GLAXOSMITHKLINE - S.p.a.
Modifica secondaria di un'autorizzazione all'immissione in commercio
di specialita' medicinale per uso umano. (Comunicazione Agenzia
italiana del farmaco).
Titolare: The Wellcome Foundation Ltd., rappresentante legale e di vendita GlaxoSmithKline S.p.a., via A. Fleming n. 2, Verona.
Specialita' medicinale: THIOGUANINE WELLCOME.
Confezione e numero di A.I.C.:
"40 mg compresse" 25 compresse - A.I.C. n. 022825018.
Modifica apportata ai sensi del regolamento (CE) n. 1084/2003.
Codice pratica: N1B/07/1786 del 15 novembre 2007.
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c Sostituzione della procedura di prova approvata TLC per l'identificazione del contenuto di tioguanina nel prodotto finito con HPLC.
Codice pratica: N1B/07/1787 del 15 novembre 2007.
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c Sostituzione della procedura di prova approvata TLC per la determinazione del contenuto delle sostanze correlate nel prodotto finito con HPLC.
Codice pratica: N1B/07/1788 del 15 novembre 2007.
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c Sostituzione della procedura di prova approvata UV per la determinazione del contenuto di tioguanina nel prodotto finito con HPLC.
Codice pratica: N1A/07/1899 del 16 novembre 2007.
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