Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 December 2013 to 31 December 2013 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)
Date: 2014-01-31
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2014029EN.01001301.xml










31.1.2014   


EN


Official Journal of the European Union


C 29/13





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

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

2014/C 29/02
—   Issuing, maintenance or modification of a national marketing authorization










Date of the decision


Name(s) of the medicinal product


Holder(s) of the marketing authorization


Member State concerned


Date of notification




20.12.2013


Nicardipine


See Annex I


See Annex I


6.1.2014




19.12.2013


Hydroxyethyl starch


See Annex II


See Annex II


20.12.2013




20.12.2013


Metoclopramide only containing products


See Annex III


See Annex III


6.1.2014




18.12.2013


Ergot derivatives - (dihydroergotoxine)


See Annex IV


See Annex IV


20.12.2013







—   Suspension of a national marketing authorization










Date of the decision


Name(s) of the medicinal product


Holder(s) of the marketing authorization


Member State concerned


Date of notification




18.12.2013


Ergot derivatives - (dihydroergotoxine)


See Annex IV


See Annex IV


20.12.2013






(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 311, 28.11.2001, p. 1.


ANNEX I

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES













Member State
(in EEA)


Applicant


Marketing authorisation holder


INN


Product name


Strength


Pharmaceutical form


Route of administration




Belgium


 







Astellas Pharma BV, Erasmus Park,




Square Marie Curie 50, Building 5, 1st floor




1070 Brussels




Belgium






Nicardipine hydrochloride


Rydene


1 mg/ml


Solution for injection


Intravenous use




Belgium







Magenta Pharma Consulting




Ericapark 38




2403 EG Alphen aan den Rijn




The Netherlands






 


Nicardipine hydrochloride


Nicardipine Aguettant


10 mg/10 ml


Solution for injection


Intravenous use




France


 







NOVARTIS PHARMA SAS




2-4, rue Lionel Terray




92500 Rueil-Malmaison




FRANCE






nicardipine (chlorhydrate de)


LOXEN 10 mg/10 ml, solution injectable (I.V.)


10 mg/10 ml


Solution for injection


Intravenous use




France


 







LABORATOIRE AGUETTANT




1, rue Alexander Fleming




69007 Lyon




FRANCE






nicardipine (chlorhydrate de)


NICARDIPINE AGUETTANT 10 mg/10 ml, solution injectable


10 mg/10 ml


Solution for injection


Intravenous use




France


 







ARROW GENERIQUES




26, avenue Tony Garnier




69007 Lyon




FRANCE






nicardipine (chlorhydrate de)


NICARDIPINE ARROW 10 mg/10 ml, solution injectable


10 mg/10 ml


Solution for injection


Intravenous use




Luxembourg


 







ASTELLAS PHARMA




Square Marie Curie 50 1




Building 5




1070 Brussels




Belgium






Nicardipine


Rydene


1 mg/ml (5 ml)


Solution for injection


Intravenous use




Spain


 







ASTELLAS PHARMA, S.A.




Paseo del Club Deportivo, 1




bloque 14




28223 Pozuelo de Alarcón




(Madrid)






Nicardipine hydrochloride


VASONASE 1 mg/ml solución para perfusión


1 mg/ml


Solution for infusion


Intravenous use




The Netherlands


 







Astellas Pharma B.V.




Sylviusweg 62




2333 BE Leiden




The Netherlands






nicardipine


Cardene IV


5 mg/5 ml


Concentrate for solution for infusion


Intravenous use




United Kingdom







Mercury Pharmaceuticals Limited




No. 1 Croydon,




12-16 Addiscombe Road,




Croydon, Surrey




CR0 0XT,




United Kingdom






 


Nicardipine hydrochloride


Nicardipine 10 mg/10 ml solution for injection


1 mg/1 ml


Solution for injection


Intravenous use







ANNEX II

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES












Member State
(in EEA)


Marketing authorisation holder


INN


Product name


Strength


Pharmaceutical form


Route of administration




Austria







Fresenius Kabi Austria GmbH




Hafnerstraße 36




8055 Graz




Austria






Hydroxyethyl Starch, Sodium Chloride


HAES-steril ‘Fresenius’ (HES 200/0,5) 6 % - Infusionsloesung


60 g/l, 9 g/l


solution for infusion


intravenous use




Austria







Fresenius Kabi Austria GmbH




Hafnerstraße 36




8055 Graz




Austria






Hydroxyethyl Starch, Sodium Chloride


HyperHAES 6 % in 7,2 % NaCl – Infusionsloesung


60 g/l, 72 g/l


solution for infusion


intravenous use




Austria







Baxter Healthcare GmbH




Stella-Klein-Loew-Weg 15




1020 Vienna




Austria






Hydroxyethyl Starch, Sodium chloride, Potassium chloride, Calcium chloride dihydrate, Magnesium chloride hexahydrate, Sodium acetate trihydrate


PlasmaHES Redibag – Infusionsloesung


60 g/l, 6 g/l, 0,4 g/l, 0,134 g/l, 0,200 g/l, 3,70 g/l


solution for infusion


intravenous use




Austria







Fresenius Kabi Austria GmbH




Hafnerstraße 36




8055 Graz




Austria






Hydroxyethyl Starch, Sodium Chloride


Refortan 6 % Infusionsflasche


60 g/l, 9 g/l


solution for infusion


intravenous use




Austria







Fresenius Kabi Austria GmbH




Hafnerstraße 36




8055 Graz




Austria






Hydroxyethyl Starch, Sodium Chloride


Refortan plus 10 % Infusionsflasche


100 g/l, 9 g/l


solution for infusion


intravenous use




Austria







Fresenius Kabi Austria GmbH




Hafnerstraße 36




8055 Graz




Austria






Hydroxyethyl Starch, Sodium Chloride


Stabisol 6 % Infusionsflasche


60 g/l, 9 g/l


solution for infusion


intravenous use




Austria







B. Braun Melsungen AG




Carl-Braun-Strasse 1




34212 Melsungen




Germany






Hydroxyethyl Starch, Sodium chloride, Potassium chloride, Calcium chloride dihydrate, Magnesium chloride hexahydrate, Sodium acetate trihydrate, Malic acid


Tetraspan 100 mg/ml Infusionsloesung


100,0 g/l, 6,25 g/l, 0,30 g/l, 0,37 g/l, 0,20 g/l, 3,27 g/l, 0,67 g/l


solution for infusion


intravenous use




Austria







B. Braun Melsungen AG




Carl-Braun-Strasse 1




34212 Melsungen




Germany






Hydroxyethyl Starch, Sodium chloride, Potassium chloride, Calcium chloride dihydrate, Magnesium chloride hexahydrate, Sodium acetate trihydrate, Malic acid


Tetraspan 60 mg/ml Infusionsloesung


60,0 g/l, 6,25 g/l, 0,30 g/l, 0,37 g/l, 0,20 g/l, 3,27 g/l, 0,67 g/l


solution for infusion


intravenous use




Austria







B. Braun Melsungen AG




Carl-Braun-Strasse 1




34212 Melsungen




Germany






Hydroxyethyl Starch, Sodium Chloride


VENOFUNDIN 60 mg/ml Infusionsloesung


60 g/l, 9 g/l


solution for infusion


intravenous use




Austria







Fresenius Kabi Austria GmbH




Hafnerstraße 36




8055 Graz




Austria






Hydroxyethyl Starch, Sodium acetate trihydrate, Sodium chloride, Potassium chloride, Magnesium chloride hexahydrate,


Volulyte 6 % Infusionsloesung


60,00 g/l, 4,63 g/l, 6,02 g/l, 0,30 g/l, 0,30 g/l


solution for infusion


intravenous use




Austria







Fresenius Kabi Austria GmbH




Hafnerstraße 36




8055 Graz




Austria






Hydroxyethyl Starch, Sodium Chloride


Voluven (HES 130/0,4) 6 % - Infusionsloesung


60 g/l, 9 g/l


solution for infusion


intravenous use




Belgium







Fresenius Kabi NV




Molenberglei 7




2627 Schelle




Belgium






Hydroxyethyl starch


Haes-Steril 10 %


100 mg/ml


solution for infusion


intravenous use




Belgium







Fresenius Kabi NV




Molenberglei 7




2627 Schelle




Belgium






Hydroxyethyl starch


Haes-Steril 6 %


60 mg/ml


solution for infusion


intravenous use




Belgium







Baxter SA




Bd Rene Branquart, 80




7860 Lessines




Belgium






Sodium Acetate (Trihydrate), Potassium Chlorid, Magnesium Chlorid Hexahydrate, Sodium Chlorid, Calcium Chlorid (Dihydrate), Hydroxyethyl starch


Plasmavolume Redibag 6 %


3,70 mg/ml, 0,40 mg/ml, 0,20 mg/ml, 6 mg/ml, 0,13 mg/ml, 60 mg/ml


solution for infusion


intravenous use




Belgium







B. Braun Melsungen AG




Carl-Braun-Strasse 1




34212 Melsugen




Germany






Sodium Acetate (Trihydrate), Potassium Chlorid, Magnesium Chlorid Hexahydrate, Sodium Chlorid, Calcium Chlorid (Dihydrate), Hydroxyethyl starch, Malic Acid


Tetraspan 10 %


3,27 mg/ml, 0,30 mg/ml, 0,20 mg/ml, 6,25 mg/ml, 0,37 mg/ml, 100 mg/ml, 0,67 mg/ml


solution for infusion


intravenous use




Belgium







B. Braun Melsungen AG




Carl-Braun-Strasse 1




34212 Melsugen




Germany






Sodium Acetate (Trihydrate), Potassium Chlorid, Magnesium Chlorid Hexahydrate, Sodium Chlorid, Calcium Chlorid (Dihydrate), Hydroxyethyl starch, Malic Acid


Tetraspan 6 %


3,27 mg/ml, 0,30 mg/ml, 0,20 mg/ml, 6,25 mg/ml, 0,37 mg/ml, 60 mg/ml, 0,67 mg/ml


solution for infusion


intravenous use




Belgium







B. Braun Melsungen AG




Carl-Braun-Strasse 1




34212 Melsugen




Germany






Sodium Chlorid, Hydroxyethyl starch


Venohes 6 %


9 mg/ml, 60 mg/ml


solution for infusion


intravenous use




Belgium







Fresenius Kabi NV




Molenberglei 7




2627 Schelle




Belgium






Sodium Acetate (Trihydrate), Potassium Chlorid, Magnesium Chlorid Hexahydrate, Sodium Chlorid, Hydroxyethyl starch


Volulyte 6 %


4,63 mg/ml, 0,30 mg/ml, 0,30 mg/ml, 6,02 mg/ml, 60 mg/ml


solution for infusion


intravenous use




Belgium







Fresenius Kabi NV




Molenberglei 7




2627 Schelle




Belgium






Sodium Chlorid, Hydroxyethyl starch


Voluven 10 %


9 mg/ml, 100 mg/ml


solution for infusion


intravenous use




Belgium







Fresenius Kabi NV




Molenberglei 7




2627 Schelle




Belgium






Sodium Chlorid, Hydroxyethyl starch


Voluven 6 %


9 mg/ml, 60 mg/ml


solution for infusion


intravenous use




Bulgaria







B.Braun Melsungen AG




Carl-Braun-Strasse 1




D-34212 Melsungen




Germany






Poly(O-2-Hydroxyethyl) starch, Sodium chloride


Hemohes 6 %


60 g/l, 9 g/l


solution for infusion


intravenous use




Bulgaria







Fresenius Kabi Deutschland GmbH




Else-Kröner-Str. 1




61352 Bad Homburg v.d.H.




Germany






Poly(O-2-Hydroxyethyl) starch, Sodium chloride


Voluven 6 %


60 g/l, 9 g/l


solution for infusion


intravenous use




Bulgaria







Fresenius Kabi EOOD




‘Alexander Jendov’ str. 1




6th floor, ap 37+Sofia




1113




Bulgaria






Poly(O-2-Hydroxyethyl) starch, Sodium chloride


Voluven 10 %


100 g/l, 9 g/l


solution for infusion


intravenous use




Bulgaria







Fresenius Kabi EOOD




‘Alexander Jendov’ str. 1




6th floor, ap 37+Sofia




1113




Bulgaria






Poly(O-2-Hydroxyethyl) starch, Sodium chloride, Sodium acetate trihtdrate, Potassium chloride, Magnesium chloride hexahydrate


Volulyte 6 %


60 g/l, 6,02 g/l, 4,63 g/l, 0,3 g/l, 0,3 g/l


solution for infusion


intravenous use




Bulgaria







Baxter Deutschland GmbH,




Edissonstrasse 4+Unterschleissheim, 85716




Germany






Hydroxyethyl Starch 130/0,42, Sodium Chloride, Potassium Chloride, Calcium Chloride Dihydrate, Magnesium Chloride Hexahydrate, Sodium Acetate Trihydrate


Plasma volume Redibag


60,0 g/l, 6 g/l, 0,400 g/l, 0,134 g/l, 0,2 g/l, 3,70 g/l


solution for infusion


intravenous use




Croatia







B. Braun Adria d.o.o




Hondlova 2/9




10000 Zagreb




Croatia






Calcium chloride dihydrate, hydroxyethyl starch (HES), potassium chloride, magnesium chloride hexahydrate, sodium chloride, sodium acetate trihydrate, malic acid


TETRASPAN 60 mg/ml SOLUTION FOR INFUSION


0,37 g/l, 60,0 g/l, 0,30 g/l, 0,2 g/l, 6,25 g/l, 3,27 g/l, 0,67 g/l


solution for infusion


intravenous use




Croatia







B. Braun Adria d.o.o




Hondlova 2/9




10000 Zagreb




Croatia






Calcium chloride dihydrate, hydroxyethyl starch (HES), potassium chloride, magnesium chloride hexahydrate, sodium chloride, sodium acetate trihydrate, malic acid


TETRASPAN 100 mg/ml SOLUTION FOR INFUSION


0,37 g/l, 100,0 g/l, 0,30 g/l, 0,2 g/l, 6,25 g/l, 3,27 g/l, 0,67 g/l


solution for infusion


intravenous use




Croatia







Fresenius Kabi d.o.o.




Trg J.F. Kennedya 6b




10000 Zagreb




Croatia






Hydroxyethyl starch, Sodium chloride, Sodium acetate trihydrate, Potassium chloride, Magnesium chloride hexahydrate


VOLULYTE 6 % SOLUTION FOR INFUSION


60,0 g/l, 6,02 g/l, 4,63 g/l, 0,30 g/l, 0,30 g/l


solution for infusion


intravenous use




Croatia







Fresenius Kabi d.o.o.




Trg J.F. Kennedya 6b




10000 Zagreb




Croatia






Hydroxyethyl starch, Sodium chloride


VOLUVEN 6 % SOLUTION FOR INFUSION


60,0 g/l, 9,0 g/l


solution for infusion


intravenous use




Cyprus







FRESENIUS KABI HELLAS AE




Mesogeion Avenue 354,




Agia Paraskevi 15341, Athens




Greece






Hydroxyethyl starch + Sodium chloride+Sodium acetate trihydrate+Potassium chloride+Magnesium chloride hexahydrate


VOLULYTE SOLUTION FOR INFUSION 6 %


60 g/l, 6,02 g/l, 4,63 g/l, 0,3 g/l, 0,3 g/l


solution for infusion


intravenous use




Cyprus







FRESENIUS KABI HELLAS AE




Mesogeion Avenue 354,




Agia Paraskevi 15341, Athens




Greece






Hydroxyethyl starch + Sodium chloride


VOLUVEN SOLUTION FOR INFUSION 10 %


100 g/l, 9 g/l


solution for infusion


intravenous use




Czech Republic







BAXTER CZECH spol. S r.o.




Karla Engliše 3201/6




150 00 Praha 5




Czech Republic






Hydroxyethyl Starch 130 000, Sodium Chloride, Potassium Chloride, Calcium Chloride Dihydrate, Magnesium Chloride Hexahydrate, Sodium Acetate Trihydrate


PLASMA VOLUME REDIBAG 6 %


60,0 g/l, 6,0 g/l, 0,4 g/l, 0,134 g/l, 0,2 g/l, 3,7 g/l


solution for infusion


intravenous use




Czech Republic







B. Braun Melsungen AG




Carl-Braun Strasse 1




342 12 Melsungen




Germany






Hydroxyethyl Starch 130 000, Sodium Chloride, Potassium Chloride, Calcium Chloride Dihydrate, Magnesium Chloride Hexahydrate, Sodium Acetate Trihydrate, L-Malic Acid


TETRASPAN 10 %


100,0 g/l, 6,25 g/l, 0,3 g/l, 0,37 g/l, 0,2 g/l, 3,27 g/l, 0,67 g/l


solution for infusion


intravenous use




Czech Republic







B. Braun Melsungen AG




Carl-Braun Strasse 1




342 12 Melsungen




Germany






Hydroxyethyl Starch 130 000, Sodium Chloride, Potassium Chloride, Calcium Chloride Dihydrate, Magnesium Chloride Hexahydrate, Sodium Acetate Trihydrate, L-Malic Acid


TETRASPAN 6 %


60,0 g/l, 6,25 g/l, 0,30 g/l, 0,37 g/l, 0,2 g/l, 3,27 g/l, 0,67 g/l


solution for infusion


intravenous use




Czech Republic







Fresenius Kabi Deutschland GmbH




Else-Kröner-Str. 1




61352 Bad Homburg v.d.H.




Germany






Hetastarch, Sodium Acetate Trihydrate, Sodium Chloride, Potassium Chloride, Magnesium Chloride Hexahydrate


VOLULYTE 6 %


60,0 g/l, 4,63 g/l, 6,02 g/l, 0,3 g/l, 0,3 g/l


solution for infusion


intravenous use




Czech Republic







Fresenius Kabi s.r.o.




Zeletavská 1525/1




140 00 Praha 4 - Michle




Czech Republic






Hetastarch, Sodium Chloride


VOLUVEN 10 %


100 g/l, 9 g/l


solution for infusion


intravenous use




Czech Republic







Fresenius Kabi Deutschland GmbH




Else-Kröner-Str. 1




61352 Bad Homburg v.d.H.




Germany






Hetastarch, Sodium Chloride


HYPERHAES


60 g/l, 72 g/l


solution for infusion


intravenous use




Czech Republic







Fresenius Kabi Deutschland GmbH




Else-Kröner-Str. 1




61352 Bad Homburg v.d.H.




Germany






Hetastarch, Sodium Chloride


VOLUVEN


60 g/l, 9 g/l


solution for infusion


intravenous use




Denmark







Baxter A/S




Gydevang 43




DK-3450 Allerød




Denmark






Calcium chloride dihydrate, hydroxyethyl starch (hes), potassium chloride, magnesium chloride hexahydrate, sodiumchloride, sodium acetate trihydrate, water


Hesra


0,134 g/l, 60 g/l, 0,4 g/l, 0,2 g/l, 6 g/l, 3,7 g/l, water ad 1 000 ml


solution for infusion


intravenous use




Denmark







Fresenius Kabi AB




Rapsgatan 7




SE-751 74 Uppsala




Sweden






Hydroxyethyl starch (HES), sodiumchloride, water


HyperHAES


60 g/l, 72 g/l, water ad 1 000 ml


solution for infusion


intravenous use




Denmark







B. Braun Melsungen




Carl-Braun-Strasse 1




DE-34212 Melsungen




Germany






Calcium chloride dihydrate, hydroxyethyl starch (HES), potassium chloride, magnesium chloride hexahydrate, sodium chloride, sodium acetate trihydrate, malic acid, sodium hydroxide, water


Tetraspan


0,37 g/l, 60 g/l, 0,3 g/l, 0,2 g/l, 6,25 g/l, 3,27 g/l, 0,67 g/l, 1,197 g/l, water ad 1 000 ml


solution for infusion


intravenous use




Denmark







B. Braun Melsungen




Carl-Braun-Strasse 1




DE-34212 Melsungen




Germany






Calcium chloride dihydrate, hydroxyethyl starch (HES), potassium chloride, magnesium chloride hexahydrate, sodium chloride, sodium acetate trihydrate, malic acid, sodium hydroxide, water


Tetraspan


0,37 g/l, 100 g/l, 0,3 g/l, 0,2 g/l, 6,25 g/l, 3,27 g/l, 0,67 g/l, 1,197 g/l, water ad 1 000 ml


solution for infusion


intravenous use




Denmark







B. Braun Melsungen




Carl-Braun-Strasse 1




DE-34212 Melsungen




Germany






Hydroxyethyl starch (HES), sodium chloride, water


Venofundin


60 g/l, 9 g/l, water ad 1 000 ml


solution for infusion


intravenous use




Denmark







Fresenius Kabi AB




Rapsgatan 7




SE-751 74 Uppsala




Sweden






Hydroxyethyl starch (HES), potassium chloride, magnesium chloride hexahydrate, sodium chloride, sodium acetate trihydrate, water


Volulyte


60 g/l, 0,3 g/l, 0,3 g/l, 6,02 g/l, 4,63 g/l, water ad 1 000 ml


solution for infusion


intravenous use




Denmark







Fresenius Kabi AB




Rapsgatan 7




SE-751 74 Uppsala




Sweden






Hydroxyethyl starch (HES), Sodium Chloride, water


Voluven


60 g/l, 9 g/l, water ad 1 000 ml


solution for infusion


intravenous use




Denmark







Fresenius Kabi AB




Rapsgatan 7




SE-751 74 Uppsala




Sweden






Hydroxyethyl starch (HES), Sodium Chloride, water


Voluven


100 g/l, 9 g/l, water ad 1 000 ml


solution for infusion


intravenous use




Estonia







B.Braun Melsungen AG




Carl-Braun-Strasse 1




Melsungen D-34212




Germany






Hydroxyethyl starch, Sodium chloride, Potassium chloride, Calcium chloride dihydrate, Magnesium chloride, Sodium acetate trihydrate, Malic acid


TETRASPAN 60 MG/ML


60 g/l, 6,25 g/l, 0,3 g/l, 0,37 g/l, 0,2 g/l, 3,27 g/l, 0,67 g/l


solution for infusion


intravenous use




Estonia







B.Braun Melsungen AG




Carl-Braun-Strasse 1




Melsungen D-34212




Germany






Hydroxyethyl starch, Sodium chloride, Potassium chloride, Calcium chloride dihydrate, Magnesium chloride, Sodium acetate trihydrate, Malic acid


TETRASPAN 100 MG/ML


100 g/l, 6,25 g/l, 0,3 g/l, 0,37 g/l, 0,2 g/l, 3,27 g/l, 0,67 g/l


solution for infusion


intravenous use




Estonia







Fresenius Kabi Deutschland GmbH




61346 Bad Homburg v.d.H




Germany






Hydroxyethyl starch, Sodium chloride


VOLUVEN


60 g/l, 9 g/l


solution for infusion


intravenous use




Estonia







Fresenius Kabi Deutschland GmbH




61346 Bad Homburg v.d.H




Germany






Hydroxyethyl starch, Sodium acetate trihydrate, Sodium chloride, Sodium chloride, Magnesium chloride


VOLULYTE


60 g/l, 4,63 g/l, 6,02 g/l, 0,3 g/l, 0,3 g/l


solution for infusion


intravenous use




Estonia







Fresenius Kabi Polska Sp.z o.o




Crown Tower




ul.Hrubieszowska 2




Warszawa




01-209




Poland






Hydroxyethyl starch, Sodium chloride


VOLUFORTE


100 g/l, 9 g/l


solution for infusion


intravenous use




Finland







Baxter Oy




Tammasaarenkatu 1




P.O.Box 119




00181 Helsinki,




Finland






Poly(o-2-hydroxyethyl) Starch, Sodium Chloride, Potassium Chloride, Calcium Chloride Dihydrate, Magnesium Chloride Dihydrate, Sodium Acetate Trihydride


HESRA


60,0 g/l, 6,000 g/l, 0,400 g/l, 0,134 g/l, 0,200 g/l, 3,700 g/l


solution for infusion


intravenous use




Finland







Fresenius Kabi Ab




Rapsgatan 7




75174 Uppsala,




Sweden






Poly(o-2-hydroxyethyl) Starch, Sodium Chloride


HYPERHAES


60,0 g/l, 72 g/l


solution for infusion


intravenous use




Finland







B. Braun Melsungen AG




Carl-Braun-Strasse 1




34209 Melsungen,




Germany






Poly(o-2-hydroxyethyl) Starch, Sodium Chloride, Potassium Chloride, Calcium Chloride Dihydrate, Magnesium Chloride Hexahydrate, Sodium Acetate Trihydride, Malic Acid


TETRASPAN


100,0 g/l, 6,252 g/l, 0,2984 g/l, 0,3675 g/l, 0,2033 g/l, 3,266 g/l, 0,671 g/l


solution for infusion


intravenous use




Finland







B. Braun Melsungen AG




Carl-Braun-Strasse 1




34209 Melsungen,




Germany






Poly(o-2-hydroxyethyl) Starch, Sodium Chloride, Potassium Chloride, Calcium Chloride Dihydrate, Magnesium Chloride Dihydrate, Sodium Acetate Trihydride, Malic Acid


TETRASPAN


60,0 g/l, 6,252 g/l, 0,2984 g/l, 0,3675 g/l, 0,2033 g/l, 3,266 g/l, 0,671 g/l


solution for infusion


intravenous use




Finland







B. Braun Melsungen AG




Carl-Braun-Strasse 1




34209 Melsungen,




Germany






Poly(o-2-hydroxyethyl) Starch, Sodium Chloride


VENOFUNDIN


60,0 g/l, 9 g/l


solution for infusion


intravenous use




Finland







Fresenius Kabi Ab




Rapsgatan 7




75174 Uppsala,




Sweden






Poly(o-2-hydroxyethyl) Starch, Sodium Acetate Trihydride, Sodium Chloride, Potassium Chloride, Magnesium Chloride Hexahydrate


VOLULYTE


60 g/l, 4,63 g/l, 6,02 g/l, 0,3 g/l, 0,3 g/l


solution for infusion


intravenous use




Finland







Fresenius Kabi Ab




Rapsgatan 7




75174 Uppsala,




Sweden






Poly(o-2-hydroxyethyl) Starch, Sodium Chloride


VOLUVEN


60 g/l, 9,0 g/l


solution for infusion


intravenous use




Finland







Fresenius Kabi Ab




Rapsgatan 7




75174 Uppsala,




Sweden






Hydroxyethyl Starch, Sodium Chloride


VOLUVEN


100 g/l, 9,0 g/l


solution for infusion


intravenous use




France







B BRAUN MELSUNGEN




Carl-Braun Strasse 1




34212 Melsungen




Germany






hydroxyethyl starch 130 000 calcium chloride dihydrate magnesium chloride hexahydrate malic acide potassium chloride sodium acetate trihydrate sodium chloride


ISOVOL 6 %, solution pour perfusion


60 g / l 0,367 g / l 0,203 g / l 0,671 g / l 0,298 g / l 3,266 g / l 6,252 g / l


solution for infusion


intravenous use




France







BAXTER S.A.S.




Avenue Louis Pasteur




ZA de Coignères Maurepas




78310 Maurepas




France






hydroxyethyl starch 130 000 calcium chloride dihydrate magnésium chloride hexahydrate potassium chloride sodium acetate trihydrate sodium chloride


PLASMAVOLUME 6 %, solution pour perfusion


60 g / l 0,134 g / l 0,2 g / l 0,4 g / l 3,7 g / l 6 g / l


solution for infusion


intravenous use




France







FRESENIUS KABI FRANCE




5, place du Marivel




92316 Sèvres Cedex




France






hydroxyethyl starch 130 000 magnesium chloride hexahydrate potassium chloride sodium acetate trihydrate sodium chloride


VOLULYTE 6 %, solution pour perfusion


60 g / l 0,3 g / l 0,3 g / l 4,63 g / l 6,02 g / l


solution for infusion


intravenous use




France







B BRAUN MELSUNGEN




Carl-Braun Strasse 1




34212 Melsungen




Germany






hydroxyethyl starch 130 000 sodium chloride


RESTORVOL 6 %, solution pour perfusion


60 g / l 9 g / l


solution for infusion


intravenous use




France







FRESENIUS KABI FRANCE




Place du Marivel 5




92316 Sèvres Cedex




France






hydroxyethyl starch 130 000 sodium chloride


VOLUVEN, solution pour perfusion


60 g / l 9 g / l


solution for infusion


intravenous use




France







FRESENIUS KABI FRANCE




Place du Marivel 5




92316 Sèvres Cedex




France






hydroxyethyl starch 200 000


ELOHES 6 %, solution pour perfusion en poche


6 g / 100 ml


solution for infusion


intravenous use




France







FRESENIUS KABI FRANCE




Place du Marivel 5




92316 Sèvres Cedex




France






hydroxyethyl starch 200 000


ELOHES 6 %, solution injectable pour perfusion en flacon


6 g / 100 ml


solution for infusion


intravenous use




France







AGUETTANT




1, rue Alexander Fleming




69007 Lyon




France






hydroxyethyl starch 200 000


PLASMOHES 6 %, solution pour perfusion


6 g / 100 ml


solution for infusion


intravenous use




France







B BRAUN MELSUNGEN




Carl-Braun Strasse 1




34212 Melsungen




Germany






hydroxyethyl starch 200 000 sodium chloride


HEAFUSINE 10 %, solution pour perfusion en poche


10 g / 100 ml 0,90 g / 100 ml


solution for infusion


intravenous use




France







B BRAUN MELSUNGEN




Carl-Braun Strasse 1




34212 Melsungen




Germany






hydroxyethyl starch 200 000 sodium chloride


HEAFUSINE 6 %, solution pour perfusion en poche


6 g / 100 ml 0,90 g / 100 ml


solution for infusion


intravenous use




France







FRESENIUS KABI FRANCE




Place du Marivel 5




92316 Sèvres Cedex




France






hydroxyethyl starch 200 000 sodium chloride


HYPERHES, solution pour perfusion


60 g / l 72 g / l


solution for infusion


intravenous use




France







FRESENIUS KABI FRANCE




Place du Marivel 5




92316 Sèvres Cedex




France






hydroxyethyl starch 240 000


HESTERIL 10 %, solution pour perfusion


10 g / 100 ml


solution for infusion


intravenous use




France







FRESENIUS KABI FRANCE




Place du Marivel 5




92316 Sèvres Cedex




France






hydroxyethyl starch 240 000


HESTERIL 6 %, solution pour perfusion


6 g / 100 ml


solution for infusion


intravenous use




France







FRESENIUS KABI FRANCE




Place du Marivel 5




92316 Sèvres Cedex




France






hydroxyethyl starch 250 000


LOMOL, solution injectable pour perfusion en poche


10 g / 100 ml


solution for infusion


intravenous use




Germany







B. Braun Melsungen AG




Carl-Braun-Str. 1




34212 Melsungen




Germany






Hydroxyethyl starch Sodium Chloride


Hemohes 6 %


60 g/l, 9 g/l


solution for infusion


intravenous use




Germany







B. Braun Melsungen AG




Carl-Braun-Str. 1




34212 Melsungen




Germany






Hydroxyethyl starch Sodium Chloride


Hemohes 10 %


100 g/l, 9 g/l


solution for infusion


intravenous use




Germany







B. Braun Melsungen AG




Carl-Braun-Str. 1




34212 Melsungen




Germany






Hydroxyethyl starch Sodium Chloride


VENOFUNDIN 60 mg/ml Infusionslösung


60 g/l, 9 g/l


solution for infusion


intravenous use




Germany







B. Braun Melsungen AG




Carl-Braun-Str. 1




34212 Melsungen




Germany






Hydroxyethyl starch, Sodium Chloride, Potassium Chloride, Calcium Chloride Dihydrate, Magnesium Chloride Hexahydrate Sodium Acetate Trihydrate, Malic Acid


Tetraspan 6 % Infusionslösung


60 g/l, 6,25 g/l, 0,3 g/l, 0,37 g/l, 0,2 g/l, 3,27 g/l, 0,67 g/l


solution for infusion


intravenous use




Germany







B. Braun Melsungen AG




Carl-Braun-Str. 1




34212 Melsungen




Germany






Hydroxyethyl starch, Sodium Chloride, Potassium Chloride, Calcium Chloride Dihydrate, Magnesium Chloride Hexahydrate Sodium Acetate Trihydrate, Malic Acid


Tetraspan 10 % Infusionslösung


100 g/l, 6,25 g/l, 0,3 g/l, 0,37 g/l, 0,2 g/l, 3,27 g/l, 0,67 g/l


solution for infusion


intravenous use




Germany







Baxter Deutschland GmbH




Edisonstr. 4




85716 Unterschleißheim




Germany






Hydroxyethyl starch, Sodium Chloride, Potassium Chloride, Calcium Chloride Dihydrate, Magnesium Chloride Hexahydrate Sodium Acetate Trihydrate


Plasma Volume Redibag


60 g/l, 6 g/l, 0,4 g/l, 0,134 g/l, 0,2 g/l, 3,7 g/l


solution for infusion


intravenous use




Germany







Berlin-Chemie AG




Glienicker Weg 125




12489 Berlin




Germany






Sodium Chloride, Hydroxyethyl starch


Refortan 6 %


9 g/l, 60 g/l


solution for infusion


intravenous use




Germany







Berlin-Chemie AG




Glienicker Weg 125




12489 Berlin




Germany






Sodium Chloride, Hydroxyethyl starch


Refortan 10 %


9 g/l, 100 g/l


solution for infusion


intravenous use




Germany







Fresenius Kabi Deutschland GmbH




Else-Kröner-Str. 1




61352 Bad Homburg v.d.H.




Germany






Hydroxyethyl starch, Sodium Acetate Trihydrate, Sodium Chloride, Potassium Chloride, Magnesium Chloride Hexahydrate


Volulyte 6 % Infusionslösung


60 g/l, 4,63 g/l, 6,02 g/l, 0,3 g/l, 0,3 g/l


solution for infusion


intravenous use




Germany







Fresenius Kabi Deutschland GmbH




Else-Kröner-Str. 1




61352 Bad Homburg v.d.H.




Germany






Sodium Chloride, Hydroxyethyl starch


Voluven 6 % Infusionslösung


9 g/l, 60 g/l


solution for infusion


intravenous use




Germany







Fresenius Kabi Deutschland GmbH




Else-Kröner-Str. 1




61352 Bad Homburg v.d.H.




Germany






Sodium Chloride, Hydroxyethyl starch


Voluven 10 % Infusionslösung


9 g/l, 100 g/l


solution for infusion


intravenous use




Germany







Fresenius Kabi Deutschland GmbH




Else-Kröner-Str. 1




61352 Bad Homburg v.d.H.




Germany






Sodium Chloride, Hydroxyethyl starch


Elohäst 6 %


9 g/l, 60 g/l


solution for infusion


intravenous use




Germany







Fresenius Kabi Deutschland GmbH




Else-Kröner-Str. 1




61352 Bad Homburg v.d.H.




Germany






Sodium Chloride, Hydroxyethyl starch


HyperHAES Infusionslösung


72 g/l, 60 g/l


solution for infusion


intravenous use




Germany







Fresenius Kabi Deutschland GmbH




Else-Kröner-Str. 1




61352 Bad Homburg v.d.H.




Germany






Sodium Chloride, Hydroxyethyl starch


HAES-steril 3 %


9 g/l, 30 g/l


solution for infusion


intravenous use




Germany







Fresenius Kabi Deutschland GmbH




Else-Kröner-Str. 1




61352 Bad Homburg v.d.H.




Germany






Sodium Chloride, Hydroxyethyl starch


Voluven Fresenius 6 % Infusionslösung


9 g/l, 60 g/l


solution for infusion


intravenous use




Germany







Fresenius Kabi Deutschland GmbH




Else-Kröner-Str. 1




61352 Bad Homburg v.d.H.




Germany






Sodium Chloride, Hydroxyethyl starch


Haes-steril 10 %


9 g/l, 100 g/l


solution for infusion


intravenous use




Germany







Fresenius Kabi Deutschland GmbH




Else-Kröner-Str. 1




61352 Bad Homburg v.d.H.




Germany






Hydroxyethyl starch, Sodium Acetate Trihydrate, Sodium Chloride, Potassium Chloride, Magnesium Chloride Hexahydrate


Volulyte 6 % Infusionslösung


60 g/l, 4,63 g/l, 6,02 g/l, 0,3 g/l, 0,3 g/l


solution for infusion


intravenous use




Germany







Fresenius Kabi Deutschland GmbH




Else-Kröner-Str. 1




61352 Bad Homburg v.d.H.




Germany






Hydroxyethyl starch, Sodium Chloride


Haes-steril 6 %


60 g/l, 9 g/l


solution for infusion


intravenous use




Germany







Fresenius Kabi Deutschland GmbH




Else-Kröner-Str. 1




61352 Bad Homburg v.d.H.




Germany






Hydroxyethyl starch, Sodium Chloride


Voluven 6 % Infusionslösung


60 g/l, 9 g/l


solution for infusion


intravenous use




Germany







Fresenius Kabi Deutschland GmbH




Else-Kröner-Str. 1




61352 Bad Homburg v.d.H.




Germany






Hydroxyethyl starch, Sodium Chloride


Voluven 10 % Infusionslösung


100 g/l, 9 g/l


solution for infusion


intravenous use




Germany







Fresenius Kabi Deutschland GmbH




Else-Kröner-Str. 1




61352 Bad Homburg v.d.H.




Germany






Hydroxyethyl starch, Sodium Chloride


HyperHAES Infusionslösung


60 g/l, 72 g/l


solution for infusion


intravenous use




Germany







Serumwerk Bernburg AG




Hallesche Landstr. 105b




06406 Bernburg




Germany






Hydroxyethyl starch, Sodium Chloride


Infukoll HES 6 %


60 g/l, 9 g/l


solution for infusion


intravenous use




Germany







Serumwerk Bernburg AG




Hallesche Landstr. 105b




06406 Bernburg




Germany






Hydroxyethyl starch, Sodium Chloride, Potassium Chloride, Calcium Chloride Dihydrate, Magnesium Chloride Hexahydrate Sodium Acetate Trihydrate


Vitafusal 10 %


100 g/l, 6 g/l, 0,4 g/l, 0,134 g/l, 0,2 g/l, 3,7 g/l


solution for infusion


intravenous use




Germany







Serumwerk Bernburg AG




Hallesche Landstr. 105b




06406 Bernburg




Germany






Hydroxyethyl starch, Sodium Chloride, Potassium Chloride, Calcium Chloride Dihydrate, Magnesium Chloride Hexahydrate Sodium Acetate Trihydrate


Vitakoll 10 %


100 g/l, 6 g/l, 0,4 g/l, 0,134 g/l, 0,2 g/l, 3,7 g/l


solution for infusion


intravenous use




Germany







Serumwerk Bernburg AG




Hallesche Landstr. 105b




06406 Bernburg




Germany






Hydroxyethyl starch, Sodium Chloride


Infukoll HES 10 %


100 g/l, 9 g/l


solution for infusion


intravenous use




Germany







Serumwerk Bernburg AG




Hallesche Landstr. 105b




06406 Bernburg




Germany






Hydroxyethyl starch, Sodium Chloride, Potassium Chloride, Calcium Chloride Dihydrate, Magnesium Chloride Hexahydrate Sodium Acetate Trihydrate


Vitafusal 6 %


60 g/l, 6 g/l, 0,4 g/l, 0,134 g/l, 0,2 g/l, 3,7 g/l


solution for infusion


intravenous use




Germany







Serumwerk Bernburg AG




Hallesche Landstr. 105b




06406 Bernburg




Germany






Hydroxyethyl starch, Sodium Chloride, Potassium Chloride, Calcium Chloride Dihydrate, Magnesium Chloride Hexahydrate Sodium Acetate Trihydrate


Vitafusal


60 g/l, 6 g/l, 0,4 g/l, 0,134 g/l, 0,2 g/l, 3,7 g/l


solution for infusion


intravenous use




Germany







Serumwerk Bernburg AG




Hallesche Landstr. 105b




06406 Bernburg




Germany






Hydroxyethyl starch, Sodium Chloride


VitaHES Infusionslösung


60 g/l, 9 g/l


solution for infusion


intravenous use




Greece







FRESENIUS KABI HELLAS AE




Mesogeion Avenue 354,




Agia Paraskevi 15341,




Athens




Greece






Poly-(o-2 hydroxyethyl)-starch (M.W 200 000) + Sodium Chloride


HAES-STERIL


60 g/l + 9 g/l


solution for infusion


intravenous use




Greece







FRESENIUS KABI HELLAS AE




Mesogeion Avenue 354,




Agia Paraskevi 15341,




Athens




Greece






Hydroxyethyl Starch + Sodium Chloride


VOLUVEN


60 g/l + 9 g/l


solution for infusion


intravenous use




Greece







FRESENIUS KABI HELLAS AE




Mesogeion Avenue 354,




Agia Paraskevi 15341,




Athens




Greece






Hydroxyethyl Starch + Sodium Chloride


VOLUVEN


100 g/l + 9 g/l


solution for infusion


intravenous use




Greece







VIOSER SA,




9th Km National Highway Trikala-Larissis,




P.O. Box 35, Taxiarhes, Trikala,




Trikala 42100




Greece






Hydroxyethyl Starch + Sodium Chloride


VENOFUNDIN


60 g/l + 9 g/l


solution for infusion


intravenous use




Greece







FRESENIUS KABI HELLAS AE




Mesogeion Avenue 354,




Agia Paraskevi 15341,




Athens




Greece






Poly-(o-2-hydroxyethyl)-starch (M.W 200 000) + sodium acetate trihydrate + sodium chloride + potassium chloride + magnesium chloride hexahydrate


VOLULYTE


60 g/l, 4,63 g/l, 6,02 g/l, 0,3 g/l, 0,3 g/l


solution for infusion


intravenous use




Greece







BAXTER HELLAS Ltd, Metsovou 3,




Neo Irakleion 14121,




Athens




Greece






Hydroxyethyl starch + Sodium Chloride + Potassium Chloride + Calcium Chloride Dihydrate + Magnesium Chloride Hexahydrate + Sodium Acetate Trihydrate


PLASMAVOLUME REDIBAG


60 g/l + 6 g/l + 0,4 g/l + 0,134 g/l + 0,2 g/l + 3,7 g/l


solution for infusion


intravenous use




Greece







VIOSER SA




9th Km National Highway Trikal-Larissa,




P.O. Box 35, Taksiarhes Trikalon,




Trikala 42100




Greece






Poly(o-2-hydroxyethyl)starch (M.W 200 000) + Sodium Chloride + Potassium Chloride + Calcium Chloride Dihydrate + Magnesium Chloride Hexahydrate + Sodium Acetate Trihydrate + Malic Acid


TETRASPAN


60 g/l, 6,25 g/l, 0,3 g/l, 0,37 g/l, 0,2 g/l, 3,27 g/l, 0,67 g/l


solution for infusion


intravenous use




Greece







VIOSER SA




9th Km National Highway Trikal-Larissa,




P.O. Box 35, Taksiarhes Trikalon,




Trikala 42100




Greece






Poly-(o-2-hydroxyethyl)-starch (MW 200 000) + Sodium Chloride + Potassium Chloride + Calcium Chloride Dihydrate + Magnesium Chloride Hexahydrate + Sodium Acetate Trihydrate + Malic Acid


TETRASPAN


100 g/l, 6,25 g/l, 0,3 g/l, 0,37 g/l, 0,2 g/l, 3,27 g/l, 0,67 g/l


solution for infusion


intravenous use




Hungary







Fresenius Kabi Deutschland GmbH




Else-Kröner-Str. 1




61352 Bad Homburg v.d.H.




Germany






Hydroxyethyl starch, Sodium chloride


VOLUVEN 10 % oldatos infúzió


100 g/l, 9,0 g/l


solution for infusion


intravenous use




Hungary







Fresenius Kabi Deutschland GmbH




Else-Kröner-Str. 1




61352 Bad Homburg v.d.H.




Germany






Hydroxyethyl starch, Sodium chloride


VOLUVEN 6 % oldatos infúzió


60,0 g/l, 9,0 g/l


solution for infusion


intravenous use




Hungary







Fresenius Kabi Deutschland GmbH




Else-Kröner-Str. 1




61352 Bad Homburg v.d.H.




Germany






Hydroxyethyl starch, Sodium chloride


HAES-STERIL 10 % oldatos infúzió


100 g/l, 9 g/l


solution for infusion


intravenous use




Hungary







Fresenius Kabi Deutschland GmbH




Else-Kröner-Str. 1




61352 Bad Homburg v.d.H.




Germany






Hydroxyethyl starch, Sodium chloride


HYPERHAES oldatos infúzió


101 g/l, 9 g/l


solution for infusion


intravenous use




Hungary







B.Braun Melsungen AG




Carl Braun Strasse 1




Melsungen




Germany






HES, Sodium Chloride, Potassium Chloride, Calcium Chloride Dihydrate, Magnesium Chloride Hexahydrate, Sodium Acetate Trihydrate, Malic Acid


Tetraspan 60 mg/ml


60 g/l, 6,252 g/l, 0,2984 g/l, 0,3675 g/l, 0,2033 g/l, 3,266 g/l, 0,67 g/l


solution for infusion


intravenous use




Hungary







B.Braun Melsungen AG




Carl Braun Strasse 1




Melsungen




Germany






HES, Sodium Chloride, Potassium Chloride, Calcium Chloride Dihydrate, Magnesium Chloride Hexahydrate, Sodium Acetate Trihydrate, Malic Acid


Tetraspan 100 mg/ml


100 g/l, 6,252 g/l, 0,2984 g/l, 0,3675 g/l, 0,2033 g/l, 3,266 g/l, 0,67 g/l


solution for infusion


intravenous use




Hungary







Baxter Hungary Kft




Népfürdő u. 22.




Budapest H-1138




Hungary






HES, Sodium Chloride, Potassium Chloride, Calcium Chloride Dihydrate, Magnesium Chloride Hexahydrate, Sodium Acetate Trihydrate


HesRa


60 g/l, 6 g/l, 0,4 g/l, 0,134 g/l, 0,2 g/l, 3,7 g/l


solution for infusion


intravenous use




Iceland







Fresenius Kabi AB




Rapsgatan 7




751 74 Uppsala




Sweden






Hydroxyethy starch, Sodium chloride


HyperHAES


60 g/l, 72 g/l


solution for infusion


intravenous use




Iceland







B.Braun Melsungen AG




Carl Braun Strasse 1




Melsungen




Germany






Hydroxyethyl starch, Sodium chloride, potassium chloride, calcium chloride, magnesium chloride, sodium acetat, malic acid


Tetraspan


60 g/l, 6,25 g/l, 0,30 g/l, 0,37 g/l, 0,20 g/l, 3,27 g/l, 0,67 g/l


solution for infusion


intravenous use




Iceland







Fresenius Kabi Deutschland GmbH




61346 Bad Homburg v.d.H




Germany






Hydroxyethyl starch, sodium acetat, sodium chloride, potassium chloride, magnesium chloride


Volulyte


60 g/l, 4,63 g/l, 6,02 g/l, 0,30 g/l, 0,30 g/l


solution for infusion


intravenous use




Iceland







Fresenius Kabi AB




Rapsgatan 7




751 74 Uppsala




Sweden






Hydroxyethyl starch, sodium chloride


Voluven


60 g/l, 9,0 g/l


solution for infusion


intravenous use




Ireland







Baxter Healthcare Limited




Caxton Way




Thetford




Norfolk




IP24 3SE




United Kingdom






Hydroxyethyl Starch, Sodium Chloride, Potassium Chloride, Calcium Chloride Dihydrate, Magnesium Chloride Hexahydrate, Sodium Acetate Trihydrate


Plasma Volume Redibag 6 % Solution for Infusion


60 g/l, 6 g/l, 0,4 g/l, 0,134 g/l, 0,200 g/l, 3,7 g/l


solution for infusion


intravenous use




Ireland







B. Braun Melsungen AG,




Harald Weis,




Carl-Braun Strasse 1,




34212 Melsungen,




Germany






Poly (O-2-hydroxyethyl) starch (HES) Sodium chloride, Potassium chloride, Calcium chloride dihydrate, Magnesium chloride hexahydrate, Sodium acetate trihydrate, L-Malic acid DAB


EquiHes 60 mg/ml solution for infusion, Ecoflac Plus


60 g/l, 6,25 g/l, 0,3 g/l, 0,37 g/l, 0,2 g/l, 3,27 g/l, 0,67 g/l


solution for infusion


intravenous use




Ireland







B. Braun Melsungen AG,




Harald Weis,




Carl-Braun Strasse 1,




34212 Melsungen,




Germany






Poly (O-2-hydroxyethyl) starch (HES), Sodium chloride, Potassium chloride, Calcium chloride dihydrate, Magnesium chloride hexahydrate, Sodium acetate trihydrate, Malic acid DAB


EquiHes 100 mg/ml solution for infusion, Ecoflac Plus


100 g/l, 6,25 g/l, 0,3 g/l, 0,37 g/l, 0,2 g/l, 3,27 g/l, 0,67 g/l


solution for infusion


intravenous use




Ireland







B. Braun Melsungen AG,




Harald Weis,




Carl-Braun Strasse 1,




34212 Melsungen,




Germany






Poly (O-2-hydroxyethyl) starch (HES), Sodium chloride, Potassium chloride, Calcium chloride dihydrate, Magnesium chloride hexahydrate, Sodium acetate trihydrate, Malic acid DAB


EquiHes 60 mg/ml solution for infusion, Ecobag


60 g/l, 6,25 g/l, 0,3 g/l, 0,37 g/l, 0,2 g/l, 3,27 g/l, 0,67 g/l


solution for infusion


intravenous use




Ireland







B. Braun Melsungen AG,




Harald Weis,




Carl-Braun Strasse 1,




34212 Melsungen,




Germany






Poly (O-2-hydroxyethyl) starch (HES), Sodium chloride, Potassium chloride, Calcium chloride dihydrate, Magnesium chloride hexahydrate, Sodium acetate trihydrate, Malic acid DAB


EquiHes 100 mg/ml solution for infusion, Ecobag


100 g/l, 6,25 g/l, 0,30 g/l, 0,37 g/l, 0,20 g/l, 3,27 g/l, 0,67 g/l


solution for infusion


intravenous use




Ireland







Fresenius Kabi Limited




Cestrian Court




Eastgate way




Manor Park




Runcorn,Cheshire




WA7 1NT




United Kingdom






poly (0-2-hydroxyethyl)starch sodium chloride


HyperHAES


60 g/l, 72 g/l


solution for infusion


intravenous use




Ireland







Fresenius Kabi Limited




Cestrian Court




Eastgate way




Manor Park




Runcorn,Cheshire




WA7 1NT




United Kingdom






poly (0-2-hydroxyethyl)starch sodium chloride


Voluven 10 % Solution for Infusion (Polyolefine Bag)


100 g/l 9 g/l


solution for infusion


intravenous use




Ireland







Fresenius Kabi Limited




Cestrian Court




Eastgate way




Manor Park




Runcorn,Cheshire




WA7 1NT




United Kingdom






poly (o-2-hydroxyethyl)starch sodium chloride


Voluven 10 % Solution for Infusion (PE Bottle)


100 g/l 9,00 g/l


solution for infusion


intravenous use




Ireland







Fresenius Kabi Limited




Cestrian Court




Eastgate way




Manor Park




Runcorn,Cheshire




WA7 1NT




United Kingdom






poly (o-2-hydroxyethyl)starch sodium chloride


Voluven 6 % Solution for Infusion (Glass bottle)


60 g/l 9 g/l


solution for infusion


intravenous use




Ireland







Fresenius Kabi Limited




Cestrian Court




Eastgate way




Manor Park




Runcorn,Cheshire




WA7 1NT




United Kingdom






poly (o-2-hydroxyethyl)starch sodium chloride


Voluven 6 % Solution for Infusion (Polyolefine/Freeflex Bag


60 g/l 9 g/l


solution for infusion


intravenous use




Ireland







Fresenius Kabi Limited




Cestrian Court




Eastgate way




Manor Park




Runcorn,Cheshire




WA7 1NT




United Kingdom






poly (o-2-hydroxyethyl)starch sodium chloride


Voluven 6 % Solution for Infusion (PVC Bag)


60 g/l 9 g/l


solution for infusion


intravenous use




Ireland







Fresenius Kabi Limited




Cestrian Court




Eastgate way




Manor Park




Runcorn,Cheshire




WA7 1NT




United Kingdom






poly(o-2-hydroxyethyl)starch sodium acetate trihydrate sodium chloride potassium chloride magnesium chloride hexahydrate


Volulyte 6 % Solution for Infusion, polyoelfine bags


60 g/l, 4,63 g/l, 6,02 g/l, 0,3 g/l, 0,3 g/l


solution for infusion


intravenous use




Ireland







Fresenius Kabi Limited




Cestrian Court




Eastgate way




Manor Park




Runcorn,Cheshire




WA7 1NT




United Kingdom






poly(o-2-hydroxyethyl)starch sodium acetate trihydrate sodium chloride potassium chloride magnesium chloride hexahydrate


Volulyte 6 % Solution for Infusion, glass bottle


60 g/l, 4,63 g/l, 6,02 g/l, 0,3 g/l, 0,3 g/l


solution for infusion


intravenous use




Italy







FRESENIUS KABI ITALIA Srl




Via Camagre, 41-43




Isola della Scala (Verona) 37063




Italy






Hydroxyethyl starch, Sodium Chloride


Vonten


100 g/l, 9 g/l


solution for infusion


intravenous use




Italy







FRESENIUS KABI ITALIA Srl




Via Camagre, 41-43




Isola della Scala (Verona) 37063




Italy






Hydroxyethyl starch, Sodium Chloride


HyperHAES


60 g/l, 72 g/l


solution for infusion


intravenous use




Italy







FRESENIUS KABI ITALIA Srl




Via Camagre, 41-43




Isola della Scala (Verona) 37063




Italy






Hydroxyethyl starch, Sodium Chloride


Voluven


60 g/l, 9 g/l


solution for infusion


intravenous use




Italy







B. Braun Melsungen AG




Carl-Braun-Straße 1




34209 Melsungen




Germany






Hydroxyethyl starch, Sodium Chloride


Amidolite


60 g/l, 9 g/l


solution for infusion


intravenous use




Italy







B. Braun Melsungen AG




Carl-Braun-Straße 1




34209 Melsungen




Germany






Hydroxyethyl starch, Sodium Chloride, Potassium chloride, Calcium chloride dihydrate, Magnesium chloride hexahydrate, Sodium acetate trihydrate, Malic acid


Tetraspan


60 g/l, 6,25 g/l, 0,30 g/l, 0,37 g/l, 0,20 g/l, 3,27 g/l, 0,67 g/l


solution for infusion


intravenous use




Italy







B. Braun Melsungen AG




Carl-Braun-Straße 1




34209 Melsungen




Germany






Hydroxyethyl starch, Sodium Chloride, Potassium chloride, Calcium chloride dihydrate, Magnesium chloride hexahydrate, Sodium acetate trihydrate, Malic acid


Tetraspan


100 g/l, 6,25 g/l, 0,30 g/l, 0,37 g/l, 0,20 g/l, 3,27 g/l, 0,67 g/l


solution for infusion


intravenous use




Italy







Baxter S.p.A.




Piazzale dell industria, 20




00144 Rome




Italy






Hydroxyethyl starch, Sodium Chloride, Potassium chloride, Calcium chloride dihydrate, Magnesium chloride hexahydrate, Sodium acetate trihydrate


Plasmavolume


60 g/l, 6 g/l, 0,4 g/l, 0,134 g/l, 0,2 g/l, 3,7 g/l


solution for infusion


intravenous use




Italy







FRESENIUS KABI ITALIA Srl




Via Camagre, 41-43




Isola della Scala (Verona) 37063




Italy






Hydroxyethyl starch, Sodium Chloride, Potassium chloride, Magnesium chloride hexahydrate, Sodium acetate trihydrate


Volulyte


60 g/l, 6,02 g/l, 0,3 g/l, 0,3 g/l, 4,63 g/l


solution for infusion


intravenous use




Italy







Fresenius Kabi Deutschland GmbH




Else-Kröner-Str. 1




61352 Bad Homburg v.d.H.




Germany






Hydroxyethyl starch, Sodium Chloride


HAES-STERIL


60 g/l, 9 g/l


solution for infusion


intravenous use




Italy







Fresenius Kabi Deutschland GmbH




Else-Kröner-Str. 1




61352 Bad Homburg v.d.H.




Germany






Hydroxyethyl starch, Sodium Chloride


HAES-STERIL


100 g/l, 9 g/l


solution for infusion


intravenous use




Latvia







Fresenius Kabi Deutschland GmbH




61346 Bad Homburg v.d.H




Germany






Poly(O-2-hydroxyethyl)starch, Sodium chloride


Voluven 6 % solution for infusion


60 g, 9 g


solution for infusion


intravenous use




Latvia







Fresenius Kabi Polska Sp.z.o.o.




Ul. Hrubieszowska 2




01-209 Warszawa




Poland






Poly(O-2-hydroxyethyl)starch, Sodium chloride


Voluforte solution for infusion


100 g, 9 g


solution for infusion


intravenous use




Latvia







Fresenius Kabi Deutschland GmbH




61346 Bad Homburg v.d.H




Germany






Poly(O-2-hydroxyethyl)starch, Sodium acetate trihydrate, Sodium chloride, Potassium chloride, Magnesium chloride hexahydrate


Volulyte 6 % solution for infusion


60 g, 4,63 g, 6,02 g, 0,30 g, 0,30 g


solution for infusion


intravenous use




Latvia







B. Braun Melsungen AG




Carl-Braun-Strasse 1




34212 Melsungen




Germany






Poly(O-2-hydroxyethyl) starch, Sodium chloride, Potassium chloride, Calcium chloride dihydrate, Magnesium chloride hexahydrate, Sodium acetate trihydrate, Malic acid


Tetraspan 60 mg/ml solution for infusion


60 g, 6,25 g, 0,30 g, 0,37 g, 0,20 g, 3,27 g, 0,67 g


solution for infusion


intravenous use




Latvia







B. Braun Melsungen AG




Carl-Braun-Strasse 1




34212 Melsungen




Germany






Poly(O-2-hydroxyethyl) starch, Sodium chloride, Potassium chloride, Calcium chloride dihydrate, Magnesium chloride hexahydrate, Sodium acetate trihydrate, Malic acid


Tetraspan 100 mg/ml solution for infusion


100 g, 6,25 g, 0,30 g, 0,37 g, 0,20 g, 3,27 g, 0,67 g


solution for infusion


intravenous use




Lithuania







UAB ‘BERLIN CHEMIE MENARINI BALTIC’




Jasinskio 16a,




LT-01112 Vilnius,




Lithuania






Hydroxyethyl starch


Refortan


60 g/l


solution for infusion


intravenous use




Lithuania







UAB ‘BERLIN CHEMIE MENARINI BALTIC’




Jasinskio 16a,




LT-01112 Vilnius,




Lithuania






Hydroxyethyl starch


Refortan Plus


100 g/l


solution for infusion


intravenous use




Lithuania







UAB ‘BERLIN CHEMIE MENARINI BALTIC’




Jasinskio 16a,




LT-01112 Vilnius,




Lithuania






Hydroxyethyl starch


Stabisol


60 g/l


solution for infusion


intravenous use




Lithuania







Fresenius Kabi Polska Sp.zo.o.




ul.Hrubieszowska 2




01-209 Warszawa,




Poland






Poli(O-2-hydroxyethyl) starch, Sodium chloride


Voluforte


100 g + 9 g/l


solution for infusion


intravenous use




Lithuania







Fresenius Kabi Deutschland GmbH




61346 Bad Homburg v.d.H




Germany






Poli(O-2-hydroxyethyl) starch


Volulyte


60 g/l


solution for infusion


intravenous use




Lithuania







Fresenius Kabi Deutschland GmbH




61346 Bad Homburg v.d.H




Germany






Poli(O-2-hydroxyethyl) starch, Sodium chloride


Voluven


60 g + 9 g/l


solution for infusion


intravenous use




Lithuania







B. Braun Melsungen AG




Carl-Braun-strasse 1




34212 Melsungen




Germany






Poli(0-2-hydroxyethyl)starch(HEK), Sodium chloride, Potassium chloride, Calcium chloride dihydrate, Magnesium chloride heksahydrate, Sodium acetate trihydrate, Malic acid


Tetraspan


60 g + 6,25 g + 0,3 g + 0,37 g + 0,2 g + 3,27 g + 0,67 g/l


solution for infusion


intravenous use




Lithuania







B. Braun Melsungen AG




Carl-Braun-strasse 1




34212 Melsungen




Germany






Poli(0-2-hydroxyethyl)starch(HEK), Sodium chloride, Potassium chloride, Calcium chloride dihydrate, Magnesium chloride heksahydrate, Sodium acetate trihydrate, Malic acid


Tetraspan


100 g + 6,25 g + 0,3 g + 0,37 g + 0,2 g + 3,27 g + 0,67 g/l


solution for infusion


intravenous use




Luxembourg







Fresenius Kabi Deutschland GmbH




61346 Bad Homburg v.d.H




Germany






Poly(0-2-hydroxyethyl)starch 200 kDa mol.substitution 0,43-0,55, Sodium chloride


Haes-steril 6 %


60 g/l, 9 g/l


solution for infusion


intravenous use




Luxembourg







Fresenius Kabi Deutschland GmbH




61346 Bad Homburg v.d.H




Germany






Poly(0-2-hydroxyethyl)starch 200 kDa mol.substitution 0,43-0,55, Sodium chloride


Haes-steril 10 %


100 g/l, 9 g/l


solution for infusion


intravenous use




Luxembourg







B.Braun Melsungen A.G.




Carl-Braun-Straße 1




D-34212 Melsungen




Germany






Poly(0-2-hydroxyethyl)starch 200 kDa mol.substitution 0,45-0,55, Sodium chloride


Hemohes 6 %


60 g/l, 9 g/l


solution for infusion


intravenous use




Luxembourg







B.Braun Melsungen A.G.




Carl-Braun-Straße 1




D-34212 Melsungen




Germany






Poly(0-2-hydroxyethyl)starch 200 kDa mol.substitution 0,45-0,55, Sodium chloride


Hemohes 10 %


100 g/l, 9 g/l


solution for infusion


intravenous use




Luxembourg







Fresenius Kabi Deutschland GmbH




61346 Bad Homburg v.d.H




Germany






Poly(0-2-hydroxyethyl)starch 200 kDa mol.substitution 0,43-0,55, Sodium chloride


Hyperhaes


60 g/l, 72 g/l


solution for infusion


intravenous use




Luxembourg







Baxter S.A.




Boulevard René Branquart 80




B-7860 Lessines




Belgium






Poly(0-2-hydroxyethyl)starch 130 kDa mol.substitution 0,42, Sodium chloride, Potassium chloride, Calcium chloride trihydrate, Magnesium chloride hexahydrate, sodium acetate trihydrate


Plasma Volume Redibag 6 %


60 g/l, 6 g/l, 0,4 g/l, 0,134 g/l, 0,2 g/l, 3,7 g/l


solution for infusion


intravenous use




Luxembourg







B.Braun Melsungen A.G.




Carl-Braun-Straße 1




D-34212 Melsungen




Germany






Poly(0-2-hydroxyethyl)starch 130 kDa mol.substitution 0,42, Sodium chloride, Potassium chloride, Calcium chloride dihydrate, Magnesium chloride hexahydrate, sodium acetate trihydrate, malic acid


Tetraspan 6 %


60 g/l, 6,25 g/l, 0,3 g/l, 0,37 g/l, 0,2 g/l, 3,27 g/l, 0,67 g/l


solution for infusion


intravenous use




Luxembourg







B.Braun Melsungen A.G.




Carl-Braun-Straße 1




D-34212 Melsungen




Germany






Poly(0-2-hydroxyethyl)starch 130 kDa mol.substitution 0,42, Sodium chloride, Potassium chloride, Calcium chloride dihydrate, Magnesium chloride hexahydrate, sodium acetate trihydrate, malic acid


Tetraspan 10 %


100 g/l, 6,25 g/l, 0,3 g/l, 0,37 g/l, 0,2 g/l, 3,27 g/l, 0,67 g/l


solution for infusion


intravenous use




Luxembourg







B.Braun Melsungen A.G.




Carl-Braun-Straße 1




D-34212 Melsungen




Germany






Poly(0-2-hydroxyethyl)starch 130 kDa mol.substitution 0,42, Sodium chloride


Venofundin 60 mg/ml


60 g/l, 9 g/l


solution for infusion


intravenous use




Luxembourg







Fresenius Kabi Deutschland GmbH




61346 Bad Homburg v.d.H




Germany






Poly(0-2-hydroxyethyl)starch 130 kDa mol.substitution 0,38-0,45, Sodium acetate trihydrate, sodium chloride, potassium chloride, magnesium chloride hexahydrate


Volulyte 6 %


60 g/l, 4,63 g/l, 6,02 g/l, 0,3 g/l 0,3 g/l


solution for infusion


intravenous use




Luxembourg







Fresenius Kabi Deutschland GmbH




61346 Bad Homburg v.d.H




Germany






Poly(0-2-hydroxyethyl)starch 130 kDa mol.substitution 0,38-0,45, Sodium chloride


Voluven 6 %


60 g/l, 9 g/l


solution for infusion


intravenous use




Luxembourg







Fresenius Kabi Deutschland GmbH




61346 Bad Homburg v.d.H




Germany






Poly(0-2-hydroxyethyl)starch 130 kDa mol.substitution 0,38-0,45, Sodium chloride


Voluven 10 %


100 g/l, 9 g/l


solution for infusion


intravenous use




Malta







Fresenius Kabi Limited




Cestrian Court




Eastgate Way




Manor Park




Runcorn




Cheshire




WA7 1NT




United Kingdom






Sodium acetate trihydrate, sodium chloride, potassium chloride, magnesium chloride hexahydrate, hydroxyethyl starch 130/0.4


Volulyte 6 % solution for infusion


4,63 g/l, 6,02 g/l. 0,3 g/l, 0,3 g/l, 60 g/l


solution for infusion


intravenous use




Malta







Baxter Healthcare Limited




Caxton Way




Thetford




Norfolk




IP24 3SE




United Kingdom






Poly (O-2-hydroxyethyl starch (HES), sodium chloride, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate, sodium acetate trihydrate


Plasma Volume Redibag 6 % solution for infusion


60 g/l, 6 g/l, 0,4 g/l, 0,134 g/l, 0,200 g/l, 3,7 g/l


solution for infusion


intravenous use




Norway







Baxter AS




Gjerdumsvei 11




0484 Oslo




Norway






Poly(O-2-hydroxyethyl) starch (HES), Sodium chloride, Potassium chloride, Calcium chloride dihydrate, Magnesium chloride hexahydrate, Sodium acetate trihydrate


Hesra


60 g/l, 6,00 g/l, 0,400 g/l, 0,134 g/l, 0,200 g/l, 3,70 g/l


solution for infusion


intravenous use




Norway







Fresenius Kabi Norge AS




Postboks 430




1753 Halden




Norway






Poly(O-2-hydroxyethyl) starch (HES), Sodium chloride


HyperHAES


60 g/l, 72 g/l


solution for infusion


intravenous use




Norway







B. Braun Melsungen AG




Carl-Braun-Straße 1




34212 Melsungen




Germany






Poly(O-2-hydroxyethyl) starch (HES), Sodium chloride, Potassium chloride, Calcium chloride dihydrate, Magnesium chloride hexahydrate, Sodium acetate trihydrate, Malic acid


Tetraspan


60 g/l, 6,25 g/l, 0,30 g/l, 0,37 g/l, 0,20 g/l, 3, 27 g/l, 0,67 g/l


solution for infusion


intravenous use




Norway







B. Braun Melsungen AG




Carl-Braun-Straße 1




34212 Melsungen




Germany






Poly(O-2-hydroxyethyl) starch (HES), Sodium chloride


Venofundin


60 g/l, 9 g/l


solution for infusion


intravenous use




Norway







Fresenius Kabi Norge AS




Postboks 430




1753 Halden




Norway






Poly(O-2-hydroxyethyl) starch (HES), Sodium acetate trihydrate, Sodium chloride, Potassium chloride, Magnesium chloride hexahydrate


Volulyte


60 g/l, 4,63 g/l, 6,02 g/l, 0,30 g/l, 0,30 g/l


solution for infusion


intravenous use




Norway







Fresenius Kabi Norge AS




Postboks 430




1753 Halden




Norway






Poly(O-2-hydroxyethyl) starch (HES), Sodium chloride


Voluven


100 g/l, 9 g/l


solution for infusion


intravenous use




Norway







Fresenius Kabi Norge AS




Postboks 430




1753 Halden




Norway






Poly(O-2-hydroxyethyl) starch (HES), Sodium chloride


Voluven


60 g/l, 9 g/l


solution for infusion


intravenous use




Poland







Fresenius Kabi Deutschland GmbH




61346 Bad Homburg v.d.H




Germany






Hydroxyethyl Starch


HAES - steril 10 %


100 g/l


solution for infusion


intravenous use




Poland







Berlin-Chemie AG




Glienicker Weg 125




12489 Berlin




Germany






Hydroxyethyl Starch, Sodium chloride


Refortan


60 g/l 9 g/l


solution for infusion


intravenous use




Poland







Baxter Polska Sp. z o.o.




ul. Kruczkowskiego 8




00-380 Warszawa




Poland






Hydroxyethyl Starch,


6 % Hydroksyetyloskrobia 200/0,5 Baxter


60 g/l


solution for infusion


intravenous use




Poland







Baxter Polska Sp. z o.o.




ul. Kruczkowskiego 8




00-380 Warszawa




Poland






Hydroxyethyl Starch


10 % Hydroksyetyloskrobia 200/0,5 Baxter


100 g/l


solution for infusion


intravenous use




Poland







Berlin-Chemie AG




Glienicker Weg 125




12489 Berlin




Germany






Hydroxyethyl Starch, Sodium chloride


Refortan Forte


100 g/l 9 g/l


solution for infusion


intravenous use




Poland







B. Braun Melsungen AG




Carl-Braun Strasse 1




34212 Melsungen




Germany






Hydroxyethyl Starch, Sodium chloride


Hemohes 6 %


60 g/l 9 g/l


solution for infusion


intravenous use




Poland







B. Braun Melsungen AG




Carl-Braun Strasse 1




34212 Melsungen




Germany






Hydroxyethyl Starch, Sodium chloride


Hemohes 10 %


100 g/l 9 g/l


solution for infusion


intravenous use




Poland







B. Braun Melsungen AG




Carl-Braun Strasse 1




34212 Melsungen




Germany






Hydroxyethyl Starch, Sodium chloride, Potassium chloride, Hydrated calcemia chloride, Hydrated magnesium chloride, Hydrated sodium acetate, Hydroxy succinic acid


Tetraspan 60 mg/ml HES roztwór do infuzji


60 g/l 6,25 g/l 0,30 g/l 0,37 g/l 0,20 g/l 3,27 g/l 0,67 g/l


solution for infusion


intravenous use




Poland







B. Braun Melsungen AG




Carl-Braun Strasse 1




34212 Melsungen




Germany






Hydroxyethyl Starch, Sodium chloride, Potassium chloride, Hydrated calcemia cloride, Hydrated magnesium chloride, Hydrated sodium acetate, Hydroxy succinic acid


Tetraspan 100 mg/ml HES roztwór do infuzji


100 g/l 6,252 g/l 0,2984 g/l 0,3675 g/l 0,2033 g/l 3,266 g/l 0,6710 g/l


solution for infusion


intravenous use




Poland







Baxter Polska Sp. z o.o.




ul. Kruczkowskiego 8




00-380 Warszawa




Poland






Hydroxyethyl Starch, Sodium chloride, Potassium chloride, Hydrated calcemia cloride, Hydrated magnesium chloride, Hydrated sodium acetate


PlasmaVolume Redibag


60 g/l 6,0 g/l 0,4 g/l 0,134 g/l 0,2 g/l 3,70 g/l


solution for infusion


intravenous use




Poland







Fresenius Kabi Polska Sp. z o.o.




ul. Hrubieszowska 2




01-209 Warszawa




Poland






Hydroxyethyl Starch, Sodium chloride


Voluven 10 %


100 g/l 9 g/l


solution for infusion


intravenous use




Poland







Fresenius Kabi Deutschland GmbH




61346 Bad Homburg v.d.H




Germany






Polyhydroxyethylstarch, Sodium chloride


HyperHAES


60 g/l, 72 g/l


solution for infusion


intravenous use




Poland







Fresenius Kabi Deutschland GmbH




61346 Bad Homburg v.d.H




Germany






Hydroxyethyl Starch, Sodium chloride


VOLUVEN


60 g/l 9 g/l


solution for infusion


intravenous use




Poland







Fresenius Kabi Deutschland GmbH




61346 Bad Homburg v.d.H




Germany






Poly(O-2-hydoxyethyl)starch 130/0.4, Sodium chloride, Sodium acetate trihydrate, Potassium chloride, Magnesium chloride hexahydrate


Volulyte 6 %


60 g/l, 6,02 g/l, 4,63 g/l, 0,30 g/l, 0,30 g/l


solution for infusion


intravenous use




Portugal







Fresenius Kabi Pharma Portugal, Lda




Av. do Forte, 3




Edifício Suécia III - Piso 2




2790-073 Carnaxide




Portugal






Hydroxyethyl starch + Sodium chloride


Haes-Steril 10 %


100 mg/ml + 9 mg/ml


solution for infusion


intravenous use




Portugal







Fresenius Kabi Pharma Portugal, Lda




Av. do Forte, 3




Edifício Suécia III - Piso 2




2790-073 Carnaxide




Portugal






Hydroxyethyl starch + Sodium chloride


Haes-Steril 6 %


60 mg/ml + 9 mg/ml


solution for infusion


intravenous use




Portugal







Fresenius Kabi Pharma Portugal, Lda




Av. do Forte, 3




Edifício Suécia III - Piso 2




2790-073 Carnaxide




Portugal






Hydroxyethyl starch + Sodium chloride


Voluven Fresenius


60 mg/ml + 9 mg/ml


solution for infusion


intravenous use




Portugal







Fresenius Kabi Pharma Portugal, Lda




Av. do Forte, 3




Edifício Suécia III - Piso 2




2790-073 Carnaxide




Portugal






Hydroxyethyl starch + Sodium chloride


HyperHAES


60 mg/ml + 72 mg/ml


solution for infusion


intravenous use




Portugal







B. Braun Melsungen A.G.




Carl-Braun Strasse, 1




D-34212 Melsungen




Germany






Hydroxyethyl starch + Sodium chloride


Venofundin


60 mg/ml + 9 mg/ml


solution for infusion


intravenous use




Portugal







Fresenius Kabi Pharma Portugal, Lda




Av. do Forte, 3




Edifício Suécia III - Piso 2




2790-073 Carnaxide




Portugal






Potassium chloride + Sodium acetate trihydrate + Magnesium chloride hexahydrate + Hydroxyethyl starch + Sodium chloride


Volulyte


0,3 mg/ml + 4,63 mg/ml + 0,3 mg/ml + 60 mg/ml + 6,02 mg/ml


solution for infusion


intravenous use




Portugal







B. Braun Melsungen A.G.




Carl-Braun Strasse, 1




D-34212 Melsungen




Germany






Potassium chloride + Sodium acetate trihydrate + Malic acid + Magnesium chloride hexahydrate + Sodium chloride + Hydroxyethyl starch + Calcium chloride dihydrate


Tetraspan


0,3 mg/ml + 3,27 mg/ml + 0,67 mg/ml + 0,2 mg/ml + 6,25 mg/ml + 60 mg/ml + 0,37 mg/ml


solution for infusion


intravenous use




Portugal







B. Braun Melsungen A.G.




Carl-Braun Strasse, 1




D-34212 Melsungen




Germany






Potassium chloride + Sodium acetate trihydrate + Malic acid + Magnesium chloride hexahydrate + Sodium chloride + Hydroxyethyl starch + Calcium chloride dihydrate


Tetraspan


0,3 mg/ml + 3,27 mg/ml + 0,67 mg/ml + 0,2 mg/ml + 6,25 mg/ml + 100 mg/ml + 0,37 mg/ml


solution for infusion


intravenous use




Portugal







Baxter Médico-Farmacêutica, Lda.




Zona Industrial da Abrunheira - Edifício 10 - Sintra Business Park




2710-089 Sintra




Portugal






Sodium acetate trihydrate + Potassium chloride + Magnesium chloride hexahydrate + Hydroxyethyl starch + Calcium chloride dihydrate + Sodium chloride


PlasmaVolume Redibag


3,7 mg/ml + 0,4 mg/ml + 0,2 mg/ml + 60 mg/ml + 0,134 mg/ml + 6 mg/ml


solution for infusion


intravenous use




Portugal







Fresenius Kabi Pharma Portugal, Lda




Av. do Forte, 3




Edifício Suécia III - Piso 2




2790-073 Carnaxide




Portugal






Hydroxyethyl starch + Sodium chloride


Voluven Fresenius


100 mg/ml + 9 mg/ml


solution for infusion


intravenous use




Romania







S.C. INFOMED FLUIDS S.R.L.,




B-dul Theodor Pallady nr. 50, sector 3, București,




032266




Romania






Hydroxyethyl starch Sodium chloride Potassium chloride Calcium chloride dihydrate Magnesium chloride hexahydrate Sodium acetate trihydrate


VITAFUSAL


60 g/l, 6 g/l, 0,40 g/l, 0,134 g/l, 0,20 g/l, 3,70 g/l


solution for infusion


intravenous use




Romania







Fresenius Kabi Deutschland GmbH




61346 Bad Homburg v.d.H




Germany






Hydroxyethyl starch Sodium chloride


Voluven 60 g/1 000 ml


60 g/l, 9 g/l


solution for infusion


intravenous use




Romania







S.C. FRESENIUS KABI ROMÂNIA S.R.L.




Strada Fânarului nr. 2A,




500464 Brașov,




Romania






Hydroxyethyl starch Sodium chloride


VOLUVEN 10 %


100 g/l, 9 g/l


solution for infusion


intravenous use




Romania







S.C. INFOMED FLUIDS S.R.L.




B-dul Theodor Pallady nr. 50, sector 3, București,




032266




Romania






Hydroxyethyl starch Sodium chloride


INFOHES 60 g/L


60 g/l, 9 g/l


solution for infusion


intravenous use




Romania







S.C. INFOMED FLUIDS S.R.L.




B-dul Theodor Pallady nr. 50, sector 3, București,




Romania






Hydroxyethyl starch Sodium chloride


INFOHES 100 g/L


100 g/l, 9 g/l


solution for infusion


intravenous use




Romania







B. BRAUN MELSUNGEN AG




Carl – Braun str. 1, D – 34212 Melsungen,




Germany






Hydroxyethyl starch Sodium chloride


HEMOHES 6 %


60 g/l, 9 g/l


solution for infusion


intravenous use




Romania







B. BRAUN MELSUNGEN AG




Carl – Braun str. 1,




D – 34212 Melsungen,




Germany






Hydroxyethyl starch Sodium chloride


HEMOHES 10 %


100 g/l, 9 g/l


solution for infusion


intravenous use




Romania







Fresenius Kabi Deutschland GmbH




61346 Bad Homburg v.d.H




Germany






Hydroxyethyl starch Sodium chloride


HAES-steril 60 g/1 000 ml


60 g/l, 9 g/l


solution for infusion


intravenous use




Romania







Fresenius Kabi Deutschland GmbH




61346 Bad Homburg v.d.H




Germany






Hydroxyethyl starch Sodium chloride


HAES-steril 100 g/1 000 ml


100 g/l, 9 g/l


solution for infusion


intravenous use




Romania







B. BRAUN MELSUNGEN AG,




Carl-Braun-Strasse 1




34212 Melsungen,




Germany






Hydroxyethyl starch Sodium chloride


Venofundin 6 g/100 ml


60 g/l, 9 g/l


solution for infusion


intravenous use




Romania







S.C. Fresenius Kabi Romania S.R.L,




strada Fanarului nr. 2A,




500464 Brasov,




Romania






Hydroxyethyl starch, Sodium acetate trihydrate, Potassium chloride, Magnesium chloride hexahydrate, Sodium chloride


Volulyte 6 %


60 g/l, 4,63 g/l, 6,02 g/l, 0,30 g/l, 0,30 g/l


solution for infusion


intravenous use




Romania







B. BRAUN MELSUNGEN AG




Carl-Braun. Str.1,




D-34212 Melsungen,




Germany






Hidroxietil amidon, Sodium chloride, Potassium chloride, Magnesium chloride hexahydrate, Calcium chloride dihydrate,Sodium acetate trihydrate, Malic acid


TETRASPAN 60 mg/ml


60 g/l, 6,252 g/l, 0,298 g/l, 0,203 g/l, 0,367 g/l, 3,266 g/l, 0,671 g/l


solution for infusion


intravenous use




Romania







B. BRAUN MELSUNGEN AG




Carl-Braun. Str.1,




D-34212 Melsungen,




Germany






Hidroxietil amidon, Sodium chloride, Potassium chloride, Magnesium chloride hexahydrate, Calcium chloride dihydrate,Sodium acetate trihydrate, Malic acid


TETRASPAN 100 mg/ml


100 g/l, 6,252 g/l, 0,298 g/l, 0,203 g/l, 0,367 g/l, 3,266 g/l, 0,671 g/l


solution for infusion


intravenous use




Slovak Republic







Fresenius Kabi Deutschland GmbH




Else-Kröner-Str. 1




61352 Bad Homburg v.d.H.




Germany






hydroxyethyl starch, Sodium chloride


HAES-steril 10 %


100 g/l, 9 g/l


solution for infusion


intravenous use




Slovak Republic







Fresenius Kabi Deutschland GmbH




Else-Kröner-Str. 1




61352 Bad Homburg v.d.H.




Germany






hydroxyethyl starch, Sodium chloride


HyperHAES


60 g/l, 72 g/l


solution for infusion


intravenous use




Slovak Republic







BAXTER CZECH spol. s r.o.




Karla Engliše 3201/6




150 00 Praha 5




Czech Republic






hydroxyethyl starch, Sodium chloride, Potassium chloride, Calcium chloride dihydrate, Magnesium chloride hexahydrate, Sodium acetate trihydrate


PlasmaVolume Redibag


60 g/l, 6 g/l, 0,4 g/l, 0,134 g/l, 0,2 g/l, 3,70 g/l


solution for infusion


intravenous use




Slovak Republic







B. Braun Melsungen AG




Carl-Braun-Straße 1




34212 Melsungen




Germany






hydroxyethyl starch, Sodium chloride, Potassium chloride, Calcium chloride, Magnesium chloride hexahydrate, sodium acetate, Malic acid


Tetraspan 10 %


100 g/l, 6,25 g/l, 0,30 g/l, 0,37 g/l, 0,20 g/l, 3,27 g /l, 0,67 g/l


solution for infusion


intravenous use




Slovak Republic







B. Braun Melsungen AG




Carl-Braun-Straße 1




34212 Melsungen




Germany






hydroxyethyl starch, Sodium chloride, Potassium chloride, Calcium chloride, Magnesium chloride hexahydrate, sodium acetate, Malic acid


Tetraspan 6 %


60 g/l, 6,25 g/l, 0,30 g/l, 0,37 g/l, 0,20 g/l, 3,27 g/l, 0,67 g/l


solution for infusion


intravenous use




Slovak Republic







Fresenius Kabi Deutschland GmbH




Else-Kröner-Str. 1




61352 Bad Homburg v.d.H.




Germany






hydroxyethyl starch, Sodium acetate trihydrate, Sodium chloride, Potassium chloride, Magnesium chloride hexahydrate


Volulyte 6 %, infúzny roztok


60 g/l, 4,63 g/l, 6,02 g/l, 0,30 g/l, 0,30 g/l


solution for infusion


intravenous use




Slovak Republic







Fresenius Kabi Deutschland GmbH




Else-Kröner-Str. 1




61352 Bad Homburg v.d.H.




Germany






hydroxyethyl starch, Sodium chloride


VOLUVEN


60 g/l, 9 g/l


solution for infusion


intravenous use




Slovak Republic







Fresenius Kabi s.r.o.




Zeletavská 1525/1




140 00 Praha 4 - Michle




Czech Republic






hydroxyethyl starch, Sodium chloride


Voluven 10 %


100 g/l, 9 g/l


solution for infusion


intravenous use




Slovenia







Medias International d.o.o.




Leskoškova cesta 9D




1000 Ljubljana




Slovenia






Hydroxyethyl Starch, Sodium chloride


HAES-steril 60 mg/ml raztopina za infundiranje


60,0 g/l, 9,0 g/l


solution for infusion


intravenous use




Slovenia







Baxter d.o.o.




Zelezna cesta 18




1000 Ljubljana




Slovenija






Hydroxyethyl Starch, Sodium chloride, Potassium chloride, Calcium chloride dihydrate, Magnesium chloride hexahydrate, Sodium acetate trihydrate


Plasma Volume Redibag 60 mg/ml raztopina za infundiranje


60,0 g/l, 6,0 g/l, 0,4 g/l, 0,134 g/l, 0,2 g/l, 3,7 g/l,


solution for infusion


intravenous use




Slovenia







B.Braun Melsungen AG




Carl-Braun-Strasse 1




34212 Melsungen




Germany






Hydroxyethyl Starch, Sodium chloride, Potassium chloride, Calcium chloride dihydrate, Magnesium chloride hexahydrate, Sodium acetate trihydrate, Malic acid


Tetraspan 60 mg/ml raztopina za infundiranje


60,0 g/l, 6,25 g/l, 0,30 g/l, 0,37 g/l, 0,20 g/l, 3,27 g/l, 0,67 g/l


solution for infusion


intravenous use




Slovenia







B.Braun Melsungen AG




Carl-Braun-Strasse 1




34212 Melsungen




Germany






Hydroxyethyl Starch, Sodium chloride, Potassium chloride, Calcium chloride dihydrate, Magnesium chloride hexahydrate, Sodium acetate trihydrate, Malic acid


Tetraspan 100 mg/ml raztopina za infundiranje


100,0 g/l, 6,25 g/l, 0,30 g/l, 0,37 g/l, 0,20 g/l, 3,27 g/l, 0,67 g/l


solution for infusion


intravenous use




Slovenia







Medias International d.o.o.




Leskoškova cesta 9D




1000 Ljubljana




Slovenia






Hydroxyethyl Starch, Sodium chloride, Potassium chloride, Magnesium chloride hexahydrate, Sodium acetate trihydrate


Volulyte 60 mg/ml raztopina za infundiranje


60,0 g/l, 6,02 g/l, 0,30 g/l, 0,30 g/l, 4,63 g/l


solution for infusion


intravenous use




Slovenia







Fresenius Kabi Deutschland GmbH




61346 Bad Homburg v.d.H




Germany






Hydroxyethyl Starch, Sodium chloride


VOLUVEN 100 mg/ml raztopina za infundiranje


100,0 g/l, 9,0 g/l


solution for infusion


intravenous use




Slovenia







Medias International d.o.o.




Leskoškova cesta 9D




1000 Ljubljana




Slovenia






Hydroxyethyl Starch, Sodium chloride


VOLUVEN 60 mg/ml raztopina za infundiranje


60,0 g/l, 9,0 g/l


solution for infusion


intravenous use




Spain







B. BRAUN MELSUNGEN AG




Carl-Braun Strasse, 1




Melsungen D-34212




Germany






Hydroxyethyl Starch + Sodium Chloride


HEMOES 6 % SOLUCIÓN


60 g/l + 9 g/l


solution for infusion


intravenous use




Spain







B. BRAUN MELSUNGEN AG




Carl-Braun Strasse, 1




Melsungen D-34212




Germany






Hydroxyethyl Starch + Sodium Chloride


HEMOES 10 % SOLUCIÓN


100 g/l + 9 g/l


solution for infusion


intravenous use




Spain







Fresenius Kabi Deutschland GmbH




Else-Kröner-Str. 1




61352 Bad Homburg v.d.H.




Germany






Hydroxyethyl Starch + Sodium Chloride


VOLUVEN 6 % SOLUCIÓN PARA PERFUSIÓN


60 g/l + 9 g/l


solution for infusion


intravenous use




Spain







FRESENIUS KABI ESPAÑA S.A.




Marina, 16-18-17




08005 Barcelona




Spain






Hydroxyethyl Starch + Sodium Chloride


VOLUVEN 10 % SOLUCIÓN PARA PERFUSIÓN


100 g/l + 9 g/l


solution for infusion


intravenous use




Spain







Fresenius Kabi Deutschland GmbH




Else-Kröner-Str. 1




61352 Bad Homburg v.d.H.




Germany






Hydroxyethyl Starch + Sodium Chloride


HES HIPERTONICO FRESENIUS SOLUCIÓN PARA PERFUSIÓN


60 g/l + 72 g/l


solution for infusion


intravenous use




Spain







Fresenius Kabi Deutschland GmbH




Else-Kröner-Str. 1




61352 Bad Homburg v.d.H.




Germany






Hydroxyethyl Starch + Sodium Acetate Trihydrate + Sodium Chloride + Potasium Chloride + Magnesium Chloride Hexahydrate


VOLULYTE 6 % SOLUCIÓN PARA PERFUSIÓN


60 g/l + 4,63 g/l + 6,02 g/l + 0,30 g/l + 0,30 g/l


solution for infusion


intravenous use




Spain







B. BRAUN MELSUNGEN AG




Carl-Braun Strasse, 1




Melsungen D-34212




Germany






Hydroxyethyl Starch + Sodium Chloride + Potasium Chloride + Calcium Chloride Dihydrate + Magnesium Chloride Hexahydrate + Sodium Acetate Trihydrate + Malic Acid


ISOHES 6 % SOLUCIÓN PARA PERFUSIÓN


60 g/l + 6,25 g/l + 0,30 g/l + 0,37 g/l + 0,20 g/l + 3,27 g/l + 0,67 g/l


solution for infusion


intravenous use




Spain







B. BRAUN MELSUNGEN AG




Carl-Braun Strasse, 1




Melsungen D-34212




Germany






Hydroxyethyl Starch + Sodium Chloride + Potasium Chloride + Calcium Chloride Dihydrate + Magnesium Chloride Hexahydrate + Sodium Acetate Trihydrate + Malic Acid


ISOHES 10 % SOLUCIÓN PARA PERFUSIÓN


100 g/l + 6,25 g/l + 0,30 g/l + 0,37 g/l + 0,20 g/l + 3,27 g/l + 0,67 g/l


solution for infusion


intravenous use




Spain







BAXTER S.L.




Polígono Industrial Sector 14




Pouet de Camilo, 2




46394 Ribarroja del Turia (Valencia)




Spain






Hydroxyethyl Starch + Sodium Chloride + Potasium Chloride + Calcium Chloride Dihydrate + Magnesium Chloride Hexahydrate + Sodium Acetate Trihydrate


PLASMAVOLUME REDIBAG SOLUCIÓN PARA PERFUSIÓN


60 g/l + 6 g/l + 0,4 g/l + 0,134 g/l + 0,2 g/l + 3,70 g/l


solution for infusion


intravenous use




Sweden







Fresenius Kabi AB,




751 74 Uppsala




Sweden






Hydroxyethyl starch, 130/0.4, Sodium chloride


Voluven


60 g/l, 9 g/l


solution for infusion


intravenous use




Sweden







Fresenius Kabi AB,




751 74 Uppsala




Sweden






Hydroxyethyl starch, 200/0.5, Sodium chloride


HyperHAES


60 g/l, 72 g/l


solution for infusion


intravenous use




Sweden







B. Braun Melsungen AG




P.O. Box 1110 +1120




DE-34209 Melsungen




Germany






Hydroxyethyl starch, 130/0.4, Sodium chloride


Venofundin®


60 g/l, 9 g/l


solution for infusion


intravenous use




Sweden







B. Braun Melsungen AG




Carl-Braun-Strasse 1




34212 Melsungen




Germany






hydroxyethyl starch, 130/0.4, sodium chloride, sodium acetate trihydrate, malic acid, calcium chloride dihydrate, potassium chloride, magnesium chloride hexahydrate


Tetraspan


60 g/l, 6,252 g/l, 3,266 g/l, 0,671 g/l, 0,368 g/l, 0,298 g/l, 0,203 g/l


solution for infusion


intravenous use




Sweden







B. Braun Melsungen AG




Carl-Braun-Strasse 1




34212 Melsungen




Germany






hydroxyethyl starch, 130/0.4, sodium chloride, sodium acetate trihydrate, malic acid, calcium chloride dihydrate, potassium chloride, magnesium chloride hexahydrate


Tetraspan


100 g/l, 6,252 g/l, 3,266 g/l, 0,671 g/l, 0,368 g/l, 0,298 g/l, 0,203 g/l


solution for infusion


intravenous use




Sweden







Fresenius Kabi AB,




751 74 Uppsala




Sweden






hydroxyethyl starch, 130/0.4, sodium chloride, sodium acetate trihydrate, magnesium chloride hexahydrate, potassium chloride


Volulyte


60 g/l, 6,020 g/l, 4,630 g/l, 0,300 g/l, 0,300 g/l


solution for infusion


intravenous use




Sweden







Baxter Medical AB




Box 63




164 94 Kista




Sweden






hydroxyethyl starch, 130/0.4, sodium chloride, sodium acetate trihydrate, potassium chloride, magnesium chloride hexahydrate, calcium chloride dihydrate


Hesra


60 g/l, 6,000 g/l, 3,700 g/l, 0,400 g/l, 0,200 g/l, 0,134 g/l


solution for infusion


intravenous use




Sweden







Fresenius Kabi AB,




751 74 Uppsala




Sweden






Hydroxyethyl starch, 130/0.4, Sodium chloride


Voluven


100 g/l, 9 g/l


solution for infusion


intravenous use




The Netherlands







Fresenius Kabi Nederland B.V.




Molenberglei 7




2627 Schelle




Belgium






active substance: hydroxyethyl starch (MR 200.000), Sodium chloride


EloHAES, infusievloeistof


60,0 g/l, 9,0 g/l


solution for infusion


intravenous use




The Netherlands







Fresenius Kabi Nederland B.V.




Molenberglei 7




2627 Schelle




Belgium






active substance: hydroxyethyl starch (MR 200.000)


HyperHAES, oplossing voor intraveneuze infusie 60 g/l


60,0 g/l


solution for infusion


intravenous use




The Netherlands







B. Braun Melsungen AG (Melsungen)




Carl-Braun-Strasse 1




34212 Melsungen




Germany






active substance: hydroxyethyl starch (MR 130.000) Sodium Chloride, malic acid, Calcium Chloride, Potassium Chloride, Magnesium Chloride, Sodium acetate


Tetraspan 10 % g/v, oplossing voor infusie 100 g/l


100,0 g/l, 9 g/l, 0,67 g/l, 0,37 g/l, 0,3 g/l, 0,2 g/l, 3,27 g/l


solution for infusion


intravenous use




The Netherlands







B. Braun Melsungen AG (Melsungen)




Carl-Braun-Strasse 1




34212 Melsungen




Germany






active substance: hydroxyethyl starch (MR 130.000) Sodium Chloride, malic acid, Calcium Chloride, Potassium Chloride, Magnesium Chloride, Sodium acetate


Tetraspan 6 % g/v, oplossing voor infusie 60 g/l


60,0 g/l, 6,25 g/l, 0,67 g/l, 0,37 g/l, 0,3 g/l, 0,2 g/l, 3,27 g/l


solution for infusion


intravenous use




The Netherlands







B. Braun Melsungen AG (Melsungen)




Carl-Braun-Strasse 1




34212 Melsungen




Germany






active substance: hydroxyethyl starch (MR 130.000), sodium chloride


Venofundin 60 mg/ml, oplossing voor intraveneuze infusie


60,0 g/l, 9 g/l


solution for infusion


intravenous use




The Netherlands







Fresenius Kabi Nederland B.V.




Molenberglei 7




2627 Schelle




Belgium






active substance: hydroxyethyl starch (MR 130.000), Sodium Chloride, Potassium Chloride, Magnesium Chloride, Sodium acetate, hydrochloric acid


Volulyte 6 % oplossing voor infusie


60,0 g/l, 6,02 g/l, 0,3 g/l, 0,3 g/l, 4,63 g/l, 0,3 g/l


solution for infusion


intravenous use




The Netherlands







Fresenius Kabi Nederland B.V.




Molenberglei 7




2627 Schelle




Belgium






active substance: hydroxyethyl starch (MR 130.000), sodium chloride


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


60,0 g/l, 0,9 g/l


solution for infusion


intravenous use




The Netherlands







Fresenius Kabi Nederland B.V.




Molenberglei 7




2627 Schelle




Belgium






active substance: hydroxyethyl starch (polymere 130/0.4) and sodium chloride


Voluven 10 % (100 mg/ml)


100 g/l, 9 g/l


solution for infusion


intravenous use




The Netherlands







Baxter B.V.




Kobaltweg 49




3542 CE UTRECHT/The Netherlands






Sodium chloride, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate, sodium acetate trihydrate, hydroxyethyl starch 130/0.42


Plasma Volume Redibag 6 %, solution for infusion


6 g/l, 0,4 g/l, 0,134 g/l, 0,2 g/l, 3,7 g/l, 60 g/l


solution for infusion


intravenous use




United Kingdom







Baxter Healthcare Limited,




Caxton Way,




Thetford,




Norfolk IP24 3SE




United Kingdom






Sodium chloride, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate, sodium acetate trihydrate, hydroxyethyl starch 130/0.42


Plasma Volume Redibag 6 % Solution for Infusion


6 g/l, 0,4 g/l, 0,134 g/l, 0,2 g/l, 3,7 g/l, 60 g/l


solution for infusion


intravenous use




United Kingdom







Fresenius Kabi Limited




Cestrian Court




Eastgate way




Manor Park




Runcorn, Cheshire




WA7 1NT




United Kingdom






Hydroxyethyl starch 130/0.4, sodium chloride


Voluven 6 % solution for injection


60 g/l, 9 g/l


solution for infusion


intravenous use




United Kingdom







Fresenius Kabi Limited




Cestrian Court




Eastgate way




Manor Park




Runcorn, Cheshire




WA7 1NT




United Kingdom






Hydroxyethyl starch 200/0.5, sodium chloride


Hyperhaes Solution for Injection


72 g/l, 60 g/l


solution for infusion


intravenous use




United Kingdom







Fresenius Kabi Limited




Cestrian Court




Eastgate way




Manor Park




Runcorn, Cheshire




WA7 1NT




United Kingdom






Sodium acetate trihydrate, sodium chloride, potassium chloride, magnesium chloride hexahydrate, hydroxyethyl starch 130/0.4


Volulyte 6 % solution for infusion


4,63 g/l, 6,02 g/l. 0,3 g/l, 0,3 g/l, 60 g/l


solution for infusion


intravenous use




United Kingdom







Fresenius Kabi Limited




Cestrian Court




Eastgate way




Manor Park




Runcorn, Cheshire




WA7 1NT




United Kingdom






Sodium chloride, hydroxyethyl starch 130/0.4


Voluven 6 % solution for infusion


9 g/l, 60 g/l


solution for infusion


intravenous use




United Kingdom







Fresenius Kabi Limited




Cestrian Court




Eastgate way




Manor Park




Runcorn, Cheshire




WA7 1NT




United Kingdom






Sodium chloride, hydroxyethyl starch 130/0.4


Voluven 10 % solution for infusion


9 g/l, 100 g/l


solution for infusion


intravenous use




United Kingdom







B Braun Melsungen AG




Carl-Braun-Strasse 1




Melsungen, D-34212




Germany






Poly (O-2-hydroxyethyl) starch mol. sub. 0,45-0,55 AV. MW 200K, sodium chloride


Venofundin 6 % solution for infusion


60 g/l, 9 g/l


solution for infusion


intravenous use




United Kingdom







B Braun Melsungen AG




Carl-Braun-Strasse 1




Melsungen, D-34212




Germany






Sodium chloride, potassium chloride, magnesium chloride hexahydrate, sodium acetate trihydrate, malic acid, poly (0-2-hydroxyethyl) starch, calcium chloride dihydrate


Tetraspan 6 % solution for infusion


6,25 g/l, 0,3 g/l, 0,2 g/l, 3,27 g/l, 0,67 g/l, 60 g/l, 0/37 g/l


solution for infusion


intravenous use




United Kingdom







B Braun Melsungen AG




Carl-Braun-Strasse 1




Melsungen, D-34212




Germany






Sodium chloride, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate,sodium acetate trihydrate, malic acid, poly (0-2-hydroxyethyl) starch


Tetraspan 10 % solution for infusion


6,25 g/l, 0,3 g/l, 0,37 g/l, 0,2 g/l, 3,27 g/l, 0,67 g/l, 100 g/l


solution for infusion


intravenous use







ANNEX III

LIST OF THE NAMES, PHARMACEUTICAL FORM(S), STRENGTH(S) OF THE MEDICINAL PRODUCT(S), ROUTE(S) OF ADMINISTRATION, MARKETING AUTHORISATION HOLDER(S) IN THE MEMBER STATES











Member State
(in EEA)


Marketing authorisation holder


Product name


Strength


Pharmaceutical form


Route of administration




Austria







Hexal Pharma GmbH




Stella-Klein-Löw-Weg 17




1020 Wien




Austria






Metogastron 10 mg - Ampullen


10 mg/2 ml


Solution for injection


Intramuscular use
Intravenous use




Austria







Hexal Pharma GmbH




Stella-Klein-Löw-Weg 17




1020 Wien




Austria






Metogastron 4 mg/ml - Tropfen


4 mg/ml


Oral drops, solution


Oral use




Austria







Abbott Products GmbH




Perfektastraße 84A




1230 Wien




Austria






Paspertin - Filmtabletten


10 mg


Film-coated tablet


Oral use




Austria







Abbott Products GmbH




Perfektastraße 84A




1230 Wien




Austria






Paspertin 10 mg - Ampullen


10 mg/2 ml


Solution for injection


Intramuscular use
Intravenous use




Austria







Abbott Products GmbH




Perfektastraße 84A




1230 Wien




Austria






Paspertin 50 mg - Konzentrat zur Infusionsbereitung


50 mg/10 ml


Concentrate for solution for infusion


Intravenous use




Austria







Abbott Products GmbH




Perfektastraße 84A




1230 Wien




Austria






Paspertin 4 mg/ml - Tropfen


4 mg/ml


Oral drops, solution


Oral use




Belgium







Sanofi-Aventis Belgium N.V.




Culliganlaan 1 C




1831 Diegem




Belgium






Primperan


10 mg


Tablet


Oral use




Belgium







Sanofi-Aventis Belgium N.V.




Culliganlaan 1 C




1831 Diegem




Belgium






Primperan


1 mg/ml


Oral solution


Oral use




Belgium







Sanofi-Aventis Belgium N.V.




Culliganlaan 1 C




1831 Diegem




Belgium






Primperan


10 mg/2 ml


Solution for injection


Intramuscular use
Intravenous use




Belgium







Sanofi-Aventis Belgium N.V.




Culliganlaan 1 C




1831 Diegem




Belgium






Primperan 20 mg


20 mg


Suppository


Rectal use




Belgium







Takeda Belgium




Gentsesteenweg 615




1080 Brussel




Belgium






Dibertil


5 mg


Capsule, soft


Oral use




Belgium







Takeda Belgium




Gentsesteenweg 615




1080 Brussel




Belgium






Dibertil


10 mg


Capsule, soft


Oral use




Bulgaria







Sopharma PLC




16 Iliensko Shosse Str.




Sofia




1220




Bulgaria






Antiemetin


5 mg/ml


Solution for injection


Intramuscular use
Intravenous use




Bulgaria







Sopharma PLC




16 Iliensko Shosse Str.




Sofia




1220




Bulgaria






Antiemetin


5 mg/ml


Syrup


Oral use




Bulgaria







AWD.pharma GmbH&Co.KG




Wasastrasse 50




Radebeul




01445




Germany






Cerucal


10 mg


Tablet


Oral use




Bulgaria







Lek Pharmaceuticals d.d.




Verovskova 57




Ljubljana




1526




Slovenia






Degan


10 mg/2 ml


Solution for injection


Intramuscular use
Intravenous use




Bulgaria







Lek Pharmaceuticals d.d.




Verovskova 57




Ljubljana




1526




Slovenia






Degan


10 mg


Tablet


Oral use




Bulgaria







CSC Pharmaceuticals Ltd.




10 Assen Yordanov str.




Sofia




1592




Bulgaria






Pramidin 10


10 mg/spray


Nasal spray, solution


Nasal use




Bulgaria







CSC Pharmaceuticals Ltd.




10 Assen Yordanov str.




Sofia




1592




Bulgaria






Pramidin 20


20 mg/spray


Nasal spray, solution


Nasal use




Bulgaria







Alkaloid Ltd




2 Ricardo Vakarini str.




Sofia




1404




Bulgaria






Reglan


10 mg


Tablet


Oral use




Cyprus







Sanofi Aventis Cyprus ltd




Charalambou Mouskou 14




2015 Strovolos Nicosia




Cyprus






Primperan for adults suppository 20 mg


20 mg


Suppository


Rectal use




Cyprus







Sanofi Aventis Cyprus ltd




Charalambou Mouskou 14




2015 Strovolos Nicosia




Cyprus






Primperan solution for injection 10 mg/2 ml


10 mg/2 ml


Solution for injection


Intramuscular use
Intravenous use




Cyprus







Sanofi Aventis Cyprus ltd




Charalambou Mouskou 14




2015 Strovolos Nicosia




Cyprus






Primperan tablets 10 mg


10 mg


Tablet


Oral use




Cyprus







Medochemie ltd




1-10 Constantinoupoleos street




P.O.BOX 51409




3505 Lemesos




Cyprus






Elitan tablets 10 mg


10 mg


Tablet


Oral use




Cyprus







Medochemie ltd




1-10 Constantinoupoleos street




P.O.BOX 51409




3505 Lemesos




Cyprus






Elitan injection 10 mg/2 ml


10 mg/2 ml


Injection


Intramuscular use
Intravenous use




Cyprus







Remedica ltd




Aharnon street




P.O.Box 51706




3508 Lemesos




Cyprus






Cloperan tablets 10 mg


10 mg


Tablet


Oral use




Cyprus







Accord Healthcare Ltd




Sage House




319 Pinner Road




North Harrow




Middlesex HA1 4HF




United Kingdom






Metoclopramide Accord 10 mg tablet


10 mg


Tablet


Oral use




Czech Republic







Lek Pharmaceuticals d.d.




Verovškova 57




1526 Ljubljana




Slovenia






Degan 10 mg tablety


10 mg


Tablet


Oral use




Czech Republic







Lek Pharmaceuticals d.d.




Verovškova 57




1526 Ljubljana




Slovenia






Degan 10 mg roztok pro injekci


5 mg/ml


Solution for injection


Intramuscular use
Intravenous use




Czech Republic







Hexal AG




Industriestrasse 25




83607 Holzkirchen




Germany






Mcp hexal 10


10 mg


Tablet


Oral use




Czech Republic







Teva Pharmaceuticals CR, s.r.o.




Radlická 3185/1c




150 00 Prague




Czech Republic






Cerucal


10 mg


Tablet


Oral use




Czech Republic







Teva Pharmaceuticals CR, s.r.o.




Radlická 3185/1c




150 00 Prague




Czech Republic






Cerucal


5 mg/ml


Solution for injection


Intramuscular use
Intravenous use




Denmark







Sanofi-aventis Denmark A/S




Slotsmarken 13




DK-2970 Hørsholm




Denmark






Primperan


10 mg/2 ml


Solution for injection


Intramuscular use
Intravenous use




Denmark







Sanofi-aventis Denmark A/S




Slotsmarken 13




DK-2970 Hørsholm




Denmark






Primperan


20 mg


Suppository


Rectal use




Denmark







Orion Corporation




Orionintie 1A




FI-02200 Espoo




Finland






Emperal


10 mg


Tablet


Oral use




Denmark







Temmler Pharma GmbH & Co




KG, Temmlerstrasse 2




DE-35039 Marburg




Germany






Gasto-Timelets


30 mg


Prolonged-release capsule, hard


Oral use




Estonia







Teva Pharma B.V.




Computerweg 10




3542 DR Utrecht




The Netherlands






CERUCAL


10 mg


Tablet


Oral use




Finland







sanofi-aventis Oy




Huopalahdentie 24




00350 Helsinki




Finland






Primperan


20 mg


Suppository


Rectal use




Finland







sanofi-aventis Oy




Huopalahdentie 24




00350 Helsinki




Finland






Primperan


10 mg


Tablet


Oral use




Finland







sanofi-aventis Oy




Huopalahdentie 24




00350 Helsinki




Finland






Primperan


5 mg/ml


Solution for injection


Intramuscular use
Intravenous use




France







Sanofi Aventis France




1-13, boulevard Romain Rolland




75014 Paris




France






PRIMPERAN 10 mg, comprimé sécable


10 mg


Tablet


Oral use




France







Sanofi Aventis France




1-13, boulevard Romain Rolland




75014 Paris




France






PRIMPERAN 10 mg, suppositoire sécable


10 mg


Suppository


Rectal use




France







Sanofi Aventis France




1-13, boulevard Romain Rolland




75014 Paris




France






PRIMPERAN 20 mg, suppositoire


20 mg


Suppository


Rectal use




France







Sanofi Aventis France




1-13, boulevard Romain Rolland




75014 Paris




France






PRIMPERAN ENFANTS 2,6 mg/ml, solution buvable


2,6 mg/ml


Oral solution


Oral use




France







Sanofi Aventis France




1-13, boulevard Romain Rolland




75014 Paris




France






PRIMPERAN NOURRISSONS ET ENFANTS 2,6 mg/ml, solution buvable


2,6 mg/ml


Oral drops, solution


Oral use




France







Sanofi Aventis France




1-13, boulevard Romain Rolland




75014 Paris




France






PRIMPERAN 0,1 % ADULTES, solution buvable édulcorée au cyclamate de sodium et à la saccharine sodique


0,10 %


Oral drops, solution


Oral use




France







Sanofi Aventis France




1-13, boulevard Romain Rolland




75014 Paris




France






PRIMPERAN 0,1 %, solution buvable édulcorée à la saccharine sodique


0,10 %


Oral solution


Oral use




France







Sanofi Aventis France




1-13, boulevard Romain Rolland




75014 Paris




France






PRIMPERAN 10 mg/2 ml, solution injectable en ampoule


10 mg/2 ml


Solution for injection


Intramuscular use
Intravenous use




France







Sanofi Aventis France




1-13, boulevard Romain Rolland




75014 Paris




France






PRIMPERAN 100 mg, solution injectable


100 mg/5 ml


Solution for injection


Intramuscular use
Intravenous use




France







Laboratoire Renaudin




Z A. Errobi




Itxassou




64250 Cambo les Bains




France






CHLORHYDRATE DE METOCLOPRAMIDE RENAUDIN 10 mg/2 ml, solution injectable en ampoule


10 mg/2 ml


Solution for injection


Intramuscular use
Intravenous use




France







Laboratoire Renaudin




Z A. Errobi




Itxassou




64250 Cambo les Bains




France






CHLORHYDRATE DE METOCLOPRAMIDE RENAUDIN 20 mg/ml, solution injectable


20 mg/ml


Solution for injection


Intramuscular use
Intravenous use




France







Panpharma




ZI du Clairay Luitré




35133 Fougères




France






DICHLORHYDRATE DE METOCLOPRAMIDE PANPHARMA 100 mg/5 ml, solution injectable (IM, IV) en ampoule


100 mg/100 ml


Solution for injection


Intramuscular use
Intravenous use




France







Laboratoires Richard




rue du Progrès




ZI des Reys de Saulce




26270 Saulce sur Rhone




France






CHLORHYDRATE DE METOCLOPRAMIDE RICHARD 1 mg/ml, solution buvable


1 mg/ml


Oral solution


Oral use




France







Mylan SAS




117, allée des Parcs




69800 Saint-Priest




France






METOCLOPRAMIDE MYLAN 10 mg, comprimé sécable


10 mg


Tablet


Oral use




France







Sandoz




49, avenue Georges Pompidou




92300 Levallois-Perret




France






METOCLOPRAMIDE SANDOZ 10 mg, comprimé sécable


10 mg


Tablet


Oral use




France







Meda Pharma France




25, boulevard de l'Amiral Bruix




75016 Paris




France






ANAUSIN METOCLOPRAMIDE 15 mg, comprimé à libération prolongée


15 mg


Prolonged-release tablet


Oral use




France







Techni-Pharma




7, rue de l'Industrie




BP 717




98014 Monaco Cedex




Monaco






PROKINYL L.P. 15 mg, gélule à libération prolongée


15 mg


Prolonged-release capsule, hard


Oral use




Germany







1 A Pharma GmbH




Keltenring 1 + 3




D-82041 Oberhaching




Germany






MCP Tropfen-1 A-Pharma


4,21 mg/1 g


Oral solution


Oral use




Germany







Abbott Arzneimittel GmbH




Freundallee 9A




30173 Hannover




Germany






Paspertin 10 mg/2 ml Ampullen


10 mg/2 ml


Solution for injection


Intramuscular use
Intravenous use




Germany







Abbott Arzneimittel GmbH




Freundallee 9A




30173 Hannover




Germany






Paspertin 50 mg/10 ml Ampullen


50 mg/10 ml


Concentrate for solution for infusion


Intravenous use




Germany







Abbott Arzneimittel GmbH




Freundallee 9A




30173 Hannover




Germany






Paspertin Filmtabletten


10 mg


Film-coated tablet


Oral use




Germany







Abbott Arzneimittel GmbH




Freundallee 9A




30173 Hannover




Germany






Paspertin Tropfen


4 mg/ml


Oral solution


Oral use




Germany







AbZ-Pharma GmbH




Graf-Arco-Str. 3




89079 Ulm




Germany






MCP AbZ 5 mg/ml Tropfen


5,91 mg/ml


Oral solution


Oral use




Germany







ALIUD PHARMA GmbH




Gottlieb-Daimler-Str. 19




D-89150 Laichingen




Germany






MCP AL 10


10,53 mg


Tablet


Oral use




Germany







ALIUD PHARMA GmbH




Gottlieb-Daimler-Str. 19




D-89150 Laichingen




Germany






MCP AL retard


30 mg


Prolonged-release capsule, hard


Oral use




Germany







ALIUD PHARMA GmbH




Gottlieb-Daimler-Str. 19




D-89150 Laichingen




Germany






MCP AL Tropfen


4,21 mg/1 ml


Oral solution


Oral use




Germany







AWD.pharma GmbH & Co.KG




Wasastr. 50




D-01445 Radebeul




Germany






Cerucal inject


10,54 mg/2 ml


Solution for injection


Intramuscular use
Intravenous use




Germany







AWD.pharma GmbH & Co.KG




Wasastr. 50




D-01445 Radebeul




Germany






Metoclopramid AWD 10 mg Tabletten


10,53 mg


Tablet


Oral use




Germany







axcount Generika AG




Max-Planck-Str. 36b




D-61381 Friedrichsdorf




Germany






MCP axcount Tropfen


4,21 mg/ml


Oral solution


Oral use




Germany







betapharm Arzneimittel GmbH




Kobelweg 95




D-86156 Augsburg




Germany






MCP-beta Tropfen


4,21 mg/ml


Oral solution


Oral use




Germany







CT Arzneimittel GmbH




Graf-Arco-Str. 3




79079 Ulm




Germany






MCP-CT 10 mg/2 ml Ampullen


10 mg/2 ml


Solution for injection


Intramuscular use
Intravenous use




Germany







CT Arzneimittel GmbH




Graf-Arco-Str. 3




79079 Ulm




Germany






MCP-CT 30 mg Retardkapseln


30 mg


Prolonged-release capsule, hard


Oral use




Germany







CT Arzneimittel GmbH




Graf-Arco-Str. 3




79079 Ulm




Germany






MCP-CT 4 mg/1 ml Tropfen


5,2 mg/ml


Oral solution


Oral use




Germany







DOCPHARM Arzneimittelvertrieb GmbH & Co




Greschbachstr. 7




D-76229 Karlsruhe




Germany






Metoclopramid Injektionslösung 10 ml PB


52,65 mg/10 ml


Solution for injection


Intravenous use




Germany







Dolorgiet GmbH & Co.KG




Otto-von-Guericke-Str. 1




D-53757 Sankt Augustin




Germany






Gastronerton


465 mg/100 ml


Oral solution


Oral use




Germany







Dolorgiet GmbH & Co.KG




Otto-von-Guericke-Str. 1




D-53757 Sankt Augustin




Germany






Gastronerton


8,92 mg


Tablet


Oral use




Germany







hameln pharmaceuticals GmbH




Langes Feld 13




D-31789 Hameln




Germany






Metoclo-hameln 5 mg/ml, Injektionslösung


10,53 mg/2 ml


Solution for injection


Intramuscular use
Intravenous use




Germany







Heumann Pharma GmbH & Co. Generica KG




Südwestpark 50




D-90449 Nürnberg




Germany






Gastrosil 10 mg Amp.


10 mg/2 ml


Solution for injection


Intramuscular use
Intravenous use




Germany







Heumann Pharma GmbH & Co. Generica KG




Südwestpark 50




D-90449 Nürnberg




Germany






Gastrosil 20 mg Supp.


20 mg


Suppository


Rectal use




Germany







Heumann Pharma GmbH & Co. Generica KG




Südwestpark 50




D-90449 Nürnberg




Germany






Gastrosil 50 mg Amp.


52,7 mg/10 ml


Solution for injection


Intravenous use




Germany







Heumann Pharma GmbH & Co. Generica KG




Südwestpark 50




D-90449 Nürnberg




Germany






Gastrosil akut Tropfen


5,97 mg/ml


Oral solution


Oral use




Germany







Heumann Pharma GmbH & Co. Generica KG




Südwestpark 50




D-90449 Nürnberg




Germany






Gastrosil retard


31,6 mg


Prolonged-release capsule, hard


Oral use




Germany







Heumann Pharma GmbH & Co. Generica KG




Südwestpark 50




D-90449 Nürnberg




Germany






Gastrosil retard mite


15,8 mg


Prolonged-release capsule, hard


Oral use




Germany







Heumann Pharma GmbH & Co. Generica KG




Südwestpark 50




D-90449 Nürnberg




Germany






Gastrosil Tabletten


10,54 mg


Tablet


Oral use




Germany







Heumann Pharma GmbH & Co. Generica KG




Südwestpark 50




D-90449 Nürnberg




Germany






Gastrsosil Tropfen


5,97 mg/ml


Oral solution


Oral use




Germany







Heumann Pharma GmbH & Co. Generica KG




Südwestpark 50




D-90449 Nürnberg




Germany






MCP Heumann 10 mg Tabletten


10,53 mg


Tablet


Oral use




Germany







HEXAL AG




Industriestr. 25




D-83607 Holzkirchen




Germany






MCP Hexal 10


10,53 mg


Tablet


Oral use




Germany







HEXAL AG




Industriestr. 25




D-83607 Holzkirchen




Germany






MCP Hexal injekt


10,53 mg/2 ml


Solution for injection


Intramuscular use
Intravenous use




Germany







HEXAL AG




Industriestr. 25




D-83607 Holzkirchen




Germany






MCP Hexal Tropfen


4,21 mg/ml


Oral solution


Oral use




Germany







Mylan dura GmbH




Wittichstr. 6




D-64295 Darmstadt




Germany






MCP dura 4 mg/ml Tropfen zum Einnehmen


4,21 mg/ml


Oral solution


Oral use




Germany







ratiopharm GmbH




Graf-Arco-Str. 3




D-89079 Ulm




Germany






MCP-ratiopharm 10 mg Tabletten


11,82 mg


Tablet


Oral use




Germany







ratiopharm GmbH




Graf-Arco-Str. 3




D-89079 Ulm




Germany






MCP-ratiopharm 10 mg Zäpfchen


10 mg


Suppository


Rectal use




Germany







ratiopharm GmbH




Graf-Arco-Str. 3




D-89079 Ulm




Germany






MCP-Ratiopharm 30 mg Retardkapseln


30 mg


Prolonged-release capsule


Oral use




Germany







ratiopharm GmbH




Graf-Arco-Str. 3




D-89079 Ulm




Germany






MCP-ratiopharm 4 mg/ml Tropfen


5,2 mg/ml


Oral solution


Oral use




Germany







ratiopharm GmbH




Graf-Arco-Str. 3




D-89079 Ulm




Germany






MCP-ratiopharm SF 10 mg/2 ml Injektionslösung


10 mg/2 ml


Solution for injection


Intramuscular use
Intravenous use




Germany







ratiopharm GmbH




Graf-Arco-Str. 3




D-89079 Ulm




Germany






MCP-ratiopharm SF 50 mg/10 ml Konzentrat zur Herstellung einer Infusionslösung


50 mg/10 ml


Concentrate for solution for infusion


Intravenous use




Germany







Sandoz Pharmaceuticals GmbH




Raiffeisenstr. 11




D-83607 Holzkirchen




Germany






MCP Sandoz 10 mg Tabletten


10,53 mg


Tablet


Oral use




Germany







Sandoz Pharmaceuticals GmbH




Raiffeisenstr. 11




D-83607 Holzkirchen




Germany






MCP Sandoz 4 mg/ml Tropfen zum Einnehmen, Lösung


4,21 mg/ml


Oral solution


Oral use




Germany







Stadapharm GmbH




Stadastr. 2 - 18




D-61118 Bad Vilbel




Germany






MCP STADA 10 mg Tabletten


10,53 mg


Tablet


Oral use




Germany







Stadapharm GmbH




Stadastr. 2 - 18




D-61118 Bad Vilbel




Germany






MCP STADA 4 mg/1 ml Tropfen zum Einnehmen, Lösung


4,21 mg/ml


Oral solution


Oral use




Germany







Temmler Pharma GmbH & Co.KG




Temmlerstr. 2




D-35039 Marburg




Germany






Cerucal


10,54 mg


Tablet


Oral use




Germany







Temmler Pharma GmbH & Co.KG




Temmlerstr. 2




D-35039 Marburg




Germany






Cerucal retard


30 mg


Prolonged-release capsule, hard


Oral use




Greece







Sanofi Aventis AEBE




348 Syngrou avenue




Building A




176 74 Kalithea – Athens




Greece






PRIMPERAN


10 mg


Suppository


Rectal use




Greece







Sanofi Aventis AEBE




348 Syngrou avenue




Building A




176 74 Kalithea – Athens




Greece






PRIMPERAN


20 mg


Suppository


Rectal use




Greece







Sanofi Aventis AEBE




348 Syngrou avenue




Building A




176 74 Kalithea – Athens




Greece






PRIMPERAN


10 mg/2 ml


Solution for injection


Intramuscular use
Intravenous use




Greece







Sanofi Aventis AEBE




348 Syngrou avenue




Building A




176 74 Kalithea – Athens




Greece






PRIMPERAN


5 mg/5 ml


Syrup


Oral use




Greece







Sanofi Aventis AEBE




348 Syngrou avenue




Building A




176 74 Kalithea – Athens




Greece






PRIMPERAN


10 mg


Tablet


Oral use




Hungary







AWD Pharma GmbH&Co. KG




Wasastrasse 50




Radebeul 1445




Germany






CERUCAL 5 mg/ml oldatos injekció


5 mg/ml


Solution for injection


Parenteral use




Hungary







AWD Pharma GmbH&Co. KG




Wasastrasse 50




Radebeul 1445




Germany






CERUCAL tabletta


10 mg


Tablet


Oral use




Iceland







Nycomed Pharma AS




P.O Box 205




NO-1375, Asker




Norway






Afipran


10 mg


Tablet


Oral use




Iceland







Nycomed Pharma AS




P.O Box 205




NO-1375, Asker




Norway






Afipran


20 mg


Suppository


Rectal use




Iceland







Nycomed Pharma AS




P.O Box 205




NO-1375, Asker




Norway






Afipran


5 mg/ml


Solution for injection


Intramuscular use
Intravenous use




Ireland







Mercury Pharmacuticals (Ireland) Ltd




4045 Kingswood Road




Citywest Business Park




Co. Dublin




Ireland






Metoclopramide


10 mg/2 ml


Solution for injection


Intramuscular use
Intravenous use




Ireland







Amdipharm Limited




Regency House




Miles Gray Road




Basildon




Essex, SS14 3AF




United Kingdom






Maxolon


5 mg/ml


Solution for injection


Intramuscular use
Intravenous use




Ireland







Amdipharm Limited




Regency House




Miles Gray Road




Basildon




Essex, SS14 3AF




United Kingdom






Maxolon


10 mg


Tablet


Oral use




Italy







Sanofi-Aventis spa




Viale Luigi BODIO, 37/B




20158 Milano




Italy






PLASIL


10 mg/2 ml


Solution for injection


Intramuscular use
Intravenous use




Italy







Sanofi-Aventis spa




Viale Luigi BODIO, 37/B




20158 Milano




Italy






PLASIL


1 mg/ml


Syrup


Oral use




Italy







Sanofi-Aventis spa




Viale Luigi BODIO, 37/B




20158 Milano




Italy






PLASIL


4 mg/ml


Oral drops, solution


Oral use




Italy







Sanofi-Aventis spa




Viale Luigi BODIO, 37/B




20158 Milano




Italy






PLASIL


10 mg


Tablet


Oral use




Italy







Teofarma srl




Via Fratelli Cervi, 8




27010 Valle Salimbene Pavia




Italy






RANDUM


10 mg


Tablet


Oral use




Italy







F.I.R.M.A. spa




Via Scandicci, 37




50143 Firenze




Italy






CLOPAN


10 mg


Solution for injection


Intramuscular use
Intravenous use




Italy







Sirton Medicare spa




Piazza XX Settembre, 2




22079 Villa Guardia - COMO




Italy






PRAMIDIN


10 mg/spray


Nasal spray, solution


Nasal use




Italy







Sirton Medicare spa




Piazza XX Settembre, 2




22079 Villa Guardia - COMO




Italy






PRAMIDIN


20 mg/spray


Nasal spray, solution


Nasal use




Italy







Sanofi-Aventis spa




Viale Luigi BODIO, 37/B




20158 Milano




Italy






DIGESTIVO S.PELLEGRINO


5 mg


Effervescent tablet


Oral use




Italy







Sanofi-Aventis spa




Viale Luigi BODIO, 37/B




20158 Milano




Italy






DIGESTIVO S.PELLEGRINO


5 mg


Effervescent granules


Oral use




Italy







Hospira Italia srl




Via Orazio, 20/22




80122 NAPOLI




Italy






METOCLOPRAMIDE CLORIDRATO HOSPIRA


10 mg


Solution for injection


Intramuscular use
Intravenous use




Italy







Farmakopea spa




Via Cavriana, 14




20134 MILANO




Italy






ISAPRANDIL


5 mg


Effervescent tablet


Oral use




Italy







Farmakopea spa




Via Cavriana, 14




20134 MILANO




Italy






ISAPRANDIL


5 mg


Effervescent granules


Oral use




Latvia







Pharmaceutical Works POLPHARMA SA




19 Pelplińska Street




83-200 Starogard Gdański




Poland






Metoclopramid Polpharma 10 mg tablets


10 mg


Tablet


Oral use




Latvia







Pharmaceutical Works POLPHARMA SA




19 Pelplińska Street




83-200 Starogard Gdański




Poland






Metoclopramid Polpharma 10 mg/2 ml solution for injection


10 mg/2 ml


Solution for injection


Intramuscular use
Intravenous use




Latvia







Teva Pharma B.V.




Computerweg 10




3542 DR Utrecht




The Netherlands






Cerucal 10 mg tablets


10 mg


Tablet


Oral use




Lithuania







Teva Pharma B.V.




Computerweg 10




3542 DR Utrecht




The Netherlands






Cerucal


10 mg


Tablet


Oral use




Lithuania







Medochemie Ltd.




p.o box 51409




CY-3505, Limassol




Cyprus






ELITAN


5 mg/ml


Solution for injection


Intramuscular use
Intravenous use




Lithuania







Pharmaceutical Works POLPHARMA SA




19 Pelplińska Street




83-200 Starogard Gdański




Poland






Metoclopramid Polpharma


10 mg


Tablet


Oral use




Lithuania







Pharmaceutical Works POLPHARMA SA




19 Pelplińska Street




83-200 Starogard Gdański




Poland






Metoclopramid Polpharma


10 mg/2 ml


Solution for injection


Intramuscular use
Intravenous use




Luxembourg







Nycomed Belgium s.a.




615, chaussee de Gand




B-1080 Bruxelles




Belgium






Dibertil


10 mg


Capsule, soft


Oral use




Luxembourg







Nycomed Belgium s.a.




615, chaussee de Gand




B-1080 Bruxelles




Belgium






Dibertil


5 mg


Capsule, soft


Oral use




Luxembourg







Dolorgiet Gmbh&Co




Otto-von-Guericke-Str. 1




D-53757 Sankt Augustin




Germany






Gastronerton


4,65 mg/ml


Oral drops


Oral use




Luxembourg







Dolorgiet Gmbh&Co




Otto-von-Guericke-Str. 1




D-53757 Sankt Augustin




Germany






Gastronerton


8,92 mg


Tablet


Oral use




Luxembourg







Ratiopharm GMBH Arzneimittel




Graf-Arco-Str. 3




D-89079 Ulm




Germany






MCP Ratiopharm


5,2 mg


Oral drops


Oral use




Luxembourg







Ratiopharm GMBH Arzneimittel




Graf-Arco-Str. 3




D-89079 Ulm




Germany






MCP Ratiopharm


10 mg


Suppository


Rectal use




Luxembourg







Ratiopharm GMBH Arzneimittel




Graf-Arco-Str. 3




D-89079 Ulm




Germany






MCP Ratiopharm


10 mg


Tablet


Oral use




Luxembourg







Ratiopharm GMBH Arzneimittel




Graf-Arco-Str. 3




D-89079 Ulm




Germany






mcP Ratiopharm SF


10 mg/2 ml


Solution for injection


Intramuscular use
Intravenous use




Luxembourg







Ratiopharm GMBH Arzneimittel




Graf-Arco-Str. 3




D-89079 Ulm




Germany






MCP Ratiopharm-30


30 mg


Modified-release capsule, soft


Oral use




Luxembourg







Eurogenerics s.a.




Heizel Esplanade B22




1020 Laeken




Belgium






Metoclopramide EG-10


10 mg


Capsule, soft


Oral use




Luxembourg







Sanofi-Aventis Belgium




Culliganlaan 1 C




1831 Diegem




Belgium






Primperan adultes


20 mg


Suppository


Rectal use




Luxembourg







Hexal AG




Industriestr. 25




D-83607 Holzkirchen




Germany






MCP Hexal-10


10 mg


Tablet


Oral use




Luxembourg







Hexal AG




Industriestr. 25




D-83607 Holzkirchen




Germany






MCP Hexal Injekt


10 mg/2 ml


Solution for injection


Intramuscular use
Intravenous use




Luxembourg







Hexal AG




Industriestr. 25




D-83607 Holzkirchen




Germany






MCP Hexal Tropfen


4 mg/ml


Oral drops


Oral use




Luxembourg







Sanofi-Aventis Belgium




Culliganlaan 1 C




1831 Diegem




Belgium






Primperan


10 mg


Tablet


Oral use




Luxembourg







Sanofi-Aventis Belgium




Culliganlaan 1 C




1831 Diegem




Belgium






Primperan


10 mg/2 ml


Solution for injection


Intramuscular use
Intravenous use




Luxembourg







Sanofi-Aventis Belgium




Culliganlaan 1 C




1831 Diegem




Belgium






Primperan


1 mg/ml


Oral solution


Oral use




Malta







Accord Healthcare Ltd




Sage House




319 Pinner Road




North Harrow




Middlesex HA1 4HF




United Kingdom






Metoclopramide 10 mg tablets


10 mg


Tablet


Oral use




Malta







Antigen International Limited




Chandler House




Castle Street, Roscrea




County Tipperary




Ireland






Metoclopramide Injection BP 10 mg/2 ml Solution for Injection


10 mg/2 ml


Solution for injection


Intramuscular use
Intravenous use




Malta







Hameln Pharmaceuticals Ltd.




Nexus, Gloucester Business Park




Gloucester GL3 4AG




United Kingdom






Metoclopramide 5 mg/ml Injection


5 mg/ml


Solution for injection


Intramuscular use
Intravenous use




Malta







Medochemie Limited




1-10 Constantinoupleos Str




3011 Limassol




Cyprus






Elitan 10 mg tablet


10 mg


Tablet


Oral use




Malta







Medochemie Ltd.




1-10, Constantinoupleos Street




3011 Limassol




Cyprus






Elitan Injection, 10 mg/2 ml, Solution for Injection


10 mg


Solution for injection


Intramuscular use
Intravenous use




Malta







Remedica Ltd.




Limassol Industrial Estate




Aharnon Street




P.O. Box 51706




3508 Limassol




Cyprus






Cloperan 10


10 mg


Tablet


Oral use




Netherlands







Sanofi-Aventis Netherlands B.V.




Kampenringweg 45 D-E




2803 PE GOUDA




The Netherlands






Primperan injectie 10/2 ml, oplossing voor injection 10 mg/2 ml


10 mg/2 ml


Solution for injection


Intravenous use




Netherlands







Sanofi-Aventis Netherlands B.V.




Kampenringweg 45 D-E




2803 PE GOUDA




The Netherlands






Primperan drank, drank
1 mg/ml


1 mg/ml


Oral solution


Oral use




Netherlands







Sanofi-Aventis Netherlands B.V.




Kampenringweg 45 D-E




2803 PE GOUDA




The Netherlands






Primperan 10, zetpillen 10 mg


10 mg


Suppository


Rectal use




Netherlands







Sanofi-Aventis Netherlands B.V.




Kampenringweg 45 D-E




2803 PE GOUDA




The Netherlands






Primperan 20, zetpillen 20 mg


20 mg


Suppository


Rectal use




Netherlands







Pharmachemie B.V.




Swensweg 5




2031 GA HAARLEM




The Netherlands






Metoclopramide HCl 10 PCH, tabletten 10 mg


10 mg


Tablet


Oral use




Netherlands







Centrafarm B.V.




Nieuwe Donk 3




4879 AC Etten Leur




The Netherlands






Metoclopramide HCl CF 10 mg, tabletten


10 mg


Tablet


Oral use




Netherlands







Accord Healthcare B.V.




De Waterman 15 A




4891 TL Rijsbergen




The Netherlands






Metoclopramidemonohydrochloride Accord 10 mg Tabletten


10 mg


Tablet


Oral use




Norway







Nycomed Pharma AS




Postboks 205




1372 Asker




Norway






Afipran


5 mg/ml


Solution for injection


Intramuscular use
Intravenous use




Norway







Nycomed Pharma AS




Postboks 205




1372 Asker




Norway






Afipran


20 mg


Suppository


Rectal use




Norway







Nycomed Pharma AS




Postboks 205




1372 Asker




Norway






Afipran


100 mg/ml


Concentrate for solution for infusion


Intravenous use




Norway







Nycomed Pharma AS




Postboks 205




1372 Asker




Norway






Afipran


1 mg/ml


Oral solution


Oral use




Norway







Nycomed Pharma AS




Postboks 205




1372 Asker




Norway






Afipran


10 mg


Tablet


Oral use




Poland







Zakłady Farmaceutyczne Polpharma SA




ul. Pelplińska 19




83-200 Starogard Gdański




Poland






Metoclopramidum 0,5 % Polpharma


5 mg/ml


Solution for injection


Intramuscular use
Intravenous use




Poland







Zakłady Farmaceutyczne Polpharma SA




ul. Pelplińska 19




83-200 Starogard Gdański




Poland






Metoclopramidum Polpharma


10 mg


Tablet


Oral use




Portugal







Sanofi - Produtos Farmacêuticos, Lda.




Empreendimento Lagoas Park




Edifício 7 - 3o Piso




2740-244 Porto Salvo




Portugal






Primperan


10 mg/2 ml


Solution for injection


Intramuscular use
Intravenous use




Portugal







Labesfal - Laboratórios Almiro, S.A.




Zona Industrial do Lagedo




3465-157 Santiago de Besteiros




Portugal






Metoclopramida Labesfal


10 mg/2 ml


Solution for injection


Intramuscular use
Intravenous use




Portugal







Labesfal - Laboratórios Almiro, S.A.




Zona Industrial do Lagedo




3465-157 Santiago de Besteiros




Portugal






Metoclopramida Labesfal


10 mg


Tablet


Oral use




Portugal







Sanofi - Produtos Farmacêuticos, Lda.




Empreendimento Lagoas Park




Edifício 7 - 3o Piso




2740-244 Porto Salvo




Portugal






Primperan


1 mg/ml


Oral solution


Oral use




Portugal







Sanofi - Produtos Farmacêuticos, Lda.




Empreendimento Lagoas Park




Edifício 7 - 3o Piso




2740-244 Porto Salvo




Portugal






Primperan


10 mg


Tablet


Oral use




Portugal







Laboratório Medinfar - Produtos Farmacêuticos, S.A.




l Ribeiro de Pavia, 1 - 1o - Venda Nova 2700-547 Amadora




Portugal






Metoclopramida Medinfar


10 mg/2 ml


Solution for injection


Intramuscular use
Intravenous use




Portugal







Laboratório Medinfar - Produtos Farmacêuticos, S.A.




Rua Manuel Ribeiro de Pavia




1 - 1 - Venda Nova




2700-547 Amadora




Portugal






Metoclopramida Medinfar


10 mg


Tablet


Oral use




Portugal







Laboratório Medinfar - Produtos Farmacêuticos, S.A.




Rua Manuel Ribeiro de Pavia




1 - 1 - Venda Nova




2700-547 Amadora




Portugal






Metoclopramida Medinfar


2,6 mg/ml


Oral drops, solution


Oral use




Portugal







Laboratório Medinfar - Produtos Farmacêuticos, S.A.




Rua Manuel Ribeiro de Pavia




1 - 1 - Venda Nova




2700-547 Amadora




Portugal






Metoclopramida Medinfar


1 mg/ml


Oral solution


Oral use




Romania







S.C. LAROPHARM S.R.L.




Șos. Alexandriei, nr 145 A




B07-Bragadiru, jud Ilfov




România






METOCLOPRAMID LAROPHARM


10 mg


Tablet


Oral use




Romania







S.C. SLAVIA PHARM S.R.L.




B-dul Theodor Pallady nr. 44C




Sector 3, București 032266




România






METOCLOPRAMID


10 mg


Tablet


Oral use




Romania







S.C. MEDUMAN S.A.




Str. Aleea Eroilor nr. 28, Vișeu de Sus,




Județul Maramureș 435700




România






N - METOCLOPRAMID


10 mg


Tablet


Oral use




Romania







S.C. ARENA GROUP S.A




Str. Stefan Mihaileanu, nr.31




sector 2; Bucuresti 024022




România






METOCLOPRAMID ARENA 10 mg


10 mg


Tablet


Oral use




Romania







S.C. TERAPIA S.A.




Str. Fabricii nr. 124




Cluj - Napoca 400632




România






METOCLOPRAMID 10 mg


10 mg


Tablet


Oral use




Romania







S.C. BIOFARM S.A.




Str. Logofăt Tăutu, nr. 99




sector 3, București 031212




Romania






METOCLOPRAMID BIOFARM 1 mg/5 ml


1 mg/5 ml


Syrup


Oral use




Romania







S.C. BIOFARM S.A.




Str. Logofăt Tăutu, nr. 99




sector 3, București 031212




Romania






METOCLOPRAMID


7 mg/ml


Oral drops, solution


Oral use




Romania







S.C. TERAPIA S.A.




Str. Fabricii nr. 124




Cluj - Napoca 400632




România






METOCLOPRAMID 10 mg


10 mg/2 ml


Solution for injection


Intramuscular use
Intravenous use




Romania







Accord Healthcar




Ltd Sage House




319 Pinner Road




North Harrow




Middlesex HA1 4HF




United Kingdom






Metoclopramid Accord 10 mg comprimate


10 mg


Tablet


Oral use




Slovak Republic







TEVA Pharmaceuticals Slovakia s.r.o.




Teslova 26




82102 Bratislava




Slovakia






Cerucal


10 mg


Tablet


Oral use




Slovak Republic







AWD. pharma GmbH & Co.KG




Wasastr. 50




01445 Radebeul




Germany






Cerucal


10 mg/2 ml


Solution for injection


Intramuscular use
Intravenous use




Slovak Republic







Sandoz Pharmaceuticals d.d.




Verovškova 57




1000 Ljubljana




Slovenia






DEGAN 10 mg


10 mg


Tablet


Oral use




Slovak Republic







Sandoz Pharmaceuticals d.d.




Verovškova 57




1000 Ljubljana




Slovenia






DEGAN 10 mg/2 ml


10 mg/2 ml


Solution for injection


Intramuscular use
Intravenous use




Slovenia







Alkaloid-INT d.o.o. Ljubljana




Slandrova ulica 4




1231 Ljubljana- Crnuce




Slovenia






Reglan 1 mg/1 ml peroralna raztopina


1 mg/ml


Oral solution


Oral use




Slovenia







Alkaloid-INT d.o.o. Ljubljana




Slandrova ulica 4




1231 Ljubljana- Crnuce




Slovenia






Reglan 10 mg tablete


10 mg


Tablet


Oral use




Spain







Sanofi Aventis, S.A.




Josep Plá, 2




08019 Barcelona




Spain






PRIMPERAN 10 mg/2 ml SOLUCION INYECTABLE


10 mg/2 ml


Solution for injection


Intramuscular use
Intravenous use




Spain







Sanofi Aventis, S.A.




Josep Plá, 2




08019 Barcelona




Spain






PRIMPERAN 1 mg/1 ml SOLUCION ORAL


1 mg/ml


Oral solution


Oral use




Spain







Sanofi Aventis, S.A.




Josep Plá, 2




08019 Barcelona




Spain






PRIMPERAN 10 mg COMPRIMIDOS


10 mg


Tablet


Oral use




Spain







Sanofi Aventis, S.A.




Josep Plá, 2




08019 Barcelona




Spain






PRIMPERAN 260 mg/100 ml GOTAS


2,6 mg/ml


Oral drops, solution


Oral use




Spain







Sanofi Aventis, S.A.




Josep Plá, 2




08019 Barcelona




Spain






PRIMPERAN 100 mg/5 ml SOLUCION INYECTABLE


100 mg/5 ml


Solution for injection


Intramuscular use
Intravenous use




Spain







Kern Pharma, S.L.




Venus, 72.




Poligono Industrial Colon II.




08228 Tarrasa




Spain






METOCLOPRAMIDA KERN PHARMA 1 mg/ml SOLUCION ORAL


1 mg/ml


Oral solution


Oral use




Spain







Pensa Pharma, S.A.U




Jorge Comín (médico pediatra)




3 - 46015 Valencia




Spain






METOCLOPRAMIDA PENSA 1 mg/ml SOLUCION ORAL


1 mg/ml


Oral solution


Oral use




Spain







Accord Healthcare, S.L.U.




Moll de Barcelona s/n




World Trade Centre




Edifici Est 6a planta




08039 Barcelona




Spain






METOCLOPRAMIDA ACCORD 10 mg COMPRIMIDOS


10 mg


Tablet


Oral use




Sweden







sanofi-aventis AB




Box 14142




167 14 Bromma




Sweden






Primperan


10 mg


Tablet


Oral use




Sweden







sanofi-aventis AB




Box 14142




167 14 Bromma




Sweden






Primperan


10 mg/2 ml


Solution for injection


Intramuscular use
Intravenous use




Sweden







sanofi-aventis AB




Box 14142




167 14 Bromma




Sweden






Primperan


20 mg


Suppository


Rectal use




United Kingdom







Actavis UK Limited




Whiddon Valley




Barnstaple




North evon EX32 8NS




United Kingdom






Metoclopramide Tablets BP 10 mg


10 mg


Tablet


Oral use




United Kingdom







Amdipharm plc




Regency House




Miles Gray Road, Basildon




Essex SS14 3AF




United Kingdom






Maxolon SR


15 mg


Modified-release capsules, hard


Oral use




United Kingdom







Amdipharm plc




Regency House




Miles Gray Road, Basildon




Essex SS14 3AF




United Kingdom






Maxolon Tablets 10 mg


10 mg


Tablet


Oral use




United Kingdom







Amdipharm plc




Regency House




Miles Gray Road, Basildon




Essex SS14 3AF




United Kingdom






Maxolon Injection 5 mg/ml


0,5 % w/v


Solution for injection


Intramuscular use
Intravenous use




United Kingdom







Amdipharm plc




Regency House




Miles Gray Road, Basildon




Essex SS14 3AF




United Kingdom






Maxolon High Dose 100 mg/20 ml


0,5 % w/v


Solution for injection


Intravenous use




United Kingdom







Chelonia Healthcare Limited




Boumpoulinas 11, 3rd Floor




Nicosia, CY-1060




Cyprus






Metoclopramide 10 mg Tablets


10 mg


Tablet


Oral use




United Kingdom







Crescent Pharma Limited




Units 3 & 4




Quidhampton Business Units




Polhampton Lane, Overton




Hampshire RG25 3ED




United Kingdom






Metoclopramide 10 mg Tablets


10 mg


Tablet


Oral use




United Kingdom







Ennogen Limited




78 York Street




London W1H 1DP




United Kingdom






Metoclopramide 10 mg Tablets


10 mg


Tablet


Oral use




United Kingdom







Ennogen Limited




78 York Street




London W1H 1DP




United Kingdom






Metoclopramide 5 mg/ml Injection


0,5 % w/v


Solution for injection


Intramuscular use
Intravenous use




United Kingdom







Generics (United Kingdom) Limited




Station Close, Potters Bar




Hertfordshire EN6 1TL




United Kingdom






Metoclopramide Tablets 10 mg


10 mg


Tablet


Oral use




United Kingdom







Hameln Pharmaceuticals Limited




Nexus, Gloucester Business Park




Gloucester GL3 4AG




United Kingdom






Metoclopramide Injection BP 5 mg/ml


0,526 % w/v


Solution for injection


Intramuscular use
Intravenous use




United Kingdom







Metwest Pharmaceuticals Limited




15 Runnelfield




Harrow on the Hill




Middlesex HA1 3NY




United Kingdom






Metoclopramide 10 mg Tablets


10 mg


Tablet


Oral use




United Kingdom







Pharmvit Limited




177 Bilton Road, Perivale




Middlesex UB6 7HQ




United Kingdom






Metoclopramide Tablets BP 10 mg


10 mg


Tablet


Oral use




United Kingdom







Rosemont Pharmaceuticals Limited




Rosemont House




Yorkdale Industrial Park




Braithwaite Street




Leeds, W Yorkshire LS11 9XE




United Kingdom






Metoclopramide Hydrochloride 5 mg/5 ml Oral Solution


5 mg/5 ml


Oral solution


Oral use




United Kingdom







Rosemont Pharmaceuticals Limited




Rosemont House




Yorkdale Industrial Park




Braithwaite Street




Leeds, W Yorkshire LS11 9XE




United Kingdom






Maxolon Paediatric Liquid


5 mg/5 ml


Oral solution


Oral use




United Kingdom







Teva United Kingdom Limted




Brampton Road




Hampden Park, Eastbourne




East Sussex BN22 9AG




United Kingdom






Primperan; Metoclopramide Tablets BP 10 mg


10 mg


Tablet


Oral use




United Kingdom







Accord Healthcare Ltd




Sage House




319 Pinner Road




North Harrow




Middlesex HA1 4HF




United Kingdom






Metoclopramide Hydrochloride 10 mg tablets


10 mg


Tablet


Oral use




United Kingdom







Mercury Pharma International Limited




4045 Kingswood Raod




City West Business Park




County Dublin




Ireland






Metoclopramide 5 mg/ml solution for injection


5 mg/ml


Solution for injection


Intramuscular use
Intravenous use







ANNEX IV

LIST OF THE NAMES, PHARMACEUTICAL FORM(S), STRENGTH(S) OF THE MEDICINAL PRODUCT(S), ROUTE(S) OF ADMINISTRATION, MARKETING AUTHORISATION HOLDER(S) IN THE MEMBER STATES











Member State
(in EEA)


Marketing Authorisaton Holder


(Invented) Name


Strength


Pharmaceutical form


Route of administration




Austria







Defiante Farmaceutica S.A.,




Rua dos Ferreiros 260,




9000-082 Funchal/Madeira,




Portugal






Hydergin Fas 4,5 mg Filmtabletten


4,5 mg (1:1:1)


film-coated tablet


oral use




Austria







Defiante Farmaceutica S.A.,




Rua dos Ferreiros 260,




9000-082 Funchal/Madeira,




Portugal






Hydergin 1 mg/ml Tropfen


1 mg/ml (1:1:1)


oral drops, solution


oral use




Austria







Defiante Farmaceutica S.A.,




Rua dos Ferreiros 260,




9000-082 Funchal/Madeira,




Portugal






Hydergin 3 mg/ml Tropfen


3 mg/ml (1:1:1)


oral drops, solution


oral use




Austria







Defiante Farmaceutica S.A.,




Rua dos Ferreiros 260,




9000-082 Funchal/Madeira,




Portugal






Hydergin 1 mg Tabletten


1 mg (1:1:1)


tablet


oral use




Austria







Defiante Farmaceutica S.A.,




Rua dos Ferreiros 260,




9000-082 Funchal/Madeira,




Portugal






Hydergin 2 mg Tabletten


2 mg (1:1:1)


tablet


oral use




Austria







Defiante Farmaceutica S.A.,




Rua dos Ferreiros 260,




9000-082 Funchal/Madeira,




Portugal






Hydergin SRO 6 mg Kapseln


6 mg (1:1:1)


modified-release capsule, hard


oral use




Belgium







Defiante Farmacêutica S.A.,




Rua dos Ferreiros 260,




9000-082 Funchal,




Portugal






Hydergine


1 mg-ml


oral solution


oral use




Belgium







Defiante Farmacêutica S.A.,




Rua dos Ferreiros 260,




9000-082 Funchal,




Portugal






Hydergine


1,5 mg


Tablets


oral use




Belgium







Defiante Farmacêutica S.A.,




Rua dos Ferreiros 260,




9000-082 Funchal,




Portugal






Hydergine


4,5 mg


Tablets


oral use




Belgium







Defiante Farmacêutica S.A.,




Rua dos Ferreiros 260,




9000-082 Funchal,




Portugal






Hydergine FAS


4,5 mg


Gastro-resistant tablet


oral use




Belgium







Nycomed Belgium N.V.




Gentsesteenweg 615




1080 Brussels




Belgium






Ibexone


1,5 mg


Tablets


oral use




Belgium







Nycomed Belgium N.V.




Gentsesteenweg 615




1080 Brussels




Belgium






Ibexone


1 mg-ml


oral solution


oral use




Belgium







Nycomed Belgium N.V.




Gentsesteenweg 615




1080 Brussels




Belgium






Ibexone


3 mg-ml


oral solution


oral use




Belgium







Nycomed Belgium N.V.




Gentsesteenweg 615




1080 Brussels




Belgium






Ibexone


4,5 mg


Tablets


oral use




Belgium







Nycomed Belgium N.V.




Gentsesteenweg 615




1080 Brussels




Belgium






STOFILAN


1,5 mg


Tablets


oral use




Belgium







Nycomed Belgium N.V.




Gentsesteenweg 615




1080 Brussels




Belgium






STOFILAN


1 mg-ml


oral drops solution


oral use




Belgium







Nycomed Belgium N.V.




Gentsesteenweg 615




1080 Brussels




Belgium






STOFILAN FORTE


4,5 mg


Tablets


oral use




Czech Republic







TEVA Czech Industries s.r.o.




Ostravská 29




747 70 Opava-Komárov




Czech Republic






SECATOXIN FORTE


2,5 MG/ML


Oral drops, solution


oral use




Finland







Defiante Farmacêutica, S.A.




Rua dos Ferreiros, 260




9000-082 Funchal




Portugal






Hydergin


1,5 mg


Tablets


oral use




Finland







Defiante Farmacêutica, S.A.




Rua dos Ferreiros, 260




9000-082 Funchal




Portugal






Hydergin


1 mg


Tablets


oral use




France







THERICA




15, avenue Henry Dunant




27400 Louviers




France






CAPERGYL 4,5 mg DOSE QUOTIDIENNE UNIQUE, capsule


4,5 mg


soft capsule


oral use




France







DEFIANTE FARMACEUTICA SA (PORTUGAL)




Rua dos Ferreiros, 260




9000-082 Funchal




Portugal






HYDERGINE 1 mg/ml, solution buvable en gouttes


1 mg/ml


oral drops, solution


oral use




France







DEFIANTE FARMACEUTICA SA (PORTUGAL)




Rua dos Ferreiros, 260




9000-082 Funchal




Portugal






HYDERGINE 4,5 mg DOSE QUOTIDIENNE UNIQUE, comprimé


4,5 mg


tablet


oral use




Germany







Defiante Farmacêutica, S.A.




Rua dos Ferreiros, 260




9000-082 Funchal




Portugal






Hydergin


2 mg


Tablets


oral use




Germany







Defiante Farmacêutica, S.A.




Rua dos Ferreiros, 260




9000-082 Funchal




Portugal






Hydergin


1 mg/ml


Oral drops


oral use




Germany







Defiante Farmacêutica, S.A.




Rua dos Ferreiros, 260




9000-082 Funchal




Portugal






Hydergin


2 mg/ml


Oral drops


oral use




Greece







Defiante Farmacêutica, S.A.




Rua dos Ferreiros, 260




9000-082 Funchal




Portugal






Hydergine


1 mg/ml


Oral drops


oral use




Italy







Defiante Farmaceutica sa




Rua dos Ferreiros, 260




Funchal Madeira -




Portugal






HYDERGINA


1,5 mg


tablet


oral use




Italy







Defiante Farmaceutica sa




Rua dos Ferreiros, 260




Funchal Madeira -




Portugal






HYDERGINA


1 mg/ml


oral solution


oral use




Luxembourg







Defiante Farmacêutica, S.A.




Rua dos Ferreiros, 260




9000-082 Funchal




Portugal






Hydergin


1 mg/ml


Oral drops


oral use




Luxembourg







Defiante Farmacêutica, S.A.




Rua dos Ferreiros, 260




9000-082 Funchal




Portugal






Hydergin


2 mg/ml


Oral drops


oral use




Poland







Farmaceutyczna




Spółdzielnia Pracy




FILOFARM




ul. Pułaskiego 39




85-619 Bydgoszcz




Poland






Dihydroergotoxinum Filofarm


1 mg/ml


oral solution


oral use




Portugal







Defiante Farmacêutica, S.A. PRT




Rua dos Ferreiros, 260




9000-082 Funchal - Madeira




Portugal






Hydergine


1,5 mg


tablet


oral use




Portugal







Defiante Farmacêutica, S.A. PRT




Rua dos Ferreiros, 260




9000-082 Funchal - Madeira




Portugal






Hydergine


4,5 mg


tablet


oral use




Portugal







Defiante Farmacêutica, S.A. PRT




Rua dos Ferreiros, 260




9000-082 Funchal - Madeira




Portugal






Hydergine


1 mg/ml


Oral drops, solution


oral use




Portugal







Defiante Farmacêutica, S.A. PRT




Rua dos Ferreiros, 260




9000-082 Funchal - Madeira




Portugal






Hydergine


3 mg/ml


Oral drops, solution


oral use




Romania







LEK PHARMACEUTICALS d.d.




Verovskova 57,




1526 Ljubljana,




Slovenia






REDERGIN


1 mg/ml


Oral drops, solution


oral use




Slovak Republic







Teva Czech Industries s.r.o.




Ostravská 29,




č. p. 305 747 70 Opava- Komárov




Czech republic






SECATOXIN FORTE


2,5 mg / 1 ml


Oral drops, solution


oral use




Slovenia







LEK farmacevtska družba d.d.,




Verovskova 57,




SI-1526 Ljubljana,




Slovenia






Redergin 1,5 mg tablete


1,5 mg


tablet


oral use




Slovenia







LEK farmacevtska družba d.d.,




Verovskova 57,




SI-1526 Ljubljana,




Slovenia






Redergin 4,5 mg tablete


4,5 mg


tablet


oral use




Slovenia







LEK farmacevtska družba d.d.,




Verovskova 57,




SI-1526 Ljubljana,




Slovenia






Redergin 1 mg/ ml peroralna raztopina


1 mg/ml


oral solution


oral use




Spain







DEFIANTE FARMACEUTICA, S.A.




Rua dos Ferreiros, 260




9000-082 Funchal




PORTUGAL






HYDERGINA SOLUCIÓN GOTAS


1 mg/ml


oral drops, solution


oral use




Spain







DEFIANTE FARMACEUTICA, S.A.




Rua dos Ferreiros, 260




9000-082 Funchal




PORTUGAL






HYDERGINA 4,5 mg COMPRIMIDOS


4,5 mg


tablet


oral use




Sweden







Defiante Farmacêutica, S.A.




Rua dos Ferreiros, 260




9000-082 Funchal




Portugal






Hydergin


1 mg


Tablets


oral use