Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2019 to 31 January 2019 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)
Date: 2019-03-04
Institutions: European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, medicinal product








C_2019080EN.01001101.xml










4.3.2019   


EN


Official Journal of the European Union


C 80/11






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2019 to 31 January 2019
(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2))
(2019/C 80/02)






—



Issuing, maintenance or modification 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




31.1.2019


Diotop 75 mg/20 mg modified-release capsules, hard and ass. names


diclofenac/omeprazole


See Annex I


See Annex I


1.2.2019




18.1.2019


Diclofenac Sodium Spray Gel 4 % Cutaneous Spray, Solution and associated names


Diclofenac sodium


See Annex III


See Annex III


21.1.2019




17.7.2018


HES (hydroxyethyl starch)


hydroxyethyl starch (HES)


See Annex IV


See Annex IV


19.7.2018










—



Refusal 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




11.1.2019


Paclitaxel Hetero and associated names


paclitaxel


See Annex II


See Annex II


14.1.2019






(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 311, 28.11.2001, p. 1.




ANNEX I
List of medicinal products and presentations











Member State EU/EEA


Marketing authorisation holder


Applicant


(Invented) Name


Strength


Pharmaceutical form


Route of administration




Austria


Aristo Pharma GmbH
Wallenroder Strasse 8-10
D-13435 Berlin
Germany


 


ArthroComb 75 mg/20 mg Hartkapseln mit veränderter Wirkstofffreisetzung


75 mg
20 mg


Modified-release capsule, hard


Oral




Germany


 


Temmler Pharma GmbH
Temmlerstrasse 2
D-35039 Marburg Germany


Diclofenac/Omeprazol Temmler 75 mg/20 mg Hartkapseln mit veränderter Wirkstofffreisetzung


75 mg
20 mg


Modified-release capsule, hard


Oral




United Kingdom


Temmler Pharma GmbH
Temmlerstrasse 2
D-35039 Marburg
Germany


 


Diotop 75 mg/20 mg modified release hard capsules


75 mg
20 mg


Modified-release capsule, hard


Oral









ANNEX II
List of medicinal products and presentations










Member State EU/EEA


Applicant company name, address


Invented Name


Strength


Pharmaceutical form


Route of administration




Germany


Hetero Europe S.L.
Viladecans Business Park — Edificio Brasil,
Catalunya 83-85
08840 Barcelona
Spain


Paclitaxel Hetero


6 mg/ml


Concentrate for solution for infusion


Intravenous use




Portugal


Hetero Europe S.L.
Viladecans Business Park — Edificio Brasil,
Catalunya 83-85
08840 Barcelona
Spain


Paclitaxel Hetero


6 mg/ml


Concentrate for solution for infusion


Intravenous use




United Kingdom


Hetero Europe S.L.
Viladecans Business Park — Edificio Brasil,
Catalunya 83-85
08840 Barcelona
Spain


Paclitaxel Hetero


6 mg/ml


Concentrate for solution for infusion


Intravenous use









ANNEX III
List of medicinal products and presentations












Member State EU/EEA


Marketing authorisation holder


Applicant


Invented Name


Strength


Pharmaceutical form4



Route of administration


Content
(concentration)




Estonia


Mika Pharma GmbH
Auestraße 39
67346 Speyer
Germany


 


DicloFlex, 40 mg/g,
nahasprei, lahus


40 mg/g


Cutaneous spray, solution


Cutaneous use


4 %




Germany


 


Mika Pharma GmbH
Auestraße 39
67346 Speyer
Germany


Spraymik 40 mg/g Spray zur Anwendung auf der Haut, Lösung


40 mg/g


Cutaneous spray, solution


Cutaneous use


4 %




Hungary


Mika Pharma GmbH
Auestraße 39
67346 Speyer
Germany


 


Doloflex 4 % külsőleges
oldatos spray


40 mg/g


Cutaneous spray, solution


Cutaneous use


4 %




Ireland


Astellas Pharma Co. Ltd
5 Waterside, Citywest Business Campus, Naas Road
Dublin 24
Ireland


 


Difene 4 % Spray Gel


40 mg/g


Cutaneous spray, solution


Cutaneous use


4 %




Italy


 


Mika Pharma GmbH
Auestraße 39
67346 Speyer
Germany


Diclofenac Giuliani


40 mg/g


Cutaneous spray, solution


Cutaneous use


4 %




Latvia


Mika Pharma GmbH
Auestraße 39
67346 Speyer
Germany


 


DicloFlex 4 % uz ādas
izsmidzināms aerosols,
šķīdums


40 mg/g


Cutaneous spray, solution


Cutaneous use


4 %




Slovenia


Mika Pharma GmbH
Auestraße 39
67346 Speyer
Germany


 


DicloFlex 40 mg/g dermalno
pršilo, raztopina


40 mg/g


Cutaneous spray, solution


Cutaneous use


4 %




Spain


 


Mika Pharma GmbH
Auestraße 39
67346 Speyer
Germany


Spraymik 4 %


40 mg/g


Cutaneous spray, solution


Cutaneous use


4 %




United Kingdom


Mika Pharma GmbH
Auestraße 39
67346 Speyer
Germany


 


Diclofenac Sodium Spray Gel
4 % cutaneous spray, solution


40 mg/g


Cutaneous spray, solution


Cutaneous use


4 %









ANNEX IV
List of medicinal products and presentations










Member State in EEA


Marketing authorisation holder


Product name


INN + Strength


Pharmaceutical form


Route of administration




Austria


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 100 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml


Solution For Infusion


Intravenous Use




Austria


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 60 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml


Solution For Infusion


Intravenous Use




Austria


B.Braun Melsungen Ag


Venofundin


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


Solution For Infusion


Intravenous Use




Austria


Fresenius Kabi Austria Gmbh


Haes-Steril Hes


Sodium Chloride 9 g/1000ml, Hydroxyethyl Starch 200/0.5 60 g/1000ml


Solution For Infusion


Intravenous Use




Austria


Fresenius Kabi Austria Gmbh


Volulyte


Magnesium Chloride Hexahydrate 0.3gl, Potassium Chloride 0.3gl, Sodium Chloride 6.02gl, Sodium Acetate Trihydrate 4.63gl, Hydroxyethyl Starch 130/0.4 60gl


Solution For Infusion


Intravenous Use




Austria


Fresenius Kabi Austria Gmbh


Voluven (Hes 130/0,4 )


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


Solution For Infusion


Intravenous Use




Belgium


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 60 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml


Solution For Infusion


Intravenous Use




Belgium


B.Braun Melsungen Ag


Venohes


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


Solution For Infusion


Intravenous Use




Belgium


Fresenius Kabi Nv/Sa


Volulyte


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 60 g/1000ml


Solution For Infusion


Intravenous Use




Belgium


Fresenius Kabi Nv/Sa


Volulyte


Magnesium Chloride Hexahydrate 0.3gl, Potassium Chloride 0.3gl, Sodium Chloride 6.02gl, Sodium Acetate Trihydrate 4.63gl, Hydroxyethyl Starch 130/0.4 60gl


Solution For Infusion


Intravenous Use




Belgium


Fresenius Kabi Nv/Sa


Voluven


Sodium Chloride 9 g/1000ml, Poly (O-2-Hydroxyethyl) Starch 130/0.4 (Ph.Eur.) 60 g/1000ml


Solution For Infusion


Intravenous Use




Belgium


Fresenius Kabi Nv/Sa


Voluven


Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 100gl


Solution For Infusion


Intravenous Use




Belgium


Fresenius Kabi Nv/Sa


Voluven


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


Solution For Infusion


Intravenous Use




Bulgaria


B.Braun Melsungen Ag


Тетраспан


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, Malic Acid 0.67 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, Poly (0 2 Hydroxyethyl) Starch 100 g/1000ml


Solution For Infusion


Intravenous Use




Bulgaria


Fresenius Kabi Bulgaria Eood


Волувен


Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 100gl


Solution For Infusion


Intravenous Use




Bulgaria


Fresenius Kabi Bulgaria Eood


Волулайт


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 60 g/1000ml


Solution For Infusion


Intravenous Use




Bulgaria


Fresenius Kabi Deutschland Gmbh


Волувен


Sodium Chloride 9 g/1000ml, Hydroxyethyl Starch 130/0.4 60 g/1000ml


Solution For Infusion


Intravenous Use




Croatia


B.Braun Adria D.O.O.


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, Malic Acid 0.67 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, Poly (0 2 Hydroxyethyl) Starch 100 g/1000ml


Solution For Infusion


Intravenous Use




Croatia


B.Braun Adria D.O.O.


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, Malic Acid 0.67 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, Poly (0 2 Hydroxyethyl) Starch 60 g/1000ml


Solution For Infusion


Intravenous Use




Croatia


Fresenius Kabi D.O.O.


Volulyte


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 60 g/1000ml


Solution For Infusion


Intravenous Use




Croatia


Fresenius Kabi D.O.O.


Voluven


Sodium Chloride 9 g/1000ml, Hydroxyethyl Starch 130/0.4 60 g/1000ml


Solution For Infusion


Intravenous Use




Cyprus


B.Braun Melsungen Ag


Venofundin


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


Solution For Infusion


Intravenous Use




Cyprus


Fresenius Kabi Deutschland Gmbh


Volulyte


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 60 g/1000ml


Solution For Infusion


Intravenous Use




Czech Republic


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 100 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml


Solution For Infusion


Intravenous Use




Czech Republic


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, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml


Solution For Infusion


Intravenous Use




Czech Republic


Fresenius Kabi Deutschland Gmbh


Volulyte


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 60 g/1000ml


Solution For Infusion


Intravenous Use




Czech Republic


Fresenius Kabi Deutschland Gmbh


Voluven


Sodium Chloride 9 g/1000ml, Hydroxyethyl Starch 130/0.4 60 g/1000ml


Solution For Infusion


Intravenous Use




Czech Republic


Fresenius Kabi S.R.O


Voluven


Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 100gl


Solution For Infusion


Intravenous Use




Denmark


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 100 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml


Solution For Infusion


Intravenous Use




Denmark


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 60 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml


Solution For Infusion


Intravenous Use




Denmark


B.Braun Melsungen Ag


Venofundin


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


Solution For Infusion


Intravenous Use




Denmark


Fresenius Kabi Ab


Volulyte


Magnesium Chloride Hexahydrate 0.3gl, Potassium Chloride 0.3gl, Sodium Chloride 6.02gl, Sodium Acetate Trihydrate 4.63gl, 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


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, Malic Acid 0.67 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, Poly (0 2 Hydroxyethyl) Starch 60 g/1000ml


Solution For Infusion


Intravenous Use




Estonia


Fresenius Kabi Deutschland Gmbh


Volulyte


Magnesium Chloride Hexahydrate 0.3gl, Potassium Chloride 0.3gl, Sodium Chloride 6.02gl, Sodium Acetate Trihydrate 4.63gl, Hydroxyethyl Starch 130/0.4 60gl


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




Estonia


Fresenius Kabi Polska Sp. Z O.O.


Voluforte


Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 100gl


Solution For Infusion


Intravenous Use




Finland


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 100 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml


Solution For Infusion


Intravenous Use




Finland


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 60 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml


Solution For Infusion


Intravenous Use




Finland


B.Braun Melsungen Ag


Venofundin


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


Solution For Infusion


Intravenous Use




Finland


Fresenius Kabi Ab


Volulyte


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.) 60 g/1000ml


Solution For Infusion


Intravenous Use




Finland


Fresenius Kabi Ab


Voluven


Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 100gl


Solution For Infusion


Intravenous Use




Finland


Fresenius Kabi Ab


Voluven


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


Solution For Infusion


Intravenous Use




France


B.Braun Melsungen Ag


Isovol


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 60 g/1000ml


Solution For Infusion


Intravenous Use




France


B.Braun Melsungen Ag


Restorvol


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


Solution For Infusion


Intravenous Use




France


Fresenius Kabi France S.A.S.


Volulyte


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 60 g/1000ml


Solution For Infusion


Intravenous Use




France


Fresenius Kabi France S.A.S.


Voluven


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


Solution For Infusion


Intravenous Use




Germany


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 100 g/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


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 60 g/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


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


Solution For Infusion


Intravenous Use




Germany


Fresenius Kabi Deutschland Gmbh


Haes-Steril


Sodium Chloride 9 g/1000ml, Hydroxyethyl Starch 200/0.5 100 g/1000ml


Solution For Infusion


Intravenous Use




Germany


Fresenius Kabi Deutschland Gmbh


Haes-Steril


Sodium Chloride 9gl, Hydroxyethyl Starch 200/0.5 30gl


Solution For Infusion


Intravenous Use




Germany


Fresenius Kabi Deutschland Gmbh


Haes-Steril


Sodium Chloride 9gl, Hydroxyethyl Starch 200/0.5 60gl


Solution For Infusion


Intravenous Use




Germany


Fresenius Kabi Deutschland Gmbh


Volulyte


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.) 60 g/1000ml


Solution For Infusion


Intravenous Use




Germany


Fresenius Kabi Deutschland Gmbh


Volulyte


Magnesium Chloride Hexahydrate 0.3gl, Potassium Chloride 0.3gl, Sodium Chloride 6.02gl, Sodium Acetate Trihydrate 4.63gl, Hydroxyethyl Starch 130/0.4 60gl


Solution For Infusion


Intravenous Use




Germany


Fresenius Kabi Deutschland Gmbh


Voluven


Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 100gl


Solution For Infusion


Intravenous Use




Germany


Fresenius Kabi Deutschland Gmbh


Voluven


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


Solution For Infusion


Intravenous Use




Germany


Serumwerk Bernburg Ag


Infukoll


Sodium Chloride 9gl, Poly (0 2 Hydroxyethyl) Starch 100gl


Solution For Infusion


Intravenous Use




Germany


Serumwerk Bernburg Ag


Infukoll


Sodium Chloride 9gl, Poly (0 2 Hydroxyethyl) Starch 60gl


Solution For Infusion


Intravenous Use




Germany


Serumwerk Bernburg Ag


Vitafusal


Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.4 g/1000ml, Sodium Chloride 6 g/1000ml, Calcium Chloride Dihydrate 0.134 g/1000ml, Sodium Acetate Trihydrate 3.7 g/1000ml, Poly (0 2 Hydroxyethyl) Starch 100 g/1000ml


Solution For Infusion


Intravenous Use




Germany


Serumwerk Bernburg Ag


Vitafusal


Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.4 g/1000ml, Sodium Chloride 6 g/1000ml, Calcium Chloride Dihydrate 0.134 g/1000ml, Sodium Acetate Trihydrate 3.7 g/1000ml, Poly (0 2 Hydroxyethyl) Starch 60 g/1000ml


Solution For Infusion


Intravenous Use




Germany


Serumwerk Bernburg Ag


Vitahes


Sodium Chloride 9 g/1000ml, Poly (0 2 Hydroxyethyl) Starch 60 g/1000ml


Solution For Infusion


Intravenous Use




Greece


B.Braun Melsungen Ag


Venofundin


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


Solution For Infusion


Intravenous Use




Greece


Fresenius Kabi Hellas A.E.


Volulyte


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 60 g/1000ml


Solution For Infusion


Intravenous Use




Greece


Fresenius Kabi Hellas A.E.


Voluven


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


Solution For Infusion


Intravenous Use




Greece


Vioser S.A.


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 100 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml


Solution For Infusion


Intravenous Use




Greece


Vioser S.A.


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 60 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml


Solution For Infusion


Intravenous Use




Hungary


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 60 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml


Solution For Infusion


Intravenous Use




Hungary


Fresenius Kabi Deutschland Gmbh


Volulyte


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.) 60 g/1000ml


Solution For Infusion


Intravenous Use




Hungary


Fresenius Kabi Deutschland Gmbh


Volulyte


Magnesium Chloride Hexahydrate 0.3 g/1000ml, Potassium Chloride 0.3gl, Sodium Chloride 6.02 g/1000ml, Sodium Acetate Trihydrate 4.63 g/1000ml, Poly (O-2-Hydroxyethyl) Starch 130/0.4 (Ph.Eur.) 60 g/1000ml


Solution For Infusion


Intravenous Use




Hungary


Fresenius Kabi Deutschland Gmbh


Volulyte


Magnesium Chloride Hexahydrate 0.3gl, Potassium Chloride 0.3gl, Sodium Chloride 6.02gl, Sodium Acetate Trihydrate 4.63gl, Hydroxyethyl Starch 130/0.4 60gl


Solution For Infusion


Intravenous Use




Hungary


Fresenius Kabi Deutschland Gmbh


Voluven


Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 100gl


Solution For Infusion


Intravenous Use




Hungary


Fresenius Kabi Deutschland Gmbh


Voluven


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


Solution For Infusion


Intravenous Use




Iceland


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 60 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml


Solution For Infusion


Intravenous Use




Iceland


Fresenius Kabi Ab


Volulyte


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 60 g/1000ml


Solution For Infusion


Intravenous Use




Iceland


Fresenius Kabi Ab


Voluven


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


Solution For Infusion


Intravenous Use




Ireland


B.Braun Melsungen Ag


Equihes Ecobag


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 100 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml


Solution For Infusion


Intravenous Use




Ireland


B.Braun Melsungen Ag


Equihes Ecobag


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 60 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml


Solution For Infusion


Intravenous Use




Ireland


B.Braun Melsungen Ag


Equihes Ecoflac Plus


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 100 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml


Solution For Infusion


Intravenous Use




Ireland


B.Braun Melsungen Ag


Equihes Ecoflac Plus


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 60 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml


Solution For Infusion


Intravenous Use




Ireland


Fresenius Kabi Limited


Volulyte


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.) 60 g/1000ml


Solution For Infusion


Intravenous Use




Ireland


Fresenius Kabi Limited


Voluven


Sodium Chloride 9 g/1000ml, Hydroxyethyl Starch 130/0.4 100 g/1000ml


Solution For Infusion


Intravenous Use




Ireland


Fresenius Kabi Limited


Voluven


Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 100gl


Solution For Infusion


Intravenous Use




Ireland


Fresenius Kabi Limited


Voluven


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


Solution For Infusion


Intravenous Use




Italy


B.Braun Melsungen Ag


Amidolite


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


Solution For Infusion


Intravenous Use




Italy


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 100 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml


Solution For Infusion


Intravenous Use




Italy


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 60 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml


Solution For Infusion


Intravenous Use




Italy


Fresenius Kabi Italia S.R.L.


Volulyte


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 60 g/1000ml


Solution For Infusion


Intravenous Use




Italy


Fresenius Kabi Italia S.R.L.


Volulyte


Magnesium Chloride Hexahydrate 0.3gl, Potassium Chloride 0.3gl, Sodium Chloride 6.02gl, Sodium Acetate Trihydrate 4.63gl, Hydroxyethyl Starch 130/0.4 60gl


Solution For Infusion


Intravenous Use




Italy


Fresenius Kabi Italia S.R.L.


Voluven


Sodium Chloride 9 g/1000ml, Poly (O-2-Hydroxyethyl) Starch 130/0.4 (Ph.Eur.) 60 g/1000ml


Solution For Infusion


Intravenous Use




Italy


Fresenius Kabi Italia S.R.L.


Voluven


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


Solution For Infusion


Intravenous Use




Italy


Fresenius Kabi Italia S.R.L.


Vonten


Sodium Chloride 9 g/1000ml, Poly (O-2-Hydroxyethyl) Starch 130/0.4 (Ph.Eur.) 100 g/1000ml


Solution For Infusion


Intravenous Use




Italy


Fresenius Kabi Italia S.R.L.


Vonten


Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 100gl


Solution For Infusion


Intravenous Use




Latvia


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 100 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml


Solution For Infusion


Intravenous Use




Latvia


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 100 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml


Solution For Infusion


Intravenous Use




Latvia


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 60 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml


Solution For Infusion


Intravenous Use




Latvia


Fresenius Kabi Deutschland Gmbh


Volulyte


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 60 g/1000ml


Solution For Infusion


Intravenous Use




Latvia


Fresenius Kabi Deutschland Gmbh


Voluven


Sodium Chloride 9 g/1000ml, Hydroxyethyl Starch 130/0.4 60 g/1000ml


Solution For Infusion


Intravenous Use




Lithuania


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 60 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml


Solution For Infusion


Intravenous Use




Lithuania


Fresenius Kabi Deutschland Gmbh


Volulyte


Magnesium Chloride Hexahydrate 0.3gl, Potassium Chloride 0.3gl, Sodium Chloride 6.02gl, Sodium Acetate Trihydrate 4.63gl, Hydroxyethyl Starch 130/0.4 60gl


Solution For Infusion


Intravenous Use




Lithuania


Fresenius Kabi Deutschland Gmbh


Voluven


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


Solution For Infusion


Intravenous Use




Lithuania


Fresenius Kabi Polska Sp. Z O.O.


Voluforte


Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 100gl


Solution For Infusion


Intravenous Use




Luxembourg


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 100 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml


Solution For Infusion


Intravenous Use




Luxembourg


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 60 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml


Solution For Infusion


Intravenous Use




Luxembourg


B.Braun Melsungen Ag


Venofundin


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


Solution For Infusion


Intravenous Use




Luxembourg


Fresenius Kabi Deutschland Gmbh


Volulyte


Magnesium Chloride Hexahydrate 0.3gl, Potassium Chloride 0.3gl, Sodium Chloride 6.02gl, Sodium Acetate Trihydrate 4.63gl, Hydroxyethyl Starch 130/0.4 60gl


Solution For Infusion


Intravenous Use




Luxembourg


Fresenius Kabi Deutschland Gmbh


Voluven


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


Solution For Infusion


Intravenous Use




Malta


Fresenius Kabi Limited


Volulyte


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 60 g/1000ml


Solution For Infusion


Intravenous Use




Netherlands


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 100 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml


Solution For Infusion


Intravenous Use




Netherlands


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 60 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml


Solution For Infusion


Intravenous Use




Netherlands


B.Braun Melsungen Ag


Venofundin


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


Solution For Infusion


Intravenous Use




Netherlands


Fresenius Kabi Nederland B.V.


Volulyte


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 60 g/1000ml


Solution For Infusion


Intravenous Use




Netherlands


Fresenius Kabi Nederland B.V.


Voluven


Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 100gl


Solution For Infusion


Intravenous Use




Netherlands


Fresenius Kabi Nederland B.V.


Voluven


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


Solution For Infusion


Intravenous Use




Norway


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, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml


Solution For Infusion


Intravenous Use




Norway


B.Braun Melsungen Ag


Venofundin


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


Solution For Infusion


Intravenous Use




Norway


Fresenius Kabi Norge As


Volulyte


Magnesium Chloride Hexahydrate 0.3gl, Potassium Chloride 0.3gl, Sodium Chloride 6.02gl, Sodium Acetate Trihydrate 4.63gl, Hydroxyethyl Starch 130/0.4 60gl


Solution For Infusion


Intravenous Use




Norway


Fresenius Kabi Norge As


Voluven


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


Solution For Infusion


Intravenous Use




Poland


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, Sodium Acetate Trihydrate 3.27 g/1000ml, Poly (0 2 Hydroxyethyl) Starch 60 g/1000ml, L-Malic Acid 0.67 g/1000ml


Solution For Infusion


Intravenous Use




Poland


B.Braun Melsungen Ag


Tetraspan Hes


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, Malic Acid 0.67 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, Poly (0 2 Hydroxyethyl) Starch 100 g/1000ml


Solution For Infusion


Intravenous Use




Poland


Fresenius Kabi Deutschland Gmbh


Volulyte


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 60 g/1000ml


Solution For Infusion


Intravenous Use




Poland


Fresenius Kabi Deutschland Gmbh


Voluven


Sodium Chloride 9 g/1000ml, Hydroxyethyl Starch 130/0.4 60 g/1000ml


Solution For Infusion


Intravenous Use




Poland


Fresenius Kabi Polska Sp. Z O.O.


Voluven


Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 100gl


Solution For Infusion


Intravenous Use




Portugal


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 100 g/1000ml, Malic Acid 0.67 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml


Solution For Infusion


Intravenous Use




Portugal


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 60 g/1000ml, Malic Acid 0.67 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml


Solution For Infusion


Intravenous Use




Portugal


B.Braun Melsungen Ag


Venofundin


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


Solution For Infusion


Intravenous Use




Portugal


Fresenius Kabi Pharma Portugal Lda.


Volulyte


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.) 60 g/1000ml


Solution For Infusion


Intravenous Use




Portugal


Fresenius Kabi Pharma Portugal Lda.


Volulyte


Magnesium Chloride Hexahydrate 0.3gl, Potassium Chloride 0.3gl, Sodium Chloride 6.02gl, Sodium Acetate Trihydrate 4.63gl, Hydroxyethyl Starch 130/0.4 60gl


Solution For Infusion


Intravenous Use




Portugal


Fresenius Kabi Pharma Portugal Lda.


Voluven


Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 100gl


Solution For Infusion


Intravenous Use




Portugal


Fresenius Kabi Pharma Portugal Lda.


Voluven


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


Solution For Infusion


Intravenous Use




Romania


B.Braun Melsungen Ag


Tetraspan


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 60 g/1000ml


Solution For Infusion


Intravenous Use




Romania


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 100 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml


Solution For Infusion


Intravenous Use




Romania


B.Braun Melsungen Ag


Venofundin


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


Solution For Infusion


Intravenous Use




Romania


Fresenius Kabi Deutschland Gmbh


Voluven


Sodium Chloride 9 g/1000ml, Hydroxyethyl Starch 130/0.4 60 g/1000ml


Solution For Infusion


Intravenous Use




Romania


Infomed Fluids Srl


Vitafusal


Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.4 g/1000ml, Sodium Chloride 6 g/1000ml, Calcium Chloride Dihydrate 0.134 g/1000ml, Hetastarch 60 g/1000ml, Sodium Acetate Trihydrate 3.7 g/1000ml


Solution For Infusion


Intravenous Use




Romania


S.C. Fresenius Kabi România S.R.L.


Volulyte


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 60 g/1000ml


Solution For Infusion


Intravenous Use




Romania


S.C. Fresenius Kabi România S.R.L.


Volulyte


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 (0 2 Hydroxyethyl) Starch 60 g/1000ml


Solution For Infusion


Intravenous Use




Romania


S.C. Fresenius Kabi România S.R.L.


Volulyte


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 (0 2 Hydroxyethyl) Starch 60 g/1000μl


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 100 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/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 60 g/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


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 60 g/1000ml


Solution For Infusion


Intravenous Use




Slovakia


Fresenius Kabi Deutschland Gmbh


Voluven


Sodium Chloride 9 g/1000ml, Hydroxyethyl Starch 130/0.4 60 g/1000ml


Solution For Infusion


Intravenous Use




Slovakia


Fresenius Kabi S.R.O


Voluven


Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 100gl


Solution For Infusion


Intravenous Use




Slovenia


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 100 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml


Solution For Infusion


Intravenous Use




Slovenia


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 60 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml


Solution For Infusion


Intravenous Use




Slovenia


Fresenius Kabi Deutschland Gmbh


Voluven


Sodium Chloride 9 g/1000ml, Hydroxyethyl Starch 130/0.4 100 g/1000ml


Solution For Infusion


Intravenous Use




Slovenia


Medias International D.O.O.


Volulyte


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 60 g/1000ml


Solution For Infusion


Intravenous Use




Slovenia


Medias International D.O.O.


Voluven


Sodium Chloride 4.5 g/500ml, Hydroxyethyl Starch 130/0.4 30 g/500ml


Solution For Infusion


Intravenous Use




Slovenia


Medias International D.O.O.


Voluven


Sodium Chloride 9 g/1000ml, Hydroxyethyl Starch 130/0.4 60 g/1000ml


Solution For Infusion


Intravenous Use




Spain


B.Braun Melsungen Ag


Isohes


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 60 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml


Solution For Infusion


Intravenous Use




Spain


Fresenius Kabi Deutschland Gmbh


Hes Hipertónico


Sodium Chloride 72 g/1000ml, Hydroxyethyl Starch 200/0.5 60 g/1000ml


Solution For Infusion


Intravenous Use




Spain


Fresenius Kabi Deutschland Gmbh


Volulyte


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 60 g/1000ml


Solution For Infusion


Intravenous Use




Spain


Fresenius Kabi Deutschland Gmbh


Voluven


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


Solution For Infusion


Intravenous Use




Spain


Fresenius Kabi España S.A.U.


Voluven


Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 100gl


Solution For Infusion


Intravenous Use




Sweden


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 100 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml


Solution For Infusion


Intravenous Use




Sweden


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 60 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml


Solution For Infusion


Intravenous Use




Sweden


B.Braun Melsungen Ag


Venofundin


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


Solution For Infusion


Intravenous Use




Sweden


Fresenius Kabi Ab


Volulyte


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 60 g/1000ml


Solution For Infusion


Intravenous Use




Sweden


Fresenius Kabi Ab


Voluven


Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 100gl


Solution For Infusion


Intravenous Use




Sweden


Fresenius Kabi Ab


Voluven


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


Solution For Infusion


Intravenous Use




United Kingdom


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 100 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml


Solution For Infusion


Intravenous Use




United Kingdom


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 60 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml


Solution For Infusion


Intravenous Use




United Kingdom


Fresenius Kabi Limited


Volulyte


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 60 g/1000ml


Solution For Infusion


Intravenous Use




United Kingdom


Fresenius Kabi Limited


Voluven


Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 100gl


Solution For Infusion


Intravenous Use




United Kingdom


Fresenius Kabi Limited


Voluven


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


Solution For Infusion


Intravenous Use