EUR-Lex Access to European Union law
This document is an excerpt from the EUR-Lex website
Document 52014XC0131(05)
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)
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)
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)
OJ C 29, 31.1.2014, p. 13–85
(BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
31.1.2014 |
EN |
Official Journal of the European Union |
C 29/13 |
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 December 2013 to 31 December 2013
(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2) )
2014/C 29/02
— Issuing, maintenance or modification of a national marketing authorization
Date of the decision |
Name(s) of the medicinal product |
Holder(s) of the marketing authorization |
Member State concerned |
Date of notification |
20.12.2013 |
Nicardipine |
See Annex I |
See Annex I |
6.1.2014 |
19.12.2013 |
Hydroxyethyl starch |
See Annex II |
See Annex II |
20.12.2013 |
20.12.2013 |
Metoclopramide only containing products |
See Annex III |
See Annex III |
6.1.2014 |
18.12.2013 |
Ergot derivatives - (dihydroergotoxine) |
See Annex IV |
See Annex IV |
20.12.2013 |
— Suspension of a national marketing authorization
Date of the decision |
Name(s) of the medicinal product |
Holder(s) of the marketing authorization |
Member State concerned |
Date of notification |
18.12.2013 |
Ergot derivatives - (dihydroergotoxine) |
See Annex IV |
See Annex IV |
20.12.2013 |
(1) OJ L 311, 28.11.2001, p. 67.
(2) OJ L 311, 28.11.2001, p. 1.
ANNEX I
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Member State (in EEA) |
Applicant |
Marketing authorisation holder |
INN |
Product name |
Strength |
Pharmaceutical form |
Route of administration |
||||||
Belgium |
|
|
Nicardipine hydrochloride |
Rydene |
1 mg/ml |
Solution for injection |
Intravenous use |
||||||
Belgium |
|
|
Nicardipine hydrochloride |
Nicardipine Aguettant |
10 mg/10 ml |
Solution for injection |
Intravenous use |
||||||
France |
|
|
nicardipine (chlorhydrate de) |
LOXEN 10 mg/10 ml, solution injectable (I.V.) |
10 mg/10 ml |
Solution for injection |
Intravenous use |
||||||
France |
|
|
nicardipine (chlorhydrate de) |
NICARDIPINE AGUETTANT 10 mg/10 ml, solution injectable |
10 mg/10 ml |
Solution for injection |
Intravenous use |
||||||
France |
|
|
nicardipine (chlorhydrate de) |
NICARDIPINE ARROW 10 mg/10 ml, solution injectable |
10 mg/10 ml |
Solution for injection |
Intravenous use |
||||||
Luxembourg |
|
|
Nicardipine |
Rydene |
1 mg/ml (5 ml) |
Solution for injection |
Intravenous use |
||||||
Spain |
|
|
Nicardipine hydrochloride |
VASONASE 1 mg/ml solución para perfusión |
1 mg/ml |
Solution for infusion |
Intravenous use |
||||||
The Netherlands |
|
|
nicardipine |
Cardene IV |
5 mg/5 ml |
Concentrate for solution for infusion |
Intravenous use |
||||||
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 |
|
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 |
|
Hydroxyethyl Starch, Sodium Chloride |
HyperHAES 6 % in 7,2 % NaCl – Infusionsloesung |
60 g/l, 72 g/l |
solution for infusion |
intravenous use |
||||||||
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 |
|
Hydroxyethyl Starch, Sodium Chloride |
Refortan 6 % Infusionsflasche |
60 g/l, 9 g/l |
solution for infusion |
intravenous use |
||||||||
Austria |
|
Hydroxyethyl Starch, Sodium Chloride |
Refortan plus 10 % Infusionsflasche |
100 g/l, 9 g/l |
solution for infusion |
intravenous use |
||||||||
Austria |
|
Hydroxyethyl Starch, Sodium Chloride |
Stabisol 6 % Infusionsflasche |
60 g/l, 9 g/l |
solution for infusion |
intravenous use |
||||||||
Austria |
|
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 |
|
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 |
|
Hydroxyethyl Starch, Sodium Chloride |
VENOFUNDIN 60 mg/ml Infusionsloesung |
60 g/l, 9 g/l |
solution for infusion |
intravenous use |
||||||||
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 |
|
Hydroxyethyl Starch, Sodium Chloride |
Voluven (HES 130/0,4) 6 % - Infusionsloesung |
60 g/l, 9 g/l |
solution for infusion |
intravenous use |
||||||||
Belgium |
|
Hydroxyethyl starch |
Haes-Steril 10 % |
100 mg/ml |
solution for infusion |
intravenous use |
||||||||
Belgium |
|
Hydroxyethyl starch |
Haes-Steril 6 % |
60 mg/ml |
solution for infusion |
intravenous use |
||||||||
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 |
|
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 |
|
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 |
|
Sodium Chlorid, Hydroxyethyl starch |
Venohes 6 % |
9 mg/ml, 60 mg/ml |
solution for infusion |
intravenous use |
||||||||
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 |
|
Sodium Chlorid, Hydroxyethyl starch |
Voluven 10 % |
9 mg/ml, 100 mg/ml |
solution for infusion |
intravenous use |
||||||||
Belgium |
|
Sodium Chlorid, Hydroxyethyl starch |
Voluven 6 % |
9 mg/ml, 60 mg/ml |
solution for infusion |
intravenous use |
||||||||
Bulgaria |
|
Poly(O-2-Hydroxyethyl) starch, Sodium chloride |
Hemohes 6 % |
60 g/l, 9 g/l |
solution for infusion |
intravenous use |
||||||||
Bulgaria |
|
Poly(O-2-Hydroxyethyl) starch, Sodium chloride |
Voluven 6 % |
60 g/l, 9 g/l |
solution for infusion |
intravenous use |
||||||||
Bulgaria |
|
Poly(O-2-Hydroxyethyl) starch, Sodium chloride |
Voluven 10 % |
100 g/l, 9 g/l |
solution for infusion |
intravenous use |
||||||||
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
Hydroxyethyl starch, Sodium chloride |
VOLUVEN 6 % SOLUTION FOR INFUSION |
60,0 g/l, 9,0 g/l |
solution for infusion |
intravenous use |
||||||||
Cyprus |
|
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 |
|
Hydroxyethyl starch + Sodium chloride |
VOLUVEN SOLUTION FOR INFUSION 10 % |
100 g/l, 9 g/l |
solution for infusion |
intravenous use |
||||||||
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 |
|
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 |
|
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 |
|
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 |
|
Hetastarch, Sodium Chloride |
VOLUVEN 10 % |
100 g/l, 9 g/l |
solution for infusion |
intravenous use |
||||||||
Czech Republic |
|
Hetastarch, Sodium Chloride |
HYPERHAES |
60 g/l, 72 g/l |
solution for infusion |
intravenous use |
||||||||
Czech Republic |
|
Hetastarch, Sodium Chloride |
VOLUVEN |
60 g/l, 9 g/l |
solution for infusion |
intravenous use |
||||||||
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 |
|
Hydroxyethyl starch (HES), sodiumchloride, water |
HyperHAES |
60 g/l, 72 g/l, water ad 1 000 ml |
solution for infusion |
intravenous use |
||||||||
Denmark |
|
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 |
|
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 |
|
Hydroxyethyl starch (HES), sodium chloride, water |
Venofundin |
60 g/l, 9 g/l, water ad 1 000 ml |
solution for infusion |
intravenous use |
||||||||
Denmark |
|
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 |
|
Hydroxyethyl starch (HES), Sodium Chloride, water |
Voluven |
60 g/l, 9 g/l, water ad 1 000 ml |
solution for infusion |
intravenous use |
||||||||
Denmark |
|
Hydroxyethyl starch (HES), Sodium Chloride, water |
Voluven |
100 g/l, 9 g/l, water ad 1 000 ml |
solution for infusion |
intravenous use |
||||||||
Estonia |
|
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 |
|
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 |
|
Hydroxyethyl starch, Sodium chloride |
VOLUVEN |
60 g/l, 9 g/l |
solution for infusion |
intravenous use |
||||||||
Estonia |
|
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 |
|
Hydroxyethyl starch, Sodium chloride |
VOLUFORTE |
100 g/l, 9 g/l |
solution for infusion |
intravenous use |
||||||||
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 |
|
Poly(o-2-hydroxyethyl) Starch, Sodium Chloride |
HYPERHAES |
60,0 g/l, 72 g/l |
solution for infusion |
intravenous use |
||||||||
Finland |
|
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 |
|
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 |
|
Poly(o-2-hydroxyethyl) Starch, Sodium Chloride |
VENOFUNDIN |
60,0 g/l, 9 g/l |
solution for infusion |
intravenous use |
||||||||
Finland |
|
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 |
|
Poly(o-2-hydroxyethyl) Starch, Sodium Chloride |
VOLUVEN |
60 g/l, 9,0 g/l |
solution for infusion |
intravenous use |
||||||||
Finland |
|
Hydroxyethyl Starch, Sodium Chloride |
VOLUVEN |
100 g/l, 9,0 g/l |
solution for infusion |
intravenous use |
||||||||
France |
|
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 |
|
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 |
|
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 |
|
hydroxyethyl starch 130 000 sodium chloride |
RESTORVOL 6 %, solution pour perfusion |
60 g / l 9 g / l |
solution for infusion |
intravenous use |
||||||||
France |
|
hydroxyethyl starch 130 000 sodium chloride |
VOLUVEN, solution pour perfusion |
60 g / l 9 g / l |
solution for infusion |
intravenous use |
||||||||
France |
|
hydroxyethyl starch 200 000 |
ELOHES 6 %, solution pour perfusion en poche |
6 g / 100 ml |
solution for infusion |
intravenous use |
||||||||
France |
|
hydroxyethyl starch 200 000 |
ELOHES 6 %, solution injectable pour perfusion en flacon |
6 g / 100 ml |
solution for infusion |
intravenous use |
||||||||
France |
|
hydroxyethyl starch 200 000 |
PLASMOHES 6 %, solution pour perfusion |
6 g / 100 ml |
solution for infusion |
intravenous use |
||||||||
France |
|
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 |
|
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 |
|
hydroxyethyl starch 200 000 sodium chloride |
HYPERHES, solution pour perfusion |
60 g / l 72 g / l |
solution for infusion |
intravenous use |
||||||||
France |
|
hydroxyethyl starch 240 000 |
HESTERIL 10 %, solution pour perfusion |
10 g / 100 ml |
solution for infusion |
intravenous use |
||||||||
France |
|
hydroxyethyl starch 240 000 |
HESTERIL 6 %, solution pour perfusion |
6 g / 100 ml |
solution for infusion |
intravenous use |
||||||||
France |
|
hydroxyethyl starch 250 000 |
LOMOL, solution injectable pour perfusion en poche |
10 g / 100 ml |
solution for infusion |
intravenous use |
||||||||
Germany |
|
Hydroxyethyl starch Sodium Chloride |
Hemohes 6 % |
60 g/l, 9 g/l |
solution for infusion |
intravenous use |
||||||||
Germany |
|
Hydroxyethyl starch Sodium Chloride |
Hemohes 10 % |
100 g/l, 9 g/l |
solution for infusion |
intravenous use |
||||||||
Germany |
|
Hydroxyethyl starch Sodium Chloride |
VENOFUNDIN 60 mg/ml Infusionslösung |
60 g/l, 9 g/l |
solution for infusion |
intravenous use |
||||||||
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 |
|
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 |
|
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 |
|
Sodium Chloride, Hydroxyethyl starch |
Refortan 6 % |
9 g/l, 60 g/l |
solution for infusion |
intravenous use |
||||||||
Germany |
|
Sodium Chloride, Hydroxyethyl starch |
Refortan 10 % |
9 g/l, 100 g/l |
solution for infusion |
intravenous use |
||||||||
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 |
|
Sodium Chloride, Hydroxyethyl starch |
Voluven 6 % Infusionslösung |
9 g/l, 60 g/l |
solution for infusion |
intravenous use |
||||||||
Germany |
|
Sodium Chloride, Hydroxyethyl starch |
Voluven 10 % Infusionslösung |
9 g/l, 100 g/l |
solution for infusion |
intravenous use |
||||||||
Germany |
|
Sodium Chloride, Hydroxyethyl starch |
Elohäst 6 % |
9 g/l, 60 g/l |
solution for infusion |
intravenous use |
||||||||
Germany |
|
Sodium Chloride, Hydroxyethyl starch |
HyperHAES Infusionslösung |
72 g/l, 60 g/l |
solution for infusion |
intravenous use |
||||||||
Germany |
|
Sodium Chloride, Hydroxyethyl starch |
HAES-steril 3 % |
9 g/l, 30 g/l |
solution for infusion |
intravenous use |
||||||||
Germany |
|
Sodium Chloride, Hydroxyethyl starch |
Voluven Fresenius 6 % Infusionslösung |
9 g/l, 60 g/l |
solution for infusion |
intravenous use |
||||||||
Germany |
|
Sodium Chloride, Hydroxyethyl starch |
Haes-steril 10 % |
9 g/l, 100 g/l |
solution for infusion |
intravenous use |
||||||||
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 |
|
Hydroxyethyl starch, Sodium Chloride |
Haes-steril 6 % |
60 g/l, 9 g/l |
solution for infusion |
intravenous use |
||||||||
Germany |
|
Hydroxyethyl starch, Sodium Chloride |
Voluven 6 % Infusionslösung |
60 g/l, 9 g/l |
solution for infusion |
intravenous use |
||||||||
Germany |
|
Hydroxyethyl starch, Sodium Chloride |
Voluven 10 % Infusionslösung |
100 g/l, 9 g/l |
solution for infusion |
intravenous use |
||||||||
Germany |
|
Hydroxyethyl starch, Sodium Chloride |
HyperHAES Infusionslösung |
60 g/l, 72 g/l |
solution for infusion |
intravenous use |
||||||||
Germany |
|
Hydroxyethyl starch, Sodium Chloride |
Infukoll HES 6 % |
60 g/l, 9 g/l |
solution for infusion |
intravenous use |
||||||||
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 |
|
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 |
|
Hydroxyethyl starch, Sodium Chloride |
Infukoll HES 10 % |
100 g/l, 9 g/l |
solution for infusion |
intravenous use |
||||||||
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 |
|
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 |
|
Hydroxyethyl starch, Sodium Chloride |
VitaHES Infusionslösung |
60 g/l, 9 g/l |
solution for infusion |
intravenous use |
||||||||
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 |
|
Hydroxyethyl Starch + Sodium Chloride |
VOLUVEN |
60 g/l + 9 g/l |
solution for infusion |
intravenous use |
||||||||
Greece |
|
Hydroxyethyl Starch + Sodium Chloride |
VOLUVEN |
100 g/l + 9 g/l |
solution for infusion |
intravenous use |
||||||||
Greece |
|
Hydroxyethyl Starch + Sodium Chloride |
VENOFUNDIN |
60 g/l + 9 g/l |
solution for infusion |
intravenous use |
||||||||
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 |
|
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 |
|
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 |
|
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 |
|
Hydroxyethyl starch, Sodium chloride |
VOLUVEN 10 % oldatos infúzió |
100 g/l, 9,0 g/l |
solution for infusion |
intravenous use |
||||||||
Hungary |
|
Hydroxyethyl starch, Sodium chloride |
VOLUVEN 6 % oldatos infúzió |
60,0 g/l, 9,0 g/l |
solution for infusion |
intravenous use |
||||||||
Hungary |
|
Hydroxyethyl starch, Sodium chloride |
HAES-STERIL 10 % oldatos infúzió |
100 g/l, 9 g/l |
solution for infusion |
intravenous use |
||||||||
Hungary |
|
Hydroxyethyl starch, Sodium chloride |
HYPERHAES oldatos infúzió |
101 g/l, 9 g/l |
solution for infusion |
intravenous use |
||||||||
Hungary |
|
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 |
|
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 |
|
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 |
|
Hydroxyethy starch, Sodium chloride |
HyperHAES |
60 g/l, 72 g/l |
solution for infusion |
intravenous use |
||||||||
Iceland |
|
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 |
|
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 |
|
Hydroxyethyl starch, sodium chloride |
Voluven |
60 g/l, 9,0 g/l |
solution for infusion |
intravenous use |
||||||||
Ireland |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
poly (0-2-hydroxyethyl)starch sodium chloride |
HyperHAES |
60 g/l, 72 g/l |
solution for infusion |
intravenous use |
||||||||
Ireland |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
Hydroxyethyl starch, Sodium Chloride |
Vonten |
100 g/l, 9 g/l |
solution for infusion |
intravenous use |
||||||||
Italy |
|
Hydroxyethyl starch, Sodium Chloride |
HyperHAES |
60 g/l, 72 g/l |
solution for infusion |
intravenous use |
||||||||
Italy |
|
Hydroxyethyl starch, Sodium Chloride |
Voluven |
60 g/l, 9 g/l |
solution for infusion |
intravenous use |
||||||||
Italy |
|
Hydroxyethyl starch, Sodium Chloride |
Amidolite |
60 g/l, 9 g/l |
solution for infusion |
intravenous use |
||||||||
Italy |
|
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 |
|
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 |
|
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 |
|
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 |
|
Hydroxyethyl starch, Sodium Chloride |
HAES-STERIL |
60 g/l, 9 g/l |
solution for infusion |
intravenous use |
||||||||
Italy |
|
Hydroxyethyl starch, Sodium Chloride |
HAES-STERIL |
100 g/l, 9 g/l |
solution for infusion |
intravenous use |
||||||||
Latvia |
|
Poly(O-2-hydroxyethyl)starch, Sodium chloride |
Voluven 6 % solution for infusion |
60 g, 9 g |
solution for infusion |
intravenous use |
||||||||
Latvia |
|
Poly(O-2-hydroxyethyl)starch, Sodium chloride |
Voluforte solution for infusion |
100 g, 9 g |
solution for infusion |
intravenous use |
||||||||
Latvia |
|
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 |
|
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 |
|
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 |
|
Hydroxyethyl starch |
Refortan |
60 g/l |
solution for infusion |
intravenous use |
||||||||
Lithuania |
|
Hydroxyethyl starch |
Refortan Plus |
100 g/l |
solution for infusion |
intravenous use |
||||||||
Lithuania |
|
Hydroxyethyl starch |
Stabisol |
60 g/l |
solution for infusion |
intravenous use |
||||||||
Lithuania |
|
Poli(O-2-hydroxyethyl) starch, Sodium chloride |
Voluforte |
100 g + 9 g/l |
solution for infusion |
intravenous use |
||||||||
Lithuania |
|
Poli(O-2-hydroxyethyl) starch |
Volulyte |
60 g/l |
solution for infusion |
intravenous use |
||||||||
Lithuania |
|
Poli(O-2-hydroxyethyl) starch, Sodium chloride |
Voluven |
60 g + 9 g/l |
solution for infusion |
intravenous use |
||||||||
Lithuania |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
Poly(O-2-hydroxyethyl) starch (HES), Sodium chloride |
HyperHAES |
60 g/l, 72 g/l |
solution for infusion |
intravenous use |
||||||||
Norway |
|
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 |
|
Poly(O-2-hydroxyethyl) starch (HES), Sodium chloride |
Venofundin |
60 g/l, 9 g/l |
solution for infusion |
intravenous use |
||||||||
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 |
|
Poly(O-2-hydroxyethyl) starch (HES), Sodium chloride |
Voluven |
100 g/l, 9 g/l |
solution for infusion |
intravenous use |
||||||||
Norway |
|
Poly(O-2-hydroxyethyl) starch (HES), Sodium chloride |
Voluven |
60 g/l, 9 g/l |
solution for infusion |
intravenous use |
||||||||
Poland |
|
Hydroxyethyl Starch |
HAES - steril 10 % |
100 g/l |
solution for infusion |
intravenous use |
||||||||
Poland |
|
Hydroxyethyl Starch, Sodium chloride |
Refortan |
60 g/l 9 g/l |
solution for infusion |
intravenous use |
||||||||
Poland |
|
Hydroxyethyl Starch, |
6 % Hydroksyetyloskrobia 200/0,5 Baxter |
60 g/l |
solution for infusion |
intravenous use |
||||||||
Poland |
|
Hydroxyethyl Starch |
10 % Hydroksyetyloskrobia 200/0,5 Baxter |
100 g/l |
solution for infusion |
intravenous use |
||||||||
Poland |
|
Hydroxyethyl Starch, Sodium chloride |
Refortan Forte |
100 g/l 9 g/l |
solution for infusion |
intravenous use |
||||||||
Poland |
|
Hydroxyethyl Starch, Sodium chloride |
Hemohes 6 % |
60 g/l 9 g/l |
solution for infusion |
intravenous use |
||||||||
Poland |
|
Hydroxyethyl Starch, Sodium chloride |
Hemohes 10 % |
100 g/l 9 g/l |
solution for infusion |
intravenous use |
||||||||
Poland |
|
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 |
|
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 |
|
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 |
|
Hydroxyethyl Starch, Sodium chloride |
Voluven 10 % |
100 g/l 9 g/l |
solution for infusion |
intravenous use |
||||||||
Poland |
|
Polyhydroxyethylstarch, Sodium chloride |
HyperHAES |
60 g/l, 72 g/l |
solution for infusion |
intravenous use |
||||||||
Poland |
|
Hydroxyethyl Starch, Sodium chloride |
VOLUVEN |
60 g/l 9 g/l |
solution for infusion |
intravenous use |
||||||||
Poland |
|
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 |
|
Hydroxyethyl starch + Sodium chloride |
Haes-Steril 10 % |
100 mg/ml + 9 mg/ml |
solution for infusion |
intravenous use |
||||||||
Portugal |
|
Hydroxyethyl starch + Sodium chloride |
Haes-Steril 6 % |
60 mg/ml + 9 mg/ml |
solution for infusion |
intravenous use |
||||||||
Portugal |
|
Hydroxyethyl starch + Sodium chloride |
Voluven Fresenius |
60 mg/ml + 9 mg/ml |
solution for infusion |
intravenous use |
||||||||
Portugal |
|
Hydroxyethyl starch + Sodium chloride |
HyperHAES |
60 mg/ml + 72 mg/ml |
solution for infusion |
intravenous use |
||||||||
Portugal |
|
Hydroxyethyl starch + Sodium chloride |
Venofundin |
60 mg/ml + 9 mg/ml |
solution for infusion |
intravenous use |
||||||||
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 |
|
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 |
|
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 |
|
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 |
|
Hydroxyethyl starch + Sodium chloride |
Voluven Fresenius |
100 mg/ml + 9 mg/ml |
solution for infusion |
intravenous use |
||||||||
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 |
|
Hydroxyethyl starch Sodium chloride |
Voluven 60 g/1 000 ml |
60 g/l, 9 g/l |
solution for infusion |
intravenous use |
||||||||
Romania |
|
Hydroxyethyl starch Sodium chloride |
VOLUVEN 10 % |
100 g/l, 9 g/l |
solution for infusion |
intravenous use |
||||||||
Romania |
|
Hydroxyethyl starch Sodium chloride |
INFOHES 60 g/L |
60 g/l, 9 g/l |
solution for infusion |
intravenous use |
||||||||
Romania |
|
Hydroxyethyl starch Sodium chloride |
INFOHES 100 g/L |
100 g/l, 9 g/l |
solution for infusion |
intravenous use |
||||||||
Romania |
|
Hydroxyethyl starch Sodium chloride |
HEMOHES 6 % |
60 g/l, 9 g/l |
solution for infusion |
intravenous use |
||||||||
Romania |
|
Hydroxyethyl starch Sodium chloride |
HEMOHES 10 % |
100 g/l, 9 g/l |
solution for infusion |
intravenous use |
||||||||
Romania |
|
Hydroxyethyl starch Sodium chloride |
HAES-steril 60 g/1 000 ml |
60 g/l, 9 g/l |
solution for infusion |
intravenous use |
||||||||
Romania |
|
Hydroxyethyl starch Sodium chloride |
HAES-steril 100 g/1 000 ml |
100 g/l, 9 g/l |
solution for infusion |
intravenous use |
||||||||
Romania |
|
Hydroxyethyl starch Sodium chloride |
Venofundin 6 g/100 ml |
60 g/l, 9 g/l |
solution for infusion |
intravenous use |
||||||||
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 |
|
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 |
|
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 |
|
hydroxyethyl starch, Sodium chloride |
HAES-steril 10 % |
100 g/l, 9 g/l |
solution for infusion |
intravenous use |
||||||||
Slovak Republic |
|
hydroxyethyl starch, Sodium chloride |
HyperHAES |
60 g/l, 72 g/l |
solution for infusion |
intravenous use |
||||||||
Slovak 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 |
|
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 |
|
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 |
|
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 |
|
hydroxyethyl starch, Sodium chloride |
VOLUVEN |
60 g/l, 9 g/l |
solution for infusion |
intravenous use |
||||||||
Slovak Republic |
|
hydroxyethyl starch, Sodium chloride |
Voluven 10 % |
100 g/l, 9 g/l |
solution for infusion |
intravenous use |
||||||||
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
Hydroxyethyl Starch + Sodium Chloride |
HEMOES 6 % SOLUCIÓN |
60 g/l + 9 g/l |
solution for infusion |
intravenous use |
||||||||
Spain |
|
Hydroxyethyl Starch + Sodium Chloride |
HEMOES 10 % SOLUCIÓN |
100 g/l + 9 g/l |
solution for infusion |
intravenous use |
||||||||
Spain |
|
Hydroxyethyl Starch + Sodium Chloride |
VOLUVEN 6 % SOLUCIÓN PARA PERFUSIÓN |
60 g/l + 9 g/l |
solution for infusion |
intravenous use |
||||||||
Spain |
|
Hydroxyethyl Starch + Sodium Chloride |
VOLUVEN 10 % SOLUCIÓN PARA PERFUSIÓN |
100 g/l + 9 g/l |
solution for infusion |
intravenous use |
||||||||
Spain |
|
Hydroxyethyl Starch + Sodium Chloride |
HES HIPERTONICO FRESENIUS SOLUCIÓN PARA PERFUSIÓN |
60 g/l + 72 g/l |
solution for infusion |
intravenous use |
||||||||
Spain |
|
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 |
|
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 |
|
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 |
|
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 |
|
Hydroxyethyl starch, 130/0.4, Sodium chloride |
Voluven |
60 g/l, 9 g/l |
solution for infusion |
intravenous use |
||||||||
Sweden |
|
Hydroxyethyl starch, 200/0.5, Sodium chloride |
HyperHAES |
60 g/l, 72 g/l |
solution for infusion |
intravenous use |
||||||||
Sweden |
|
Hydroxyethyl starch, 130/0.4, Sodium chloride |
Venofundin® |
60 g/l, 9 g/l |
solution for infusion |
intravenous use |
||||||||
Sweden |
|
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 |
|
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 |
|
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 |
|
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 |
|
Hydroxyethyl starch, 130/0.4, Sodium chloride |
Voluven |
100 g/l, 9 g/l |
solution for infusion |
intravenous use |
||||||||
The Netherlands |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
Hydroxyethyl starch 200/0.5, sodium chloride |
Hyperhaes Solution for Injection |
72 g/l, 60 g/l |
solution for infusion |
intravenous use |
||||||||
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
Metogastron 10 mg - Ampullen |
10 mg/2 ml |
Solution for injection |
Intramuscular use Intravenous use |
||||||
Austria |
|
Metogastron 4 mg/ml - Tropfen |
4 mg/ml |
Oral drops, solution |
Oral use |
||||||
Austria |
|
Paspertin - Filmtabletten |
10 mg |
Film-coated tablet |
Oral use |
||||||
Austria |
|
Paspertin 10 mg - Ampullen |
10 mg/2 ml |
Solution for injection |
Intramuscular use Intravenous use |
||||||
Austria |
|
Paspertin 50 mg - Konzentrat zur Infusionsbereitung |
50 mg/10 ml |
Concentrate for solution for infusion |
Intravenous use |
||||||
Austria |
|
Paspertin 4 mg/ml - Tropfen |
4 mg/ml |
Oral drops, solution |
Oral use |
||||||
Belgium |
|
Primperan |
10 mg |
Tablet |
Oral use |
||||||
Belgium |
|
Primperan |
1 mg/ml |
Oral solution |
Oral use |
||||||
Belgium |
|
Primperan |
10 mg/2 ml |
Solution for injection |
Intramuscular use Intravenous use |
||||||
Belgium |
|
Primperan 20 mg |
20 mg |
Suppository |
Rectal use |
||||||
Belgium |
|
Dibertil |
5 mg |
Capsule, soft |
Oral use |
||||||
Belgium |
|
Dibertil |
10 mg |
Capsule, soft |
Oral use |
||||||
Bulgaria |
|
Antiemetin |
5 mg/ml |
Solution for injection |
Intramuscular use Intravenous use |
||||||
Bulgaria |
|
Antiemetin |
5 mg/ml |
Syrup |
Oral use |
||||||
Bulgaria |
|
Cerucal |
10 mg |
Tablet |
Oral use |
||||||
Bulgaria |
|
Degan |
10 mg/2 ml |
Solution for injection |
Intramuscular use Intravenous use |
||||||
Bulgaria |
|
Degan |
10 mg |
Tablet |
Oral use |
||||||
Bulgaria |
|
Pramidin 10 |
10 mg/spray |
Nasal spray, solution |
Nasal use |
||||||
Bulgaria |
|
Pramidin 20 |
20 mg/spray |
Nasal spray, solution |
Nasal use |
||||||
Bulgaria |
|
Reglan |
10 mg |
Tablet |
Oral use |
||||||
Cyprus |
|
Primperan for adults suppository 20 mg |
20 mg |
Suppository |
Rectal use |
||||||
Cyprus |
|
Primperan solution for injection 10 mg/2 ml |
10 mg/2 ml |
Solution for injection |
Intramuscular use Intravenous use |
||||||
Cyprus |
|
Primperan tablets 10 mg |
10 mg |
Tablet |
Oral use |
||||||
Cyprus |
|
Elitan tablets 10 mg |
10 mg |
Tablet |
Oral use |
||||||
Cyprus |
|
Elitan injection 10 mg/2 ml |
10 mg/2 ml |
Injection |
Intramuscular use Intravenous use |
||||||
Cyprus |
|
Cloperan tablets 10 mg |
10 mg |
Tablet |
Oral use |
||||||
Cyprus |
|
Metoclopramide Accord 10 mg tablet |
10 mg |
Tablet |
Oral use |
||||||
Czech Republic |
|
Degan 10 mg tablety |
10 mg |
Tablet |
Oral use |
||||||
Czech Republic |
|
Degan 10 mg roztok pro injekci |
5 mg/ml |
Solution for injection |
Intramuscular use Intravenous use |
||||||
Czech Republic |
|
Mcp hexal 10 |
10 mg |
Tablet |
Oral use |
||||||
Czech Republic |
|
Cerucal |
10 mg |
Tablet |
Oral use |
||||||
Czech Republic |
|
Cerucal |
5 mg/ml |
Solution for injection |
Intramuscular use Intravenous use |
||||||
Denmark |
|
Primperan |
10 mg/2 ml |
Solution for injection |
Intramuscular use Intravenous use |
||||||
Denmark |
|
Primperan |
20 mg |
Suppository |
Rectal use |
||||||
Denmark |
|
Emperal |
10 mg |
Tablet |
Oral use |
||||||
Denmark |
|
Gasto-Timelets |
30 mg |
Prolonged-release capsule, hard |
Oral use |
||||||
Estonia |
|
CERUCAL |
10 mg |
Tablet |
Oral use |
||||||
Finland |
|
Primperan |
20 mg |
Suppository |
Rectal use |
||||||
Finland |
|
Primperan |
10 mg |
Tablet |
Oral use |
||||||
Finland |
|
Primperan |
5 mg/ml |
Solution for injection |
Intramuscular use Intravenous use |
||||||
France |
|
PRIMPERAN 10 mg, comprimé sécable |
10 mg |
Tablet |
Oral use |
||||||
France |
|
PRIMPERAN 10 mg, suppositoire sécable |
10 mg |
Suppository |
Rectal use |
||||||
France |
|
PRIMPERAN 20 mg, suppositoire |
20 mg |
Suppository |
Rectal use |
||||||
France |
|
PRIMPERAN ENFANTS 2,6 mg/ml, solution buvable |
2,6 mg/ml |
Oral solution |
Oral use |
||||||
France |
|
PRIMPERAN NOURRISSONS ET ENFANTS 2,6 mg/ml, solution buvable |
2,6 mg/ml |
Oral drops, solution |
Oral use |
||||||
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 |
|
PRIMPERAN 0,1 %, solution buvable édulcorée à la saccharine sodique |
0,10 % |
Oral solution |
Oral use |
||||||
France |
|
PRIMPERAN 10 mg/2 ml, solution injectable en ampoule |
10 mg/2 ml |
Solution for injection |
Intramuscular use Intravenous use |
||||||
France |
|
PRIMPERAN 100 mg, solution injectable |
100 mg/5 ml |
Solution for injection |
Intramuscular use Intravenous use |
||||||
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 |
|
CHLORHYDRATE DE METOCLOPRAMIDE RENAUDIN 20 mg/ml, solution injectable |
20 mg/ml |
Solution for injection |
Intramuscular use Intravenous use |
||||||
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 |
|
CHLORHYDRATE DE METOCLOPRAMIDE RICHARD 1 mg/ml, solution buvable |
1 mg/ml |
Oral solution |
Oral use |
||||||
France |
|
METOCLOPRAMIDE MYLAN 10 mg, comprimé sécable |
10 mg |
Tablet |
Oral use |
||||||
France |
|
METOCLOPRAMIDE SANDOZ 10 mg, comprimé sécable |
10 mg |
Tablet |
Oral use |
||||||
France |
|
ANAUSIN METOCLOPRAMIDE 15 mg, comprimé à libération prolongée |
15 mg |
Prolonged-release tablet |
Oral use |
||||||
France |
|
PROKINYL L.P. 15 mg, gélule à libération prolongée |
15 mg |
Prolonged-release capsule, hard |
Oral use |
||||||
Germany |
|
MCP Tropfen-1 A-Pharma |
4,21 mg/1 g |
Oral solution |
Oral use |
||||||
Germany |
|
Paspertin 10 mg/2 ml Ampullen |
10 mg/2 ml |
Solution for injection |
Intramuscular use Intravenous use |
||||||
Germany |
|
Paspertin 50 mg/10 ml Ampullen |
50 mg/10 ml |
Concentrate for solution for infusion |
Intravenous use |
||||||
Germany |
|
Paspertin Filmtabletten |
10 mg |
Film-coated tablet |
Oral use |
||||||
Germany |
|
Paspertin Tropfen |
4 mg/ml |
Oral solution |
Oral use |
||||||
Germany |
|
MCP AbZ 5 mg/ml Tropfen |
5,91 mg/ml |
Oral solution |
Oral use |
||||||
Germany |
|
MCP AL 10 |
10,53 mg |
Tablet |
Oral use |
||||||
Germany |
|
MCP AL retard |
30 mg |
Prolonged-release capsule, hard |
Oral use |
||||||
Germany |
|
MCP AL Tropfen |
4,21 mg/1 ml |
Oral solution |
Oral use |
||||||
Germany |
|
Cerucal inject |
10,54 mg/2 ml |
Solution for injection |
Intramuscular use Intravenous use |
||||||
Germany |
|
Metoclopramid AWD 10 mg Tabletten |
10,53 mg |
Tablet |
Oral use |
||||||
Germany |
|
MCP axcount Tropfen |
4,21 mg/ml |
Oral solution |
Oral use |
||||||
Germany |
|
MCP-beta Tropfen |
4,21 mg/ml |
Oral solution |
Oral use |
||||||
Germany |
|
MCP-CT 10 mg/2 ml Ampullen |
10 mg/2 ml |
Solution for injection |
Intramuscular use Intravenous use |
||||||
Germany |
|
MCP-CT 30 mg Retardkapseln |
30 mg |
Prolonged-release capsule, hard |
Oral use |
||||||
Germany |
|
MCP-CT 4 mg/1 ml Tropfen |
5,2 mg/ml |
Oral solution |
Oral use |
||||||
Germany |
|
Metoclopramid Injektionslösung 10 ml PB |
52,65 mg/10 ml |
Solution for injection |
Intravenous use |
||||||
Germany |
|
Gastronerton |
465 mg/100 ml |
Oral solution |
Oral use |
||||||
Germany |
|
Gastronerton |
8,92 mg |
Tablet |
Oral use |
||||||
Germany |
|
Metoclo-hameln 5 mg/ml, Injektionslösung |
10,53 mg/2 ml |
Solution for injection |
Intramuscular use Intravenous use |
||||||
Germany |
|
Gastrosil 10 mg Amp. |
10 mg/2 ml |
Solution for injection |
Intramuscular use Intravenous use |
||||||
Germany |
|
Gastrosil 20 mg Supp. |
20 mg |
Suppository |
Rectal use |
||||||
Germany |
|
Gastrosil 50 mg Amp. |
52,7 mg/10 ml |
Solution for injection |
Intravenous use |
||||||
Germany |
|
Gastrosil akut Tropfen |
5,97 mg/ml |
Oral solution |
Oral use |
||||||
Germany |
|
Gastrosil retard |
31,6 mg |
Prolonged-release capsule, hard |
Oral use |
||||||
Germany |
|
Gastrosil retard mite |
15,8 mg |
Prolonged-release capsule, hard |
Oral use |
||||||
Germany |
|
Gastrosil Tabletten |
10,54 mg |
Tablet |
Oral use |
||||||
Germany |
|
Gastrsosil Tropfen |
5,97 mg/ml |
Oral solution |
Oral use |
||||||
Germany |
|
MCP Heumann 10 mg Tabletten |
10,53 mg |
Tablet |
Oral use |
||||||
Germany |
|
MCP Hexal 10 |
10,53 mg |
Tablet |
Oral use |
||||||
Germany |
|
MCP Hexal injekt |
10,53 mg/2 ml |
Solution for injection |
Intramuscular use Intravenous use |
||||||
Germany |
|
MCP Hexal Tropfen |
4,21 mg/ml |
Oral solution |
Oral use |
||||||
Germany |
|
MCP dura 4 mg/ml Tropfen zum Einnehmen |
4,21 mg/ml |
Oral solution |
Oral use |
||||||
Germany |
|
MCP-ratiopharm 10 mg Tabletten |
11,82 mg |
Tablet |
Oral use |
||||||
Germany |
|
MCP-ratiopharm 10 mg Zäpfchen |
10 mg |
Suppository |
Rectal use |
||||||
Germany |
|
MCP-Ratiopharm 30 mg Retardkapseln |
30 mg |
Prolonged-release capsule |
Oral use |
||||||
Germany |
|
MCP-ratiopharm 4 mg/ml Tropfen |
5,2 mg/ml |
Oral solution |
Oral use |
||||||
Germany |
|
MCP-ratiopharm SF 10 mg/2 ml Injektionslösung |
10 mg/2 ml |
Solution for injection |
Intramuscular use Intravenous use |
||||||
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 |
|
MCP Sandoz 10 mg Tabletten |
10,53 mg |
Tablet |
Oral use |
||||||
Germany |
|
MCP Sandoz 4 mg/ml Tropfen zum Einnehmen, Lösung |
4,21 mg/ml |
Oral solution |
Oral use |
||||||
Germany |
|
MCP STADA 10 mg Tabletten |
10,53 mg |
Tablet |
Oral use |
||||||
Germany |
|
MCP STADA 4 mg/1 ml Tropfen zum Einnehmen, Lösung |
4,21 mg/ml |
Oral solution |
Oral use |
||||||
Germany |
|
Cerucal |
10,54 mg |
Tablet |
Oral use |
||||||
Germany |
|
Cerucal retard |
30 mg |
Prolonged-release capsule, hard |
Oral use |
||||||
Greece |
|
PRIMPERAN |
10 mg |
Suppository |
Rectal use |
||||||
Greece |
|
PRIMPERAN |
20 mg |
Suppository |
Rectal use |
||||||
Greece |
|
PRIMPERAN |
10 mg/2 ml |
Solution for injection |
Intramuscular use Intravenous use |
||||||
Greece |
|
PRIMPERAN |
5 mg/5 ml |
Syrup |
Oral use |
||||||
Greece |
|
PRIMPERAN |
10 mg |
Tablet |
Oral use |
||||||
Hungary |
|
CERUCAL 5 mg/ml oldatos injekció |
5 mg/ml |
Solution for injection |
Parenteral use |
||||||
Hungary |
|
CERUCAL tabletta |
10 mg |
Tablet |
Oral use |
||||||
Iceland |
|
Afipran |
10 mg |
Tablet |
Oral use |
||||||
Iceland |
|
Afipran |
20 mg |
Suppository |
Rectal use |
||||||
Iceland |
|
Afipran |
5 mg/ml |
Solution for injection |
Intramuscular use Intravenous use |
||||||
Ireland |
|
Metoclopramide |
10 mg/2 ml |
Solution for injection |
Intramuscular use Intravenous use |
||||||
Ireland |
|
Maxolon |
5 mg/ml |
Solution for injection |
Intramuscular use Intravenous use |
||||||
Ireland |
|
Maxolon |
10 mg |
Tablet |
Oral use |
||||||
Italy |
|
PLASIL |
10 mg/2 ml |
Solution for injection |
Intramuscular use Intravenous use |
||||||
Italy |
|
PLASIL |
1 mg/ml |
Syrup |
Oral use |
||||||
Italy |
|
PLASIL |
4 mg/ml |
Oral drops, solution |
Oral use |
||||||
Italy |
|
PLASIL |
10 mg |
Tablet |
Oral use |
||||||
Italy |
|
RANDUM |
10 mg |
Tablet |
Oral use |
||||||
Italy |
|
CLOPAN |
10 mg |
Solution for injection |
Intramuscular use Intravenous use |
||||||
Italy |
|
PRAMIDIN |
10 mg/spray |
Nasal spray, solution |
Nasal use |
||||||
Italy |
|
PRAMIDIN |
20 mg/spray |
Nasal spray, solution |
Nasal use |
||||||
Italy |
|
DIGESTIVO S.PELLEGRINO |
5 mg |
Effervescent tablet |
Oral use |
||||||
Italy |
|
DIGESTIVO S.PELLEGRINO |
5 mg |
Effervescent granules |
Oral use |
||||||
Italy |
|
METOCLOPRAMIDE CLORIDRATO HOSPIRA |
10 mg |
Solution for injection |
Intramuscular use Intravenous use |
||||||
Italy |
|
ISAPRANDIL |
5 mg |
Effervescent tablet |
Oral use |
||||||
Italy |
|
ISAPRANDIL |
5 mg |
Effervescent granules |
Oral use |
||||||
Latvia |
|
Metoclopramid Polpharma 10 mg tablets |
10 mg |
Tablet |
Oral use |
||||||
Latvia |
|
Metoclopramid Polpharma 10 mg/2 ml solution for injection |
10 mg/2 ml |
Solution for injection |
Intramuscular use Intravenous use |
||||||
Latvia |
|
Cerucal 10 mg tablets |
10 mg |
Tablet |
Oral use |
||||||
Lithuania |
|
Cerucal |
10 mg |
Tablet |
Oral use |
||||||
Lithuania |
|
ELITAN |
5 mg/ml |
Solution for injection |
Intramuscular use Intravenous use |
||||||
Lithuania |
|
Metoclopramid Polpharma |
10 mg |
Tablet |
Oral use |
||||||
Lithuania |
|
Metoclopramid Polpharma |
10 mg/2 ml |
Solution for injection |
Intramuscular use Intravenous use |
||||||
Luxembourg |
|
Dibertil |
10 mg |
Capsule, soft |
Oral use |
||||||
Luxembourg |
|
Dibertil |
5 mg |
Capsule, soft |
Oral use |
||||||
Luxembourg |
|
Gastronerton |
4,65 mg/ml |
Oral drops |
Oral use |
||||||
Luxembourg |
|
Gastronerton |
8,92 mg |
Tablet |
Oral use |
||||||
Luxembourg |
|
MCP Ratiopharm |
5,2 mg |
Oral drops |
Oral use |
||||||
Luxembourg |
|
MCP Ratiopharm |
10 mg |
Suppository |
Rectal use |
||||||
Luxembourg |
|
MCP Ratiopharm |
10 mg |
Tablet |
Oral use |
||||||
Luxembourg |
|
mcP Ratiopharm SF |
10 mg/2 ml |
Solution for injection |
Intramuscular use Intravenous use |
||||||
Luxembourg |
|
MCP Ratiopharm-30 |
30 mg |
Modified-release capsule, soft |
Oral use |
||||||
Luxembourg |
|
Metoclopramide EG-10 |
10 mg |
Capsule, soft |
Oral use |
||||||
Luxembourg |
|
Primperan adultes |
20 mg |
Suppository |
Rectal use |
||||||
Luxembourg |
|
MCP Hexal-10 |
10 mg |
Tablet |
Oral use |
||||||
Luxembourg |
|
MCP Hexal Injekt |
10 mg/2 ml |
Solution for injection |
Intramuscular use Intravenous use |
||||||
Luxembourg |
|
MCP Hexal Tropfen |
4 mg/ml |
Oral drops |
Oral use |
||||||
Luxembourg |
|
Primperan |
10 mg |
Tablet |
Oral use |
||||||
Luxembourg |
|
Primperan |
10 mg/2 ml |
Solution for injection |
Intramuscular use Intravenous use |
||||||
Luxembourg |
|
Primperan |
1 mg/ml |
Oral solution |
Oral use |
||||||
Malta |
|
Metoclopramide 10 mg tablets |
10 mg |
Tablet |
Oral use |
||||||
Malta |
|
Metoclopramide Injection BP 10 mg/2 ml Solution for Injection |
10 mg/2 ml |
Solution for injection |
Intramuscular use Intravenous use |
||||||
Malta |
|
Metoclopramide 5 mg/ml Injection |
5 mg/ml |
Solution for injection |
Intramuscular use Intravenous use |
||||||
Malta |
|
Elitan 10 mg tablet |
10 mg |
Tablet |
Oral use |
||||||
Malta |
|
Elitan Injection, 10 mg/2 ml, Solution for Injection |
10 mg |
Solution for injection |
Intramuscular use Intravenous use |
||||||
Malta |
|
Cloperan 10 |
10 mg |
Tablet |
Oral use |
||||||
Netherlands |
|
Primperan injectie 10/2 ml, oplossing voor injection 10 mg/2 ml |
10 mg/2 ml |
Solution for injection |
Intravenous use |
||||||
Netherlands |
|
Primperan drank, drank 1 mg/ml |
1 mg/ml |
Oral solution |
Oral use |
||||||
Netherlands |
|
Primperan 10, zetpillen 10 mg |
10 mg |
Suppository |
Rectal use |
||||||
Netherlands |
|
Primperan 20, zetpillen 20 mg |
20 mg |
Suppository |
Rectal use |
||||||
Netherlands |
|
Metoclopramide HCl 10 PCH, tabletten 10 mg |
10 mg |
Tablet |
Oral use |
||||||
Netherlands |
|
Metoclopramide HCl CF 10 mg, tabletten |
10 mg |
Tablet |
Oral use |
||||||
Netherlands |
|
Metoclopramidemonohydrochloride Accord 10 mg Tabletten |
10 mg |
Tablet |
Oral use |
||||||
Norway |
|
Afipran |
5 mg/ml |
Solution for injection |
Intramuscular use Intravenous use |
||||||
Norway |
|
Afipran |
20 mg |
Suppository |
Rectal use |
||||||
Norway |
|
Afipran |
100 mg/ml |
Concentrate for solution for infusion |
Intravenous use |
||||||
Norway |
|
Afipran |
1 mg/ml |
Oral solution |
Oral use |
||||||
Norway |
|
Afipran |
10 mg |
Tablet |
Oral use |
||||||
Poland |
|
Metoclopramidum 0,5 % Polpharma |
5 mg/ml |
Solution for injection |
Intramuscular use Intravenous use |
||||||
Poland |
|
Metoclopramidum Polpharma |
10 mg |
Tablet |
Oral use |
||||||
Portugal |
|
Primperan |
10 mg/2 ml |
Solution for injection |
Intramuscular use Intravenous use |
||||||
Portugal |
|
Metoclopramida Labesfal |
10 mg/2 ml |
Solution for injection |
Intramuscular use Intravenous use |
||||||
Portugal |
|
Metoclopramida Labesfal |
10 mg |
Tablet |
Oral use |
||||||
Portugal |
|
Primperan |
1 mg/ml |
Oral solution |
Oral use |
||||||
Portugal |
|
Primperan |
10 mg |
Tablet |
Oral use |
||||||
Portugal |
|
Metoclopramida Medinfar |
10 mg/2 ml |
Solution for injection |
Intramuscular use Intravenous use |
||||||
Portugal |
|
Metoclopramida Medinfar |
10 mg |
Tablet |
Oral use |
||||||
Portugal |
|
Metoclopramida Medinfar |
2,6 mg/ml |
Oral drops, solution |
Oral use |
||||||
Portugal |
|
Metoclopramida Medinfar |
1 mg/ml |
Oral solution |
Oral use |
||||||
Romania |
|
METOCLOPRAMID LAROPHARM |
10 mg |
Tablet |
Oral use |
||||||
Romania |
|
METOCLOPRAMID |
10 mg |
Tablet |
Oral use |
||||||
Romania |
|
N - METOCLOPRAMID |
10 mg |
Tablet |
Oral use |
||||||
Romania |
|
METOCLOPRAMID ARENA 10 mg |
10 mg |
Tablet |
Oral use |
||||||
Romania |
|
METOCLOPRAMID 10 mg |
10 mg |
Tablet |
Oral use |
||||||
Romania |
|
METOCLOPRAMID BIOFARM 1 mg/5 ml |
1 mg/5 ml |
Syrup |
Oral use |
||||||
Romania |
|
METOCLOPRAMID |
7 mg/ml |
Oral drops, solution |
Oral use |
||||||
Romania |
|
METOCLOPRAMID 10 mg |
10 mg/2 ml |
Solution for injection |
Intramuscular use Intravenous use |
||||||
Romania |
|
Metoclopramid Accord 10 mg comprimate |
10 mg |
Tablet |
Oral use |
||||||
Slovak Republic |
|
Cerucal |
10 mg |
Tablet |
Oral use |
||||||
Slovak Republic |
|
Cerucal |
10 mg/2 ml |
Solution for injection |
Intramuscular use Intravenous use |
||||||
Slovak Republic |
|
DEGAN 10 mg |
10 mg |
Tablet |
Oral use |
||||||
Slovak Republic |
|
DEGAN 10 mg/2 ml |
10 mg/2 ml |
Solution for injection |
Intramuscular use Intravenous use |
||||||
Slovenia |
|
Reglan 1 mg/1 ml peroralna raztopina |
1 mg/ml |
Oral solution |
Oral use |
||||||
Slovenia |
|
Reglan 10 mg tablete |
10 mg |
Tablet |
Oral use |
||||||
Spain |
|
PRIMPERAN 10 mg/2 ml SOLUCION INYECTABLE |
10 mg/2 ml |
Solution for injection |
Intramuscular use Intravenous use |
||||||
Spain |
|
PRIMPERAN 1 mg/1 ml SOLUCION ORAL |
1 mg/ml |
Oral solution |
Oral use |
||||||
Spain |
|
PRIMPERAN 10 mg COMPRIMIDOS |
10 mg |
Tablet |
Oral use |
||||||
Spain |
|
PRIMPERAN 260 mg/100 ml GOTAS |
2,6 mg/ml |
Oral drops, solution |
Oral use |
||||||
Spain |
|
PRIMPERAN 100 mg/5 ml SOLUCION INYECTABLE |
100 mg/5 ml |
Solution for injection |
Intramuscular use Intravenous use |
||||||
Spain |
|
METOCLOPRAMIDA KERN PHARMA 1 mg/ml SOLUCION ORAL |
1 mg/ml |
Oral solution |
Oral use |
||||||
Spain |
|
METOCLOPRAMIDA PENSA 1 mg/ml SOLUCION ORAL |
1 mg/ml |
Oral solution |
Oral use |
||||||
Spain |
|
METOCLOPRAMIDA ACCORD 10 mg COMPRIMIDOS |
10 mg |
Tablet |
Oral use |
||||||
Sweden |
|
Primperan |
10 mg |
Tablet |
Oral use |
||||||
Sweden |
|
Primperan |
10 mg/2 ml |
Solution for injection |
Intramuscular use Intravenous use |
||||||
Sweden |
|
Primperan |
20 mg |
Suppository |
Rectal use |
||||||
United Kingdom |
|
Metoclopramide Tablets BP 10 mg |
10 mg |
Tablet |
Oral use |
||||||
United Kingdom |
|
Maxolon SR |
15 mg |
Modified-release capsules, hard |
Oral use |
||||||
United Kingdom |
|
Maxolon Tablets 10 mg |
10 mg |
Tablet |
Oral use |
||||||
United Kingdom |
|
Maxolon Injection 5 mg/ml |
0,5 % w/v |
Solution for injection |
Intramuscular use Intravenous use |
||||||
United Kingdom |
|
Maxolon High Dose 100 mg/20 ml |
0,5 % w/v |
Solution for injection |
Intravenous use |
||||||
United Kingdom |
|
Metoclopramide 10 mg Tablets |
10 mg |
Tablet |
Oral use |
||||||
United Kingdom |
|
Metoclopramide 10 mg Tablets |
10 mg |
Tablet |
Oral use |
||||||
United Kingdom |
|
Metoclopramide 10 mg Tablets |
10 mg |
Tablet |
Oral use |
||||||
United Kingdom |
|
Metoclopramide 5 mg/ml Injection |
0,5 % w/v |
Solution for injection |
Intramuscular use Intravenous use |
||||||
United Kingdom |
|
Metoclopramide Tablets 10 mg |
10 mg |
Tablet |
Oral use |
||||||
United Kingdom |
|
Metoclopramide Injection BP 5 mg/ml |
0,526 % w/v |
Solution for injection |
Intramuscular use Intravenous use |
||||||
United Kingdom |
|
Metoclopramide 10 mg Tablets |
10 mg |
Tablet |
Oral use |
||||||
United Kingdom |
|
Metoclopramide Tablets BP 10 mg |
10 mg |
Tablet |
Oral use |
||||||
United Kingdom |
|
Metoclopramide Hydrochloride 5 mg/5 ml Oral Solution |
5 mg/5 ml |
Oral solution |
Oral use |
||||||
United Kingdom |
|
Maxolon Paediatric Liquid |
5 mg/5 ml |
Oral solution |
Oral use |
||||||
United Kingdom |
|
Primperan; Metoclopramide Tablets BP 10 mg |
10 mg |
Tablet |
Oral use |
||||||
United Kingdom |
|
Metoclopramide Hydrochloride 10 mg tablets |
10 mg |
Tablet |
Oral use |
||||||
United Kingdom |
|
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 |
|
Hydergin Fas 4,5 mg Filmtabletten |
4,5 mg (1:1:1) |
film-coated tablet |
oral use |
||||||
Austria |
|
Hydergin 1 mg/ml Tropfen |
1 mg/ml (1:1:1) |
oral drops, solution |
oral use |
||||||
Austria |
|
Hydergin 3 mg/ml Tropfen |
3 mg/ml (1:1:1) |
oral drops, solution |
oral use |
||||||
Austria |
|
Hydergin 1 mg Tabletten |
1 mg (1:1:1) |
tablet |
oral use |
||||||
Austria |
|
Hydergin 2 mg Tabletten |
2 mg (1:1:1) |
tablet |
oral use |
||||||
Austria |
|
Hydergin SRO 6 mg Kapseln |
6 mg (1:1:1) |
modified-release capsule, hard |
oral use |
||||||
Belgium |
|
Hydergine |
1 mg-ml |
oral solution |
oral use |
||||||
Belgium |
|
Hydergine |
1,5 mg |
Tablets |
oral use |
||||||
Belgium |
|
Hydergine |
4,5 mg |
Tablets |
oral use |
||||||
Belgium |
|
Hydergine FAS |
4,5 mg |
Gastro-resistant tablet |
oral use |
||||||
Belgium |
|
Ibexone |
1,5 mg |
Tablets |
oral use |
||||||
Belgium |
|
Ibexone |
1 mg-ml |
oral solution |
oral use |
||||||
Belgium |
|
Ibexone |
3 mg-ml |
oral solution |
oral use |
||||||
Belgium |
|
Ibexone |
4,5 mg |
Tablets |
oral use |
||||||
Belgium |
|
STOFILAN |
1,5 mg |
Tablets |
oral use |
||||||
Belgium |
|
STOFILAN |
1 mg-ml |
oral drops solution |
oral use |
||||||
Belgium |
|
STOFILAN FORTE |
4,5 mg |
Tablets |
oral use |
||||||
Czech Republic |
|
SECATOXIN FORTE |
2,5 MG/ML |
Oral drops, solution |
oral use |
||||||
Finland |
|
Hydergin |
1,5 mg |
Tablets |
oral use |
||||||
Finland |
|
Hydergin |
1 mg |
Tablets |
oral use |
||||||
France |
|
CAPERGYL 4,5 mg DOSE QUOTIDIENNE UNIQUE, capsule |
4,5 mg |
soft capsule |
oral use |
||||||
France |
|
HYDERGINE 1 mg/ml, solution buvable en gouttes |
1 mg/ml |
oral drops, solution |
oral use |
||||||
France |
|
HYDERGINE 4,5 mg DOSE QUOTIDIENNE UNIQUE, comprimé |
4,5 mg |
tablet |
oral use |
||||||
Germany |
|
Hydergin |
2 mg |
Tablets |
oral use |
||||||
Germany |
|
Hydergin |
1 mg/ml |
Oral drops |
oral use |
||||||
Germany |
|
Hydergin |
2 mg/ml |
Oral drops |
oral use |
||||||
Greece |
|
Hydergine |
1 mg/ml |
Oral drops |
oral use |
||||||
Italy |
|
HYDERGINA |
1,5 mg |
tablet |
oral use |
||||||
Italy |
|
HYDERGINA |
1 mg/ml |
oral solution |
oral use |
||||||
Luxembourg |
|
Hydergin |
1 mg/ml |
Oral drops |
oral use |
||||||
Luxembourg |
|
Hydergin |
2 mg/ml |
Oral drops |
oral use |
||||||
Poland |
|
Dihydroergotoxinum Filofarm |
1 mg/ml |
oral solution |
oral use |
||||||
Portugal |
|
Hydergine |
1,5 mg |
tablet |
oral use |
||||||
Portugal |
|
Hydergine |
4,5 mg |
tablet |
oral use |
||||||
Portugal |
|
Hydergine |
1 mg/ml |
Oral drops, solution |
oral use |
||||||
Portugal |
|
Hydergine |
3 mg/ml |
Oral drops, solution |
oral use |
||||||
Romania |
|
REDERGIN |
1 mg/ml |
Oral drops, solution |
oral use |
||||||
Slovak Republic |
|
SECATOXIN FORTE |
2,5 mg / 1 ml |
Oral drops, solution |
oral use |
||||||
Slovenia |
|
Redergin 1,5 mg tablete |
1,5 mg |
tablet |
oral use |
||||||
Slovenia |
|
Redergin 4,5 mg tablete |
4,5 mg |
tablet |
oral use |
||||||
Slovenia |
|
Redergin 1 mg/ ml peroralna raztopina |
1 mg/ml |
oral solution |
oral use |
||||||
Spain |
|
HYDERGINA SOLUCIÓN GOTAS |
1 mg/ml |
oral drops, solution |
oral use |
||||||
Spain |
|
HYDERGINA 4,5 mg COMPRIMIDOS |
4,5 mg |
tablet |
oral use |
||||||
Sweden |
|
Hydergin |
1 mg |
Tablets |
oral use |