COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Clinimix» (20A01629)
Estratto determina AAM/PPA n. 185/2020 del 3 marzo 2020 Autorizzazione del grouping di variazioni: si autorizza il seguente grouping di variazioni: 3 x A.7) soppressione di un sito di fabbricazione per un principio attivo e un sito di confezionamento del prodotto finito;
soppressione di un sito di produzione di un intermedio di un principio attivo;
B.II.b.1.b) sostituzione di un sito di confezionamento primario del prodotto finito;
B.II.b.1.z) sostituzione di un sito di fabbricazione per la totalita' del procedimento di fabbricazione del prodotto finito;
altra variazione;
B.II.b.2.c).2 modifiche a livello di modalita' di rilascio dei lotti e di prove di controllo qualitativo del prodotto finito;
sostituzione di un fabbricante responsabile del rilascio dei lotti, incluso il controllo dei lotti e le prove;
5 x B.II.d.1.c) modifica dei parametri di specifica e dei limiti del prodotto finito;
aggiunta di un nuovo parametro di specifica alla specifica con il corrispondente metodo di prova;
3 x B.II.d.1.z) modifica dei parametri di specifica e/o dei limiti del prodotto finito;
altra variazione;
2 x B.II.d.2.b) modifica della procedura di prova del prodotto finito;
soppressione di una procedura di prova quando e' gia' autorizzato un metodo alternativo;
3 x B.II.d.2.d) modifica della procedura di prova del prodotto finito;
sostituzione di una procedura di prova;
B.II.e.1.b).2 modifica del confezionamento primario del prodotto finito;
modifica del tipo di contenitore per medicinali sterili;
B.II.e.1.b).3 modifica del confezionamento primario del prodotto finito;
soppressione di un tipo di contenitore che non comporta l'eliminazione completa di un dosaggio o di una forma farmaceutica;
B.II.e.6.a) modifica di un...
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