26 October 2017 EMA/690754/2017 Human Medicines Evaluation Division 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.
National Number SMOFlipid SE/H/0421/001 76/123/05-C ESENIUS KABI AB CZ SE/H/0421/001 19351 ESENIUS KABI AB FI infuusioneste, emulsio SE/H/0421/001 IS/1/04/027/01 ESENIUS KABI AB IS innrennslislyf, fleyti. SMOFlipid, 200 mg/ml, SE/H/0421/001 11377 ESENIUS KABI AB PL emulsja do infuzji SMOFlipid infúzna SE/H/0421/001 76/0070/05-S ESENIUS KABI AB SK emulzia SMOFlipid 20% SE/H/0421/001 05-0116 ESENIUS KABI AB LV infūzijām SE/H/0421/001 LT/1/05/0194/001 ESENIUS KABI AB LT SMOFlipid 200 g/1000 ml not available 6105/2014/01 ESENIUS KABI AB RO SE/H/0421/001 66.581 ESENIUS KABI AB ES emulsión para perfusión SE/H/0421/001 18854 ESENIUS KABI AB SE infusionsvätska, emulsion SMOFlipid, 20% SE/H/0421/001 468905 ESENIUS KABI AB EE infusiooniemulsioon SE/H/0421/001 1-25645 ESENIUS KABI AUSTRIA AT GMBH SMOFlipid SE/H/0421/001 0452/0510069 ESENIUS KABI LU DEUTSCHLAND GMBH SE/H/0421/001 60028.00.00 ESENIUS KABI DEUTSCHLAND GMBH DE EMA/690754/2017 Page 2/11
National Number SE/H/0421/001 48238/8-7-2010 ESENIUS KABI HELLAS GR γαλάκτωμα για έγχυση. A.E. SMOFlipid, 200mg/ml, SE/H/0421/001 20184 ESENIUS KABI HELLAS CY γαλάκτωμα για έγχυση A.E. SE/H/0421/001 PL 08828/0166 ESENIUS KABI LIMED UK emulsion for infusion SE/H/0421/001 PA 566/35/1 ESENIUS KABI LIMED IE emulsion for infusion SE/H/0421/001 RVG 30787 ESENIUS KABI NL NEDERLAND B.V. SE/H/0421/001 BE277487 ESENIUS KABI NV/SA BE SE/H/0421/001 BE277487 ESENIUS KABI NV/SA BE SMOflipid 200 mg/ml, SE/H/0421/001 BE277487 ESENIUS KABI NV/SA BE SE/H/0421/001 04-2640 ESENIUS KABI NORGE AS NO infusjonsvæske, emulsjon SE/H/0421/001 5609789 ESENIUS KABI PHARMA PT SMOFlipid 20% emulzija not available UP/I-530-09/11-02/319 ESENIUS KABI HR za infuziju SMOFlipid 200 g/1000 ml not available 6105/2014/02 ESENIUS KABI AB RO SMOFlipid 200 g/1000 ml not available 6105/2014/03 ESENIUS KABI AB RO SMOFlipid 200 g/1000 ml not available 6105/2014/04 ESENIUS KABI AB RO EMA/690754/2017 Page 3/11
SMOFlipid 200 g/1000 ml SMOFlipid 200 g/1000 ml SMOflipid 200 mg/ml, SMOflipid 200 mg/ml, SMOflipid 200 mg/ml, SMOflipid 200 mg/ml, SMOflipid 200 mg/ml, National Number not available 6105/2014/05 ESENIUS KABI AB RO not available 6105/2014/06 ESENIUS KABI AB RO SE/H/0421/001 BE277496 ESENIUS KABI NV/SA BE SE/H/0421/001 BE277505 ESENIUS KABI NV/SA BE SE/H/0421/001 BE270751 ESENIUS KABI NV/SA BE SE/H/0421/001 BE270767 ESENIUS KABI NV/SA BE SE/H/0421/001 BE270776 ESENIUS KABI NV/SA BE SE/H/0421/001 BE277496 ESENIUS KABI NV/SA BE SE/H/0421/001 BE277505 ESENIUS KABI NV/SA BE SE/H/0421/001 BE270751 ESENIUS KABI NV/SA BE SE/H/0421/001 BE270767 ESENIUS KABI NV/SA BE SE/H/0421/001 BE270776 ESENIUS KABI NV/SA BE SE/H/0421/001 BE277496 ESENIUS KABI NV/SA BE SE/H/0421/001 BE277505 ESENIUS KABI NV/SA BE EMA/690754/2017 Page 4/11
emulsion for infusion National Number SE/H/0421/001 BE270751 ESENIUS KABI NV/SA BE SE/H/0421/001 BE270767 ESENIUS KABI NV/SA BE SE/H/0421/001 BE270776 ESENIUS KABI NV/SA BE SE/H/0421/001 5171889 ESENIUS KABI PHARMA PT SE/H/0421/001 5171681 ESENIUS KABI PHARMA PT SE/H/0421/001 5171780 ESENIUS KABI PHARMA PT SE/H/0421/001 5610282 ESENIUS KABI PHARMA PT SE/H/0421/001 5610183 ESENIUS KABI PHARMA PT SE/H/0421/001 5610084 ESENIUS KABI PHARMA PT SE/H/0421/001 5609987 ESENIUS KABI PHARMA PT SE/H/0421/001 5609888 ESENIUS KABI PHARMA PT SE/H/0421/001 PA 566/35/2 ESENIUS KABI LIMED IE SE/H/0421/001 LT/1/05/0194/002 ESENIUS KABI AB LT SE/H/0421/001 LT/1/05/0194/003 ESENIUS KABI AB LT EMA/690754/2017 Page 5/11
emulziós infúzió emulziós infúzió emulziós infúzió emulziós infúzió emulziós infúzió National Number SE/H/0421/001 LT/1/05/0194/004 ESENIUS KABI AB LT SE/H/0421/001 LT/1/05/0194/006 ESENIUS KABI AB LT SE/H/0421/001 LT/1/05/0194/007 ESENIUS KABI AB LT SE/H/0421/001 LT/1/05/0194/008 ESENIUS KABI AB LT SE/H/0421/001 LT/1/05/0194/009 ESENIUS KABI AB LT SE/H/0421/001 LT/1/05/0194/010 ESENIUS KABI AB LT SE/H/0421/001 LT/1/05/0194/011 ESENIUS KABI AB LT SE/H/0421/001 LT/1/05/0194/012 ESENIUS KABI AB LT SE/H/0421/001 OGYI-T-10 109/02 ESENIUS KABI AB HU SE/H/0421/001 OGYI-T-10 109/03 ESENIUS KABI AB HU SE/H/0421/001 OGYI-T-10 109/04 ESENIUS KABI AB HU SE/H/0421/001 OGYI-T-10 109/05 ESENIUS KABI AB HU SE/H/0421/001 OGYI-T-10 109/06 ESENIUS KABI AB HU SE/H/0557/001 34009 385 113 5 2 ESENIUS KABI ANCE EMA/690754/2017 Page 6/11
National Number SE/H/0421/001 H/05/01433/001 MEDIAS INTERNATIONAL SE/H/0421/001 H/05/01433/003 MEDIAS INTERNATIONAL SE/H/0421/001 H/05/01433/002 MEDIAS INTERNATIONAL SE/H/0421/001 H/05/01433/006 MEDIAS INTERNATIONAL SE/H/0421/001 H/05/01433/005 MEDIAS INTERNATIONAL SE/H/0421/001 H/05/01433/004 MEDIAS INTERNATIONAL SE/H/0421/001 H/05/01433/007 MEDIAS INTERNATIONAL SE/H/0421/001 H/05/01433/008 MEDIAS INTERNATIONAL SE/H/0421/001 H/05/01433/009 MEDIAS INTERNATIONAL SE/H/0421/001 H/05/01433/010 MEDIAS INTERNATIONAL SE/H/0421/001 H/05/01433/011 MEDIAS INTERNATIONAL SE/H/0421/001 H/05/01433/012 MEDIAS INTERNATIONAL SE/H/0421/001 34009 300 381 2 3 ESENIUS KABI ANCE SE/H/0421/001 34009 300 381 3 0 ESENIUS KABI ANCE EMA/690754/2017 Page 7/11
Optilipid 200 mg/ml infusionsvätska, emulsion National Number SE/H/0421/001 34009 300 381 4 7 ESENIUS KABI ANCE SE/H/0421/001 34009 300 381 5 4 ESENIUS KABI ANCE SE/H/0421/001 34009 300 381 6 1 ESENIUS KABI ANCE SE/H/0421/001 34009 300 381 7 8 ESENIUS KABI ANCE SE/H/0421/001 5691878 ESENIUS KABI PHARMA PT SE/H/0421/001 5691902 ESENIUS KABI PHARMA PT SE/H/0421/001 5691910 ESENIUS KABI PHARMA PT SE/H/0421/001 5691928 ESENIUS KABI PHARMA PT SE/H/0421/001 5691936 ESENIUS KABI PHARMA PT SE/H/0421/001 5691944 ESENIUS KABI PHARMA PT SE/H/0558/001 21832 ESENIUS KABI AB SE SE/H/0558/001 037135011 ESENIUS KABI ALIA SE/H/0558/001 037135023 ESENIUS KABI ALIA SE/H/0558/001 037135035 ESENIUS KABI ALIA EMA/690754/2017 Page 8/11
National Number SE/H/0558/001 037135047 ESENIUS KABI ALIA SE/H/0558/001 037135050 ESENIUS KABI ALIA SE/H/0558/001 037135062 ESENIUS KABI ALIA SE/H/0558/001 037135074 ESENIUS KABI ALIA SE/H/0558/001 037135086 ESENIUS KABI ALIA SE/H/0558/001 037135098 ESENIUS KABI ALIA SE/H/0558/001 037135100 ESENIUS KABI ALIA SE/H/0558/001 037135112 ESENIUS KABI ALIA SE/H/0558/001 037135124 ESENIUS KABI ALIA SE/H/0558/001 037135136 ESENIUS KABI ALIA SE/H/0558/001 037135148 ESENIUS KABI ALIA SE/H/0558/001 037135151 ESENIUS KABI ALIA SE/H/0558/001 037135163 ESENIUS KABI ALIA SE/H/0558/001 037135175 ESENIUS KABI ALIA EMA/690754/2017 Page 9/11
Kombilipid 200 mg/ml infusionsvätska, emulsion National Number SE/H/0558/001 037135187 ESENIUS KABI ALIA SE/H/0557/001 21831 ESENIUS KABI AB SE SE/H/0557/001 34009 385 118 7 1 ESENIUS KABI ANCE SE/H/0557/001 34009 376 001 3 2 ESENIUS KABI ANCE SE/H/0557/001 34009 376 707 3 9 ESENIUS KABI ANCE SE/H/0557/001 34009 376 705 0 0 ESENIUS KABI ANCE SE/H/0557/001 34009 376 000 7 1 ESENIUS KABI ANCE SE/H/0557/001 34009 376 706 7 8 ESENIUS KABI ANCE SE/H/0557/001 34009 375 999 0 0 ESENIUS KABI ANCE SE/H/0557/001 34009 385 117 0 3 ESENIUS KABI ANCE SE/H/0557/001 34009 385 116 4 2 ESENIUS KABI ANCE SE/H/0557/001 34009 385 115 8 1 ESENIUS KABI ANCE SE/H/0557/001 34009 385 113 5 2 ESENIUS KABI ANCE SE/H/0557/001 34009 385 114 1 3 ESENIUS KABI ANCE EMA/690754/2017 Page 10/11
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