Parte Seconda n. 120 del 9-10-2014
Altri annunzi
Specialita' medicinali, presidi sanitari e medico chirurgici
SIGMA-TAU I.F.R. S.P.A.
Sede legale: viale Shakespeare, 47 - 00144 Roma
(GU Parte Seconda n.120 del 9-10-2014)

Modifica secondaria di autorizzazione all'immissione in commercio di
medicinale per uso umano. Modifica apportata ai sensi del D.Lgs
219/2006 e s.m.i.


Titolare: Sigma-Tau I.F.R. SpA - Viale Shakespeare, 47 00144 Roma
Specialità medicinale: SYNACTHEN
Confezioni e numero di AIC: 1 mg/ml sosp. iniett. a rilascio prol.
per uso IM , 1 fiala 1 ml - AIC n. 020780021
Grouping di n. 12 variazioni apportate ai sensi del Regolamento CE
n. 1234/2008, così come modificato dal Regolamento (UE) n. 712/2012:
Cod. pratica: N1B/2013/3098
Var. n. 1: IB unforseen: B.II.d.1.z: Change in the specification
parameters and/or limits of the finished product: Other (Appearance).
Var. n. 1: IB (upgraded): B.II.d.1.h: Change in the specification
parameters and/or limits for the finished product: Update of the
dossier to comply with the provisions of an updated general monograph
of the Ph. Eur for the finished product (Change in the limit of the
test Extractable volume from "1.0-1.2 ml" to "not less than 1.0 ml").
Var. n. 1: IB (upgraded): B.II.d.1.a: Change in the specification
parameters and/or limits for the finished product: Tightening of
specification limits (Tightening of specification limits for the test
"Degradation products of Thetracosactide").
Var. n. 1: IA: B.II.d.1.c: Change in the specification parameters
and/or limits for the finished product: Addition of a new
specification parameter to the specification with its corresponding
test method (addition of the parameter "Identification of Benzyl
Alcohol by RR-LC" to the release specification only).
Var. n. 1: IA: B.II.d.1.c: Change in the specification parameters
and/or limits for the finished product: Addition of a new
specification parameter to the specification with its corresponding
test method (addition of the parameter "Assay of Benzyl Alcohol by
RR-LC" both at release and at shelf-life).
Var. n. 1: IA: B.II.d.1.d: Change in the specification parameters
and/or limits for the finished product: Deletion of a non-significant
parameter (e.g. deletion of an obsolete parameter such as odour and
taste or identification test for a colouring or flavouring material)
(deletion of the parameter "Assay of Benzyl Alcohol by HPLC" both at
release and at shelf-life).
Var. n. 1: IA: B.II.d.1.c: Change in the specification parameters
and/or limits for the finished product: Addition of a new
specification parameter to the specification with its corresponding
test method (addition of the parameter "Sterility" to the shelf file
specifications, to be performed during the stability studies at the
end of the investigated storage period).
Var. n. 1: IB: B.II.d.2.d: Change in test procedure for the
finished product. Other changes to a test procedure (including
replacement or addition) (replacement of the TLC method used for
Identity Tetracosactide).
Var. n. 1: IB: B.II.d.2.d: Change in test procedure for the
finished product: Other changes to a test procedure (including
replacement or addition) (replacement of the HPLC method used for
Identity, Assay and Degradation product of Tetracosactide)
Var. n. 1: IB: B.II.d.2.d: Change in test procedure for the
finished product: Other changes to a test procedure (including
replacement or addition) (replacement of the HPLC method used for the
quantification of Benzaldehyde, the degradation product of Benzyl
alcohol).
Var. n. 1: IB (upgraded): B.II.f.1.a.1 Change in the shelf-life or
storage conditions of the finished product: Reduction of the shelf
life of the finished product, As packaged for sale (Reduction of the
shelf life of the finished product from 36 months to 24 months).
Var. n. 1: IB (upgraded) B.II.d.2.a: Change in test procedure for
the finished product: Minor changes to an approved test procedure
(Minor change to the analytical method for the test "Sterility"
detailed in Ph. Eur. monograph 2.6.1, passing from the Direct
inoculation" technique to the "Membrane filtration" technique).
I lotti già prodotti sono mantenuti in commercio fino alla data di
scadenza indicata in etichetta. Decorrenza della modifica: dal giorno
successivo alla data di pubblicazione nella Gazzetta Ufficiale.

Direttore affari regolatori
dott.ssa Mirella Franci


T14ADD11878