Parte Seconda n. 126 del 29-10-2011
Altri annunzi
Specialita' medicinali, presidi sanitari e medico chirurgici
RB PHARMACEUTICALS LTD
(GU Parte Seconda n.126 del 29-10-2011)

Modifica secondaria di un'autorizzazione all'immissione in commercio
di una specialità medicinale per uso umano. Modifica apportata ai
sensi del Decreto Legislativo 29 dicembre 2007,n. 274

Titolare AIC: RB Pharmaceuticals Ltd, con sede in 103-105 Bath Road
- Slough, Berkshire SL1 3UH, Regno Unito
Specialità Medicinale: Subutex
Confezioni e numero AIC:
0,4 mg compresse sublinguali - AIC n. 033791017
2 mg compresse sublinguali - AIC n. 033791029
8 mg compresse sublinguali - AIC n. 033791031
Codice Pratica N1B/2011/1520
Modifica apportata ai sensi del Regolamento (CE) 1234/2008
grouping di 6 variazioni tipo IA e IB: Type IA n B.II.b.3 Change in
the manufacturing process of the finished product a) minor change in
the manufacturing process of an immediate release solid oral dosage
form or oral solutions; Type IA n B.II.b.5 Change to in-process tests
or limits applied during the manufacture of the finished product b)
Addition of new tests and limits; Type IA n B.II.e.1 Change in
immediate packaging of the finished product a) Qualitative and
quantitative composition 1) Solid pharmaceutical forms; Type IA n
B.II.e.4 Change in shape or dimensions of the container or closure
(immediate packaging) a) Non-sterile medicinal products; Type IB n
B.II.f.1 Change in the shelf-life or storage conditions of the
finished product b) Extension of the shelf-life of the finished
product 1) As packaged for sale (supported by real time data): Shelf
Life: Three years; Type IB n B.II.f.1 Change in the shelf-life of the
finished product b) extension of the shelf life of the finished
product z) other variation (real time data does not cover the
proposed shelf-life): Shelf Life Subutex 2 mg: Two years, Subutex 0,4
mg e Subutex 8mg: Three years
Codice Pratica N1B/2011/1529
Modifica apportata ai sensi del Regolamento (CE) 1234/2008
grouping di 19 variazioni tipo IA e IB
Type IA n B.II.d.1 Change in the specification parameters and/or
limits of the finished products c) addition of a new specification
paramater to the specification with its corresponding test method:
shelf-life, weight uniformity (Subutex 0,4 mg, 2mg, 8mg); N. 3 Type
IA variations n B.II.d.1 Change in the specification parameters
and/or limits of the finished products c) addition of a new
specification parameter to the specification with its corresponding
test method: shelf-life, buprenorphine content uniformity (Subutex
0,4 mg, 2mg, 8mg); Type IB n B.II.d.1 Change in the specification
parameters and/or limits of the finished products c) addition of a
new specification parameter to the specification with its
corresponding test method: microbial quality at release and
shelf-life (Subutex 0,4 mg, 2mg, 8mg); N. 2 Type IB variations n
B.II.d.2 Change in the test procedure for the finished product d)
other changes to an approved test procedure: dissolution at release
and shelf-life: dissolution method (Subutex 0,4 mg, 2mg, 8mg); Type
IA n B.II.d.1 Change in the specification parameters and/or limits of
the finished products c) addition of a new specification parameter to
the specification with its corresponding test method: Release,
Buprenorphine related impurities (Subutex 0,4 mg, 2mg, 8mg); N. 2
Type IA variations n B.II.d.1 Change in the specification parameters
and/or the limits of the finished product a) tightening of the
specification limits: at release and shelf-life (Subutex 0,4 mg);
Type IA n B.II.d.2 Change in the test procedure for the finished
product b) deletion of a test procedure if an alternative method is
already approved: shelf-life, identity and content of buprenorphine
(Subutex 0,4 mg, 2mg, 8mg); N. 5 Type IA variations n B.II.d.2 Change
in the test procedure for the finished product b) deletion of a test
procedure if an alternative method is already approved: shelf-life,
identity of buprenorphine (Subutex 0,4 mg, 2mg, 8mg); Type IB n
B.II.d.2 Change in test procedure for the finished product d) Other
changes to a test procedure (including replacement or addition):
identification of Buprenorphine at release (Subutex 2mg, 8mg); N.2
Type IB variations n B.II.d.2 Change in test procedure for the
finished product d) Other changes to a test procedure (including
replacement or addition): identification and content of Buprenorphine
at shelf life (Subutex 2mg, 8mg).
I lotti già prodotti alla data della pubblicazione in Gazzetta
Ufficiale possono essere mantenuti in commercio fino alla data di
scadenza indicata in etichetta.

Un procuratore
Laura Crippa


T11ADD15026