COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Haemoctin» (19A02347)
Estratto determina AAM/PPA n. 276 del 26 marzo 2019 Autorizzazione delle variazioni: Variazione di tipo II: B.II.a.5) «Modifica nella concentrazione di un prodotto monodose per uso parenterale, utilizzazione totale, quando la quantita' di sostanza attiva per dose unitaria (vale a dire il dosaggio) rimane la stessa» e la variazione di tipo IAIN : B.IV.1.a.1) «Modifica di un dosatore o di un dispositivo di somministrazione - Aggiunta o sostituzione di un dispositivo che non costituisce parte integrante del confezionamento primario - Dispositivo munito di marcatura CE», relativamente al medicinale HAEMOCTIN. Numero di procedura: n. DE/H/0478/001-003/II/048/G. Sono autorizzate le seguenti variazioni: dimezzamento del volume di solvente «Sterilized Water for Injections (WFI)» da 10 ml a 5 ml;
sostituzione della siringa monouso da 10 ml con una siringa da 5 ml. Aggiornamento del riassunto delle caratteristiche del prodotto alle sezioni 2, 6.5 e 8 e corrispondenti paragrafi del foglio illustrativo e delle etichette, relativamente al medicinale «Haemoctin», nelle forme e confezioni autorizzate all'immissione in commercio in Italia a seguito di procedura di mutuo riconoscimento. Gli stampati corretti ed approvati sono allegati alla determina, di cui al presente estratto. Titolare A.I.C.: Biotest Pharma GmbH, con sede legale e domicilio fiscale in D-63303 Dreieich, Landsteinerstrasse 5, Germania (DE). Stampati 1. Il titolare dell'autorizzazione all'immissione in commercio deve apportare le modifiche autorizzate, dalla data di entrata in vigore della presente...
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