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, Article 38 of Directive 2001/82/EC or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council)
Date: 2022-06-30
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, medicinal product








C_2022249EN.01000901.xml










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






(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.




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