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ALLEGATO I RIASSUNTO DELLE CARATTERISTICHE DEL …
Compromissione renale Non sono stati condotti studi clinici specifici in pazienti con compromissione renale. Pazienti con ... dell’epatite B e casi di epatite E, che potrebbe essere cronica. Nei pazienti trattati con IMBRUVICA si è manifestata insufficienza epatica, inclusi eventi fatali. È necessario valutare la funzionalità epatica e ...
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www.ema.europa.euICH guideline Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management EMA/CHMP/ICH/804273/2017 Page 3/36
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Guideline for good clinical practice E6(R2)
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