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

  Titolare A.I.C.: B. Braun Melsungen AG, Melsungen (Germania) 
  Codice pratica: C1A/2011/744. 
  Specialita' medicinale, confezione e  n.  di  A.I.C.:  Amixal  10%,
tutte le confezioni e relativi numeri di A.I.C. 
  Modifica apportata ai sensi del regolamento CE 1234/2008. 
  Procedura  n.:  DE/H/0543/IA/006/G  -  Grouping  variation  (Annual
Report). 
    B.III.1.a).1: Submission of a new or updated Ph. Eur. certificate
of  suitability:  -  For  an  active  substance;  -  For  a  starting
material/reagent/intermediate used in the  manufacturing  process  of
the active substance;- For an excipient. a) Europ. Pharmacopoieal CEP
to the relevant Ph.Eur.Monograph. 1) New certificate from an  already
approved manufacturer. 
    New Certificate n. R0-CEP 2005-060-Rev 00 for Lysine  Acetate  by
Ajinomoto Co., Inc., JP 104-8315 Tokyo. 
    B.III.1.a).2: Submission of a new or updated Ph. Eur. certificate
of  suitability:  -  For  an  active  substance;  -  For  a  starting
material/reagent/intermediate used in the  manufacturing  process  of
the active substance;- For an excipient. a) Europ. Pharmacopoieal CEP
to the relevant Ph.Eur.Monograph.  2)  Updated  certificate  from  an
already approved manufacturer. 
    Updated Certificate n. R1-CEP  1999-013-Rev  01  for  Alanine  by
KYOWA HAKKO BIO Co., Ltd., JP 100-8185 Tokyo. 
    Updated Certificate n. R1-CEP 1998-104-Rev  02  for  Arginine  by
Ajinomoto Co., Inc., JP 104-8315 Tokyo. 
    Updated Certificate n. R1-CEP 1998-109-Rev  02  for  Arginine  by
KYOWA HAKKO BIO Co., Ltd., JP 100-8185 Tokyo. 
    Updated Certificate n. R1-CEP 2003-143-Rev 02 for  Aspartic  Acid
by Ajinomoto Co., Inc., JP 104-8315 Tokyo. 
    Updated Certificate n. R1-CEP 1999-190-Rev 01 for  Aspartic  Acid
by KYOWA HAKKO BIO Co., Ltd., JP 100-8185 Tokyo. 
    Updated Certificate n. R1-CEP 1998-107-Rev 01  for  Histidine  by
Ajinomoto Co., Inc., JP 104-8315 Tokyo. 
    Updated Certificate n. R1-CEP 1999-027-Rev 02  for  Histidine  by
KYOWA HAKKO BIO Co., Ltd., JP 100-8185 Tokyo. 
    Updated Certificate n. R0-CEP 2004-228-Rev 02 for  Isoleucine  by
AMINO GmbH, DE 38373 Frellstedt. 
    Updated Certificate n. R1-CEP 1999-014-Rev 02 for  Isoleucine  by
KYOWA HAKKO BIO Co., Ltd., JP 100-8185 Tokyo. 
    Updated Certificate n. R1-CEP  1999-160-Rev  02  for  Leucine  by
KYOWA HAKKO BIO Co., Ltd., JP 100-8185 Tokyo. 
    Updated Certificate n. R0-CEP 2005-190-Rev 01 for  Methionine  by
EVONIK REXIM (NANNING) PHARMACEUTICAL Co., Ltd., CN 530  100  Nanning
City. 
    Updated Certificate n. R1-CEP 1998-067-Rev 01  for  Phenylalanine
by Ajinomoto Co., Inc., JP 104-8315 Tokyo. 
    Updated Certificate n. R1-CEP 1999-084-Rev 02  for  Phenylalanine
by KYOWA HAKKO BIO Co., Lttd., JP 100-8185 Tokyo. 
    Updated Certificate n. R0-CEP 2007-166-Rev 00  for  Phenylalanine
by EVONIK REXIM S.A.S, FR 80400 Ham. 
    Updated Certificate n. R1-CEP  1999-018-Rev  01  for  Proline  by
KYOWA HAKKO BIO Co., Ltd., JP 100-8185 Tokyo. 
    Updated Certificate n. R1-CEP 1999-019-Rev 01 for Serine by KYOWA
HAKKO BIO Co., Ltd., JP 100-8185 Tokyo. 
    Updated Certificate n. R0-CEP 2004-277-Rev 02  for  Threonine  by
AMINO GmbH, DE 38373 Frellstedt. 
    Updated Certificate n. R1-CEP 1999-015-Rev 01  for  Threonine  by
KYOWA HAKKO BIO Co., Ltd., JP 100-8185 Tokyo. 
    Updated Certificate n. R1-CEP 1998-137-Rev 01 for  Tryptophan  by
Ajinomoto Co., Inc., JP 104-8315 Tokyo. 
    Updated Certificate n. R1-CEP 1999-050-Rev 04 for  Tryptophan  by
AMINO GmbH, DE 38373 Frellstedt. 
    Updated Certificate n. R1-CEP 1999-189-Rev 01 for  Tryptophan  by
KYOWA HAKKO BIO Co., Ltd., JP 100-8185 Tokyo. 
    Updated Certificate n. R1-CEP 1998-034-Rev  01  for  Tyrosine  by
AMINO GmbH, DE 38373 Frellstedt. 
    Updated Certificate n.  R1-CEP  1998-106-Rev  03  for  Valine  by
Ajinomoto Co., Inc., JP 104-8315 Tokyo. 
    Updated Certificate n. R1-CEP 1999-016-Rev 01 for Valine by KYOWA
HAKKO BIO Co., Ltd., JP 100-8185 Tokyo. 
    B.III.1.a).3: Submission of a new or updated Ph. Eur. certificate
of  suitability:  For   an   active   substance;   For   a   starting
material/reagent/intermediate used in the  manufacturing  process  of
the active substance;- For an excipient. a) Europ. Pharmacopoieal CEP
to the relevant Ph.Eur.Monograph.  3)  New  certificate  from  a  new
manufacturer (replacement or addition). 
    Addition of EVONIK REXIM (NANNING) PHARMACEUTICAL Co.,  Ltd.,  CN
530 100 Nanning City, as manufacturer for Glycine with CEP n.  R0-CEP
2008-099-Rev 00. 
    Addition of EVONIK REXIM (NANNING) PHARMACEUTICAL Co.,  Ltd.,  CN
530 100 Nanning City, as manufacturer  for  Isoleucine  with  CEP  n.
R0-CEP 2008-098-Rev 00 
  I lotti gia' prodotti sono mantenuti in commercio fino alla data di
scadenza indicata in etichetta ai sensi art.14 D.L.vo 178/91 e s.m.i.
Decorrenza della modifica: dal giorno successivo alla data della  sua
pubblicazione in G.U. 

                      L'amministratore delegato 
                         dott. Luigi Boggio 

 
T11ADD9422