Member State EU/EEA

Marketing authorisation holder

(Invented) Name

Strength

Pharmaceutical form

Route of administration

Austria

Arimidex

1 mg

Film-coated Tablets

Oral use

Belgium

Arimidex

1 mg

Film-coated Tablets

Oral use

Bulgaria

Arimidex

1 mg

Film-coated Tablets

Oral use

Cyprus

Arimidex

1 mg

Film-coated Tablets

Oral use

Czech Republic

Arimidex

1 mg

Film-coated Tablets

Oral use

Denmark

Arimidex

1 mg

Film-coated Tablets

Oral use

Estonia

Arimidex

1 mg

Film-coated Tablets

Oral use

Finland

Arimidex

1 mg

Film-coated Tablets

Oral use

France

Arimidex

1 mg

Film-coated Tablets

Oral use

Germany

Arimidex

1 mg

Film-coated Tablets

Oral use

Greece

Arimidex

1 mg

Film-coated Tablets

Oral use

Hungary

Arimidex

1 mg

Film-coated Tablets

Oral use

Iceland

Arimidex

1 mg

Film-coated Tablets

Oral use

Ireland

Arimidex

1 mg

Film-coated Tablets

Oral use

Italy

Arimidex

1 mg

Film-coated Tablets

Oral use

Latvia

Arimidex

1 mg

Film-coated Tablets

Oral use

Lithuania

Arimidex

1 mg

Film-coated Tablets

Oral use

Luxembourg

Arimidex

1 mg

Film-coated Tablets

Oral use

Malta

Arimidex

1 mg

Film-coated Tablets

Oral use

Netherlands

Arimidex

1 mg

Film-coated Tablets

Oral use

Norway

Arimidex

1 mg

Film-coated Tablets

Oral use

Poland

Arimidex

1 mg

Film-coated Tablets

Oral use

Portugal

Arimidex

1 mg

Film-coated Tablets

Oral use

Romania

Arimidex

1 mg

Film-coated Tablets

Oral use

Slovak Republic

Arimidex

1 mg

Film-coated Tablets

Oral use

Slovenia

Arimidex 1 mg filmsko obložene tablete

1 mg

Film-coated Tablets

Oral use

Spain

Arimidex

1 mg

Film-coated Tablets

Oral use

Sweden

Arimidex

1 mg

Film-coated Tablets

Oral use

United Kingdom

Arimidex

1 mg

Film-coated Tablets

Oral use

Member State

Marketing authorisation holder

Product name

Strength

Pharmaceutical form

Route of administration

Austria

Baxter Healthcare GmbH, Stella-Klein-Löw-Weg 15, A-1020 Wien, Austria

Dianeal PD4 Glucose 1,36 % w/v/13,6 mg/ml - Peritonealdialyselösung

Anhydrous glucose 13,6 g/L, sodium chloride 5,38 g/L, sodium-L(+) lactate 4,48 g/L, calcium chloride dihydrate 0,184 g/L, magnesium chloride hexahydrate 0,051 g/L

Solution for peritoneal dialysis

Intraperitoneal use

Austria

Baxter Healthcare GmbH, Stella-Klein-Löw-Weg 15, A-1020 Wien, Austria

Dianeal PD4 Glucose 2,27 % w/v/22,7 mg/ml - Peritonealdialyselösung

Anhydrous glucose 22,7 g/L, sodium chloride 5,38 g/L, sodium-L(+) lactate 4,48 g/L, calcium chloride dihydrate 0,184 g/L, magnesium chloride hexahydrate 0,051 g/L

Solution for peritoneal dialysis

Intraperitoneal use

Austria

Baxter Healthcare GmbH, Stella-Klein-Löw-Weg 15, A-1020 Wien, Austria

Dianeal PD4 Glucose 3,86 % w/v/38,6 mg/ml - Peritonealdialyselösung

Anhydrous glucose 38,6 g/L, sodium chloride 5,38 g/L, sodium-L(+) lactate 4,48 g/L, calcium chloride dihydrate 0,184 g/L, magnesium chloride hexahydrate 0,051 g/L

Solution for peritoneal dialysis

Intraperitoneal use

Austria

Baxter Healthcare GmbH, Stella-Klein-Löw-Weg 15, A-1020 Wien, Austria

EXTRANEAL - Peritonealdialyselösung

75 g/L

Solution for peritoneal dialysis

Intraperitoneal use

Belgium

Dianeal PD4 Glucose 1,36 % (13,6 mg/ml), solution pour dialyse péritonéale.

13,6 g/l glucose anhydrate

Solution for peritoneal dialysis

Intraperitoneal use

Belgium

Dianeal PD4 Glucose 2,27 % (22,7 mg/ml), solution pour dialyse péritonéale.

22,7 g/l glucose anhydrate

Solution for peritoneal dialysis

Intraperitoneal use

Belgium

Dianeal PD4 Glucose 3,86 % (38,6 mg/ml), solution pour dialyse péritonéale.

38,6 g/l glucose anhydrate

Solution for peritoneal dialysis

Intraperitoneal use

Belgium

EXTRANEAL 7,5 %, solution pour dialyse péritonéale

75,00 g/l Icodextrine

Solution for peritoneal dialysis

Intraperitoneal use

Bulgaria

BAXTER d.o.o., Zelezna cesta 18, 1000 Ljubljana, Slovenia

Dianeal PD4 Glucose

2,27 % w/v/ 22,7 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Bulgaria

BAXTER d.o.o., Zelezna cesta 18, 1000 Ljubljana, Slovenia

Dianeal PD4 Glucose

3,86 % w/v/ 38,6 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Bulgaria

BAXTER d.o.o., Zelezna cesta 18, 1000 Ljubljana, Slovenia

Dianeal PD4 Glucose 1,36 % w/v/ 13,6 mg/ml

1,36 % w/v/ 13,6 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Bulgaria

BAXTER d.o.o., Zelezna cesta 18, 1000 Ljubljana, Slovenia

Extraneal

7,50 %

Solution for peritoneal dialysis

Intraperitoneal use

Czech Republic

Baxter Healthcare S.A. Moneen Road Castlebar, Co. Mayo Ireland

Dianeal PD4 Glucose 1,36 % w/v/13,6 mg/ml

1,36 % w/v/13,6 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Czech Republic

Baxter Healthcare S.A. Moneen Road Castlebar, Co. Mayo Ireland

Dianeal PD4 Glucose 2,27 % w/v/22,7 mg/ml

2,27 % w/v/22,6 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Czech Republic

Baxter Healthcare S.A. Moneen Road Castlebar, Co. Mayo Ireland

Dianeal PD4 Glucose 3,86 % w/v/38,6 mg/ml

3,86 % w/v/38,6 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Czech Republic

Baxter Healthcare S.A. Moneen Road Castlebar, Co. Mayo Ireland

EXTRANEAL

7,5 % 75 g/1 000 ml

Solution for peritoneal dialysis

Intraperitoneal use

Denmark

Baxter A/S, Gydevang 43, DK-3450 Allerød, Denmark

Dianeal PD4 med Glucos

13,6 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Denmark

Baxter A/S, Gydevang 43, DK-3450 Allerød, Denmark

Dianeal PD4 med Glucos

22,7 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Denmark

Baxter A/S, Gydevang 43, DK-3450 Allerød, Denmark

Dianeal PD4 med Glucos

38,6 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Denmark

Baxter A/S, Gydevang 43, DK-3450 Allerød, Denmark

Extraneal

75 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Estonia

Baxter OY P.O box 270, Valimotie 15A, Helsinki 00381 Finland

EXTRANEAL

7,50 %

Solution for peritoneal dialysis

Intraperitoneal use

Finland

Baxter Healthcare S.A. Moneen Road, Castlebar County Mayo Ireland

Dianeal PD4 Glucose

13,6 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Finland

Baxter Healthcare S.A. Moneen Road, Castlebar County Mayo Ireland

Dianeal PD4 Glucose

22,7 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Finland

Baxter Healthcare S.A. Moneen Road, Castlebar County Mayo Ireland

Dianeal PD4 Glucose

38,6 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Finland

Baxter Oy Valimotie 15 A 00380 Helsinki Finland

Extraneal

7,5 %

Solution for peritoneal dialysis

Intraperitoneal use

France

DIANEAL PD4 GLUCOSE 1,36 %, solution pour dialyse péritonéale en poche

1,36 %

Solution for peritoneal dialysis

Intraperitoneal use

France

DIANEAL PD4 GLUCOSE 2,27 %, solution pour dialyse péritonéale en poche

2,27 %

Solution for peritoneal dialysis

Intraperitoneal use

France

DIANEAL PD4 GLUCOSE 3,86 %, solution pour dialyse péritonéale en poche

3,86 %

Solution for peritoneal dialysis

Intraperitoneal use

France

EXTRANEAL, solution pour dialyse péritonéale

7,50 %

Solution for peritoneal dialysis

Intraperitoneal use

Germany

Dianeal PD4 Glucose 1,36 % w/v

13,6 g/l

5,4 g/l

4,5 g/l

0,184 g/l

0,051 g/l

Solution for peritoneal dialysis

Intraperitoneal use

Germany

Dianeal PD4 Glucose 2,27 % w/v

22,7 g/l

5,4 g/l

4,5 g/l

0,184 g/l

0,051 g/l

Solution for peritoneal dialysis

Intraperitoneal use

Germany

Dianeal PD4 Glucose 3,86 % w/v

38,6 g/l

5,4 g/l

4,5 g/l

0,184 g/l

0,051 g/l

Solution for peritoneal dialysis

Intraperitoneal use

Germany

Dianeal PDG4 1,36 %

13,6 g/l

5,38 g/l

4,48 g/ l

0,184 g/l

0,051 g/l

Solution for peritoneal dialysis

Intraperitoneal use

Germany

Dianeal PDG4 2,27 %

22,7 g/l

5,38 g/l

4,48 g/ l

0,184 g/l

0,051 g/l

Solution for peritoneal dialysis

Intraperitoneal use

Germany

Extraneal

75 g/l

5,4. g/l

4,5 g/l

0,257 g/l

0,051 g/l

Solution for peritoneal dialysis

Intraperitoneal use

Greece

DIANEAL PD4

1,36 %

Solution for peritoneal dialysis

Intraperitoneal use

Greece

EXTRANEAL

(7,5 + 0,54 + 0,45 + 0,0257 + 0,0051) % w/v

Solution for peritoneal dialysis

Intraperitoneal use

Hungary

DIANEAL PD 4 Glucose 1,36 % peritoneális dializáló oldat

1,36 %

Solution for peritoneal dialysis

Intraperitoneal use

Hungary

DIANEAL PD 4 Glucose 2,27 % peritoneális dializáló oldat

2,27 %

Solution for peritoneal dialysis

Intraperitoneal use

Hungary

DIANEAL PD 4 Glucose 3,86 % peritoneális dializáló oldat

3,86 %

Solution for peritoneal dialysis

Intraperitoneal use

Hungary

EXTRANEAL peritoneális dializáló oldat

7,5 % (icodextrin)

Solution for peritoneal dialysis

Intraperitoneal use

Iceland

Baxter Healthare SA Moneen Road Castlebar County Mayo Irland

Dianeal PD4 Glucose

13,6 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Iceland

Baxter Healthare SA Moneen Road Castlebar County Mayo Irland

Dianeal PD4 Glucose

22,7 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Iceland

Baxter Healthare SA Moneen Road Castlebar County Mayo Irland

Dianeal PD4 Glucose

38,6 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Ireland

Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk, IP24 3SE, United Kingdom

Dianeal PD4 Glucose 1,36 % w/v (13,6 mg/ml) Solution for peritoneal dialysis

1,36 % w/v (13,6 mg/ml)

Solution for peritoneal dialysis

Intraperitoneal use

Ireland

Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk, IP24 3SE, United Kingdom

Dianeal PD4 Glucose 2,27 % w/v (22,7 mg/ml) Solution for peritoneal dialysis

2,27 % w/v (22,7 mg/ml)

Solution for peritoneal dialysis

Intraperitoneal use

Ireland

Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk, IP24 3SE, United Kingdom

Dianeal PD4 Glucose 3,86 % w/v (38,6 mg/ml) Solution for peritoneal dialysis

3,86 % w/v (38,6 mg/ml)

Solution for peritoneal dialysis

Intraperitoneal use

Ireland

Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk, IP24 3SE, United Kingdom

EXTRANEAL Solution for peritoneal dialysis

Solution for peritoneal dialysis

Intraperitoneal use

Italy

EXTRANEAL

7,5 %

Solution for dialysis peritoneal

Intraperitoneal use

Italy

SOLUZIONI PER DIALISI PERITONEALE BAXTER

4,95 g/l - 49,54 g/l;

Solution for dialysis peritoneal

Intraperitoneal use

Latvia

Dianeal PD4 Glucose 1,36 % w/v/13,6 mg/ml solution for peritoneal dialysis

1,36 % w/v 0,538 % w/v 0,448 % w/v 0,0184 % w/v 0,0051 % w/v

Solution for peritoneal dialysis

Intraperitoneal use

Latvia

Dianeal PD4 Glucose 2,27 % w/v/22,7 mg/ml solution for peritoneal dialysis

2,27 % w/v

0,538 % w/v 0,448 % w/v

0,0184 % w/v 0,0051 % w/v

Solution for peritoneal dialysis

Intraperitoneal use

Latvia

Dianeal PD4 Glucose 3,86 % w/v/38,6 mg/ml solution for peritoneal dialysis

3,86 % w/v 0,538 % w/v 0,448 % w/v 0,0184 % w/v 0,0051 % w/v

Solution for peritoneal dialysis

Intraperitoneal use

Latvia

Extraneal solution for peritoneal dialysis

75 g/L 5,4 g/L 4,5 g/L 0,257 g/L 0,051 g/L

Solution for peritoneal dialysis

Intraperitoneal use

Lithuania

Baxter Healthcare S.A., Moneen Road, Castlebar County Mayo, Ireland

Dianeal PD4 Glucose

13,6 g + 5,38g + 4,48 g + 0,184 g + 0,051 g/l

Solution for peritoneal dialysis

Intraperitoneal use

Lithuania

Baxter Healthcare S.A., Moneen Road, Castlebar County Mayo, Ireland

Dianeal PD4 Glucose

22,7 g + 5,38 g + 4,48 g + 0,184 g + 0,051 g/l

Solution for peritoneal dialysis

Intraperitoneal use

Lithuania

Baxter Healthcare S.A., Moneen Road, Castlebar County Mayo, Ireland

Dianeal PD4 Glucose

38,6 g + 5,38 g + 4,48 g + 0,184 g + 0,051 g/l

Solution for peritoneal dialysis

Intraperitoneal use

Lithuania

Baxter Oy, P.O. Box 270 Valimotie 15A 00381 Helsinki, Finland

EXTRANEAL

75 g + 5,4 g + 4,5 g + 0,257 g + 0,051 g/1 000 ml

Solution for peritoneal dialysis

Intraperitoneal use

Luxembourg

Dianeal PD4 Glucose

1,36 %/2,27 %/3,86 % dextrose anydre

Solution for peritoneal dialysis

Intraperitoneal use

Luxembourg

Extraneal

75,00 g/l Icodextrine

Solution for peritoneal dialysis

Intraperitoneal use

Malta

Dianeal PD4 Glucose 1,36 % w/v 13,6 mg/ml

Anhydrous Glucose Ph.Eur. 1,36 % w/v

or Glucose Monohydrate Ph.Eur. 1,50 % w/v

Sodium Chloride Ph.Eur. 0,538 % w/v

Sodium Lactate Ph.Eur. 0,448 % w/v

Calcium Chloride Ph.Eur. 0,0184 % w/v

Magnesium Chloride Ph.Eur. 0,0051 % w/v

Solution for peritoneal dialysis

Intraperitoneal use

Malta

Dianeal PD4 Glucose 2,27 % w/v 22,7 mg/ml

Anhydrous Glucose Ph.Eur. 2,27 % w/v

or Glucose Monohydrate Ph.Eur. 2,50 % w/v

Sodium Chloride Ph.Eur. 0,538 % w/v

Sodium Lactate Ph.Eur. 0,448 % w/v

Calcium Chloride Ph.Eur. 0,0184 % w/v

Magnesium Chloride Ph.Eur. 0,0051 % w/v

Solution for peritoneal dialysis

Intraperitoneal use

Malta

Dianeal PD4 Glucose 3,86 % w/v 38,6 mg/ml

Anhydrous Glucose Ph.Eur. 3,86 % w/v

or Glucose Monohydrate Ph.Eur. 4,25 % w/v

Sodium Chloride Ph.Eur. 0,538 % w/v

Sodium Lactate Ph.Eur. 0,448 % w/v

Calcium Chloride Ph.Eur. 0,0184 % w/v

Magnesium Chloride Ph.Eur. 0,0051 % w/v

Solution for peritoneal dialysis

Intraperitoneal use

Malta

Extraneal (Icodextrin 7,5 %)

Icodextrin (75 g/l), Sodium chloride (5,4 g/l),

Calcium chloride (0,257 g/l), Magnesium chloride

(0,051 g/l), Sodium lactate solution (4,5 g/l)

Solution for peritoneal dialysis

Intraperitoneal use

Norway

Extraneal

75 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Poland

Dianeal PD4 (glukoza 1,36 %). Zestaw do dializy otrzewnowej

Solution for peritoneal dialysis

Intraperitoneal use

Poland

Dianeal PD4 (glukoza 2,27 %). Zestaw do dializy otrzewnowej

Solution for peritoneal dialysis

Intraperitoneal use

Poland

Dianeal PD4 (glukoza 3,86 %). Zestaw do dializy otrzewnowej

Solution for peritoneal dialysis

Intraperitoneal use

Poland

Extraneal Zestaw do dializy otrzewnowej

Solution for peritoneal dialysis

Intraperitoneal use

Poland

Extraneal Zestaw do dializy otrzewnowej

Solution for peritoneal dialysis

Intraperitoneal use

Portugal

Baxter Médico-Farmacêutica, Lda. Zona Industrial da Abrunheira - Edifício 10 - Sintra Business Park, 2710-089 Sintra Portugal

Dianeal Pd4

42,5 mg/ml Glucose Monohydrate; 5,38 mg/ml Sodium Chloride; 0,184 mg/ml Calcium Chloride Dihydrate; 0,051 mg/ml Magnesium Chloride Hexahydrate; 4,48 mg/ml Sodium Lactate.

Solution for peritoneal dialysis

Intraperitoneal use

Portugal

Baxter Médico-Farmacêutica, Lda. Zona Industrial da Abrunheira - Edifício 10 - Sintra Business Park, 2710-089 Sintra Portugal

Dianeal Pd4

25 mg/ml Glucose Monohydrate; 5,38 mg/ml Sodium Chloride; 0,184 mg/ml Calcium Chloride Dihydrate; 0,051 mg/ml Magnesium Chloride Hexahydrate; 4,48 mg/ml Sodium Lactate.

Solution for peritoneal dialysis

Intraperitoneal use

Portugal

Baxter Médico-Farmacêutica, Lda. Zona Industrial da Abrunheira - Edifício 10 - Sintra Business Park, 2710-089 Sintra Portugal

Dianeal Pd4

15 mg/ml Glucose Monohydrate; 5,38 mg/ml Sodium Chloride; 0,184 mg/ml Calcium Chloride Dihydrate; 0,051 mg/ml Magnesium Chloride Hexahydrate; 4,48 mg/ml Sodium Lactate.

Solution for peritoneal dialysis

Intraperitoneal use

Portugal

Baxter Médico-Farmacêutica, Lda. Zona Industrial da Abrunheira - Edifício 10 - Sintra Business Park, 2710-089 Sintra Portugal

Extraneal

75 mg/ml Icodextrin; 5,4 mg/ml Sodium Chloride; 4,5 mg/ml Sodium (S) - lactate solution; 0,051 mg/ml Magnesium Chloride; 0,257 mg/ml Calcium Chloride.

Solution for peritoneal dialysis

Intraperitoneal use

Romania

DIANEAL PD4 GLUCOSE 1,36 % m/v (13,6 mg/ml),

13,6 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Romania

DIANEAL PD4 GLUCOSE 2,27 % m/v (22,7 mg/ml)

22,7 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Romania

DIANEAL PD4 GLUCOSE 3,86 % m/v (38,6 mg/ml)

38,6 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Romania

EXTRANEAL

75 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Slovak Republic

DIANEAL PD4 glucose 1,36 % w/v/13,6 mg/ ml

13,6 mg/1 ml

Solution for peritoneal dialysis

Intraperitoneal use

Slovak Republic

DIANEAL PD4 glucose 2,27 % w/v/22,7 mg/ ml

22,7 mg/1 ml

Solution for peritoneal dialysis

Intraperitoneal use

Slovak Republic

DIANEAL PD4 glucose 3,86 % w/v/38,6 mg/ ml

38,6 mg/1 ml

Solution for peritoneal dialysis

Intraperitoneal use

Slovak Republic

Baxter Healthcare Ltd. Caxton Way Thetford Norfolk IP24 3SE United Kingdom

EXTRANEAL

7,5 %

Solution for peritoneal dialysis

Intraperitoneal use

Slovenia

Baxter d.o.o., Zelezna cesta 18, Ljubljana, SI-1000, Slovenia

Dianeal PD4 13,6 mg/ml glukoze raztopina za peritonelano dializo

13,6 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Slovenia

Baxter d.o.o., Zelezna cesta 18, Ljubljana, SI-1000, Slovenia

Dianeal PD4 22,7 mg/ml glukoze raztopina za peritonelano dializo

22,7 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Slovenia

Baxter d.o.o., Zelezna cesta 18, Ljubljana, SI-1000, Slovenia

Dianeal PD4 38,6 mg/ml glukoze raztopina za peritonelano dializo

38,6 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Slovenia

Baxter d.o.o., Zelezna cesta 18, Ljubljana, SI-1000, Slovenia

Extraneal 75 mg/ml ikodekstrina raztopina za peritonealno dializo

75 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Spain

Dianeal PD4 Glucosa 1,36 %

15,0 g/l; 5,38 g/l; 4,48 g/l; 0,184 g/l; 0,051 g/l

Solution for peritoneal dialysis

Intraperitoneal use

Spain

Dianeal PD4 Glucosa 1,36 % con sistema de desconexión integrado

15,0 g/l; 5,38 g/l; 4,48 g/l; 0,184 g/l; 0,051 g/l

Solution for peritoneal dialysis

Intraperitoneal use

Spain

Dianeal PD4 Glucosa 2,27 %

25,0 g/l; 5,38 g/l; 4,48 g/l; 0,184 g/l; 0,051 g/l

Solution for peritoneal dialysis

Intraperitoneal use

Spain

Dianeal PD4 Glucosa 2,27 % con sistema de desconexión integrado

25,0 g/l; 5,38 g/l; 4,48 g/l; 0,184 g/l; 0,051 g/l

Solution for peritoneal dialysis

Intraperitoneal use

Spain

Dianeal PD4 Glucosa 3,86 %

42,50 g/l; 5,38 g/l; 4,48 g/l; 0,184 g/l; 0,051 g/l

Solution for peritoneal dialysis

Intraperitoneal use

Spain

Dianeal PD4 Glucosa 3,86 % con sistema de desconexión integrado

42,50 g/l; 5,38 g/l; 4,48 g/l; 0,184 g/l; 0,051 g/l

Solution for peritoneal dialysis

Intraperitoneal use

Spain

EXTRANEAL

Solución para diálisis peritoneal

75 g/l; 5,4 g/l; 4,5 g/l; 0,257 g/l; 0,051 g/l

Solution for peritoneal dialysis

Intraperitoneal use

Sweden

Baxter Healthare SA Moneen Road Castlebar County Mayo Irland

Dianeal PD4 med glucos 13,6 mg/ml

13,6 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Sweden

Baxter Healthare SA Moneen Road Castlebar County Mayo Irland

Dianeal PD4 med glucos 22,7 mg/ml

22,7 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Sweden

Baxter Healthare SA Moneen Road Castlebar County Mayo Irland

Dianeal PD4 med glucos 38,6 mg/ml

38,6 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Sweden

Baxter Medical AB Box 63 164 94 Kista Sverige Sweden

Extraneal

7,5 %

Solution for peritoneal dialysis

Intraperitoneal use

The Netherlands

Baxter B.V., Kobaltweg 49, 3542 CE Utrecht, the Netherlands

Dianeal PD4 Glucose 1,36 %/13,6 mg/ml, peritoneaaldialysevloeistof

13,6 g/l glucose anhydrate

Solution for peritoneal dialysis

Intraperitoneal use

The Netherlands

Baxter B.V., Kobaltweg 49, 3542 CE Utrecht, the Netherlands

Dianeal PD4 Glucose 2,27 %/22,7 mg/ml, peritoneaaldialysevloeistof

22,7 g/l glucose anhydrate

Solution for peritoneal dialysis

Intraperitoneal use

The Netherlands

Baxter B.V., Kobaltweg 49, 3542 CE Utrecht, the Netherlands

Dianeal PD4 Glucose 3,86 %/38,6 mg/ml, peritoneaaldialysevloeistof

38,6 g/l glucose anhydrate

Solution for peritoneal dialysis

Intraperitoneal use

The Netherlands

Baxter B.V., Kobaltweg 49, 3542 CE Utrecht, the Netherlands

EXTRANEAL 7,5 %, oplossing voor peritoneale dialyse

75 g/l icodextrine

Solution for peritoneal dialysis

Intraperitoneal use

United Kingdom

Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk IP24 3SE, United Kingdom

Dianeal PD4 Glucose 1,36 % w/v /13,6 mg/ml

magnseium chloride 0,005 % w/v; glucose 1,36 % w/v; sodium lactate 0,45 % w/v; calcium chloride 0,018 % w/v; sodium chloride 0,54 % w/v

Solution for peritoneal dialysis

Intraperitoneal use

United Kingdom

Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk IP24 3SE, United Kingdom

Dianeal PD4 Glucose 2,27 % w/v /22,7 mg/ml

magnseium chloride 0,005 % w/v; glucose 2,27 % w/v; sodium lactate 0,45 % w/v; calcium chloride 0,018 % w/v; sodium chloride 0,54 % w/v

Solution for peritoneal dialysis

Intraperitoneal use

United Kingdom

Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk IP24 3SE, United Kingdom

Dianeal PD4 Glucose 3,86 % w/v /38,6 mg/ml

magnseium chloride 0,005 % w/v; glucose 3,86 % w/v; sodium lactate 0,45 % w/v; calcium chloride 0,018 % w/v; sodium chloride 0,54 % w/v

Solution for peritoneal dialysis

Intraperitoneal use

United Kingdom

Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk IP24 3SE, United Kingdom

Extraneal (Icodextrin 7,5 %) Solution for peritoneal dialysis

icodextrin 75 g/l; sodium chloride 5,4 g/l; calcium chloride 0,257 g/l; magnesium chloride 0,051 g/l; sodium s-lactate 4,5 g/l

Solution for peritoneal dialysis

Intraperitoneal use

Member State EU/EEA

Marketing authorisation holder

Applicant

(Invented) Name

Strength

Pharmaceutical form

Route of administration

France

ISOTRETINOINE RANBAXY 10 mg, capsule molle

10 mg

Capsules, soft

Oral

France

ISOTRETINOINE RANBAXY 20 mg, capsule molle

20 mg

Capsules, soft

Oral

Spain

ISOTRETINOINA RANBAXY 10 mg CAPSULAS BLANDAS EFG

10 mg

Capsules, soft

Oral

Spain

ISOTRETINOINA RANBAXY 20 mg CAPSULAS BLANDAS EFG

20 mg

Capsules, soft

Oral

United Kingdom

Isotretinoin 10 mg Capsules

10 mg

Capsules, soft

Oral

United Kingdom

Isotretinoin 20 mg Capsules

20 mg

Capsules, soft

Oral

Member State EU/EEA

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

AT - Austria

Octagam 100 mg/ml Infusionslösung

100 mg/ml

Solution for infusion

Intravenous Use

AT - Austria

Octagam 50 mg/ml Infusionslösung

50 mg/ml

Solution for infusion

Intravenous Use

BE - Belgium

Octagam 10 %, solution pour perfusion

10 % (100 mg/ml)

Solution for infusion

Intravenous Use

BE - Belgium

Octagam 50 mg/ml solution pour perfusion

50 mg/ml

Solution for infusion

Intravenous Use

BG - Bulgaria

Octagam 10 %

100 mg/ml

Solution for infusion

Intravenous Use

CY - Cyprus

OCTAGAM INFUSION 10 %

10 %

Solution for infusion

Intravenous use

CY - Cyprus

OCTAGAM INFUSION 5 %

5 %

Solution for infusion

Intravenous use

CZ - Czech Republic

OCTAGAM

50 mg/ml

Solution for infusion

Intravenous Use

CZ - Czech Republic

OCTAGAM 10 %

100 mg/ml

Solution for infusion

Intravenous Use

DE - Germany

Octagam 50 mg/ml

50 mg/ml

Solution for infusion

Intravenous Use

DE - Germany

Octagam 5 %

50 mg/ml

Solution for infusion

Intravenous Use

DE - Germany

Octagam 10 %

100 mg/ml

Solution for infusion

Intravenous Use

DK - Denmark

Octagam

50 mg/ml

Solution for infusion

Intravenous Use

DK - Denmark

Octagam

100 mg/ml

Solution for infusion

Intravenous Use

EL - Greece

OCTAGAM

5 % (W/V)

Solution for infusion

Intravenous Use

EL - Greece

OCTAGAM

10 % (100 MG/ML)

Solution for infusion

Intravenous Use

ES - Spain

Octagamocta 100 mg/ml solución para perfusión

100 mg/ml

Solution for infusion

Intravenous use

ES - Spain

Octagamocta 50 mg/ml solución para perfusión

50 mg/ml

Solution for infusion

Intravenous use

ET - Estonia

OCTAGAM

50 mg/ml

Solution for infusion

Intravenous Use

ET - Estonia

OCTAGAM 10 %

100 mg/1 ml

Solution for infusion

Intravenous Use

FI - Finland

OCTAGAM

50 mg/ml

100 mg/ml

Solution for infusion

Intravenous Use

FR - France

OCTAGAM 100 mg/ml, solution pour perfusion

100 mg/ml

Solution for infusion

Intravenous Use

FR - France

OCTAGAM 50 mg/ml, solution pour perfusion

50 mg/ml

Solution for infusion

Intravenous Use

HU - Hungary

OCTAGAM 50 mg/ml oldatos infúzió

50 mg/ml

Solution for infusion

Intravenous Use

HU - Hungary

OCTAGAM 100 mg/ml oldatos infúzió

100 mg/ml

Solution for infusion

Intravenous Use

IS - Iceland

Octagam 5 %

50 mg/ml

Solution for infusion

Intravenous Use

IS - Iceland

Octagam 10 %

100 mg/ml

Solution for infusion

Intravenous Use

IT - Italy

OCTAGAM

5 %

Solution for infusion

Intravenous Use

LT - Lithuania

octagam

100 mg/ml

Solution for infusion

Intravenous Use

LU - Luxembourg

Octagam

5 %

Solution for infusion

Intravenous use

LU - Luxembourg

Octagam-10

10 %

Solution for infusion

Intravenous use

LV - Latvia

Octagam 50 mg/ml solution for infusion

1 g/20 ml

Solution for infusion

Intravenous Use

LV - Latvia

Octagam 50 mg/ml solution for infusion

2,5 g/50 ml

Solution for infusion

Intravenous Use

LV - Latvia

Octagam 50 mg/ml solution for infusion

5 g/100 ml

Solution for infusion

Intravenous Use

LV - Latvia

Octagam 50 mg/ml solution for infusion

10 g/200 ml

Solution for infusion

Intravenous Use

LV - Latvia

Octagam 100 mg/ml šķīdums infūzijām, 2 g/20 ml

2 g/20 ml

Solution for infusion

Intravenous Use

LV - Latvia

Octagam 100 mg/ml šķīdums infūzijām, 5 g/50 ml

5 g/50 ml

Solution for infusion

Intravenous Use

LV - Latvia

Octagam 100 mg/ml šķīdums infūzijām, 10 g/100 ml

10 g/100 ml

Solution for infusion

Intravenous Use

LV - Latvia

Octagam 100 mg/ml šķīdums infūzijām, 20 g/200 ml

20 g/200 ml

Solution for infusion

Intravenous Use

MT - Malta

OCTAGAM 10 %

1 ml contains: protein 100 mg (of which ≥ 95 % is human Immunoglobulin G), IgA ≤ 0,4 mg, IgM ≤ 0,3 mg

Solution for infusion

Intravenous use

NL - Netherlands

Octagam 10 %

100 mg/ml

Solution for infusion

Intravenous Use

NL - Netherlands

Octagam 5 %

50 mg/ml

Solution for infusion

Intravenous Use

NO - Norway

Octagam

50 mg/ml

Solution for infusion

Intravenous Use

NO - Norway

Octagam

100 mg/ml

Solution for infusion

Intravenous Use

PL - Poland

Octagam

2,5 g/50 ml

Solution for infusion

Intravenous Use

PL - Poland

Octagam

5 g/100 ml

Solution for infusion

Intravenous Use

PL - Poland

Octagam 10 %

20 g/200 ml

Solution for infusion

Intravenous Use

PL - Poland

Octagam 10 %

100 mg/ml

Solution for infusion

Intravenous Use

PT - Portugal

Octagam

50 mg/ml

Solution for infusion

Intravenous use

PT - Portugal

Octagam

100 mg/ml

Solution for infusion

Intravenous use

RO - Romania

OCTAGAM

50 mg/ml

Solution for infusion

Intravenous use

RO - Romania

OCTAGAM 10 %

100 mg/ml

Solution for infusion

Intravenous use

SE - Sweden

Octagem

50 mg/ml

Solution for infusion

Intravenous use

SE - Sweden

Octagem

100 mg/ml

Solution for infusion

Intravenous use

SI - Slovenia

Octagam 50 mg/ml raztopina za infundiranje

50 mg/ ml

Solution for infusion

Intravenous use

SI - Slovenia

Octagam 100 mg/ml raztopina za infundiranje

100 mg/ ml

Solution for infusion

Intravenous use

SK - Slovakia

Octagam

20 ml 50 mg/ml

Solution for infusion

Intravenous use

SK - Slovakia

Octagam

50 ml 50 mg/ml

Solution for infusion

Intravenous use

SK - Slovakia

Octagam

100 ml 50 mg/ml

Solution for infusion

Intravenous use

SK - Slovakia

Octagam

200 ml 50 mg/ml

Solution for infusion

Intravenous use

SK - Slovakia

Octagam 10 %

20 ml 100 mg/ml

Solution for infusion

Intravenous use

SK - Slovakia

Octagam 10 %

50 ml 100 mg/ml

Solution for infusion

Intravenous use

SK - Slovakia

Octagam 10 %

100 ml 100 mg/ml

Solution for infusion

Intravenous use

SK - Slovakia

Octagam 10 %

200 ml 100 mg/ml

Solution for infusion

Intravenous use

UK - United Kingdom

Octagam Infusion

5 % w/v

Solution for infusion

Intravenous use

UK - United Kingdom

Octagam 10 % solution for Infusion

10 % w/v

Solution for infusion

Intravenous use

Member State EU/EEA

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

AT - Austria

Octagam 100 mg/ml Infusionslösung

100 mg/ml

Solution for infusion

Intravenous Use

AT - Austria

Octagam 50 mg/ml Infusionslösung

50 mg/ml

Solution for infusion

Intravenous Use

BE - Belgium

Octagam 10 %, solution pour perfusion

10 % (100 mg/ml)

Solution for infusion

Intravenous Use

BE - Belgium

Octagam 50 mg/ml solution pour perfusion

50 mg/ml

Solution for infusion

Intravenous Use

BG - Bulgaria

Octagam 10 %

100 mg/ml

Solution for infusion

Intravenous Use

CY - Cyprus

Octagam Infusion 10 %

10 %

Solution for infusion

Intravenous use

CY - Cyprus

Octagam Infusion 5 %

5 %

Solution for infusion

Intravenous use

CZ - Czech Republic

Octagam

50 mg/ml

Solution for infusion

Intravenous Use

CZ - Czech Republic

Octagam 10 %

100 mg/ml

Solution for infusion

Intravenous Use

DE - Germany

Octagam 50 mg/ml

50 mg/ml

Solution for infusion

Intravenous Use

DE - Germany

Octagam 5 %

50 mg/ml

Solution for infusion

Intravenous Use

DE - Germany

Octagam 10 %

100 mg/ml

Solution for infusion

Intravenous Use

DK - Denmark

Octagam

50 mg/ml

Solution for infusion

Intravenous Use

DK - Denmark

Octagam

100 mg/ml

Solution for infusion

Intravenous Use

EL - Greece

Octagam

5 % (W/V)

Solution for infusion

Intravenous Use

EL - Greece

Octagam

10 % (100 MG/ML)

Solution for infusion

Intravenous Use

ES - Spain

Octagamocta 100 mg/ml solución para perfusión

100 mg/ml

Solution for infusion

Intravenous use

ES - Spain

Octagamocta 50 mg/ml solución para perfusión

50 mg/ml

Solution for infusion

Intravenous use

ET - Estonia

Octagam

50 mg/ml

Solution for infusion

Intravenous Use

ET - Estonia

Octagam 10 %

100 mg/1 ml

Solution for infusion

Intravenous Use

FI - Finland

Octagam

50 mg/ml

100 mg/ml

Solution for infusion

Intravenous Use

FR - France

Octagam 100 mg/ml, solution pour perfusion

100 mg/ml

Solution for infusion

Intravenous Use

FR - France

Octagam 50 mg/ml, solution pour perfusion

50 mg/ml

Solution for infusion

Intravenous Use

HU - Hungary

Octagam 50 mg/ml oldatos infúzió

50 mg/ml

Solution for infusion

Intravenous Use

HU - Hungary

Octagam 100 mg/ml oldatos infúzió

100 mg/ml

Solution for infusion

Intravenous Use

IS - Iceland

Octagam 5 %

50 mg/ml

Solution for infusion

Intravenous Use

IS - Iceland

Octagam 10 %

100 mg/ml

Solution for infusion

Intravenous Use

IT - Italy

Octagam

5 %

Solution for infusion

Intravenous Use

IT – Italy

Gamten

10 %

Solution for infusion

Intravenous Use

LT - Lithuania

Octagam

100 mg/ml

Solution for infusion

Intravenous Use

LU - Luxembourg

Octagam

5 %

Solution for infusion

Intravenous use

LU - Luxembourg

Octagam-10

10 %

Solution for infusion

Intravenous use

LV - Latvia

Octagam 50 mg/ml solution for infusion

1 g/20 ml

Solution for infusion

Intravenous Use

LV - Latvia

Octagam 50 mg/ml solution for infusion

2,5 g/50 ml

Solution for infusion

Intravenous Use

LV - Latvia

Octagam 50 mg/ml solution for infusion

5 g/100 ml

Solution for infusion

Intravenous Use

LV - Latvia

Octagam 50 mg/ml solution for infusion

10 g/200 ml

Solution for infusion

Intravenous Use

LV - Latvia

Octagam 100 mg/ml solution for infusion, 2 g/20 ml

2 g/20 ml

Solution for infusion

Intravenous Use

LV - Latvia

Octagam 100 mg/ml solution for infusion, 5 g/50 ml

5 g/50 ml

Solution for infusion

Intravenous Use

LV - Latvia

Octagam 100 mg/ml solution for infusion, 10 g/100 ml

10 g/100 ml

Solution for infusion

Intravenous Use

LV - Latvia

Octagam 100 mg/ml solution for infusion, 20 g/200 ml

20 g/200 ml

Solution for infusion

Intravenous Use

MT - Malta

Octagam 10 %, solution for infusion

1 ml contains: protein 100 mg (of which ≥ 95 % is human Immunoglobulin G), IgA ≤ 0,4 mg, IgM ≤ 0,3 mg

Solution for infusion

Intravenous use

NL - Netherlands

Octagam 10 %

100 mg/ml

Solution for infusion

Intravenous Use

NL - Netherlands

Octagam 5 %

50 mg/ml

Solution for infusion

Intravenous Use

NO - Norway

Octagam

50 mg/ml

Solution for infusion

Intravenous Use

NO - Norway

Octagam

100 mg/ml

Solution for infusion

Intravenous Use

PL - Poland

Octagam

2,5 g/50 ml

Solution for infusion

Intravenous Use

PL - Poland

Octagam

5 g/100 ml

Solution for infusion

Intravenous Use

PL - Poland

Octagam

10 g/200 ml

Solution for infusion

Intravenous Use

PL - Poland

Octagam 10 %

100 mg/ml

Solution for infusion

Intravenous Use

PT - Portugal

Octagam

50 mg/ml

Solution for infusion

Intravenous use

PT - Portugal

Octagam

100 mg/ml

Solution for infusion

Intravenous use

RO - Romania

Octagam

50 mg/ml

Solution for infusion

Intravenous use

RO - Romania

Octagam 10 %

100 mg/ml

Solution for infusion

Intravenous use

SE - Sweden

Octagam

50 mg/ml

Solution for infusion

Intravenous use

SE - Sweden

Octagam

100 mg/ml

Solution for infusion

Intravenous use

SI - Slovenia

Octagam 50 mg/ml raztopina za infundiranje

50 mg/ ml

Solution for infusion

Intravenous use

SI - Slovenia

Octagam 100 mg/ml raztopina za infundiranje

100 mg/ ml

Solution for infusion

Intravenous use

SK - Slovakia

Octagam

50 mg/ml

Solution for infusion

Intravenous use

SK - Slovakia

Octagam 10 %

100 mg/ml

Solution for infusion

Intravenous use

UK - United Kingdom

Octagam Infusion

5 % w/v

Solution for infusion

Intravenous use

UK - United Kingdom

Octagam 10 % solution for Infusion

10 % w/v

Solution for infusion

Intravenous use