Sep 1, 2017 - List of nationally authorised medicinal products. Active substance: amino acid combinations / glucose / tr
1 September 2017 EMA/580171/2017 Human Medicines Evaluation Division
List of nationally authorised medicinal products
Active substance: amino acid combinations / glucose / triglyceride combinations (e.g. olive oil, soya bean oil, fish oil)/ with or without electrolytes/ mineral compounds (i.v. application) - only for the drug Numeta
Procedure no.: PSUSA/00010190/201612
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© European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Numeta G 13 % E
SE/H/0918/004
136880
BAXTER HEALTHCARE GMBH
AT
SE/H/0918/004
94744.00.00
BAXTER DEUTSCHLAND
DE
Emulsion zur Infusion Numeta G 13 % E Emulsion zur Infusion Numeta G 16 % E
GMBH SE/H/0918/002
1-30165
BAXTER HEALTHCARE GMBH
AT
SE/H/0918/002
80159.00.00
BAXTER DEUTSCHLAND
DE
Emulsion zur Infusion Numeta G 16 % E Emulsion zur Infusion Numeta G 19 % E
GMBH SE/H/0918/003
1-30166
BAXTER HEALTHCARE GMBH
AT
SE/H/0918/003
80160.00.00
BAXTER DEUTSCHLAND
DE
Emulsion zur Infusion Numeta G 19 % E Emulsion zur Infusion Numeta G 19 % E infuzní
GMBH SE/H/0918/003
76/330/11-C
BAXTER CZECH SPOL. S R.O.
CZ
SE/H/0918/004
RVG 117231
BAXTER B.V.
NL
SE/H/0918/004
PA0167/139/4
BAXTER HEALTHCARE LTD.
IE
SE/H/918/04/DC
MA 161/04301
BAXTER HEALTHCARE LTD.
MT
emulze Numeta G13%E emulsie voor infusie Numeta G13%E Preterm, emulsion for infusion Numeta G13%E Preterm, emulsion for infusion
List of nationally authorised medicinal products EMA/580171/2017
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Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Numeta G13%E Preterm,
SE/H/0918/004
PL 00116/0659
BAXTER HEALTHCARE LTD.
UK
SE/H/0918/004
23257
BAXTER POLSKA SP Z O.O.
PL
SE/H/0918/004
5693460
BAXTER MÉDICO-
PT
emulsion for infusion Numeta G13%E Preterm, emulsja do infuzji Numeta G13%E, emulsão para perfusão NUMETA G13%E,
FARMACÊUTICA, LDA. SE/H/0918/004
81161
BAXTER, S.L.
ES
SE/H/0918/004
76/307/16-C
BAXTER CZECH SPOL. S R.O.
CZ
SE/H/0918/004
15-10661
BAXTER AS
NO
SE/H/0918/004
33327
BAXTER OY
FI
SE/H/0918/004
040774073
BAXTER S.P.A.
IT
SE/H/0918/004
040774085
BAXTER S.P.A.
IT
emulsión para perfusión NUMETA G13%E, infuzní emulze Numeta G13E infusjonsvæske, emulsjon Numeta G13E infuusioneste, emulsio NUMETA G13E, emulsione per infusione NUMETA G13E, emulsione per infusione
List of nationally authorised medicinal products EMA/580171/2017
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Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Numeta G13E,
SE/H/0918/004
55811
BAXTER A/S
DK
SE/H/0918/004
52833
BAXTER MEDICAL AB
SE
SE/H/0918/002
76/329/11-C
BAXTER CZECH SPOL. S R.O.
CZ
SE/H/0918/002
RVG 106436
BAXTER B.V.
NL
SE/H/0918/002
PA 167/139/002
BAXTER HEALTHCARE LTD.
IE
not available
AA 161/04202
BAXTER HEALTHCARE LTD.
MT
SE/H/0918/002
PL 00116/0648
BAXTER HEALTHCARE LTD.
UK
SE/H/0918/002
5382841
BAXTER MÉDICO-
PT
infusionsvæske, emulsion Numeta G13E, infusionsvätska, emulsion NUMETA G16% E, infuzní emulze NUMETA G16%E emulsie voor infusie Numeta G16%E emulsion for infusion Numeta G16%E emulsion for infusion Numeta G16%E emulsion for infusion Numeta G16%E, emulsão para perfusão NUMETA G16%E,
FARMACÊUTICA, LDA. SE/H/0918/002
74.019
BAXTER, S.L.
ES
emulsión para perfusión
List of nationally authorised medicinal products EMA/580171/2017
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Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
NUMETA G16%E, emulsja
SE/H/0918/002
18172
BAXTER POLSKA SP Z O.O.
PL
SE/H/0918/002
64135
BAXTER HELLAS
GR
SE/H/0918/002
09-7178
BAXTER AS
NO
SE/H/0918/002
28120
BAXTER OY
FI
SE/H/0918/002
040774022
BAXTER S.P.A.
IT
SE/H/0918/002
040774059
BAXTER S.P.A.
IT
SE/H/0918/002
45932
BAXTER A/S
DK
SE/H/0918/002
43303
BAXTER MEDICAL AB
SE
SE/H/0918/003
RVG 106437
BAXTER B.V.
NL
do infuzji Numeta G16%E, γαλάκτωμα για έγχυση Numeta G16E infusjonsvæske, emulsjon Numeta G16E infuusioneste, emulsio Numeta G16E, emulsione per infusione Numeta G16E, emulsione per infusione Numeta G16E, infusionsvæske, emulsion Numeta G16E, infusionsvätska, emulsion NUMETA G19%E emulsie voor infusie
List of nationally authorised medicinal products EMA/580171/2017
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Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Numeta G19%E emulsion
SE/H/0918/003
PA 167/139/3
BAXTER HEALTHCARE LTD.
IE
not available
AA 161/04203
BAXTER HEALTHCARE LTD.
MT
SE/H/0918/003
5382858
BAXTER MÉDICO-
PT
for infusion Numeta G19%E emulsion for infusion Numeta G19%E, emulsão para perfusão NUMETA G19%E,
FARMACÊUTICA, LDA. SE/H/0918/003
74.020
BAXTER, S.L.
ES
SE/H/0918/003
18173
BAXTER POLSKA SP Z O.O.
PL
SE/H/0918/003
64136
BAXTER HELLAS
GR
SE/H/0918/003
PL 00116/0649
BAXTER HEALTHCARE LTD.
UK
SE/H/0918/003
09-7179
BAXTER AS
NO
SE/H/918/003
28121
BAXTER OY
FI
emulsión para perfusión NUMETA G19%E, emulsja do infuzji Numeta G19%E, γαλάκτωμα για έγχυση Numeta G19E emulsion for infusion Numeta G19E infusjonsvæske, emulsjon Numeta G19E infuusioneste, emulsio
List of nationally authorised medicinal products EMA/580171/2017
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Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
NUMETA G19E, emulsione
SE/H/0918/003
040774034
BAXTER S.P.A.
IT
SE/H/0918/003
040774061
BAXTER S.P.A.
IT
SE/H/0918/003
45933
BAXTER A/S
DK
SE/H/0918/003
43304
BAXTER MEDICAL AB
SE
SE/H/0918/004
98648
BAXTER HELLAS
GR
SE/H/0918/004
34009 300 608 6 5
BAXTER SAS
FR
SE/H/0918/004
34009 300 608 5 8
BAXTER SAS
FR
SE/H/0918/002
34009 416 624 6 1
BAXTER SAS
FR
SE/H/0918/003
34009 416 625 2 2
BAXTER SAS
FR
per infusione NUMETA G19E, emulsione per infusione Numeta G19E, infusionsvæske, emulsion Numeta G19E, infusionsvätska, emulsion NUMETA Preterm G13E, γαλάκτωμα για έγχυση NUMETAH G13% E PREMATURES, émulsion pour perfusion NUMETAH G13% E PREMATURES, émulsion pour perfusion NUMETAH G16%E, émulsion pour perfusion NUMETAH G19%E, émulsion pour perfusion
List of nationally authorised medicinal products EMA/580171/2017
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Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
NUMETZAH G 16%E
SE/H/0918/002
BE394694
BAXTER SA
BE
SE/H/0918/004
BE496097
BAXTER SA
BE
SE/H/0918/004
BE496097
BAXTER SA
BE
SE/H/0918/004
BE496097
BAXTER SA
BE
SE/H/0918/004
0826001
BAXTER SA
LU
SE/H/0918/002
BE394694
BAXTER SA
BE
SE/H/0918/002
BE394694
BAXTER SA
BE
SE/H/0918/002
0625291
BAXTER SA
LU
SE/H/0918/003
BE394703
BAXTER SA
BE
emulsie voor infusie Numetzah G13%E emulsie voor infusie Numetzah G13%E Emulsion zur Infusion Numetzah G13%E, émulsion pour perfusion Numetzah G13%E, émulsion pour perfusion NUMETZAH G16%E Emulsion zur Infusion NUMETZAH G16%E, émulsion pour perfusion NUMETZAH G16%E, émulsion pour perfusion NUMETZAH G19%E emulsie voor infusie
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Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
NUMETZAH G19%E
SE/H/918/003
BE394703
BAXTER SA
BE
SE/H/0918/003
BE394703
BAXTER SA
BE
SE/H/0918/003
0625307
BAXTER SA
LU
Emulsion zur Infusion NUMETZAH G19%E, émulsion pour perfusion NUMETZAH G19%E, émulsion pour perfusion
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