List of nationally authorised medicinal products
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1 26 October 2017 EMA/690754/2017 Human Medicines Evaluation Division Active substance: fish oil / olive oil / soybean oil / triglycerides mediumchain Procedure no.: PSUSA/ / Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0) Facsimile +44 (0) Send a question via our website An agency of the European Union European Medicines Agency, Reproduction is authorised provided the source is acknowledged.
2 National Number SMOFlipid SE/H/0421/001 76/123/05-C ESENIUS KABI AB CZ SE/H/0421/ 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/ 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/ 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/ ESENIUS KABI AB ES emulsión para perfusión SE/H/0421/ ESENIUS KABI AB SE infusionsvätska, emulsion SMOFlipid, 20% SE/H/0421/ ESENIUS KABI AB EE infusiooniemulsioon SE/H/0421/ ESENIUS KABI AUSTRIA AT GMBH SMOFlipid SE/H/0421/ / ESENIUS KABI LU DEUTSCHLAND GMBH SE/H/0421/ ESENIUS KABI DEUTSCHLAND GMBH DE EMA/690754/2017 Page 2/11
3 National Number SE/H/0421/ / ESENIUS KABI HELLAS GR γαλάκτωμα για έγχυση. A.E. SMOFlipid, 200mg/ml, SE/H/0421/ 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 ESENIUS KABI NL NEDERLAND B.V. SE/H/0421/001 BE ESENIUS KABI NV/SA BE SE/H/0421/001 BE ESENIUS KABI NV/SA BE SMOflipid 200 mg/ml, SE/H/0421/001 BE ESENIUS KABI NV/SA BE SE/H/0421/ ESENIUS KABI NORGE AS NO infusjonsvæske, emulsjon SE/H/0421/ ESENIUS KABI PHARMA PT SMOFlipid 20% emulzija not available UP/I /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
4 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 BE ESENIUS KABI NV/SA BE SE/H/0421/001 BE ESENIUS KABI NV/SA BE SE/H/0421/001 BE ESENIUS KABI NV/SA BE SE/H/0421/001 BE ESENIUS KABI NV/SA BE SE/H/0421/001 BE ESENIUS KABI NV/SA BE SE/H/0421/001 BE ESENIUS KABI NV/SA BE SE/H/0421/001 BE ESENIUS KABI NV/SA BE SE/H/0421/001 BE ESENIUS KABI NV/SA BE SE/H/0421/001 BE ESENIUS KABI NV/SA BE SE/H/0421/001 BE ESENIUS KABI NV/SA BE SE/H/0421/001 BE ESENIUS KABI NV/SA BE SE/H/0421/001 BE ESENIUS KABI NV/SA BE EMA/690754/2017 Page 4/11
5 emulsion for infusion National Number SE/H/0421/001 BE ESENIUS KABI NV/SA BE SE/H/0421/001 BE ESENIUS KABI NV/SA BE SE/H/0421/001 BE ESENIUS KABI NV/SA BE SE/H/0421/ ESENIUS KABI PHARMA PT SE/H/0421/ ESENIUS KABI PHARMA PT SE/H/0421/ ESENIUS KABI PHARMA PT SE/H/0421/ ESENIUS KABI PHARMA PT SE/H/0421/ ESENIUS KABI PHARMA PT SE/H/0421/ ESENIUS KABI PHARMA PT SE/H/0421/ ESENIUS KABI PHARMA PT SE/H/0421/ 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
6 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 /02 ESENIUS KABI AB HU SE/H/0421/001 OGYI-T /03 ESENIUS KABI AB HU SE/H/0421/001 OGYI-T /04 ESENIUS KABI AB HU SE/H/0421/001 OGYI-T /05 ESENIUS KABI AB HU SE/H/0421/001 OGYI-T /06 ESENIUS KABI AB HU SE/H/0557/ ESENIUS KABI ANCE EMA/690754/2017 Page 6/11
7 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/ ESENIUS KABI ANCE SE/H/0421/ ESENIUS KABI ANCE EMA/690754/2017 Page 7/11
8 Optilipid 200 mg/ml infusionsvätska, emulsion National Number SE/H/0421/ ESENIUS KABI ANCE SE/H/0421/ ESENIUS KABI ANCE SE/H/0421/ ESENIUS KABI ANCE SE/H/0421/ ESENIUS KABI ANCE SE/H/0421/ ESENIUS KABI PHARMA PT SE/H/0421/ ESENIUS KABI PHARMA PT SE/H/0421/ ESENIUS KABI PHARMA PT SE/H/0421/ ESENIUS KABI PHARMA PT SE/H/0421/ ESENIUS KABI PHARMA PT SE/H/0421/ ESENIUS KABI PHARMA PT SE/H/0558/ ESENIUS KABI AB SE SE/H/0558/ ESENIUS KABI ALIA SE/H/0558/ ESENIUS KABI ALIA SE/H/0558/ ESENIUS KABI ALIA EMA/690754/2017 Page 8/11
9 National Number SE/H/0558/ ESENIUS KABI ALIA SE/H/0558/ ESENIUS KABI ALIA SE/H/0558/ ESENIUS KABI ALIA SE/H/0558/ ESENIUS KABI ALIA SE/H/0558/ ESENIUS KABI ALIA SE/H/0558/ ESENIUS KABI ALIA SE/H/0558/ ESENIUS KABI ALIA SE/H/0558/ ESENIUS KABI ALIA SE/H/0558/ ESENIUS KABI ALIA SE/H/0558/ ESENIUS KABI ALIA SE/H/0558/ ESENIUS KABI ALIA SE/H/0558/ ESENIUS KABI ALIA SE/H/0558/ ESENIUS KABI ALIA SE/H/0558/ ESENIUS KABI ALIA EMA/690754/2017 Page 9/11
10 Kombilipid 200 mg/ml infusionsvätska, emulsion National Number SE/H/0558/ ESENIUS KABI ALIA SE/H/0557/ ESENIUS KABI AB SE SE/H/0557/ ESENIUS KABI ANCE SE/H/0557/ ESENIUS KABI ANCE SE/H/0557/ ESENIUS KABI ANCE SE/H/0557/ ESENIUS KABI ANCE SE/H/0557/ ESENIUS KABI ANCE SE/H/0557/ ESENIUS KABI ANCE SE/H/0557/ ESENIUS KABI ANCE SE/H/0557/ ESENIUS KABI ANCE SE/H/0557/ ESENIUS KABI ANCE SE/H/0557/ ESENIUS KABI ANCE SE/H/0557/ ESENIUS KABI ANCE SE/H/0557/ ESENIUS KABI ANCE EMA/690754/2017 Page 10/11
11 EMA/690754/2017 Page 11/11
List of nationally authorised medicinal products
10 September 2015 EMA/677092/2015 Procedure Management and Committees Support Active substance: glatiramer Procedure no.: PSUSA/00001529/201411 30 Churchill Place Canary Wharf London E14 5EU United Kingdom
More informationList of nationally authorised medicinal products
10 September 2015 EMA/612853/2015 Procedure Management and Committees Support Active substance: tobramycin (nebuliser solution) Procedure no.: PSUSA/00009316/201412 30 Churchill Place Canary Wharf London
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6 September 2018 EMA/615391/2018 Human Medicines Evaluation Division Active substance: tobramycin (nebuliser solution) (apart from centrally authorised product) Procedure no.: PSUSA/00009316/201712 30
More informationList of nationally authorised medicinal products
20 July 2016 EMA/270645/2015 Procedure Management and Committees Support Active substance: apomorphine Procedure no.: PSUSA/00000227/201511 30 Churchill Place Canary Wharf London E14 5EU United Kingdom
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01 December 2016 Human Medicines Evaluation Division Active substance: Procedure no.: PSUSA/00002591/201604 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0)20 3660 6000 Facsimile
More informationList of nationally authorised medicinal products
06 July 2017 EMA/436040/2017 Human Medicines Evaluation Division Active substance: Procedure no.: PSUSA/00001815/201610 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0)20
More informationList of nationally authorised medicinal products
09 June 2017 EMA/36849/2017 Human Medicines Evaluation Division Active substance(s): brimonidine / timolol Procedure No.: PSUSA/00000431/201609 30 Churchill Place Canary Wharf London E14 5EU United Kingdom
More informationList of nationally authorised medicinal products
30 November 2017 EMA/795271/2017 Human Medicines Evaluation Division Active substance: vinorelbine Procedure no.: PSUSA/00003124/201704 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone
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11 September 2017 EMA/604559/2017 Human Medicines Evaluation Division Active substance: iron / parenteral preparations Procedure no.: PSUSA/00010236/201701 30 Churchill Place Canary Wharf London E14 5EU
More informationList of nationally authorised medicinal products
28 September 2017 EMA/639167/2017 Human Medicines Evaluation Division Active substance: zanamivir Procedure no.: PSUSA/00003141/201701 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone
More informationList of nationally authorised medicinal products
1 December 2016 EMA/750653/2016 Human Medicines Evaluation Division Active substance: valganciclovir Procedure no.: PSUSA/00003089/201603 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone
More informationList of nationally authorised medicinal products
21 June 2017 EMA/610895/2017 Human Medicines Evaluation Division Active substance: felbamate Procedure no.: PSUSA/00010155/201609 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone
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28 September 2017 EMA/658449/2017 Human Medicines Evaluation Division Active substance: olodaterol Procedure no.: PSUSA/00010245/201703 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone
More informationList of nationally authorised medicinal products
10 September 2015 EMA/622830/2015 Procedure Management and Committees Support Active substance: azelastine Procedure no.: PSUSA/00000277/201412 30 Churchill Place Canary Wharf London E14 5EU United Kingdom
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29 November 2018 EMA/880324/2018 Human Medicines Evaluation Division Active substance: enalapril Procedure no.: PSUSA/00001211/201803 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone
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12 January 2017 EMA/36356/2017 Human Medicines Evaluation Division Active substance: hydroxyzine chloride / hydroxyzine pamoate and all fixed combination, hydroxyzine Procedure no.: PSUSA/00001696/201605
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17 May 2018 EMA/303456/2018 Human Medicines Evaluation Division Active substance: bromazepam Procedure no.: PSUSA/00000435/201708 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone
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12 April 2018 EMA/231137/2018 Human Medicines Evaluation Division Active substance: fluvoxamine Procedure no.: PSUSA/00001458/201707 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone
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30 November 2017 EMA/817337/2017 Human Medicines Evaluation Division Active substance: Itraconazole Procedure no.: PSUSA/00001798/201703 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone
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29 September 2017 EMA/658556/2017 Procedure Management and Committees Support Active substance: loratadine Procedure no.: PSU/00001907/201702 30 Churchill Place Canary Wharf London E14 5EU United Kingdom
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11 January 2018 EMA/24585/2018 Human Medicines Evaluation Division Active substance: esomeprazole / naproxen Procedure no.: PSUSA/00001270/201704 30 Churchill Place Canary Wharf London E14 5EU United Kingdom
More informationList of nationally authorised medicinal products
30 November 2017 EMA/812360/2017 Human Medicines Evaluation Division Active substance(s): mupirocin Procedure No.: PSUSA/00002096/201703 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone
More informationList of nationally authorised medicinal products
8 March 2018 EMA/182668/2018 Human Medicines Evaluation Division Active substance(s): triamcinolone (topical and nasal formulations) Procedure No.: PSUSA/00003017/201707 30 Churchill Place Canary Wharf
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5 November 2015 EMA/230130/2016 Procedure Management and Committees Support Active substance: cabergoline Procedure no.: PSUSA/00000477/201503 30 Churchill Place Canary Wharf London E14 5EU United Kingdom
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11 October 2017 EMA/784453/2017 Human Medicines Evaluation Division List of nationally authorised medicinal products Active substance(s): ipratropium / salbutamol Procedure No.: PSUSA/00001781/201701 30
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14 April 2016 EMA/284169/2016 Procedure Management and Committees Support Active substance: influenza vaccine (split virion, inactivated) (non centrally products) Procedure no.: PSUSA/00010298/201508 30
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1 September 2017 EMA/580096/2017 Human Medicines Evaluation Division Active substance: terbutaline Procedure no.: PSUSA/00002897/201612 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone
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6 September 2018 EMA/608492/2018 Human Medicines Evaluation Division Active substance: betahistine Procedure no.: PSUSA/00000389/201712 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone
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5 May 2017 EMA/288255/2017 Human Medicines Evaluation Division Active substance: pilocarpine (ophthalmic formulation) Procedure no.: PSUSA/00002410/201608 30 Churchill Place Canary Wharf London E14 5EU
More informationList of nationally authorised medicinal products
08 March 2018 EMA/170163/2018 Human Medicines Evaluation Division Active substance: enalapril / hydrochlorothiazide Procedure no.: PSUSA/00001212/201707 30 Churchill Place Canary Wharf London E14 5EU United
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13 September 2017 EMA/706786/2017 Human Medicines Evaluation Division Active substance: Octenidine dihydrochloride / phenoxyethanol Procedure no.: PSUSA/00002199/201701 30 Churchill Place Canary Wharf
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30 November 2017 EMA/817351/2017 Human Medicines Evaluation Division Active substance: Lidocaine / prilocaine (not centrally authorised product) Procedure no.: PSUSA/00001867/201703 30 Churchill Place
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27 October 2016 EMA/719205/2016 Human Medicines Evaluation Division Active substance: ethinylestradiol / gestodene (except for transdermal application) Procedure no.: PSUSA/00001308/201603 30 Churchill
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12 July 2018 EMA/497430/2018 Human Medicines Evaluation Division Active substance: tafluprost / timolol Procedure no.: PSUSA/00010324/201712 30 Churchill Place Canary Wharf London E14 5EU United Kingdom
More informationList of nationally authorised medicinal products
12 July 2018 EMA/462856/2018 Human Medicines Evaluation Division Active substance: econazole, econazole nitrate / triamcinolone acetonide, econazole nitrate / zinc oxide Procedure no.: PSUSA/00001195/201711
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8 March 2018 EMA/182904/2018 Human Medicines Evaluation Division Active substance(s): fluticasone propionate / formoterol fumarate dihydrate Procedure No.: PSUSA/00010339/201707 30 Churchill Place Canary
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11 February 2016 EMA/255959/2016 Procedure Management and Committees Support Active substance: calcitonin salmon, synthetic analogue of eel calcitonin Procedure No.: PSUSA/00000494/201506 30 Churchill
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12 April 2018 EMA/243033/2018 Human Medicines Evaluation Division Active substance: fenofibrate Procedure no.: PSUSA/00001362/201707 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone
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12 April 2018 EMA/382206/2018 Human Medicines Evaluation Division Active substance(s): naproxen Procedure No.: PSUSA/00002125/201708 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone
More informationList of nationally authorised medicinal products
3 December 2015 EMA/98477/2016 Procedure Management and Committees Support Active substance: acarbose Procedure no.: PSUSA/00000017/201503 30 Churchill Place Canary Wharf London E14 5EU United Kingdom
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7 July 2016 EMA/437334/2016 Procedure Management and Committees Support Division Active substance: Terazosin Procedure no.: PSUSA/00002895/201511 30 Churchill Place Canary Wharf London E14 5EU United Kingdom
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6 September 2018 EMA/619619/2018 Human Medicines Evaluation Division Active substance: haemophilus influenzae / klebsiella ozaenae / klebsiella pneumoniae / moraxella catarrhalis / staphylococcus aureus
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