COMUNICATO - Variazione di tipo II all'autorizzazione, secondo procedura di mutuo riconoscimento, del medicinale «Octanine». (13A00387)
Estratto determinazione V &
A/1954 del 29 novembre 2012 Medicinale: OCTANINE Confezioni: relativamente alle confezioni autorizzate all'immissione in commercio in Italia a seguito di Procedura di Mutuo Riconoscimento. Titolare AIC: OCTAPHARMA ITALY S.P.A. N° Procedura Mutuo Riconoscimento: DE/H/0213/001-002/II/037/G. Tipo di Modifica: Modifiche nel procedimento di fabbricazione della sostanza attiva. La modifica riguarda una sostanza biologica/immunologica o l'utilizzazione di una sostanza derivata chimicamente differente nella fabbricazione di un medicinale biologico/immunologicoe non collegata a un protocollo. Modifica Apportata: Il grouping di variazioni :"Modifiche nel procedimento di fabbricazione della sostanza attiva. La modifica riguarda una sostanza biologica/immunologica o l'utilizzazione di una sostanza derivata chimicamente differente nella fabbricazione di un medicinale biologico/immunologico e non e' collegata a un protocollo. "Modifica dei parametri di specifica e/o dei limiti del principio attivo, di una materia prima, di una sostanza intermedia o di un reattivo utilizzato nel procedimento di fabbricazione del principio attivo"." Soppressione di un parametro di specifica non significativo (ad...
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