIL 21.
Confezione e numero di A.I.C.:
"0,15 mg + 0,03 mg compresse" 21 compresse - A.I.C. n. 025253016.
Codice pratica: N1A/07/1243BIS.
Modifica apportata ai sensi del regolamento (CE) n. 1084/2003: 38.a Modifiche minori del metodo TLC impiegato per l'identificazione del desogestrel, etinilestradiolo e all-rac-alfa-tocoferolo nel prodotto finito.
Codice pratica: N1A/07/1242BIS.
Modifica apportata ai sensi del regolamento (CE) n. 1084/2003: 38.a Modifiche minori del metodo HPLC impiegato per la determinazione del desogestrel, etinilestradiolo e all-rac - alfa-tocoferolo, per la verifica dell'unita' di contenuto del desogestrel e dell'etinilestradiolo e per la determinazione dei prodotti di degradazione.
Comunicazioni Agenzia italiana del farmaco del 5 ottobre 2007.
Specialita' medicinale: PRACTIL 21.
Confezione e numero di A.I.C.:
"0,15 mg + 0,03 mg compresse" 21 compresse - A.I.C. n. 025253016.
Codice pratica: N1B/07/1190.
Modifica apportata ai sensi del regolamento (CE) n. 1084/2003: 37.b Aggiunta del paramentro di prova "degradation product" alle specifiche al termine del periodo di validita' del prodotto finito.
Codice pratica: N1B/07/1189.
Modifica apportata ai sensi del regolamento (CE) n. 1084/2003: 37.b Aggiunta del parametro di prova "contaminazione microbica" col relativo metodo per la determinazione descritto nella corrente edizione della Farmacopea europea, alle specifiche al rilascio del prodotto finito.
Comunicazione Agenzia italiana del farmaco del...
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