# C_2011250EN.01001801.xml

| 26.8.2011 | EN | Official Journal of the European Union | C 250/18 |
| --- | --- | --- | --- |

26.8.2011

EN

Official Journal of the European Union

C 250/18

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2011 to 30 June 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

)

2011/C 250/02

—   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 |
| --- | --- | --- | --- | --- |
| 18.5.2011 | Arimidex and associated names - Referral Art 30 (amend) | See Annex I | See Annex I | 20.5.2011 |
| 12.5.2011 | Dianeal, Extraneal and Nutrineal and associated names - Art. 31 (amend) | See Annex II | See Annex II | 13.5.2011 |
| 15.6.2011 | Cinryze | ViroPharma SPRL-BVBA, rue Montoyer 47, 1000 Bruxelles, Belgique / Montoyerstraat 47, 1000 Brussel, België | These Decisions are addressed to the Member States. | 20.6.2011 |
| 29.6.2011 | Instanyl | Nycomed Danmark ApS, Langebjerg 1, DK-4000 Roskilde, Danmark | These Decisions are addressed to the Member States. | 4.7.2011 |
| 6.5.2011 | ReFacto AF | Wyeth Europa Ltd., Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | These Decisions are addressed to the Member States. | 10.5.2011 |
| 6.5.2011 | Tygacil | Wyeth Europa Ltd., Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | These Decisions are addressed to the Member States. | 12.5.2011 |
| 27.5.2011 | Lucentis | Novartis Europharm Ltd, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | These Decisions are addressed to the Member States. | 31.5.2011 |
| 16.6.2011 | Tysabri | Elan Pharma International Ltd., Monksland, Athlone, County Westmeath, Ireland | These Decisions are addressed to the Member States. | 20.6.2011 |
| 2.5.2011 | Revolade | GlaxoSmithKline Trading Services Limited, 6900 Cork Airport Business Park, Kinsale Road, Cork, Ireland | These Decisions are addressed to the Member States. | 3.5.2011 |
| 16.6.2011 | Ozurdex | Allergan Pharmaceuticals (Ireland) Ltd, Castlebar Road, Westport, Co. Mayo, Ireland | These Decisions are addressed to the Member States. | 20.6.2011 |
| 6.5.2011 | Rotarix | GlaxoSmithKline Biologicals S.A., rue de l’Institut 89, Rixensart, B-1330 Belgique | These Decisions are addressed to the Member States. | 11.5.2011 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

18.5.2011

Arimidex and associated names - Referral Art 30 (amend)

See Annex I

See Annex I

20.5.2011

12.5.2011

Dianeal, Extraneal and Nutrineal and associated names - Art. 31 (amend)

See Annex II

See Annex II

13.5.2011

15.6.2011

Cinryze

ViroPharma SPRL-BVBA, rue Montoyer 47, 1000 Bruxelles, Belgique / Montoyerstraat 47, 1000 Brussel, België

These Decisions are addressed to the Member States.

20.6.2011

29.6.2011

Instanyl

Nycomed Danmark ApS, Langebjerg 1, DK-4000 Roskilde, Danmark

These Decisions are addressed to the Member States.

4.7.2011

6.5.2011

ReFacto AF

Wyeth Europa Ltd., Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom

These Decisions are addressed to the Member States.

10.5.2011

6.5.2011

Tygacil

Wyeth Europa Ltd., Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom

These Decisions are addressed to the Member States.

12.5.2011

27.5.2011

Lucentis

Novartis Europharm Ltd, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

These Decisions are addressed to the Member States.

31.5.2011

16.6.2011

Tysabri

Elan Pharma International Ltd., Monksland, Athlone, County Westmeath, Ireland

These Decisions are addressed to the Member States.

20.6.2011

2.5.2011

Revolade

GlaxoSmithKline Trading Services Limited, 6900 Cork Airport Business Park, Kinsale Road, Cork, Ireland

These Decisions are addressed to the Member States.

3.5.2011

16.6.2011

Ozurdex

Allergan Pharmaceuticals (Ireland) Ltd, Castlebar Road, Westport, Co. Mayo, Ireland

These Decisions are addressed to the Member States.

20.6.2011

6.5.2011

Rotarix

GlaxoSmithKline Biologicals S.A., rue de l’Institut 89, Rixensart, B-1330 Belgique

These Decisions are addressed to the Member States.

11.5.2011

—   Refusal of a national marketing authorization

Refusal of a national marketing authorization

| Date of the decision | Name(s) of the medicinal product | Holder(s) of the marketing authorization | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- |
| 18.5.2011 | Isotretinoin | See Annex III | See Annex III | 19.5.2011 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

18.5.2011

Isotretinoin

See Annex III

See Annex III

19.5.2011

—   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 |
| --- | --- | --- | --- | --- |
| 18.5.2011 | Isotretinoin | See Annex III | See Annex III | 19.5.2011 |
| 23.5.2011 | Octagam Article 107 Final measures | See Annex IV | See Annex IV | 25.5.2011 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

18.5.2011

Isotretinoin

See Annex III

See Annex III

19.5.2011

23.5.2011

Octagam Article 107 Final measures

See Annex IV

See Annex IV

25.5.2011

—   Lift of suspension of a national marketing authorization

Lift of 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 |
| --- | --- | --- | --- | --- |
| 30.5.2011 | Octagam Art 31 Lift of suspension | See Annex V | See Annex V | 31.5.2011 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

30.5.2011

Octagam Art 31 Lift of suspension

See Annex V

See Annex V

31.5.2011

---

(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 | AstraZeneca Österreich GmbH, |
| Schwarzenbergplatz 7, |
| A-1037 Wien, |
| Austria |

Member State EU/EEA

Marketing authorisation holder

(Invented) Name

Strength

Pharmaceutical form

Route of administration

Austria

AstraZeneca Österreich GmbH,

Schwarzenbergplatz 7,

A-1037 Wien,

Austria

Arimidex

1 mg

Film-coated Tablets

Oral use

Belgium

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Brussels, |
| Belgium |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussels,

Belgium

Arimidex

1 mg

Film-coated Tablets

Oral use

Bulgaria

| AstraZeneca Pharmaceuticals AB, |
| --- |
| S-15185 Södertälje, |
| Sweden |

AstraZeneca Pharmaceuticals AB,

S-15185 Södertälje,

Sweden

Arimidex

1 mg

Film-coated Tablets

Oral use

Cyprus

| AstraZeneca UK Ltd |
| --- |
| Silk Road Business Park |
| Macclesfield |
| Cheshire |
| SK10 2NA |
| United Kingdom |

AstraZeneca UK Ltd

Silk Road Business Park

Macclesfield

Cheshire

SK10 2NA

United Kingdom

Arimidex

1 mg

Film-coated Tablets

Oral use

Czech Republic

| AstraZeneca UK Ltd |
| --- |
| Silk Road Business Park |
| Macclesfield |
| Cheshire |
| SK10 2NA |
| United Kingdom |

AstraZeneca UK Ltd

Silk Road Business Park

Macclesfield

Cheshire

SK10 2NA

United Kingdom

Arimidex

1 mg

Film-coated Tablets

Oral use

Denmark

| AstraZeneca A/S |
| --- |
| Roskildevej 22 |
| 2620 Albertslund, |
| Denmark |

AstraZeneca A/S

Roskildevej 22

2620 Albertslund,

Denmark

Arimidex

1 mg

Film-coated Tablets

Oral use

Estonia

| AstraZeneca UK Ltd. |
| --- |
| 2 Kingdom Street, |
| London |
| W2 6BD, |
| United Kingdom |

AstraZeneca UK Ltd.

2 Kingdom Street,

London

W2 6BD,

United Kingdom

Arimidex

1 mg

Film-coated Tablets

Oral use

Finland

| AstraZeneca Oy |
| --- |
| Luomanportti 3 |
| 02200 Espoo |
| Finland |

AstraZeneca Oy

Luomanportti 3

02200 Espoo

Finland

Arimidex

1 mg

Film-coated Tablets

Oral use

France

| AstraZeneca |
| --- |
| 1, Place Renault |
| 92844 RUEIL-MALMAISON CEDEX |
| France |

AstraZeneca

1, Place Renault

92844 RUEIL-MALMAISON CEDEX

France

Arimidex

1 mg

Film-coated Tablets

Oral use

Germany

| AstraZeneca GmbH |
| --- |
| Tinsdaler Weg 183 |
| 22880 Wedel |
| Postanschrift 22876 Wedel |
| Germany |

AstraZeneca GmbH

Tinsdaler Weg 183

22880 Wedel

Postanschrift 22876 Wedel

Germany

Arimidex

1 mg

Film-coated Tablets

Oral use

Greece

| AstraZeneca S.A. |
| --- |
| 4 Theotokopoulou & Astronafton str |
| 151 25 Maroussi |
| Athens, |
| Greece |

AstraZeneca S.A.

4 Theotokopoulou & Astronafton str

151 25 Maroussi

Athens,

Greece

Arimidex

1 mg

Film-coated Tablets

Oral use

Hungary

| AstraZeneca Kft. |
| --- |
| 1113 Budapest, Bocskai ut 134-146 |
| Hungary |

AstraZeneca Kft.

1113 Budapest, Bocskai ut 134-146

Hungary

Arimidex

1 mg

Film-coated Tablets

Oral use

Iceland

| AstraZeneca AB |
| --- |
| 151 85 Södertälje |
| Sweden |

AstraZeneca AB

151 85 Södertälje

Sweden

Arimidex

1 mg

Film-coated Tablets

Oral use

Ireland

| AstraZeneca UK Limited |
| --- |
| 600 Capability Green |
| Luton LU1 3LU |
| United Kingdom |

AstraZeneca UK Limited

600 Capability Green

Luton LU1 3LU

United Kingdom

Arimidex

1 mg

Film-coated Tablets

Oral use

Italy

| AstraZeneca UK Limited |
| --- |
| 600 Capability Green |
| Luton LU1 3LU |
| United Kingdom |

AstraZeneca UK Limited

600 Capability Green

Luton LU1 3LU

United Kingdom

Arimidex

1 mg

Film-coated Tablets

Oral use

Latvia

| AstraZeneca UK Limited |
| --- |
| Silk Road Business Park Macclesfield, |
| Cheshire |
| SK 10 2NA |
| United Kingdom |

AstraZeneca UK Limited

Silk Road Business Park Macclesfield,

Cheshire

SK 10 2NA

United Kingdom

Arimidex

1 mg

Film-coated Tablets

Oral use

Lithuania

| AstraZeneca UK Ltd. |
| --- |
| Silk Road Business Park |
| Macclesfield, |
| Cheshire |
| SK10 2NA |
| United Kingdom |

AstraZeneca UK Ltd.

Silk Road Business Park

Macclesfield,

Cheshire

SK10 2NA

United Kingdom

Arimidex

1 mg

Film-coated Tablets

Oral use

Luxembourg

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Brussels, |
| Belgium |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussels,

Belgium

Arimidex

1 mg

Film-coated Tablets

Oral use

Malta

| AstraZeneca UK Ltd. |
| --- |
| Silk Road Business Park |
| Macclesfield, |
| Cheshire |
| SK10 2NA |
| United Kingdom |

AstraZeneca UK Ltd.

Silk Road Business Park

Macclesfield,

Cheshire

SK10 2NA

United Kingdom

Arimidex

1 mg

Film-coated Tablets

Oral use

Netherlands

| AstraZeneca BV |
| --- |
| Louis Pasteurlaan 5 |
| 2719 EE Zoetermeer |
| The Netherlands |

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

The Netherlands

Arimidex

1 mg

Film-coated Tablets

Oral use

Norway

| AstraZeneca AS |
| --- |
| Innspurten 15, 0663 OSLO, Postboks 6050 |
| Etterstad 0601, |
| OSLO |
| Norway |

AstraZeneca AS

Innspurten 15, 0663 OSLO, Postboks 6050

Etterstad 0601,

OSLO

Norway

Arimidex

1 mg

Film-coated Tablets

Oral use

Poland

| AstraZeneca UK Ltd. |
| --- |
| Silk Road Business Park |
| Macclesfield, |
| Cheshire, |
| SK10 2NA |
| United Kingdom |

AstraZeneca UK Ltd.

Silk Road Business Park

Macclesfield,

Cheshire,

SK10 2NA

United Kingdom

Arimidex

1 mg

Film-coated Tablets

Oral use

Portugal

| AstraZeneca Produtos Farmacêuticos, Lda. |
| --- |
| Rua Humberto Madeira, n.o 7, Queluz de Baixo, |
| 2730-097 Barcarena, |
| Portugal |

AstraZeneca Produtos Farmacêuticos, Lda.

Rua Humberto Madeira, n.o 7, Queluz de Baixo,

2730-097 Barcarena,

Portugal

Arimidex

1 mg

Film-coated Tablets

Oral use

Romania

| AstraZeneca UK Limited |
| --- |
| 600 Capability Green |
| Luton, |
| LU1 3LU |
| United Kingdom |

AstraZeneca UK Limited

600 Capability Green

Luton,

LU1 3LU

United Kingdom

Arimidex

1 mg

Film-coated Tablets

Oral use

Slovak Republic

| AstraZeneca UK Ltd. |
| --- |
| Silk Road Business Park |
| Macclesfield, |
| Cheshire, |
| SK10 2NA |
| United Kingdom |

AstraZeneca UK Ltd.

Silk Road Business Park

Macclesfield,

Cheshire,

SK10 2NA

United Kingdom

Arimidex

1 mg

Film-coated Tablets

Oral use

Slovenia

| AstraZeneca UK Limited |
| --- |
| 2 Kingdom Street, |
| London |
| W2 6BD, |
| United Kingdom |

AstraZeneca UK Limited

2 Kingdom Street,

London

W2 6BD,

United Kingdom

Arimidex 1 mg filmsko obložene tablete

1 mg

Film-coated Tablets

Oral use

Spain

| AstraZeneca Farmacéutica Spain, S.A. |
| --- |
| C/ Serrano Galvache, 56 Edificio Roble |
| 28033 Madrid, |
| Spain |

AstraZeneca Farmacéutica Spain, S.A.

C/ Serrano Galvache, 56 Edificio Roble

28033 Madrid,

Spain

Arimidex

1 mg

Film-coated Tablets

Oral use

Sweden

| AstraZeneca AB |
| --- |
| 151 85 Södertälje |
| Sweden |

AstraZeneca AB

151 85 Södertälje

Sweden

Arimidex

1 mg

Film-coated Tablets

Oral use

United Kingdom

| AstraZeneca UK Limited |
| --- |
| 600 Capability Green |
| Luton |
| LU1 3LU |
| United Kingdom |

AstraZeneca UK Limited

600 Capability Green

Luton

LU1 3LU

United Kingdom

Arimidex

1 mg

Film-coated Tablets

Oral use

---

ANNEX II

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

| 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 | Baxter SA |
| Bld R Branquart 80 |
| 7860 Lessines |
| Belgium |

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

Baxter SA

Bld R Branquart 80

7860 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 |
| --- |
| Bld R Branquart 80 |
| 7860 Lessines |
| Belgium |

Baxter SA

Bld R Branquart 80

7860 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 |
| --- |
| Bld R Branquart 80 |
| 7860 Lessines |
| Belgium |

Baxter SA

Bld R Branquart 80

7860 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 |
| --- |
| Bld R Branquart 80 |
| 7860 Lessines |
| Belgium |

Baxter SA

Bld R Branquart 80

7860 Lessines

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

| 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

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 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

EXTRANEAL, solution pour dialyse péritonéale

7,50 %

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 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

| 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

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

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

DIOPHAR S.A.

Kifissias Avenue 368,

Halandri, 152 33

Greece

DIANEAL PD4

1,36 %

Solution for peritoneal dialysis

Intraperitoneal use

Greece

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

DIOPHAR S.A.

Kifissias Avenue 368,

Halandri, 152 33

Greece

EXTRANEAL

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

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

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

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

| 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

SOLUZIONI PER DIALISI PERITONEALE BAXTER

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

Solution for dialysis peritoneal

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

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

Baxter Oy Valimotie 15 A 00380 Helsinki Finland

FINLAND

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

| 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

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

| 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 22,7 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

| 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 38,6 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

| 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

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 Warsawa, Poland |

Baxter Polska SP. z o.o.

Kruczkowskiego 8 st.,

00-380 Warsawa, Poland

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

Solution for peritoneal dialysis

Intraperitoneal use

Poland

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

Baxter Polska SP. z o.o.

Kruczkowskiego 8 st.,

00-380 Warsawa, Poland

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

Solution for peritoneal dialysis

Intraperitoneal use

Poland

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

Baxter Polska SP. z o.o.

Kruczkowskiego 8 st.,

00-380 Warsawa, Poland

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

Solution for peritoneal dialysis

Intraperitoneal use

Poland

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

Baxter Polska SP. z o.o.

Kruczkowskiego 8 st.,

00-380 Warsawa, Poland

Extraneal Zestaw do dializy otrzewnowej

Solution for peritoneal dialysis

Intraperitoneal use

Poland

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

Baxter Polska SP. z o.o.

Kruczkowskiego 8 st.,

00-380 Warsawa, 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

| 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 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

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

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

| 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 %

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

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 %

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

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 %

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

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 |
| 46394 Ribarroja del Turia (Valencia) |
| Spain |

BAXTER S.L.

Pouet de Camilo 2

46394 Ribarroja del Turia (Valencia)

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

---

ANNEX III

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, APPLICANTS/MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES

| Member State EU/EEA | Marketing authorisation holder | Applicant | (Invented) Name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- | --- |
| France | | Ranbaxy (UK) Ltd. |
| Building 4, Chiswick Park, |
| 566 Chiswick High Road, |
| London W4 5YE, |
| United Kingdom |

Member State EU/EEA

Marketing authorisation holder

Applicant

(Invented) Name

Strength

Pharmaceutical form

Route of administration

France

Ranbaxy (UK) Ltd.

Building 4, Chiswick Park,

566 Chiswick High Road,

London W4 5YE,

United Kingdom

ISOTRETINOINE RANBAXY 10 mg, capsule molle

10 mg

Capsules, soft

Oral

France

| Ranbaxy (UK) Ltd. |
| --- |
| Building 4, Chiswick Park, |
| 566 Chiswick High Road, |
| London W4 5YE, |
| United Kingdom |

Ranbaxy (UK) Ltd.

Building 4, Chiswick Park,

566 Chiswick High Road,

London W4 5YE,

United Kingdom

ISOTRETINOINE RANBAXY 20 mg, capsule molle

20 mg

Capsules, soft

Oral

Spain

| Ranbaxy (UK) Ltd. |
| --- |
| Building 4, Chiswick Park, |
| 566 Chiswick High Road, |
| London W4 5YE, |
| United Kingdom |

Ranbaxy (UK) Ltd.

Building 4, Chiswick Park,

566 Chiswick High Road,

London W4 5YE,

United Kingdom

ISOTRETINOINA RANBAXY 10 mg CAPSULAS BLANDAS EFG

10 mg

Capsules, soft

Oral

Spain

| Ranbaxy (UK) Ltd. |
| --- |
| Building 4, Chiswick Park, |
| 566 Chiswick High Road, |
| London W4 5YE, |
| United Kingdom |

Ranbaxy (UK) Ltd.

Building 4, Chiswick Park,

566 Chiswick High Road,

London W4 5YE,

United Kingdom

ISOTRETINOINA RANBAXY 20 mg CAPSULAS BLANDAS EFG

20 mg

Capsules, soft

Oral

United Kingdom

| Ranbaxy (UK) Ltd. |
| --- |
| Building 4, Chiswick Park, |
| 566 Chiswick High Road, |
| London W4 5YE, |
| United Kingdom |

Ranbaxy (UK) Ltd.

Building 4, Chiswick Park,

566 Chiswick High Road,

London W4 5YE,

United Kingdom

Isotretinoin 10 mg Capsules

10 mg

Capsules, soft

Oral

United Kingdom

| Ranbaxy (UK) Ltd. |
| --- |
| Building 4, Chiswick Park, |
| 566 Chiswick High Road, |
| London W4 5YE, |
| United Kingdom |

Ranbaxy (UK) Ltd.

Building 4, Chiswick Park,

566 Chiswick High Road,

London W4 5YE,

United Kingdom

Isotretinoin 20 mg Capsules

20 mg

Capsules, soft

Oral

---

ANNEX IV

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

| Member State EU/EEA | Marketing Authorisation Holder | Invented name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| AT - Austria | Octapharma Pharmazeutika |
| Produktionsgesellschaft m.b.H. |
| Oberlaaerstraße 235 |
| A-1100 Wien |
| Austria |

Member State EU/EEA

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

AT - Austria

Octapharma Pharmazeutika

Produktionsgesellschaft m.b.H.

Oberlaaerstraße 235

A-1100 Wien

Austria

Octagam 100 mg/ml Infusionslösung

100 mg/ml

Solution for infusion

Intravenous Use

AT - Austria

| Octapharma Pharmazeutika |
| --- |
| Produktionsgesellschaft m.b.H. |
| Oberlaaerstraße 235 |
| A-1100 Wien |
| Austria |

Octapharma Pharmazeutika

Produktionsgesellschaft m.b.H.

Oberlaaerstraße 235

A-1100 Wien

Austria

Octagam 50 mg/ml Infusionslösung

50 mg/ml

Solution for infusion

Intravenous Use

BE - Belgium

| OCTAPHARMA BENELUX SA |
| --- |
| Rue de Stalle 63 |
| 1180 Bruxelles (Brussels) |
| Belgium |

OCTAPHARMA BENELUX SA

Rue de Stalle 63

1180 Bruxelles (Brussels)

Belgium

Octagam 10 %, solution pour perfusion

10 % (100 mg/ml)

Solution for infusion

Intravenous Use

BE - Belgium

| OCTAPHARMA BENELUX SA |
| --- |
| Rue de Stalle 63 |
| 1180 Bruxelles (Brussels) |
| Belgium |

OCTAPHARMA BENELUX SA

Rue de Stalle 63

1180 Bruxelles (Brussels)

Belgium

Octagam 50 mg/ml solution pour perfusion

50 mg/ml

Solution for infusion

Intravenous Use

BG - Bulgaria

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam 10 %

100 mg/ml

Solution for infusion

Intravenous Use

CY - Cyprus

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

OCTAGAM INFUSION 10 %

10 %

Solution for infusion

Intravenous use

CY - Cyprus

| Hospitec Co Ltd |
| --- |
| 5 Thessalonikis, Block B |
| 2085 Lefkosia |
| Cyprus |

Hospitec Co Ltd

5 Thessalonikis, Block B

2085 Lefkosia

Cyprus

OCTAGAM INFUSION 5 %

5 %

Solution for infusion

Intravenous use

CZ - Czech Republic

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

OCTAGAM

50 mg/ml

Solution for infusion

Intravenous Use

CZ - Czech Republic

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

OCTAGAM 10 %

100 mg/ml

Solution for infusion

Intravenous Use

DE - Germany

| OCTAPHARMA GmbH |
| --- |
| Elisabeth-Selbert-Str. 11 |
| 40764 Langenfeld |
| Germany |

OCTAPHARMA GmbH

Elisabeth-Selbert-Str. 11

40764 Langenfeld

Germany

Octagam 50 mg/ml

50 mg/ml

Solution for infusion

Intravenous Use

DE - Germany

| OCTAPHARMA GmbH |
| --- |
| Elisabeth-Selbert-Str. 11 |
| 40764 Langenfeld |
| Germany |

OCTAPHARMA GmbH

Elisabeth-Selbert-Str. 11

40764 Langenfeld

Germany

Octagam 5 %

50 mg/ml

Solution for infusion

Intravenous Use

DE - Germany

| OCTAPHARMA GmbH |
| --- |
| Elisabeth-Selbert-Str. 11 |
| 40764 Langenfeld |
| Germany |

OCTAPHARMA GmbH

Elisabeth-Selbert-Str. 11

40764 Langenfeld

Germany

Octagam 10 %

100 mg/ml

Solution for infusion

Intravenous Use

DK - Denmark

| Octapharma AB |
| --- |
| Elersvägen 40 |
| SE-11275 Stockholm |
| Sweden |

Octapharma AB

Elersvägen 40

SE-11275 Stockholm

Sweden

Octagam

50 mg/ml

Solution for infusion

Intravenous Use

DK - Denmark

| Octapharma AB |
| --- |
| Elersvägen 40 |
| SE-11275 Stockholm |
| Sweden |

Octapharma AB

Elersvägen 40

SE-11275 Stockholm

Sweden

Octagam

100 mg/ml

Solution for infusion

Intravenous Use

EL - Greece

| Octapharma Hellas SA |
| --- |
| George Kalbitzer |
| 60, posidonos Ave. |
| 166 75 Glyfada Attiki |
| Greece |

Octapharma Hellas SA

George Kalbitzer

60, posidonos Ave.

166 75 Glyfada Attiki

Greece

OCTAGAM

5 % (W/V)

Solution for infusion

Intravenous Use

EL - Greece

| Octapharma Hellas SA |
| --- |
| George Kalbitzer |
| 60, posidonos Ave. |
| 166 75 Glyfada Attiki |
| Greece |

Octapharma Hellas SA

George Kalbitzer

60, posidonos Ave.

166 75 Glyfada Attiki

Greece

OCTAGAM

10 % (100 MG/ML)

Solution for infusion

Intravenous Use

ES - Spain

| OCTAPHARMA, S.A. |
| --- |
| C/ Velázquez, 150 |
| 28002 Madrid |
| ESPAÑA |

OCTAPHARMA, S.A.

C/ Velázquez, 150

28002 Madrid

ESPAÑA

Octagamocta 100 mg/ml solución para perfusión

100 mg/ml

Solution for infusion

Intravenous use

ES - Spain

| OCTAPHARMA, S.A. |
| --- |
| C/ Velázquez, 150 |
| 28002 Madrid |
| ESPAÑA |

OCTAPHARMA, S.A.

C/ Velázquez, 150

28002 Madrid

ESPAÑA

Octagamocta 50 mg/ml solución para perfusión

50 mg/ml

Solution for infusion

Intravenous use

ET - Estonia

| Octapharma AB |
| --- |
| Elersvägen 40 |
| SE-11275 Stockholm |
| Sweden |

Octapharma AB

Elersvägen 40

SE-11275 Stockholm

Sweden

OCTAGAM

50 mg/ml

Solution for infusion

Intravenous Use

ET - Estonia

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

OCTAGAM 10 %

100 mg/1 ml

Solution for infusion

Intravenous Use

FI - Finland

| OCTAPHARMA |
| --- |
| Rajatorpantie 41 C |
| 01640 Vantaa |
| FINLAND |

OCTAPHARMA

Rajatorpantie 41 C

01640 Vantaa

FINLAND

OCTAGAM

50 mg/ml

100 mg/ml

Solution for infusion

Intravenous Use

FR - France

| Octapharma France SAS |
| --- |
| Laurent de Narbonne |
| 62Bis Avenue André Morizet |
| F- 92100 Boulogne |
| Billancourt |
| France |

Octapharma France SAS

Laurent de Narbonne

62Bis Avenue André Morizet

F- 92100 Boulogne

Billancourt

France

OCTAGAM 100 mg/ml, solution pour perfusion

100 mg/ml

Solution for infusion

Intravenous Use

FR - France

| Octapharma France SAS |
| --- |
| Laurent de Narbonne |
| 62Bis Avenue André Morizet |
| F- 92100 Boulogne |
| Billancourt |
| France |

Octapharma France SAS

Laurent de Narbonne

62Bis Avenue André Morizet

F- 92100 Boulogne

Billancourt

France

OCTAGAM 50 mg/ml, solution pour perfusion

50 mg/ml

Solution for infusion

Intravenous Use

HU - Hungary

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

OCTAGAM 50 mg/ml oldatos infúzió

50 mg/ml

Solution for infusion

Intravenous Use

HU - Hungary

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

OCTAGAM 100 mg/ml oldatos infúzió

100 mg/ml

Solution for infusion

Intravenous Use

IS - Iceland

| Octapharma AB |
| --- |
| Nordenflychtsvägen 55 |
| SE-112 75 Stockholm |
| Sweden |

Octapharma AB

Nordenflychtsvägen 55

SE-112 75 Stockholm

Sweden

Octagam 5 %

50 mg/ml

Solution for infusion

Intravenous Use

IS - Iceland

| Octapharma AB |
| --- |
| Nordenflychtsvägen 55 |
| SE-112 75 Stockholm |
| Sweden |

Octapharma AB

Nordenflychtsvägen 55

SE-112 75 Stockholm

Sweden

Octagam 10 %

100 mg/ml

Solution for infusion

Intravenous Use

IT - Italy

| Octapharma Ltd |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma Ltd

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

OCTAGAM

5 %

Solution for infusion

Intravenous Use

LT - Lithuania

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

octagam

100 mg/ml

Solution for infusion

Intravenous Use

LU - Luxembourg

| OCTAPHARMA BENELUX SA |
| --- |
| Rue de Stalle 63 |
| 1180 Bruxelles (Brussels) |
| Belgium |

OCTAPHARMA BENELUX SA

Rue de Stalle 63

1180 Bruxelles (Brussels)

Belgium

Octagam

5 %

Solution for infusion

Intravenous use

LU - Luxembourg

| OCTAPHARMA BENELUX SA |
| --- |
| Rue de Stalle 63 |
| 1180 Bruxelles (Brussels) |
| Belgium |

OCTAPHARMA BENELUX SA

Rue de Stalle 63

1180 Bruxelles (Brussels)

Belgium

Octagam-10

10 %

Solution for infusion

Intravenous use

LV - Latvia

| Octapharma AB |
| --- |
| Elesvagen 40 |
| Stockholm, S-112 75 |
| Sweden |

Octapharma AB

Elesvagen 40

Stockholm, S-112 75

Sweden

Octagam 50 mg/ml solution for infusion

1 g/20 ml

Solution for infusion

Intravenous Use

LV - Latvia

| Octapharma AB |
| --- |
| Elesvagen 40 |
| Stockholm, S-112 75 |
| Sweden |

Octapharma AB

Elesvagen 40

Stockholm, S-112 75

Sweden

Octagam 50 mg/ml solution for infusion

2,5 g/50 ml

Solution for infusion

Intravenous Use

LV - Latvia

| Octapharma AB |
| --- |
| Elesvagen 40 |
| Stockholm, S-112 75 |
| Sweden |

Octapharma AB

Elesvagen 40

Stockholm, S-112 75

Sweden

Octagam 50 mg/ml solution for infusion

5 g/100 ml

Solution for infusion

Intravenous Use

LV - Latvia

| Octapharma AB |
| --- |
| Elesvagen 40 |
| Stockholm, S-112 75 |
| Sweden |

Octapharma AB

Elesvagen 40

Stockholm, S-112 75

Sweden

Octagam 50 mg/ml solution for infusion

10 g/200 ml

Solution for infusion

Intravenous Use

LV - Latvia

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

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

2 g/20 ml

Solution for infusion

Intravenous Use

LV - Latvia

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

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

5 g/50 ml

Solution for infusion

Intravenous Use

LV - Latvia

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

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

10 g/100 ml

Solution for infusion

Intravenous Use

LV - Latvia

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

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

20 g/200 ml

Solution for infusion

Intravenous Use

MT - Malta

| Octapharma (IP) Limited, |
| --- |
| The Zenith Building, |
| 26 Spring Gardens, Manchester M2 1AB, |
| United Kingdom |

Octapharma (IP) Limited,

The Zenith Building,

26 Spring Gardens, Manchester M2 1AB,

United Kingdom

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

| Octapharma GmbH |
| --- |
| Reinhard Rettinghaus |
| Elisabeth-Selbert-Str. 11 |
| 40764 Langenfeld |
| Germany |

Octapharma GmbH

Reinhard Rettinghaus

Elisabeth-Selbert-Str. 11

40764 Langenfeld

Germany

Octagam 10 %

100 mg/ml

Solution for infusion

Intravenous Use

NL - Netherlands

| Octapharma GmbH |
| --- |
| Reinhard Rettinghaus |
| Elisabeth-Selbert-Str. 11 |
| 40764 Langenfeld |
| Germany |

Octapharma GmbH

Reinhard Rettinghaus

Elisabeth-Selbert-Str. 11

40764 Langenfeld

Germany

Octagam 5 %

50 mg/ml

Solution for infusion

Intravenous Use

NO - Norway

| Octapharma AG |
| --- |
| Kim Björnstrup |
| Seidenstraße 2 |
| CH-8853 Lachen |
| Switzerland |

Octapharma AG

Kim Björnstrup

Seidenstraße 2

CH-8853 Lachen

Switzerland

Octagam

50 mg/ml

Solution for infusion

Intravenous Use

NO - Norway

| Octapharma AG |
| --- |
| Kim Björnstrup |
| Seidenstraße 2 |
| CH-8853 Lachen |
| Switzerland |

Octapharma AG

Kim Björnstrup

Seidenstraße 2

CH-8853 Lachen

Switzerland

Octagam

100 mg/ml

Solution for infusion

Intravenous Use

PL - Poland

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam

2,5 g/50 ml

Solution for infusion

Intravenous Use

PL - Poland

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam

5 g/100 ml

Solution for infusion

Intravenous Use

PL - Poland

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam 10 %

20 g/200 ml

Solution for infusion

Intravenous Use

PL - Poland

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam 10 %

100 mg/ml

Solution for infusion

Intravenous Use

PT - Portugal

| Octapharma |
| --- |
| Produtos Farmaceuticos, Lda. |
| Paulo Castro |
| Rua da Graca, 14 |
| P-1170-169 Lisboa |
| Portugal |

Octapharma

Produtos Farmaceuticos, Lda.

Paulo Castro

Rua da Graca, 14

P-1170-169 Lisboa

Portugal

Octagam

50 mg/ml

Solution for infusion

Intravenous use

PT - Portugal

| Octapharma |
| --- |
| Produtos Farmaceuticos, Lda. |
| Paulo Castro |
| Rua da Graca, 14 |
| P-1170-169 Lisboa |
| Portugal |

Octapharma

Produtos Farmaceuticos, Lda.

Paulo Castro

Rua da Graca, 14

P-1170-169 Lisboa

Portugal

Octagam

100 mg/ml

Solution for infusion

Intravenous use

RO - Romania

| OCTAPHARMA (IP) Ltd. |
| --- |
| The Zenith Building 26 Spring Gardens |
| Manchester, M2 1AB |
| United Kingdom |

OCTAPHARMA (IP) Ltd.

The Zenith Building 26 Spring Gardens

Manchester, M2 1AB

United Kingdom

OCTAGAM

50 mg/ml

Solution for infusion

Intravenous use

RO - Romania

| OCTAPHARMA (IP) Ltd. |
| --- |
| The Zenith Building 26 Spring Gardens |
| Manchester, M2 1AB |
| United Kingdom |

OCTAPHARMA (IP) Ltd.

The Zenith Building 26 Spring Gardens

Manchester, M2 1AB

United Kingdom

OCTAGAM 10 %

100 mg/ml

Solution for infusion

Intravenous use

SE - Sweden

| Octapharma AB |
| --- |
| Olivier Clairotte |
| Elersvägen 40 |
| SE-11275 Stockholm |
| Sweden |

Octapharma AB

Olivier Clairotte

Elersvägen 40

SE-11275 Stockholm

Sweden

Octagem

50 mg/ml

Solution for infusion

Intravenous use

SE - Sweden

| Octapharma AB |
| --- |
| Olivier Clairotte |
| Elersvägen 40 |
| SE-11275 Stockholm |
| Sweden |

Octapharma AB

Olivier Clairotte

Elersvägen 40

SE-11275 Stockholm

Sweden

Octagem

100 mg/ml

Solution for infusion

Intravenous use

SI - Slovenia

| Zavod Republike Slovenije za transfuzijsko medicino |
| --- |
| Šlajmerjeva 6 |
| 1000 Ljubljana |
| Slovenija |

Zavod Republike Slovenije za transfuzijsko medicino

Šlajmerjeva 6

1000 Ljubljana

Slovenija

Octagam 50 mg/ml raztopina za infundiranje

50 mg/ ml

Solution for infusion

Intravenous use

SI - Slovenia

| Zavod Republike Slovenije za transfuzijsko medicino |
| --- |
| Šlajmerjeva 6 |
| 1000 Ljubljana |
| Slovenija |

Zavod Republike Slovenije za transfuzijsko medicino

Šlajmerjeva 6

1000 Ljubljana

Slovenija

Octagam 100 mg/ml raztopina za infundiranje

100 mg/ ml

Solution for infusion

Intravenous use

SK - Slovakia

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam

20 ml 50 mg/ml

Solution for infusion

Intravenous use

SK - Slovakia

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam

50 ml 50 mg/ml

Solution for infusion

Intravenous use

SK - Slovakia

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam

100 ml 50 mg/ml

Solution for infusion

Intravenous use

SK - Slovakia

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam

200 ml 50 mg/ml

Solution for infusion

Intravenous use

SK - Slovakia

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam 10 %

20 ml 100 mg/ml

Solution for infusion

Intravenous use

SK - Slovakia

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam 10 %

50 ml 100 mg/ml

Solution for infusion

Intravenous use

SK - Slovakia

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam 10 %

100 ml 100 mg/ml

Solution for infusion

Intravenous use

SK - Slovakia

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam 10 %

200 ml 100 mg/ml

Solution for infusion

Intravenous use

UK - United Kingdom

| Octapharma Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam Infusion

5 % w/v

Solution for infusion

Intravenous use

UK - United Kingdom

| Octapharma Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam 10 % solution for Infusion

10 % w/v

Solution for infusion

Intravenous use

---

ANNEX V

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

| Member State EU/EEA | Marketing Authorisation Holder | Invented name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| AT - Austria | Octapharma Pharmazeutika |
| Produktionsgesellschaft m.b.H. |
| Oberlaaerstraße 235 |
| A-1100 Wien |
| Austria |

Member State EU/EEA

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

AT - Austria

Octapharma Pharmazeutika

Produktionsgesellschaft m.b.H.

Oberlaaerstraße 235

A-1100 Wien

Austria

Octagam 100 mg/ml Infusionslösung

100 mg/ml

Solution for infusion

Intravenous Use

AT - Austria

| Octapharma Pharmazeutika |
| --- |
| Produktionsgesellschaft m.b.H. |
| Oberlaaerstraße 235 |
| A-1100 Wien |
| Austria |

Octapharma Pharmazeutika

Produktionsgesellschaft m.b.H.

Oberlaaerstraße 235

A-1100 Wien

Austria

Octagam 50 mg/ml Infusionslösung

50 mg/ml

Solution for infusion

Intravenous Use

BE - Belgium

| OCTAPHARMA BENELUX SA |
| --- |
| Rue de Stalle 63 |
| 1180 Bruxelles (Brussels) |
| Belgium |

OCTAPHARMA BENELUX SA

Rue de Stalle 63

1180 Bruxelles (Brussels)

Belgium

Octagam 10 %, solution pour perfusion

10 % (100 mg/ml)

Solution for infusion

Intravenous Use

BE - Belgium

| OCTAPHARMA BENELUX SA |
| --- |
| Rue de Stalle 63 |
| 1180 Bruxelles (Brussels) |
| Belgium |

OCTAPHARMA BENELUX SA

Rue de Stalle 63

1180 Bruxelles (Brussels)

Belgium

Octagam 50 mg/ml solution pour perfusion

50 mg/ml

Solution for infusion

Intravenous Use

BG - Bulgaria

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam 10 %

100 mg/ml

Solution for infusion

Intravenous Use

CY - Cyprus

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam Infusion 10 %

10 %

Solution for infusion

Intravenous use

CY - Cyprus

| Hospitec Co Ltd |
| --- |
| 5 Thessalonikis, Block B |
| 2085 Nicosia |
| Cyprus |

Hospitec Co Ltd

5 Thessalonikis, Block B

2085 Nicosia

Cyprus

Octagam Infusion 5 %

5 %

Solution for infusion

Intravenous use

CZ - Czech Republic

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam

50 mg/ml

Solution for infusion

Intravenous Use

CZ - Czech Republic

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam 10 %

100 mg/ml

Solution for infusion

Intravenous Use

DE - Germany

| OCTAPHARMA GmbH |
| --- |
| Elisabeth-Selbert-Str. 11 |
| 40764 Langenfeld |
| Germany |

OCTAPHARMA GmbH

Elisabeth-Selbert-Str. 11

40764 Langenfeld

Germany

Octagam 50 mg/ml

50 mg/ml

Solution for infusion

Intravenous Use

DE - Germany

| OCTAPHARMA GmbH |
| --- |
| Elisabeth-Selbert-Str. 11 |
| 40764 Langenfeld |
| Germany |

OCTAPHARMA GmbH

Elisabeth-Selbert-Str. 11

40764 Langenfeld

Germany

Octagam 5 %

50 mg/ml

Solution for infusion

Intravenous Use

DE - Germany

| OCTAPHARMA GmbH |
| --- |
| Elisabeth-Selbert-Str. 11 |
| 40764 Langenfeld |
| Germany |

OCTAPHARMA GmbH

Elisabeth-Selbert-Str. 11

40764 Langenfeld

Germany

Octagam 10 %

100 mg/ml

Solution for infusion

Intravenous Use

DK - Denmark

| Octapharma AB |
| --- |
| Elersvägen 40 |
| SE-11275 Stockholm |
| Sweden |

Octapharma AB

Elersvägen 40

SE-11275 Stockholm

Sweden

Octagam

50 mg/ml

Solution for infusion

Intravenous Use

DK - Denmark

| Octapharma AB |
| --- |
| Elersvägen 40 |
| SE-11275 Stockholm |
| Sweden |

Octapharma AB

Elersvägen 40

SE-11275 Stockholm

Sweden

Octagam

100 mg/ml

Solution for infusion

Intravenous Use

EL - Greece

| Octapharma Hellas SA |
| --- |
| 60, posidonos Ave. |
| 166 75 Glyfada Attiki |
| Greece |

Octapharma Hellas SA

60, posidonos Ave.

166 75 Glyfada Attiki

Greece

Octagam

5 % (W/V)

Solution for infusion

Intravenous Use

EL - Greece

| Octapharma Hellas SA |
| --- |
| 60, posidonos Ave. |
| 166 75 Glyfada Attiki |
| Greece |

Octapharma Hellas SA

60, posidonos Ave.

166 75 Glyfada Attiki

Greece

Octagam

10 % (100 MG/ML)

Solution for infusion

Intravenous Use

ES - Spain

| OCTAPHARMA, S.A. |
| --- |
| C/ Velázquez, 150 |
| 28002 Madrid |
| ESPAÑA |

OCTAPHARMA, S.A.

C/ Velázquez, 150

28002 Madrid

ESPAÑA

Octagamocta 100 mg/ml solución para perfusión

100 mg/ml

Solution for infusion

Intravenous use

ES - Spain

| OCTAPHARMA, S.A. |
| --- |
| C/ Velázquez, 150 |
| 28002 Madrid |
| ESPAÑA |

OCTAPHARMA, S.A.

C/ Velázquez, 150

28002 Madrid

ESPAÑA

Octagamocta 50 mg/ml solución para perfusión

50 mg/ml

Solution for infusion

Intravenous use

ET - Estonia

| Octapharma AB |
| --- |
| Elersvägen 40 |
| SE-11275 Stockholm |
| Sweden |

Octapharma AB

Elersvägen 40

SE-11275 Stockholm

Sweden

Octagam

50 mg/ml

Solution for infusion

Intravenous Use

ET - Estonia

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam 10 %

100 mg/1 ml

Solution for infusion

Intravenous Use

FI - Finland

| Octapharma AB |
| --- |
| Elersvägen 40 |
| SE-11275 Stockholm |
| Sweden |

Octapharma AB

Elersvägen 40

SE-11275 Stockholm

Sweden

Octagam

50 mg/ml

100 mg/ml

Solution for infusion

Intravenous Use

FR - France

| Octapharma France SAS |
| --- |
| 62Bis Avenue André Morizet |
| F- 92100 Boulogne |
| Billancourt |
| France |

Octapharma France SAS

62Bis Avenue André Morizet

F- 92100 Boulogne

Billancourt

France

Octagam 100 mg/ml, solution pour perfusion

100 mg/ml

Solution for infusion

Intravenous Use

FR - France

| Octapharma France SAS |
| --- |
| 62Bis Avenue André Morizet |
| F- 92100 Boulogne |
| Billancourt |
| France |

Octapharma France SAS

62Bis Avenue André Morizet

F- 92100 Boulogne

Billancourt

France

Octagam 50 mg/ml, solution pour perfusion

50 mg/ml

Solution for infusion

Intravenous Use

HU - Hungary

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam 50 mg/ml oldatos infúzió

50 mg/ml

Solution for infusion

Intravenous Use

HU - Hungary

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam 100 mg/ml oldatos infúzió

100 mg/ml

Solution for infusion

Intravenous Use

IS - Iceland

| Octapharma AB |
| --- |
| Nordenflychtsvägen 55 |
| SE-112 75 Stockholm |
| Sweden |

Octapharma AB

Nordenflychtsvägen 55

SE-112 75 Stockholm

Sweden

Octagam 5 %

50 mg/ml

Solution for infusion

Intravenous Use

IS - Iceland

| Octapharma AB |
| --- |
| Nordenflychtsvägen 55 |
| SE-112 75 Stockholm |
| Sweden |

Octapharma AB

Nordenflychtsvägen 55

SE-112 75 Stockholm

Sweden

Octagam 10 %

100 mg/ml

Solution for infusion

Intravenous Use

IT - Italy

| Octapharma Ltd |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma Ltd

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam

5 %

Solution for infusion

Intravenous Use

IT – Italy

| Octapharma Italy S.p.A |
| --- |
| Via Cisanello 145 |
| 56100 Pisa |
| Italy |

Octapharma Italy S.p.A

Via Cisanello 145

56100 Pisa

Italy

Gamten

10 %

Solution for infusion

Intravenous Use

LT - Lithuania

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam

100 mg/ml

Solution for infusion

Intravenous Use

LU - Luxembourg

| OCTAPHARMA BENELUX SA |
| --- |
| Rue de Stalle 63 |
| 1180 Bruxelles (Brussels) |
| Belgium |

OCTAPHARMA BENELUX SA

Rue de Stalle 63

1180 Bruxelles (Brussels)

Belgium

Octagam

5 %

Solution for infusion

Intravenous use

LU - Luxembourg

| OCTAPHARMA BENELUX SA |
| --- |
| Rue de Stalle 63 |
| 1180 Bruxelles (Brussels) |
| Belgium |

OCTAPHARMA BENELUX SA

Rue de Stalle 63

1180 Bruxelles (Brussels)

Belgium

Octagam-10

10 %

Solution for infusion

Intravenous use

LV - Latvia

| Octapharma AB |
| --- |
| Elesvagen 40 |
| Stockholm, S-112 75 |
| Sweden |

Octapharma AB

Elesvagen 40

Stockholm, S-112 75

Sweden

Octagam 50 mg/ml solution for infusion

1 g/20 ml

Solution for infusion

Intravenous Use

LV - Latvia

| Octapharma AB |
| --- |
| Elesvagen 40 |
| Stockholm, S-112 75 |
| Sweden |

Octapharma AB

Elesvagen 40

Stockholm, S-112 75

Sweden

Octagam 50 mg/ml solution for infusion

2,5 g/50 ml

Solution for infusion

Intravenous Use

LV - Latvia

| Octapharma AB |
| --- |
| Elesvagen 40 |
| Stockholm, S-112 75 |
| Sweden |

Octapharma AB

Elesvagen 40

Stockholm, S-112 75

Sweden

Octagam 50 mg/ml solution for infusion

5 g/100 ml

Solution for infusion

Intravenous Use

LV - Latvia

| Octapharma AB |
| --- |
| Elesvagen 40 |
| Stockholm, S-112 75 |
| Sweden |

Octapharma AB

Elesvagen 40

Stockholm, S-112 75

Sweden

Octagam 50 mg/ml solution for infusion

10 g/200 ml

Solution for infusion

Intravenous Use

LV - Latvia

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

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

2 g/20 ml

Solution for infusion

Intravenous Use

LV - Latvia

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

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

5 g/50 ml

Solution for infusion

Intravenous Use

LV - Latvia

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

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

10 g/100 ml

Solution for infusion

Intravenous Use

LV - Latvia

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

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

20 g/200 ml

Solution for infusion

Intravenous Use

MT - Malta

| Octapharma (IP) Limited, |
| --- |
| The Zenith Building, |
| 26 Spring Gardens, Manchester M2 1AB, |
| United Kingdom |

Octapharma (IP) Limited,

The Zenith Building,

26 Spring Gardens, Manchester M2 1AB,

United Kingdom

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

| Octapharma GmbH |
| --- |
| Elisabeth-Selbert-Str. 11 |
| 40764 Langenfeld |
| Germany |

Octapharma GmbH

Elisabeth-Selbert-Str. 11

40764 Langenfeld

Germany

Octagam 10 %

100 mg/ml

Solution for infusion

Intravenous Use

NL - Netherlands

| Octapharma GmbH |
| --- |
| Elisabeth-Selbert-Str. 11 |
| 40764 Langenfeld |
| Germany |

Octapharma GmbH

Elisabeth-Selbert-Str. 11

40764 Langenfeld

Germany

Octagam 5 %

50 mg/ml

Solution for infusion

Intravenous Use

NO - Norway

| Octapharma AG |
| --- |
| Seidenstraße 2 |
| CH-8853 Lachen |
| Switzerland |

Octapharma AG

Seidenstraße 2

CH-8853 Lachen

Switzerland

Octagam

50 mg/ml

Solution for infusion

Intravenous Use

NO - Norway

| Octapharma AG |
| --- |
| Seidenstraße 2 |
| CH-8853 Lachen |
| Switzerland |

Octapharma AG

Seidenstraße 2

CH-8853 Lachen

Switzerland

Octagam

100 mg/ml

Solution for infusion

Intravenous Use

PL - Poland

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam

2,5 g/50 ml

Solution for infusion

Intravenous Use

PL - Poland

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam

5 g/100 ml

Solution for infusion

Intravenous Use

PL - Poland

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam

10 g/200 ml

Solution for infusion

Intravenous Use

PL - Poland

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam 10 %

100 mg/ml

Solution for infusion

Intravenous Use

PT - Portugal

| Octapharma |
| --- |
| Produtos Farmaceuticos, Lda. |
| Rua dos Lagares D'el Rei, 21C r/c Dto. |
| P-1170-268 Lisboa |
| Portugal |

Octapharma

Produtos Farmaceuticos, Lda.

Rua dos Lagares D'el Rei, 21C r/c Dto.

P-1170-268 Lisboa

Portugal

Octagam

50 mg/ml

Solution for infusion

Intravenous use

PT - Portugal

| Octapharma |
| --- |
| Produtos Farmaceuticos, Lda. |
| Rua dos Lagares D'el Rei, 21C r/c Dto. |
| P-1170-268 Lisboa |
| Portugal |

Octapharma

Produtos Farmaceuticos, Lda.

Rua dos Lagares D'el Rei, 21C r/c Dto.

P-1170-268 Lisboa

Portugal

Octagam

100 mg/ml

Solution for infusion

Intravenous use

RO - Romania

| OCTAPHARMA (IP) Ltd. |
| --- |
| The Zenith Building 26 Spring Gardens |
| Manchester, M2 1AB |
| United Kingdom |

OCTAPHARMA (IP) Ltd.

The Zenith Building 26 Spring Gardens

Manchester, M2 1AB

United Kingdom

Octagam

50 mg/ml

Solution for infusion

Intravenous use

RO - Romania

| OCTAPHARMA (IP) Ltd. |
| --- |
| The Zenith Building 26 Spring Gardens |
| Manchester, M2 1AB |
| United Kingdom |

OCTAPHARMA (IP) Ltd.

The Zenith Building 26 Spring Gardens

Manchester, M2 1AB

United Kingdom

Octagam 10 %

100 mg/ml

Solution for infusion

Intravenous use

SE - Sweden

| Octapharma AB |
| --- |
| Elersvägen 40 |
| 112 75 Stockholm |
| Sweden |

Octapharma AB

Elersvägen 40

112 75 Stockholm

Sweden

Octagam

50 mg/ml

Solution for infusion

Intravenous use

SE - Sweden

| Octapharma AB |
| --- |
| Elersvägen 40 |
| 112 75 Stockholm |
| Sweden |

Octapharma AB

Elersvägen 40

112 75 Stockholm

Sweden

Octagam

100 mg/ml

Solution for infusion

Intravenous use

SI - Slovenia

| Zavod Republike Slovenije za transfuzijsko medicino |
| --- |
| Šlajmerjeva 6 |
| 1000 Ljubljana |
| Slovenija |

Zavod Republike Slovenije za transfuzijsko medicino

Šlajmerjeva 6

1000 Ljubljana

Slovenija

Octagam 50 mg/ml raztopina za infundiranje

50 mg/ ml

Solution for infusion

Intravenous use

SI - Slovenia

| Zavod Republike Slovenije za transfuzijsko medicino |
| --- |
| Šlajmerjeva 6 |
| 1000 Ljubljana |
| Slovenija |

Zavod Republike Slovenije za transfuzijsko medicino

Šlajmerjeva 6

1000 Ljubljana

Slovenija

Octagam 100 mg/ml raztopina za infundiranje

100 mg/ ml

Solution for infusion

Intravenous use

SK - Slovakia

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam

50 mg/ml

Solution for infusion

Intravenous use

SK - Slovakia

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam 10 %

100 mg/ml

Solution for infusion

Intravenous use

UK - United Kingdom

| Octapharma Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam Infusion

5 % w/v

Solution for infusion

Intravenous use

UK - United Kingdom

| Octapharma Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam 10 % solution for Infusion

10 % w/v

Solution for infusion

Intravenous use

---