Parte Seconda n. 31 del 19-3-2011
Altri annunzi
Specialita' medicinali, presidi sanitari e medico chirurgici
SPEPHARM HOLDING BV
(GU Parte Seconda n.31 del 19-3-2011)

Modifica secondaria di un'autorizzazione all'immissione in commercio
di specialità medicinale per uso umano. Modifica apportata ai
sensi D.Lgs. 274/07

Titolare AIC: SpePharm Holding BV, con sede in Kingsfordweg, 151 -
1043GR Amsterdam (Paesi Bassi)
Specialità Medicinale: Dantrium
Confezioni e numero AIC: 20 mg polvere per soluzione per infusione
- 12 flaconcini AIC n. 024372094
20 mg polvere per soluzione per infusione - 36 flaconcini AIC n.
024372082
Codice Pratica N1B/2010/3443
Modifica apportata ai sensi del Regolamento (CE) 1234/2008
grouping di 19 variazioni tipo IA, IAIN, IB forseen, IB unforseen:
B.II.b.1.f Replacement of a manufacturing site for part of the
manufacturing process of the finished product from Ben Venue
Laboratories, Inc. to Recipharm GmbH; B.II.b.1.a Replacement of a
manufacturing site for secondary packaging of the finished product
from Farmaceutici Formenti S.p.A. to Stegemann Lohnverpackung und
Logistischer Service e.K; n. 3 B.II.b.2.a Change to batch release
arrangements and quality control testing of the finished product,
addition of a site where testing takes place Recipharm GmbH,
replacement of a site where testing takes place from Farmaceutici
Formenti to Rottendorf Pharma GmbH, replacement of a site where
quality control testing takes place from Biolab S.p.A. to
Mikrobiologisches Laboratorium Dr. Manfred Jacobs; B.II.b.2.b Change
to batch release arrangements of the finished product from
Farmaceutici Formenti S.p.A. to SpePharm Holding B.V., n. 3 B.II.b.5
Change to in-process tests or limits applied during the manufacture
of the finished product, a) Tightening of in-process limits: PH; b)
addition of a new tests and limits: density; c) deletion of a
non-significant in-process test: Water Content; n. 5 B.II.d.1 Change
in the specification parameters and/or limits of the finished
product, c) addition of a new specification parameter and method:
solubility at shelf-life; c) addition of a new specification
parameter and method: particulate contamination (sub-visible
particles) at release; a) tightening of specification limits: PH at
release; a) tightening of specification limits: assay limits at
release and shelf-life; a) tightening of specification limits:
degradation product F-524; n. 4 B.II.d.2 Change in test procedure for
the finished product, d) other changes to a test procedure: Heavy
metals; d) other changes to a test procedure: Content uniformity; d)
other changes to a test procedure: addition of a method for
determination of degradation product F-524; d) other changes to a
test procedure: addition of a method for the assay of dantrolene
sodium; B.II.b.3 Change in the manufacturing process of the finished
product: filtration phase.
Codice Pratica N1B/2010/4242
Modifica apportata ai sensi del Regolamento (CE) 1234/2008
variazione tipo IB n. B.II.b.3 Change in the manufacturing process of
the finished product: phase of preparation of the solution.
I lotti già prodotti alla data della pubblicazione in G.U. possono
essere mantenuti in commercio fino alla data di scadenza indicata in
etichetta.

Un Procuratore
Dr.Ssa Ida Caramazza


T11ADD3156