COMUNICATO - Variazione di tipo II all'autorizzazione, secondo procedura nazionale, del medicinale per uso umano «Contramal». (13A07064)
Estratto determinazione V &
A n. 1381 del 6 agosto 2013 Titolare AIC: Grunenthal Italia S.r.l. con sede legale e domicilio fiscale in via Vittor Pisani, 16, 20124 - Milano (MI) codice fiscale 04485620159. Medicinale: CONTRAMAL. Variazione AIC: B.II.b.1 d) Sostituzione o aggiunta di un sito di fabbricazione per una parte o per la totalita' del procedimento di fabbricazione del prodotto finito Sito che richiede un'ispezione iniziale o specifica a un prodotto. L'autorizzazione all'immissione in commercio e' modificata come di seguito indicata e' autorizzata la modifica relativa all'introduzione del produttore Grunental GmbH (Zieglerstrasse,6 -52078 Aachen Germania) per le seguenti fasi: produzione del bulk e confezionamento...
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