COMUNICATO - Modificazione dell'autorizzazione all'immissione in commercio del medicinale 'Buccalin'
Estratto determinazione AIC/N/V n. 1947 del 14 settembre 2007
Medicinale: BUCCALIN.
Titolare A.I.C.: Laboratorio Farmaceutico Sit Specialita' Igienico Terapeutiche S.r.l., con sede legale e domicilio fiscale in via Cavour, 70 - 27035 Mede (Pavia), codice fiscale n. 01108720598.
Variazione A.I.C.: aggiunta/sostituzione di officina di produzione del prodotto finito per tutte o alcune fasi della produzione e adeguamento standard terms.
L'autorizzazione all'immissione in commercio e' modificata come di seguito indicato: e' autorizzata la modifica relativa alla sostituzione dell'officina Istituto Sieroterapico e vaccinogeno Berna sito in Berna (Svizzera) con l'officina Laboratorio Farmaceutico SIT srl sito in via Cavour, 70 - Mede (Pavia) per le fasi di produzione, confezionamento primario e secondario, controlli e rilascio del lotto, relativamente alle confezioni sottoelencate:
bb 4 compresse 0,2 g - A.I.C. n. 022928016;
ad 7 compresse 0,2 g - A.I.C. n. 022928028.
Sono inoltre modificate, secondo...
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