Dompe' S.P.A
Modifiche secondarie di un'autorizzazione all'immissione in commercio di specialita' medicinali per uso umano. Modifiche apportate ai sensi del D.Lgs 29 dicembre 2007, n. 274.
Titolare: United Therapeutics Europe Ltd - Chertsey, KT16 9FG (UK) Specialita' medicinale: REMODULIN confezioni e numeri A.I.C.: 037057 - 'Tutte le confezioni' Modifiche apportate ai sensi del Regolamento (CE) 1084/2003:
- var. tipo IB n. 33: modifica minore della produzione del prodotto finito (PMR n. FR/H/0278/001-004/IB/013).
- var tipo IB n. 42) a) 1: modifica del periodo di validita' del prodotto finito confezionato per la vendita (da 30 mesi a 3 anni)...
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