Fish oil-olive oil-soybean oil-triglycerides medium-chain - European ...

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European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged. 26 October 2017. EMA/69
26 October 2017 EMA/690754/2017 Human Medicines Evaluation Division

List of nationally authorised medicinal products

Active substance: fish oil / olive oil / soybean oil / triglycerides mediumchain

Procedure no.: PSUSA/00010223/201702

30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5525 Send a question via our website www.ema.europa.eu/contact

An agency of the European Union

© 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

SMOFlipid

SE/H/0421/001

76/123/05-C

FRESENIUS KABI AB

CZ

SMOFlipid 200 mg/ml

SE/H/0421/001

19351

FRESENIUS KABI AB

FI

SE/H/0421/001

IS/1/04/027/01

FRESENIUS KABI AB

IS

SE/H/0421/001

11377

FRESENIUS KABI AB

PL

SE/H/0421/001

76/0070/05-S

FRESENIUS KABI AB

SK

SE/H/0421/001

05-0116

FRESENIUS KABI AB

LV

SE/H/0421/001

LT/1/05/0194/001

FRESENIUS KABI AB

LT

not available

6105/2014/01

FRESENIUS KABI AB

RO

SE/H/0421/001

66.581

FRESENIUS KABI AB

ES

SE/H/0421/001

18854

FRESENIUS KABI AB

SE

SE/H/0421/001

468905

FRESENIUS KABI AB

EE

SE/H/0421/001

1-25645

FRESENIUS KABI AUSTRIA

AT

infuusioneste, emulsio SMOFlipid 200 mg/ml innrennslislyf, fleyti. SMOFlipid, 200 mg/ml, emulsja do infuzji SMOFlipid infúzna emulzia SMOFlipid 20% emulsija infūzijām SMOFlipid 20% infuzine emulsija SMOFlipid 200 g/1000 ml emulsie perfuzabilă SMOFlipid 200 mg/ml emulsión para perfusión SMOFlipid 200 mg/ml infusionsvätska, emulsion SMOFlipid, 20% infusiooniemulsioon SMOFlipid 200 mg/ml Emulsion zur Infusion SMOFlipid

GMBH SE/H/0421/001

0452/0510069

FRESENIUS KABI

LU

DEUTSCHLAND GMBH SMOFlipid 200 mg/ml

SE/H/0421/001

Emulsion zur Infusion

List of nationally authorised medicinal products EMA/690754/2017

60028.00.00

FRESENIUS KABI

DE

DEUTSCHLAND GMBH

Page 2/11

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

SMOFlipid 200 mg/ml

SE/H/0421/001

48238/8-7-2010

FRESENIUS KABI HELLAS

GR

γαλάκτωμα για έγχυση. SMOFlipid, 200mg/ml,

A.E. SE/H/0421/001

20184

γαλάκτωμα για έγχυση SMOFlipid 200 mg/ml

FRESENIUS KABI HELLAS

CY

A.E. SE/H/0421/001

PL 08828/0166

FRESENIUS KABI LIMITED

UK

SE/H/0421/001

PA 566/35/1

FRESENIUS KABI LIMITED

IE

SE/H/0421/001

RVG 30787

FRESENIUS KABI

NL

emulsion for infusion SMOFlipid 200 mg/ml emulsion for infusion SMOFlipid 200 mg/ml

NEDERLAND B.V. SMOFlipid 200 mg/ml,

SE/H/0421/001

BE277487

FRESENIUS KABI NV/SA

BE

SE/H/0421/001

BE277487

FRESENIUS KABI NV/SA

BE

SE/H/0421/001

BE277487

FRESENIUS KABI NV/SA

BE

SE/H/0421/001

04-2640

FRESENIUS KABI NORGE AS

NO

SE/H/0421/001

5609789

FRESENIUS KABI PHARMA

PT

émulsion pour perfusion SMOFlipid 200 mg/ml, Emulsion zur Infusion SMOflipid 200 mg/ml, emulsie voor infusie SMOFlipid 200 mg/ml infusjonsvæske, emulsjon SMOFlipid 200 mg/ml, emuls テ」o para perfus テ」o SMOFlipid 20% emulzija

PORTUGAL LDA. not available

UP/I-530-09/11-02/319

FRESENIUS KABI D.O.O.

HR

not available

6105/2014/02

FRESENIUS KABI AB

RO

not available

6105/2014/03

FRESENIUS KABI AB

RO

not available

6105/2014/04

FRESENIUS KABI AB

RO

za infuziju SMOFlipid 200 g/1000 ml emulsie perfuzabilă SMOFlipid 200 g/1000 ml emulsie perfuzabilă SMOFlipid 200 g/1000 ml emulsie perfuzabilă List of nationally authorised medicinal products EMA/690754/2017

Page 3/11

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

SMOFlipid 200 g/1000 ml

not available

6105/2014/05

FRESENIUS KABI AB

RO

not available

6105/2014/06

FRESENIUS KABI AB

RO

SE/H/0421/001

BE277496

FRESENIUS KABI NV/SA

BE

SE/H/0421/001

BE277505

FRESENIUS KABI NV/SA

BE

SE/H/0421/001

BE270751

FRESENIUS KABI NV/SA

BE

SE/H/0421/001

BE270767

FRESENIUS KABI NV/SA

BE

SE/H/0421/001

BE270776

FRESENIUS KABI NV/SA

BE

SE/H/0421/001

BE277496

FRESENIUS KABI NV/SA

BE

SE/H/0421/001

BE277505

FRESENIUS KABI NV/SA

BE

SE/H/0421/001

BE270751

FRESENIUS KABI NV/SA

BE

SE/H/0421/001

BE270767

FRESENIUS KABI NV/SA

BE

SE/H/0421/001

BE270776

FRESENIUS KABI NV/SA

BE

SE/H/0421/001

BE277496

FRESENIUS KABI NV/SA

BE

SE/H/0421/001

BE277505

FRESENIUS KABI NV/SA

BE

emulsie perfuzabilă SMOFlipid 200 g/1000 ml emulsie perfuzabilă SMOflipid 200 mg/ml, emulsie voor infusie SMOflipid 200 mg/ml, emulsie voor infusie SMOflipid 200 mg/ml, emulsie voor infusie SMOflipid 200 mg/ml, emulsie voor infusie SMOflipid 200 mg/ml, emulsie voor infusie SMOFlipid 200 mg/ml, émulsion pour perfusion SMOFlipid 200 mg/ml, émulsion pour perfusion SMOFlipid 200 mg/ml, émulsion pour perfusion SMOFlipid 200 mg/ml, émulsion pour perfusion SMOFlipid 200 mg/ml, émulsion pour perfusion SMOFlipid 200 mg/ml, Emulsion zur Infusion SMOFlipid 200 mg/ml, Emulsion zur Infusion List of nationally authorised medicinal products EMA/690754/2017

Page 4/11

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

SMOFlipid 200 mg/ml,

SE/H/0421/001

BE270751

FRESENIUS KABI NV/SA

BE

SE/H/0421/001

BE270767

FRESENIUS KABI NV/SA

BE

SE/H/0421/001

BE270776

FRESENIUS KABI NV/SA

BE

SE/H/0421/001

5171889

FRESENIUS KABI PHARMA

PT

SE/H/0421/001

5171681

Emulsion zur Infusion SMOFlipid 200 mg/ml, Emulsion zur Infusion SMOFlipid 200 mg/ml, Emulsion zur Infusion SMOFlipid 200 mg/ml, emuls テ」o para perfus テ」o SMOFlipid 200 mg/ml,

PORTUGAL LDA.

emuls テ」o para perfus テ」o SMOFlipid 200 mg/ml,

SE/H/0421/001

5171780

SE/H/0421/001

5610282

SE/H/0421/001

5610183

SE/H/0421/001

5610084

SE/H/0421/001

5609987

FRESENIUS KABI PHARMA

PT

FRESENIUS KABI PHARMA

PT

FRESENIUS KABI PHARMA

PT

PORTUGAL LDA. SE/H/0421/001

5609888

SE/H/0421/001

PA 566/35/2

FRESENIUS KABI LIMITED

IE

SE/H/0421/001

LT/1/05/0194/002

FRESENIUS KABI AB

LT

SE/H/0421/001

LT/1/05/0194/003

FRESENIUS KABI AB

LT

emuls テ」o para perfus テ」o SMOFlipid 200 mg/ml

PT

PORTUGAL LDA.

emuls テ」o para perfus テ」o SMOFlipid 200 mg/ml,

FRESENIUS KABI PHARMA

PORTUGAL LDA.

emuls テ」o para perfus テ」o SMOFlipid 200 mg/ml,

PT

PORTUGAL LDA.

emuls テ」o para perfus テ」o SMOFlipid 200 mg/ml,

FRESENIUS KABI PHARMA PORTUGAL LDA.

emuls テ」o para perfus テ」o SMOFlipid 200 mg/ml,

PT

PORTUGAL LDA.

emuls テ」o para perfus テ」o SMOFlipid 200 mg/ml,

FRESENIUS KABI PHARMA

FRESENIUS KABI PHARMA

PT

PORTUGAL LDA.

emulsion for infusion SMOFlipid 20% infuzine emulsija SMOFlipid 20% infuzine emulsija List of nationally authorised medicinal products EMA/690754/2017

Page 5/11

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

SMOFlipid 20% infuzine

SE/H/0421/001

LT/1/05/0194/004

FRESENIUS KABI AB

LT

SE/H/0421/001

LT/1/05/0194/006

FRESENIUS KABI AB

LT

SE/H/0421/001

LT/1/05/0194/007

FRESENIUS KABI AB

LT

SE/H/0421/001

LT/1/05/0194/008

FRESENIUS KABI AB

LT

SE/H/0421/001

LT/1/05/0194/009

FRESENIUS KABI AB

LT

SE/H/0421/001

LT/1/05/0194/010

FRESENIUS KABI AB

LT

SE/H/0421/001

LT/1/05/0194/011

FRESENIUS KABI AB

LT

SE/H/0421/001

LT/1/05/0194/012

FRESENIUS KABI AB

LT

SE/H/0421/001

OGYI-T-10 109/02

FRESENIUS KABI AB

HU

SE/H/0421/001

OGYI-T-10 109/03

FRESENIUS KABI AB

HU

SE/H/0421/001

OGYI-T-10 109/04

FRESENIUS KABI AB

HU

SE/H/0421/001

OGYI-T-10 109/05

FRESENIUS KABI AB

HU

SE/H/0421/001

OGYI-T-10 109/06

FRESENIUS KABI AB

HU

SE/H/0557/001

34009 385 113 5 2

FRESENIUS KABI FRANCE

FR

emulsija SMOFlipid 20% infuzine emulsija SMOFlipid 20% infuzine emulsija SMOFlipid 20% infuzine emulsija SMOFlipid 20% infuzine emulsija SMOFlipid 20% infuzine emulsija SMOFlipid 20% infuzine emulsija SMOFlipid 20% infuzine emulsija SMOFlipid 200 mg/ml emulziós infúzió SMOFlipid 200 mg/ml emulziós infúzió SMOFlipid 200 mg/ml emulziós infúzió SMOFlipid 200 mg/ml emulziós infúzió SMOFlipid 200 mg/ml emulziós infúzió SMOFlipid 200 mg/ml, émulsion pour perfusion List of nationally authorised medicinal products EMA/690754/2017

S.A.S.

Page 6/11

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

SMOFlipid 200 mg/ml

SE/H/0421/001

H/05/01433/001

MEDIAS INTERNATIONAL

SI

emulzija za infundiranje SMOFlipid 200 mg/ml

D.O.O. SE/H/0421/001

H/05/01433/003

emulzija za infundiranje SMOFlipid 200 mg/ml

SE/H/0421/001

H/05/01433/002

SE/H/0421/001

H/05/01433/006

SE/H/0421/001

H/05/01433/005

SE/H/0421/001

H/05/01433/004

SE/H/0421/001

H/05/01433/007

SE/H/0421/001

H/05/01433/008

SE/H/0421/001

H/05/01433/009

SE/H/0421/001

H/05/01433/010

MEDIAS INTERNATIONAL MEDIAS INTERNATIONAL MEDIAS INTERNATIONAL

H/05/01433/011

MEDIAS INTERNATIONAL

SE/H/0421/001

H/05/01433/012

MEDIAS INTERNATIONAL

SI SI SI SI SI

D.O.O. SI

D.O.O. SE/H/0421/001

34009 300 381 2 3

émulsion pour perfusion SMOFlipid 200 mg/ml,

MEDIAS INTERNATIONAL

SE/H/0421/001

emulzija za infundiranje SMOFlipid 200 mg/ml,

SI

D.O.O.

emulzija za infundiranje SMOFlipid 200 mg/ml

MEDIAS INTERNATIONAL

D.O.O.

emulzija za infundiranje SMOFlipid 200 mg/ml

SI

D.O.O.

emulzija za infundiranje SMOFlipid 200 mg/ml

MEDIAS INTERNATIONAL

D.O.O.

emulzija za infundiranje SMOFlipid 200 mg/ml

SI

D.O.O.

emulzija za infundiranje SMOFlipid 200 mg/ml

MEDIAS INTERNATIONAL

D.O.O.

emulzija za infundiranje SMOFlipid 200 mg/ml

SI

D.O.O.

emulzija za infundiranje SMOFlipid 200 mg/ml

MEDIAS INTERNATIONAL D.O.O.

emulzija za infundiranje SMOFlipid 200 mg/ml

SI

D.O.O.

emulzija za infundiranje SMOFlipid 200 mg/ml

MEDIAS INTERNATIONAL

FRESENIUS KABI FRANCE

FR

S.A.S. SE/H/0421/001

émulsion pour perfusion List of nationally authorised medicinal products EMA/690754/2017

34009 300 381 3 0

FRESENIUS KABI FRANCE

FR

S.A.S.

Page 7/11

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

SMOFlipid 200 mg/ml,

SE/H/0421/001

34009 300 381 4 7

FRESENIUS KABI FRANCE

FR

émulsion pour perfusion SMOFlipid 200 mg/ml,

S.A.S. SE/H/0421/001

34009 300 381 5 4

émulsion pour perfusion SMOFlipid 200 mg/ml,

SE/H/0421/001

34009 300 381 6 1

SE/H/0421/001

34009 300 381 7 8

SE/H/0421/001

5691878

SE/H/0421/001

5691902

SE/H/0421/001

5691910

SE/H/0421/001

5691928

SE/H/0421/001

5691936

FRESENIUS KABI PHARMA

PT

FRESENIUS KABI PHARMA

PT

FRESENIUS KABI PHARMA

PT

FRESENIUS KABI PHARMA

PT

PORTUGAL LDA. SE/H/0421/001

5691944

emulsão para perfusão Optilipid 200 mg/ml

PT

PORTUGAL LDA.

emulsão para perfusão SMOFlipid 200 mg/ml,

FRESENIUS KABI PHARMA

PORTUGAL LDA.

emulsão para perfusão SMOFlipid 200 mg/ml,

FR

PORTUGAL LDA.

emulsão para perfusão SMOFlipid 200 mg/ml,

FRESENIUS KABI FRANCE

PORTUGAL LDA.

emulsão para perfusão SMOFlipid 200 mg/ml,

FR

S.A.S.

emulsão para perfusão SMOFlipid 200 mg/ml,

FRESENIUS KABI FRANCE S.A.S.

émulsion pour perfusion SMOFlipid 200 mg/ml,

FR

S.A.S.

émulsion pour perfusion SMOFlipid 200 mg/ml,

FRESENIUS KABI FRANCE

FRESENIUS KABI PHARMA

PT

PORTUGAL LDA. SE/H/0558/001

21832

FRESENIUS KABI AB

SE

SE/H/0558/001

037135011

FRESENIUS KABI ITALIA

IT

infusionsvätska, emulsion SMOFlipid 200 mg/ml, emulsione per infusione. SMOFlipid 200 mg/ml,

S.R.L. SE/H/0558/001

037135023

emulsione per infusione. SMOFlipid 200 mg/ml,

FRESENIUS KABI ITALIA

IT

S.R.L. SE/H/0558/001

emulsione per infusione. List of nationally authorised medicinal products EMA/690754/2017

037135035

FRESENIUS KABI ITALIA

IT

S.R.L.

Page 8/11

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

SMOFlipid 200 mg/ml,

SE/H/0558/001

037135047

FRESENIUS KABI ITALIA

IT

emulsione per infusione. SMOFlipid 200 mg/ml,

S.R.L. SE/H/0558/001

037135050

emulsione per infusione. SMOFlipid 200 mg/ml,

SE/H/0558/001

037135062

SE/H/0558/001

037135074

SE/H/0558/001

037135086

SE/H/0558/001

037135098

SE/H/0558/001

037135100

SE/H/0558/001

037135112

SE/H/0558/001

037135124

SE/H/0558/001

037135136

FRESENIUS KABI ITALIA FRESENIUS KABI ITALIA FRESENIUS KABI ITALIA

037135148

FRESENIUS KABI ITALIA

SE/H/0558/001

037135151

FRESENIUS KABI ITALIA

IT IT IT IT IT

S.R.L. IT

S.R.L. SE/H/0558/001

037135163

emulsione per infusione. SMOFlipid 200 mg/ml,

FRESENIUS KABI ITALIA

SE/H/0558/001

emulsione per infusione. SMOFlipid 200 mg/ml,

IT

S.R.L.

emulsione per infusione. SMOFlipid 200 mg/ml,

FRESENIUS KABI ITALIA

S.R.L.

emulsione per infusione. SMOFlipid 200 mg/ml,

IT

S.R.L.

emulsione per infusione. SMOFlipid 200 mg/ml,

FRESENIUS KABI ITALIA

S.R.L.

emulsione per infusione. SMOFlipid 200 mg/ml,

IT

S.R.L.

emulsione per infusione. SMOFlipid 200 mg/ml,

FRESENIUS KABI ITALIA

S.R.L.

emulsione per infusione. SMOFlipid 200 mg/ml,

IT

S.R.L.

emulsione per infusione. SMOFlipid 200 mg/ml,

FRESENIUS KABI ITALIA S.R.L.

emulsione per infusione. SMOFlipid 200 mg/ml,

IT

S.R.L.

emulsione per infusione. SMOFlipid 200 mg/ml,

FRESENIUS KABI ITALIA

FRESENIUS KABI ITALIA

IT

S.R.L. SE/H/0558/001

emulsione per infusione. List of nationally authorised medicinal products EMA/690754/2017

037135175

FRESENIUS KABI ITALIA

IT

S.R.L.

Page 9/11

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

SMOFlipid 200 mg/ml,

SE/H/0558/001

037135187

FRESENIUS KABI ITALIA

IT

emulsione per infusione. Kombilipid 200 mg/ml

S.R.L. SE/H/0557/001

21831

FRESENIUS KABI AB

SE

SE/H/0557/001

34009 385 118 7 1

FRESENIUS KABI FRANCE

FR

infusionsvätska, emulsion SMOFlipid 200 mg/ml, émulsion pour perfusion SMOFlipid 200 mg/ml,

S.A.S. SE/H/0557/001

34009 376 001 3 2

SE/H/0557/001

34009 376 707 3 9

émulsion pour perfusion SMOFlipid 200 mg/ml,

SE/H/0557/001

34009 376 705 0 0

SE/H/0557/001

34009 376 000 7 1

SE/H/0557/001

34009 376 706 7 8

SE/H/0557/001

34009 375 999 0 0

SE/H/0557/001

34009 385 117 0 3

SE/H/0557/001

34009 385 116 4 2

SE/H/0557/001

34009 385 115 8 1

FR

FRESENIUS KABI FRANCE

FR

FRESENIUS KABI FRANCE

FR

FRESENIUS KABI FRANCE

FR

FRESENIUS KABI FRANCE

FR

S.A.S. SE/H/0557/001

34009 385 113 5 2

émulsion pour perfusion SMOFlipid 200 mg/ml,

FRESENIUS KABI FRANCE

S.A.S.

émulsion pour perfusion SMOFlipid 200 mg/ml,

FR

S.A.S.

émulsion pour perfusion SMOFlipid 200 mg/ml,

FRESENIUS KABI FRANCE

S.A.S.

émulsion pour perfusion SMOFlipid 200 mg/ml,

FR

S.A.S.

émulsion pour perfusion SMOFlipid 200 mg/ml,

FRESENIUS KABI FRANCE

S.A.S.

émulsion pour perfusion SMOFlipid 200 mg/ml,

FR

S.A.S.

émulsion pour perfusion SMOFlipid 200 mg/ml,

FRESENIUS KABI FRANCE S.A.S.

émulsion pour perfusion SMOFlipid 200 mg/ml,

FR

S.A.S.

émulsion pour perfusion SMOFlipid 200 mg/ml,

FRESENIUS KABI FRANCE

FRESENIUS KABI FRANCE

FR

S.A.S. SE/H/0557/001

émulsion pour perfusion List of nationally authorised medicinal products EMA/690754/2017

34009 385 114 1 3

FRESENIUS KABI FRANCE

FR

S.A.S.

Page 10/11

List of nationally authorised medicinal products EMA/690754/2017

Page 11/11