# C_2022249EN.01000901.xml

| 30.6.2022 | EN | Official Journal of the European Union | C 249/9 |
| --- | --- | --- | --- |

30.6.2022

EN

Official Journal of the European Union

C 249/9

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2022 to 31 May 2022

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1)
  , Article 38 of Directive 2001/82/EC (2)
  or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council (3)
  )

(2022/C 249/02)

—   Suspension of a national marketing authorisation

| Date of the decision | Name(s) of the medicinal product | INN (International Non-Proprietary Name) | Holder(s) of the marketing authorisation | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- | --- |
| 24.5.2022 | HES (hydroxyethyl starch) | hydroxyethyl starch (HES), solutions for infusion | See Annex | See Annex | 25.5.2022 |

Date of the decision

Name(s) of the medicinal product

INN (International Non-Proprietary Name)

Holder(s) of the marketing authorisation

Member State concerned

Date of notification

24.5.2022

HES (hydroxyethyl starch)

hydroxyethyl starch (HES), solutions for infusion

See Annex

See Annex

25.5.2022

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

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

(3)  OJ L 4, 7.1.2019, p. 43.

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ANNEX

List of medicinal products and presentations

| Member State in EEA | Marketing authorisation holder | Product Name (in authorisation country) | INN + Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | Fresenius Kabi Austria GmbH | Volulyte 6 % infusionslösung | Magnesium chloride hexahydrate, potassium chloride, sodium chloride, sodium acetate trihydrate, hydroxyethyl starch 130/0,4 | Solution For Infusion | Intravenous Use |
| Austria | Fresenius Kabi Austria GmbH | Voluven (HES 130/0,4 ) 6 % infusionslösung | Sodium chloride, hetastarch | Solution For Infusion | Intravenous Use |
| Belgium | Fresenius Kabi nv/sa | Volulyte 6 % infusionslösung/6 % oplossing voor
  Infusie/ 6 %
  solution pour perfusion | Magnesium chloride hexahydrate, potassium chloride, sodium chloride, sodium acetate trihydrate, hydroxyethyl starch 130/0,4 | Solution For Infusion | Intravenous Use |
| Belgium | Fresenius Kabi nv/sa | Voluven, 6 % (60 mg/ml) Infusionslösung, Voluven, 6 % (60 mg/ml) oplossing voor infusie, Voluven, 6 % (60 mg/ml) solution
  pour perfusion | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4 | Solution For Infusion | Intravenous Use |
| Belgium | Fresenius Kabi nv/sa | Voluven, 10 % (100 mg/ml) Infusionslösung, Voluven, 10 % (100 mg/ml) oplossing voor infusie, Voluven,
  10 % (100 mg/ml) solution
  pour perfusion | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4  100gl | Solution For Infusion | Intravenous Use |
| Belgium | B. Braun Melsungen AG | Tetraspan 6 % oplossing
  voor infusie | Magnesium Chloride Hexahydrate 0,2 g/1000ml, Potassium Chloride 0,3 g/1000ml, Sodium Chloride 6,25 g/1000ml, Calcium Chloride Dihydrate 0,37 g/1000ml, Hetastarch 60g/1000ml, Sodium Acetate Trihydrate 3,27 g/1000ml, L-Malic Acid 0,67 g/1000ml | Solution For Infusion | Intravenous Use |
| Bulgaria | Fresenius Kabi Bulgaria EOOD | Волулайт 6 % инфузионен разтвор | Magnesium Chloride Hexahydrate 0,3 g/1000ml, Potassium Chloride 0,3 g/1000ml, Sodium Chloride 6,02 g/1000ml, Sodium Acetate Trihydrate 4,63 g/1000ml, Hydroxyethyl Starch 130/0,4 60g/1000ml | Solution For Infusion | Intravenous Use |
| Bulgaria | Fresenius Kabi Deutschland GmbH | ВОЛУВЕН 6 % инфузионен разтвор | Sodium chloride, hetastarch | Solution For Infusion | Intravenous Use |
| Croatia | Fresenius Kabi d.o.o. | Volulyte 6 % otopina za infuziju | Magnesium Chloride Hexahydrate 0,3 g/1000ml, Potassium Chloride 0,3 g/1000ml, Sodium Chloride 6,02 g/1000ml, Sodium Acetate Trihydrate 4,63 g/1000ml, Hydroxyethyl Starch 130/0,4 60g/1000ml | Solution For Infusion | Intravenous Use |
| Croatia | Fresenius Kabi d.o.o. | Voluven 6 % otopina za infuziju | Sodium chloride, hetastarch | Solution For Infusion | Intravenous Use |
| Cyprus | Fresenius Kabi Deutschland GmbH | Volulyte 6 %, Διάλυμα για έγχυση | Magnesium Chloride Hexahydrate 0,3 g/1000ml, Potassium Chloride 0,3 g/1000ml, Sodium Chloride 6,02 g/1000ml, Sodium Acetate Trihydrate 4,63 g/1000ml, Hydroxyethyl Starch 130/0,4 60g/1000ml | Solution For Infusion | Intravenous Use |
| Czechia | Fresenius Kabi Deutschland GmbH | Volulyte 6 % infuzní roztok | Magnesium Chloride Hexahydrate 0,3 g/1000ml, Potassium Chloride 0,3 g/1000ml, Sodium Chloride 6,02 g/1000ml, Sodium Acetate Trihydrate 4,63 g/1000ml, Hydroxyethyl Starch 130/0,4 60g/1000ml | Solution For Infusion | Intravenous Use |
| Czechia | Fresenius Kabi s.r.o. | VOLUVEN 6 % INFUZNÍ ROZTOK | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4  100gl | Solution For Infusion | Intravenous Use |
| Czechia | Fresenius Kabi s.r.o. | Voluven 10 %, infuzní roztok | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4  100gl | Solution For Infusion | Intravenous Use |
| Denmark | Fresenius Kabi AB | Volulyte, infusionsvæske,
  opløsning | Magnesium Chloride Hexahydrate 0,3 gl, Potassium Chloride 0,3 gl, Sodium Chloride 6,02 gl, Sodium Acetate Trihydrate 4,63 gl, Hydroxyethyl Starch 130/0,4 60gl | Solution For Infusion | Intravenous Use |
| Denmark | Fresenius Kabi AB | Voluven | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4 100gl | Solution For Infusion | Intravenous Use |
| Denmark | Fresenius Kabi AB | Voluven | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4 60gl | Solution For Infusion | Intravenous Use |
| Estonia | Fresenius Kabi Deutschland GmbH | Volulyte | Magnesium Chloride Hexahydrate 0,3 gl, Potassium Chloride 0,3 gl, Sodium Chloride 6,02 gl, Sodium Acetate Trihydrate 4,63 gl, Hydroxyethyl Starch 130/0,4 60gl | Solution For Infusion | Intravenous Use |
| Estonia | Fresenius Kabi Polska Sp. z o.o. | Voluforte | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4  100gl | Solution For Infusion | Intravenous Use |
| Estonia | Fresenius Kabi Deutschland GmbH | Voluven | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4 60gl | Solution For Infusion | Intravenous Use |
| Finland | Fresenius Kabi AB | Volulyte 60 mg/ml infuusioneste, liuos | Magnesium Chloride Hexahydrate 0,3 g/1000ml, Potassium Chloride 0,3 g/1000ml, Sodium Chloride 6,02 g/1000ml, Sodium Acetate Trihydrate 4,63 g/1000ml, Poly (O-2-Hydroxyethyl) Starch 130/0,4 (Ph.Eur.) 60g/1000ml | Solution For Infusion | Intravenous Use |
| Finland | Fresenius Kabi AB | Voluven 100 mg/ml infuusioneste, liuos | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4  100gl | Solution For Infusion | Intravenous Use |
| Finland | Fresenius Kabi AB | Voluven 60 mg/ml infuusioneste, liuos | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4 60gl | Solution For Infusion | Intravenous Use |
| France | Fresenius Kabi France S.A.S. | Volulyte 6 %, solution pour perfusion | Magnesium Chloride Hexahydrate 0,3 g/1000ml, Potassium Chloride 0,3 g/1000ml, Sodium Chloride 6,02 g/1000ml, Sodium Acetate Trihydrate 4,63 g/1000ml, Hydroxyethyl Starch 130/0,4 60g/1000ml | Solution For Infusion | Intravenous Use |
| France | Fresenius Kabi France S.A.S. | Voluven, solution pour perfusion | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4 60gl | Solution For Infusion | Intravenous Use |
| France | B. Braun Melsungen AG | ISOVOL 6 %, solution pour perfusion | Magnesium Chloride Hexahydrate 0,203 g/1000ml, Potassium Chloride 0,298 g/1000ml, Sodium Chloride 6,252 g/1000ml, Calcium Chloride Dihydrate 0,367 g/1000ml, Malic Acid 0,671 g/1000ml, Sodium Acetate Trihydrate 3,266 g/1000ml, Hydroxyethyl Starch 130/0,4 60g/1000ml | Solution For Infusion | Intravenous Use |
| France | B. Braun Melsungen AG | Restorvol perfusion 6 % solution pour | Sodium Chloride 9g/1000ml, Hetastarch 60g/1000ml | Solution For Infusion | Intravenous Use |
| Germany | Fresenius Kabi Deutschland GmbH | Volulyte 6 % Infusionslösung | Magnesium Chloride Hexahydrate 0,3 g/1000ml, Potassium Chloride 0,3 g/1000ml, Sodium Chloride 6,02 g/1000ml, Sodium Acetate Trihydrate 4,63 g/1000ml, Poly (O-2-Hydroxyethyl) Starch 130/0,4 (Ph.Eur.) 60g/1000ml | Solution For Infusion | Intravenous Use |
| Germany | Fresenius Kabi Deutschland GmbH | Volulyte 6 % Infusionslösung | Magnesium Chloride Hexahydrate 0,3 gl, Potassium Chloride 0,3 gl, Sodium Chloride 6,02 gl, Sodium Acetate Trihydrate 4,63 gl, Hydroxyethyl Starch 130/0,4 60gl | Solution For Infusion | Intravenous Use |
| Germany | Fresenius Kabi Deutschland GmbH | Voluven 10 % Infusionslösung | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4  100gl | Solution For Infusion | Intravenous Use |
| Germany | Fresenius Kabi Deutschland GmbH | Voluven 6 %; Infusionslösung | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4 60gl | Solution For Infusion | Intravenous Use |
| Germany | Fresenius Kabi Deutschland GmbH | Voluven 6 % Infusionslösung | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4 60gl | Solution For Infusion | Intravenous Use |
| Germany | Fresenius Kabi Deutschland GmbH | Voluven Fresenius; 6 % Infusionslösung | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4 60gl | Solution For Infusion | Intravenous Use |
| Germany | B. Braun Melsungen AG | Tetraspan 6 %
  Infusionslösung | Magnesium Chloride Hexahydrate 0,2 g/1000ml, Potassium Chloride 0,3 g/1000ml, Sodium Chloride 6,25 g/1000ml, Calcium Chloride Dihydrate 0,37 g/1000ml, Hetastarch 60g/1000ml, Sodium Acetate Trihydrate 3,27 g/1000ml, L-Malic Acid 0,67 g/1000ml | Solution For Infusion | Intravenous Use |
| Germany | B. Braun Melsungen AG | Tetraspan 10 % Infusionslösung | Magnesium Chloride Hexahydrate 0,2 g/1000ml, Potassium Chloride 0,3 g/1000ml, Sodium Chloride 6,25 g/1000ml, Calcium Chloride Dihydrate 0,37 g/1000ml, Hetastarch 100g/1000ml, Sodium Acetate Trihydrate 3,27 g/1000ml, L-Malic Acid 0,67 g/1000ml | Solution For Infusion | Intravenous Use |
| Germany | B. Braun Melsungen AG | Venofundin 60 mg/ml Infusionslösung | Sodium Chloride 9g/1000ml, Hetastarch 60g/1000ml | Solution For Infusion | Intravenous Use |
| Greece | Fresenius Kabi Hellas A.E. | Volulyte 6 %W/V,
  Διάλυμα για έγχυση | Magnesium Chloride Hexahydrate 0,3 g/1000ml, Potassium Chloride 0,3 g/1000ml, Sodium Chloride 6,02 g/1000ml, Sodium Acetate Trihydrate 4,63 g/1000ml, Hydroxyethyl Starch 130/0,4 60g/1000ml | Solution For Infusion | Intravenous Use |
| Greece | Fresenius Kabi Hellas A.E. | Voluven 6 % διάλυμα για έγχυση | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4 60gl | Solution For Infusion | Intravenous Use |
| Hungary | Fresenius Kabi Deutschland GmbH | Volulyte 6 % oldatos infúzió | Magnesium Chloride Hexahydrate 0,3 g/1000ml, Potassium Chloride 0,3 g/1000ml, Sodium Chloride 6,02 g/1000ml, Sodium Acetate Trihydrate 4,63 g/1000ml, Poly (O-2-Hydroxyethyl) Starch 130/0,4 (Ph.Eur.) 60g/1000ml | Solution For Infusion | Intravenous Use |
| Hungary | Fresenius Kabi Deutschland GmbH | Volulyte 6 % oldatos infúzió | Magnesium Chloride Hexahydrate 0,3 g/1000ml, Potassium Chloride 0,3 g/1000ml, Sodium Chloride 6,02 g/1000ml, Sodium Acetate Trihydrate 4,63 g/1000ml, Poly (O-2-Hydroxyethyl) Starch 130/0,4 (Ph.Eur.) 60g/1000ml | Solution For Infusion | Intravenous Use |
| Hungary | Fresenius Kabi Deutschland GmbH | Voluven 10 % oldatos infúzió | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4  100gl | Solution For Infusion | Intravenous Use |
| Hungary | Fresenius Kabi Deutschland GmbH | Voluven 6 % oldatos infúzió | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4 60gl | Solution For Infusion | Intravenous Use |
| Iceland | Fresenius Kabi AB | Volulyte 60 mg/ml innrennslislyf, lausn | Magnesium Chloride Hexahydrate 0,3 g/1000ml, Potassium Chloride 0,3 g/1000ml, Sodium Chloride 6,02 g/1000ml, Sodium Acetate Trihydrate 4,63 g/1000ml, Hydroxyethyl Starch 130/0,4 60g/1000ml | Solution For Infusion | Intravenous Use |
| Iceland | Fresenius Kabi AB | Volulyte 60 mg/ml innrennslislyf, lausn | Magnesium Chloride Hexahydrate 0,3 g/1000ml, Potassium Chloride 0,3 g/1000ml, Sodium Chloride 6,02 g/1000ml, Sodium Acetate Trihydrate 4,63 g/1000ml, Hydroxyethyl Starch 130/0,4 60g/1000ml | Solution For Infusion | Intravenous Use |
| Iceland | Fresenius Kabi AB | Voluven 6 %. Innrennslislyf, lausn. | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4 60gl | Solution For Infusion | Intravenous Use |
| Italy | Fresenius Kabi Italia S.r.l. | Volulyte 6 % Soluzione per infusione | Magnesium Chloride Hexahydrate 0,3 g/1000ml, Potassium Chloride 0,3 g/1000ml, Sodium Chloride 6,02 g/1000ml, Sodium Acetate Trihydrate 4,63 g/1000ml, Hydroxyethyl Starch 130/0,4 60g/1000ml | Solution For Infusion | Intravenous Use |
| Italy | Fresenius Kabi Italia S.r.l. | Volulyte 6 % Soluzione per infusione | Magnesium Chloride Hexahydrate 0,3 gl, Potassium Chloride 0,3 gl, Sodium Chloride 6,02 gl, Sodium Acetate Trihydrate 4,63 gl, Hydroxyethyl Starch 130/0,4 60gl | Solution For Infusion | Intravenous Use |
| Italy | Fresenius Kabi Italia S.r.l. | Voluven soluzione per infusione al 6 % | Sodium Chloride 9g/1000ml, Poly (O-2-Hydroxyethyl) Starch 130/0,4 (Ph.Eur.) 60g/1000ml | Solution For Infusion | Intravenous Use |
| Italy | Fresenius Kabi Italia S.r.l. | Voluven soluzione per infusione al 6 % | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4 60gl | Solution For Infusion | Intravenous Use |
| Latvia | Fresenius Kabi Deutschland GmbH | Volulyte 6 % šķīdums infūzijām | Magnesium Chloride Hexahydrate 0,3 g/1000ml, Potassium Chloride 0,3 g/1000ml, Sodium Chloride 6,02 g/1000ml, Sodium Acetate Trihydrate 4,63 g/1000ml, Hydroxyethyl Starch 130/0,4 60g/1000ml | Solution For Infusion | Intravenous Use |
| Latvia | Fresenius Kabi Deutschland GmbH | Volulyte 6 % šķīdums infūzijām | Magnesium Chloride Hexahydrate 0,3 g/1000ml, Potassium Chloride 0,3 g/1000ml, Sodium Chloride 6,02 g/1000ml, Sodium Acetate Trihydrate 4,63 g/1000ml, Hydroxyethyl Starch 130/0,4 60g/1000ml | Solution For Infusion | Intravenous Use |
| Latvia | Fresenius Kabi Deutschland GmbH | Voluven 6 % šķīdums infūzijām | Sodium Chloride 9g/1000ml, Hydroxyethyl Starch 130/0,4 60g/1000ml | Solution For Infusion | Intravenous Use |
| Lithuania | Fresenius Kabi Deutschland GmbH | Volulyte 6 % infuzinis tirpalas | Magnesium Chloride Hexahydrate 0,3 gl, Potassium Chloride 0,3 gl, Sodium Chloride 6,02 gl, Sodium Acetate Trihydrate 4,63 gl, Hydroxyethyl Starch 130/0,4 60gl | Solution For Infusion | Intravenous Use |
| Lithuania | Fresenius Kabi Polska Sp. z o.o. | Voluforte 10 % infuzinis tirpalas | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4  100gl | Solution For Infusion | Intravenous Use |
| Lithuania | Fresenius Kabi Deutschland GmbH | Voluven 6 % infuzinis tirpalas | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4 60gl | Solution For Infusion | Intravenous Use |
| Luxembourg | Fresenius Kabi Deutschland GmbH | Volulyte 6 % Infusionslösung | Magnesium Chloride Hexahydrate 0,3 gl, Potassium Chloride 0,3 gl, Sodium Chloride 6,02 gl, Sodium Acetate Trihydrate 4,63 gl, Hydroxyethyl Starch 130/0,4 60gl | Solution For Infusion | Intravenous Use |
| Luxembourg | Fresenius Kabi Deutschland GmbH | Voluven 6 % Infusionslösung | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4 60gl | Solution For Infusion | Intravenous Use |
| Malta | Fresenius Kabi Italia S.r.l. | Volulyte 6 % Solution for Infusion | Magnesium Chloride Hexahydrate 0,3 g/1000ml, Potassium Chloride 0,3 g/1000ml, Sodium Chloride 6,02 g/1000ml, Sodium Acetate Trihydrate 4,63 g/1000ml, Hydroxyethyl Starch 130/0,4 60g/1000ml | Solution For Infusion | Intravenous Use |
| Netherlands | Fresenius Kabi Nederland b.v. | Volulyte 6 % oplossing voor infusie | Magnesium Chloride Hexahydrate 0,3 g/1000ml, Potassium Chloride 0,3 g/1000ml, Sodium Chloride 6,02 g/1000ml, Sodium Acetate Trihydrate 4,63 g/1000ml, Hydroxyethyl Starch 130/0,4 60g/1000ml | Solution For Infusion | Intravenous Use |
| Netherlands | Fresenius Kabi Nederland b.v. | Voluven, 10 % (100 mg/ml) oplossing voor infusie | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4 100gl | Solution For Infusion | Intravenous Use |
| Netherlands | Fresenius Kabi Nederland b.v. | Voluven, 6 % (60 mg/ml) oplossing voor infusie | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4 60gl | Solution For Infusion | Intravenous Use |
| Norway | Fresenius Kabi Norge AS | Volulyte 60 mg/ml infusjonsvæske,
  oppløsning | Magnesium Chloride Hexahydrate 0,3 gl, Potassium Chloride 0,3 gl, Sodium Chloride 6,02 gl, Sodium Acetate Trihydrate 4,63 gl, Hydroxyethyl Starch 130/0,4 60gl | Solution For Infusion | Intravenous Use |
| Norway | Fresenius Kabi Norge AS
  P | Voluven 60 mg/ml infusjonsvæske,
  oppløsning | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 60gl | Solution For Infusion | Intravenous Use |
| Poland | Fresenius Kabi Deutschland GmbH | Volulyte 6 %, roztwór do infuzji | Magnesium Chloride Hexahydrate 0,3 g/1000ml, Potassium Chloride 0,3 g/1000ml, Sodium Chloride 6,02 g/1000ml, Sodium Acetate Trihydrate 4,63 g/1000ml, Hydroxyethyl Starch 130/0,4 60g/1000ml | Solution For Infusion | Intravenous Use |
| Poland | Fresenius Kabi Polska Sp. z o.o. | Voluven 10 %, 10 % + 0,9  %, roztwór do infuzji | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4  100gl | Solution For Infusion | Intravenous Use |
| Poland | Fresenius Kabi Deutschland GmbH | VOLUVEN, (60 mg + 9 mg)/ml, roztwór do infuzji | Sodium Chloride 9g/1000ml, Hydroxyethyl Starch 130/0,4 60g/1000ml | Solution For Infusion | Intravenous Use |
| Poland | B. Braun Melsungen AG | Tetraspan 60 mg/ml HES roztwór do infuzji | Magnesium Chloride Hexahydrate 0,2 g/1000ml, Potassium Chloride 0,3 g/1000ml, Sodium Chloride 6,25 g/1000ml, Calcium Chloride Dihydrate 0,37 g/1000ml, Sodium Acetate Trihydrate 3,27 g/1000ml, Poly (0 2 Hydroxyethyl) Starch 60g/1000ml, L-Malic Acid 0,67 g/1000ml | Solution For Infusion | Intravenous Use |
| Portugal | Fresenius Kabi Pharma Portugal, Lda. | Volulyte 60 mg/ml Solução para Perfusão | Magnesium Chloride Hexahydrate 0,3 g/1000ml, Potassium Chloride 0,3 g/1000ml, Sodium Chloride 6,02 g/1000ml, Sodium Acetate Trihydrate 4,63 g/1000ml, Poly (O-2-Hydroxyethyl) Starch 130/0,4 (Ph.Eur.) 60g/1000ml | Solution For Infusion | Intravenous Use |
| Portugal | Fresenius Kabi Pharma Portugal, Lda. | Voluven Fresenius 100 mg/ml + 9 mg/ml solução para perfusão | Magnesium Chloride Hexahydrate 0,3 gl, Potassium Chloride 0,3 gl, Sodium Chloride 6,02 gl, Sodium Acetate Trihydrate 4,63 gl, Hydroxyethyl Starch 130/0,4 60gl | Solution For Infusion | Intravenous Use |
| Portugal | Fresenius Kabi Pharma Portugal, Lda. | Voluven Fresenius 60 mg/ml + 9 mg/ml solução para perfusão | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4 60gl | Solution For Infusion | Intravenous Use |
| Portugal | B. Braun Melsungen AG | Tetraspan 60 mg/ml solução para perfusão | Magnesium Chloride Hexahydrate 0,2 g/1000ml, Potassium Chloride 0,3 g/1000ml, Sodium Chloride 6,25 g/1000ml, Calcium Chloride Dihydrate 0,37 g/1000ml, Hetastarch 100g/1000ml, Malic Acid 0,67 g/1000ml, Sodium Acetate Trihydrate 3,27 g/1000ml | Solution For Infusion | Intravenous Use |
| Romania | Fresenius Kabi Romania srl | Volulyte 6 %, soluţie perfuzabilă | Magnesium Chloride Hexahydrate 0,3 g/1000ml, Potassium Chloride 0,3 g/1000ml, Sodium Chloride 6,02 g/1000ml, Sodium Acetate Trihydrate 4,63 g/1000ml, Hydroxyethyl Starch 130/0,4 60g/1000ml | Solution For Infusion | Intravenous Use |
| Romania | Fresenius Kabi Deutschland GmbH | Voluven 60 g/1000 ml soluţie perfuzabilă | Sodium Chloride 9g/1000ml, Hydroxyethyl Starch 130/0,4 60g/1000ml | Solution For Infusion | Intravenous Use |
| Romania | B. Braun Melsungen AG | Tetraspan 60 mg/ml | Magnesium Chloride Hexahydrate 0,203 g/1000ml, Potassium Chloride 0,298 g/1000ml, Sodium Chloride 6,252 g/1000ml, Calcium Chloride Dihydrate 0,367 g/1000ml, Sodium Acetate Trihydrate 3,266 g/1000ml, L-Malic Acid 0,671 g/1000ml, Hydroxyethyl Starch 130/0,4 60g/1000ml | Solution For Infusion | Intravenous Use |
| Slovakia | B.Braun Melsungen Ag | Tetraspan | Magnesium Chloride Hexahydrate 0,2 g/1000ml, Potassium Chloride 0,3 g/1000ml, Sodium Chloride 6,25 g/1000ml, Calcium Chloride Dihydrate 0,37 g/1000ml, Hetastarch 100g/1000ml, Sodium Acetate Trihydrate 3,27 g/1000ml, L-Malic Acid 0,67 g/1000ml | Solution For Infusion | Intravenous Use |
| Slovakia | Fresenius Kabi Deutschland GmbH | Volulyte 6 %, infúzny roztok | Magnesium Chloride Hexahydrate 0,3 g/1000ml, Potassium Chloride 0,3 g/1000ml, Sodium Chloride 6,02 g/1000ml, Sodium Acetate Trihydrate 4,63 g/1000ml, Hydroxyethyl Starch 130/0,4 60g/1000ml | Solution For Infusion | Intravenous Use |
| Slovakia | Fresenius Kabi s.r.o. | Voluven 10 %, infúzny roztok | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4  100gl | Solution For Infusion | Intravenous Use |
| Slovakia | Fresenius Kabi Deutschland GmbH | Voluven, 6 % infúzny
  roztok | Sodium Chloride 9g/1000ml, Hydroxyethyl Starch 130/0,4 60g/1000ml | Solution For Infusion | Intravenous Use |
| Slovenia | Fresenius Kabi Austria GmbH | Volulyte 60 mg/ml raztopina za infundiranje | Magnesium Chloride Hexahydrate 0,3 g/1000ml, Potassium Chloride 0,3 g/1000ml, Sodium Chloride 6,02 g/1000ml, Sodium Acetate Trihydrate 4,63 g/1000ml, Hydroxyethyl Starch 130/0,4 60g/1000ml | Solution For Infusion | Intravenous Use |
| Slovenia | Fresenius Kabi Deutschland GmbH | Voluven 100 mg/ml raztopina za infundiranje | Sodium Chloride 9g/1000ml, Hydroxyethyl Starch 130/0,4 100g/1000ml | Solution For Infusion | Intravenous Use |
| Slovenia | Fresenius Kabi Austria GmbH | VOLUVEN 60 mg/ml
  raztopina za infundiranje | Sodium Chloride 9g/1000ml, Hydroxyethyl Starch 130/0,4 60g/1000ml | Solution For Infusion | Intravenous Use |
| Spain | Fresenius Kabi Deutschland GmbH | Volulyte 6 % solución para perfusión | Magnesium Chloride Hexahydrate 0,3 g/1000ml, Potassium Chloride 0,3 g/1000ml, Sodium Chloride 6,02 g/1000ml, Sodium Acetate Trihydrate 4,63 g/1000ml, Hydroxyethyl Starch 130/0,4 60g/1000ml | Solution For Infusion | Intravenous Use |
| Spain | Fresenius Kabi Austria GmbH | Voluven 6 % Solución
  para perfusion | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4 60gl | Solution For Infusion | Intravenous Use |
| Spain | B. Braun Melsungen AG | Isohes 6 % Solución para perfusión | Magnesium Chloride Hexahydrate 0,2 g/1000ml, Potassium Chloride 0,3 g/1000ml, Sodium Chloride 6,25 g/1000ml, Calcium Chloride Dihydrate 0,37 g/1000ml, Hetastarch 60g/1000ml, Sodium Acetate Trihydrate 3,27 g/1000ml, L-Malic Acid 0,67 g/1000ml | Solution For Infusion | Intravenous Use |

Member State in EEA

Marketing authorisation holder

Product Name (in authorisation country)

INN + Strength

Pharmaceutical form

Route of administration

Austria

Fresenius Kabi Austria GmbH

Volulyte 6 % infusionslösung

Magnesium chloride hexahydrate, potassium chloride, sodium chloride, sodium acetate trihydrate, hydroxyethyl starch 130/0,4

Solution For Infusion

Intravenous Use

Austria

Fresenius Kabi Austria GmbH

Voluven (HES 130/0,4 ) 6 % infusionslösung

Sodium chloride, hetastarch

Solution For Infusion

Intravenous Use

Belgium

Fresenius Kabi nv/sa

Volulyte 6 % infusionslösung/6 % oplossing voor

Infusie/ 6 %

solution pour perfusion

Magnesium chloride hexahydrate, potassium chloride, sodium chloride, sodium acetate trihydrate, hydroxyethyl starch 130/0,4

Solution For Infusion

Intravenous Use

Belgium

Fresenius Kabi nv/sa

Voluven, 6 % (60 mg/ml) Infusionslösung, Voluven, 6 % (60 mg/ml) oplossing voor infusie, Voluven, 6 % (60 mg/ml) solution

pour perfusion

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4

Solution For Infusion

Intravenous Use

Belgium

Fresenius Kabi nv/sa

Voluven, 10 % (100 mg/ml) Infusionslösung, Voluven, 10 % (100 mg/ml) oplossing voor infusie, Voluven,

10 % (100 mg/ml) solution

pour perfusion

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4  100gl

Solution For Infusion

Intravenous Use

Belgium

B. Braun Melsungen AG

Tetraspan 6 % oplossing

voor infusie

Magnesium Chloride Hexahydrate 0,2 g/1000ml, Potassium Chloride 0,3 g/1000ml, Sodium Chloride 6,25 g/1000ml, Calcium Chloride Dihydrate 0,37 g/1000ml, Hetastarch 60g/1000ml, Sodium Acetate Trihydrate 3,27 g/1000ml, L-Malic Acid 0,67 g/1000ml

Solution For Infusion

Intravenous Use

Bulgaria

Fresenius Kabi Bulgaria EOOD

Волулайт 6 % инфузионен разтвор

Magnesium Chloride Hexahydrate 0,3 g/1000ml, Potassium Chloride 0,3 g/1000ml, Sodium Chloride 6,02 g/1000ml, Sodium Acetate Trihydrate 4,63 g/1000ml, Hydroxyethyl Starch 130/0,4 60g/1000ml

Solution For Infusion

Intravenous Use

Bulgaria

Fresenius Kabi Deutschland GmbH

ВОЛУВЕН 6 % инфузионен разтвор

Sodium chloride, hetastarch

Solution For Infusion

Intravenous Use

Croatia

Fresenius Kabi d.o.o.

Volulyte 6 % otopina za infuziju

Magnesium Chloride Hexahydrate 0,3 g/1000ml, Potassium Chloride 0,3 g/1000ml, Sodium Chloride 6,02 g/1000ml, Sodium Acetate Trihydrate 4,63 g/1000ml, Hydroxyethyl Starch 130/0,4 60g/1000ml

Solution For Infusion

Intravenous Use

Croatia

Fresenius Kabi d.o.o.

Voluven 6 % otopina za infuziju

Sodium chloride, hetastarch

Solution For Infusion

Intravenous Use

Cyprus

Fresenius Kabi Deutschland GmbH

Volulyte 6 %, Διάλυμα για έγχυση

Magnesium Chloride Hexahydrate 0,3 g/1000ml, Potassium Chloride 0,3 g/1000ml, Sodium Chloride 6,02 g/1000ml, Sodium Acetate Trihydrate 4,63 g/1000ml, Hydroxyethyl Starch 130/0,4 60g/1000ml

Solution For Infusion

Intravenous Use

Czechia

Fresenius Kabi Deutschland GmbH

Volulyte 6 % infuzní roztok

Magnesium Chloride Hexahydrate 0,3 g/1000ml, Potassium Chloride 0,3 g/1000ml, Sodium Chloride 6,02 g/1000ml, Sodium Acetate Trihydrate 4,63 g/1000ml, Hydroxyethyl Starch 130/0,4 60g/1000ml

Solution For Infusion

Intravenous Use

Czechia

Fresenius Kabi s.r.o.

VOLUVEN 6 % INFUZNÍ ROZTOK

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4  100gl

Solution For Infusion

Intravenous Use

Czechia

Fresenius Kabi s.r.o.

Voluven 10 %, infuzní roztok

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4  100gl

Solution For Infusion

Intravenous Use

Denmark

Fresenius Kabi AB

Volulyte, infusionsvæske,

opløsning

Magnesium Chloride Hexahydrate 0,3 gl, Potassium Chloride 0,3 gl, Sodium Chloride 6,02 gl, Sodium Acetate Trihydrate 4,63 gl, Hydroxyethyl Starch 130/0,4 60gl

Solution For Infusion

Intravenous Use

Denmark

Fresenius Kabi AB

Voluven

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4 100gl

Solution For Infusion

Intravenous Use

Denmark

Fresenius Kabi AB

Voluven

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4 60gl

Solution For Infusion

Intravenous Use

Estonia

Fresenius Kabi Deutschland GmbH

Volulyte

Magnesium Chloride Hexahydrate 0,3 gl, Potassium Chloride 0,3 gl, Sodium Chloride 6,02 gl, Sodium Acetate Trihydrate 4,63 gl, Hydroxyethyl Starch 130/0,4 60gl

Solution For Infusion

Intravenous Use

Estonia

Fresenius Kabi Polska Sp. z o.o.

Voluforte

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4  100gl

Solution For Infusion

Intravenous Use

Estonia

Fresenius Kabi Deutschland GmbH

Voluven

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4 60gl

Solution For Infusion

Intravenous Use

Finland

Fresenius Kabi AB

Volulyte 60 mg/ml infuusioneste, liuos

Magnesium Chloride Hexahydrate 0,3 g/1000ml, Potassium Chloride 0,3 g/1000ml, Sodium Chloride 6,02 g/1000ml, Sodium Acetate Trihydrate 4,63 g/1000ml, Poly (O-2-Hydroxyethyl) Starch 130/0,4 (Ph.Eur.) 60g/1000ml

Solution For Infusion

Intravenous Use

Finland

Fresenius Kabi AB

Voluven 100 mg/ml infuusioneste, liuos

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4  100gl

Solution For Infusion

Intravenous Use

Finland

Fresenius Kabi AB

Voluven 60 mg/ml infuusioneste, liuos

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4 60gl

Solution For Infusion

Intravenous Use

France

Fresenius Kabi France S.A.S.

Volulyte 6 %, solution pour perfusion

Magnesium Chloride Hexahydrate 0,3 g/1000ml, Potassium Chloride 0,3 g/1000ml, Sodium Chloride 6,02 g/1000ml, Sodium Acetate Trihydrate 4,63 g/1000ml, Hydroxyethyl Starch 130/0,4 60g/1000ml

Solution For Infusion

Intravenous Use

France

Fresenius Kabi France S.A.S.

Voluven, solution pour perfusion

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4 60gl

Solution For Infusion

Intravenous Use

France

B. Braun Melsungen AG

ISOVOL 6 %, solution pour perfusion

Magnesium Chloride Hexahydrate 0,203 g/1000ml, Potassium Chloride 0,298 g/1000ml, Sodium Chloride 6,252 g/1000ml, Calcium Chloride Dihydrate 0,367 g/1000ml, Malic Acid 0,671 g/1000ml, Sodium Acetate Trihydrate 3,266 g/1000ml, Hydroxyethyl Starch 130/0,4 60g/1000ml

Solution For Infusion

Intravenous Use

France

B. Braun Melsungen AG

Restorvol perfusion 6 % solution pour

Sodium Chloride 9g/1000ml, Hetastarch 60g/1000ml

Solution For Infusion

Intravenous Use

Germany

Fresenius Kabi Deutschland GmbH

Volulyte 6 % Infusionslösung

Magnesium Chloride Hexahydrate 0,3 g/1000ml, Potassium Chloride 0,3 g/1000ml, Sodium Chloride 6,02 g/1000ml, Sodium Acetate Trihydrate 4,63 g/1000ml, Poly (O-2-Hydroxyethyl) Starch 130/0,4 (Ph.Eur.) 60g/1000ml

Solution For Infusion

Intravenous Use

Germany

Fresenius Kabi Deutschland GmbH

Volulyte 6 % Infusionslösung

Magnesium Chloride Hexahydrate 0,3 gl, Potassium Chloride 0,3 gl, Sodium Chloride 6,02 gl, Sodium Acetate Trihydrate 4,63 gl, Hydroxyethyl Starch 130/0,4 60gl

Solution For Infusion

Intravenous Use

Germany

Fresenius Kabi Deutschland GmbH

Voluven 10 % Infusionslösung

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4  100gl

Solution For Infusion

Intravenous Use

Germany

Fresenius Kabi Deutschland GmbH

Voluven 6 %; Infusionslösung

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4 60gl

Solution For Infusion

Intravenous Use

Germany

Fresenius Kabi Deutschland GmbH

Voluven 6 % Infusionslösung

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4 60gl

Solution For Infusion

Intravenous Use

Germany

Fresenius Kabi Deutschland GmbH

Voluven Fresenius; 6 % Infusionslösung

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4 60gl

Solution For Infusion

Intravenous Use

Germany

B. Braun Melsungen AG

Tetraspan 6 %

Infusionslösung

Magnesium Chloride Hexahydrate 0,2 g/1000ml, Potassium Chloride 0,3 g/1000ml, Sodium Chloride 6,25 g/1000ml, Calcium Chloride Dihydrate 0,37 g/1000ml, Hetastarch 60g/1000ml, Sodium Acetate Trihydrate 3,27 g/1000ml, L-Malic Acid 0,67 g/1000ml

Solution For Infusion

Intravenous Use

Germany

B. Braun Melsungen AG

Tetraspan 10 % Infusionslösung

Magnesium Chloride Hexahydrate 0,2 g/1000ml, Potassium Chloride 0,3 g/1000ml, Sodium Chloride 6,25 g/1000ml, Calcium Chloride Dihydrate 0,37 g/1000ml, Hetastarch 100g/1000ml, Sodium Acetate Trihydrate 3,27 g/1000ml, L-Malic Acid 0,67 g/1000ml

Solution For Infusion

Intravenous Use

Germany

B. Braun Melsungen AG

Venofundin 60 mg/ml Infusionslösung

Sodium Chloride 9g/1000ml, Hetastarch 60g/1000ml

Solution For Infusion

Intravenous Use

Greece

Fresenius Kabi Hellas A.E.

Volulyte 6 %W/V,

Διάλυμα για έγχυση

Magnesium Chloride Hexahydrate 0,3 g/1000ml, Potassium Chloride 0,3 g/1000ml, Sodium Chloride 6,02 g/1000ml, Sodium Acetate Trihydrate 4,63 g/1000ml, Hydroxyethyl Starch 130/0,4 60g/1000ml

Solution For Infusion

Intravenous Use

Greece

Fresenius Kabi Hellas A.E.

Voluven 6 % διάλυμα για έγχυση

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4 60gl

Solution For Infusion

Intravenous Use

Hungary

Fresenius Kabi Deutschland GmbH

Volulyte 6 % oldatos infúzió

Magnesium Chloride Hexahydrate 0,3 g/1000ml, Potassium Chloride 0,3 g/1000ml, Sodium Chloride 6,02 g/1000ml, Sodium Acetate Trihydrate 4,63 g/1000ml, Poly (O-2-Hydroxyethyl) Starch 130/0,4 (Ph.Eur.) 60g/1000ml

Solution For Infusion

Intravenous Use

Hungary

Fresenius Kabi Deutschland GmbH

Volulyte 6 % oldatos infúzió

Magnesium Chloride Hexahydrate 0,3 g/1000ml, Potassium Chloride 0,3 g/1000ml, Sodium Chloride 6,02 g/1000ml, Sodium Acetate Trihydrate 4,63 g/1000ml, Poly (O-2-Hydroxyethyl) Starch 130/0,4 (Ph.Eur.) 60g/1000ml

Solution For Infusion

Intravenous Use

Hungary

Fresenius Kabi Deutschland GmbH

Voluven 10 % oldatos infúzió

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4  100gl

Solution For Infusion

Intravenous Use

Hungary

Fresenius Kabi Deutschland GmbH

Voluven 6 % oldatos infúzió

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4 60gl

Solution For Infusion

Intravenous Use

Iceland

Fresenius Kabi AB

Volulyte 60 mg/ml innrennslislyf, lausn

Magnesium Chloride Hexahydrate 0,3 g/1000ml, Potassium Chloride 0,3 g/1000ml, Sodium Chloride 6,02 g/1000ml, Sodium Acetate Trihydrate 4,63 g/1000ml, Hydroxyethyl Starch 130/0,4 60g/1000ml

Solution For Infusion

Intravenous Use

Iceland

Fresenius Kabi AB

Volulyte 60 mg/ml innrennslislyf, lausn

Magnesium Chloride Hexahydrate 0,3 g/1000ml, Potassium Chloride 0,3 g/1000ml, Sodium Chloride 6,02 g/1000ml, Sodium Acetate Trihydrate 4,63 g/1000ml, Hydroxyethyl Starch 130/0,4 60g/1000ml

Solution For Infusion

Intravenous Use

Iceland

Fresenius Kabi AB

Voluven 6 %. Innrennslislyf, lausn.

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4 60gl

Solution For Infusion

Intravenous Use

Italy

Fresenius Kabi Italia S.r.l.

Volulyte 6 % Soluzione per infusione

Magnesium Chloride Hexahydrate 0,3 g/1000ml, Potassium Chloride 0,3 g/1000ml, Sodium Chloride 6,02 g/1000ml, Sodium Acetate Trihydrate 4,63 g/1000ml, Hydroxyethyl Starch 130/0,4 60g/1000ml

Solution For Infusion

Intravenous Use

Italy

Fresenius Kabi Italia S.r.l.

Volulyte 6 % Soluzione per infusione

Magnesium Chloride Hexahydrate 0,3 gl, Potassium Chloride 0,3 gl, Sodium Chloride 6,02 gl, Sodium Acetate Trihydrate 4,63 gl, Hydroxyethyl Starch 130/0,4 60gl

Solution For Infusion

Intravenous Use

Italy

Fresenius Kabi Italia S.r.l.

Voluven soluzione per infusione al 6 %

Sodium Chloride 9g/1000ml, Poly (O-2-Hydroxyethyl) Starch 130/0,4 (Ph.Eur.) 60g/1000ml

Solution For Infusion

Intravenous Use

Italy

Fresenius Kabi Italia S.r.l.

Voluven soluzione per infusione al 6 %

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4 60gl

Solution For Infusion

Intravenous Use

Latvia

Fresenius Kabi Deutschland GmbH

Volulyte 6 % šķīdums infūzijām

Magnesium Chloride Hexahydrate 0,3 g/1000ml, Potassium Chloride 0,3 g/1000ml, Sodium Chloride 6,02 g/1000ml, Sodium Acetate Trihydrate 4,63 g/1000ml, Hydroxyethyl Starch 130/0,4 60g/1000ml

Solution For Infusion

Intravenous Use

Latvia

Fresenius Kabi Deutschland GmbH

Volulyte 6 % šķīdums infūzijām

Magnesium Chloride Hexahydrate 0,3 g/1000ml, Potassium Chloride 0,3 g/1000ml, Sodium Chloride 6,02 g/1000ml, Sodium Acetate Trihydrate 4,63 g/1000ml, Hydroxyethyl Starch 130/0,4 60g/1000ml

Solution For Infusion

Intravenous Use

Latvia

Fresenius Kabi Deutschland GmbH

Voluven 6 % šķīdums infūzijām

Sodium Chloride 9g/1000ml, Hydroxyethyl Starch 130/0,4 60g/1000ml

Solution For Infusion

Intravenous Use

Lithuania

Fresenius Kabi Deutschland GmbH

Volulyte 6 % infuzinis tirpalas

Magnesium Chloride Hexahydrate 0,3 gl, Potassium Chloride 0,3 gl, Sodium Chloride 6,02 gl, Sodium Acetate Trihydrate 4,63 gl, Hydroxyethyl Starch 130/0,4 60gl

Solution For Infusion

Intravenous Use

Lithuania

Fresenius Kabi Polska Sp. z o.o.

Voluforte 10 % infuzinis tirpalas

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4  100gl

Solution For Infusion

Intravenous Use

Lithuania

Fresenius Kabi Deutschland GmbH

Voluven 6 % infuzinis tirpalas

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4 60gl

Solution For Infusion

Intravenous Use

Luxembourg

Fresenius Kabi Deutschland GmbH

Volulyte 6 % Infusionslösung

Magnesium Chloride Hexahydrate 0,3 gl, Potassium Chloride 0,3 gl, Sodium Chloride 6,02 gl, Sodium Acetate Trihydrate 4,63 gl, Hydroxyethyl Starch 130/0,4 60gl

Solution For Infusion

Intravenous Use

Luxembourg

Fresenius Kabi Deutschland GmbH

Voluven 6 % Infusionslösung

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4 60gl

Solution For Infusion

Intravenous Use

Malta

Fresenius Kabi Italia S.r.l.

Volulyte 6 % Solution for Infusion

Magnesium Chloride Hexahydrate 0,3 g/1000ml, Potassium Chloride 0,3 g/1000ml, Sodium Chloride 6,02 g/1000ml, Sodium Acetate Trihydrate 4,63 g/1000ml, Hydroxyethyl Starch 130/0,4 60g/1000ml

Solution For Infusion

Intravenous Use

Netherlands

Fresenius Kabi Nederland b.v.

Volulyte 6 % oplossing voor infusie

Magnesium Chloride Hexahydrate 0,3 g/1000ml, Potassium Chloride 0,3 g/1000ml, Sodium Chloride 6,02 g/1000ml, Sodium Acetate Trihydrate 4,63 g/1000ml, Hydroxyethyl Starch 130/0,4 60g/1000ml

Solution For Infusion

Intravenous Use

Netherlands

Fresenius Kabi Nederland b.v.

Voluven, 10 % (100 mg/ml) oplossing voor infusie

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4 100gl

Solution For Infusion

Intravenous Use

Netherlands

Fresenius Kabi Nederland b.v.

Voluven, 6 % (60 mg/ml) oplossing voor infusie

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4 60gl

Solution For Infusion

Intravenous Use

Norway

Fresenius Kabi Norge AS

Volulyte 60 mg/ml infusjonsvæske,

oppløsning

Magnesium Chloride Hexahydrate 0,3 gl, Potassium Chloride 0,3 gl, Sodium Chloride 6,02 gl, Sodium Acetate Trihydrate 4,63 gl, Hydroxyethyl Starch 130/0,4 60gl

Solution For Infusion

Intravenous Use

Norway

Fresenius Kabi Norge AS

P

Voluven 60 mg/ml infusjonsvæske,

oppløsning

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 60gl

Solution For Infusion

Intravenous Use

Poland

Fresenius Kabi Deutschland GmbH

Volulyte 6 %, roztwór do infuzji

Magnesium Chloride Hexahydrate 0,3 g/1000ml, Potassium Chloride 0,3 g/1000ml, Sodium Chloride 6,02 g/1000ml, Sodium Acetate Trihydrate 4,63 g/1000ml, Hydroxyethyl Starch 130/0,4 60g/1000ml

Solution For Infusion

Intravenous Use

Poland

Fresenius Kabi Polska Sp. z o.o.

Voluven 10 %, 10 % + 0,9  %, roztwór do infuzji

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4  100gl

Solution For Infusion

Intravenous Use

Poland

Fresenius Kabi Deutschland GmbH

VOLUVEN, (60 mg + 9 mg)/ml, roztwór do infuzji

Sodium Chloride 9g/1000ml, Hydroxyethyl Starch 130/0,4 60g/1000ml

Solution For Infusion

Intravenous Use

Poland

B. Braun Melsungen AG

Tetraspan 60 mg/ml HES roztwór do infuzji

Magnesium Chloride Hexahydrate 0,2 g/1000ml, Potassium Chloride 0,3 g/1000ml, Sodium Chloride 6,25 g/1000ml, Calcium Chloride Dihydrate 0,37 g/1000ml, Sodium Acetate Trihydrate 3,27 g/1000ml, Poly (0 2 Hydroxyethyl) Starch 60g/1000ml, L-Malic Acid 0,67 g/1000ml

Solution For Infusion

Intravenous Use

Portugal

Fresenius Kabi Pharma Portugal, Lda.

Volulyte 60 mg/ml Solução para Perfusão

Magnesium Chloride Hexahydrate 0,3 g/1000ml, Potassium Chloride 0,3 g/1000ml, Sodium Chloride 6,02 g/1000ml, Sodium Acetate Trihydrate 4,63 g/1000ml, Poly (O-2-Hydroxyethyl) Starch 130/0,4 (Ph.Eur.) 60g/1000ml

Solution For Infusion

Intravenous Use

Portugal

Fresenius Kabi Pharma Portugal, Lda.

Voluven Fresenius 100 mg/ml + 9 mg/ml solução para perfusão

Magnesium Chloride Hexahydrate 0,3 gl, Potassium Chloride 0,3 gl, Sodium Chloride 6,02 gl, Sodium Acetate Trihydrate 4,63 gl, Hydroxyethyl Starch 130/0,4 60gl

Solution For Infusion

Intravenous Use

Portugal

Fresenius Kabi Pharma Portugal, Lda.

Voluven Fresenius 60 mg/ml + 9 mg/ml solução para perfusão

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4 60gl

Solution For Infusion

Intravenous Use

Portugal

B. Braun Melsungen AG

Tetraspan 60 mg/ml solução para perfusão

Magnesium Chloride Hexahydrate 0,2 g/1000ml, Potassium Chloride 0,3 g/1000ml, Sodium Chloride 6,25 g/1000ml, Calcium Chloride Dihydrate 0,37 g/1000ml, Hetastarch 100g/1000ml, Malic Acid 0,67 g/1000ml, Sodium Acetate Trihydrate 3,27 g/1000ml

Solution For Infusion

Intravenous Use

Romania

Fresenius Kabi Romania srl

Volulyte 6 %, soluţie perfuzabilă

Magnesium Chloride Hexahydrate 0,3 g/1000ml, Potassium Chloride 0,3 g/1000ml, Sodium Chloride 6,02 g/1000ml, Sodium Acetate Trihydrate 4,63 g/1000ml, Hydroxyethyl Starch 130/0,4 60g/1000ml

Solution For Infusion

Intravenous Use

Romania

Fresenius Kabi Deutschland GmbH

Voluven 60 g/1000 ml soluţie perfuzabilă

Sodium Chloride 9g/1000ml, Hydroxyethyl Starch 130/0,4 60g/1000ml

Solution For Infusion

Intravenous Use

Romania

B. Braun Melsungen AG

Tetraspan 60 mg/ml

Magnesium Chloride Hexahydrate 0,203 g/1000ml, Potassium Chloride 0,298 g/1000ml, Sodium Chloride 6,252 g/1000ml, Calcium Chloride Dihydrate 0,367 g/1000ml, Sodium Acetate Trihydrate 3,266 g/1000ml, L-Malic Acid 0,671 g/1000ml, Hydroxyethyl Starch 130/0,4 60g/1000ml

Solution For Infusion

Intravenous Use

Slovakia

B.Braun Melsungen Ag

Tetraspan

Magnesium Chloride Hexahydrate 0,2 g/1000ml, Potassium Chloride 0,3 g/1000ml, Sodium Chloride 6,25 g/1000ml, Calcium Chloride Dihydrate 0,37 g/1000ml, Hetastarch 100g/1000ml, Sodium Acetate Trihydrate 3,27 g/1000ml, L-Malic Acid 0,67 g/1000ml

Solution For Infusion

Intravenous Use

Slovakia

Fresenius Kabi Deutschland GmbH

Volulyte 6 %, infúzny roztok

Magnesium Chloride Hexahydrate 0,3 g/1000ml, Potassium Chloride 0,3 g/1000ml, Sodium Chloride 6,02 g/1000ml, Sodium Acetate Trihydrate 4,63 g/1000ml, Hydroxyethyl Starch 130/0,4 60g/1000ml

Solution For Infusion

Intravenous Use

Slovakia

Fresenius Kabi s.r.o.

Voluven 10 %, infúzny roztok

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4  100gl

Solution For Infusion

Intravenous Use

Slovakia

Fresenius Kabi Deutschland GmbH

Voluven, 6 % infúzny

roztok

Sodium Chloride 9g/1000ml, Hydroxyethyl Starch 130/0,4 60g/1000ml

Solution For Infusion

Intravenous Use

Slovenia

Fresenius Kabi Austria GmbH

Volulyte 60 mg/ml raztopina za infundiranje

Magnesium Chloride Hexahydrate 0,3 g/1000ml, Potassium Chloride 0,3 g/1000ml, Sodium Chloride 6,02 g/1000ml, Sodium Acetate Trihydrate 4,63 g/1000ml, Hydroxyethyl Starch 130/0,4 60g/1000ml

Solution For Infusion

Intravenous Use

Slovenia

Fresenius Kabi Deutschland GmbH

Voluven 100 mg/ml raztopina za infundiranje

Sodium Chloride 9g/1000ml, Hydroxyethyl Starch 130/0,4 100g/1000ml

Solution For Infusion

Intravenous Use

Slovenia

Fresenius Kabi Austria GmbH

VOLUVEN 60 mg/ml

raztopina za infundiranje

Sodium Chloride 9g/1000ml, Hydroxyethyl Starch 130/0,4 60g/1000ml

Solution For Infusion

Intravenous Use

Spain

Fresenius Kabi Deutschland GmbH

Volulyte 6 % solución para perfusión

Magnesium Chloride Hexahydrate 0,3 g/1000ml, Potassium Chloride 0,3 g/1000ml, Sodium Chloride 6,02 g/1000ml, Sodium Acetate Trihydrate 4,63 g/1000ml, Hydroxyethyl Starch 130/0,4 60g/1000ml

Solution For Infusion

Intravenous Use

Spain

Fresenius Kabi Austria GmbH

Voluven 6 % Solución

para perfusion

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4 60gl

Solution For Infusion

Intravenous Use

Spain

B. Braun Melsungen AG

Isohes 6 % Solución para perfusión

Magnesium Chloride Hexahydrate 0,2 g/1000ml, Potassium Chloride 0,3 g/1000ml, Sodium Chloride 6,25 g/1000ml, Calcium Chloride Dihydrate 0,37 g/1000ml, Hetastarch 60g/1000ml, Sodium Acetate Trihydrate 3,27 g/1000ml, L-Malic Acid 0,67 g/1000ml

Solution For Infusion

Intravenous Use

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