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

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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

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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

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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

List of nationally authorised medicinal products EMA/580171/2017

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