Ferring S.p.A.
MODIFICHE SECONDARIE DI UN'AUTORIZZAZIONE ALL'IMMISSIONE IN COMMERCIO DI SPECIALITA' MEDICINALE PER USO UMANO. MODIFICHE APPORTATE AI SENSI DEL DECRETO LEGISLATIVO 29 DICEMBRE 2007, n. 274
TITOLARE: FERRING S.p.A.
SPECIALITA' MEDICINALE: ZOMACTON CONFEZIONE E NUMERO A.I.C.:
- 1 flac.liof.4 mg + 1 fiala solv.3,5 ml - AIC n. 027743032/M VARIAZIONE DI TIPO IA SECONDO PROCEDURA DI MUTUO RICONOSCIMENTO Modifica apportata ai sensi del regolamento (CE) 1084/2003: n.43a1 - aggiunta di un dispositivo di somministrazione che non e' parte integrante del confezionamento primario (needle injection device).
Procedura n.FR/H/0016/002/IA/038 conclusasi in data 28 ottobre 2009.
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