EN Official Journal of the European Union C 29/13

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 December 2013 to 31 December 2013

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2) )

2014/C 29/02

— Issuing, maintenance or modification of a national marketing authorization

Date of the decision Name(s) of the medicinal product Holder(s) of the marketing authorization Member State concerned Date of notification 20.12.2013 Nicardipine See Annex I See Annex I 6.1.2014 19.12.2013 Hydroxyethyl starch See Annex II See Annex II 20.12.2013 20.12.2013 Metoclopramide only containing products See Annex III See Annex III 6.1.2014 18.12.2013 Ergot derivatives - (dihydroergotoxine) See Annex IV See Annex IV 20.12.2013





— Suspension of a national marketing authorization

Date of the decision Name(s) of the medicinal product Holder(s) of the marketing authorization Member State concerned Date of notification 18.12.2013 Ergot derivatives - (dihydroergotoxine) See Annex IV See Annex IV 20.12.2013

(1) OJ L 311, 28.11.2001, p. 67.

(2) OJ L 311, 28.11.2001, p. 1.

ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES Member State (in EEA) Applicant Marketing authorisation holder INN Product name Strength Pharmaceutical form Route of administration Belgium Astellas Pharma BV, Erasmus Park, Square Marie Curie 50, Building 5, 1st floor 1070 Brussels Belgium Nicardipine hydrochloride Rydene 1 mg/ml Solution for injection Intravenous use Belgium Magenta Pharma Consulting Ericapark 38 2403 EG Alphen aan den Rijn The Netherlands Nicardipine hydrochloride Nicardipine Aguettant 10 mg/10 ml Solution for injection Intravenous use France NOVARTIS PHARMA SAS 2-4, rue Lionel Terray 92500 Rueil-Malmaison FRANCE nicardipine (chlorhydrate de) LOXEN 10 mg/10 ml, solution injectable (I.V.) 10 mg/10 ml Solution for injection Intravenous use France LABORATOIRE AGUETTANT 1, rue Alexander Fleming 69007 Lyon FRANCE nicardipine (chlorhydrate de) NICARDIPINE AGUETTANT 10 mg/10 ml, solution injectable 10 mg/10 ml Solution for injection Intravenous use France ARROW GENERIQUES 26, avenue Tony Garnier 69007 Lyon FRANCE nicardipine (chlorhydrate de) NICARDIPINE ARROW 10 mg/10 ml, solution injectable 10 mg/10 ml Solution for injection Intravenous use Luxembourg ASTELLAS PHARMA Square Marie Curie 50 1 Building 5 1070 Brussels Belgium Nicardipine Rydene 1 mg/ml (5 ml) Solution for injection Intravenous use Spain ASTELLAS PHARMA, S.A. Paseo del Club Deportivo, 1 bloque 14 28223 Pozuelo de Alarcón (Madrid) Nicardipine hydrochloride VASONASE 1 mg/ml solución para perfusión 1 mg/ml Solution for infusion Intravenous use The Netherlands Astellas Pharma B.V. Sylviusweg 62 2333 BE Leiden The Netherlands nicardipine Cardene IV 5 mg/5 ml Concentrate for solution for infusion Intravenous use United Kingdom Mercury Pharmaceuticals Limited No. 1 Croydon, 12-16 Addiscombe Road, Croydon, Surrey CR0 0XT, United Kingdom Nicardipine hydrochloride Nicardipine 10 mg/10 ml solution for injection 1 mg/1 ml Solution for injection Intravenous use

ANNEX II LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES Member State (in EEA) Marketing authorisation holder INN Product name Strength Pharmaceutical form Route of administration Austria Fresenius Kabi Austria GmbH Hafnerstraße 36 8055 Graz Austria Hydroxyethyl Starch, Sodium Chloride HAES-steril ‘Fresenius’ (HES 200/0,5) 6 % - Infusionsloesung 60 g/l, 9 g/l solution for infusion intravenous use Austria Fresenius Kabi Austria GmbH Hafnerstraße 36 8055 Graz Austria Hydroxyethyl Starch, Sodium Chloride HyperHAES 6 % in 7,2 % NaCl – Infusionsloesung 60 g/l, 72 g/l solution for infusion intravenous use Austria Baxter Healthcare GmbH Stella-Klein-Loew-Weg 15 1020 Vienna Austria Hydroxyethyl Starch, Sodium chloride, Potassium chloride, Calcium chloride dihydrate, Magnesium chloride hexahydrate, Sodium acetate trihydrate PlasmaHES Redibag – Infusionsloesung 60 g/l, 6 g/l, 0,4 g/l, 0,134 g/l, 0,200 g/l, 3,70 g/l solution for infusion intravenous use Austria Fresenius Kabi Austria GmbH Hafnerstraße 36 8055 Graz Austria Hydroxyethyl Starch, Sodium Chloride Refortan 6 % Infusionsflasche 60 g/l, 9 g/l solution for infusion intravenous use Austria Fresenius Kabi Austria GmbH Hafnerstraße 36 8055 Graz Austria Hydroxyethyl Starch, Sodium Chloride Refortan plus 10 % Infusionsflasche 100 g/l, 9 g/l solution for infusion intravenous use Austria Fresenius Kabi Austria GmbH Hafnerstraße 36 8055 Graz Austria Hydroxyethyl Starch, Sodium Chloride Stabisol 6 % Infusionsflasche 60 g/l, 9 g/l solution for infusion intravenous use Austria B. Braun Melsungen AG Carl-Braun-Strasse 1 34212 Melsungen Germany Hydroxyethyl Starch, Sodium chloride, Potassium chloride, Calcium chloride dihydrate, Magnesium chloride hexahydrate, Sodium acetate trihydrate, Malic acid Tetraspan 100 mg/ml Infusionsloesung 100,0 g/l, 6,25 g/l, 0,30 g/l, 0,37 g/l, 0,20 g/l, 3,27 g/l, 0,67 g/l solution for infusion intravenous use Austria B. Braun Melsungen AG Carl-Braun-Strasse 1 34212 Melsungen Germany Hydroxyethyl Starch, Sodium chloride, Potassium chloride, Calcium chloride dihydrate, Magnesium chloride hexahydrate, Sodium acetate trihydrate, Malic acid Tetraspan 60 mg/ml Infusionsloesung 60,0 g/l, 6,25 g/l, 0,30 g/l, 0,37 g/l, 0,20 g/l, 3,27 g/l, 0,67 g/l solution for infusion intravenous use Austria B. Braun Melsungen AG Carl-Braun-Strasse 1 34212 Melsungen Germany Hydroxyethyl Starch, Sodium Chloride VENOFUNDIN 60 mg/ml Infusionsloesung 60 g/l, 9 g/l solution for infusion intravenous use Austria Fresenius Kabi Austria GmbH Hafnerstraße 36 8055 Graz Austria Hydroxyethyl Starch, Sodium acetate trihydrate, Sodium chloride, Potassium chloride, Magnesium chloride hexahydrate, Volulyte 6 % Infusionsloesung 60,00 g/l, 4,63 g/l, 6,02 g/l, 0,30 g/l, 0,30 g/l solution for infusion intravenous use Austria Fresenius Kabi Austria GmbH Hafnerstraße 36 8055 Graz Austria Hydroxyethyl Starch, Sodium Chloride Voluven (HES 130/0,4) 6 % - Infusionsloesung 60 g/l, 9 g/l solution for infusion intravenous use Belgium Fresenius Kabi NV Molenberglei 7 2627 Schelle Belgium Hydroxyethyl starch Haes-Steril 10 % 100 mg/ml solution for infusion intravenous use Belgium Fresenius Kabi NV Molenberglei 7 2627 Schelle Belgium Hydroxyethyl starch Haes-Steril 6 % 60 mg/ml solution for infusion intravenous use Belgium Baxter SA Bd Rene Branquart, 80 7860 Lessines Belgium Sodium Acetate (Trihydrate), Potassium Chlorid, Magnesium Chlorid Hexahydrate, Sodium Chlorid, Calcium Chlorid (Dihydrate), Hydroxyethyl starch Plasmavolume Redibag 6 % 3,70 mg/ml, 0,40 mg/ml, 0,20 mg/ml, 6 mg/ml, 0,13 mg/ml, 60 mg/ml solution for infusion intravenous use Belgium B. Braun Melsungen AG Carl-Braun-Strasse 1 34212 Melsugen Germany Sodium Acetate (Trihydrate), Potassium Chlorid, Magnesium Chlorid Hexahydrate, Sodium Chlorid, Calcium Chlorid (Dihydrate), Hydroxyethyl starch, Malic Acid Tetraspan 10 % 3,27 mg/ml, 0,30 mg/ml, 0,20 mg/ml, 6,25 mg/ml, 0,37 mg/ml, 100 mg/ml, 0,67 mg/ml solution for infusion intravenous use Belgium B. Braun Melsungen AG Carl-Braun-Strasse 1 34212 Melsugen Germany Sodium Acetate (Trihydrate), Potassium Chlorid, Magnesium Chlorid Hexahydrate, Sodium Chlorid, Calcium Chlorid (Dihydrate), Hydroxyethyl starch, Malic Acid Tetraspan 6 % 3,27 mg/ml, 0,30 mg/ml, 0,20 mg/ml, 6,25 mg/ml, 0,37 mg/ml, 60 mg/ml, 0,67 mg/ml solution for infusion intravenous use Belgium B. Braun Melsungen AG Carl-Braun-Strasse 1 34212 Melsugen Germany Sodium Chlorid, Hydroxyethyl starch Venohes 6 % 9 mg/ml, 60 mg/ml solution for infusion intravenous use Belgium Fresenius Kabi NV Molenberglei 7 2627 Schelle Belgium Sodium Acetate (Trihydrate), Potassium Chlorid, Magnesium Chlorid Hexahydrate, Sodium Chlorid, Hydroxyethyl starch Volulyte 6 % 4,63 mg/ml, 0,30 mg/ml, 0,30 mg/ml, 6,02 mg/ml, 60 mg/ml solution for infusion intravenous use Belgium Fresenius Kabi NV Molenberglei 7 2627 Schelle Belgium Sodium Chlorid, Hydroxyethyl starch Voluven 10 % 9 mg/ml, 100 mg/ml solution for infusion intravenous use Belgium Fresenius Kabi NV Molenberglei 7 2627 Schelle Belgium Sodium Chlorid, Hydroxyethyl starch Voluven 6 % 9 mg/ml, 60 mg/ml solution for infusion intravenous use Bulgaria B.Braun Melsungen AG Carl-Braun-Strasse 1 D-34212 Melsungen Germany Poly(O-2-Hydroxyethyl) starch, Sodium chloride Hemohes 6 % 60 g/l, 9 g/l solution for infusion intravenous use Bulgaria Fresenius Kabi Deutschland GmbH Else-Kröner-Str. 1 61352 Bad Homburg v.d.H. Germany Poly(O-2-Hydroxyethyl) starch, Sodium chloride Voluven 6 % 60 g/l, 9 g/l solution for infusion intravenous use Bulgaria Fresenius Kabi EOOD ‘Alexander Jendov’ str. 1 6th floor, ap 37+Sofia 1113 Bulgaria Poly(O-2-Hydroxyethyl) starch, Sodium chloride Voluven 10 % 100 g/l, 9 g/l solution for infusion intravenous use Bulgaria Fresenius Kabi EOOD ‘Alexander Jendov’ str. 1 6th floor, ap 37+Sofia 1113 Bulgaria Poly(O-2-Hydroxyethyl) starch, Sodium chloride, Sodium acetate trihtdrate, Potassium chloride, Magnesium chloride hexahydrate Volulyte 6 % 60 g/l, 6,02 g/l, 4,63 g/l, 0,3 g/l, 0,3 g/l solution for infusion intravenous use Bulgaria Baxter Deutschland GmbH, Edissonstrasse 4+Unterschleissheim, 85716 Germany Hydroxyethyl Starch 130/0,42, Sodium Chloride, Potassium Chloride, Calcium Chloride Dihydrate, Magnesium Chloride Hexahydrate, Sodium Acetate Trihydrate Plasma volume Redibag 60,0 g/l, 6 g/l, 0,400 g/l, 0,134 g/l, 0,2 g/l, 3,70 g/l solution for infusion intravenous use Croatia B. Braun Adria d.o.o Hondlova 2/9 10000 Zagreb Croatia Calcium chloride dihydrate, hydroxyethyl starch (HES), potassium chloride, magnesium chloride hexahydrate, sodium chloride, sodium acetate trihydrate, malic acid TETRASPAN 60 mg/ml SOLUTION FOR INFUSION 0,37 g/l, 60,0 g/l, 0,30 g/l, 0,2 g/l, 6,25 g/l, 3,27 g/l, 0,67 g/l solution for infusion intravenous use Croatia B. Braun Adria d.o.o Hondlova 2/9 10000 Zagreb Croatia Calcium chloride dihydrate, hydroxyethyl starch (HES), potassium chloride, magnesium chloride hexahydrate, sodium chloride, sodium acetate trihydrate, malic acid TETRASPAN 100 mg/ml SOLUTION FOR INFUSION 0,37 g/l, 100,0 g/l, 0,30 g/l, 0,2 g/l, 6,25 g/l, 3,27 g/l, 0,67 g/l solution for infusion intravenous use Croatia Fresenius Kabi d.o.o. Trg J.F. Kennedya 6b 10000 Zagreb Croatia Hydroxyethyl starch, Sodium chloride, Sodium acetate trihydrate, Potassium chloride, Magnesium chloride hexahydrate VOLULYTE 6 % SOLUTION FOR INFUSION 60,0 g/l, 6,02 g/l, 4,63 g/l, 0,30 g/l, 0,30 g/l solution for infusion intravenous use Croatia Fresenius Kabi d.o.o. Trg J.F. Kennedya 6b 10000 Zagreb Croatia Hydroxyethyl starch, Sodium chloride VOLUVEN 6 % SOLUTION FOR INFUSION 60,0 g/l, 9,0 g/l solution for infusion intravenous use Cyprus FRESENIUS KABI HELLAS AE Mesogeion Avenue 354, Agia Paraskevi 15341, Athens Greece Hydroxyethyl starch + Sodium chloride+Sodium acetate trihydrate+Potassium chloride+Magnesium chloride hexahydrate VOLULYTE SOLUTION FOR INFUSION 6 % 60 g/l, 6,02 g/l, 4,63 g/l, 0,3 g/l, 0,3 g/l solution for infusion intravenous use Cyprus FRESENIUS KABI HELLAS AE Mesogeion Avenue 354, Agia Paraskevi 15341, Athens Greece Hydroxyethyl starch + Sodium chloride VOLUVEN SOLUTION FOR INFUSION 10 % 100 g/l, 9 g/l solution for infusion intravenous use Czech Republic BAXTER CZECH spol. S r.o. Karla Engliše 3201/6 150 00 Praha 5 Czech Republic Hydroxyethyl Starch 130 000, Sodium Chloride, Potassium Chloride, Calcium Chloride Dihydrate, Magnesium Chloride Hexahydrate, Sodium Acetate Trihydrate PLASMA VOLUME REDIBAG 6 % 60,0 g/l, 6,0 g/l, 0,4 g/l, 0,134 g/l, 0,2 g/l, 3,7 g/l solution for infusion intravenous use Czech Republic B. Braun Melsungen AG Carl-Braun Strasse 1 342 12 Melsungen Germany Hydroxyethyl Starch 130 000, Sodium Chloride, Potassium Chloride, Calcium Chloride Dihydrate, Magnesium Chloride Hexahydrate, Sodium Acetate Trihydrate, L-Malic Acid TETRASPAN 10 % 100,0 g/l, 6,25 g/l, 0,3 g/l, 0,37 g/l, 0,2 g/l, 3,27 g/l, 0,67 g/l solution for infusion intravenous use Czech Republic B. Braun Melsungen AG Carl-Braun Strasse 1 342 12 Melsungen Germany Hydroxyethyl Starch 130 000, Sodium Chloride, Potassium Chloride, Calcium Chloride Dihydrate, Magnesium Chloride Hexahydrate, Sodium Acetate Trihydrate, L-Malic Acid TETRASPAN 6 % 60,0 g/l, 6,25 g/l, 0,30 g/l, 0,37 g/l, 0,2 g/l, 3,27 g/l, 0,67 g/l solution for infusion intravenous use Czech Republic Fresenius Kabi Deutschland GmbH Else-Kröner-Str. 1 61352 Bad Homburg v.d.H. Germany Hetastarch, Sodium Acetate Trihydrate, Sodium Chloride, Potassium Chloride, Magnesium Chloride Hexahydrate VOLULYTE 6 % 60,0 g/l, 4,63 g/l, 6,02 g/l, 0,3 g/l, 0,3 g/l solution for infusion intravenous use Czech Republic Fresenius Kabi s.r.o. Zeletavská 1525/1 140 00 Praha 4 - Michle Czech Republic Hetastarch, Sodium Chloride VOLUVEN 10 % 100 g/l, 9 g/l solution for infusion intravenous use Czech Republic Fresenius Kabi Deutschland GmbH Else-Kröner-Str. 1 61352 Bad Homburg v.d.H. Germany Hetastarch, Sodium Chloride HYPERHAES 60 g/l, 72 g/l solution for infusion intravenous use Czech Republic Fresenius Kabi Deutschland GmbH Else-Kröner-Str. 1 61352 Bad Homburg v.d.H. Germany Hetastarch, Sodium Chloride VOLUVEN 60 g/l, 9 g/l solution for infusion intravenous use Denmark Baxter A/S Gydevang 43 DK-3450 Allerød Denmark Calcium chloride dihydrate, hydroxyethyl starch (hes), potassium chloride, magnesium chloride hexahydrate, sodiumchloride, sodium acetate trihydrate, water Hesra 0,134 g/l, 60 g/l, 0,4 g/l, 0,2 g/l, 6 g/l, 3,7 g/l, water ad 1 000 ml solution for infusion intravenous use Denmark Fresenius Kabi AB Rapsgatan 7 SE-751 74 Uppsala Sweden Hydroxyethyl starch (HES), sodiumchloride, water HyperHAES 60 g/l, 72 g/l, water ad 1 000 ml solution for infusion intravenous use Denmark B. Braun Melsungen Carl-Braun-Strasse 1 DE-34212 Melsungen Germany Calcium chloride dihydrate, hydroxyethyl starch (HES), potassium chloride, magnesium chloride hexahydrate, sodium chloride, sodium acetate trihydrate, malic acid, sodium hydroxide, water Tetraspan 0,37 g/l, 60 g/l, 0,3 g/l, 0,2 g/l, 6,25 g/l, 3,27 g/l, 0,67 g/l, 1,197 g/l, water ad 1 000 ml solution for infusion intravenous use Denmark B. Braun Melsungen Carl-Braun-Strasse 1 DE-34212 Melsungen Germany Calcium chloride dihydrate, hydroxyethyl starch (HES), potassium chloride, magnesium chloride hexahydrate, sodium chloride, sodium acetate trihydrate, malic acid, sodium hydroxide, water Tetraspan 0,37 g/l, 100 g/l, 0,3 g/l, 0,2 g/l, 6,25 g/l, 3,27 g/l, 0,67 g/l, 1,197 g/l, water ad 1 000 ml solution for infusion intravenous use Denmark B. Braun Melsungen Carl-Braun-Strasse 1 DE-34212 Melsungen Germany Hydroxyethyl starch (HES), sodium chloride, water Venofundin 60 g/l, 9 g/l, water ad 1 000 ml solution for infusion intravenous use Denmark Fresenius Kabi AB Rapsgatan 7 SE-751 74 Uppsala Sweden Hydroxyethyl starch (HES), potassium chloride, magnesium chloride hexahydrate, sodium chloride, sodium acetate trihydrate, water Volulyte 60 g/l, 0,3 g/l, 0,3 g/l, 6,02 g/l, 4,63 g/l, water ad 1 000 ml solution for infusion intravenous use Denmark Fresenius Kabi AB Rapsgatan 7 SE-751 74 Uppsala Sweden Hydroxyethyl starch (HES), Sodium Chloride, water Voluven 60 g/l, 9 g/l, water ad 1 000 ml solution for infusion intravenous use Denmark Fresenius Kabi AB Rapsgatan 7 SE-751 74 Uppsala Sweden Hydroxyethyl starch (HES), Sodium Chloride, water Voluven 100 g/l, 9 g/l, water ad 1 000 ml solution for infusion intravenous use Estonia B.Braun Melsungen AG Carl-Braun-Strasse 1 Melsungen D-34212 Germany Hydroxyethyl starch, Sodium chloride, Potassium chloride, Calcium chloride dihydrate, Magnesium chloride, Sodium acetate trihydrate, Malic acid TETRASPAN 60 MG/ML 60 g/l, 6,25 g/l, 0,3 g/l, 0,37 g/l, 0,2 g/l, 3,27 g/l, 0,67 g/l solution for infusion intravenous use Estonia B.Braun Melsungen AG Carl-Braun-Strasse 1 Melsungen D-34212 Germany Hydroxyethyl starch, Sodium chloride, Potassium chloride, Calcium chloride dihydrate, Magnesium chloride, Sodium acetate trihydrate, Malic acid TETRASPAN 100 MG/ML 100 g/l, 6,25 g/l, 0,3 g/l, 0,37 g/l, 0,2 g/l, 3,27 g/l, 0,67 g/l solution for infusion intravenous use Estonia Fresenius Kabi Deutschland GmbH 61346 Bad Homburg v.d.H Germany Hydroxyethyl starch, Sodium chloride VOLUVEN 60 g/l, 9 g/l solution for infusion intravenous use Estonia Fresenius Kabi Deutschland GmbH 61346 Bad Homburg v.d.H Germany Hydroxyethyl starch, Sodium acetate trihydrate, Sodium chloride, Sodium chloride, Magnesium chloride VOLULYTE 60 g/l, 4,63 g/l, 6,02 g/l, 0,3 g/l, 0,3 g/l solution for infusion intravenous use Estonia Fresenius Kabi Polska Sp.z o.o Crown Tower ul.Hrubieszowska 2 Warszawa 01-209 Poland Hydroxyethyl starch, Sodium chloride VOLUFORTE 100 g/l, 9 g/l solution for infusion intravenous use Finland Baxter Oy Tammasaarenkatu 1 P.O.Box 119 00181 Helsinki, Finland Poly(o-2-hydroxyethyl) Starch, Sodium Chloride, Potassium Chloride, Calcium Chloride Dihydrate, Magnesium Chloride Dihydrate, Sodium Acetate Trihydride HESRA 60,0 g/l, 6,000 g/l, 0,400 g/l, 0,134 g/l, 0,200 g/l, 3,700 g/l solution for infusion intravenous use Finland Fresenius Kabi Ab Rapsgatan 7 75174 Uppsala, Sweden Poly(o-2-hydroxyethyl) Starch, Sodium Chloride HYPERHAES 60,0 g/l, 72 g/l solution for infusion intravenous use Finland B. Braun Melsungen AG Carl-Braun-Strasse 1 34209 Melsungen, Germany Poly(o-2-hydroxyethyl) Starch, Sodium Chloride, Potassium Chloride, Calcium Chloride Dihydrate, Magnesium Chloride Hexahydrate, Sodium Acetate Trihydride, Malic Acid TETRASPAN 100,0 g/l, 6,252 g/l, 0,2984 g/l, 0,3675 g/l, 0,2033 g/l, 3,266 g/l, 0,671 g/l solution for infusion intravenous use Finland B. Braun Melsungen AG Carl-Braun-Strasse 1 34209 Melsungen, Germany Poly(o-2-hydroxyethyl) Starch, Sodium Chloride, Potassium Chloride, Calcium Chloride Dihydrate, Magnesium Chloride Dihydrate, Sodium Acetate Trihydride, Malic Acid TETRASPAN 60,0 g/l, 6,252 g/l, 0,2984 g/l, 0,3675 g/l, 0,2033 g/l, 3,266 g/l, 0,671 g/l solution for infusion intravenous use Finland B. Braun Melsungen AG Carl-Braun-Strasse 1 34209 Melsungen, Germany Poly(o-2-hydroxyethyl) Starch, Sodium Chloride VENOFUNDIN 60,0 g/l, 9 g/l solution for infusion intravenous use Finland Fresenius Kabi Ab Rapsgatan 7 75174 Uppsala, Sweden Poly(o-2-hydroxyethyl) Starch, Sodium Acetate Trihydride, Sodium Chloride, Potassium Chloride, Magnesium Chloride Hexahydrate VOLULYTE 60 g/l, 4,63 g/l, 6,02 g/l, 0,3 g/l, 0,3 g/l solution for infusion intravenous use Finland Fresenius Kabi Ab Rapsgatan 7 75174 Uppsala, Sweden Poly(o-2-hydroxyethyl) Starch, Sodium Chloride VOLUVEN 60 g/l, 9,0 g/l solution for infusion intravenous use Finland Fresenius Kabi Ab Rapsgatan 7 75174 Uppsala, Sweden Hydroxyethyl Starch, Sodium Chloride VOLUVEN 100 g/l, 9,0 g/l solution for infusion intravenous use France B BRAUN MELSUNGEN Carl-Braun Strasse 1 34212 Melsungen Germany hydroxyethyl starch 130 000 calcium chloride dihydrate magnesium chloride hexahydrate malic acide potassium chloride sodium acetate trihydrate sodium chloride ISOVOL 6 %, solution pour perfusion 60 g / l 0,367 g / l 0,203 g / l 0,671 g / l 0,298 g / l 3,266 g / l 6,252 g / l solution for infusion intravenous use France BAXTER S.A.S. Avenue Louis Pasteur ZA de Coignères Maurepas 78310 Maurepas France hydroxyethyl starch 130 000 calcium chloride dihydrate magnésium chloride hexahydrate potassium chloride sodium acetate trihydrate sodium chloride PLASMAVOLUME 6 %, solution pour perfusion 60 g / l 0,134 g / l 0,2 g / l 0,4 g / l 3,7 g / l 6 g / l solution for infusion intravenous use France FRESENIUS KABI FRANCE 5, place du Marivel 92316 Sèvres Cedex France hydroxyethyl starch 130 000 magnesium chloride hexahydrate potassium chloride sodium acetate trihydrate sodium chloride VOLULYTE 6 %, solution pour perfusion 60 g / l 0,3 g / l 0,3 g / l 4,63 g / l 6,02 g / l solution for infusion intravenous use France B BRAUN MELSUNGEN Carl-Braun Strasse 1 34212 Melsungen Germany hydroxyethyl starch 130 000 sodium chloride RESTORVOL 6 %, solution pour perfusion 60 g / l 9 g / l solution for infusion intravenous use France FRESENIUS KABI FRANCE Place du Marivel 5 92316 Sèvres Cedex France hydroxyethyl starch 130 000 sodium chloride VOLUVEN, solution pour perfusion 60 g / l 9 g / l solution for infusion intravenous use France FRESENIUS KABI FRANCE Place du Marivel 5 92316 Sèvres Cedex France hydroxyethyl starch 200 000 ELOHES 6 %, solution pour perfusion en poche 6 g / 100 ml solution for infusion intravenous use France FRESENIUS KABI FRANCE Place du Marivel 5 92316 Sèvres Cedex France hydroxyethyl starch 200 000 ELOHES 6 %, solution injectable pour perfusion en flacon 6 g / 100 ml solution for infusion intravenous use France AGUETTANT 1, rue Alexander Fleming 69007 Lyon France hydroxyethyl starch 200 000 PLASMOHES 6 %, solution pour perfusion 6 g / 100 ml solution for infusion intravenous use France B BRAUN MELSUNGEN Carl-Braun Strasse 1 34212 Melsungen Germany hydroxyethyl starch 200 000 sodium chloride HEAFUSINE 10 %, solution pour perfusion en poche 10 g / 100 ml 0,90 g / 100 ml solution for infusion intravenous use France B BRAUN MELSUNGEN Carl-Braun Strasse 1 34212 Melsungen Germany hydroxyethyl starch 200 000 sodium chloride HEAFUSINE 6 %, solution pour perfusion en poche 6 g / 100 ml 0,90 g / 100 ml solution for infusion intravenous use France FRESENIUS KABI FRANCE Place du Marivel 5 92316 Sèvres Cedex France hydroxyethyl starch 200 000 sodium chloride HYPERHES, solution pour perfusion 60 g / l 72 g / l solution for infusion intravenous use France FRESENIUS KABI FRANCE Place du Marivel 5 92316 Sèvres Cedex France hydroxyethyl starch 240 000 HESTERIL 10 %, solution pour perfusion 10 g / 100 ml solution for infusion intravenous use France FRESENIUS KABI FRANCE Place du Marivel 5 92316 Sèvres Cedex France hydroxyethyl starch 240 000 HESTERIL 6 %, solution pour perfusion 6 g / 100 ml solution for infusion intravenous use France FRESENIUS KABI FRANCE Place du Marivel 5 92316 Sèvres Cedex France hydroxyethyl starch 250 000 LOMOL, solution injectable pour perfusion en poche 10 g / 100 ml solution for infusion intravenous use Germany B. Braun Melsungen AG Carl-Braun-Str. 1 34212 Melsungen Germany Hydroxyethyl starch Sodium Chloride Hemohes 6 % 60 g/l, 9 g/l solution for infusion intravenous use Germany B. Braun Melsungen AG Carl-Braun-Str. 1 34212 Melsungen Germany Hydroxyethyl starch Sodium Chloride Hemohes 10 % 100 g/l, 9 g/l solution for infusion intravenous use Germany B. Braun Melsungen AG Carl-Braun-Str. 1 34212 Melsungen Germany Hydroxyethyl starch Sodium Chloride VENOFUNDIN 60 mg/ml Infusionslösung 60 g/l, 9 g/l solution for infusion intravenous use Germany B. Braun Melsungen AG Carl-Braun-Str. 1 34212 Melsungen Germany Hydroxyethyl starch, Sodium Chloride, Potassium Chloride, Calcium Chloride Dihydrate, Magnesium Chloride Hexahydrate Sodium Acetate Trihydrate, Malic Acid Tetraspan 6 % Infusionslösung 60 g/l, 6,25 g/l, 0,3 g/l, 0,37 g/l, 0,2 g/l, 3,27 g/l, 0,67 g/l solution for infusion intravenous use Germany B. Braun Melsungen AG Carl-Braun-Str. 1 34212 Melsungen Germany Hydroxyethyl starch, Sodium Chloride, Potassium Chloride, Calcium Chloride Dihydrate, Magnesium Chloride Hexahydrate Sodium Acetate Trihydrate, Malic Acid Tetraspan 10 % Infusionslösung 100 g/l, 6,25 g/l, 0,3 g/l, 0,37 g/l, 0,2 g/l, 3,27 g/l, 0,67 g/l solution for infusion intravenous use Germany Baxter Deutschland GmbH Edisonstr. 4 85716 Unterschleißheim Germany Hydroxyethyl starch, Sodium Chloride, Potassium Chloride, Calcium Chloride Dihydrate, Magnesium Chloride Hexahydrate Sodium Acetate Trihydrate Plasma Volume Redibag 60 g/l, 6 g/l, 0,4 g/l, 0,134 g/l, 0,2 g/l, 3,7 g/l solution for infusion intravenous use Germany Berlin-Chemie AG Glienicker Weg 125 12489 Berlin Germany Sodium Chloride, Hydroxyethyl starch Refortan 6 % 9 g/l, 60 g/l solution for infusion intravenous use Germany Berlin-Chemie AG Glienicker Weg 125 12489 Berlin Germany Sodium Chloride, Hydroxyethyl starch Refortan 10 % 9 g/l, 100 g/l solution for infusion intravenous use Germany Fresenius Kabi Deutschland GmbH Else-Kröner-Str. 1 61352 Bad Homburg v.d.H. Germany Hydroxyethyl starch, Sodium Acetate Trihydrate, Sodium Chloride, Potassium Chloride, Magnesium Chloride Hexahydrate Volulyte 6 % Infusionslösung 60 g/l, 4,63 g/l, 6,02 g/l, 0,3 g/l, 0,3 g/l solution for infusion intravenous use Germany Fresenius Kabi Deutschland GmbH Else-Kröner-Str. 1 61352 Bad Homburg v.d.H. Germany Sodium Chloride, Hydroxyethyl starch Voluven 6 % Infusionslösung 9 g/l, 60 g/l solution for infusion intravenous use Germany Fresenius Kabi Deutschland GmbH Else-Kröner-Str. 1 61352 Bad Homburg v.d.H. Germany Sodium Chloride, Hydroxyethyl starch Voluven 10 % Infusionslösung 9 g/l, 100 g/l solution for infusion intravenous use Germany Fresenius Kabi Deutschland GmbH Else-Kröner-Str. 1 61352 Bad Homburg v.d.H. Germany Sodium Chloride, Hydroxyethyl starch Elohäst 6 % 9 g/l, 60 g/l solution for infusion intravenous use Germany Fresenius Kabi Deutschland GmbH Else-Kröner-Str. 1 61352 Bad Homburg v.d.H. Germany Sodium Chloride, Hydroxyethyl starch HyperHAES Infusionslösung 72 g/l, 60 g/l solution for infusion intravenous use Germany Fresenius Kabi Deutschland GmbH Else-Kröner-Str. 1 61352 Bad Homburg v.d.H. Germany Sodium Chloride, Hydroxyethyl starch HAES-steril 3 % 9 g/l, 30 g/l solution for infusion intravenous use Germany Fresenius Kabi Deutschland GmbH Else-Kröner-Str. 1 61352 Bad Homburg v.d.H. Germany Sodium Chloride, Hydroxyethyl starch Voluven Fresenius 6 % Infusionslösung 9 g/l, 60 g/l solution for infusion intravenous use Germany Fresenius Kabi Deutschland GmbH Else-Kröner-Str. 1 61352 Bad Homburg v.d.H. Germany Sodium Chloride, Hydroxyethyl starch Haes-steril 10 % 9 g/l, 100 g/l solution for infusion intravenous use Germany Fresenius Kabi Deutschland GmbH Else-Kröner-Str. 1 61352 Bad Homburg v.d.H. Germany Hydroxyethyl starch, Sodium Acetate Trihydrate, Sodium Chloride, Potassium Chloride, Magnesium Chloride Hexahydrate Volulyte 6 % Infusionslösung 60 g/l, 4,63 g/l, 6,02 g/l, 0,3 g/l, 0,3 g/l solution for infusion intravenous use Germany Fresenius Kabi Deutschland GmbH Else-Kröner-Str. 1 61352 Bad Homburg v.d.H. Germany Hydroxyethyl starch, Sodium Chloride Haes-steril 6 % 60 g/l, 9 g/l solution for infusion intravenous use Germany Fresenius Kabi Deutschland GmbH Else-Kröner-Str. 1 61352 Bad Homburg v.d.H. Germany Hydroxyethyl starch, Sodium Chloride Voluven 6 % Infusionslösung 60 g/l, 9 g/l solution for infusion intravenous use Germany Fresenius Kabi Deutschland GmbH Else-Kröner-Str. 1 61352 Bad Homburg v.d.H. Germany Hydroxyethyl starch, Sodium Chloride Voluven 10 % Infusionslösung 100 g/l, 9 g/l solution for infusion intravenous use Germany Fresenius Kabi Deutschland GmbH Else-Kröner-Str. 1 61352 Bad Homburg v.d.H. Germany Hydroxyethyl starch, Sodium Chloride HyperHAES Infusionslösung 60 g/l, 72 g/l solution for infusion intravenous use Germany Serumwerk Bernburg AG Hallesche Landstr. 105b 06406 Bernburg Germany Hydroxyethyl starch, Sodium Chloride Infukoll HES 6 % 60 g/l, 9 g/l solution for infusion intravenous use Germany Serumwerk Bernburg AG Hallesche Landstr. 105b 06406 Bernburg Germany Hydroxyethyl starch, Sodium Chloride, Potassium Chloride, Calcium Chloride Dihydrate, Magnesium Chloride Hexahydrate Sodium Acetate Trihydrate Vitafusal 10 % 100 g/l, 6 g/l, 0,4 g/l, 0,134 g/l, 0,2 g/l, 3,7 g/l solution for infusion intravenous use Germany Serumwerk Bernburg AG Hallesche Landstr. 105b 06406 Bernburg Germany Hydroxyethyl starch, Sodium Chloride, Potassium Chloride, Calcium Chloride Dihydrate, Magnesium Chloride Hexahydrate Sodium Acetate Trihydrate Vitakoll 10 % 100 g/l, 6 g/l, 0,4 g/l, 0,134 g/l, 0,2 g/l, 3,7 g/l solution for infusion intravenous use Germany Serumwerk Bernburg AG Hallesche Landstr. 105b 06406 Bernburg Germany Hydroxyethyl starch, Sodium Chloride Infukoll HES 10 % 100 g/l, 9 g/l solution for infusion intravenous use Germany Serumwerk Bernburg AG Hallesche Landstr. 105b 06406 Bernburg Germany Hydroxyethyl starch, Sodium Chloride, Potassium Chloride, Calcium Chloride Dihydrate, Magnesium Chloride Hexahydrate Sodium Acetate Trihydrate Vitafusal 6 % 60 g/l, 6 g/l, 0,4 g/l, 0,134 g/l, 0,2 g/l, 3,7 g/l solution for infusion intravenous use Germany Serumwerk Bernburg AG Hallesche Landstr. 105b 06406 Bernburg Germany Hydroxyethyl starch, Sodium Chloride, Potassium Chloride, Calcium Chloride Dihydrate, Magnesium Chloride Hexahydrate Sodium Acetate Trihydrate Vitafusal 60 g/l, 6 g/l, 0,4 g/l, 0,134 g/l, 0,2 g/l, 3,7 g/l solution for infusion intravenous use Germany Serumwerk Bernburg AG Hallesche Landstr. 105b 06406 Bernburg Germany Hydroxyethyl starch, Sodium Chloride VitaHES Infusionslösung 60 g/l, 9 g/l solution for infusion intravenous use Greece FRESENIUS KABI HELLAS AE Mesogeion Avenue 354, Agia Paraskevi 15341, Athens Greece Poly-(o-2 hydroxyethyl)-starch (M.W 200 000) + Sodium Chloride HAES-STERIL 60 g/l + 9 g/l solution for infusion intravenous use Greece FRESENIUS KABI HELLAS AE Mesogeion Avenue 354, Agia Paraskevi 15341, Athens Greece Hydroxyethyl Starch + Sodium Chloride VOLUVEN 60 g/l + 9 g/l solution for infusion intravenous use Greece FRESENIUS KABI HELLAS AE Mesogeion Avenue 354, Agia Paraskevi 15341, Athens Greece Hydroxyethyl Starch + Sodium Chloride VOLUVEN 100 g/l + 9 g/l solution for infusion intravenous use Greece VIOSER SA, 9th Km National Highway Trikala-Larissis, P.O. Box 35, Taxiarhes, Trikala, Trikala 42100 Greece Hydroxyethyl Starch + Sodium Chloride VENOFUNDIN 60 g/l + 9 g/l solution for infusion intravenous use Greece FRESENIUS KABI HELLAS AE Mesogeion Avenue 354, Agia Paraskevi 15341, Athens Greece Poly-(o-2-hydroxyethyl)-starch (M.W 200 000) + sodium acetate trihydrate + sodium chloride + potassium chloride + magnesium chloride hexahydrate VOLULYTE 60 g/l, 4,63 g/l, 6,02 g/l, 0,3 g/l, 0,3 g/l solution for infusion intravenous use Greece BAXTER HELLAS Ltd, Metsovou 3, Neo Irakleion 14121, Athens Greece Hydroxyethyl starch + Sodium Chloride + Potassium Chloride + Calcium Chloride Dihydrate + Magnesium Chloride Hexahydrate + Sodium Acetate Trihydrate PLASMAVOLUME REDIBAG 60 g/l + 6 g/l + 0,4 g/l + 0,134 g/l + 0,2 g/l + 3,7 g/l solution for infusion intravenous use Greece VIOSER SA 9th Km National Highway Trikal-Larissa, P.O. Box 35, Taksiarhes Trikalon, Trikala 42100 Greece Poly(o-2-hydroxyethyl)starch (M.W 200 000) + Sodium Chloride + Potassium Chloride + Calcium Chloride Dihydrate + Magnesium Chloride Hexahydrate + Sodium Acetate Trihydrate + Malic Acid TETRASPAN 60 g/l, 6,25 g/l, 0,3 g/l, 0,37 g/l, 0,2 g/l, 3,27 g/l, 0,67 g/l solution for infusion intravenous use Greece VIOSER SA 9th Km National Highway Trikal-Larissa, P.O. Box 35, Taksiarhes Trikalon, Trikala 42100 Greece Poly-(o-2-hydroxyethyl)-starch (MW 200 000) + Sodium Chloride + Potassium Chloride + Calcium Chloride Dihydrate + Magnesium Chloride Hexahydrate + Sodium Acetate Trihydrate + Malic Acid TETRASPAN 100 g/l, 6,25 g/l, 0,3 g/l, 0,37 g/l, 0,2 g/l, 3,27 g/l, 0,67 g/l solution for infusion intravenous use Hungary Fresenius Kabi Deutschland GmbH Else-Kröner-Str. 1 61352 Bad Homburg v.d.H. Germany Hydroxyethyl starch, Sodium chloride VOLUVEN 10 % oldatos infúzió 100 g/l, 9,0 g/l solution for infusion intravenous use Hungary Fresenius Kabi Deutschland GmbH Else-Kröner-Str. 1 61352 Bad Homburg v.d.H. Germany Hydroxyethyl starch, Sodium chloride VOLUVEN 6 % oldatos infúzió 60,0 g/l, 9,0 g/l solution for infusion intravenous use Hungary Fresenius Kabi Deutschland GmbH Else-Kröner-Str. 1 61352 Bad Homburg v.d.H. Germany Hydroxyethyl starch, Sodium chloride HAES-STERIL 10 % oldatos infúzió 100 g/l, 9 g/l solution for infusion intravenous use Hungary Fresenius Kabi Deutschland GmbH Else-Kröner-Str. 1 61352 Bad Homburg v.d.H. Germany Hydroxyethyl starch, Sodium chloride HYPERHAES oldatos infúzió 101 g/l, 9 g/l solution for infusion intravenous use Hungary B.Braun Melsungen AG Carl Braun Strasse 1 Melsungen Germany HES, Sodium Chloride, Potassium Chloride, Calcium Chloride Dihydrate, Magnesium Chloride Hexahydrate, Sodium Acetate Trihydrate, Malic Acid Tetraspan 60 mg/ml 60 g/l, 6,252 g/l, 0,2984 g/l, 0,3675 g/l, 0,2033 g/l, 3,266 g/l, 0,67 g/l solution for infusion intravenous use Hungary B.Braun Melsungen AG Carl Braun Strasse 1 Melsungen Germany HES, Sodium Chloride, Potassium Chloride, Calcium Chloride Dihydrate, Magnesium Chloride Hexahydrate, Sodium Acetate Trihydrate, Malic Acid Tetraspan 100 mg/ml 100 g/l, 6,252 g/l, 0,2984 g/l, 0,3675 g/l, 0,2033 g/l, 3,266 g/l, 0,67 g/l solution for infusion intravenous use Hungary Baxter Hungary Kft Népfürdő u. 22. Budapest H-1138 Hungary HES, Sodium Chloride, Potassium Chloride, Calcium Chloride Dihydrate, Magnesium Chloride Hexahydrate, Sodium Acetate Trihydrate HesRa 60 g/l, 6 g/l, 0,4 g/l, 0,134 g/l, 0,2 g/l, 3,7 g/l solution for infusion intravenous use Iceland Fresenius Kabi AB Rapsgatan 7 751 74 Uppsala Sweden Hydroxyethy starch, Sodium chloride HyperHAES 60 g/l, 72 g/l solution for infusion intravenous use Iceland B.Braun Melsungen AG Carl Braun Strasse 1 Melsungen Germany Hydroxyethyl starch, Sodium chloride, potassium chloride, calcium chloride, magnesium chloride, sodium acetat, malic acid Tetraspan 60 g/l, 6,25 g/l, 0,30 g/l, 0,37 g/l, 0,20 g/l, 3,27 g/l, 0,67 g/l solution for infusion intravenous use Iceland Fresenius Kabi Deutschland GmbH 61346 Bad Homburg v.d.H Germany Hydroxyethyl starch, sodium acetat, sodium chloride, potassium chloride, magnesium chloride Volulyte 60 g/l, 4,63 g/l, 6,02 g/l, 0,30 g/l, 0,30 g/l solution for infusion intravenous use Iceland Fresenius Kabi AB Rapsgatan 7 751 74 Uppsala Sweden Hydroxyethyl starch, sodium chloride Voluven 60 g/l, 9,0 g/l solution for infusion intravenous use Ireland Baxter Healthcare Limited Caxton Way Thetford Norfolk IP24 3SE United Kingdom Hydroxyethyl Starch, Sodium Chloride, Potassium Chloride, Calcium Chloride Dihydrate, Magnesium Chloride Hexahydrate, Sodium Acetate Trihydrate Plasma Volume Redibag 6 % Solution for Infusion 60 g/l, 6 g/l, 0,4 g/l, 0,134 g/l, 0,200 g/l, 3,7 g/l solution for infusion intravenous use Ireland B. Braun Melsungen AG, Harald Weis, Carl-Braun Strasse 1, 34212 Melsungen, Germany Poly (O-2-hydroxyethyl) starch (HES) Sodium chloride, Potassium chloride, Calcium chloride dihydrate, Magnesium chloride hexahydrate, Sodium acetate trihydrate, L-Malic acid DAB EquiHes 60 mg/ml solution for infusion, Ecoflac Plus 60 g/l, 6,25 g/l, 0,3 g/l, 0,37 g/l, 0,2 g/l, 3,27 g/l, 0,67 g/l solution for infusion intravenous use Ireland B. Braun Melsungen AG, Harald Weis, Carl-Braun Strasse 1, 34212 Melsungen, Germany Poly (O-2-hydroxyethyl) starch (HES), Sodium chloride, Potassium chloride, Calcium chloride dihydrate, Magnesium chloride hexahydrate, Sodium acetate trihydrate, Malic acid DAB EquiHes 100 mg/ml solution for infusion, Ecoflac Plus 100 g/l, 6,25 g/l, 0,3 g/l, 0,37 g/l, 0,2 g/l, 3,27 g/l, 0,67 g/l solution for infusion intravenous use Ireland B. Braun Melsungen AG, Harald Weis, Carl-Braun Strasse 1, 34212 Melsungen, Germany Poly (O-2-hydroxyethyl) starch (HES), Sodium chloride, Potassium chloride, Calcium chloride dihydrate, Magnesium chloride hexahydrate, Sodium acetate trihydrate, Malic acid DAB EquiHes 60 mg/ml solution for infusion, Ecobag 60 g/l, 6,25 g/l, 0,3 g/l, 0,37 g/l, 0,2 g/l, 3,27 g/l, 0,67 g/l solution for infusion intravenous use Ireland B. Braun Melsungen AG, Harald Weis, Carl-Braun Strasse 1, 34212 Melsungen, Germany Poly (O-2-hydroxyethyl) starch (HES), Sodium chloride, Potassium chloride, Calcium chloride dihydrate, Magnesium chloride hexahydrate, Sodium acetate trihydrate, Malic acid DAB EquiHes 100 mg/ml solution for infusion, Ecobag 100 g/l, 6,25 g/l, 0,30 g/l, 0,37 g/l, 0,20 g/l, 3,27 g/l, 0,67 g/l solution for infusion intravenous use Ireland Fresenius Kabi Limited Cestrian Court Eastgate way Manor Park Runcorn,Cheshire WA7 1NT United Kingdom poly (0-2-hydroxyethyl)starch sodium chloride HyperHAES 60 g/l, 72 g/l solution for infusion intravenous use Ireland Fresenius Kabi Limited Cestrian Court Eastgate way Manor Park Runcorn,Cheshire WA7 1NT United Kingdom poly (0-2-hydroxyethyl)starch sodium chloride Voluven 10 % Solution for Infusion (Polyolefine Bag) 100 g/l 9 g/l solution for infusion intravenous use Ireland Fresenius Kabi Limited Cestrian Court Eastgate way Manor Park Runcorn,Cheshire WA7 1NT United Kingdom poly (o-2-hydroxyethyl)starch sodium chloride Voluven 10 % Solution for Infusion (PE Bottle) 100 g/l 9,00 g/l solution for infusion intravenous use Ireland Fresenius Kabi Limited Cestrian Court Eastgate way Manor Park Runcorn,Cheshire WA7 1NT United Kingdom poly (o-2-hydroxyethyl)starch sodium chloride Voluven 6 % Solution for Infusion (Glass bottle) 60 g/l 9 g/l solution for infusion intravenous use Ireland Fresenius Kabi Limited Cestrian Court Eastgate way Manor Park Runcorn,Cheshire WA7 1NT United Kingdom poly (o-2-hydroxyethyl)starch sodium chloride Voluven 6 % Solution for Infusion (Polyolefine/Freeflex Bag 60 g/l 9 g/l solution for infusion intravenous use Ireland Fresenius Kabi Limited Cestrian Court Eastgate way Manor Park Runcorn,Cheshire WA7 1NT United Kingdom poly (o-2-hydroxyethyl)starch sodium chloride Voluven 6 % Solution for Infusion (PVC Bag) 60 g/l 9 g/l solution for infusion intravenous use Ireland Fresenius Kabi Limited Cestrian Court Eastgate way Manor Park Runcorn,Cheshire WA7 1NT United Kingdom poly(o-2-hydroxyethyl)starch sodium acetate trihydrate sodium chloride potassium chloride magnesium chloride hexahydrate Volulyte 6 % Solution for Infusion, polyoelfine bags 60 g/l, 4,63 g/l, 6,02 g/l, 0,3 g/l, 0,3 g/l solution for infusion intravenous use Ireland Fresenius Kabi Limited Cestrian Court Eastgate way Manor Park Runcorn,Cheshire WA7 1NT United Kingdom poly(o-2-hydroxyethyl)starch sodium acetate trihydrate sodium chloride potassium chloride magnesium chloride hexahydrate Volulyte 6 % Solution for Infusion, glass bottle 60 g/l, 4,63 g/l, 6,02 g/l, 0,3 g/l, 0,3 g/l solution for infusion intravenous use Italy FRESENIUS KABI ITALIA Srl Via Camagre, 41-43 Isola della Scala (Verona) 37063 Italy Hydroxyethyl starch, Sodium Chloride Vonten 100 g/l, 9 g/l solution for infusion intravenous use Italy FRESENIUS KABI ITALIA Srl Via Camagre, 41-43 Isola della Scala (Verona) 37063 Italy Hydroxyethyl starch, Sodium Chloride HyperHAES 60 g/l, 72 g/l solution for infusion intravenous use Italy FRESENIUS KABI ITALIA Srl Via Camagre, 41-43 Isola della Scala (Verona) 37063 Italy Hydroxyethyl starch, Sodium Chloride Voluven 60 g/l, 9 g/l solution for infusion intravenous use Italy B. Braun Melsungen AG Carl-Braun-Straße 1 34209 Melsungen Germany Hydroxyethyl starch, Sodium Chloride Amidolite 60 g/l, 9 g/l solution for infusion intravenous use Italy B. Braun Melsungen AG Carl-Braun-Straße 1 34209 Melsungen Germany Hydroxyethyl starch, Sodium Chloride, Potassium chloride, Calcium chloride dihydrate, Magnesium chloride hexahydrate, Sodium acetate trihydrate, Malic acid Tetraspan 60 g/l, 6,25 g/l, 0,30 g/l, 0,37 g/l, 0,20 g/l, 3,27 g/l, 0,67 g/l solution for infusion intravenous use Italy B. Braun Melsungen AG Carl-Braun-Straße 1 34209 Melsungen Germany Hydroxyethyl starch, Sodium Chloride, Potassium chloride, Calcium chloride dihydrate, Magnesium chloride hexahydrate, Sodium acetate trihydrate, Malic acid Tetraspan 100 g/l, 6,25 g/l, 0,30 g/l, 0,37 g/l, 0,20 g/l, 3,27 g/l, 0,67 g/l solution for infusion intravenous use Italy Baxter S.p.A. Piazzale dell industria, 20 00144 Rome Italy Hydroxyethyl starch, Sodium Chloride, Potassium chloride, Calcium chloride dihydrate, Magnesium chloride hexahydrate, Sodium acetate trihydrate Plasmavolume 60 g/l, 6 g/l, 0,4 g/l, 0,134 g/l, 0,2 g/l, 3,7 g/l solution for infusion intravenous use Italy FRESENIUS KABI ITALIA Srl Via Camagre, 41-43 Isola della Scala (Verona) 37063 Italy Hydroxyethyl starch, Sodium Chloride, Potassium chloride, Magnesium chloride hexahydrate, Sodium acetate trihydrate Volulyte 60 g/l, 6,02 g/l, 0,3 g/l, 0,3 g/l, 4,63 g/l solution for infusion intravenous use Italy Fresenius Kabi Deutschland GmbH Else-Kröner-Str. 1 61352 Bad Homburg v.d.H. Germany Hydroxyethyl starch, Sodium Chloride HAES-STERIL 60 g/l, 9 g/l solution for infusion intravenous use Italy Fresenius Kabi Deutschland GmbH Else-Kröner-Str. 1 61352 Bad Homburg v.d.H. Germany Hydroxyethyl starch, Sodium Chloride HAES-STERIL 100 g/l, 9 g/l solution for infusion intravenous use Latvia Fresenius Kabi Deutschland GmbH 61346 Bad Homburg v.d.H Germany Poly(O-2-hydroxyethyl)starch, Sodium chloride Voluven 6 % solution for infusion 60 g, 9 g solution for infusion intravenous use Latvia Fresenius Kabi Polska Sp.z.o.o. Ul. Hrubieszowska 2 01-209 Warszawa Poland Poly(O-2-hydroxyethyl)starch, Sodium chloride Voluforte solution for infusion 100 g, 9 g solution for infusion intravenous use Latvia Fresenius Kabi Deutschland GmbH 61346 Bad Homburg v.d.H Germany Poly(O-2-hydroxyethyl)starch, Sodium acetate trihydrate, Sodium chloride, Potassium chloride, Magnesium chloride hexahydrate Volulyte 6 % solution for infusion 60 g, 4,63 g, 6,02 g, 0,30 g, 0,30 g solution for infusion intravenous use Latvia B. Braun Melsungen AG Carl-Braun-Strasse 1 34212 Melsungen Germany Poly(O-2-hydroxyethyl) starch, Sodium chloride, Potassium chloride, Calcium chloride dihydrate, Magnesium chloride hexahydrate, Sodium acetate trihydrate, Malic acid Tetraspan 60 mg/ml solution for infusion 60 g, 6,25 g, 0,30 g, 0,37 g, 0,20 g, 3,27 g, 0,67 g solution for infusion intravenous use Latvia B. Braun Melsungen AG Carl-Braun-Strasse 1 34212 Melsungen Germany Poly(O-2-hydroxyethyl) starch, Sodium chloride, Potassium chloride, Calcium chloride dihydrate, Magnesium chloride hexahydrate, Sodium acetate trihydrate, Malic acid Tetraspan 100 mg/ml solution for infusion 100 g, 6,25 g, 0,30 g, 0,37 g, 0,20 g, 3,27 g, 0,67 g solution for infusion intravenous use Lithuania UAB ‘BERLIN CHEMIE MENARINI BALTIC’ Jasinskio 16a, LT-01112 Vilnius, Lithuania Hydroxyethyl starch Refortan 60 g/l solution for infusion intravenous use Lithuania UAB ‘BERLIN CHEMIE MENARINI BALTIC’ Jasinskio 16a, LT-01112 Vilnius, Lithuania Hydroxyethyl starch Refortan Plus 100 g/l solution for infusion intravenous use Lithuania UAB ‘BERLIN CHEMIE MENARINI BALTIC’ Jasinskio 16a, LT-01112 Vilnius, Lithuania Hydroxyethyl starch Stabisol 60 g/l solution for infusion intravenous use Lithuania Fresenius Kabi Polska Sp.zo.o. ul.Hrubieszowska 2 01-209 Warszawa, Poland Poli(O-2-hydroxyethyl) starch, Sodium chloride Voluforte 100 g + 9 g/l solution for infusion intravenous use Lithuania Fresenius Kabi Deutschland GmbH 61346 Bad Homburg v.d.H Germany Poli(O-2-hydroxyethyl) starch Volulyte 60 g/l solution for infusion intravenous use Lithuania Fresenius Kabi Deutschland GmbH 61346 Bad Homburg v.d.H Germany Poli(O-2-hydroxyethyl) starch, Sodium chloride Voluven 60 g + 9 g/l solution for infusion intravenous use Lithuania B. Braun Melsungen AG Carl-Braun-strasse 1 34212 Melsungen Germany Poli(0-2-hydroxyethyl)starch(HEK), Sodium chloride, Potassium chloride, Calcium chloride dihydrate, Magnesium chloride heksahydrate, Sodium acetate trihydrate, Malic acid Tetraspan 60 g + 6,25 g + 0,3 g + 0,37 g + 0,2 g + 3,27 g + 0,67 g/l solution for infusion intravenous use Lithuania B. Braun Melsungen AG Carl-Braun-strasse 1 34212 Melsungen Germany Poli(0-2-hydroxyethyl)starch(HEK), Sodium chloride, Potassium chloride, Calcium chloride dihydrate, Magnesium chloride heksahydrate, Sodium acetate trihydrate, Malic acid Tetraspan 100 g + 6,25 g + 0,3 g + 0,37 g + 0,2 g + 3,27 g + 0,67 g/l solution for infusion intravenous use Luxembourg Fresenius Kabi Deutschland GmbH 61346 Bad Homburg v.d.H Germany Poly(0-2-hydroxyethyl)starch 200 kDa mol.substitution 0,43-0,55, Sodium chloride Haes-steril 6 % 60 g/l, 9 g/l solution for infusion intravenous use Luxembourg Fresenius Kabi Deutschland GmbH 61346 Bad Homburg v.d.H Germany Poly(0-2-hydroxyethyl)starch 200 kDa mol.substitution 0,43-0,55, Sodium chloride Haes-steril 10 % 100 g/l, 9 g/l solution for infusion intravenous use Luxembourg B.Braun Melsungen A.G. Carl-Braun-Straße 1 D-34212 Melsungen Germany Poly(0-2-hydroxyethyl)starch 200 kDa mol.substitution 0,45-0,55, Sodium chloride Hemohes 6 % 60 g/l, 9 g/l solution for infusion intravenous use Luxembourg B.Braun Melsungen A.G. Carl-Braun-Straße 1 D-34212 Melsungen Germany Poly(0-2-hydroxyethyl)starch 200 kDa mol.substitution 0,45-0,55, Sodium chloride Hemohes 10 % 100 g/l, 9 g/l solution for infusion intravenous use Luxembourg Fresenius Kabi Deutschland GmbH 61346 Bad Homburg v.d.H Germany Poly(0-2-hydroxyethyl)starch 200 kDa mol.substitution 0,43-0,55, Sodium chloride Hyperhaes 60 g/l, 72 g/l solution for infusion intravenous use Luxembourg Baxter S.A. Boulevard René Branquart 80 B-7860 Lessines Belgium Poly(0-2-hydroxyethyl)starch 130 kDa mol.substitution 0,42, Sodium chloride, Potassium chloride, Calcium chloride trihydrate, Magnesium chloride hexahydrate, sodium acetate trihydrate Plasma Volume Redibag 6 % 60 g/l, 6 g/l, 0,4 g/l, 0,134 g/l, 0,2 g/l, 3,7 g/l solution for infusion intravenous use Luxembourg B.Braun Melsungen A.G. Carl-Braun-Straße 1 D-34212 Melsungen Germany Poly(0-2-hydroxyethyl)starch 130 kDa mol.substitution 0,42, Sodium chloride, Potassium chloride, Calcium chloride dihydrate, Magnesium chloride hexahydrate, sodium acetate trihydrate, malic acid Tetraspan 6 % 60 g/l, 6,25 g/l, 0,3 g/l, 0,37 g/l, 0,2 g/l, 3,27 g/l, 0,67 g/l solution for infusion intravenous use Luxembourg B.Braun Melsungen A.G. Carl-Braun-Straße 1 D-34212 Melsungen Germany Poly(0-2-hydroxyethyl)starch 130 kDa mol.substitution 0,42, Sodium chloride, Potassium chloride, Calcium chloride dihydrate, Magnesium chloride hexahydrate, sodium acetate trihydrate, malic acid Tetraspan 10 % 100 g/l, 6,25 g/l, 0,3 g/l, 0,37 g/l, 0,2 g/l, 3,27 g/l, 0,67 g/l solution for infusion intravenous use Luxembourg B.Braun Melsungen A.G. Carl-Braun-Straße 1 D-34212 Melsungen Germany Poly(0-2-hydroxyethyl)starch 130 kDa mol.substitution 0,42, Sodium chloride Venofundin 60 mg/ml 60 g/l, 9 g/l solution for infusion intravenous use Luxembourg Fresenius Kabi Deutschland GmbH 61346 Bad Homburg v.d.H Germany Poly(0-2-hydroxyethyl)starch 130 kDa mol.substitution 0,38-0,45, Sodium acetate trihydrate, sodium chloride, potassium chloride, magnesium chloride hexahydrate Volulyte 6 % 60 g/l, 4,63 g/l, 6,02 g/l, 0,3 g/l 0,3 g/l solution for infusion intravenous use Luxembourg Fresenius Kabi Deutschland GmbH 61346 Bad Homburg v.d.H Germany Poly(0-2-hydroxyethyl)starch 130 kDa mol.substitution 0,38-0,45, Sodium chloride Voluven 6 % 60 g/l, 9 g/l solution for infusion intravenous use Luxembourg Fresenius Kabi Deutschland GmbH 61346 Bad Homburg v.d.H Germany Poly(0-2-hydroxyethyl)starch 130 kDa mol.substitution 0,38-0,45, Sodium chloride Voluven 10 % 100 g/l, 9 g/l solution for infusion intravenous use Malta Fresenius Kabi Limited Cestrian Court Eastgate Way Manor Park Runcorn Cheshire WA7 1NT United Kingdom Sodium acetate trihydrate, sodium chloride, potassium chloride, magnesium chloride hexahydrate, hydroxyethyl starch 130/0.4 Volulyte 6 % solution for infusion 4,63 g/l, 6,02 g/l. 0,3 g/l, 0,3 g/l, 60 g/l solution for infusion intravenous use Malta Baxter Healthcare Limited Caxton Way Thetford Norfolk IP24 3SE United Kingdom Poly (O-2-hydroxyethyl starch (HES), sodium chloride, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate, sodium acetate trihydrate Plasma Volume Redibag 6 % solution for infusion 60 g/l, 6 g/l, 0,4 g/l, 0,134 g/l, 0,200 g/l, 3,7 g/l solution for infusion intravenous use Norway Baxter AS Gjerdumsvei 11 0484 Oslo Norway Poly(O-2-hydroxyethyl) starch (HES), Sodium chloride, Potassium chloride, Calcium chloride dihydrate, Magnesium chloride hexahydrate, Sodium acetate trihydrate Hesra 60 g/l, 6,00 g/l, 0,400 g/l, 0,134 g/l, 0,200 g/l, 3,70 g/l solution for infusion intravenous use Norway Fresenius Kabi Norge AS Postboks 430 1753 Halden Norway Poly(O-2-hydroxyethyl) starch (HES), Sodium chloride HyperHAES 60 g/l, 72 g/l solution for infusion intravenous use Norway B. Braun Melsungen AG Carl-Braun-Straße 1 34212 Melsungen Germany Poly(O-2-hydroxyethyl) starch (HES), Sodium chloride, Potassium chloride, Calcium chloride dihydrate, Magnesium chloride hexahydrate, Sodium acetate trihydrate, Malic acid Tetraspan 60 g/l, 6,25 g/l, 0,30 g/l, 0,37 g/l, 0,20 g/l, 3, 27 g/l, 0,67 g/l solution for infusion intravenous use Norway B. Braun Melsungen AG Carl-Braun-Straße 1 34212 Melsungen Germany Poly(O-2-hydroxyethyl) starch (HES), Sodium chloride Venofundin 60 g/l, 9 g/l solution for infusion intravenous use Norway Fresenius Kabi Norge AS Postboks 430 1753 Halden Norway Poly(O-2-hydroxyethyl) starch (HES), Sodium acetate trihydrate, Sodium chloride, Potassium chloride, Magnesium chloride hexahydrate Volulyte 60 g/l, 4,63 g/l, 6,02 g/l, 0,30 g/l, 0,30 g/l solution for infusion intravenous use Norway Fresenius Kabi Norge AS Postboks 430 1753 Halden Norway Poly(O-2-hydroxyethyl) starch (HES), Sodium chloride Voluven 100 g/l, 9 g/l solution for infusion intravenous use Norway Fresenius Kabi Norge AS Postboks 430 1753 Halden Norway Poly(O-2-hydroxyethyl) starch (HES), Sodium chloride Voluven 60 g/l, 9 g/l solution for infusion intravenous use Poland Fresenius Kabi Deutschland GmbH 61346 Bad Homburg v.d.H Germany Hydroxyethyl Starch HAES - steril 10 % 100 g/l solution for infusion intravenous use Poland Berlin-Chemie AG Glienicker Weg 125 12489 Berlin Germany Hydroxyethyl Starch, Sodium chloride Refortan 60 g/l 9 g/l solution for infusion intravenous use Poland Baxter Polska Sp. z o.o. ul. Kruczkowskiego 8 00-380 Warszawa Poland Hydroxyethyl Starch, 6 % Hydroksyetyloskrobia 200/0,5 Baxter 60 g/l solution for infusion intravenous use Poland Baxter Polska Sp. z o.o. ul. Kruczkowskiego 8 00-380 Warszawa Poland Hydroxyethyl Starch 10 % Hydroksyetyloskrobia 200/0,5 Baxter 100 g/l solution for infusion intravenous use Poland Berlin-Chemie AG Glienicker Weg 125 12489 Berlin Germany Hydroxyethyl Starch, Sodium chloride Refortan Forte 100 g/l 9 g/l solution for infusion intravenous use Poland B. Braun Melsungen AG Carl-Braun Strasse 1 34212 Melsungen Germany Hydroxyethyl Starch, Sodium chloride Hemohes 6 % 60 g/l 9 g/l solution for infusion intravenous use Poland B. Braun Melsungen AG Carl-Braun Strasse 1 34212 Melsungen Germany Hydroxyethyl Starch, Sodium chloride Hemohes 10 % 100 g/l 9 g/l solution for infusion intravenous use Poland B. Braun Melsungen AG Carl-Braun Strasse 1 34212 Melsungen Germany Hydroxyethyl Starch, Sodium chloride, Potassium chloride, Hydrated calcemia chloride, Hydrated magnesium chloride, Hydrated sodium acetate, Hydroxy succinic acid Tetraspan 60 mg/ml HES roztwór do infuzji 60 g/l 6,25 g/l 0,30 g/l 0,37 g/l 0,20 g/l 3,27 g/l 0,67 g/l solution for infusion intravenous use Poland B. Braun Melsungen AG Carl-Braun Strasse 1 34212 Melsungen Germany Hydroxyethyl Starch, Sodium chloride, Potassium chloride, Hydrated calcemia cloride, Hydrated magnesium chloride, Hydrated sodium acetate, Hydroxy succinic acid Tetraspan 100 mg/ml HES roztwór do infuzji 100 g/l 6,252 g/l 0,2984 g/l 0,3675 g/l 0,2033 g/l 3,266 g/l 0,6710 g/l solution for infusion intravenous use Poland Baxter Polska Sp. z o.o. ul. Kruczkowskiego 8 00-380 Warszawa Poland Hydroxyethyl Starch, Sodium chloride, Potassium chloride, Hydrated calcemia cloride, Hydrated magnesium chloride, Hydrated sodium acetate PlasmaVolume Redibag 60 g/l 6,0 g/l 0,4 g/l 0,134 g/l 0,2 g/l 3,70 g/l solution for infusion intravenous use Poland Fresenius Kabi Polska Sp. z o.o. ul. Hrubieszowska 2 01-209 Warszawa Poland Hydroxyethyl Starch, Sodium chloride Voluven 10 % 100 g/l 9 g/l solution for infusion intravenous use Poland Fresenius Kabi Deutschland GmbH 61346 Bad Homburg v.d.H Germany Polyhydroxyethylstarch, Sodium chloride HyperHAES 60 g/l, 72 g/l solution for infusion intravenous use Poland Fresenius Kabi Deutschland GmbH 61346 Bad Homburg v.d.H Germany Hydroxyethyl Starch, Sodium chloride VOLUVEN 60 g/l 9 g/l solution for infusion intravenous use Poland Fresenius Kabi Deutschland GmbH 61346 Bad Homburg v.d.H Germany Poly(O-2-hydoxyethyl)starch 130/0.4, Sodium chloride, Sodium acetate trihydrate, Potassium chloride, Magnesium chloride hexahydrate Volulyte 6 % 60 g/l, 6,02 g/l, 4,63 g/l, 0,30 g/l, 0,30 g/l solution for infusion intravenous use Portugal Fresenius Kabi Pharma Portugal, Lda Av. do Forte, 3 Edifício Suécia III - Piso 2 2790-073 Carnaxide Portugal Hydroxyethyl starch + Sodium chloride Haes-Steril 10 % 100 mg/ml + 9 mg/ml solution for infusion intravenous use Portugal Fresenius Kabi Pharma Portugal, Lda Av. do Forte, 3 Edifício Suécia III - Piso 2 2790-073 Carnaxide Portugal Hydroxyethyl starch + Sodium chloride Haes-Steril 6 % 60 mg/ml + 9 mg/ml solution for infusion intravenous use Portugal Fresenius Kabi Pharma Portugal, Lda Av. do Forte, 3 Edifício Suécia III - Piso 2 2790-073 Carnaxide Portugal Hydroxyethyl starch + Sodium chloride Voluven Fresenius 60 mg/ml + 9 mg/ml solution for infusion intravenous use Portugal Fresenius Kabi Pharma Portugal, Lda Av. do Forte, 3 Edifício Suécia III - Piso 2 2790-073 Carnaxide Portugal Hydroxyethyl starch + Sodium chloride HyperHAES 60 mg/ml + 72 mg/ml solution for infusion intravenous use Portugal B. Braun Melsungen A.G. Carl-Braun Strasse, 1 D-34212 Melsungen Germany Hydroxyethyl starch + Sodium chloride Venofundin 60 mg/ml + 9 mg/ml solution for infusion intravenous use Portugal Fresenius Kabi Pharma Portugal, Lda Av. do Forte, 3 Edifício Suécia III - Piso 2 2790-073 Carnaxide Portugal Potassium chloride + Sodium acetate trihydrate + Magnesium chloride hexahydrate + Hydroxyethyl starch + Sodium chloride Volulyte 0,3 mg/ml + 4,63 mg/ml + 0,3 mg/ml + 60 mg/ml + 6,02 mg/ml solution for infusion intravenous use Portugal B. Braun Melsungen A.G. Carl-Braun Strasse, 1 D-34212 Melsungen Germany Potassium chloride + Sodium acetate trihydrate + Malic acid + Magnesium chloride hexahydrate + Sodium chloride + Hydroxyethyl starch + Calcium chloride dihydrate Tetraspan 0,3 mg/ml + 3,27 mg/ml + 0,67 mg/ml + 0,2 mg/ml + 6,25 mg/ml + 60 mg/ml + 0,37 mg/ml solution for infusion intravenous use Portugal B. Braun Melsungen A.G. Carl-Braun Strasse, 1 D-34212 Melsungen Germany Potassium chloride + Sodium acetate trihydrate + Malic acid + Magnesium chloride hexahydrate + Sodium chloride + Hydroxyethyl starch + Calcium chloride dihydrate Tetraspan 0,3 mg/ml + 3,27 mg/ml + 0,67 mg/ml + 0,2 mg/ml + 6,25 mg/ml + 100 mg/ml + 0,37 mg/ml solution for infusion intravenous use Portugal Baxter Médico-Farmacêutica, Lda. Zona Industrial da Abrunheira - Edifício 10 - Sintra Business Park 2710-089 Sintra Portugal Sodium acetate trihydrate + Potassium chloride + Magnesium chloride hexahydrate + Hydroxyethyl starch + Calcium chloride dihydrate + Sodium chloride PlasmaVolume Redibag 3,7 mg/ml + 0,4 mg/ml + 0,2 mg/ml + 60 mg/ml + 0,134 mg/ml + 6 mg/ml solution for infusion intravenous use Portugal Fresenius Kabi Pharma Portugal, Lda Av. do Forte, 3 Edifício Suécia III - Piso 2 2790-073 Carnaxide Portugal Hydroxyethyl starch + Sodium chloride Voluven Fresenius 100 mg/ml + 9 mg/ml solution for infusion intravenous use Romania S.C. INFOMED FLUIDS S.R.L., B-dul Theodor Pallady nr. 50, sector 3, București, 032266 Romania Hydroxyethyl starch Sodium chloride Potassium chloride Calcium chloride dihydrate Magnesium chloride hexahydrate Sodium acetate trihydrate VITAFUSAL 60 g/l, 6 g/l, 0,40 g/l, 0,134 g/l, 0,20 g/l, 3,70 g/l solution for infusion intravenous use Romania Fresenius Kabi Deutschland GmbH 61346 Bad Homburg v.d.H Germany Hydroxyethyl starch Sodium chloride Voluven 60 g/1 000 ml 60 g/l, 9 g/l solution for infusion intravenous use Romania S.C. FRESENIUS KABI ROMÂNIA S.R.L. Strada Fânarului nr. 2A, 500464 Brașov, Romania Hydroxyethyl starch Sodium chloride VOLUVEN 10 % 100 g/l, 9 g/l solution for infusion intravenous use Romania S.C. INFOMED FLUIDS S.R.L. B-dul Theodor Pallady nr. 50, sector 3, București, 032266 Romania Hydroxyethyl starch Sodium chloride INFOHES 60 g/L 60 g/l, 9 g/l solution for infusion intravenous use Romania S.C. INFOMED FLUIDS S.R.L. B-dul Theodor Pallady nr. 50, sector 3, București, Romania Hydroxyethyl starch Sodium chloride INFOHES 100 g/L 100 g/l, 9 g/l solution for infusion intravenous use Romania B. BRAUN MELSUNGEN AG Carl – Braun str. 1, D – 34212 Melsungen, Germany Hydroxyethyl starch Sodium chloride HEMOHES 6 % 60 g/l, 9 g/l solution for infusion intravenous use Romania B. BRAUN MELSUNGEN AG Carl – Braun str. 1, D – 34212 Melsungen, Germany Hydroxyethyl starch Sodium chloride HEMOHES 10 % 100 g/l, 9 g/l solution for infusion intravenous use Romania Fresenius Kabi Deutschland GmbH 61346 Bad Homburg v.d.H Germany Hydroxyethyl starch Sodium chloride HAES-steril 60 g/1 000 ml 60 g/l, 9 g/l solution for infusion intravenous use Romania Fresenius Kabi Deutschland GmbH 61346 Bad Homburg v.d.H Germany Hydroxyethyl starch Sodium chloride HAES-steril 100 g/1 000 ml 100 g/l, 9 g/l solution for infusion intravenous use Romania B. BRAUN MELSUNGEN AG, Carl-Braun-Strasse 1 34212 Melsungen, Germany Hydroxyethyl starch Sodium chloride Venofundin 6 g/100 ml 60 g/l, 9 g/l solution for infusion intravenous use Romania S.C. Fresenius Kabi Romania S.R.L, strada Fanarului nr. 2A, 500464 Brasov, Romania Hydroxyethyl starch, Sodium acetate trihydrate, Potassium chloride, Magnesium chloride hexahydrate, Sodium chloride Volulyte 6 % 60 g/l, 4,63 g/l, 6,02 g/l, 0,30 g/l, 0,30 g/l solution for infusion intravenous use Romania B. BRAUN MELSUNGEN AG Carl-Braun. Str.1, D-34212 Melsungen, Germany Hidroxietil amidon, Sodium chloride, Potassium chloride, Magnesium chloride hexahydrate, Calcium chloride dihydrate,Sodium acetate trihydrate, Malic acid TETRASPAN 60 mg/ml 60 g/l, 6,252 g/l, 0,298 g/l, 0,203 g/l, 0,367 g/l, 3,266 g/l, 0,671 g/l solution for infusion intravenous use Romania B. BRAUN MELSUNGEN AG Carl-Braun. Str.1, D-34212 Melsungen, Germany Hidroxietil amidon, Sodium chloride, Potassium chloride, Magnesium chloride hexahydrate, Calcium chloride dihydrate,Sodium acetate trihydrate, Malic acid TETRASPAN 100 mg/ml 100 g/l, 6,252 g/l, 0,298 g/l, 0,203 g/l, 0,367 g/l, 3,266 g/l, 0,671 g/l solution for infusion intravenous use Slovak Republic Fresenius Kabi Deutschland GmbH Else-Kröner-Str. 1 61352 Bad Homburg v.d.H. Germany hydroxyethyl starch, Sodium chloride HAES-steril 10 % 100 g/l, 9 g/l solution for infusion intravenous use Slovak Republic Fresenius Kabi Deutschland GmbH Else-Kröner-Str. 1 61352 Bad Homburg v.d.H. Germany hydroxyethyl starch, Sodium chloride HyperHAES 60 g/l, 72 g/l solution for infusion intravenous use Slovak Republic BAXTER CZECH spol. s r.o. Karla Engliše 3201/6 150 00 Praha 5 Czech Republic hydroxyethyl starch, Sodium chloride, Potassium chloride, Calcium chloride dihydrate, Magnesium chloride hexahydrate, Sodium acetate trihydrate PlasmaVolume Redibag 60 g/l, 6 g/l, 0,4 g/l, 0,134 g/l, 0,2 g/l, 3,70 g/l solution for infusion intravenous use Slovak Republic B. Braun Melsungen AG Carl-Braun-Straße 1 34212 Melsungen Germany hydroxyethyl starch, Sodium chloride, Potassium chloride, Calcium chloride, Magnesium chloride hexahydrate, sodium acetate, Malic acid Tetraspan 10 % 100 g/l, 6,25 g/l, 0,30 g/l, 0,37 g/l, 0,20 g/l, 3,27 g /l, 0,67 g/l solution for infusion intravenous use Slovak Republic B. Braun Melsungen AG Carl-Braun-Straße 1 34212 Melsungen Germany hydroxyethyl starch, Sodium chloride, Potassium chloride, Calcium chloride, Magnesium chloride hexahydrate, sodium acetate, Malic acid Tetraspan 6 % 60 g/l, 6,25 g/l, 0,30 g/l, 0,37 g/l, 0,20 g/l, 3,27 g/l, 0,67 g/l solution for infusion intravenous use Slovak Republic Fresenius Kabi Deutschland GmbH Else-Kröner-Str. 1 61352 Bad Homburg v.d.H. Germany hydroxyethyl starch, Sodium acetate trihydrate, Sodium chloride, Potassium chloride, Magnesium chloride hexahydrate Volulyte 6 %, infúzny roztok 60 g/l, 4,63 g/l, 6,02 g/l, 0,30 g/l, 0,30 g/l solution for infusion intravenous use Slovak Republic Fresenius Kabi Deutschland GmbH Else-Kröner-Str. 1 61352 Bad Homburg v.d.H. Germany hydroxyethyl starch, Sodium chloride VOLUVEN 60 g/l, 9 g/l solution for infusion intravenous use Slovak Republic Fresenius Kabi s.r.o. Zeletavská 1525/1 140 00 Praha 4 - Michle Czech Republic hydroxyethyl starch, Sodium chloride Voluven 10 % 100 g/l, 9 g/l solution for infusion intravenous use Slovenia Medias International d.o.o. Leskoškova cesta 9D 1000 Ljubljana Slovenia Hydroxyethyl Starch, Sodium chloride HAES-steril 60 mg/ml raztopina za infundiranje 60,0 g/l, 9,0 g/l solution for infusion intravenous use Slovenia Baxter d.o.o. Zelezna cesta 18 1000 Ljubljana Slovenija Hydroxyethyl Starch, Sodium chloride, Potassium chloride, Calcium chloride dihydrate, Magnesium chloride hexahydrate, Sodium acetate trihydrate Plasma Volume Redibag 60 mg/ml raztopina za infundiranje 60,0 g/l, 6,0 g/l, 0,4 g/l, 0,134 g/l, 0,2 g/l, 3,7 g/l, solution for infusion intravenous use Slovenia B.Braun Melsungen AG Carl-Braun-Strasse 1 34212 Melsungen Germany Hydroxyethyl Starch, Sodium chloride, Potassium chloride, Calcium chloride dihydrate, Magnesium chloride hexahydrate, Sodium acetate trihydrate, Malic acid Tetraspan 60 mg/ml raztopina za infundiranje 60,0 g/l, 6,25 g/l, 0,30 g/l, 0,37 g/l, 0,20 g/l, 3,27 g/l, 0,67 g/l solution for infusion intravenous use Slovenia B.Braun Melsungen AG Carl-Braun-Strasse 1 34212 Melsungen Germany Hydroxyethyl Starch, Sodium chloride, Potassium chloride, Calcium chloride dihydrate, Magnesium chloride hexahydrate, Sodium acetate trihydrate, Malic acid Tetraspan 100 mg/ml raztopina za infundiranje 100,0 g/l, 6,25 g/l, 0,30 g/l, 0,37 g/l, 0,20 g/l, 3,27 g/l, 0,67 g/l solution for infusion intravenous use Slovenia Medias International d.o.o. Leskoškova cesta 9D 1000 Ljubljana Slovenia Hydroxyethyl Starch, Sodium chloride, Potassium chloride, Magnesium chloride hexahydrate, Sodium acetate trihydrate Volulyte 60 mg/ml raztopina za infundiranje 60,0 g/l, 6,02 g/l, 0,30 g/l, 0,30 g/l, 4,63 g/l solution for infusion intravenous use Slovenia Fresenius Kabi Deutschland GmbH 61346 Bad Homburg v.d.H Germany Hydroxyethyl Starch, Sodium chloride VOLUVEN 100 mg/ml raztopina za infundiranje 100,0 g/l, 9,0 g/l solution for infusion intravenous use Slovenia Medias International d.o.o. Leskoškova cesta 9D 1000 Ljubljana Slovenia Hydroxyethyl Starch, Sodium chloride VOLUVEN 60 mg/ml raztopina za infundiranje 60,0 g/l, 9,0 g/l solution for infusion intravenous use Spain B. BRAUN MELSUNGEN AG Carl-Braun Strasse, 1 Melsungen D-34212 Germany Hydroxyethyl Starch + Sodium Chloride HEMOES 6 % SOLUCIÓN 60 g/l + 9 g/l solution for infusion intravenous use Spain B. BRAUN MELSUNGEN AG Carl-Braun Strasse, 1 Melsungen D-34212 Germany Hydroxyethyl Starch + Sodium Chloride HEMOES 10 % SOLUCIÓN 100 g/l + 9 g/l solution for infusion intravenous use Spain Fresenius Kabi Deutschland GmbH Else-Kröner-Str. 1 61352 Bad Homburg v.d.H. Germany Hydroxyethyl Starch + Sodium Chloride VOLUVEN 6 % SOLUCIÓN PARA PERFUSIÓN 60 g/l + 9 g/l solution for infusion intravenous use Spain FRESENIUS KABI ESPAÑA S.A. Marina, 16-18-17 08005 Barcelona Spain Hydroxyethyl Starch + Sodium Chloride VOLUVEN 10 % SOLUCIÓN PARA PERFUSIÓN 100 g/l + 9 g/l solution for infusion intravenous use Spain Fresenius Kabi Deutschland GmbH Else-Kröner-Str. 1 61352 Bad Homburg v.d.H. Germany Hydroxyethyl Starch + Sodium Chloride HES HIPERTONICO FRESENIUS SOLUCIÓN PARA PERFUSIÓN 60 g/l + 72 g/l solution for infusion intravenous use Spain Fresenius Kabi Deutschland GmbH Else-Kröner-Str. 1 61352 Bad Homburg v.d.H. Germany Hydroxyethyl Starch + Sodium Acetate Trihydrate + Sodium Chloride + Potasium Chloride + Magnesium Chloride Hexahydrate VOLULYTE 6 % SOLUCIÓN PARA PERFUSIÓN 60 g/l + 4,63 g/l + 6,02 g/l + 0,30 g/l + 0,30 g/l solution for infusion intravenous use Spain B. BRAUN MELSUNGEN AG Carl-Braun Strasse, 1 Melsungen D-34212 Germany Hydroxyethyl Starch + Sodium Chloride + Potasium Chloride + Calcium Chloride Dihydrate + Magnesium Chloride Hexahydrate + Sodium Acetate Trihydrate + Malic Acid ISOHES 6 % SOLUCIÓN PARA PERFUSIÓN 60 g/l + 6,25 g/l + 0,30 g/l + 0,37 g/l + 0,20 g/l + 3,27 g/l + 0,67 g/l solution for infusion intravenous use Spain B. BRAUN MELSUNGEN AG Carl-Braun Strasse, 1 Melsungen D-34212 Germany Hydroxyethyl Starch + Sodium Chloride + Potasium Chloride + Calcium Chloride Dihydrate + Magnesium Chloride Hexahydrate + Sodium Acetate Trihydrate + Malic Acid ISOHES 10 % SOLUCIÓN PARA PERFUSIÓN 100 g/l + 6,25 g/l + 0,30 g/l + 0,37 g/l + 0,20 g/l + 3,27 g/l + 0,67 g/l solution for infusion intravenous use Spain BAXTER S.L. Polígono Industrial Sector 14 Pouet de Camilo, 2 46394 Ribarroja del Turia (Valencia) Spain Hydroxyethyl Starch + Sodium Chloride + Potasium Chloride + Calcium Chloride Dihydrate + Magnesium Chloride Hexahydrate + Sodium Acetate Trihydrate PLASMAVOLUME REDIBAG SOLUCIÓN PARA PERFUSIÓN 60 g/l + 6 g/l + 0,4 g/l + 0,134 g/l + 0,2 g/l + 3,70 g/l solution for infusion intravenous use Sweden Fresenius Kabi AB, 751 74 Uppsala Sweden Hydroxyethyl starch, 130/0.4, Sodium chloride Voluven 60 g/l, 9 g/l solution for infusion intravenous use Sweden Fresenius Kabi AB, 751 74 Uppsala Sweden Hydroxyethyl starch, 200/0.5, Sodium chloride HyperHAES 60 g/l, 72 g/l solution for infusion intravenous use Sweden B. Braun Melsungen AG P.O. Box 1110 +1120 DE-34209 Melsungen Germany Hydroxyethyl starch, 130/0.4, Sodium chloride Venofundin® 60 g/l, 9 g/l solution for infusion intravenous use Sweden B. Braun Melsungen AG Carl-Braun-Strasse 1 34212 Melsungen Germany hydroxyethyl starch, 130/0.4, sodium chloride, sodium acetate trihydrate, malic acid, calcium chloride dihydrate, potassium chloride, magnesium chloride hexahydrate Tetraspan 60 g/l, 6,252 g/l, 3,266 g/l, 0,671 g/l, 0,368 g/l, 0,298 g/l, 0,203 g/l solution for infusion intravenous use Sweden B. Braun Melsungen AG Carl-Braun-Strasse 1 34212 Melsungen Germany hydroxyethyl starch, 130/0.4, sodium chloride, sodium acetate trihydrate, malic acid, calcium chloride dihydrate, potassium chloride, magnesium chloride hexahydrate Tetraspan 100 g/l, 6,252 g/l, 3,266 g/l, 0,671 g/l, 0,368 g/l, 0,298 g/l, 0,203 g/l solution for infusion intravenous use Sweden Fresenius Kabi AB, 751 74 Uppsala Sweden hydroxyethyl starch, 130/0.4, sodium chloride, sodium acetate trihydrate, magnesium chloride hexahydrate, potassium chloride Volulyte 60 g/l, 6,020 g/l, 4,630 g/l, 0,300 g/l, 0,300 g/l solution for infusion intravenous use Sweden Baxter Medical AB Box 63 164 94 Kista Sweden hydroxyethyl starch, 130/0.4, sodium chloride, sodium acetate trihydrate, potassium chloride, magnesium chloride hexahydrate, calcium chloride dihydrate Hesra 60 g/l, 6,000 g/l, 3,700 g/l, 0,400 g/l, 0,200 g/l, 0,134 g/l solution for infusion intravenous use Sweden Fresenius Kabi AB, 751 74 Uppsala Sweden Hydroxyethyl starch, 130/0.4, Sodium chloride Voluven 100 g/l, 9 g/l solution for infusion intravenous use The Netherlands Fresenius Kabi Nederland B.V. Molenberglei 7 2627 Schelle Belgium active substance: hydroxyethyl starch (MR 200.000), Sodium chloride EloHAES, infusievloeistof 60,0 g/l, 9,0 g/l solution for infusion intravenous use The Netherlands Fresenius Kabi Nederland B.V. Molenberglei 7 2627 Schelle Belgium active substance: hydroxyethyl starch (MR 200.000) HyperHAES, oplossing voor intraveneuze infusie 60 g/l 60,0 g/l solution for infusion intravenous use The Netherlands B. Braun Melsungen AG (Melsungen) Carl-Braun-Strasse 1 34212 Melsungen Germany active substance: hydroxyethyl starch (MR 130.000) Sodium Chloride, malic acid, Calcium Chloride, Potassium Chloride, Magnesium Chloride, Sodium acetate Tetraspan 10 % g/v, oplossing voor infusie 100 g/l 100,0 g/l, 9 g/l, 0,67 g/l, 0,37 g/l, 0,3 g/l, 0,2 g/l, 3,27 g/l solution for infusion intravenous use The Netherlands B. Braun Melsungen AG (Melsungen) Carl-Braun-Strasse 1 34212 Melsungen Germany active substance: hydroxyethyl starch (MR 130.000) Sodium Chloride, malic acid, Calcium Chloride, Potassium Chloride, Magnesium Chloride, Sodium acetate Tetraspan 6 % g/v, oplossing voor infusie 60 g/l 60,0 g/l, 6,25 g/l, 0,67 g/l, 0,37 g/l, 0,3 g/l, 0,2 g/l, 3,27 g/l solution for infusion intravenous use The Netherlands B. Braun Melsungen AG (Melsungen) Carl-Braun-Strasse 1 34212 Melsungen Germany active substance: hydroxyethyl starch (MR 130.000), sodium chloride Venofundin 60 mg/ml, oplossing voor intraveneuze infusie 60,0 g/l, 9 g/l solution for infusion intravenous use The Netherlands Fresenius Kabi Nederland B.V. Molenberglei 7 2627 Schelle Belgium active substance: hydroxyethyl starch (MR 130.000), Sodium Chloride, Potassium Chloride, Magnesium Chloride, Sodium acetate, hydrochloric acid Volulyte 6 % oplossing voor infusie 60,0 g/l, 6,02 g/l, 0,3 g/l, 0,3 g/l, 4,63 g/l, 0,3 g/l solution for infusion intravenous use The Netherlands Fresenius Kabi Nederland B.V. Molenberglei 7 2627 Schelle Belgium active substance: hydroxyethyl starch (MR 130.000), sodium chloride Voluven, 6 % (60 mg/ml) oplossing voor infusie 60,0 g/l, 0,9 g/l solution for infusion intravenous use The Netherlands Fresenius Kabi Nederland B.V. Molenberglei 7 2627 Schelle Belgium active substance: hydroxyethyl starch (polymere 130/0.4) and sodium chloride Voluven 10 % (100 mg/ml) 100 g/l, 9 g/l solution for infusion intravenous use The Netherlands Baxter B.V. Kobaltweg 49 3542 CE UTRECHT/The Netherlands Sodium chloride, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate, sodium acetate trihydrate, hydroxyethyl starch 130/0.42 Plasma Volume Redibag 6 %, solution for infusion 6 g/l, 0,4 g/l, 0,134 g/l, 0,2 g/l, 3,7 g/l, 60 g/l solution for infusion intravenous use United Kingdom Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk IP24 3SE United Kingdom Sodium chloride, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate, sodium acetate trihydrate, hydroxyethyl starch 130/0.42 Plasma Volume Redibag 6 % Solution for Infusion 6 g/l, 0,4 g/l, 0,134 g/l, 0,2 g/l, 3,7 g/l, 60 g/l solution for infusion intravenous use United Kingdom Fresenius Kabi Limited Cestrian Court Eastgate way Manor Park Runcorn, Cheshire WA7 1NT United Kingdom Hydroxyethyl starch 130/0.4, sodium chloride Voluven 6 % solution for injection 60 g/l, 9 g/l solution for infusion intravenous use United Kingdom Fresenius Kabi Limited Cestrian Court Eastgate way Manor Park Runcorn, Cheshire WA7 1NT United Kingdom Hydroxyethyl starch 200/0.5, sodium chloride Hyperhaes Solution for Injection 72 g/l, 60 g/l solution for infusion intravenous use United Kingdom Fresenius Kabi Limited Cestrian Court Eastgate way Manor Park Runcorn, Cheshire WA7 1NT United Kingdom Sodium acetate trihydrate, sodium chloride, potassium chloride, magnesium chloride hexahydrate, hydroxyethyl starch 130/0.4 Volulyte 6 % solution for infusion 4,63 g/l, 6,02 g/l. 0,3 g/l, 0,3 g/l, 60 g/l solution for infusion intravenous use United Kingdom Fresenius Kabi Limited Cestrian Court Eastgate way Manor Park Runcorn, Cheshire WA7 1NT United Kingdom Sodium chloride, hydroxyethyl starch 130/0.4 Voluven 6 % solution for infusion 9 g/l, 60 g/l solution for infusion intravenous use United Kingdom Fresenius Kabi Limited Cestrian Court Eastgate way Manor Park Runcorn, Cheshire WA7 1NT United Kingdom Sodium chloride, hydroxyethyl starch 130/0.4 Voluven 10 % solution for infusion 9 g/l, 100 g/l solution for infusion intravenous use United Kingdom B Braun Melsungen AG Carl-Braun-Strasse 1 Melsungen, D-34212 Germany Poly (O-2-hydroxyethyl) starch mol. sub. 0,45-0,55 AV. MW 200K, sodium chloride Venofundin 6 % solution for infusion 60 g/l, 9 g/l solution for infusion intravenous use United Kingdom B Braun Melsungen AG Carl-Braun-Strasse 1 Melsungen, D-34212 Germany Sodium chloride, potassium chloride, magnesium chloride hexahydrate, sodium acetate trihydrate, malic acid, poly (0-2-hydroxyethyl) starch, calcium chloride dihydrate Tetraspan 6 % solution for infusion 6,25 g/l, 0,3 g/l, 0,2 g/l, 3,27 g/l, 0,67 g/l, 60 g/l, 0/37 g/l solution for infusion intravenous use United Kingdom B Braun Melsungen AG Carl-Braun-Strasse 1 Melsungen, D-34212 Germany Sodium chloride, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate,sodium acetate trihydrate, malic acid, poly (0-2-hydroxyethyl) starch Tetraspan 10 % solution for infusion 6,25 g/l, 0,3 g/l, 0,37 g/l, 0,2 g/l, 3,27 g/l, 0,67 g/l, 100 g/l solution for infusion intravenous use

ANNEX III LIST OF THE NAMES, PHARMACEUTICAL FORM(S), STRENGTH(S) OF THE MEDICINAL PRODUCT(S), ROUTE(S) OF ADMINISTRATION, MARKETING AUTHORISATION HOLDER(S) IN THE MEMBER STATES Member State (in EEA) Marketing authorisation holder Product name Strength Pharmaceutical form Route of administration Austria Hexal Pharma GmbH Stella-Klein-Löw-Weg 17 1020 Wien Austria Metogastron 10 mg - Ampullen 10 mg/2 ml Solution for injection Intramuscular use Intravenous use Austria Hexal Pharma GmbH Stella-Klein-Löw-Weg 17 1020 Wien Austria Metogastron 4 mg/ml - Tropfen 4 mg/ml Oral drops, solution Oral use Austria Abbott Products GmbH Perfektastraße 84A 1230 Wien Austria Paspertin - Filmtabletten 10 mg Film-coated tablet Oral use Austria Abbott Products GmbH Perfektastraße 84A 1230 Wien Austria Paspertin 10 mg - Ampullen 10 mg/2 ml Solution for injection Intramuscular use Intravenous use Austria Abbott Products GmbH Perfektastraße 84A 1230 Wien Austria Paspertin 50 mg - Konzentrat zur Infusionsbereitung 50 mg/10 ml Concentrate for solution for infusion Intravenous use Austria Abbott Products GmbH Perfektastraße 84A 1230 Wien Austria Paspertin 4 mg/ml - Tropfen 4 mg/ml Oral drops, solution Oral use Belgium Sanofi-Aventis Belgium N.V. Culliganlaan 1 C 1831 Diegem Belgium Primperan 10 mg Tablet Oral use Belgium Sanofi-Aventis Belgium N.V. Culliganlaan 1 C 1831 Diegem Belgium Primperan 1 mg/ml Oral solution Oral use Belgium Sanofi-Aventis Belgium N.V. Culliganlaan 1 C 1831 Diegem Belgium Primperan 10 mg/2 ml Solution for injection Intramuscular use Intravenous use Belgium Sanofi-Aventis Belgium N.V. Culliganlaan 1 C 1831 Diegem Belgium Primperan 20 mg 20 mg Suppository Rectal use Belgium Takeda Belgium Gentsesteenweg 615 1080 Brussel Belgium Dibertil 5 mg Capsule, soft Oral use Belgium Takeda Belgium Gentsesteenweg 615 1080 Brussel Belgium Dibertil 10 mg Capsule, soft Oral use Bulgaria Sopharma PLC 16 Iliensko Shosse Str. Sofia 1220 Bulgaria Antiemetin 5 mg/ml Solution for injection Intramuscular use Intravenous use Bulgaria Sopharma PLC 16 Iliensko Shosse Str. Sofia 1220 Bulgaria Antiemetin 5 mg/ml Syrup Oral use Bulgaria AWD.pharma GmbH&Co.KG Wasastrasse 50 Radebeul 01445 Germany Cerucal 10 mg Tablet Oral use Bulgaria Lek Pharmaceuticals d.d. Verovskova 57 Ljubljana 1526 Slovenia Degan 10 mg/2 ml Solution for injection Intramuscular use Intravenous use Bulgaria Lek Pharmaceuticals d.d. Verovskova 57 Ljubljana 1526 Slovenia Degan 10 mg Tablet Oral use Bulgaria CSC Pharmaceuticals Ltd. 10 Assen Yordanov str. Sofia 1592 Bulgaria Pramidin 10 10 mg/spray Nasal spray, solution Nasal use Bulgaria CSC Pharmaceuticals Ltd. 10 Assen Yordanov str. Sofia 1592 Bulgaria Pramidin 20 20 mg/spray Nasal spray, solution Nasal use Bulgaria Alkaloid Ltd 2 Ricardo Vakarini str. Sofia 1404 Bulgaria Reglan 10 mg Tablet Oral use Cyprus Sanofi Aventis Cyprus ltd Charalambou Mouskou 14 2015 Strovolos Nicosia Cyprus Primperan for adults suppository 20 mg 20 mg Suppository Rectal use Cyprus Sanofi Aventis Cyprus ltd Charalambou Mouskou 14 2015 Strovolos Nicosia Cyprus Primperan solution for injection 10 mg/2 ml 10 mg/2 ml Solution for injection Intramuscular use Intravenous use Cyprus Sanofi Aventis Cyprus ltd Charalambou Mouskou 14 2015 Strovolos Nicosia Cyprus Primperan tablets 10 mg 10 mg Tablet Oral use Cyprus Medochemie ltd 1-10 Constantinoupoleos street P.O.BOX 51409 3505 Lemesos Cyprus Elitan tablets 10 mg 10 mg Tablet Oral use Cyprus Medochemie ltd 1-10 Constantinoupoleos street P.O.BOX 51409 3505 Lemesos Cyprus Elitan injection 10 mg/2 ml 10 mg/2 ml Injection Intramuscular use Intravenous use Cyprus Remedica ltd Aharnon street P.O.Box 51706 3508 Lemesos Cyprus Cloperan tablets 10 mg 10 mg Tablet Oral use Cyprus Accord Healthcare Ltd Sage House 319 Pinner Road North Harrow Middlesex HA1 4HF United Kingdom Metoclopramide Accord 10 mg tablet 10 mg Tablet Oral use Czech Republic Lek Pharmaceuticals d.d. Verovškova 57 1526 Ljubljana Slovenia Degan 10 mg tablety 10 mg Tablet Oral use Czech Republic Lek Pharmaceuticals d.d. Verovškova 57 1526 Ljubljana Slovenia Degan 10 mg roztok pro injekci 5 mg/ml Solution for injection Intramuscular use Intravenous use Czech Republic Hexal AG Industriestrasse 25 83607 Holzkirchen Germany Mcp hexal 10 10 mg Tablet Oral use Czech Republic Teva Pharmaceuticals CR, s.r.o. Radlická 3185/1c 150 00 Prague Czech Republic Cerucal 10 mg Tablet Oral use Czech Republic Teva Pharmaceuticals CR, s.r.o. Radlická 3185/1c 150 00 Prague Czech Republic Cerucal 5 mg/ml Solution for injection Intramuscular use Intravenous use Denmark Sanofi-aventis Denmark A/S Slotsmarken 13 DK-2970 Hørsholm Denmark Primperan 10 mg/2 ml Solution for injection Intramuscular use Intravenous use Denmark Sanofi-aventis Denmark A/S Slotsmarken 13 DK-2970 Hørsholm Denmark Primperan 20 mg Suppository Rectal use Denmark Orion Corporation Orionintie 1A FI-02200 Espoo Finland Emperal 10 mg Tablet Oral use Denmark Temmler Pharma GmbH & Co KG, Temmlerstrasse 2 DE-35039 Marburg Germany Gasto-Timelets 30 mg Prolonged-release capsule, hard Oral use Estonia Teva Pharma B.V. Computerweg 10 3542 DR Utrecht The Netherlands CERUCAL 10 mg Tablet Oral use Finland sanofi-aventis Oy Huopalahdentie 24 00350 Helsinki Finland Primperan 20 mg Suppository Rectal use Finland sanofi-aventis Oy Huopalahdentie 24 00350 Helsinki Finland Primperan 10 mg Tablet Oral use Finland sanofi-aventis Oy Huopalahdentie 24 00350 Helsinki Finland Primperan 5 mg/ml Solution for injection Intramuscular use Intravenous use France Sanofi Aventis France 1-13, boulevard Romain Rolland 75014 Paris France PRIMPERAN 10 mg, comprimé sécable 10 mg Tablet Oral use France Sanofi Aventis France 1-13, boulevard Romain Rolland 75014 Paris France PRIMPERAN 10 mg, suppositoire sécable 10 mg Suppository Rectal use France Sanofi Aventis France 1-13, boulevard Romain Rolland 75014 Paris France PRIMPERAN 20 mg, suppositoire 20 mg Suppository Rectal use France Sanofi Aventis France 1-13, boulevard Romain Rolland 75014 Paris France PRIMPERAN ENFANTS 2,6 mg/ml, solution buvable 2,6 mg/ml Oral solution Oral use France Sanofi Aventis France 1-13, boulevard Romain Rolland 75014 Paris France PRIMPERAN NOURRISSONS ET ENFANTS 2,6 mg/ml, solution buvable 2,6 mg/ml Oral drops, solution Oral use France Sanofi Aventis France 1-13, boulevard Romain Rolland 75014 Paris France PRIMPERAN 0,1 % ADULTES, solution buvable édulcorée au cyclamate de sodium et à la saccharine sodique 0,10 % Oral drops, solution Oral use France Sanofi Aventis France 1-13, boulevard Romain Rolland 75014 Paris France PRIMPERAN 0,1 %, solution buvable édulcorée à la saccharine sodique 0,10 % Oral solution Oral use France Sanofi Aventis France 1-13, boulevard Romain Rolland 75014 Paris France PRIMPERAN 10 mg/2 ml, solution injectable en ampoule 10 mg/2 ml Solution for injection Intramuscular use Intravenous use France Sanofi Aventis France 1-13, boulevard Romain Rolland 75014 Paris France PRIMPERAN 100 mg, solution injectable 100 mg/5 ml Solution for injection Intramuscular use Intravenous use France Laboratoire Renaudin Z A. Errobi Itxassou 64250 Cambo les Bains France CHLORHYDRATE DE METOCLOPRAMIDE RENAUDIN 10 mg/2 ml, solution injectable en ampoule 10 mg/2 ml Solution for injection Intramuscular use Intravenous use France Laboratoire Renaudin Z A. Errobi Itxassou 64250 Cambo les Bains France CHLORHYDRATE DE METOCLOPRAMIDE RENAUDIN 20 mg/ml, solution injectable 20 mg/ml Solution for injection Intramuscular use Intravenous use France Panpharma ZI du Clairay Luitré 35133 Fougères France DICHLORHYDRATE DE METOCLOPRAMIDE PANPHARMA 100 mg/5 ml, solution injectable (IM, IV) en ampoule 100 mg/100 ml Solution for injection Intramuscular use Intravenous use France Laboratoires Richard rue du Progrès ZI des Reys de Saulce 26270 Saulce sur Rhone France CHLORHYDRATE DE METOCLOPRAMIDE RICHARD 1 mg/ml, solution buvable 1 mg/ml Oral solution Oral use France Mylan SAS 117, allée des Parcs 69800 Saint-Priest France METOCLOPRAMIDE MYLAN 10 mg, comprimé sécable 10 mg Tablet Oral use France Sandoz 49, avenue Georges Pompidou 92300 Levallois-Perret France METOCLOPRAMIDE SANDOZ 10 mg, comprimé sécable 10 mg Tablet Oral use France Meda Pharma France 25, boulevard de l'Amiral Bruix 75016 Paris France ANAUSIN METOCLOPRAMIDE 15 mg, comprimé à libération prolongée 15 mg Prolonged-release tablet Oral use France Techni-Pharma 7, rue de l'Industrie BP 717 98014 Monaco Cedex Monaco PROKINYL L.P. 15 mg, gélule à libération prolongée 15 mg Prolonged-release capsule, hard Oral use Germany 1 A Pharma GmbH Keltenring 1 + 3 D-82041 Oberhaching Germany MCP Tropfen-1 A-Pharma 4,21 mg/1 g Oral solution Oral use Germany Abbott Arzneimittel GmbH Freundallee 9A 30173 Hannover Germany Paspertin 10 mg/2 ml Ampullen 10 mg/2 ml Solution for injection Intramuscular use Intravenous use Germany Abbott Arzneimittel GmbH Freundallee 9A 30173 Hannover Germany Paspertin 50 mg/10 ml Ampullen 50 mg/10 ml Concentrate for solution for infusion Intravenous use Germany Abbott Arzneimittel GmbH Freundallee 9A 30173 Hannover Germany Paspertin Filmtabletten 10 mg Film-coated tablet Oral use Germany Abbott Arzneimittel GmbH Freundallee 9A 30173 Hannover Germany Paspertin Tropfen 4 mg/ml Oral solution Oral use Germany AbZ-Pharma GmbH Graf-Arco-Str. 3 89079 Ulm Germany MCP AbZ 5 mg/ml Tropfen 5,91 mg/ml Oral solution Oral use Germany ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19 D-89150 Laichingen Germany MCP AL 10 10,53 mg Tablet Oral use Germany ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19 D-89150 Laichingen Germany MCP AL retard 30 mg Prolonged-release capsule, hard Oral use Germany ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19 D-89150 Laichingen Germany MCP AL Tropfen 4,21 mg/1 ml Oral solution Oral use Germany AWD.pharma GmbH & Co.KG Wasastr. 50 D-01445 Radebeul Germany Cerucal inject 10,54 mg/2 ml Solution for injection Intramuscular use Intravenous use Germany AWD.pharma GmbH & Co.KG Wasastr. 50 D-01445 Radebeul Germany Metoclopramid AWD 10 mg Tabletten 10,53 mg Tablet Oral use Germany axcount Generika AG Max-Planck-Str. 36b D-61381 Friedrichsdorf Germany MCP axcount Tropfen 4,21 mg/ml Oral solution Oral use Germany betapharm Arzneimittel GmbH Kobelweg 95 D-86156 Augsburg Germany MCP-beta Tropfen 4,21 mg/ml Oral solution Oral use Germany CT Arzneimittel GmbH Graf-Arco-Str. 3 79079 Ulm Germany MCP-CT 10 mg/2 ml Ampullen 10 mg/2 ml Solution for injection Intramuscular use Intravenous use Germany CT Arzneimittel GmbH Graf-Arco-Str. 3 79079 Ulm Germany MCP-CT 30 mg Retardkapseln 30 mg Prolonged-release capsule, hard Oral use Germany CT Arzneimittel GmbH Graf-Arco-Str. 3 79079 Ulm Germany MCP-CT 4 mg/1 ml Tropfen 5,2 mg/ml Oral solution Oral use Germany DOCPHARM Arzneimittelvertrieb GmbH & Co Greschbachstr. 7 D-76229 Karlsruhe Germany Metoclopramid Injektionslösung 10 ml PB 52,65 mg/10 ml Solution for injection Intravenous use Germany Dolorgiet GmbH & Co.KG Otto-von-Guericke-Str. 1 D-53757 Sankt Augustin Germany Gastronerton 465 mg/100 ml Oral solution Oral use Germany Dolorgiet GmbH & Co.KG Otto-von-Guericke-Str. 1 D-53757 Sankt Augustin Germany Gastronerton 8,92 mg Tablet Oral use Germany hameln pharmaceuticals GmbH Langes Feld 13 D-31789 Hameln Germany Metoclo-hameln 5 mg/ml, Injektionslösung 10,53 mg/2 ml Solution for injection Intramuscular use Intravenous use Germany Heumann Pharma GmbH & Co. Generica KG Südwestpark 50 D-90449 Nürnberg Germany Gastrosil 10 mg Amp. 10 mg/2 ml Solution for injection Intramuscular use Intravenous use Germany Heumann Pharma GmbH & Co. Generica KG Südwestpark 50 D-90449 Nürnberg Germany Gastrosil 20 mg Supp. 20 mg Suppository Rectal use Germany Heumann Pharma GmbH & Co. Generica KG Südwestpark 50 D-90449 Nürnberg Germany Gastrosil 50 mg Amp. 52,7 mg/10 ml Solution for injection Intravenous use Germany Heumann Pharma GmbH & Co. Generica KG Südwestpark 50 D-90449 Nürnberg Germany Gastrosil akut Tropfen 5,97 mg/ml Oral solution Oral use Germany Heumann Pharma GmbH & Co. Generica KG Südwestpark 50 D-90449 Nürnberg Germany Gastrosil retard 31,6 mg Prolonged-release capsule, hard Oral use Germany Heumann Pharma GmbH & Co. Generica KG Südwestpark 50 D-90449 Nürnberg Germany Gastrosil retard mite 15,8 mg Prolonged-release capsule, hard Oral use Germany Heumann Pharma GmbH & Co. Generica KG Südwestpark 50 D-90449 Nürnberg Germany Gastrosil Tabletten 10,54 mg Tablet Oral use Germany Heumann Pharma GmbH & Co. Generica KG Südwestpark 50 D-90449 Nürnberg Germany Gastrsosil Tropfen 5,97 mg/ml Oral solution Oral use Germany Heumann Pharma GmbH & Co. Generica KG Südwestpark 50 D-90449 Nürnberg Germany MCP Heumann 10 mg Tabletten 10,53 mg Tablet Oral use Germany HEXAL AG Industriestr. 25 D-83607 Holzkirchen Germany MCP Hexal 10 10,53 mg Tablet Oral use Germany HEXAL AG Industriestr. 25 D-83607 Holzkirchen Germany MCP Hexal injekt 10,53 mg/2 ml Solution for injection Intramuscular use Intravenous use Germany HEXAL AG Industriestr. 25 D-83607 Holzkirchen Germany MCP Hexal Tropfen 4,21 mg/ml Oral solution Oral use Germany Mylan dura GmbH Wittichstr. 6 D-64295 Darmstadt Germany MCP dura 4 mg/ml Tropfen zum Einnehmen 4,21 mg/ml Oral solution Oral use Germany ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany MCP-ratiopharm 10 mg Tabletten 11,82 mg Tablet Oral use Germany ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany MCP-ratiopharm 10 mg Zäpfchen 10 mg Suppository Rectal use Germany ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany MCP-Ratiopharm 30 mg Retardkapseln 30 mg Prolonged-release capsule Oral use Germany ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany MCP-ratiopharm 4 mg/ml Tropfen 5,2 mg/ml Oral solution Oral use Germany ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany MCP-ratiopharm SF 10 mg/2 ml Injektionslösung 10 mg/2 ml Solution for injection Intramuscular use Intravenous use Germany ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany MCP-ratiopharm SF 50 mg/10 ml Konzentrat zur Herstellung einer Infusionslösung 50 mg/10 ml Concentrate for solution for infusion Intravenous use Germany Sandoz Pharmaceuticals GmbH Raiffeisenstr. 11 D-83607 Holzkirchen Germany MCP Sandoz 10 mg Tabletten 10,53 mg Tablet Oral use Germany Sandoz Pharmaceuticals GmbH Raiffeisenstr. 11 D-83607 Holzkirchen Germany MCP Sandoz 4 mg/ml Tropfen zum Einnehmen, Lösung 4,21 mg/ml Oral solution Oral use Germany Stadapharm GmbH Stadastr. 2 - 18 D-61118 Bad Vilbel Germany MCP STADA 10 mg Tabletten 10,53 mg Tablet Oral use Germany Stadapharm GmbH Stadastr. 2 - 18 D-61118 Bad Vilbel Germany MCP STADA 4 mg/1 ml Tropfen zum Einnehmen, Lösung 4,21 mg/ml Oral solution Oral use Germany Temmler Pharma GmbH & Co.KG Temmlerstr. 2 D-35039 Marburg Germany Cerucal 10,54 mg Tablet Oral use Germany Temmler Pharma GmbH & Co.KG Temmlerstr. 2 D-35039 Marburg Germany Cerucal retard 30 mg Prolonged-release capsule, hard Oral use Greece Sanofi Aventis AEBE 348 Syngrou avenue Building A 176 74 Kalithea – Athens Greece PRIMPERAN 10 mg Suppository Rectal use Greece Sanofi Aventis AEBE 348 Syngrou avenue Building A 176 74 Kalithea – Athens Greece PRIMPERAN 20 mg Suppository Rectal use Greece Sanofi Aventis AEBE 348 Syngrou avenue Building A 176 74 Kalithea – Athens Greece PRIMPERAN 10 mg/2 ml Solution for injection Intramuscular use Intravenous use Greece Sanofi Aventis AEBE 348 Syngrou avenue Building A 176 74 Kalithea – Athens Greece PRIMPERAN 5 mg/5 ml Syrup Oral use Greece Sanofi Aventis AEBE 348 Syngrou avenue Building A 176 74 Kalithea – Athens Greece PRIMPERAN 10 mg Tablet Oral use Hungary AWD Pharma GmbH&Co. KG Wasastrasse 50 Radebeul 1445 Germany CERUCAL 5 mg/ml oldatos injekció 5 mg/ml Solution for injection Parenteral use Hungary AWD Pharma GmbH&Co. KG Wasastrasse 50 Radebeul 1445 Germany CERUCAL tabletta 10 mg Tablet Oral use Iceland Nycomed Pharma AS P.O Box 205 NO-1375, Asker Norway Afipran 10 mg Tablet Oral use Iceland Nycomed Pharma AS P.O Box 205 NO-1375, Asker Norway Afipran 20 mg Suppository Rectal use Iceland Nycomed Pharma AS P.O Box 205 NO-1375, Asker Norway Afipran 5 mg/ml Solution for injection Intramuscular use Intravenous use Ireland Mercury Pharmacuticals (Ireland) Ltd 4045 Kingswood Road Citywest Business Park Co. Dublin Ireland Metoclopramide 10 mg/2 ml Solution for injection Intramuscular use Intravenous use Ireland Amdipharm Limited Regency House Miles Gray Road Basildon Essex, SS14 3AF United Kingdom Maxolon 5 mg/ml Solution for injection Intramuscular use Intravenous use Ireland Amdipharm Limited Regency House Miles Gray Road Basildon Essex, SS14 3AF United Kingdom Maxolon 10 mg Tablet Oral use Italy Sanofi-Aventis spa Viale Luigi BODIO, 37/B 20158 Milano Italy PLASIL 10 mg/2 ml Solution for injection Intramuscular use Intravenous use Italy Sanofi-Aventis spa Viale Luigi BODIO, 37/B 20158 Milano Italy PLASIL 1 mg/ml Syrup Oral use Italy Sanofi-Aventis spa Viale Luigi BODIO, 37/B 20158 Milano Italy PLASIL 4 mg/ml Oral drops, solution Oral use Italy Sanofi-Aventis spa Viale Luigi BODIO, 37/B 20158 Milano Italy PLASIL 10 mg Tablet Oral use Italy Teofarma srl Via Fratelli Cervi, 8 27010 Valle Salimbene Pavia Italy RANDUM 10 mg Tablet Oral use Italy F.I.R.M.A. spa Via Scandicci, 37 50143 Firenze Italy CLOPAN 10 mg Solution for injection Intramuscular use Intravenous use Italy Sirton Medicare spa Piazza XX Settembre, 2 22079 Villa Guardia - COMO Italy PRAMIDIN 10 mg/spray Nasal spray, solution Nasal use Italy Sirton Medicare spa Piazza XX Settembre, 2 22079 Villa Guardia - COMO Italy PRAMIDIN 20 mg/spray Nasal spray, solution Nasal use Italy Sanofi-Aventis spa Viale Luigi BODIO, 37/B 20158 Milano Italy DIGESTIVO S.PELLEGRINO 5 mg Effervescent tablet Oral use Italy Sanofi-Aventis spa Viale Luigi BODIO, 37/B 20158 Milano Italy DIGESTIVO S.PELLEGRINO 5 mg Effervescent granules Oral use Italy Hospira Italia srl Via Orazio, 20/22 80122 NAPOLI Italy METOCLOPRAMIDE CLORIDRATO HOSPIRA 10 mg Solution for injection Intramuscular use Intravenous use Italy Farmakopea spa Via Cavriana, 14 20134 MILANO Italy ISAPRANDIL 5 mg Effervescent tablet Oral use Italy Farmakopea spa Via Cavriana, 14 20134 MILANO Italy ISAPRANDIL 5 mg Effervescent granules Oral use Latvia Pharmaceutical Works POLPHARMA SA 19 Pelplińska Street 83-200 Starogard Gdański Poland Metoclopramid Polpharma 10 mg tablets 10 mg Tablet Oral use Latvia Pharmaceutical Works POLPHARMA SA 19 Pelplińska Street 83-200 Starogard Gdański Poland Metoclopramid Polpharma 10 mg/2 ml solution for injection 10 mg/2 ml Solution for injection Intramuscular use Intravenous use Latvia Teva Pharma B.V. Computerweg 10 3542 DR Utrecht The Netherlands Cerucal 10 mg tablets 10 mg Tablet Oral use Lithuania Teva Pharma B.V. Computerweg 10 3542 DR Utrecht The Netherlands Cerucal 10 mg Tablet Oral use Lithuania Medochemie Ltd. p.o box 51409 CY-3505, Limassol Cyprus ELITAN 5 mg/ml Solution for injection Intramuscular use Intravenous use Lithuania Pharmaceutical Works POLPHARMA SA 19 Pelplińska Street 83-200 Starogard Gdański Poland Metoclopramid Polpharma 10 mg Tablet Oral use Lithuania Pharmaceutical Works POLPHARMA SA 19 Pelplińska Street 83-200 Starogard Gdański Poland Metoclopramid Polpharma 10 mg/2 ml Solution for injection Intramuscular use Intravenous use Luxembourg Nycomed Belgium s.a. 615, chaussee de Gand B-1080 Bruxelles Belgium Dibertil 10 mg Capsule, soft Oral use Luxembourg Nycomed Belgium s.a. 615, chaussee de Gand B-1080 Bruxelles Belgium Dibertil 5 mg Capsule, soft Oral use Luxembourg Dolorgiet Gmbh&Co Otto-von-Guericke-Str. 1 D-53757 Sankt Augustin Germany Gastronerton 4,65 mg/ml Oral drops Oral use Luxembourg Dolorgiet Gmbh&Co Otto-von-Guericke-Str. 1 D-53757 Sankt Augustin Germany Gastronerton 8,92 mg Tablet Oral use Luxembourg Ratiopharm GMBH Arzneimittel Graf-Arco-Str. 3 D-89079 Ulm Germany MCP Ratiopharm 5,2 mg Oral drops Oral use Luxembourg Ratiopharm GMBH Arzneimittel Graf-Arco-Str. 3 D-89079 Ulm Germany MCP Ratiopharm 10 mg Suppository Rectal use Luxembourg Ratiopharm GMBH Arzneimittel Graf-Arco-Str. 3 D-89079 Ulm Germany MCP Ratiopharm 10 mg Tablet Oral use Luxembourg Ratiopharm GMBH Arzneimittel Graf-Arco-Str. 3 D-89079 Ulm Germany mcP Ratiopharm SF 10 mg/2 ml Solution for injection Intramuscular use Intravenous use Luxembourg Ratiopharm GMBH Arzneimittel Graf-Arco-Str. 3 D-89079 Ulm Germany MCP Ratiopharm-30 30 mg Modified-release capsule, soft Oral use Luxembourg Eurogenerics s.a. Heizel Esplanade B22 1020 Laeken Belgium Metoclopramide EG-10 10 mg Capsule, soft Oral use Luxembourg Sanofi-Aventis Belgium Culliganlaan 1 C 1831 Diegem Belgium Primperan adultes 20 mg Suppository Rectal use Luxembourg Hexal AG Industriestr. 25 D-83607 Holzkirchen Germany MCP Hexal-10 10 mg Tablet Oral use Luxembourg Hexal AG Industriestr. 25 D-83607 Holzkirchen Germany MCP Hexal Injekt 10 mg/2 ml Solution for injection Intramuscular use Intravenous use Luxembourg Hexal AG Industriestr. 25 D-83607 Holzkirchen Germany MCP Hexal Tropfen 4 mg/ml Oral drops Oral use Luxembourg Sanofi-Aventis Belgium Culliganlaan 1 C 1831 Diegem Belgium Primperan 10 mg Tablet Oral use Luxembourg Sanofi-Aventis Belgium Culliganlaan 1 C 1831 Diegem Belgium Primperan 10 mg/2 ml Solution for injection Intramuscular use Intravenous use Luxembourg Sanofi-Aventis Belgium Culliganlaan 1 C 1831 Diegem Belgium Primperan 1 mg/ml Oral solution Oral use Malta Accord Healthcare Ltd Sage House 319 Pinner Road North Harrow Middlesex HA1 4HF United Kingdom Metoclopramide 10 mg tablets 10 mg Tablet Oral use Malta Antigen International Limited Chandler House Castle Street, Roscrea County Tipperary Ireland Metoclopramide Injection BP 10 mg/2 ml Solution for Injection 10 mg/2 ml Solution for injection Intramuscular use Intravenous use Malta Hameln Pharmaceuticals Ltd. Nexus, Gloucester Business Park Gloucester GL3 4AG United Kingdom Metoclopramide 5 mg/ml Injection 5 mg/ml Solution for injection Intramuscular use Intravenous use Malta Medochemie Limited 1-10 Constantinoupleos Str 3011 Limassol Cyprus Elitan 10 mg tablet 10 mg Tablet Oral use Malta Medochemie Ltd. 1-10, Constantinoupleos Street 3011 Limassol Cyprus Elitan Injection, 10 mg/2 ml, Solution for Injection 10 mg Solution for injection Intramuscular use Intravenous use Malta Remedica Ltd. Limassol Industrial Estate Aharnon Street P.O. Box 51706 3508 Limassol Cyprus Cloperan 10 10 mg Tablet Oral use Netherlands Sanofi-Aventis Netherlands B.V. Kampenringweg 45 D-E 2803 PE GOUDA The Netherlands Primperan injectie 10/2 ml, oplossing voor injection 10 mg/2 ml 10 mg/2 ml Solution for injection Intravenous use Netherlands Sanofi-Aventis Netherlands B.V. Kampenringweg 45 D-E 2803 PE GOUDA The Netherlands Primperan drank, drank 1 mg/ml 1 mg/ml Oral solution Oral use Netherlands Sanofi-Aventis Netherlands B.V. Kampenringweg 45 D-E 2803 PE GOUDA The Netherlands Primperan 10, zetpillen 10 mg 10 mg Suppository Rectal use Netherlands Sanofi-Aventis Netherlands B.V. Kampenringweg 45 D-E 2803 PE GOUDA The Netherlands Primperan 20, zetpillen 20 mg 20 mg Suppository Rectal use Netherlands Pharmachemie B.V. Swensweg 5 2031 GA HAARLEM The Netherlands Metoclopramide HCl 10 PCH, tabletten 10 mg 10 mg Tablet Oral use Netherlands Centrafarm B.V. Nieuwe Donk 3 4879 AC Etten Leur The Netherlands Metoclopramide HCl CF 10 mg, tabletten 10 mg Tablet Oral use Netherlands Accord Healthcare B.V. De Waterman 15 A 4891 TL Rijsbergen The Netherlands Metoclopramidemonohydrochloride Accord 10 mg Tabletten 10 mg Tablet Oral use Norway Nycomed Pharma AS Postboks 205 1372 Asker Norway Afipran 5 mg/ml Solution for injection Intramuscular use Intravenous use Norway Nycomed Pharma AS Postboks 205 1372 Asker Norway Afipran 20 mg Suppository Rectal use Norway Nycomed Pharma AS Postboks 205 1372 Asker Norway Afipran 100 mg/ml Concentrate for solution for infusion Intravenous use Norway Nycomed Pharma AS Postboks 205 1372 Asker Norway Afipran 1 mg/ml Oral solution Oral use Norway Nycomed Pharma AS Postboks 205 1372 Asker Norway Afipran 10 mg Tablet Oral use Poland Zakłady Farmaceutyczne Polpharma SA ul. Pelplińska 19 83-200 Starogard Gdański Poland Metoclopramidum 0,5 % Polpharma 5 mg/ml Solution for injection Intramuscular use Intravenous use Poland Zakłady Farmaceutyczne Polpharma SA ul. Pelplińska 19 83-200 Starogard Gdański Poland Metoclopramidum Polpharma 10 mg Tablet Oral use Portugal Sanofi - Produtos Farmacêuticos, Lda. Empreendimento Lagoas Park Edifício 7 - 3o Piso 2740-244 Porto Salvo Portugal Primperan 10 mg/2 ml Solution for injection Intramuscular use Intravenous use Portugal Labesfal - Laboratórios Almiro, S.A. Zona Industrial do Lagedo 3465-157 Santiago de Besteiros Portugal Metoclopramida Labesfal 10 mg/2 ml Solution for injection Intramuscular use Intravenous use Portugal Labesfal - Laboratórios Almiro, S.A. Zona Industrial do Lagedo 3465-157 Santiago de Besteiros Portugal Metoclopramida Labesfal 10 mg Tablet Oral use Portugal Sanofi - Produtos Farmacêuticos, Lda. Empreendimento Lagoas Park Edifício 7 - 3o Piso 2740-244 Porto Salvo Portugal Primperan 1 mg/ml Oral solution Oral use Portugal Sanofi - Produtos Farmacêuticos, Lda. Empreendimento Lagoas Park Edifício 7 - 3o Piso 2740-244 Porto Salvo Portugal Primperan 10 mg Tablet Oral use Portugal Laboratório Medinfar - Produtos Farmacêuticos, S.A. l Ribeiro de Pavia, 1 - 1o - Venda Nova 2700-547 Amadora Portugal Metoclopramida Medinfar 10 mg/2 ml Solution for injection Intramuscular use Intravenous use Portugal Laboratório Medinfar - Produtos Farmacêuticos, S.A. Rua Manuel Ribeiro de Pavia 1 - 1 - Venda Nova 2700-547 Amadora Portugal Metoclopramida Medinfar 10 mg Tablet Oral use Portugal Laboratório Medinfar - Produtos Farmacêuticos, S.A. Rua Manuel Ribeiro de Pavia 1 - 1 - Venda Nova 2700-547 Amadora Portugal Metoclopramida Medinfar 2,6 mg/ml Oral drops, solution Oral use Portugal Laboratório Medinfar - Produtos Farmacêuticos, S.A. Rua Manuel Ribeiro de Pavia 1 - 1 - Venda Nova 2700-547 Amadora Portugal Metoclopramida Medinfar 1 mg/ml Oral solution Oral use Romania S.C. LAROPHARM S.R.L. Șos. Alexandriei, nr 145 A B07-Bragadiru, jud Ilfov România METOCLOPRAMID LAROPHARM 10 mg Tablet Oral use Romania S.C. SLAVIA PHARM S.R.L. B-dul Theodor Pallady nr. 44C Sector 3, București 032266 România METOCLOPRAMID 10 mg Tablet Oral use Romania S.C. MEDUMAN S.A. Str. Aleea Eroilor nr. 28, Vișeu de Sus, Județul Maramureș 435700 România N - METOCLOPRAMID 10 mg Tablet Oral use Romania S.C. ARENA GROUP S.A Str. Stefan Mihaileanu, nr.31 sector 2; Bucuresti 024022 România METOCLOPRAMID ARENA 10 mg 10 mg Tablet Oral use Romania S.C. TERAPIA S.A. Str. Fabricii nr. 124 Cluj - Napoca 400632 România METOCLOPRAMID 10 mg 10 mg Tablet Oral use Romania S.C. BIOFARM S.A. Str. Logofăt Tăutu, nr. 99 sector 3, București 031212 Romania METOCLOPRAMID BIOFARM 1 mg/5 ml 1 mg/5 ml Syrup Oral use Romania S.C. BIOFARM S.A. Str. Logofăt Tăutu, nr. 99 sector 3, București 031212 Romania M