Prostrakan limited
Modifica secondaria di un'autorizzazione all'immissione in commercio di una specialita' medicinale per uso umano. (Modifiche apportate ai sensi del decreto legislativo 29 dicembre 2007, n. 274).
Modifiche apportate ai sensi del regolamento n. 1084/2003/CE.
Specialita' medicinale: RECTOGESIC.
Confezione e numero di A.I.C.:
4 mg/ml unguento rettale tubo da 30 g - A.I.C. n. 037537014/M.
MRP n. UK/H/823/01/IA/11, Variazione Tipo IA n. 38a, modifica minore di una procedura di prova approvata del prodotto finito:
modifica relativa al test di viscosita'.
MRP n. UK/H/823/01/IA/12, Variazione Tipo IA n. 6 a, modifica del codice ATC per medicinali destinati all'uso umano, categoria farmacoterapeutica: muscolo rilassante; ATC: C05AE01.
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