31.1.2014

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

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

		ISSN 1977-091X doi:10.3000/1977091X.C_2014.029.eng
Official Journal of the European Union		C 29

English edition	Information and Notices	Volume 57 31 January 2014

Notice No	Contents	page
	IV Notices
	NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES
	European Commission
2014/C 029/01	Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 December 2013 to 31 December 2013(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)	1

2014/C 029/02	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)	13