11 February 2016 EMA/146018/2016 Procedure Management and Committees Support

List of nationally authorised medicinal products

Active substance: 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/00010190/201506

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Product Name MRP DCP Authorisation National Authorisation MAH Name Authorisation Number Number country Numeta G 16 % SE/H/0918/002 1-30165 Baxter Healthcare Gmbh Austria E Numeta G 16 % SE/H/0918/002 80159.00.00 Baxter Deutschland Gmbh. Germany E Numeta G 19 % SE/H/0918/003 1-30166 Baxter Healthcare Gmbh Austria E Numeta G 19 % SE/H/0918/003 76/330/11-C Baxter Czech Spol. S R.O. Czech Republic E Numeta G 19 % SE/H/0918/003 80160.00.00 Baxter Deutschland Gmbh. Germany E Numeta G16% E SE/H/0918/002 76/329/11-C Baxter Czech Spol. S R.O. Czech Republic Numeta G16%e SE/H/0918/002 64135/12-09-2012 Baxter Hellas Greece Numeta G16%e SE/H/0918/002 PA 167/139/002 Baxter Healthcare Ltd. Ireland Numeta G16%e SE/H/0918/002 040774022 Baxter S.P.A. Italy Numeta G16%e AA 161/04202 Baxter Healthcare Ltd. Malta Numeta G16%e SE/H/0918/002 RVG 106436 Baxter B.V. Netherlands Numeta G16%e SE/H/0918/002 18172 Baxter Polska Sp Z O.O. Poland Numeta G16%e SE/H/0918/002 5382841 Baxter Médico-Farmacêutica, Portugal Lda. Numeta G16%e SE/H/0918/002 74.019 Baxter, S.L. Spain Numeta G16%e SE/H/0918/002 PL 00116/0648 Baxter Healthcare Ltd. United Kingdom Numeta G16e SE/H/0918/002 45932 Baxter A/S Denmark Numeta G16e SE/H/0918/002 28120 Baxter Oy Finland Numeta G16e SE/H/0918/002 09-7178 Baxter As Norway Numeta G16e SE/H/0918/002 43303 Baxter Medical Ab Sweden Numeta G19%e SE/H/0918/003 64136/12-09-2012 Baxter Hellas Greece Numeta G19%e SE/H/0918/003 PA 167/139/3 Baxter Healthcare Ltd. Ireland Numeta G19%e SE/H/0918/003 040774034 Baxter S.P.A. Italy Numeta G19%e AA 161/04203 Baxter Healthcare Ltd. Malta Numeta G19%e SE/H/0918/003 RVG 106437 Baxter B.V. Netherlands Numeta G19%e SE/H/0918/003 18173 Baxter Polska Sp Z O.O. Poland

List of nationally authorised medicinal products EMA/146018/2016 Page 2/3

Product Name MRP DCP Authorisation National Authorisation MAH Name Authorisation Number Number country Numeta G19%e SE/H/0918/003 5382858 Baxter Médico-Farmacêutica, Portugal Lda. Numeta G19%e SE/H/0918/003 74.020 Baxter, S.L. Spain Numeta G19e SE/H/0918/003 45933 Baxter A/S Denmark Numeta G19e SE/H/918/003 28121 Baxter Oy Finland Numeta G19e SE/H/0918/003 09-7179 Baxter As Norway Numeta G19e SE/H/0918/003 43304 Baxter Medical Ab Sweden Numeta G19e SE/H/0918/003 PL 00116/0649 Baxter Healthcare Ltd. United Kingdom Numetah G16%e SE/H/0918/002 34009 416 624 6 1 Baxter Sas France Numetah G19%e SE/H/0918/003 34009 416 625 2 2 Baxter Sas France Numetzah SE/H/0918/002 BE394694 Baxter Sa Belgium G16%e Numetzah SE/H/0918/002 0625291 Baxter Sa Luxembourg G16%e Numetzah SE/H/0918/003 BE394703 Baxter Sa Belgium G19%e Numetzah SE/H/0918/003 0625307 Baxter Sa Luxembourg G19%e

List of nationally authorised medicinal products EMA/146018/2016 Page 3/3