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
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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
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
