List of nationally authorised medicinal products

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1 2 September 2016 EMA/607402/2016 Human Medicines Evaluation Division Active substance(s): alanine / arginine / aspartic acid / cysteine / glucose anhydrous / glutamic acid / glycine / histidine / isoleucine / leucine / lysine / methionine / olive oil refined / ornithine / phenylalanine / proline / serine / sodium chloride / sodium glycerophosphate hydrated / soya bean oil refined / taurine / threonine / tryptophan / tyrosine / valine / potassium acetate / calcium chloride dihydrate / magnesium acetate tetrahydrate 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 Numeta G 13 % E Emulsion zur Infusion SE/H/0918/ BAXTER DEUTSCHLAND GMBH. DE Numeta G 16 % E Emulsion zur Infusion SE/H/0918/ BAXTER HEALTHCARE GMBH AT Numeta G 16 % E Emulsion zur Infusion SE/H/0918/ BAXTER DEUTSCHLAND GMBH DE Numeta G 19 % E Emulsion zur Infusion SE/H/0918/ BAXTER HEALTHCARE GMBH AT Numeta G 19 % E Emulsion zur Infusion SE/H/0918/ BAXTER DEUTSCHLAND GMBH DE Numeta G 19 % E infuzní emulze SE/H/0918/003 76/330/11-C BAXTER CZECH SPOL. S R.O. CZ NUMETA G13% E, infuzní emulze SE/H/0918/001 76/328/11-C BAXTER CZECH SPOL. S R.O. CZ NUMETA G13%E emulsie voor infusie SE/H/0918/001 RVG BAXTER B.V. NL Numeta G13%E emulsion for infusion SE/H/0918/001 PA 167/139/1 BAXTER HEALTHCARE LTD. IE Numeta G13%E emulsion for infusion not available AA 161/04201 BAXTER HEALTHCARE LTD. MT Numeta g13%e emulsione per infusione SE/H/0918/ BAXTER S.P.A. IT Numeta G13%E, emulsão para perfusão SE/H/0918/ NUMETA G13%E, emulsión para perfusión SE/H/0918/ BAXTER, S.L. ES NUMETA G13%E, emulsja do infuzji SE/H/0918/ BAXTER POLSKA SP Z O.O. PL Numeta G13%E, γαλάκτωμα για έγχυση SE/H/0918/ BAXTER HELLAS GR Numeta G13E emulsion for infusion SE/H/0918/001 PL 00116/0647 BAXTER HEALTHCARE LTD. UK Numeta G13E infusjonsvæske, emulsjon SE/H/0918/ BAXTER AS NO Numeta G13E infuusioneste, emulsio SE/H/0918/ BAXTER OY FI EMA/607402/2016 Page 2/5

3 National Number Numeta G13E, infusionsvæske, emulsion SE/H/0918/ BAXTER A/S DK Numeta G13E, infusionsvätska, emulsion SE/H/0918/ BAXTER MEDICAL AB SE NUMETA G16% E, infuzní emulze SE/H/0918/002 76/329/11-C BAXTER CZECH SPOL. S R.O. CZ NUMETA G16%E emulsie voor infusie SE/H/0918/002 RVG BAXTER B.V. NL for infusion SE/H/0918/002 PA 167/139/002 BAXTER HEALTHCARE LTD. IE for infusion not available AA 161/04202 BAXTER HEALTHCARE LTD. MT for infusion SE/H/0918/002 PL 00116/0648 BAXTER HEALTHCARE LTD. UK Numeta g16%e emulsione per infusione SE/H/0918/ BAXTER S.P.A. IT Numeta G16%E, emulsão para perfusão SE/H/0918/ NUMETA G16%E, emulsión para perfusión SE/H/0918/ BAXTER, S.L. ES NUMETA G16%E, emulsja do infuzji SE/H/0918/ BAXTER POLSKA SP Z O.O. PL Numeta G16%E, γαλάκτωμα για έγχυση SE/H/0918/ BAXTER HELLAS GR Numeta G16E infusjonsvæske, emulsjon SE/H/0918/ BAXTER AS NO Numeta G16E infuusioneste, emulsio SE/H/0918/ BAXTER OY FI Numeta G16E, infusionsvæske, emulsion SE/H/0918/ BAXTER A/S DK Numeta G16E, infusionsvätska, emulsion SE/H/0918/ BAXTER MEDICAL AB SE NUMETA G19%E emulsie voor infusie SE/H/0918/003 RVG BAXTER B.V. NL EMA/607402/2016 Page 3/5

4 National Number Numeta G19%E emulsion for infusion SE/H/0918/003 PA 167/139/3 BAXTER HEALTHCARE LTD. IE Numeta G19%E emulsion for infusion not available AA 161/04203 BAXTER HEALTHCARE LTD. MT Numeta g19%e emulsione per infusione SE/H/0918/ BAXTER S.P.A. IT Numeta G19%E, emulsão para perfusão SE/H/0918/ NUMETA G19%E, emulsión para perfusión SE/H/0918/ BAXTER, S.L. ES NUMETA G19%E, emulsja do infuzji SE/H/0918/ BAXTER POLSKA SP Z O.O. PL Numeta G19%E, γαλάκτωμα για έγχυση SE/H/0918/ BAXTER HELLAS GR Numeta G19E emulsion for infusion SE/H/0918/003 PL 00116/0649 BAXTER HEALTHCARE LTD. UK Numeta G19E infusjonsvæske, emulsjon SE/H/0918/ BAXTER AS NO Numeta G19E infuusioneste, emulsio SE/H/918/ BAXTER OY FI Numeta G19E, infusionsvæske, emulsion SE/H/0918/ BAXTER A/S DK Numeta G19E, infusionsvätska, emulsion SE/H/0918/ BAXTER MEDICAL AB SE NUMETAH G13%E, émulsion pour perfusion SE/H/0918/ BAXTER SAS FR NUMETAH G16%E, émulsion pour perfusion SE/H/0918/ BAXTER SAS FR NUMETAH G19%E, émulsion pour perfusion SE/H/0918/ BAXTER SAS FR NUMETZAH G 16%E emulsie voor infusie SE/H/0918/002 BE BAXTER SA BE NUMETZAH G13%E emulsie voor infusie SE/H/0918/001 BE BAXTER SA BE EMA/607402/2016 Page 4/5

5 National Number NUMETZAH G13%E emulsie voor infusie SE/H/0918/001 BE BAXTER SA BE NUMETZAH G13%E Emulsion zur Infusion SE/H/0918/001 BE BAXTER SA BE NUMETZAH G13%E, émulsion pour perfusion SE/H/0918/ BAXTER SA LU NUMETZAH G16%E Emulsion zur Infusion SE/H/0918/002 BE BAXTER SA BE NUMETZAH G16%E, émulsion pour perfusion SE/H/0918/002 BE BAXTER SA BE NUMETZAH G16%E, émulsion pour perfusion SE/H/0918/ BAXTER SA LU NUMETZAH G19%E emulsie voor infusie SE/H/0918/003 BE BAXTER SA BE NUMETZAH G19%E Emulsion zur Infusion SE/H/918/003 BE BAXTER SA BE NUMETZAH G19%E, émulsion pour perfusion SE/H/0918/003 BE BAXTER SA BE NUMETZAH G19%E, émulsion pour perfusion SE/H/0918/ BAXTER SA LU EMA/607402/2016 Page 5/5