Parte Seconda n. 71 del 23-6-2011
Altri annunzi
Specialita' medicinali, presidi sanitari e medico chirurgici
B. BRAUN MILANO S.P.A.
(GU Parte Seconda n.71 del 23-6-2011)

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

Titolare A.I.C.: B. Braun Melsungen AG, Melsungen (Germania)
Codice pratica: C1A/2011/743.
Specialità medicinale, confezione e n. di A.I.C.: Amielect 5% e
Amielect 10%, tutte le confezioni e relativi numeri di A.I.C..
Modifica apportata ai sensi del regolamento CE 1234/2008.
Procedura n.: DE/H/0544/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 2006-264-Rev 01 for Magnesium Chloride
hexahydrate by Macco Organisques s.r.o., CZ 79201 Bruntal.
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. R1-CEP 1999-083-Rev 01 for Lysine
Hydrochloride 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., Ltd., JP 100-8185 Tokyo.
Updated Certificate n. R0-CEP 2007-166-Rev 00 for Phenylalanine
by EVONIK REXIM S.A.A, 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 Frellested.
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 già 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
dr. Luigi Boggio


T11ADD9432