# C_2012056EN.01002601.xml

| 24.2.2012 | EN | Official Journal of the European Union | C 56/26 |
| --- | --- | --- | --- |

24.2.2012

EN

Official Journal of the European Union

C 56/26

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2011 to 31 December 2011

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

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC

1

or Article 38 of Directive 2001/82/EC

2

)

2012/C 56/02

—   Issuing, maintenance or modification of a national marketing authorization

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 |
| --- | --- | --- | --- | --- |
| 16.12.2011 | Dianeal, Extraneal, Nutrineal, Monosol and sodium chloride 0,9% solution for haemodialysis
  (Baxter) | See Annex I | See Annex I | 19.12.2011 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

16.12.2011

Dianeal, Extraneal, Nutrineal, Monosol and sodium chloride 0,9% solution for haemodialysis

(Baxter)

See Annex I

See Annex I

19.12.2011

—   Suspension of a national marketing authorization

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 |
| --- | --- | --- | --- | --- |
| 3.11.2011 | HIPRABOVIS PNEUMOS Emulsion for injection for cattle | See Annex II | See Annex II | 7.11.2011 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

3.11.2011

HIPRABOVIS PNEUMOS Emulsion for injection for cattle

See Annex II

See Annex II

7.11.2011

---

(1)  OJ L 311, 28.11.2001, p. 67.

1

(2)  OJ L 311, 28.11.2001, p. 1.

2

---

ANNEX I

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

| Member State EU/EEA | Marketing authorisation holder | Invented name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | Baxter Healthcare GmbH, |
| Stella-Klein-Löw-Weg 15, |
| A-1020 Wien |
| Austria |

Member State EU/EEA

Marketing authorisation holder

Invented name

Strength

Pharmaceutical form

Route of administration

Austria

Baxter Healthcare GmbH,

Stella-Klein-Löw-Weg 15,

A-1020 Wien

Austria

EXTRANEAL - Peritonealdialyselösung

75 g/L

solution for peritoneal dialysis

intraperitoneal use

Austria

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

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 |

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 |

Baxter Healthcare GmbH,

Stella-Klein-Löw-Weg 15,

A-1020 Wien

Austria

Nutrineal PD4 mit 1,1 % Aminosäuren - Peritonealdialyselösung

alanine 951 mg/L, arginine 1 071 mg/L, glycine 510 mg/L, histidine 714 mg/L, isoleucine 850 mg/L, leucine 1 020 mg/L, lysine hydrochloride 955 mg/L, methionine 850 mg/L, phenylalanine 570 mg/L, proline 595 mg/L, serine 510 mg/L, threonine 646 mg/L, tryptophan 270 mg/L, tyrosine 300 mg/L, valine 1 393 mg/L, sodium chloride 5 380 mg/L, calcium chloride dihydrate 184 mg/L, magnesium chloride hexahydrate 51 mg/L, sodium(s)-lactate 4 480 mg/L

solution for peritoneal dialysis

intraperitoneal use

Austria

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

Baxter Healthcare GmbH,

Stella-Klein-Löw-Weg 15,

A-1020 Wien

Austria

Monosol Hämodialyse-, Hämodiafiltrations- und Hämofiltrationslösung

Glucose monohydrate 1,1 g/L, sodium chloride 6,43 g/L, sodium lactate 3,36 g/L, calcium chloride dihydrate 0,257 g/L, magnesium chloride hexahydrate 0,152 g/L

solution for haemodialysis, haemodiafiltration and haemofiltration

intraarterial use, intravenous use, hemodialysis

Austria

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

Baxter Healthcare GmbH,

Stella-Klein-Löw-Weg 15,

A-1020 Wien

Austria

Monosol-K mit 2mEq Kalium/l Hämodialyse-, Hämodiafiltrations- und Hämofiltrationslösung

Glucose monohydrate 1,1 g/L, sodium chloride 6,43 g/L, sodium lactate 3,36 g/L, calcium chloride dihydrate 0,257 g/L, magnesium chloride hexahydrate 0,152 g/L, potassium chloride 0,149 g/L

solution for haemodialysis, haemodiafiltration and haemofiltration

intraarterial use, intravenous use, hemodialysis

Austria

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

Baxter Healthcare GmbH,

Stella-Klein-Löw-Weg 15,

A-1020 Wien

Austria

Monosol-K mit 4mEq Kalium/l Hämodialyse-, Hämodiafiltrations- und Hämofiltrationslösung

Glucose monohydrate 1,1 g/L, sodium chloride 6,43 g/L, sodium lactate 3,36 g/L, calcium chloride dihydrate 0,257 g/L, magnesium chloride hexahydrate 0,152 g/L, potassium chloride 0,298 g/L

solution for haemodialysis, haemodiafiltration and haemofiltration

intraarterial use, intravenous use, hemodialysis

Belgium

| Baxter SA |
| --- |
| Boulevard R. Branquart 80 |
| 7680 Lessines |
| Belgium |

Baxter SA

Boulevard R. Branquart 80

7680 Lessines

Belgium

EXTRANEAL 7,5 %, solution pour dialyse péritonéale

75,00 g/l Icodextrine

solution for peritoneal dialysis

intraperitoneal use

Belgium

| Baxter SA |
| --- |
| Boulevard R. Branquart 80 |
| 7680 Lessines |
| Belgium |

Baxter SA

Boulevard R. Branquart 80

7680 Lessines

Belgium

Dianeal PD1 Glucose 1,36 % (13,6 mg/ml), solution pour dialyse péritonéale

13,60 g/l glucose anhydrate

solution for peritoneal dialysis

intraperitoneal use

Belgium

| Baxter SA |
| --- |
| Boulevard R. Branquart 80 |
| 7680 Lessines |
| Belgium |

Baxter SA

Boulevard R. Branquart 80

7680 Lessines

Belgium

Dianeal PD1 Glucose 2,27 % (22,7 mg/ml), solution pour dialyse péritonéale

22,7 g/l glucose anhydrate

solution for peritoneal dialysis

intraperitoneal use

Belgium

| Baxter SA |
| --- |
| Boulevard R. Branquart 80 |
| 7680 Lessines |
| Belgium |

Baxter SA

Boulevard R. Branquart 80

7680 Lessines

Belgium

Dianeal PD1 Glucose 3,86 % (38,6 mg/ml), solution pour dialyse péritonéale

38,6 g/l glucose anhydrate

solution for peritoneal dialysis

intraperitoneal use

Belgium

| Baxter SA |
| --- |
| Boulevard R. Branquart 80 |
| 7680 Lessines |
| Belgium |

Baxter SA

Boulevard R. Branquart 80

7680 Lessines

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

| Baxter SA |
| --- |
| Boulevard R. Branquart 80 |
| 7680 Lessines |
| Belgium |

Baxter SA

Boulevard R. Branquart 80

7680 Lessines

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

| Baxter SA |
| --- |
| Boulevard R. Branquart 80 |
| 7680 Lessines |
| Belgium |

Baxter SA

Boulevard R. Branquart 80

7680 Lessines

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

| Baxter SA |
| --- |
| Boulevard R. Branquart 80 |
| 7680 Lessines |
| Belgium |

Baxter SA

Boulevard R. Branquart 80

7680 Lessines

Belgium

Nutrineal Peritoneal Dialysis 4 à 1,1 % d’acides aminés, solution pour dialyse péritonéale

4 to 1,1% acides aminés

solution for peritoneal dialysis

intraperitoneal use

Bulgaria

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

BAXTER d.o.o.,

Zelezna cesta 18,

1000 Ljubljana

Slovenia

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

1,36% w/v/ 13,6mg/ml

solution for peritoneal dialysis

intraperitoneal use

Bulgaria

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

BAXTER d.o.o.,

Zelezna cesta 18,

1000 Ljubljana

Slovenia

Dianeal PD4 Glucose

2,27% w/v/ 22,7mg/ml

solution for peritoneal dialysis

intraperitoneal use

Bulgaria

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

BAXTER d.o.o.,

Zelezna cesta 18,

1000 Ljubljana

Slovenia

Dianeal PD4 Glucose

3,86% w/v/ 38,6mg/ml

solution for peritoneal dialysis

intraperitoneal use

Bulgaria

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

BAXTER d.o.o.,

Zelezna cesta 18,

1000 Ljubljana

Slovenia

Extraneal

7,50%

solution for peritoneal dialysis

intraperitoneal use

Bulgaria

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

BAXTER d.o.o.,

Zelezna cesta 18,

1000 Ljubljana

Slovenia

Nutrineal PD 4 with 1,1% Amino Acids

solution for peritoneal dialysis

intraperitoneal use

Czech Republic

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

Baxter Healthcare S.A.

Moneen Road Castlebar,

Co. Mayo

Ireland

EXTRANEAL

7,5 % 75 g / 1 000 ml

solution for peritoneal dialysis

peritoneal use

Czech Republic

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

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

peritoneal use

Czech Republic

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

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 / 22,7 mg/ml

solution for peritoneal dialysis

peritoneal use

Czech Republic

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

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

peritoneal use

Czech Republic

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

Baxter Healthcare S.A.

Moneen Road Castlebar,

Co. Mayo

Ireland

NUTRINEAL PD4 WITH 1,1% AMINOACIDS

1,10%

solution for peritoneal dialysis

peritoneal use

Denmark

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

Baxter A/S,

Gydevang 43,

DK-3450 Allerød

Denmark

Natriumklorid Baxter 9 mg/ml

9 mg/ml

solution for infusion

intravenous use

Denmark

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

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 |

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 |

Baxter A/S,

Gydevang 43,

DK-3450 Allerød

Denmark

Extraneal

75 mg/ml

solution for peritoneal dialysis

intraperitoneal use

Denmark

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

Baxter A/S,

Gydevang 43,

DK-3450 Allerød

Denmark

Nutrineal PD4 med 1,1 % aminosyrer

1,1 %/1 000 ml

solution for peritoneal dialysis

intraperitoneal use

Estonia

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

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 |

Baxter Healthcare S.A.

Moneen Road, Castlebar

County Mayo

Ireland

Natriumklorid Baxter 9 mg/ml

9 mg/ml

solution for infusion

intravenous use

Finland

| Baxter Oy |
| --- |
| Valimotie 15 A |
| 00380 Helsinki |
| Finland |

Baxter Oy

Valimotie 15 A

00380 Helsinki

Finland

Extraneal

7,50%

solution for peritoneal dialysis

intraperitoneal use

Finland

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

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 |

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 |

Baxter Healthcare S.A.

Moneen Road, Castlebar

County Mayo

Ireland

Dianeal PD4 Glucose

38,6 mg/ml

solution for peritoneal dialysis

intraperitoneal use

France

| Baxter SAS |
| --- |
| Avenue louis Pasteur |
| ZA de Coignères Maurepas |
| 78310 Maurepas |
| France |

Baxter SAS

Avenue louis Pasteur

ZA de Coignères Maurepas

78310 Maurepas

France

DIANEAL PD1 GLUCOSE 1,36 %, solution pour dialyse péritonéale en poche

1,36%

solution for peritoneal dialysis

intraperitoneal use

France

| Baxter SAS |
| --- |
| Avenue louis Pasteur |
| ZA de Coignères Maurepas |
| 78310 Maurepas |
| France |

Baxter SAS

Avenue louis Pasteur

ZA de Coignères Maurepas

78310 Maurepas

France

DIANEAL PD1 GLUCOSE 3,86 %, solution pour dialyse péritonéale en poche

3,86%

solution for peritoneal dialysis

intraperitoneal use

France

| Baxter SAS |
| --- |
| Avenue louis Pasteur |
| ZA de Coignères Maurepas |
| 78310 Maurepas |
| France |

Baxter SAS

Avenue louis Pasteur

ZA de Coignères Maurepas

78310 Maurepas

France

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

3,86%

solution for peritoneal dialysis

intraperitoneal use

France

| Baxter SAS |
| --- |
| Avenue louis Pasteur |
| ZA de Coignères Maurepas |
| 78310 Maurepas |
| France |

Baxter SAS

Avenue louis Pasteur

ZA de Coignères Maurepas

78310 Maurepas

France

DIANEAL PD1 GLUCOSE 2,27 %, solution pour dialyse péritonéale en poche

2,27%

solution for peritoneal dialysis

Intraperitoneal use

France

| Baxter SAS |
| --- |
| Avenue louis Pasteur |
| ZA de Coignères Maurepas |
| 78310 Maurepas |
| France |

Baxter SAS

Avenue louis Pasteur

ZA de Coignères Maurepas

78310 Maurepas

France

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

2,27%

solution for peritoneal dialysis

Intraperitoneal use

France

| Baxter SAS |
| --- |
| Avenue louis Pasteur |
| ZA de Coignères Maurepas |
| 78310 Maurepas |
| France |

Baxter SAS

Avenue louis Pasteur

ZA de Coignères Maurepas

78310 Maurepas

France

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

1,36%

solution for peritoneal dialysis

Intraperitoneal use

France

| Baxter SAS |
| --- |
| Avenue louis Pasteur |
| ZA de Coignères Maurepas |
| 78310 Maurepas |
| France |

Baxter SAS

Avenue louis Pasteur

ZA de Coignères Maurepas

78310 Maurepas

France

EXTRANEAL, solution pour dialyse péritonéale

7,50%

solution for peritoneal dialysis

Intraperitoneal use

France

| Baxter SAS |
| --- |
| Avenue louis Pasteur |
| ZA de Coignères Maurepas |
| 78310 Maurepas |
| France |

Baxter SAS

Avenue louis Pasteur

ZA de Coignères Maurepas

78310 Maurepas

France

NUTRINEAL PD4 A 1,1 % D'ACIDES AMINES, solution pour dialyse péritonéale

1,10%

solution for peritoneal dialysis

Intraperitoneal use

Germany

| Baxter Deutschland GmbH |
| --- |
| Edisonstr. 4 |
| D-85716 Unterschleißheim |
| Germany |

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

Germany

Dianeal PD1 Glucose 1,36% w/v

13,6 g / l

5,67 g / l

3,92 g / l

0,257 g / l

0,152 g / l

solution for peritoneal dialysis

Intraperitoneal use

Germany

| Baxter Deutschland GmbH |
| --- |
| Edisonstr. 4 |
| D-85716 Unterschleißheim |
| Germany |

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

Germany

Dianeal PD1 Glucose 2,27% w/v

22,7 g / l

5,67 g / l

3,92 g / l

0,257 g / l

0,152 g / l

solution for peritoneal dialysis

Intraperitoneal use

Germany

| Baxter Deutschland GmbH |
| --- |
| Edisonstr. 4 |
| D-85716 Unterschleißheim |
| Germany |

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

Germany

Dianeal PD1 Glucose 3,86% w/v

38,6 g / l

5,67 g / l

3,92 g / l

0,257 g / l

0,152 g / l

solution for peritoneal dialysis

Intraperitoneal use

Germany

| Baxter Deutschland GmbH |
| --- |
| Edisonstr. 4 |
| D-85716 Unterschleißheim |
| Germany |

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

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

| Baxter Deutschland GmbH |
| --- |
| Edisonstr. 4 |
| D-85716 Unterschleißheim |
| Germany |

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

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

| Baxter Deutschland GmbH |
| --- |
| Edisonstr. 4 |
| D-85716 Unterschleißheim |
| Germany |

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

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

| Baxter Deutschland GmbH |
| --- |
| Edisonstr. 4 |
| D-85716 Unterschleißheim |
| Germany |

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

Germany

Dianeal PDG1 1,36 %

13,6 g / l

5,67 g / l

3,92 g / l

0,257 g / l

0,0152 g / l

solution for peritoneal dialysis

intraperitoneal use

Germany

| Baxter Deutschland GmbH |
| --- |
| Edisonstr. 4 |
| D-85716 Unterschleißheim |
| Germany |

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

Germany

Dianeal PDG1 2,27 %

22,7 g / l

5,67 g / l

3,92 g / l

0,257 g / l

0,0152 g / l

solution for peritoneal dialysis

intraperitoneal use

Germany

| Baxter Deutschland GmbH |
| --- |
| Edisonstr. 4 |
| D-85716 Unterschleißheim |
| Germany |

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

Germany

Dianeal PDG1 3,86 %

38,6 g / l

5,67 g / l

3,92 g / l

0,257 g / l

0,0152 g / l

solution for peritoneal dialysis

intraperitoneal use

Germany

| Baxter Deutschland GmbH |
| --- |
| Edisonstr. 4 |
| D-85716 Unterschleißheim |
| Germany |

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

Germany

Dianeal PDG4 1,36 %

13,6g / l

5,38 g / l

4,48 g/ l

0,184 g / l

0,051 g / l

solution for peritoneal dialysis

intraperitoneal use

Germany

| Baxter Deutschland GmbH |
| --- |
| Edisonstr. 4 |
| D-85716 Unterschleißheim |
| Germany |

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

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

| Baxter Deutschland GmbH |
| --- |
| Edisonstr. 4 |
| D-85716 Unterschleißheim |
| Germany |

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

Germany

Dianeal PDG4 3,86 %

38,6 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

| Baxter Deutschland GmbH |
| --- |
| Edisonstr. 4 |
| D-85716 Unterschleißheim |
| Germany |

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

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

Germany

| Baxter Deutschland GmbH |
| --- |
| Edisonstr. 4 |
| D-85716 Unterschleißheim |
| Germany |

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

Germany

Nutrineal PD4 mit 1,1 % Aminosäuren

11,205 g / l

5,38 g / l

0,184 g / l

0,0508 g / l

4,48 g / l

solution for peritoneal dialysis

intraperitoneal use

Germany

| Baxter Deutschland GmbH |
| --- |
| Edisonstr. 4 |
| D-85716 Unterschleißheim |
| Germany |

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

Germany

Monosol

1,1 g / l

6,43 g / l

0,257 g / l

0,152 g / l

3,36 g / l

solution for haemodialysis

hemodialysis

Germany

| Baxter Deutschland GmbH |
| --- |
| Edisonstr. 4 |
| D-85716 Unterschleißheim |
| Germany |

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

Germany

Monosol-K mit 2 mmol Kalium/l

1,1 g / l

6,43 g / l

0,257 g / l

0,149 g / l

0,152 g / l

3,36 g / l

solution for haemodialysis

hemodialysis

Germany

| Baxter Deutschland GmbH |
| --- |
| Edisonstr. 4 |
| D-85716 Unterschleißheim |
| Germany |

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

Germany

Monosol-K mit 4 mmol Kalium/l

1,1 g / l

6,43 g / l

0,257 g / l

0,298 g / l

0,152 g / l

3,36 g / l

solution for haemodialysis

hemodialysis

Greece

| DIOPHAR S.A. |
| --- |
| Kifissias Avenue 368, |
| Halandri, 152 33 |
| Greece |

DIOPHAR S.A.

Kifissias Avenue 368,

Halandri, 152 33

Greece

DIANEAL PD1

1,36% W/V

2,27% W/V

3,86% W/V

solution for peritoneal dialysis

Intraperitoneal use

Greece

| DIOPHAR S.A. |
| --- |
| Kifissias Avenue 368, |
| 152 33 Halandri, |
| Greece |

DIOPHAR S.A.

Kifissias Avenue 368,

152 33 Halandri,

Greece

DIANEAL PD4

1,36%

2,27% W/V

3,86% W/V

solution for peritoneal dialysis

intraperitoneal use

Greece

| DIOPHAR S.A. |
| --- |
| Kifissias Avenue 368, |
| 152 33 Halandri, |
| Greece |

DIOPHAR S.A.

Kifissias Avenue 368,

152 33 Halandri,

Greece

EXTRANEAL

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

solution for peritoneal dialysis

intraperitoneal use

Greece

| DIOPHAR S.A. |
| --- |
| Kifissias Avenue 368, |
| 152 33 Halandri, |
| Greece |

DIOPHAR S.A.

Kifissias Avenue 368,

152 33 Halandri,

Greece

Nutrineal PD4

1,1%

solution for peritoneal dialysis

intraperitoneal use

Hungary

| Baxter Hungary Kft. |
| --- |
| Népfürdő u. 22. |
| 1138, Budapest |
| Hungary |

Baxter Hungary Kft.

Népfürdő u. 22.

1138, Budapest

Hungary

EXTRANEAL peritoneális dializáló oldat

7,5% (icodextrin)

solution for peritoneal dialysis

intraperitoneal use

Hungary

| Baxter Hungary Kft. |
| --- |
| Népfürdő u. 22. |
| 1138, Budapest |
| Hungary |

Baxter Hungary Kft.

Népfürdő u. 22.

1138, Budapest

Hungary

DIANEAL PD 1 Glucose 1,36% peritoneális dializáló oldat

1,36%

solution for peritoneal dialysis

intraperitoneal use

Hungary

| Baxter Hungary Kft. |
| --- |
| Népfürdő u. 22. |
| 1138, Budapest |
| Hungary |

Baxter Hungary Kft.

Népfürdő u. 22.

1138, Budapest

Hungary

DIANEAL PD 1 Glucose 2,27% peritoneális dializáló oldat

2,27%

solution for peritoneal dialysis

intraperitoneal use

Hungary

| Baxter Hungary Kft. |
| --- |
| Népfürdő u. 22. |
| 1138, Budapest |
| Hungary |

Baxter Hungary Kft.

Népfürdő u. 22.

1138, Budapest

Hungary

DIANEAL PD 1 Glucose 3,86% peritoneális dializáló oldat

3,86%

solution for peritoneal dialysis

intraperitoneal use

Hungary

| Baxter Hungary Kft. |
| --- |
| Népfürdő u. 22. |
| 1138, Budapest |
| Hungary |

Baxter Hungary Kft.

Népfürdő u. 22.

1138, Budapest

Hungary

DIANEAL PD 4 Glucose 1,36% peritoneális dializáló oldat

1,36%

solution for peritoneal dialysis

intraperitoneal use

Hungary

| Baxter Hungary Kft. |
| --- |
| Népfürdő u. 22. |
| 1138, Budapest |
| Hungary |

Baxter Hungary Kft.

Népfürdő u. 22.

1138, Budapest

Hungary

DIANEAL PD 4 Glucose 2,27% peritoneális dializáló oldat

2,27%

solution for peritoneal dialysis

intraperitoneal use

Hungary

| Baxter Hungary Kft. |
| --- |
| Népfürdő u. 22. |
| 1138, Budapest |
| Hungary |

Baxter Hungary Kft.

Népfürdő u. 22.

1138, Budapest

Hungary

DIANEAL PD 4 Glucose 3,86% peritoneális dializáló oldat

3,86%

solution for peritoneal dialysis

intraperitoneal use

Iceland

| Baxter Healthare SA |
| --- |
| Moneen Road Castlebar |
| County Mayo |
| Ireland |

Baxter Healthare SA

Moneen Road Castlebar

County Mayo

Ireland

Dianeal PD4 Glucose

13,6 mg/ml

solution for peritoneal dialysis

intraperitoneal use

Iceland

| Baxter Healthare SA |
| --- |
| Moneen Road Castlebar |
| County Mayo |
| Ireland |

Baxter Healthare SA

Moneen Road Castlebar

County Mayo

Ireland

Dianeal PD4 Glucose

22,7 mg/ml

solution for peritoneal dialysis

intraperitoneal use

Iceland

| Baxter Healthare SA |
| --- |
| Moneen Road Castlebar |
| County Mayo |
| Ireland |

Baxter Healthare SA

Moneen Road Castlebar

County Mayo

Ireland

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 |

Baxter Healthcare Limited,

Caxton Way,

Thetford,

Norfolk,

IP24 3SE

United Kingdom

Monosol, Solution for haemodialysis, haemodiafiltration and haemofiltration

Glucose Monohydrate Ph. Eur.1,1, Sodium Chloride Ph. Eur. 6,43, Calcium Chloride Dihydrate Ph. Eur., 0,257, Magnesium Chloride Hexahydrate Ph. Eur.0,152, Sodium Lactate Ph. Eur. 3,36

solution for haemodialysis, haemodiafiltration and haemofiltration

hemodialysis

Ireland

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

Baxter Healthcare Limited,

Caxton Way,

Thetford,

Norfolk,

IP24 3SE

United Kingdom

Monosol-K with 2 mEq Potassium/l, Solution for haemodialysis, haemodiafiltration and haemofiltration

Glucose Monohydrate Ph. Eur. 1,1, Sodium Chloride Ph. Eur. 6,43, Calcium Chloride Dihydrate Ph. Eur. 0,257, Magnesium Chloride Hexahydrate Ph. Eur. 0,152, Sodium Lactate Ph. Eur. 3,36, Potassium Chloride Ph. Eur. 0,149

solution for haemodialysis, haemodiafiltration and haemofiltration

hemodialysis

Ireland

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

Baxter Healthcare Limited,

Caxton Way,

Thetford,

Norfolk,

IP24 3SE,

United Kingdom

Monosol-K with 4 mEq Potassium/l, Solution for haemodialysis, haemodiafiltration and haemofiltration

Glucose Monohydrate Ph. Eur. 1,1, Sodium Chloride Ph. Eur. 6,43, Calcium Chloride Dihydrate Ph. Eur. 0,257, Magnesium Chloride Hexahydrate Ph. Eur. 0,152, Sodium Lactate Ph. Eur. 3,36, Potassium Chloride Ph. Eur. 0,298

solution for haemodialysis, haemodiafiltration and haemofiltration

hemodialysis

Ireland

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

Baxter Healthcare Limited,

Caxton Way,

Thetford,

Norfolk,

IP24 3SE,

United Kingdom

Dianeal PD1 Glucose 1,36% w/v (13,6mg/ml) Solution for Peritoneal Dialysis

1,36% w/v

solution for peritoneal dialysis

intraperitoneal use

Ireland

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

Baxter Healthcare Limited,

Caxton Way,

Thetford,

Norfolk,

IP24 3SE,

United Kingdom

Dianeal PD1 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 |

Baxter Healthcare Limited,

Caxton Way,

Thetford,

Norfolk,

IP24 3SE,

United Kingdom

Dianeal PD1 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 |

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 |

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 |

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 |

Baxter Healthcare Limited,

Caxton Way,

Thetford,

Norfolk,

IP24 3SE,

United Kingdom

Nutrineal Solution for Peritoneal Dialysis 4 with 1,1% Amino Acids

solution for peritoneal dialysis

intraperitoneal use

Ireland

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

Baxter Healthcare Limited,

Caxton Way,

Thetford,

Norfolk,

IP24 3SE,

United Kingdom

EXTRANEAL Solution for peritoneal dialysis

solution for peritoneal dialysis

intraperitoneal use

Italy

| Baxter SPA |
| --- |
| piazzale dell' industria 20 - |
| 00144 Roma, |
| Italy |

Baxter SPA

piazzale dell' industria 20 -

00144 Roma,

Italy

EXTRANEAL

7,5%

solution for dialysis peritoneal

intraperitoneal use

Italy

| Baxter SPA |
| --- |
| piazzale dell' industria 20 – |
| 00144 Roma, |
| Italy |

Baxter SPA

piazzale dell' industria 20 –

00144 Roma,

Italy

NUTRINEAL PD4

1,1%

solution for dialysis peritoneal

intraperitoneal use

Italy

| Baxter SPA |
| --- |
| piazzale dell' industria 20 – |
| 00144 Roma, |
| Italy |

Baxter SPA

piazzale dell' industria 20 –

00144 Roma,

Italy

SOLUZIONI PER DIALISI PERITONEALE BAXTER

4,95 g/l - 49,54 g/l;

solution for dialysis peritoneal

intraperitoneal use

Latvia

| Baxter Oy |
| --- |
| Valimotie 15 A |
| 00381 Helsinki |
| Finland |

Baxter Oy

Valimotie 15 A

00381 Helsinki

Finland

Extraneal solution for peritoneal dialysis

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

solution for peritoneal dialysis

intraperitoneal use

Latvia

| Baxter Healthcare S.A. |
| --- |
| Moneen Road Castlebar |
| County Mayo |
| Ireland |

Baxter Healthcare S.A.

Moneen Road Castlebar

County Mayo

Ireland

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

| Baxter Healthcare S.A. |
| --- |
| Moneen Road Castlebar |
| County Mayo |
| Ireland |

Baxter Healthcare S.A.

Moneen Road Castlebar

County Mayo

Ireland

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

| Baxter Healthcare S.A. |
| --- |
| Moneen Road Castlebar |
| County Mayo |
| Ireland |

Baxter Healthcare S.A.

Moneen Road Castlebar

County Mayo

Ireland

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

Lithuania

| Baxter Healthcare S.A. |
| --- |
| Moneen Road Castlebar |
| County Mayo |
| Ireland |

Baxter Healthcare S.A.

Moneen Road Castlebar

County Mayo

Ireland

Dianeal PD4 Glucose

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

solution for peritoneal dialysis

intraperitoneal use

Lithuania

| Baxter Healthcare S.A. |
| --- |
| Moneen Road Castlebar |
| County Mayo |
| Ireland |

Baxter Healthcare S.A.

Moneen Road Castlebar

County Mayo

Ireland

Dianeal PD4 Glucose

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

solution for peritoneal dialysis

intraperitoneal use

Lithuania

| Baxter Healthcare S.A. |
| --- |
| Moneen Road Castlebar |
| County Mayo |
| Ireland |

Baxter Healthcare S.A.

Moneen Road Castlebar

County Mayo

Ireland

Dianeal PD4 Glucose

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

solution for peritoneal dialysis

intraperitoneal use

Lithuania

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

Baxter Oy,

P.O. Box 270

Valimotie 15A

00381 Helsinki

Finland

EXTRANEAL

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

solution for peritoneal dialysis

intraperitoneal use

Luxembourg

| Baxter SA, |
| --- |
| Bd René Branquart 80, |
| B-7860 Lessines |
| Belgium |

Baxter SA,

Bd René Branquart 80,

B-7860 Lessines

Belgium

Nutrineal PD4+A.A.1,1%

1,1% amino acids

solution for peritoneal dialysis

intraperitoneal use

Luxembourg

| Baxter SA, |
| --- |
| Bd René Branquart 80, |
| B-7860 Lessines |
| Belgium |

Baxter SA,

Bd René Branquart 80,

B-7860 Lessines

Belgium

Dianeal PD1 Glucose

1,36%/2,27%/3,86% dextrose anydre

solution for peritoneal dialysis

intraperitoneal use

Luxembourg

| Baxter SA, |
| --- |
| Bd René Branquart 80, |
| B-7860 Lessines |
| Belgium |

Baxter SA,

Bd René Branquart 80,

B-7860 Lessines

Belgium

Dianeal PD4 Glucose

1,36%/2,27%/3,86% dextrose anydre

solution for peritoneal dialysis

intraperitoneal use

Luxembourg

| Baxter SA, |
| --- |
| Bd René Branquart 80, |
| B-7860 Lessines |
| Belgium |

Baxter SA,

Bd René Branquart 80,

B-7860 Lessines

Belgium

Extraneal

75,00 g/l Icodextrine

solution for peritoneal dialysis

intraperitoneal use

Malta

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

Baxter Healthcare Ltd.,

Caxton Way,

Thetford,

Norfolk,

IP24 3SE

United Kingdom

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

Malta

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

Baxter Healthcare Ltd.,

Caxton Way,

Thetford,

Norfolk,

IP24 3SE

United Kingdom

Nutrineal PD4 with 1,1% amino acids

L-Tyrosine 0,300 g/l

L-Tryptophan 0,270 g/l

L-Phenylalanine 0,570 g/l

L-Threonine 0,646 g/l

L-Serine 0,510 g/l

L-Proline 0,595 g/l

Glycine 0,510 g/l

L-Alanine 0,951 g/l

L-Valine 1,393 g/l

L-Methionine 0,850 g/l

L-Isoleucine 0,850 g/l

L-Leucine 1,020 g/l

L-Lysine (chlorhydrate) 0,955 g/l

L-Histidine 0,714 g/l

L-Arginine 1,071 g/l

Calcium chloride dihydrate 0,184 g/l

Magnesium chloride hexahydrate 0,051 g/l

Sodium Lactate 4,48 g/l

Sodium Chloride 5,38 g/l

Quantitative Composition of Sodium Lactate

Lactic Acid 139 g

Sodium Hydroxide 52,25 g

Water for Injections to 100 ml

solution for peritoneal dialysis

intraperitoneal use

Malta

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

Baxter Healthcare Ltd.,

Caxton Way,

Thetford,

Norfolk,

IP24 3SE

United Kingdom

Dianeal PD1 Glucose 1,36%w/v 13,6mg/ml

Anhydrous Glucose Ph.Eur. 1,36 % w/v

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

Sodium Chloride Ph.Eur. 0,57 % w/v

Sodium Lactate Ph.Eur. 0,39 % w/v

Calcium Chloride Ph.Eur. 0,0257 % w/v

Magnesium Chloride Ph.Eur. 0,0152 % w/v

solution for peritoneal dialysis

intraperitoneal use

Malta

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

Baxter Healthcare Ltd.,

Caxton Way,

Thetford,

Norfolk,

IP24 3SE

United Kingdom

Dianeal PD1 Glucose 2,27%w/v 22,7mg/ml

Anhydrous Glucose Ph.Eur. 2,27 % w/v

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

Sodium Chloride Ph.Eur. 0,57 % w/v

Sodium Lactate Ph.Eur. 0,39 % w/v

Calcium Chloride Ph.Eur. 0,0257 % w/v

Magnesium Chloride Ph.Eur. 0,0152 % w/v

solution for peritoneal dialysis

intraperitoneal use

Malta

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

Baxter Healthcare Ltd.,

Caxton Way,

Thetford,

Norfolk,

IP24 3SE

United Kingdom

Dianeal PD1 Glucose 3,86%w/v 38.6mg/ml

Anhydrous Glucose Ph.Eur. 3,86 % w/v

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

Sodium Chloride Ph.Eur. 0,57 % w/v

Sodium Lactate Ph.Eur. 0,39 % w/v

Calcium Chloride Ph.Eur. 0,0257 % w/v

Magnesium Chloride Ph.Eur. 0,0152 % w/v

solution for peritoneal dialysis

intraperitoneal use

Malta

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

Baxter Healthcare Ltd.,

Caxton Way,

Thetford,

Norfolk,

IP24 3SE

United Kingdom

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

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

Baxter Healthcare Ltd.,

Caxton Way,

Thetford,

Norfolk,

IP24 3SE

United Kingdom

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

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

Baxter Healthcare Ltd.,

Caxton Way,

Thetford,

Norfolk,

IP24 3SE

United Kingdom

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

| Baxter Healthcare Limited, |
| --- |
| Caxton Way, |
| Thetford, |
| Norfolk |
| IP24 3SE, |
| UK |

Baxter Healthcare Limited,

Caxton Way,

Thetford,

Norfolk

IP24 3SE,

UK

Monosol

Glucose Monohydrate 1,1 g/l,

Sodium Chloride 6,43 g/l,

Calcium Chloride Dihydrate 0,257 g/l,

Magnesium Chloride Hexahydrate 0,152 g/l,

Sodium Lactate 3,36 g/l

solution for haemodialysis/haemofiltration

intraarterial use, intravenous use

Malta

| Baxter Healthcare Limited, |
| --- |
| Caxton Way, |
| Thetford, |
| Norfolk |
| IP24 3SE, |
| UK |

Baxter Healthcare Limited,

Caxton Way,

Thetford,

Norfolk

IP24 3SE,

UK

Monosol-K with 2MEQ Potassium/L

Glucose Monohydrate 1,1 g/l,

Sodium Chloride 6,43 g/l,

Calcium Chloride Dihydrate 0,257 g/l,

Magnesium Chloride Hexahydrate 0,152 g/l,

Potassium Chloride 0,149 g/l,

Sodium Lactate 3,36 g/l

solution for haemodialysis/haemofiltration

intra-arterial use, intravenous use

Netherlands

| Baxter B.V., |
| --- |
| Kobaltweg 49, |
| 3542 CE Utrecht |
| The Netherlands |

Baxter B.V.,

Kobaltweg 49,

3542 CE Utrecht

The Netherlands

Dianeal PD1 Glucose 1,36%/13,6 mg/ml, peritoneaaldialysevloeistof

13,6 g/l glucose anhydrate

solution for peritoneal dialysis

intraperitoneal use

Netherlands

| Baxter B.V., |
| --- |
| Kobaltweg 49, |
| 3542 CE Utrecht |
| The Netherlands |

Baxter B.V.,

Kobaltweg 49,

3542 CE Utrecht

The Netherlands

Dianeal PD1 Glucose 2,27%/22,7 mg/ml, peritoneaaldialysevloeistof

22,7 g/l glucose anhydrate

solution for peritoneal dialysis

intraperitoneal use

Netherlands

| Baxter B.V., |
| --- |
| Kobaltweg 49, |
| 3542 CE Utrecht |
| The Netherlands |

Baxter B.V.,

Kobaltweg 49,

3542 CE Utrecht

The Netherlands

Dianeal PD1 Glucose 3,86%/38,6 mg/ml, peritoneaaldialysevloeistof

38,6 g/l glucose anhydrate

solution for peritoneal dialysis

intraperitoneal use

Netherlands

| Baxter B.V., |
| --- |
| Kobaltweg 49, |
| 3542 CE Utrecht |
| 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

Netherlands

| Baxter B.V., |
| --- |
| Kobaltweg 49, |
| 3542 CE Utrecht |
| 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

Netherlands

| Baxter B.V., |
| --- |
| Kobaltweg 49, |
| 3542 CE Utrecht |
| 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

Netherlands

| Baxter B.V., |
| --- |
| Kobaltweg 49, |
| 3542 CE Utrecht |
| The Netherlands |

Baxter B.V.,

Kobaltweg 49,

3542 CE Utrecht

The Netherlands

Nutrineal PD4 met 11 g/l aminozuren en Ca 1,25 mmol/l, peritoneaaldialysevloeistof

11 g/l amino acids and 1,25 mmol/l Ca.

solution for peritoneal dialysis

intraperitoneal use

Netherlands

| Baxter B.V., |
| --- |
| Kobaltweg 49, |
| 3542 CE Utrecht |
| 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

Norway

| Baxter AS |
| --- |
| Gjerdrumsvei 11 |
| 0484 Oslo |
| Norway |

Baxter AS

Gjerdrumsvei 11

0484 Oslo

Norway

Natriumklorid Baxter 9 mg/ml

9 mg/ml

solution for infusion

intravenous use

Norway

| Baxter AS |
| --- |
| Gjerdrumsvei 11 |
| 0484 Oslo |
| Norway |

Baxter AS

Gjerdrumsvei 11

0484 Oslo

Norway

Nutrineal PD4 amino Acids 1,1 %

1,10%

solution for peritoneal dialysis

intraperitoneal use

Norway

| Baxter AS |
| --- |
| Gjerdrumsvei 11 |
| 0484 Oslo |
| Norway |

Baxter AS

Gjerdrumsvei 11

0484 Oslo

Norway

Extraneal

75 mg/ml

solution for peritoneal dialysis

intraperitoneal use

Poland

| Baxter Polska SP. z o.o. |
| --- |
| Kruczkowskiego 8 st., |
| 00-380 Warszawa |
| Poland |

Baxter Polska SP. z o.o.

Kruczkowskiego 8 st.,

00-380 Warszawa

Poland

Dianeal PD1 (glukoza 1,36%). Zestaw do dializy otrzewnowej

15 mg/ml Glucose Monohydrate; 5,67 mg/ml Sodium Chloride; 0,257 mg/ml Calcium Chloride Dihydrate; 0,152 mg/ml Magnesium Chloride Hexahydrate; 3,92 mg/ml Sodium Lactate

solution for peritoneal dialysis

intraperitoneal use

Poland

| Baxter Polska SP. z o.o. |
| --- |
| Kruczkowskiego 8 st., |
| 00-380 Warszawa |
| Poland |

Baxter Polska SP. z o.o.

Kruczkowskiego 8 st.,

00-380 Warszawa

Poland

Dianeal PD1 (glukoza 2,27%). Zestaw do dializy otrzewnowej

25 mg/ml Glucose Monohydrate; 5,67 mg/ml Sodium Chloride; 0,257 mg/ml Calcium Chloride Dihydrate; 0,152 mg/ml Magnesium Chloride Hexahydrate; 3,92 mg/ml Sodium Lactate

solution for peritoneal dialysis

intraperitoneal use

Poland

| Baxter Polska SP. z o.o. |
| --- |
| Kruczkowskiego 8 st., |
| 00-380 Warszawa |
| Poland |

Baxter Polska SP. z o.o.

Kruczkowskiego 8 st.,

00-380 Warszawa

Poland

Dianeal PD1 (glukoza 3,86%). Zestaw do dializy otrzewnowej

42,5 mg/ml Glucose Monohydrate; 5,67 mg/ml Sodium Chloride; 2,57 mg/ml Calcium Chloride Dihydrate; 0,152 mg/ml Magnesium Chloride Hexahydrate; 3,92 mg/ml Sodium Lactate

solution for peritoneal dialysis

intraperitoneal use

Poland

| Baxter Polska SP. z o.o. |
| --- |
| Kruczkowskiego 8 st., |
| 00-380 Warszawa |
| Poland |

Baxter Polska SP. z o.o.

Kruczkowskiego 8 st.,

00-380 Warszawa

Poland

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

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

Poland

| Baxter Polska SP. z o.o. |
| --- |
| Kruczkowskiego 8 st., |
| 00-380 Warszawa |
| Poland |

Baxter Polska SP. z o.o.

Kruczkowskiego 8 st.,

00-380 Warszawa

Poland

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

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

Poland

| Baxter Polska SP. z o.o. |
| --- |
| Kruczkowskiego 8 st., |
| 00-380 Warszawa |
| Poland |

Baxter Polska SP. z o.o.

Kruczkowskiego 8 st.,

00-380 Warszawa

Poland

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

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

Poland

| Baxter Polska SP. z o.o. |
| --- |
| Kruczkowskiego 8 st., |
| 00-380 Warszawa |
| Poland |

Baxter Polska SP. z o.o.

Kruczkowskiego 8 st.,

00-380 Warszawa

Poland

Extraneal Zestaw do dializy otrzewnowej

75 mg/ml

solution for peritoneal dialysis

intraperitoneal use

Poland

| Baxter Polska SP. z o.o. |
| --- |
| Kruczkowskiego 8 st., |
| 00-380 Warszawa |
| Poland |

Baxter Polska SP. z o.o.

Kruczkowskiego 8 st.,

00-380 Warszawa

Poland

Nutrineal PD4 (z 1,1% roztworem aminokwasów)

1,071 mg/ml Arginine; 0,714 mg/ml Histine; 0,955 mg/ml Lysine hydrochloride; 1,02 mg/ml Leucine; 0,85 mg/ml Isoleucine; 0,85 mg/ml Methionine; 1,393 mg/ml Valine; 0,951 mg/ml Alanine; 0,51 mg/ml Glycine; 0,595 mg/ml Proline; 0,51 mg/ml Serine; 0,646 mg/ml Threonine; 0,57 mg/ml Phenylalanine; 0,27 mg/ml Tryptophan; 0,3 mg/ml Tyrosine; 0,184 mg/ml Calcium Chloride Dihydrate; 0,051 mg/ml Magnesium Chloride Hexahydrate; 5,38 mg/ml Sodium Chloride; 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 |

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

Portugal

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

Baxter Médico-Farmacêutica, Lda.

Zona Industrial da Abrunheira –

Edifício 10 - Sintra Business Park,

2710-089 Sintra

Portugal

Dianeal Pd1

42,5 mg/ml Glucose Monohydrate; 5,67 mg/ml Sodium Chloride; 2,57 mg/ml Calcium Chloride Dihydrate; 0,152 mg/ml Magnesium Chloride Hexahydrate; 3,92 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 |

Baxter Médico-Farmacêutica, Lda.

Zona Industrial da Abrunheira –

Edifício 10 - Sintra Business Park,

2710-089 Sintra

Portugal

Dianeal Pd1

25 mg/ml Glucose Monohydrate; 5,67 mg/ml Sodium Chloride; 0,257 mg/ml Calcium Chloride Dihydrate; 0,152 mg/ml Magnesium Chloride Hexahydrate; 3,92 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 |

Baxter Médico-Farmacêutica, Lda.

Zona Industrial da Abrunheira –

Edifício 10 - Sintra Business Park,

2710-089 Sintra

Portugal

Dianeal Pd1

15 mg/ml Glucose Monohydrate; 5,67 mg/ml Sodium Chloride; 0,257 mg/ml Calcium Chloride Dihydrate; 0,152 mg/ml Magnesium Hydroxide; 3,92 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 |

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 |

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 |

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 |

Baxter Médico-Farmacêutica, Lda.

Zona Industrial da Abrunheira –

Edifício 10 - Sintra Business Park,

2710-089 Sintra

Portugal

Nutrineal PD4

1,071 mg/ml Arginine; 0,714 mg/ml Histine; 0,955 mg/ml Lysine hydrochloride; 1,02 mg/ml Leucine; 0,85 mg/ml Isoleucine; 0,85 mg/ml Methionine; 1,393 mg/ml Valine; 0,951 mg/ml Alanine; 0,51 mg/ml Glycine; 0,595 mg/ml Proline; 0,51 mg/ml Serine; 0,646 mg/ml Threonine; 0,57 mg/ml Phenylalanine; 0,27 mg/ml Tryptophan; 0,3 mg/ml Tyrosine; 0,184 mg/ml Calcium Chloride Dihydrate; 0,051 mg/ml Magnesium Chloride Hexahydrate; 5,38 mg/ml Sodium Chloride; 4,48 mg/ml Sodium Lactate

solution for peritoneal dialysis

intraperitoneal use

Romania

| BAXTER HEALTHCARE Ltd., |
| --- |
| Caxton Way, |
| Thetford, |
| Norfolk, |
| 1P24 3SE, Thetford, |
| United Kingdom |

BAXTER HEALTHCARE Ltd.,

Caxton Way,

Thetford,

Norfolk,

1P24 3SE, Thetford,

United Kingdom

EXTRANEAL

75 mg/ml

solution for peritoneal dialysis

intraperitoneal use

Romania

| BAXTER HEALTHCARE S.A. |
| --- |
| Moneen Road, Castelbar, |
| County Mayo |
| Ireland |

BAXTER HEALTHCARE S.A.

Moneen Road, Castelbar,

County Mayo

Ireland

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

13,6 mg/ml

solution for peritoneal dialysis

intraperitoneal use

Romania

| BAXTER HEALTHCARE S.A. |
| --- |
| Moneen Road, Castelbar, |
| County Mayo |
| Ireland |

BAXTER HEALTHCARE S.A.

Moneen Road, Castelbar,

County Mayo

Ireland

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

22,7 mg/ml

solution for peritoneal dialysis

Intraperitoneal use

Romania

| BAXTER HEALTHCARE S.A. |
| --- |
| Moneen Road, Castelbar, |
| County Mayo |
| Ireland |

BAXTER HEALTHCARE S.A.

Moneen Road, Castelbar,

County Mayo

Ireland

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

38,6 mg/ml

solution for peritoneal dialysis

intraperitoneal use

Romania

| BAXTER d.o.o. |
| --- |
| Zelezna cesta 14, |
| SI-1000 Ljubljana |
| Slovenia |

BAXTER d.o.o.

Zelezna cesta 14,

SI-1000 Ljubljana

Slovenia

NUTRINEAL PD4 cu 1,1% aminoacizi

1,1%

solution for peritoneal dialysis

intraperitoneal use

Slovak Republic

| Baxter Healthcare SA |
| --- |
| Moneen Rd Castlebar, |
| Co. Mayo |
| Ireland |

Baxter Healthcare SA

Moneen Rd Castlebar,

Co. Mayo

Ireland

Dianeal® PD1 glucose 1,36% w/v /13,6 mg/ml

13,6 mg/1 ml

solution for peritoneal dialysis

intraperitoneal use

Slovak Republic

| Baxter Healthcare SA |
| --- |
| Moneen Rd Castlebar, |
| Co. Mayo |
| Ireland |

Baxter Healthcare SA

Moneen Rd Castlebar,

Co. Mayo

Ireland

Dianeal® PD1 glucose 2,27% w/v /22,7 mg/ml

22,7 mg/1 ml

solution for peritoneal dialysis

intraperitoneal use

Slovak Republic

| Baxter Healthcare SA |
| --- |
| Moneen Rd Castlebar, |
| Co. Mayo |
| Ireland |

Baxter Healthcare SA

Moneen Rd Castlebar,

Co. Mayo

Ireland

Dianeal® PD1 glucose 3,86% w/v /38,6 mg/ml

38,6 mg/1 ml

solution for peritoneal dialysis

intraperitoneal use

Slovak Republic

| Baxter Healthcare SA |
| --- |
| Moneen Rd Castlebar, |
| Co. Mayo |
| Ireland |

Baxter Healthcare SA

Moneen Rd Castlebar,

Co. Mayo

Ireland

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

13,6 mg/1 ml

solution for peritoneal dialysis

intraperitoneal use

Slovak Republic

| Baxter Healthcare SA |
| --- |
| Moneen Rd Castlebar, |
| Co. Mayo |
| Ireland |

Baxter Healthcare SA

Moneen Rd Castlebar,

Co. Mayo

Ireland

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

22,7 mg/1 ml

solution for peritoneal dialysis

intraperitoneal use

Slovak Republic

| Baxter Healthcare SA |
| --- |
| Moneen Rd Castlebar, |
| Co. Mayo |
| Ireland |

Baxter Healthcare SA

Moneen Rd Castlebar,

Co. Mayo

Ireland

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 |

Baxter Healthcare Ltd.

Caxton Way

Thetford

Norfolk

IP24 3SE

United Kingdom

EXTRANEAL

7,5%

solution for peritoneal dialysis

intraperitoneal use

Slovak Republic

| Baxter Healthcare SA |
| --- |
| Moneen Rd Castlebar, |
| Co. Mayo |
| Ireland |

Baxter Healthcare SA

Moneen Rd Castlebar,

Co. Mayo

Ireland

Nutrineal PD4 with 1,1 % Amino Acids

1,1%

solution for peritoneal dialysis

intraperitoneal use

Slovenia

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

Baxter d.o.o.,

Zelezna cesta 18,

SI-1000 Ljubljana,

Slovenia

Extraneal 75 mg/ml ikodekstrina raztopina za peritonealno dializo

75 mg/ml

solution for peritoneal dialysis

intraperitoneal use

Slovenia

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

Baxter d.o.o.,

Zelezna cesta 18,

SI-1000 Ljubljana,

Slovenia

Nutrineal PD4 11 mg/ml amino kislin raztopina za peritonealno dializo

11 mg/ml

solution for peritoneal dialysis

intraperitoneal use

Slovenia

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

Baxter d.o.o.,

Zelezna cesta 18,

SI-1000 Ljubljana,

Slovenia

Dianeal PD1 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, |
| SI-1000 Ljubljana, |
| Slovenia |

Baxter d.o.o.,

Zelezna cesta 18,

SI-1000 Ljubljana,

Slovenia

Dianeal PD1 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, |
| SI-1000 Ljubljana, |
| Slovenia |

Baxter d.o.o.,

Zelezna cesta 18,

SI-1000 Ljubljana,

Slovenia

Dianeal PD1 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, |
| SI-1000 Ljubljana, |
| Slovenia |

Baxter d.o.o.,

Zelezna cesta 18,

SI-1000 Ljubljana,

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, |
| SI-1000 Ljubljana, |
| Slovenia |

Baxter d.o.o.,

Zelezna cesta 18,

SI-1000 Ljubljana,

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, |
| SI-1000 Ljubljana, |
| Slovenia |

Baxter d.o.o.,

Zelezna cesta 18,

SI-1000 Ljubljana,

Slovenia

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

38,6 mg/ml

solution for peritoneal dialysis

intraperitoneal use

Spain

| BAXTER S.L. |
| --- |
| Pouet de Camilo 2 |
| Ribarroja del Turia Valencia) |
| 46394 |
| Spain |

BAXTER S.L.

Pouet de Camilo 2

Ribarroja del Turia Valencia)

46394

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

Spain

| BAXTER S.L. |
| --- |
| Pouet de Camilo 2 |
| Ribarroja del Turia (Valencia) |
| 46394 |
| Spain |

BAXTER S.L.

Pouet de Camilo 2

Ribarroja del Turia (Valencia)

46394

Spain

Nutrineal PD4 con 1,1% de aminoácidos solución para diálisis peritoneal

951 mg/l; 1 071 mg/l; 510 mg/l; 714 mg/l; 850 mg/l; 1 020 mg/l; 955 mg/l; 850 mg/l; 570 mg/l; 595 mg/l; 510 mg/l; 646 mg/l; 270 mg/l; 300 mg/l; 393 mg/l; 5 380 mg/l; 184 mg/l; 51 mg/l; 4 480 mg/l

solution for peritoneal dialysis

intraperitoneal use

Spain

| BAXTER S.L. |
| --- |
| Pouet de Camilo 2 |
| Ribarroja del Turia (Valencia) |
| 46394 |
| Spain |

BAXTER S.L.

Pouet de Camilo 2

Ribarroja del Turia (Valencia)

46394

Spain

Nutrineal PD4 con 1,1% de aminoácidos con sistema de desconexión integrado solución para diálisis peritoneal

951 mg/l; 1 071 mg/l; 510 mg/l; 714 mg/l; 850 mg/l; 1 020 mg/l; 955 mg/l; 850 mg/l; 570 mg/l; 595 mg/l; 510 mg/l; 646 mg/l; 720 mg/l; 300 mg/l; 1 393 mg/l; 5 380 mg/l; 184 mg/l; 51 mg/l; 4 480 mg/l

solution for peritoneal dialysis

intraperitoneal use

Spain

| BAXTER S.L. |
| --- |
| Pouet de Camilo 2 |
| Ribarroja del Turia (Valencia) |
| 46394 |
| Spain |

BAXTER S.L.

Pouet de Camilo 2

Ribarroja del Turia (Valencia)

46394

Spain

Dianeal PD1 Glucosa 1,36% solución para diálisis peritoneal

15 g/l; 5,67 g/l; 3,92 g/l; 0,257 g/l; 0,152 g/l

solution for peritoneal dialysis

intraperitoneal use

Spain

| BAXTER S.L. |
| --- |
| Pouet de Camilo 2 |
| Ribarroja del Turia (Valencia) |
| 46394 |
| Spain |

BAXTER S.L.

Pouet de Camilo 2

Ribarroja del Turia (Valencia)

46394

Spain

Dianeal PD1 Glucosa 1,36% con sistema de desconexión integrado solución para diálisis peritoneal.

15 g/l; 5,67 g/l; 3,92 g/l; 0,257 g/l; 0,152 g/l

solution for peritoneal dialysis

intraperitoneal use

Spain

| BAXTER S.L. |
| --- |
| Pouet de Camilo 2 |
| Ribarroja del Turia (Valencia) |
| 46394 |
| Spain |

BAXTER S.L.

Pouet de Camilo 2

Ribarroja del Turia (Valencia)

46394

Spain

Dianeal PD1 Glucosa 2,27% solución para diálisis peritoneal

25,0 g/l; 5,67 g/l; 3,92 g/l; 0,257 g/l; 0,152 g/l

solution for peritoneal dialysis

intraperitoneal use

Spain

| BAXTER S.L. |
| --- |
| Pouet de Camilo 2 |
| Ribarroja del Turia (Valencia) |
| 46394 |
| Spain |

BAXTER S.L.

Pouet de Camilo 2

Ribarroja del Turia (Valencia)

46394

Spain

Dianeal PD1 Glucosa 2,27% con sistema de desconexión integrado solución para diálisis peritoneal

25,0 g/l; 5,67 g/l; 3,92 g/l; 0,257 g/l; 0,152 g/l

solution for peritoneal dialysis

intraperitoneal use

Spain

| BAXTER S.L. |
| --- |
| Pouet de Camilo 2 |
| Ribarroja del Turia (Valencia) |
| 46394 |
| Spain |

BAXTER S.L.

Pouet de Camilo 2

Ribarroja del Turia (Valencia)

46394

Spain

Dianeal PD1 Glucosa 3,86% solución para diálisis peritoneal

42,50 g/l; 5,67 g/l; 3,92 g/l; 0,257 g/l; 0,152 g/l

solution for peritoneal dialysis

intraperitoneal use

Spain

| BAXTER S.L. |
| --- |
| Pouet de Camilo 2 |
| Ribarroja del Turia (Valencia) |
| 46394 |
| Spain |

BAXTER S.L.

Pouet de Camilo 2

Ribarroja del Turia (Valencia)

46394

Spain

Dianeal PD1 Glucosa 3,86% con sistema de desconexión integrado solución para diálisis peritoneal

42,50 g/l; 5,67 g/l; 3,92 g/l; 0,257 g/l; 0,152 g/l

solution for peritoneal dialysis

intraperitoneal use

Spain

| BAXTER S.L. |
| --- |
| Pouet de Camilo 2 |
| Ribarroja del Turia (Valencia) |
| 46394 |
| Spain |

BAXTER S.L.

Pouet de Camilo 2

Ribarroja del Turia (Valencia)

46394

Spain

Dianeal PD4 Glucosa 1,36% solución para diálisis peritoneal

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

| BAXTER S.L. |
| --- |
| Pouet de Camilo 2 |
| Ribarroja del Turia (Valencia) |
| 46394 |
| Spain |

BAXTER S.L.

Pouet de Camilo 2

Ribarroja del Turia (Valencia)

46394

Spain

Dianeal PD4 Glucosa 1,36% con sistema de desconexión integrado solución para diálisis peritoneal.

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

| BAXTER S.L. |
| --- |
| Pouet de Camilo 2 |
| Ribarroja del Turia (Valencia) |
| 46394 |
| Spain |

BAXTER S.L.

Pouet de Camilo 2

Ribarroja del Turia (Valencia)

46394

Spain

Dianeal PD4 Glucosa 2,27% solución para diálisis peritoneal

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

| BAXTER S.L. |
| --- |
| Pouet de Camilo 2 |
| Ribarroja del Turia (Valencia) |
| 46394 |
| Spain |

BAXTER S.L.

Pouet de Camilo 2

Ribarroja del Turia (Valencia)

46394

Spain

Dianeal PD4 Glucosa 2,27% con sistema de desconexión integrado solución para diálisis peritoneal

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

| BAXTER S.L. |
| --- |
| Pouet de Camilo 2 |
| Ribarroja del Turia (Valencia) |
| 46394 |
| Spain |

BAXTER S.L.

Pouet de Camilo 2

Ribarroja del Turia (Valencia)

46394

Spain

Dianeal PD4 Glucosa 3,86% solución para diálisis peritoneal

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

| BAXTER S.L. |
| --- |
| Pouet de Camilo 2 |
| Ribarroja del Turia (Valencia) |
| 46394 |
| Spain |

BAXTER S.L.

Pouet de Camilo 2

Ribarroja del Turia (Valencia)

46394

Spain

Dianeal PD4 Glucosa 3,86% con sistema de desconexión integrado solución para diálisis peritoneal

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

Sweden

| Baxter Medical AB |
| --- |
| Box 63 |
| 164 94 Kista |
| Sweden |

Baxter Medical AB

Box 63

164 94 Kista

Sweden

Natriumklorid Baxter 9 mg/ml

9 mg/ml

solution for infusion

intravenous use

Sweden

| Baxter Healthare SA |
| --- |
| Moneen Road Castlebar |
| County Mayo |
| Ireland |

Baxter Healthare SA

Moneen Road Castlebar

County Mayo

Ireland

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 |
| Ireland |

Baxter Healthare SA

Moneen Road Castlebar

County Mayo

Ireland

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 |
| Ireland |

Baxter Healthare SA

Moneen Road Castlebar

County Mayo

Ireland

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 |
| Sweden |

Baxter Medical AB

Box 63

164 94 Kista

Sweden

Extraneal

7,5%

solution for peritoneal dialysis

intraperitoneal use

Sweden

| Baxter Medical AB |
| --- |
| Box 63 |
| 164 94 Kista |
| Sweden |

Baxter Medical AB

Box 63

164 94 Kista

Sweden

Nutrineal PD4 1,1 % Aminosyror

1,10%

solution for peritoneal dialysis

intraperitoneal use

United Kingdom

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

Baxter Healthcare Limited,

Caxton Way,

Thetford,

Norfolk

IP24 3SE

United Kingdom

Monosol

Calcium Chloride: 0,026% w/v. glucose 0,110%w/v; sodium lactate 0,336%w/v; sodium chloride 0,643%w/v; magnesium chloride 0,015%w/v

solution for haemodialysis/haemofiltration

intraarterial use, intravenous use

United Kingdom

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

Baxter Healthcare Limited,

Caxton Way,

Thetford,

Norfolk

IP24 3SE

United Kingdom

Monosol-K with 2MEQ Potassium/L

sodium chloride 0,643%w/v; magnesium chloride 0,015%w/v; calcium chloride 0,026%w/v; glucoae 0,110%w/v; potassium chloride 0,015%w/v; sodium lactate 0,336%w/v

solution for haemodialysis/haemofiltration

intraarterial use, intravenous use

United Kingdom

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

Baxter Healthcare Limited,

Caxton Way,

Thetford,

Norfolk

IP24 3SE

United Kingdom

Monosol-K with 4MEQ Potassium/L

magnesium chloride 0,015%w/v; potassium chloride 0,029%w/v; calcium chloride 0,026%w/v; sodium lactate 0,336%w/v; sodium chloride 0,643%w/v; glucose 0,110%w/v

solution for haemodialysis/haemofiltration

intraarterial use, intravenous use

United Kingdom

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

Baxter Healthcare Limited,

Caxton Way,

Thetford,

Norfolk

IP24 3SE

United Kingdom

Dianeal PD1 Glucose 1,36% w/v /13,6mg/ml

magnesium chloride 0,015%w/v; calcium chloride 0,026%w/v; glucose 1,36%w/v; sodium lactate 0,39%w/v; sodium chloride 0,57%w/v

solution for peritoneal dialysis

intraperitoneal use

United Kingdom

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

Baxter Healthcare Limited,

Caxton Way,

Thetford,

Norfolk

IP24 3SE

United Kingdom

Dianeal PD1 Glucose 3.86% w/v /38,6mg/ml

magnesium chloride 0,015%w/v; calcium chloride 0,026%w/v; glucose 3,86%w/v; sodium lactate 0,39%w/v; sodium chloride 0,57%w/v

solution for peritoneal dialysis

intraperitoneal use

United Kingdom

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

Baxter Healthcare Limited,

Caxton Way,

Thetford,

Norfolk

IP24 3SE

United Kingdom

Dianeal PD1 Glucose 2,27% w/v /22,7mg/ml

sodium chloride 0,57%w/v; glucose 2,27%w/v; magnesium chloride 0,015%w/v; sodium lactate 0,39%w/v; calcium chloride 0,026%w/v

solution for peritoneal dialysis

intraperitoneal use

United Kingdom

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

Baxter Healthcare Limited,

Caxton Way,

Thetford,

Norfolk

IP24 3SE

United Kingdom

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

magnesium 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 |

Baxter Healthcare Limited,

Caxton Way,

Thetford,

Norfolk

IP24 3SE

United Kingdom

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

magnesium 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 |

Baxter Healthcare Limited,

Caxton Way,

Thetford,

Norfolk

IP24 3SE

United Kingdom

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

magnesium 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 |

Baxter Healthcare Limited,

Caxton Way,

Thetford,

Norfolk

IP24 3SE

United Kingdom

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

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

solution for peritoneal dialysis

intraperitoneal use

United Kingdom

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

Baxter Healthcare Limited,

Caxton Way,

Thetford,

Norfolk

IP24 3SE

United Kingdom

Nutrineal PD4 with 1,1% Amino Acids

tyrosine 0,03%w/v; tryptophan 0,027%w/v; phenylalanine 0,057%w/v; threonine 0,064%w/v; L-serine 0,051%w/v; L-proline 0,058%w/v; glycine 0,.051%w/v; L-alanine 0,095%w/v; valine 0,139%w/v; methionine 0,085%w/v; isoleucine 0,085%w/v; leucine 0,102%w/v; lysine 0,095%w/v; histidine 0/071%w/v; arginine 0,107%w/v; calcium chloride 0,018%w/v; magnesium chloride 0,005%w/v; sodium chloride 0,538%w/v; sodium s-lactate 0,448%w/v

solution for peritoneal dialysis

intraperitoneal use

---

ANNEX II

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCT, ANIMAL SPECIES AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

| Member State EU/EEA | Marketing authorisation holder | Invented name | Strength | Pharmaceutical form | Animal species |
| --- | --- | --- | --- | --- | --- |
| Austria | LABORATORIOS HIPRA, S.A. |
| Avda. la Selva, 135 |
| 17170- AMER (Girona) |
| SPAIN |

Member State EU/EEA

Marketing authorisation holder

Invented name

Strength

Pharmaceutical form

Animal species

Austria

LABORATORIOS HIPRA, S.A.

Avda. la Selva, 135

17170- AMER (Girona)

SPAIN

HIPRABOVIS PNEUMOS -

Emulsion zur Injektion für Rinder

Mannheimia haemolytica Biotype A serotype A1, inactivated cell free suspension containing leukotoxoid Ph. Eur. Inactivated Histophilus somni Bailie strain

Emulsion for injection

Cattle from 2 months of age

Belgium

| LABORATORIOS HIPRA, S.A. |
| --- |
| Avda. la Selva, 135 |
| 17170- AMER (Girona) |
| SPAIN |

LABORATORIOS HIPRA, S.A.

Avda. la Selva, 135

17170- AMER (Girona)

SPAIN

HIPRABOVIS PNEUMOS

Mannheimia haemolytica Biotype A serotype A1, inactivated cell free suspension containing leukotoxoid Ph. Eur. Inactivated Histophilus somni Bailie strain

Emulsion for injection

Cattle from 2 months of age

Czech Republic

| LABORATORIOS HIPRA, S.A. |
| --- |
| Avda. la Selva, 135 |
| 17170- AMER (Girona) |
| SPAIN |

LABORATORIOS HIPRA, S.A.

Avda. la Selva, 135

17170- AMER (Girona)

SPAIN

HIPRABOVIS PNEUMOS

Injekční emulze pro skot

Mannheimia haemolytica Biotype A serotype A1, inactivated cell free suspension containing leukotoxoid Ph. Eur. Inactivated Histophilus somni Bailie strain

Emulsion for injection

Cattle from 2 months of age

Denmark

| LABORATORIOS HIPRA, S.A. |
| --- |
| Avda. la Selva, 135 |
| 17170- AMER (Girona) |
| SPAIN |

LABORATORIOS HIPRA, S.A.

Avda. la Selva, 135

17170- AMER (Girona)

SPAIN

HIPRABOVIS PNEUMOS

Mannheimia haemolytica Biotype A serotype A1, inactivated cell free suspension containing leukotoxoid Ph. Eur. Inactivated Histophilus somni Bailie strain

Emulsion for injection

Cattle from 2 months of age

France

| LABORATORIOS HIPRA, S.A. |
| --- |
| Avda. la Selva, 135 |
| 17170- AMER (Girona) |
| SPAIN |

LABORATORIOS HIPRA, S.A.

Avda. la Selva, 135

17170- AMER (Girona)

SPAIN

HIPRABOVIS PNEUMOS EMULSION INJECTABLE POUR BOVINS

Mannheimia haemolytica Biotype A serotype A1, inactivated cell free suspension containing leukotoxoid Ph. Eur. Inactivated Histophilus somni Bailie strain

Emulsion for injection

Cattle from 2 months of age

Germany

| LABORATORIOS HIPRA, S.A. |
| --- |
| Avda. la Selva, 135 |
| 17170- AMER (Girona) |
| SPAIN |

LABORATORIOS HIPRA, S.A.

Avda. la Selva, 135

17170- AMER (Girona)

SPAIN

HIPRABOVIS PNEUMOS

Mannheimia haemolytica Biotype A serotype A1, inactivated cell free suspension containing leukotoxoid Ph. Eur. Inactivated Histophilus somni Bailie strain

Emulsion for injection

Cattle from 2 months of age

Greece

| LABORATORIOS HIPRA, S.A. |
| --- |
| Avda. la Selva, 135 |
| 17170- AMER (Girona) |
| SPAIN |

LABORATORIOS HIPRA, S.A.

Avda. la Selva, 135

17170- AMER (Girona)

SPAIN

HIPRABOVIS PNEUMOS

Mannheimia haemolytica Biotype A serotype A1, inactivated cell free suspension containing leukotoxoid Ph. Eur. Inactivated Histophilus somni Bailie strain

Emulsion for injection

Cattle from 2 months of age

Hungary

| LABORATORIOS HIPRA, S.A. |
| --- |
| Avda. la Selva, 135 |
| 17170- AMER (Girona) |
| SPAIN |

LABORATORIOS HIPRA, S.A.

Avda. la Selva, 135

17170- AMER (Girona)

SPAIN

HIPRABOVIS PNEUMOS

vakcina A.U.V.

Mannheimia haemolytica Biotype A serotype A1, inactivated cell free suspension containing leukotoxoid Ph. Eur. Inactivated Histophilus somni Bailie strain

Emulsion for injection

Cattle from 2 months of age

Ireland

| LABORATORIOS HIPRA, S.A. |
| --- |
| Avda. la Selva, 135 |
| 17170- AMER (Girona) |
| SPAIN |

LABORATORIOS HIPRA, S.A.

Avda. la Selva, 135

17170- AMER (Girona)

SPAIN

HIPRABOVIS PNEUMOS

Emulsion for injection for cattle

Mannheimia haemolytica Biotype A serotype A1, inactivated cell free suspension containing leukotoxoid Ph. Eur. Inactivated Histophilus somni Bailie strain

Emulsion for injection

Cattle from 2 months of age

Italy

| LABORATORIOS HIPRA, S.A. |
| --- |
| Avda. la Selva, 135 |
| 17170- AMER (Girona) |
| SPAIN |

LABORATORIOS HIPRA, S.A.

Avda. la Selva, 135

17170- AMER (Girona)

SPAIN

HIPRABOVIS PNEUMOS

Emulsion for injection for cattle

Mannheimia haemolytica Biotype A serotype A1, inactivated cell free suspension containing leukotoxoid Ph. Eur. Inactivated Histophilus somni Bailie strain

Emulsion for injection

Cattle from 2 months of age

Poland

| LABORATORIOS HIPRA, S.A. |
| --- |
| Avda. la Selva, 135 |
| 17170- AMER (Girona) |
| SPAIN |

LABORATORIOS HIPRA, S.A.

Avda. la Selva, 135

17170- AMER (Girona)

SPAIN

HIPRABOVIS PNEUMOS

emulsja do wstrzykiwań dla bydła

Mannheimia haemolytica Biotype A serotype A1, inactivated cell free suspension containing leukotoxoid Ph. Eur. Inactivated Histophilus somni Bailie strain

Emulsion for injection

Cattle from 2 months of age

Portugal

| LABORATORIOS HIPRA, S.A. |
| --- |
| Avda. la Selva, 135 |
| 17170- AMER (Girona) |
| SPAIN |

LABORATORIOS HIPRA, S.A.

Avda. la Selva, 135

17170- AMER (Girona)

SPAIN

HIPRABOVIS PNEUMOS

Emulsão para injecção para bovinos

Mannheimia haemolytica Biotype A serotype A1, inactivated cell free suspension containing leukotoxoid Ph. Eur. Inactivated Histophilus somni Bailie strain

Emulsion for injection

Cattle from 2 months of age

Slovak Republic

| LABORATORIOS HIPRA, S.A. |
| --- |
| Avda. la Selva, 135 |
| 17170- AMER (Girona) |
| SPAIN |

LABORATORIOS HIPRA, S.A.

Avda. la Selva, 135

17170- AMER (Girona)

SPAIN

HIPRABOVIS PNEUMOS

injekčná emulzia pre dobytok

Mannheimia haemolytica Biotype A serotype A1, inactivated cell free suspension containing leukotoxoid Ph. Eur. Inactivated Histophilus somni Bailie strain

Emulsion for injection

Cattle from 2 months of age

Spain

| LABORATORIOS HIPRA, S.A. |
| --- |
| Avda. la Selva, 135 |
| 17170- AMER (Girona) |
| SPAIN |

LABORATORIOS HIPRA, S.A.

Avda. la Selva, 135

17170- AMER (Girona)

SPAIN

HIPRABOVIS PNEUMOS

Mannheimia haemolytica Biotype A serotype A1, inactivated cell free suspension containing leukotoxoid Ph. Eur. Inactivated Histophilus somni Bailie strain

Emulsion for injection

Cattle from 2 months of age

The Netherlands

| LABORATORIOS HIPRA, S.A. |
| --- |
| Avda. la Selva, 135 |
| 17170- AMER (Girona) |
| SPAIN |

LABORATORIOS HIPRA, S.A.

Avda. la Selva, 135

17170- AMER (Girona)

SPAIN

HIPRABOVIS PNEUMOS

Mannheimia haemolytica Biotype A serotype A1, inactivated cell free suspension containing leukotoxoid Ph. Eur. Inactivated Histophilus somni Bailie strain

Emulsion for injection

Cattle from 2 months of age

United Kingdom

| LABORATORIOS HIPRA, S.A. |
| --- |
| Avda. la Selva, 135 |
| 17170- AMER (Girona) |
| SPAIN |

LABORATORIOS HIPRA, S.A.

Avda. la Selva, 135

17170- AMER (Girona)

SPAIN

HIPRABOVIS PNEUMOS

Emulsion for Injection for Cattle

Mannheimia haemolytica Biotype A serotype A1, inactivated cell free suspension containing leukotoxoid Ph. Eur. Inactivated Histophilus somni Bailie strain

Emulsion for injection

Cattle from 2 months of age

---