Modifica secondaria di un'autorizzazione all'immissione in  commercio
  di una specialita' 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 
  Specialita' 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 gia' 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