COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Broncho Vaxom» (18A06043)
Estratto determina AAM/PPA n. 743 del 3 settembre 2018 Autorizzazione delle variazioni: variazioni di tipo II: B.I.a.2) modifiche nel procedimento di fabbricazione del principio attivo;
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la modifica riguarda una sostanza biologica/immunologica o l'utilizzo di una sostanza derivata chimicamente diversa nella fabbricazione di una sostanza biologica/immunologica, tale da avere un impatto significativo sulla qualita', la sicurezza e l'efficacia del medicinale e che non e' collegata a un protocollo, e delle variazioni di tipo IA: B.I.a.4) modifiche delle prove in corso di fabbricazione o dei limiti applicati durante la fabbricazione del principio attivo;
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soppressione di una prova in corso di fabbricazione non significativa;
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aggiunta di nuove prove e di nuovi limiti in corso di fabbricazione, relativamente al medicinale BRONCHO VAXOM;
Codice pratica: VN2/2017/407. Sono autorizzate le seguenti variazioni: le modifiche del processo produttivo della sostanza attiva riguardo: alle condizioni della coltura batterica del ceppo Haemophilus Influenzae;
al protocollo di miscelazione dei diversi ceppi da effettuarsi in un unico passaggio;
all'eliminazione di due parametri non critici tra i controlli di processo;
all'individuazione e all'utilizzo di un valore target di residuo secco (gr/box) per ogni ceppo relativamente al medicinale «Broncho Vaxom», nelle forme e confezioni: A.I.C. n. 026029013 - «Adulti 7 mg capsule rigide» 10 capsule;
A.I.C. n. 026029037 - «Bambini 3,5 mg capsule...
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