# Official Journal C 80/4 Ma

| | ISSN 1977-091X |
| --- | --- |
| Official Journal
  of the European Union | C 80 |
| | |
| English edition | Information and Notices | Volume 624 March 2019 |

ISSN 1977-091X

Official Journal

of the European Union

C 80

English edition

Information and Notices

Volume 624 March 2019

---

| Contents | page |
| --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2019/C 80/01 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2019 to 31 January 2019(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) | 1 |
| 2019/C 80/02 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2019 to 31 January 2019(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC) | 11 |

Contents

page

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2019/C 80/01

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2019 to 31 January 2019(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

1

2019/C 80/02

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2019 to 31 January 2019(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)

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

11

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| EN | |
| --- | --- |

EN

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IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 4.3.2019 | EN | Official Journal of the European Union | C 80/1 |
| --- | --- | --- | --- |

4.3.2019

EN

Official Journal of the European Union

C 80/1

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2019 to 31 January 2019

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))

(2019/C 80/01)

| — | Issuing of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted |
| --- | --- |

—

Issuing of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorisation | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 7.1.2019 | Silodosin Recordati | silodosin | Recordati Ireland Ltd
  Raheens East, Ringaskiddy Co. Cork, Ireland | EU/1/18/1343 | Capsule, hard | G04CA04 | 9.1.2019 |
| 11.1.2019 | Macimorelin Aeterna Zentaris | macimorelin | Æterna Zentaris GmbH
  Weismüllerstraße 50, 60314 Frankfurt am Main, Deutschland | EU/1/18/1337 | Granules for oral solution | V04CD06 | 15.1.2019 |
| 14.1.2019 | Erleada | apalutamide | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/18/1342 | Film-coated tablet | L02BB05 | 16.1.2019 |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorisation

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

7.1.2019

Silodosin Recordati

silodosin

Recordati Ireland Ltd

Raheens East, Ringaskiddy Co. Cork, Ireland

EU/1/18/1343

Capsule, hard

G04CA04

9.1.2019

11.1.2019

Macimorelin Aeterna Zentaris

macimorelin

Æterna Zentaris GmbH

Weismüllerstraße 50, 60314 Frankfurt am Main, Deutschland

EU/1/18/1337

Granules for oral solution

V04CD06

15.1.2019

14.1.2019

Erleada

apalutamide

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/18/1342

Film-coated tablet

L02BB05

16.1.2019

| — | Issuing of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Rejected |
| --- | --- |

—

Issuing of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Rejected

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 7.1.2019 | Eladynos | Radius International Ltd
  Liberty House, 222 Regent Street, W1B 5TR, London, United Kingdom | — | 23.1.2019 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

7.1.2019

Eladynos

Radius International Ltd

Liberty House, 222 Regent Street, W1B 5TR, London, United Kingdom

—

23.1.2019

| — | Modification of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted |
| --- | --- |

—

Modification of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 7.1.2019 | Ivabradine Anpharm | ANPHARM Przedsiębiorstwo Farmaceutyczne S.A.
  ul. Annopol 6B, 03–236 Warszawa, Polska | EU/1/15/1041 | 9.1.2019 |
| 7.1.2019 | Omidria | Omeros London Limited
  Berkeley Square House, Berkeley Square, London, W1J 6BD, United Kingdom | EU/1/15/1018 | 9.1.2019 |
| 7.1.2019 | Pregabalin Sandoz | Sandoz GmbH
  Biochemiestrasse 10, 6250 Kundl, Österreich | EU/1/15/1011 | 9.1.2019 |
| 7.1.2019 | Pregabalin Sandoz GmbH | Sandoz GmbH
  Biochemiestrasse 10, 6250 Kundl, Österreich | EU/1/15/1012 | 9.1.2019 |
| 7.1.2019 | Strensiq | Alexion Europe SAS
  1-15 avenue Edouard Belin, 92500 Rueil-Malmaison, France | EU/1/15/1015 | 10.1.2019 |
| 7.1.2019 | Thymanax | Servier (Ireland) Industries Limited
  Gorey Road, Arklow, Co. Wicklow, Ireland | EU/1/08/498 | 9.1.2019 |
| 11.1.2019 | Corlentor | Les Laboratoires Servier
  50 rue Carnot, 92284 Suresnes Cedex, France | EU/1/05/317 | 15.1.2019 |
| 11.1.2019 | Ebymect | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/15/1051 | 16.1.2019 |
| 11.1.2019 | Hemangiol | Pierre Fabre Dermatologie
  45 place Abel Gance, 92100 Boulogne, France | EU/1/14/919 | 15.1.2019 |
| 11.1.2019 | Hizentra | CSL Behring GmbH
  Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland | EU/1/11/687 | 15.1.2019 |
| 11.1.2019 | Imatinib Actavis | Actavis Group PTC ehf.
  Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland | EU/1/13/825 | 15.1.2019 |
| 11.1.2019 | Incruse Ellipta | GlaxoSmithKline (Ireland) Limited
  12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland | EU/1/14/922 | 15.1.2019 |
| 11.1.2019 | KEYTRUDA | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/15/1024 | 15.1.2019 |
| 11.1.2019 | Laventair Ellipta | GlaxoSmithKline (Ireland) Limited
  12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland | EU/1/14/899 | 15.1.2019 |
| 11.1.2019 | Opdivo | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/15/1014 | 15.1.2019 |
| 11.1.2019 | Orbactiv | Menarini International Operations Luxembourg S.A.
  1 avenue de la Gare, 1611 Luxembourg, Grand-Duché de Luxembourg | EU/1/15/989 | 16.1.2019 |
| 11.1.2019 | Ovaleap | Theramex Ireland Limited
  3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland | EU/1/13/871 | 16.1.2019 |
| 11.1.2019 | Procoralan | Les Laboratoires Servier
  50 rue Carnot, 92284 Suresnes Cedex, France | EU/1/05/316 | 15.1.2019 |
| 11.1.2019 | Savene | Clinigen Healthcare B.V.
  Schiphol Boulevard 359, WTC Schiphol Airport, D Tower 11th floor, 1118BJ Schiphol, The Netherlands | EU/1/06/350 | 17.1.2019 |
| 11.1.2019 | Sirturo | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/13/901 | 15.1.2019 |
| 11.1.2019 | Symkevi | Vertex Pharmaceuticals (Ireland) Limited
  28-32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland | EU/1/18/1306 | 15.1.2019 |
| 11.1.2019 | Tamiflu | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/02/222 | 16.1.2019 |
| 11.1.2019 | Vepacel | Ology Bioservices Ireland LTD
  Wilton Park House, Wilton Place, Dublin 2, D02P447, Ireland | EU/1/12/752 | 16.1.2019 |
| 11.1.2019 | Vizamyl | GE Healthcare AS
  Nycoveien 1, 0485, Oslo, Norge | EU/1/14/941 | 15.1.2019 |
| 11.1.2019 | Yervoy | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/11/698 | 15.1.2019 |
| 14.1.2019 | Cyltezo | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/17/1240 | 16.1.2019 |
| 14.1.2019 | Onivyde | Les Laboratoires Servier
  50 rue Carnot, 92284 Suresnes Cedex, France | EU/1/16/1130 | 16.1.2019 |
| 15.1.2019 | Anoro Ellipta | GlaxoSmithKline (Ireland) Limited
  12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland | EU/1/14/898 | 17.1.2019 |
| 15.1.2019 | Armisarte | Actavis Group PTC ehf.
  Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland | EU/1/15/1063 | 17.1.2019 |
| 15.1.2019 | Caprelsa | Genzyme Europe B.V.
  Gooimeer 10, 1411 DD Naarden, Nederland | EU/1/11/749 | 17.1.2019 |
| 15.1.2019 | Hemangiol | Pierre Fabre Dermatologie
  45 place Abel Gance, 92100 Boulogne, France | EU/1/14/919 | 17.1.2019 |
| 15.1.2019 | Holoclar | Chiesi Farmaceutici S.p.A.
  Via Palermo 26/A, 43122 Parma, Italia | EU/1/14/987 | 17.1.2019 |
| 15.1.2019 | Natpar | Shire Pharmaceuticals Ireland Limited
  Block 2 & 3 Miesian Plaza, 50 — 58 Baggot Street Lower, Dublin 2, IRELAND | EU/1/15/1078 | 17.1.2019 |
| 15.1.2019 | Orkambi | Vertex Pharmaceuticals (Ireland) Limited
  28-32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland | EU/1/15/1059 | 17.1.2019 |
| 15.1.2019 | RoActemra | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/08/492 | 17.1.2019 |
| 15.1.2019 | Ulunar Breezhaler | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/14/917 | 17.1.2019 |
| 17.1.2019 | CRYSVITA | Kyowa Kirin Holdings B.V.
  Bloemlaan 2, 2132 NP Hoofddorp, Nederland | EU/1/17/1262 | 21.1.2019 |
| 18.1.2019 | Adempas | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/13/907 | 22.1.2019 |
| 18.1.2019 | Blincyto | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/15/1047 | 22.1.2019 |
| 18.1.2019 | Dexdor | Orion Corporation
  Orionintie 1, 02200 Espoo, Suomi | EU/1/11/718 | 22.1.2019 |
| 18.1.2019 | Lumigan | Allergan Pharmaceuticals Ireland
  Castlebar Road, Westport, County Mayo, Ireland | EU/1/02/205 | 22.1.2019 |
| 18.1.2019 | Silapo | STADA Arzneimittel AG
  Stadastraße 2-18, 61118 Bad Vilbel, Deutschland | EU/1/07/432 | 22.1.2019 |
| 21.1.2019 | Humalog | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/96/007 | 23.1.2019 |
| 21.1.2019 | Lonquex | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/13/856 | 23.1.2019 |
| 23.1.2019 | Axumin | Blue Earth Diagnostics Ireland Ltd
  6th Floor, 2 Grand Canal Square, Dublin 2, Ιreland | EU/1/17/1186 | 25.1.2019 |
| 23.1.2019 | Biopoin | Teva GmbH
  Graf-Arco-Straße 3, 89079 Ulm, Deutschland | EU/1/09/565 | 25.1.2019 |
| 23.1.2019 | Bronchitol | Pharmaxis Europe Limited
  108 Q House, Furze Road, Sandyford Dublin 18, D18AY29, Ireland | EU/1/12/760 | 25.1.2019 |
| 23.1.2019 | Dacogen | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/12/792 | 25.1.2019 |
| 23.1.2019 | Emtricitabine/Tenofovir disoproxil Zentiva | Zentiva, k.s.
  U Kabelovny 130, 102 37 Praha 10, Česká republika | EU/1/16/1148 | 6.2.2019 |
| 23.1.2019 | Infanrix hexa | GlaxoSmithKline Biologicals S.A.
  rue de l’Institut 89, 1330 Rixensart, Belgique | EU/1/00/152 | 25.1.2019 |
| 23.1.2019 | Juluca | ViiV Healthcare BV
  Huis ter Heideweg 62, 3705 LZ Zeist, Nederland | EU/1/18/1282 | 25.1.2019 |
| 23.1.2019 | Luxturna | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/18/1331 | 25.1.2019 |
| 23.1.2019 | OCALIVA | Intercept Pharma International Ltd
  10 Earlsfort Terrace, Dublin 2, Ireland | EU/1/16/1139 | 28.1.2019 |
| 23.1.2019 | Pregabalin Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/15/1027 | 25.1.2019 |
| 23.1.2019 | Rapiscan | GE Healthcare AS
  Nycoveien 1, 0485, Oslo, Norge | EU/1/10/643 | 25.1.2019 |
| 23.1.2019 | Revestive | Shire Pharmaceuticals Ireland Limited
  Block 2-3 Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, Ireland | EU/1/12/787 | 25.1.2019 |
| 23.1.2019 | Rubraca | Clovis Oncology Ireland Limited
  Regus Dublin Airport, Skybridge House — Dublin Airport, Swords, Co. Dublin, K67 P6K2, Ireland | EU/1/17/1250 | 25.1.2019 |
| 23.1.2019 | Topotecan Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/09/552 | 25.1.2019 |
| 23.1.2019 | Trimbow | Chiesi Farmaceutici S.p.A.
  Via Palermo 26/A, 43122 Parma, Italia | EU/1/17/1208 | 25.1.2019 |
| 23.1.2019 | Zoely | Theramex Ireland Limited
  3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland | EU/1/11/690 | 25.1.2019 |
| 31.1.2019 | Aripiprazole Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/15/1045 | 4.2.2019 |
| 31.1.2019 | Clopidogrel Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/09/540 | 4.2.2019 |
| 31.1.2019 | Combivir | ViiV Healthcare BV
  Huis ter Heideweg 62, 3705 LZ Zeist, Nederland | EU/1/98/058 | 4.2.2019 |
| 31.1.2019 | Elmiron | bene-Arzneimittel GmbH
  Herterichstraße 1-3, 81479 München, Deutschland | EU/1/17/1189 | 4.2.2019 |
| 31.1.2019 | Feraccru | Norgine B.V.
  Antonio Vivaldistraat 150, 1083 HP Amsterdam, Nederland | EU/1/15/1075 | 4.2.2019 |
| 31.1.2019 | Imatinib Medac | medac Gesellschaft für klinische Spezialpräparate mbH
  Theaterstraße 6, 22880 Wedel, Deutschland | EU/1/13/876 | 4.2.2019 |
| 31.1.2019 | Memantine Accord | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España | EU/1/13/880 | 4.2.2019 |
| 31.1.2019 | Nplate | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/08/497 | 4.2.2019 |
| 31.1.2019 | Olanzapine Glenmark | Glenmark Arzneimittel GmbH
  Industriestr. 31, D — 82194 Gröbenzell, Deutschland | EU/1/09/587 | 4.2.2019 |
| 31.1.2019 | Olanzapine Glenmark Europe | Glenmark Arzneimittel GmbH
  Industriestr. 31, D — 82194 Gröbenzell, Deutschland | EU/1/09/588 | 4.2.2019 |
| 31.1.2019 | Onivyde | Les Laboratoires Servier
  50 rue Carnot, 92284 Suresnes Cedex, France | EU/1/16/1130 | 4.2.2019 |
| 31.1.2019 | Plenadren | Shire Services BVBA
  rue Montoyer 47, 1000 Bruxelles, Belgique/Montoyerstraat 47, 1000 Brussel, België | EU/1/11/715 | 4.2.2019 |
| 31.1.2019 | Privigen | CSL Behring GmbH
  Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland | EU/1/08/446 | 4.2.2019 |
| 31.1.2019 | Resolor | Shire Pharmaceuticals Ireland Limited
  Block 2-3 Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, Ireland | EU/1/09/581 | 4.2.2019 |
| 31.1.2019 | Respreeza | CSL Behring GmbH
  Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland | EU/1/15/1006 | 4.2.2019 |
| 31.1.2019 | Revestive | Shire Pharmaceuticals Ireland Limited
  Block 2-3 Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, Ireland | EU/1/12/787 | 4.2.2019 |
| 31.1.2019 | Reyataz | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/03/267 | 4.2.2019 |
| 31.1.2019 | Stalevo | Orion Corporation
  Orionintie 1, 02200 Espoo, Suomi | EU/1/03/260 | 4.2.2019 |
| 31.1.2019 | Taxotere | Aventis Pharma S.A.
  20 avenue Raymond Aron, 92165 Antony Cedex, France | EU/1/95/002 | 4.2.2019 |
| 31.1.2019 | Vizarsin | Krka d. d., Novo mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/09/551 | 4.2.2019 |
| 31.1.2019 | Xaluprine | Nova Laboratories Ireland Limited
  3rd Floor, Ulysses House, Foley Street, Dublin 1, Ireland | EU/1/11/727 | 4.2.2019 |
| 31.1.2019 | Zoely | Theramex Ireland Limited
  3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland | EU/1/11/690 | 4.2.2019 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

7.1.2019

Ivabradine Anpharm

ANPHARM Przedsiębiorstwo Farmaceutyczne S.A.

ul. Annopol 6B, 03–236 Warszawa, Polska

EU/1/15/1041

9.1.2019

7.1.2019

Omidria

Omeros London Limited

Berkeley Square House, Berkeley Square, London, W1J 6BD, United Kingdom

EU/1/15/1018

9.1.2019

7.1.2019

Pregabalin Sandoz

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/15/1011

9.1.2019

7.1.2019

Pregabalin Sandoz GmbH

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/15/1012

9.1.2019

7.1.2019

Strensiq

Alexion Europe SAS

1-15 avenue Edouard Belin, 92500 Rueil-Malmaison, France

EU/1/15/1015

10.1.2019

7.1.2019

Thymanax

Servier (Ireland) Industries Limited

Gorey Road, Arklow, Co. Wicklow, Ireland

EU/1/08/498

9.1.2019

11.1.2019

Corlentor

Les Laboratoires Servier

50 rue Carnot, 92284 Suresnes Cedex, France

EU/1/05/317

15.1.2019

11.1.2019

Ebymect

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/15/1051

16.1.2019

11.1.2019

Hemangiol

Pierre Fabre Dermatologie

45 place Abel Gance, 92100 Boulogne, France

EU/1/14/919

15.1.2019

11.1.2019

Hizentra

CSL Behring GmbH

Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland

EU/1/11/687

15.1.2019

11.1.2019

Imatinib Actavis

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland

EU/1/13/825

15.1.2019

11.1.2019

Incruse Ellipta

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/14/922

15.1.2019

11.1.2019

KEYTRUDA

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/15/1024

15.1.2019

11.1.2019

Laventair Ellipta

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/14/899

15.1.2019

11.1.2019

Opdivo

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/15/1014

15.1.2019

11.1.2019

Orbactiv

Menarini International Operations Luxembourg S.A.

1 avenue de la Gare, 1611 Luxembourg, Grand-Duché de Luxembourg

EU/1/15/989

16.1.2019

11.1.2019

Ovaleap

Theramex Ireland Limited

3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland

EU/1/13/871

16.1.2019

11.1.2019

Procoralan

Les Laboratoires Servier

50 rue Carnot, 92284 Suresnes Cedex, France

EU/1/05/316

15.1.2019

11.1.2019

Savene

Clinigen Healthcare B.V.

Schiphol Boulevard 359, WTC Schiphol Airport, D Tower 11th floor, 1118BJ Schiphol, The Netherlands

EU/1/06/350

17.1.2019

11.1.2019

Sirturo

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/13/901

15.1.2019

11.1.2019

Symkevi

Vertex Pharmaceuticals (Ireland) Limited

28-32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland

EU/1/18/1306

15.1.2019

11.1.2019

Tamiflu

Roche Registration GmbH

Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland

EU/1/02/222

16.1.2019

11.1.2019

Vepacel

Ology Bioservices Ireland LTD

Wilton Park House, Wilton Place, Dublin 2, D02P447, Ireland

EU/1/12/752

16.1.2019

11.1.2019

Vizamyl

GE Healthcare AS

Nycoveien 1, 0485, Oslo, Norge

EU/1/14/941

15.1.2019

11.1.2019

Yervoy

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/11/698

15.1.2019

14.1.2019

Cyltezo

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/17/1240

16.1.2019

14.1.2019

Onivyde

Les Laboratoires Servier

50 rue Carnot, 92284 Suresnes Cedex, France

EU/1/16/1130

16.1.2019

15.1.2019

Anoro Ellipta

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/14/898

17.1.2019

15.1.2019

Armisarte

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland

EU/1/15/1063

17.1.2019

15.1.2019

Caprelsa

Genzyme Europe B.V.

Gooimeer 10, 1411 DD Naarden, Nederland

EU/1/11/749

17.1.2019

15.1.2019

Hemangiol

Pierre Fabre Dermatologie

45 place Abel Gance, 92100 Boulogne, France

EU/1/14/919

17.1.2019

15.1.2019

Holoclar

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A, 43122 Parma, Italia

EU/1/14/987

17.1.2019

15.1.2019

Natpar

Shire Pharmaceuticals Ireland Limited

Block 2 & 3 Miesian Plaza, 50 — 58 Baggot Street Lower, Dublin 2, IRELAND

EU/1/15/1078

17.1.2019

15.1.2019

Orkambi

Vertex Pharmaceuticals (Ireland) Limited

28-32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland

EU/1/15/1059

17.1.2019

15.1.2019

RoActemra

Roche Registration GmbH

Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland

EU/1/08/492

17.1.2019

15.1.2019

Ulunar Breezhaler

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/14/917

17.1.2019

17.1.2019

CRYSVITA

Kyowa Kirin Holdings B.V.

Bloemlaan 2, 2132 NP Hoofddorp, Nederland

EU/1/17/1262

21.1.2019

18.1.2019

Adempas

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/13/907

22.1.2019

18.1.2019

Blincyto

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/15/1047

22.1.2019

18.1.2019

Dexdor

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/1/11/718

22.1.2019

18.1.2019

Lumigan

Allergan Pharmaceuticals Ireland

Castlebar Road, Westport, County Mayo, Ireland

EU/1/02/205

22.1.2019

18.1.2019

Silapo

STADA Arzneimittel AG

Stadastraße 2-18, 61118 Bad Vilbel, Deutschland

EU/1/07/432

22.1.2019

21.1.2019

Humalog

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/96/007

23.1.2019

21.1.2019

Lonquex

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/13/856

23.1.2019

23.1.2019

Axumin

Blue Earth Diagnostics Ireland Ltd

6th Floor, 2 Grand Canal Square, Dublin 2, Ιreland

EU/1/17/1186

25.1.2019

23.1.2019

Biopoin

Teva GmbH

Graf-Arco-Straße 3, 89079 Ulm, Deutschland

EU/1/09/565

25.1.2019

23.1.2019

Bronchitol

Pharmaxis Europe Limited

108 Q House, Furze Road, Sandyford Dublin 18, D18AY29, Ireland

EU/1/12/760

25.1.2019

23.1.2019

Dacogen

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/12/792

25.1.2019

23.1.2019

Emtricitabine/Tenofovir disoproxil Zentiva

Zentiva, k.s.

U Kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/16/1148

6.2.2019

23.1.2019

Infanrix hexa

GlaxoSmithKline Biologicals S.A.

rue de l’Institut 89, 1330 Rixensart, Belgique

EU/1/00/152

25.1.2019

23.1.2019

Juluca

ViiV Healthcare BV

Huis ter Heideweg 62, 3705 LZ Zeist, Nederland

EU/1/18/1282

25.1.2019

23.1.2019

Luxturna

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/18/1331

25.1.2019

23.1.2019

OCALIVA

Intercept Pharma International Ltd

10 Earlsfort Terrace, Dublin 2, Ireland

EU/1/16/1139

28.1.2019

23.1.2019

Pregabalin Accord

Accord Healthcare Limited

Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom

EU/1/15/1027

25.1.2019

23.1.2019

Rapiscan

GE Healthcare AS

Nycoveien 1, 0485, Oslo, Norge

EU/1/10/643

25.1.2019

23.1.2019

Revestive

Shire Pharmaceuticals Ireland Limited

Block 2-3 Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, Ireland

EU/1/12/787

25.1.2019

23.1.2019

Rubraca

Clovis Oncology Ireland Limited

Regus Dublin Airport, Skybridge House — Dublin Airport, Swords, Co. Dublin, K67 P6K2, Ireland

EU/1/17/1250

25.1.2019

23.1.2019

Topotecan Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/552

25.1.2019

23.1.2019

Trimbow

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A, 43122 Parma, Italia

EU/1/17/1208

25.1.2019

23.1.2019

Zoely

Theramex Ireland Limited

3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland

EU/1/11/690

25.1.2019

31.1.2019

Aripiprazole Accord

Accord Healthcare Limited

Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom

EU/1/15/1045

4.2.2019

31.1.2019

Clopidogrel Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/540

4.2.2019

31.1.2019

Combivir

ViiV Healthcare BV

Huis ter Heideweg 62, 3705 LZ Zeist, Nederland

EU/1/98/058

4.2.2019

31.1.2019

Elmiron

bene-Arzneimittel GmbH

Herterichstraße 1-3, 81479 München, Deutschland

EU/1/17/1189

4.2.2019

31.1.2019

Feraccru

Norgine B.V.

Antonio Vivaldistraat 150, 1083 HP Amsterdam, Nederland

EU/1/15/1075

4.2.2019

31.1.2019

Imatinib Medac

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstraße 6, 22880 Wedel, Deutschland

EU/1/13/876

4.2.2019

31.1.2019

Memantine Accord

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España

EU/1/13/880

4.2.2019

31.1.2019

Nplate

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/08/497

4.2.2019

31.1.2019

Olanzapine Glenmark

Glenmark Arzneimittel GmbH

Industriestr. 31, D — 82194 Gröbenzell, Deutschland

EU/1/09/587

4.2.2019

31.1.2019

Olanzapine Glenmark Europe

Glenmark Arzneimittel GmbH

Industriestr. 31, D — 82194 Gröbenzell, Deutschland

EU/1/09/588

4.2.2019

31.1.2019

Onivyde

Les Laboratoires Servier

50 rue Carnot, 92284 Suresnes Cedex, France

EU/1/16/1130

4.2.2019

31.1.2019

Plenadren

Shire Services BVBA

rue Montoyer 47, 1000 Bruxelles, Belgique/Montoyerstraat 47, 1000 Brussel, België

EU/1/11/715

4.2.2019

31.1.2019

Privigen

CSL Behring GmbH

Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland

EU/1/08/446

4.2.2019

31.1.2019

Resolor

Shire Pharmaceuticals Ireland Limited

Block 2-3 Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, Ireland

EU/1/09/581

4.2.2019

31.1.2019

Respreeza

CSL Behring GmbH

Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland

EU/1/15/1006

4.2.2019

31.1.2019

Revestive

Shire Pharmaceuticals Ireland Limited

Block 2-3 Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, Ireland

EU/1/12/787

4.2.2019

31.1.2019

Reyataz

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/03/267

4.2.2019

31.1.2019

Stalevo

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/1/03/260

4.2.2019

31.1.2019

Taxotere

Aventis Pharma S.A.

20 avenue Raymond Aron, 92165 Antony Cedex, France

EU/1/95/002

4.2.2019

31.1.2019

Vizarsin

Krka d. d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/09/551

4.2.2019

31.1.2019

Xaluprine

Nova Laboratories Ireland Limited

3rd Floor, Ulysses House, Foley Street, Dublin 1, Ireland

EU/1/11/727

4.2.2019

31.1.2019

Zoely

Theramex Ireland Limited

3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland

EU/1/11/690

4.2.2019

| — | Withdrawal of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) |
| --- | --- |

—

Withdrawal of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 11.1.2019 | Topotecan Actavis | Actavis Group PTC ehf.
  Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland | EU/1/09/536 | 15.1.2019 |
| 15.1.2019 | Cyltezo | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/17/1240 | 17.1.2019 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

11.1.2019

Topotecan Actavis

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland

EU/1/09/536

15.1.2019

15.1.2019

Cyltezo

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/17/1240

17.1.2019

| — | Issuing of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted |
| --- | --- |

—

Issuing of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorisation | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 9.1.2019 | Isemid | Torasemide | Ceva Santé Animale
  10 avenue de la Ballastière, 33500 Libourne, France | EU/2/18/232 | Chewable tablet | QC03CA04 | 11.1.2019 |
| 9.1.2019 | Syvazul BTV | Bluetongue virus vaccine (inactivated) (multistrain: 1-2 strains out of a set of 3) | LABORATORIOS SYVA, S.A.U.
  Av. Párroco Pablo Diez 49-57, 24010 León, España | EU/2/18/231 | Suspension for injection | QI04AA02 | 11.1.2019 |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorisation

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

9.1.2019

Isemid

Torasemide

Ceva Santé Animale

10 avenue de la Ballastière, 33500 Libourne, France

EU/2/18/232

Chewable tablet

QC03CA04

11.1.2019

9.1.2019

Syvazul BTV

Bluetongue virus vaccine (inactivated) (multistrain: 1-2 strains out of a set of 3)

LABORATORIOS SYVA, S.A.U.

Av. Párroco Pablo Diez 49-57, 24010 León, España

EU/2/18/231

Suspension for injection

QI04AA02

11.1.2019

| — | Modification of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted |
| --- | --- |

—

Modification of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 9.1.2019 | Parvoduk | Merial
  29 avenue Tony Garnier, 69007 Lyon, France | EU/2/14/162 | 11.1.2019 |
| 11.1.2019 | Meloxidyl | Ceva Santé Animale
  10 avenue de la Ballastière, 33500 Libourne, France | EU/2/06/070 | 15.1.2019 |
| 23.1.2019 | Loxicom | Norbrook Laboratories Ltd
  Station Works, Newry, Co. Down, BT35 6JP, United Kindgom | EU/2/08/090 | 25.1.2019 |
| 24.1.2019 | Clomicalm | Elanco GmbH
  Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland | EU/2/98/007 | 28.1.2019 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

9.1.2019

Parvoduk

Merial

29 avenue Tony Garnier, 69007 Lyon, France

EU/2/14/162

11.1.2019

11.1.2019

Meloxidyl

Ceva Santé Animale

10 avenue de la Ballastière, 33500 Libourne, France

EU/2/06/070

15.1.2019

23.1.2019

Loxicom

Norbrook Laboratories Ltd

Station Works, Newry, Co. Down, BT35 6JP, United Kindgom

EU/2/08/090

25.1.2019

24.1.2019

Clomicalm

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/98/007

28.1.2019

Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:

| European Medicines Agency |
| --- |
| 30 Churchill Place |
| Canary Wharf |
| London E14 5EU |
| United Kingdom |

European Medicines Agency

30 Churchill Place

Canary Wharf

London E14 5EU

United Kingdom

---

(1)  OJ L 136, 30.4.2004, p. 1.

---

| 4.3.2019 | EN | Official Journal of the European Union | C 80/11 |
| --- | --- | --- | --- |

4.3.2019

EN

Official Journal of the European Union

C 80/11

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2019 to 31 January 2019

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

(2019/C 80/02)

| — | Issuing, maintenance or modification of a national marketing authorisation |
| --- | --- |

—

Issuing, maintenance or modification of a national marketing authorisation

| Date of the decision | Name(s) of the medicinal product | INN (International Non-Proprietary Name) | Holder(s) of the marketing authorisation | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- | --- |
| 31.1.2019 | Diotop 75 mg/20 mg modified-release capsules, hard and ass. names | diclofenac/omeprazole | See Annex I | See Annex I | 1.2.2019 |
| 18.1.2019 | Diclofenac Sodium Spray Gel 4 % Cutaneous Spray, Solution and associated names | Diclofenac sodium | See Annex III | See Annex III | 21.1.2019 |
| 17.7.2018 | HES (hydroxyethyl starch) | hydroxyethyl starch (HES) | See Annex IV | See Annex IV | 19.7.2018 |

Date of the decision

Name(s) of the medicinal product

INN (International Non-Proprietary Name)

Holder(s) of the marketing authorisation

Member State concerned

Date of notification

31.1.2019

Diotop 75 mg/20 mg modified-release capsules, hard and ass. names

diclofenac/omeprazole

See Annex I

See Annex I

1.2.2019

18.1.2019

Diclofenac Sodium Spray Gel 4 % Cutaneous Spray, Solution and associated names

Diclofenac sodium

See Annex III

See Annex III

21.1.2019

17.7.2018

HES (hydroxyethyl starch)

hydroxyethyl starch (HES)

See Annex IV

See Annex IV

19.7.2018

| — | Refusal of a national marketing authorisation |
| --- | --- |

—

Refusal of a national marketing authorisation

| Date of the decision | Name(s) of the medicinal product | INN (International Non-Proprietary Name) | Holder(s) of the marketing authorisation | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- | --- |
| 11.1.2019 | Paclitaxel Hetero and associated names | paclitaxel | See Annex II | See Annex II | 14.1.2019 |

Date of the decision

Name(s) of the medicinal product

INN (International Non-Proprietary Name)

Holder(s) of the marketing authorisation

Member State concerned

Date of notification

11.1.2019

Paclitaxel Hetero and associated names

paclitaxel

See Annex II

See Annex II

14.1.2019

---

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

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

---

ANNEX I

List of medicinal products and presentations

| Member State EU/EEA | Marketing authorisation holder | Applicant | (Invented) Name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- | --- |
| Austria | Aristo Pharma GmbH
  Wallenroder Strasse 8-10
  D-13435 Berlin
  Germany | | ArthroComb 75 mg/20 mg Hartkapseln mit veränderter Wirkstofffreisetzung | 75 mg
  20 mg | Modified-release capsule, hard | Oral |
| Germany | | Temmler Pharma GmbH
  Temmlerstrasse 2
  D-35039 Marburg Germany | Diclofenac/Omeprazol Temmler 75 mg/20 mg Hartkapseln mit veränderter Wirkstofffreisetzung | 75 mg
  20 mg | Modified-release capsule, hard | Oral |
| United Kingdom | Temmler Pharma GmbH
  Temmlerstrasse 2
  D-35039 Marburg
  Germany | | Diotop 75 mg/20 mg modified release hard capsules | 75 mg
  20 mg | Modified-release capsule, hard | Oral |

Member State EU/EEA

Marketing authorisation holder

Applicant

(Invented) Name

Strength

Pharmaceutical form

Route of administration

Austria

Aristo Pharma GmbH

Wallenroder Strasse 8-10

D-13435 Berlin

Germany

ArthroComb 75 mg/20 mg Hartkapseln mit veränderter Wirkstofffreisetzung

75 mg

20 mg

Modified-release capsule, hard

Oral

Germany

Temmler Pharma GmbH

Temmlerstrasse 2

D-35039 Marburg Germany

Diclofenac/Omeprazol Temmler 75 mg/20 mg Hartkapseln mit veränderter Wirkstofffreisetzung

75 mg

20 mg

Modified-release capsule, hard

Oral

United Kingdom

Temmler Pharma GmbH

Temmlerstrasse 2

D-35039 Marburg

Germany

Diotop 75 mg/20 mg modified release hard capsules

75 mg

20 mg

Modified-release capsule, hard

Oral

---

ANNEX II

List of medicinal products and presentations

| Member State EU/EEA | Applicant company name, address | Invented Name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Germany | Hetero Europe S.L.
  Viladecans Business Park — Edificio Brasil,
  Catalunya 83-85
  08840 Barcelona
  Spain | Paclitaxel Hetero | 6 mg/ml | Concentrate for solution for infusion | Intravenous use |
| Portugal | Hetero Europe S.L.
  Viladecans Business Park — Edificio Brasil,
  Catalunya 83-85
  08840 Barcelona
  Spain | Paclitaxel Hetero | 6 mg/ml | Concentrate for solution for infusion | Intravenous use |
| United Kingdom | Hetero Europe S.L.
  Viladecans Business Park — Edificio Brasil,
  Catalunya 83-85
  08840 Barcelona
  Spain | Paclitaxel Hetero | 6 mg/ml | Concentrate for solution for infusion | Intravenous use |

Member State EU/EEA

Applicant company name, address

Invented Name

Strength

Pharmaceutical form

Route of administration

Germany

Hetero Europe S.L.

Viladecans Business Park — Edificio Brasil,

Catalunya 83-85

08840 Barcelona

Spain

Paclitaxel Hetero

6 mg/ml

Concentrate for solution for infusion

Intravenous use

Portugal

Hetero Europe S.L.

Viladecans Business Park — Edificio Brasil,

Catalunya 83-85

08840 Barcelona

Spain

Paclitaxel Hetero

6 mg/ml

Concentrate for solution for infusion

Intravenous use

United Kingdom

Hetero Europe S.L.

Viladecans Business Park — Edificio Brasil,

Catalunya 83-85

08840 Barcelona

Spain

Paclitaxel Hetero

6 mg/ml

Concentrate for solution for infusion

Intravenous use

---

ANNEX III

List of medicinal products and presentations

| Member State EU/EEA | Marketing authorisation holder | Applicant | Invented Name | Strength | Pharmaceutical form4 | Route of administration | Content
  (concentration) |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Estonia | Mika Pharma GmbH
  Auestraße 39
  67346 Speyer
  Germany | | DicloFlex, 40 mg/g,
  nahasprei, lahus | 40 mg/g | Cutaneous spray, solution | Cutaneous use | 4 % |
| Germany | | Mika Pharma GmbH
  Auestraße 39
  67346 Speyer
  Germany | Spraymik 40 mg/g Spray zur Anwendung auf der Haut, Lösung | 40 mg/g | Cutaneous spray, solution | Cutaneous use | 4 % |
| Hungary | Mika Pharma GmbH
  Auestraße 39
  67346 Speyer
  Germany | | Doloflex 4 % külsőleges
  oldatos spray | 40 mg/g | Cutaneous spray, solution | Cutaneous use | 4 % |
| Ireland | Astellas Pharma Co. Ltd
  5 Waterside, Citywest Business Campus, Naas Road
  Dublin 24
  Ireland | | Difene 4 % Spray Gel | 40 mg/g | Cutaneous spray, solution | Cutaneous use | 4 % |
| Italy | | Mika Pharma GmbH
  Auestraße 39
  67346 Speyer
  Germany | Diclofenac Giuliani | 40 mg/g | Cutaneous spray, solution | Cutaneous use | 4 % |
| Latvia | Mika Pharma GmbH
  Auestraße 39
  67346 Speyer
  Germany | | DicloFlex 4 % uz ādas
  izsmidzināms aerosols,
  šķīdums | 40 mg/g | Cutaneous spray, solution | Cutaneous use | 4 % |
| Slovenia | Mika Pharma GmbH
  Auestraße 39
  67346 Speyer
  Germany | | DicloFlex 40 mg/g dermalno
  pršilo, raztopina | 40 mg/g | Cutaneous spray, solution | Cutaneous use | 4 % |
| Spain | | Mika Pharma GmbH
  Auestraße 39
  67346 Speyer
  Germany | Spraymik 4 % | 40 mg/g | Cutaneous spray, solution | Cutaneous use | 4 % |
| United Kingdom | Mika Pharma GmbH
  Auestraße 39
  67346 Speyer
  Germany | | Diclofenac Sodium Spray Gel
  4 % cutaneous spray, solution | 40 mg/g | Cutaneous spray, solution | Cutaneous use | 4 % |

Member State EU/EEA

Marketing authorisation holder

Applicant

Invented Name

Strength

Pharmaceutical form4

Route of administration

Content

(concentration)

Estonia

Mika Pharma GmbH

Auestraße 39

67346 Speyer

Germany

DicloFlex, 40 mg/g,

nahasprei, lahus

40 mg/g

Cutaneous spray, solution

Cutaneous use

4 %

Germany

Mika Pharma GmbH

Auestraße 39

67346 Speyer

Germany

Spraymik 40 mg/g Spray zur Anwendung auf der Haut, Lösung

40 mg/g

Cutaneous spray, solution

Cutaneous use

4 %

Hungary

Mika Pharma GmbH

Auestraße 39

67346 Speyer

Germany

Doloflex 4 % külsőleges

oldatos spray

40 mg/g

Cutaneous spray, solution

Cutaneous use

4 %

Ireland

Astellas Pharma Co. Ltd

5 Waterside, Citywest Business Campus, Naas Road

Dublin 24

Ireland

Difene 4 % Spray Gel

40 mg/g

Cutaneous spray, solution

Cutaneous use

4 %

Italy

Mika Pharma GmbH

Auestraße 39

67346 Speyer

Germany

Diclofenac Giuliani

40 mg/g

Cutaneous spray, solution

Cutaneous use

4 %

Latvia

Mika Pharma GmbH

Auestraße 39

67346 Speyer

Germany

DicloFlex 4 % uz ādas

izsmidzināms aerosols,

šķīdums

40 mg/g

Cutaneous spray, solution

Cutaneous use

4 %

Slovenia

Mika Pharma GmbH

Auestraße 39

67346 Speyer

Germany

DicloFlex 40 mg/g dermalno

pršilo, raztopina

40 mg/g

Cutaneous spray, solution

Cutaneous use

4 %

Spain

Mika Pharma GmbH

Auestraße 39

67346 Speyer

Germany

Spraymik 4 %

40 mg/g

Cutaneous spray, solution

Cutaneous use

4 %

United Kingdom

Mika Pharma GmbH

Auestraße 39

67346 Speyer

Germany

Diclofenac Sodium Spray Gel

4 % cutaneous spray, solution

40 mg/g

Cutaneous spray, solution

Cutaneous use

4 %

---

ANNEX IV

List of medicinal products and presentations

| Member State in EEA | Marketing authorisation holder | Product name | INN + Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | B.Braun Melsungen Ag | Tetraspan | Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Hetastarch 100 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml | Solution For Infusion | Intravenous Use |
| Austria | B.Braun Melsungen Ag | Tetraspan | Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Hetastarch 60 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml | Solution For Infusion | Intravenous Use |
| Austria | B.Braun Melsungen Ag | Venofundin | Sodium Chloride 9 g/1000ml, Hetastarch 60 g/1000ml | Solution For Infusion | Intravenous Use |
| Austria | Fresenius Kabi Austria Gmbh | Haes-Steril Hes | Sodium Chloride 9 g/1000ml, Hydroxyethyl Starch 200/0.5 60 g/1000ml | Solution For Infusion | Intravenous Use |
| Austria | Fresenius Kabi Austria Gmbh | Volulyte | Magnesium Chloride Hexahydrate 0.3gl, Potassium Chloride 0.3gl, Sodium Chloride 6.02gl, Sodium Acetate Trihydrate 4.63gl, Hydroxyethyl Starch 130/0.4 60gl | Solution For Infusion | Intravenous Use |
| Austria | Fresenius Kabi Austria Gmbh | Voluven (Hes 130/0,4 ) | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 60gl | Solution For Infusion | Intravenous Use |
| Belgium | B.Braun Melsungen Ag | Tetraspan | Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Hetastarch 60 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml | Solution For Infusion | Intravenous Use |
| Belgium | B.Braun Melsungen Ag | Venohes | Sodium Chloride 9 g/1000ml, Hetastarch 60 g/1000ml | Solution For Infusion | Intravenous Use |
| Belgium | Fresenius Kabi Nv/Sa | Volulyte | Magnesium Chloride Hexahydrate 0.3 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.02 g/1000ml, Sodium Acetate Trihydrate 4.63 g/1000ml, Hydroxyethyl Starch 130/0.4 60 g/1000ml | Solution For Infusion | Intravenous Use |
| Belgium | Fresenius Kabi Nv/Sa | Volulyte | Magnesium Chloride Hexahydrate 0.3gl, Potassium Chloride 0.3gl, Sodium Chloride 6.02gl, Sodium Acetate Trihydrate 4.63gl, Hydroxyethyl Starch 130/0.4 60gl | Solution For Infusion | Intravenous Use |
| Belgium | Fresenius Kabi Nv/Sa | Voluven | Sodium Chloride 9 g/1000ml, Poly (O-2-Hydroxyethyl) Starch 130/0.4 (Ph.Eur.) 60 g/1000ml | Solution For Infusion | Intravenous Use |
| Belgium | Fresenius Kabi Nv/Sa | Voluven | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 100gl | Solution For Infusion | Intravenous Use |
| Belgium | Fresenius Kabi Nv/Sa | Voluven | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 60gl | Solution For Infusion | Intravenous Use |
| Bulgaria | B.Braun Melsungen Ag | Тетраспан | Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Malic Acid 0.67 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, Poly (0 2 Hydroxyethyl) Starch 100 g/1000ml | Solution For Infusion | Intravenous Use |
| Bulgaria | Fresenius Kabi Bulgaria Eood | Волувен | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 100gl | Solution For Infusion | Intravenous Use |
| Bulgaria | Fresenius Kabi Bulgaria Eood | Волулайт | Magnesium Chloride Hexahydrate 0.3 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.02 g/1000ml, Sodium Acetate Trihydrate 4.63 g/1000ml, Hydroxyethyl Starch 130/0.4 60 g/1000ml | Solution For Infusion | Intravenous Use |
| Bulgaria | Fresenius Kabi Deutschland Gmbh | Волувен | Sodium Chloride 9 g/1000ml, Hydroxyethyl Starch 130/0.4 60 g/1000ml | Solution For Infusion | Intravenous Use |
| Croatia | B.Braun Adria D.O.O. | Tetraspan | Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Malic Acid 0.67 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, Poly (0 2 Hydroxyethyl) Starch 100 g/1000ml | Solution For Infusion | Intravenous Use |
| Croatia | B.Braun Adria D.O.O. | Tetraspan | Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Malic Acid 0.67 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, Poly (0 2 Hydroxyethyl) Starch 60 g/1000ml | Solution For Infusion | Intravenous Use |
| Croatia | Fresenius Kabi D.O.O. | Volulyte | Magnesium Chloride Hexahydrate 0.3 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.02 g/1000ml, Sodium Acetate Trihydrate 4.63 g/1000ml, Hydroxyethyl Starch 130/0.4 60 g/1000ml | Solution For Infusion | Intravenous Use |
| Croatia | Fresenius Kabi D.O.O. | Voluven | Sodium Chloride 9 g/1000ml, Hydroxyethyl Starch 130/0.4 60 g/1000ml | Solution For Infusion | Intravenous Use |
| Cyprus | B.Braun Melsungen Ag | Venofundin | Sodium Chloride 9 g/1000ml, Hetastarch 60 g/1000ml | Solution For Infusion | Intravenous Use |
| Cyprus | Fresenius Kabi Deutschland Gmbh | Volulyte | Magnesium Chloride Hexahydrate 0.3 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.02 g/1000ml, Sodium Acetate Trihydrate 4.63 g/1000ml, Hydroxyethyl Starch 130/0.4 60 g/1000ml | Solution For Infusion | Intravenous Use |
| Czech Republic | B.Braun Melsungen Ag | Tetraspan | Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Hetastarch 100 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml | Solution For Infusion | Intravenous Use |
| Czech Republic | B.Braun Melsungen Ag | Tetraspan | Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml | Solution For Infusion | Intravenous Use |
| Czech Republic | Fresenius Kabi Deutschland Gmbh | Volulyte | Magnesium Chloride Hexahydrate 0.3 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.02 g/1000ml, Sodium Acetate Trihydrate 4.63 g/1000ml, Hydroxyethyl Starch 130/0.4 60 g/1000ml | Solution For Infusion | Intravenous Use |
| Czech Republic | Fresenius Kabi Deutschland Gmbh | Voluven | Sodium Chloride 9 g/1000ml, Hydroxyethyl Starch 130/0.4 60 g/1000ml | Solution For Infusion | Intravenous Use |
| Czech Republic | Fresenius Kabi S.R.O | Voluven | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 100gl | Solution For Infusion | Intravenous Use |
| Denmark | B.Braun Melsungen Ag | Tetraspan | Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Hetastarch 100 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml | Solution For Infusion | Intravenous Use |
| Denmark | B.Braun Melsungen Ag | Tetraspan | Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Hetastarch 60 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml | Solution For Infusion | Intravenous Use |
| Denmark | B.Braun Melsungen Ag | Venofundin | Sodium Chloride 9 g/1000ml, Hetastarch 60 g/1000ml | Solution For Infusion | Intravenous Use |
| Denmark | Fresenius Kabi Ab | Volulyte | Magnesium Chloride Hexahydrate 0.3gl, Potassium Chloride 0.3gl, Sodium Chloride 6.02gl, Sodium Acetate Trihydrate 4.63gl, Hydroxyethyl Starch 130/0.4 60gl | Solution For Infusion | Intravenous Use |
| Denmark | Fresenius Kabi Ab | Voluven | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 100gl | Solution For Infusion | Intravenous Use |
| Denmark | Fresenius Kabi Ab | Voluven | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 60gl | Solution For Infusion | Intravenous Use |
| Estonia | B.Braun Melsungen Ag | Tetraspan | Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Malic Acid 0.67 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, Poly (0 2 Hydroxyethyl) Starch 60 g/1000ml | Solution For Infusion | Intravenous Use |
| Estonia | Fresenius Kabi Deutschland Gmbh | Volulyte | Magnesium Chloride Hexahydrate 0.3gl, Potassium Chloride 0.3gl, Sodium Chloride 6.02gl, Sodium Acetate Trihydrate 4.63gl, Hydroxyethyl Starch 130/0.4 60gl | Solution For Infusion | Intravenous Use |
| Estonia | Fresenius Kabi Deutschland Gmbh | Voluven | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 60gl | Solution For Infusion | Intravenous Use |
| Estonia | Fresenius Kabi Polska Sp. Z O.O. | Voluforte | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 100gl | Solution For Infusion | Intravenous Use |
| Finland | B.Braun Melsungen Ag | Tetraspan | Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Hetastarch 100 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml | Solution For Infusion | Intravenous Use |
| Finland | B.Braun Melsungen Ag | Tetraspan | Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Hetastarch 60 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml | Solution For Infusion | Intravenous Use |
| Finland | B.Braun Melsungen Ag | Venofundin | Sodium Chloride 9 g/1000ml, Hetastarch 60 g/1000ml | Solution For Infusion | Intravenous Use |
| Finland | Fresenius Kabi Ab | Volulyte | Magnesium Chloride Hexahydrate 0.3 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.02 g/1000ml, Sodium Acetate Trihydrate 4.63 g/1000ml, Poly (O-2-Hydroxyethyl) Starch 130/0.4 (Ph.Eur.) 60 g/1000ml | Solution For Infusion | Intravenous Use |
| Finland | Fresenius Kabi Ab | Voluven | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 100gl | Solution For Infusion | Intravenous Use |
| Finland | Fresenius Kabi Ab | Voluven | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 60gl | Solution For Infusion | Intravenous Use |
| France | B.Braun Melsungen Ag | Isovol | Magnesium Chloride Hexahydrate 0.203 g/1000ml, Potassium Chloride 0.298 g/1000ml, Sodium Chloride 6.252 g/1000ml, Calcium Chloride Dihydrate 0.367 g/1000ml, Malic Acid 0.671 g/1000ml, Sodium Acetate Trihydrate 3.266 g/1000ml, Hydroxyethyl Starch 130/0.4 60 g/1000ml | Solution For Infusion | Intravenous Use |
| France | B.Braun Melsungen Ag | Restorvol | Sodium Chloride 9 g/1000ml, Hetastarch 60 g/1000ml | Solution For Infusion | Intravenous Use |
| France | Fresenius Kabi France S.A.S. | Volulyte | Magnesium Chloride Hexahydrate 0.3 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.02 g/1000ml, Sodium Acetate Trihydrate 4.63 g/1000ml, Hydroxyethyl Starch 130/0.4 60 g/1000ml | Solution For Infusion | Intravenous Use |
| France | Fresenius Kabi France S.A.S. | Voluven | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 60gl | Solution For Infusion | Intravenous Use |
| Germany | B.Braun Melsungen Ag | Tetraspan | Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Hetastarch 100 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml | Solution For Infusion | Intravenous Use |
| Germany | B.Braun Melsungen Ag | Tetraspan | Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Hetastarch 60 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml | Solution For Infusion | Intravenous Use |
| Germany | B.Braun Melsungen Ag | Venofundin | Sodium Chloride 9 g/1000ml, Hetastarch 60 g/1000ml | Solution For Infusion | Intravenous Use |
| Germany | Fresenius Kabi Deutschland Gmbh | Haes-Steril | Sodium Chloride 9 g/1000ml, Hydroxyethyl Starch 200/0.5 100 g/1000ml | Solution For Infusion | Intravenous Use |
| Germany | Fresenius Kabi Deutschland Gmbh | Haes-Steril | Sodium Chloride 9gl, Hydroxyethyl Starch 200/0.5 30gl | Solution For Infusion | Intravenous Use |
| Germany | Fresenius Kabi Deutschland Gmbh | Haes-Steril | Sodium Chloride 9gl, Hydroxyethyl Starch 200/0.5 60gl | Solution For Infusion | Intravenous Use |
| Germany | Fresenius Kabi Deutschland Gmbh | Volulyte | Magnesium Chloride Hexahydrate 0.3 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.02 g/1000ml, Sodium Acetate Trihydrate 4.63 g/1000ml, Poly (O-2-Hydroxyethyl) Starch 130/0.4 (Ph.Eur.) 60 g/1000ml | Solution For Infusion | Intravenous Use |
| Germany | Fresenius Kabi Deutschland Gmbh | Volulyte | Magnesium Chloride Hexahydrate 0.3gl, Potassium Chloride 0.3gl, Sodium Chloride 6.02gl, Sodium Acetate Trihydrate 4.63gl, Hydroxyethyl Starch 130/0.4 60gl | Solution For Infusion | Intravenous Use |
| Germany | Fresenius Kabi Deutschland Gmbh | Voluven | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 100gl | Solution For Infusion | Intravenous Use |
| Germany | Fresenius Kabi Deutschland Gmbh | Voluven | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 60gl | Solution For Infusion | Intravenous Use |
| Germany | Serumwerk Bernburg Ag | Infukoll | Sodium Chloride 9gl, Poly (0 2 Hydroxyethyl) Starch 100gl | Solution For Infusion | Intravenous Use |
| Germany | Serumwerk Bernburg Ag | Infukoll | Sodium Chloride 9gl, Poly (0 2 Hydroxyethyl) Starch 60gl | Solution For Infusion | Intravenous Use |
| Germany | Serumwerk Bernburg Ag | Vitafusal | Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.4 g/1000ml, Sodium Chloride 6 g/1000ml, Calcium Chloride Dihydrate 0.134 g/1000ml, Sodium Acetate Trihydrate 3.7 g/1000ml, Poly (0 2 Hydroxyethyl) Starch 100 g/1000ml | Solution For Infusion | Intravenous Use |
| Germany | Serumwerk Bernburg Ag | Vitafusal | Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.4 g/1000ml, Sodium Chloride 6 g/1000ml, Calcium Chloride Dihydrate 0.134 g/1000ml, Sodium Acetate Trihydrate 3.7 g/1000ml, Poly (0 2 Hydroxyethyl) Starch 60 g/1000ml | Solution For Infusion | Intravenous Use |
| Germany | Serumwerk Bernburg Ag | Vitahes | Sodium Chloride 9 g/1000ml, Poly (0 2 Hydroxyethyl) Starch 60 g/1000ml | Solution For Infusion | Intravenous Use |
| Greece | B.Braun Melsungen Ag | Venofundin | Sodium Chloride 9 g/1000ml, Hetastarch 60 g/1000ml | Solution For Infusion | Intravenous Use |
| Greece | Fresenius Kabi Hellas A.E. | Volulyte | Magnesium Chloride Hexahydrate 0.3 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.02 g/1000ml, Sodium Acetate Trihydrate 4.63 g/1000ml, Hydroxyethyl Starch 130/0.4 60 g/1000ml | Solution For Infusion | Intravenous Use |
| Greece | Fresenius Kabi Hellas A.E. | Voluven | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 60gl | Solution For Infusion | Intravenous Use |
| Greece | Vioser S.A. | Tetraspan | Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Hetastarch 100 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml | Solution For Infusion | Intravenous Use |
| Greece | Vioser S.A. | Tetraspan | Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Hetastarch 60 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml | Solution For Infusion | Intravenous Use |
| Hungary | B.Braun Melsungen Ag | Tetraspan | Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Hetastarch 60 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml | Solution For Infusion | Intravenous Use |
| Hungary | Fresenius Kabi Deutschland Gmbh | Volulyte | Magnesium Chloride Hexahydrate 0.3 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.02 g/1000ml, Sodium Acetate Trihydrate 4.63 g/1000ml, Poly (O-2-Hydroxyethyl) Starch 130/0.4 (Ph.Eur.) 60 g/1000ml | Solution For Infusion | Intravenous Use |
| Hungary | Fresenius Kabi Deutschland Gmbh | Volulyte | Magnesium Chloride Hexahydrate 0.3 g/1000ml, Potassium Chloride 0.3gl, Sodium Chloride 6.02 g/1000ml, Sodium Acetate Trihydrate 4.63 g/1000ml, Poly (O-2-Hydroxyethyl) Starch 130/0.4 (Ph.Eur.) 60 g/1000ml | Solution For Infusion | Intravenous Use |
| Hungary | Fresenius Kabi Deutschland Gmbh | Volulyte | Magnesium Chloride Hexahydrate 0.3gl, Potassium Chloride 0.3gl, Sodium Chloride 6.02gl, Sodium Acetate Trihydrate 4.63gl, Hydroxyethyl Starch 130/0.4 60gl | Solution For Infusion | Intravenous Use |
| Hungary | Fresenius Kabi Deutschland Gmbh | Voluven | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 100gl | Solution For Infusion | Intravenous Use |
| Hungary | Fresenius Kabi Deutschland Gmbh | Voluven | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 60gl | Solution For Infusion | Intravenous Use |
| Iceland | B.Braun Melsungen Ag | Tetraspan | Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Hetastarch 60 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml | Solution For Infusion | Intravenous Use |
| Iceland | Fresenius Kabi Ab | Volulyte | Magnesium Chloride Hexahydrate 0.3 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.02 g/1000ml, Sodium Acetate Trihydrate 4.63 g/1000ml, Hydroxyethyl Starch 130/0.4 60 g/1000ml | Solution For Infusion | Intravenous Use |
| Iceland | Fresenius Kabi Ab | Voluven | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 60gl | Solution For Infusion | Intravenous Use |
| Ireland | B.Braun Melsungen Ag | Equihes Ecobag | Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Hetastarch 100 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml | Solution For Infusion | Intravenous Use |
| Ireland | B.Braun Melsungen Ag | Equihes Ecobag | Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Hetastarch 60 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml | Solution For Infusion | Intravenous Use |
| Ireland | B.Braun Melsungen Ag | Equihes Ecoflac Plus | Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Hetastarch 100 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml | Solution For Infusion | Intravenous Use |
| Ireland | B.Braun Melsungen Ag | Equihes Ecoflac Plus | Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Hetastarch 60 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml | Solution For Infusion | Intravenous Use |
| Ireland | Fresenius Kabi Limited | Volulyte | Magnesium Chloride Hexahydrate 0.3 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.02 g/1000ml, Sodium Acetate Trihydrate 4.63 g/1000ml, Poly (O-2-Hydroxyethyl) Starch 130/0.4 (Ph.Eur.) 60 g/1000ml | Solution For Infusion | Intravenous Use |
| Ireland | Fresenius Kabi Limited | Voluven | Sodium Chloride 9 g/1000ml, Hydroxyethyl Starch 130/0.4 100 g/1000ml | Solution For Infusion | Intravenous Use |
| Ireland | Fresenius Kabi Limited | Voluven | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 100gl | Solution For Infusion | Intravenous Use |
| Ireland | Fresenius Kabi Limited | Voluven | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 60gl | Solution For Infusion | Intravenous Use |
| Italy | B.Braun Melsungen Ag | Amidolite | Sodium Chloride 9 g/1000ml, Hetastarch 60 g/1000ml | Solution For Infusion | Intravenous Use |
| Italy | B.Braun Melsungen Ag | Tetraspan | Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Hetastarch 100 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml | Solution For Infusion | Intravenous Use |
| Italy | B.Braun Melsungen Ag | Tetraspan | Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Hetastarch 60 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml | Solution For Infusion | Intravenous Use |
| Italy | Fresenius Kabi Italia S.R.L. | Volulyte | Magnesium Chloride Hexahydrate 0.3 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.02 g/1000ml, Sodium Acetate Trihydrate 4.63 g/1000ml, Hydroxyethyl Starch 130/0.4 60 g/1000ml | Solution For Infusion | Intravenous Use |
| Italy | Fresenius Kabi Italia S.R.L. | Volulyte | Magnesium Chloride Hexahydrate 0.3gl, Potassium Chloride 0.3gl, Sodium Chloride 6.02gl, Sodium Acetate Trihydrate 4.63gl, Hydroxyethyl Starch 130/0.4 60gl | Solution For Infusion | Intravenous Use |
| Italy | Fresenius Kabi Italia S.R.L. | Voluven | Sodium Chloride 9 g/1000ml, Poly (O-2-Hydroxyethyl) Starch 130/0.4 (Ph.Eur.) 60 g/1000ml | Solution For Infusion | Intravenous Use |
| Italy | Fresenius Kabi Italia S.R.L. | Voluven | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 60gl | Solution For Infusion | Intravenous Use |
| Italy | Fresenius Kabi Italia S.R.L. | Vonten | Sodium Chloride 9 g/1000ml, Poly (O-2-Hydroxyethyl) Starch 130/0.4 (Ph.Eur.) 100 g/1000ml | Solution For Infusion | Intravenous Use |
| Italy | Fresenius Kabi Italia S.R.L. | Vonten | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 100gl | Solution For Infusion | Intravenous Use |
| Latvia | B.Braun Melsungen Ag | Tetraspan | Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Hetastarch 100 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml | Solution For Infusion | Intravenous Use |
| Latvia | B.Braun Melsungen Ag | Tetraspan | Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Hetastarch 100 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml | Solution For Infusion | Intravenous Use |
| Latvia | B.Braun Melsungen Ag | Tetraspan | Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Hetastarch 60 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml | Solution For Infusion | Intravenous Use |
| Latvia | Fresenius Kabi Deutschland Gmbh | Volulyte | Magnesium Chloride Hexahydrate 0.3 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.02 g/1000ml, Sodium Acetate Trihydrate 4.63 g/1000ml, Hydroxyethyl Starch 130/0.4 60 g/1000ml | Solution For Infusion | Intravenous Use |
| Latvia | Fresenius Kabi Deutschland Gmbh | Voluven | Sodium Chloride 9 g/1000ml, Hydroxyethyl Starch 130/0.4 60 g/1000ml | Solution For Infusion | Intravenous Use |
| Lithuania | B.Braun Melsungen Ag | Tetraspan | Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Hetastarch 60 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml | Solution For Infusion | Intravenous Use |
| Lithuania | Fresenius Kabi Deutschland Gmbh | Volulyte | Magnesium Chloride Hexahydrate 0.3gl, Potassium Chloride 0.3gl, Sodium Chloride 6.02gl, Sodium Acetate Trihydrate 4.63gl, Hydroxyethyl Starch 130/0.4 60gl | Solution For Infusion | Intravenous Use |
| Lithuania | Fresenius Kabi Deutschland Gmbh | Voluven | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 60gl | Solution For Infusion | Intravenous Use |
| Lithuania | Fresenius Kabi Polska Sp. Z O.O. | Voluforte | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 100gl | Solution For Infusion | Intravenous Use |
| Luxembourg | B.Braun Melsungen Ag | Tetraspan | Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Hetastarch 100 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml | Solution For Infusion | Intravenous Use |
| Luxembourg | B.Braun Melsungen Ag | Tetraspan | Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Hetastarch 60 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml | Solution For Infusion | Intravenous Use |
| Luxembourg | B.Braun Melsungen Ag | Venofundin | Sodium Chloride 9 g/1000ml, Hetastarch 60 g/1000ml | Solution For Infusion | Intravenous Use |
| Luxembourg | Fresenius Kabi Deutschland Gmbh | Volulyte | Magnesium Chloride Hexahydrate 0.3gl, Potassium Chloride 0.3gl, Sodium Chloride 6.02gl, Sodium Acetate Trihydrate 4.63gl, Hydroxyethyl Starch 130/0.4 60gl | Solution For Infusion | Intravenous Use |
| Luxembourg | Fresenius Kabi Deutschland Gmbh | Voluven | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 60gl | Solution For Infusion | Intravenous Use |
| Malta | Fresenius Kabi Limited | Volulyte | Magnesium Chloride Hexahydrate 0.3 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.02 g/1000ml, Sodium Acetate Trihydrate 4.63 g/1000ml, Hydroxyethyl Starch 130/0.4 60 g/1000ml | Solution For Infusion | Intravenous Use |
| Netherlands | B.Braun Melsungen Ag | Tetraspan | Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Hetastarch 100 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml | Solution For Infusion | Intravenous Use |
| Netherlands | B.Braun Melsungen Ag | Tetraspan | Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Hetastarch 60 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml | Solution For Infusion | Intravenous Use |
| Netherlands | B.Braun Melsungen Ag | Venofundin | Sodium Chloride 9 g/1000ml, Hetastarch 60 g/1000ml | Solution For Infusion | Intravenous Use |
| Netherlands | Fresenius Kabi Nederland B.V. | Volulyte | Magnesium Chloride Hexahydrate 0.3 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.02 g/1000ml, Sodium Acetate Trihydrate 4.63 g/1000ml, Hydroxyethyl Starch 130/0.4 60 g/1000ml | Solution For Infusion | Intravenous Use |
| Netherlands | Fresenius Kabi Nederland B.V. | Voluven | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 100gl | Solution For Infusion | Intravenous Use |
| Netherlands | Fresenius Kabi Nederland B.V. | Voluven | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 60gl | Solution For Infusion | Intravenous Use |
| Norway | B.Braun Melsungen Ag | Tetraspan | Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml | Solution For Infusion | Intravenous Use |
| Norway | B.Braun Melsungen Ag | Venofundin | Sodium Chloride 9 g/1000ml, Hetastarch 60 g/1000ml | Solution For Infusion | Intravenous Use |
| Norway | Fresenius Kabi Norge As | Volulyte | Magnesium Chloride Hexahydrate 0.3gl, Potassium Chloride 0.3gl, Sodium Chloride 6.02gl, Sodium Acetate Trihydrate 4.63gl, Hydroxyethyl Starch 130/0.4 60gl | Solution For Infusion | Intravenous Use |
| Norway | Fresenius Kabi Norge As | Voluven | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 60gl | Solution For Infusion | Intravenous Use |
| Poland | B.Braun Melsungen Ag | Tetraspan | Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, Poly (0 2 Hydroxyethyl) Starch 60 g/1000ml, L-Malic Acid 0.67 g/1000ml | Solution For Infusion | Intravenous Use |
| Poland | B.Braun Melsungen Ag | Tetraspan Hes | Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Malic Acid 0.67 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, Poly (0 2 Hydroxyethyl) Starch 100 g/1000ml | Solution For Infusion | Intravenous Use |
| Poland | Fresenius Kabi Deutschland Gmbh | Volulyte | Magnesium Chloride Hexahydrate 0.3 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.02 g/1000ml, Sodium Acetate Trihydrate 4.63 g/1000ml, Hydroxyethyl Starch 130/0.4 60 g/1000ml | Solution For Infusion | Intravenous Use |
| Poland | Fresenius Kabi Deutschland Gmbh | Voluven | Sodium Chloride 9 g/1000ml, Hydroxyethyl Starch 130/0.4 60 g/1000ml | Solution For Infusion | Intravenous Use |
| Poland | Fresenius Kabi Polska Sp. Z O.O. | Voluven | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 100gl | Solution For Infusion | Intravenous Use |
| Portugal | B.Braun Melsungen Ag | Tetraspan | Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Hetastarch 100 g/1000ml, Malic Acid 0.67 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml | Solution For Infusion | Intravenous Use |
| Portugal | B.Braun Melsungen Ag | Tetraspan | Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Hetastarch 60 g/1000ml, Malic Acid 0.67 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml | Solution For Infusion | Intravenous Use |
| Portugal | B.Braun Melsungen Ag | Venofundin | Sodium Chloride 9 g/1000ml, Hetastarch 60 g/1000ml | Solution For Infusion | Intravenous Use |
| Portugal | Fresenius Kabi Pharma Portugal Lda. | Volulyte | Magnesium Chloride Hexahydrate 0.3 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.02 g/1000ml, Sodium Acetate Trihydrate 4.63 g/1000ml, Poly (O-2-Hydroxyethyl) Starch 130/0.4 (Ph.Eur.) 60 g/1000ml | Solution For Infusion | Intravenous Use |
| Portugal | Fresenius Kabi Pharma Portugal Lda. | Volulyte | Magnesium Chloride Hexahydrate 0.3gl, Potassium Chloride 0.3gl, Sodium Chloride 6.02gl, Sodium Acetate Trihydrate 4.63gl, Hydroxyethyl Starch 130/0.4 60gl | Solution For Infusion | Intravenous Use |
| Portugal | Fresenius Kabi Pharma Portugal Lda. | Voluven | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 100gl | Solution For Infusion | Intravenous Use |
| Portugal | Fresenius Kabi Pharma Portugal Lda. | Voluven | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 60gl | Solution For Infusion | Intravenous Use |
| Romania | B.Braun Melsungen Ag | Tetraspan | Magnesium Chloride Hexahydrate 0.203 g/1000ml, Potassium Chloride 0.298 g/1000ml, Sodium Chloride 6.252 g/1000ml, Calcium Chloride Dihydrate 0.367 g/1000ml, Sodium Acetate Trihydrate 3.266 g/1000ml, L-Malic Acid 0.671 g/1000ml, Hydroxyethyl Starch 130/0.4 60 g/1000ml | Solution For Infusion | Intravenous Use |
| Romania | B.Braun Melsungen Ag | Tetraspan | Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Hetastarch 100 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml | Solution For Infusion | Intravenous Use |
| Romania | B.Braun Melsungen Ag | Venofundin | Sodium Chloride 9 g/1000ml, Hetastarch 60 g/1000ml | Solution For Infusion | Intravenous Use |
| Romania | Fresenius Kabi Deutschland Gmbh | Voluven | Sodium Chloride 9 g/1000ml, Hydroxyethyl Starch 130/0.4 60 g/1000ml | Solution For Infusion | Intravenous Use |
| Romania | Infomed Fluids Srl | Vitafusal | Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.4 g/1000ml, Sodium Chloride 6 g/1000ml, Calcium Chloride Dihydrate 0.134 g/1000ml, Hetastarch 60 g/1000ml, Sodium Acetate Trihydrate 3.7 g/1000ml | Solution For Infusion | Intravenous Use |
| Romania | S.C. Fresenius Kabi România S.R.L. | Volulyte | Magnesium Chloride Hexahydrate 0.3 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.02 g/1000ml, Sodium Acetate Trihydrate 4.63 g/1000ml, Hydroxyethyl Starch 130/0.4 60 g/1000ml | Solution For Infusion | Intravenous Use |
| Romania | S.C. Fresenius Kabi România S.R.L. | Volulyte | Magnesium Chloride Hexahydrate 0.3 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.02 g/1000ml, Sodium Acetate Trihydrate 4.63 g/1000ml, Poly (0 2 Hydroxyethyl) Starch 60 g/1000ml | Solution For Infusion | Intravenous Use |
| Romania | S.C. Fresenius Kabi România S.R.L. | Volulyte | Magnesium Chloride Hexahydrate 0.3 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.02 g/1000ml, Sodium Acetate Trihydrate 4.63 g/1000ml, Poly (0 2 Hydroxyethyl) Starch 60 g/1000μl | Solution For Infusion | Intravenous Use |
| Slovakia | B.Braun Melsungen Ag | Tetraspan | Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Hetastarch 100 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml | Solution For Infusion | Intravenous Use |
| Slovakia | B.Braun Melsungen Ag | Tetraspan | Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Hetastarch 60 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml | Solution For Infusion | Intravenous Use |
| Slovakia | Fresenius Kabi Deutschland Gmbh | Volulyte | Magnesium Chloride Hexahydrate 0.3 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.02 g/1000ml, Sodium Acetate Trihydrate 4.63 g/1000ml, Hydroxyethyl Starch 130/0.4 60 g/1000ml | Solution For Infusion | Intravenous Use |
| Slovakia | Fresenius Kabi Deutschland Gmbh | Voluven | Sodium Chloride 9 g/1000ml, Hydroxyethyl Starch 130/0.4 60 g/1000ml | Solution For Infusion | Intravenous Use |
| Slovakia | Fresenius Kabi S.R.O | Voluven | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 100gl | Solution For Infusion | Intravenous Use |
| Slovenia | B.Braun Melsungen Ag | Tetraspan | Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Hetastarch 100 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml | Solution For Infusion | Intravenous Use |
| Slovenia | B.Braun Melsungen Ag | Tetraspan | Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Hetastarch 60 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml | Solution For Infusion | Intravenous Use |
| Slovenia | Fresenius Kabi Deutschland Gmbh | Voluven | Sodium Chloride 9 g/1000ml, Hydroxyethyl Starch 130/0.4 100 g/1000ml | Solution For Infusion | Intravenous Use |
| Slovenia | Medias International D.O.O. | Volulyte | Magnesium Chloride Hexahydrate 0.3 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.02 g/1000ml, Sodium Acetate Trihydrate 4.63 g/1000ml, Hydroxyethyl Starch 130/0.4 60 g/1000ml | Solution For Infusion | Intravenous Use |
| Slovenia | Medias International D.O.O. | Voluven | Sodium Chloride 4.5 g/500ml, Hydroxyethyl Starch 130/0.4 30 g/500ml | Solution For Infusion | Intravenous Use |
| Slovenia | Medias International D.O.O. | Voluven | Sodium Chloride 9 g/1000ml, Hydroxyethyl Starch 130/0.4 60 g/1000ml | Solution For Infusion | Intravenous Use |
| Spain | B.Braun Melsungen Ag | Isohes | Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Hetastarch 60 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml | Solution For Infusion | Intravenous Use |
| Spain | Fresenius Kabi Deutschland Gmbh | Hes Hipertónico | Sodium Chloride 72 g/1000ml, Hydroxyethyl Starch 200/0.5 60 g/1000ml | Solution For Infusion | Intravenous Use |
| Spain | Fresenius Kabi Deutschland Gmbh | Volulyte | Magnesium Chloride Hexahydrate 0.3 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.02 g/1000ml, Sodium Acetate Trihydrate 4.63 g/1000ml, Hydroxyethyl Starch 130/0.4 60 g/1000ml | Solution For Infusion | Intravenous Use |
| Spain | Fresenius Kabi Deutschland Gmbh | Voluven | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 60gl | Solution For Infusion | Intravenous Use |
| Spain | Fresenius Kabi España S.A.U. | Voluven | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 100gl | Solution For Infusion | Intravenous Use |
| Sweden | B.Braun Melsungen Ag | Tetraspan | Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Hetastarch 100 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml | Solution For Infusion | Intravenous Use |
| Sweden | B.Braun Melsungen Ag | Tetraspan | Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Hetastarch 60 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml | Solution For Infusion | Intravenous Use |
| Sweden | B.Braun Melsungen Ag | Venofundin | Sodium Chloride 9 g/1000ml, Hetastarch 60 g/1000ml | Solution For Infusion | Intravenous Use |
| Sweden | Fresenius Kabi Ab | Volulyte | Magnesium Chloride Hexahydrate 0.3 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.02 g/1000ml, Sodium Acetate Trihydrate 4.63 g/1000ml, Hydroxyethyl Starch 130/0.4 60 g/1000ml | Solution For Infusion | Intravenous Use |
| Sweden | Fresenius Kabi Ab | Voluven | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 100gl | Solution For Infusion | Intravenous Use |
| Sweden | Fresenius Kabi Ab | Voluven | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 60gl | Solution For Infusion | Intravenous Use |
| United Kingdom | B.Braun Melsungen Ag | Tetraspan | Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Hetastarch 100 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml | Solution For Infusion | Intravenous Use |
| United Kingdom | B.Braun Melsungen Ag | Tetraspan | Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Hetastarch 60 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml | Solution For Infusion | Intravenous Use |
| United Kingdom | Fresenius Kabi Limited | Volulyte | Magnesium Chloride Hexahydrate 0.3 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.02 g/1000ml, Sodium Acetate Trihydrate 4.63 g/1000ml, Hydroxyethyl Starch 130/0.4 60 g/1000ml | Solution For Infusion | Intravenous Use |
| United Kingdom | Fresenius Kabi Limited | Voluven | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 100gl | Solution For Infusion | Intravenous Use |
| United Kingdom | Fresenius Kabi Limited | Voluven | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 60gl | Solution For Infusion | Intravenous Use |

Member State in EEA

Marketing authorisation holder

Product name

INN + Strength

Pharmaceutical form

Route of administration

Austria

B.Braun Melsungen Ag

Tetraspan

Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Hetastarch 100 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml

Solution For Infusion

Intravenous Use

Austria

B.Braun Melsungen Ag

Tetraspan

Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Hetastarch 60 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml

Solution For Infusion

Intravenous Use

Austria

B.Braun Melsungen Ag

Venofundin

Sodium Chloride 9 g/1000ml, Hetastarch 60 g/1000ml

Solution For Infusion

Intravenous Use

Austria

Fresenius Kabi Austria Gmbh

Haes-Steril Hes

Sodium Chloride 9 g/1000ml, Hydroxyethyl Starch 200/0.5 60 g/1000ml

Solution For Infusion

Intravenous Use

Austria

Fresenius Kabi Austria Gmbh

Volulyte

Magnesium Chloride Hexahydrate 0.3gl, Potassium Chloride 0.3gl, Sodium Chloride 6.02gl, Sodium Acetate Trihydrate 4.63gl, Hydroxyethyl Starch 130/0.4 60gl

Solution For Infusion

Intravenous Use

Austria

Fresenius Kabi Austria Gmbh

Voluven (Hes 130/0,4 )

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 60gl

Solution For Infusion

Intravenous Use

Belgium

B.Braun Melsungen Ag

Tetraspan

Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Hetastarch 60 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml

Solution For Infusion

Intravenous Use

Belgium

B.Braun Melsungen Ag

Venohes

Sodium Chloride 9 g/1000ml, Hetastarch 60 g/1000ml

Solution For Infusion

Intravenous Use

Belgium

Fresenius Kabi Nv/Sa

Volulyte

Magnesium Chloride Hexahydrate 0.3 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.02 g/1000ml, Sodium Acetate Trihydrate 4.63 g/1000ml, Hydroxyethyl Starch 130/0.4 60 g/1000ml

Solution For Infusion

Intravenous Use

Belgium

Fresenius Kabi Nv/Sa

Volulyte

Magnesium Chloride Hexahydrate 0.3gl, Potassium Chloride 0.3gl, Sodium Chloride 6.02gl, Sodium Acetate Trihydrate 4.63gl, Hydroxyethyl Starch 130/0.4 60gl

Solution For Infusion

Intravenous Use

Belgium

Fresenius Kabi Nv/Sa

Voluven

Sodium Chloride 9 g/1000ml, Poly (O-2-Hydroxyethyl) Starch 130/0.4 (Ph.Eur.) 60 g/1000ml

Solution For Infusion

Intravenous Use

Belgium

Fresenius Kabi Nv/Sa

Voluven

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 100gl

Solution For Infusion

Intravenous Use

Belgium

Fresenius Kabi Nv/Sa

Voluven

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 60gl

Solution For Infusion

Intravenous Use

Bulgaria

B.Braun Melsungen Ag

Тетраспан

Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Malic Acid 0.67 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, Poly (0 2 Hydroxyethyl) Starch 100 g/1000ml

Solution For Infusion

Intravenous Use

Bulgaria

Fresenius Kabi Bulgaria Eood

Волувен

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 100gl

Solution For Infusion

Intravenous Use

Bulgaria

Fresenius Kabi Bulgaria Eood

Волулайт

Magnesium Chloride Hexahydrate 0.3 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.02 g/1000ml, Sodium Acetate Trihydrate 4.63 g/1000ml, Hydroxyethyl Starch 130/0.4 60 g/1000ml

Solution For Infusion

Intravenous Use

Bulgaria

Fresenius Kabi Deutschland Gmbh

Волувен

Sodium Chloride 9 g/1000ml, Hydroxyethyl Starch 130/0.4 60 g/1000ml

Solution For Infusion

Intravenous Use

Croatia

B.Braun Adria D.O.O.

Tetraspan

Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Malic Acid 0.67 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, Poly (0 2 Hydroxyethyl) Starch 100 g/1000ml

Solution For Infusion

Intravenous Use

Croatia

B.Braun Adria D.O.O.

Tetraspan

Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Malic Acid 0.67 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, Poly (0 2 Hydroxyethyl) Starch 60 g/1000ml

Solution For Infusion

Intravenous Use

Croatia

Fresenius Kabi D.O.O.

Volulyte

Magnesium Chloride Hexahydrate 0.3 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.02 g/1000ml, Sodium Acetate Trihydrate 4.63 g/1000ml, Hydroxyethyl Starch 130/0.4 60 g/1000ml

Solution For Infusion

Intravenous Use

Croatia

Fresenius Kabi D.O.O.

Voluven

Sodium Chloride 9 g/1000ml, Hydroxyethyl Starch 130/0.4 60 g/1000ml

Solution For Infusion

Intravenous Use

Cyprus

B.Braun Melsungen Ag

Venofundin

Sodium Chloride 9 g/1000ml, Hetastarch 60 g/1000ml

Solution For Infusion

Intravenous Use

Cyprus

Fresenius Kabi Deutschland Gmbh

Volulyte

Magnesium Chloride Hexahydrate 0.3 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.02 g/1000ml, Sodium Acetate Trihydrate 4.63 g/1000ml, Hydroxyethyl Starch 130/0.4 60 g/1000ml

Solution For Infusion

Intravenous Use

Czech Republic

B.Braun Melsungen Ag

Tetraspan

Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Hetastarch 100 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml

Solution For Infusion

Intravenous Use

Czech Republic

B.Braun Melsungen Ag

Tetraspan

Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml

Solution For Infusion

Intravenous Use

Czech Republic

Fresenius Kabi Deutschland Gmbh

Volulyte

Magnesium Chloride Hexahydrate 0.3 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.02 g/1000ml, Sodium Acetate Trihydrate 4.63 g/1000ml, Hydroxyethyl Starch 130/0.4 60 g/1000ml

Solution For Infusion

Intravenous Use

Czech Republic

Fresenius Kabi Deutschland Gmbh

Voluven

Sodium Chloride 9 g/1000ml, Hydroxyethyl Starch 130/0.4 60 g/1000ml

Solution For Infusion

Intravenous Use

Czech Republic

Fresenius Kabi S.R.O

Voluven

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 100gl

Solution For Infusion

Intravenous Use

Denmark

B.Braun Melsungen Ag

Tetraspan

Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Hetastarch 100 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml

Solution For Infusion

Intravenous Use

Denmark

B.Braun Melsungen Ag

Tetraspan

Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Hetastarch 60 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml

Solution For Infusion

Intravenous Use

Denmark

B.Braun Melsungen Ag

Venofundin

Sodium Chloride 9 g/1000ml, Hetastarch 60 g/1000ml

Solution For Infusion

Intravenous Use

Denmark

Fresenius Kabi Ab

Volulyte

Magnesium Chloride Hexahydrate 0.3gl, Potassium Chloride 0.3gl, Sodium Chloride 6.02gl, Sodium Acetate Trihydrate 4.63gl, Hydroxyethyl Starch 130/0.4 60gl

Solution For Infusion

Intravenous Use

Denmark

Fresenius Kabi Ab

Voluven

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 100gl

Solution For Infusion

Intravenous Use

Denmark

Fresenius Kabi Ab

Voluven

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 60gl

Solution For Infusion

Intravenous Use

Estonia

B.Braun Melsungen Ag

Tetraspan

Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Malic Acid 0.67 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, Poly (0 2 Hydroxyethyl) Starch 60 g/1000ml

Solution For Infusion

Intravenous Use

Estonia

Fresenius Kabi Deutschland Gmbh

Volulyte

Magnesium Chloride Hexahydrate 0.3gl, Potassium Chloride 0.3gl, Sodium Chloride 6.02gl, Sodium Acetate Trihydrate 4.63gl, Hydroxyethyl Starch 130/0.4 60gl

Solution For Infusion

Intravenous Use

Estonia

Fresenius Kabi Deutschland Gmbh

Voluven

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 60gl

Solution For Infusion

Intravenous Use

Estonia

Fresenius Kabi Polska Sp. Z O.O.

Voluforte

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 100gl

Solution For Infusion

Intravenous Use

Finland

B.Braun Melsungen Ag

Tetraspan

Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Hetastarch 100 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml

Solution For Infusion

Intravenous Use

Finland

B.Braun Melsungen Ag

Tetraspan

Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Hetastarch 60 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml

Solution For Infusion

Intravenous Use

Finland

B.Braun Melsungen Ag

Venofundin

Sodium Chloride 9 g/1000ml, Hetastarch 60 g/1000ml

Solution For Infusion

Intravenous Use

Finland

Fresenius Kabi Ab

Volulyte

Magnesium Chloride Hexahydrate 0.3 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.02 g/1000ml, Sodium Acetate Trihydrate 4.63 g/1000ml, Poly (O-2-Hydroxyethyl) Starch 130/0.4 (Ph.Eur.) 60 g/1000ml

Solution For Infusion

Intravenous Use

Finland

Fresenius Kabi Ab

Voluven

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 100gl

Solution For Infusion

Intravenous Use

Finland

Fresenius Kabi Ab

Voluven

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 60gl

Solution For Infusion

Intravenous Use

France

B.Braun Melsungen Ag

Isovol

Magnesium Chloride Hexahydrate 0.203 g/1000ml, Potassium Chloride 0.298 g/1000ml, Sodium Chloride 6.252 g/1000ml, Calcium Chloride Dihydrate 0.367 g/1000ml, Malic Acid 0.671 g/1000ml, Sodium Acetate Trihydrate 3.266 g/1000ml, Hydroxyethyl Starch 130/0.4 60 g/1000ml

Solution For Infusion

Intravenous Use

France

B.Braun Melsungen Ag

Restorvol

Sodium Chloride 9 g/1000ml, Hetastarch 60 g/1000ml

Solution For Infusion

Intravenous Use

France

Fresenius Kabi France S.A.S.

Volulyte

Magnesium Chloride Hexahydrate 0.3 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.02 g/1000ml, Sodium Acetate Trihydrate 4.63 g/1000ml, Hydroxyethyl Starch 130/0.4 60 g/1000ml

Solution For Infusion

Intravenous Use

France

Fresenius Kabi France S.A.S.

Voluven

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 60gl

Solution For Infusion

Intravenous Use

Germany

B.Braun Melsungen Ag

Tetraspan

Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Hetastarch 100 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml

Solution For Infusion

Intravenous Use

Germany

B.Braun Melsungen Ag

Tetraspan

Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Hetastarch 60 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml

Solution For Infusion

Intravenous Use

Germany

B.Braun Melsungen Ag

Venofundin

Sodium Chloride 9 g/1000ml, Hetastarch 60 g/1000ml

Solution For Infusion

Intravenous Use

Germany

Fresenius Kabi Deutschland Gmbh

Haes-Steril

Sodium Chloride 9 g/1000ml, Hydroxyethyl Starch 200/0.5 100 g/1000ml

Solution For Infusion

Intravenous Use

Germany

Fresenius Kabi Deutschland Gmbh

Haes-Steril

Sodium Chloride 9gl, Hydroxyethyl Starch 200/0.5 30gl

Solution For Infusion

Intravenous Use

Germany

Fresenius Kabi Deutschland Gmbh

Haes-Steril

Sodium Chloride 9gl, Hydroxyethyl Starch 200/0.5 60gl

Solution For Infusion

Intravenous Use

Germany

Fresenius Kabi Deutschland Gmbh

Volulyte

Magnesium Chloride Hexahydrate 0.3 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.02 g/1000ml, Sodium Acetate Trihydrate 4.63 g/1000ml, Poly (O-2-Hydroxyethyl) Starch 130/0.4 (Ph.Eur.) 60 g/1000ml

Solution For Infusion

Intravenous Use

Germany

Fresenius Kabi Deutschland Gmbh

Volulyte

Magnesium Chloride Hexahydrate 0.3gl, Potassium Chloride 0.3gl, Sodium Chloride 6.02gl, Sodium Acetate Trihydrate 4.63gl, Hydroxyethyl Starch 130/0.4 60gl

Solution For Infusion

Intravenous Use

Germany

Fresenius Kabi Deutschland Gmbh

Voluven

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 100gl

Solution For Infusion

Intravenous Use

Germany

Fresenius Kabi Deutschland Gmbh

Voluven

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 60gl

Solution For Infusion

Intravenous Use

Germany

Serumwerk Bernburg Ag

Infukoll

Sodium Chloride 9gl, Poly (0 2 Hydroxyethyl) Starch 100gl

Solution For Infusion

Intravenous Use

Germany

Serumwerk Bernburg Ag

Infukoll

Sodium Chloride 9gl, Poly (0 2 Hydroxyethyl) Starch 60gl

Solution For Infusion

Intravenous Use

Germany

Serumwerk Bernburg Ag

Vitafusal

Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.4 g/1000ml, Sodium Chloride 6 g/1000ml, Calcium Chloride Dihydrate 0.134 g/1000ml, Sodium Acetate Trihydrate 3.7 g/1000ml, Poly (0 2 Hydroxyethyl) Starch 100 g/1000ml

Solution For Infusion

Intravenous Use

Germany

Serumwerk Bernburg Ag

Vitafusal

Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.4 g/1000ml, Sodium Chloride 6 g/1000ml, Calcium Chloride Dihydrate 0.134 g/1000ml, Sodium Acetate Trihydrate 3.7 g/1000ml, Poly (0 2 Hydroxyethyl) Starch 60 g/1000ml

Solution For Infusion

Intravenous Use

Germany

Serumwerk Bernburg Ag

Vitahes

Sodium Chloride 9 g/1000ml, Poly (0 2 Hydroxyethyl) Starch 60 g/1000ml

Solution For Infusion

Intravenous Use

Greece

B.Braun Melsungen Ag

Venofundin

Sodium Chloride 9 g/1000ml, Hetastarch 60 g/1000ml

Solution For Infusion

Intravenous Use

Greece

Fresenius Kabi Hellas A.E.

Volulyte

Magnesium Chloride Hexahydrate 0.3 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.02 g/1000ml, Sodium Acetate Trihydrate 4.63 g/1000ml, Hydroxyethyl Starch 130/0.4 60 g/1000ml

Solution For Infusion

Intravenous Use

Greece

Fresenius Kabi Hellas A.E.

Voluven

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 60gl

Solution For Infusion

Intravenous Use

Greece

Vioser S.A.

Tetraspan

Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Hetastarch 100 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml

Solution For Infusion

Intravenous Use

Greece

Vioser S.A.

Tetraspan

Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Hetastarch 60 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml

Solution For Infusion

Intravenous Use

Hungary

B.Braun Melsungen Ag

Tetraspan

Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Hetastarch 60 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml

Solution For Infusion

Intravenous Use

Hungary

Fresenius Kabi Deutschland Gmbh

Volulyte

Magnesium Chloride Hexahydrate 0.3 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.02 g/1000ml, Sodium Acetate Trihydrate 4.63 g/1000ml, Poly (O-2-Hydroxyethyl) Starch 130/0.4 (Ph.Eur.) 60 g/1000ml

Solution For Infusion

Intravenous Use

Hungary

Fresenius Kabi Deutschland Gmbh

Volulyte

Magnesium Chloride Hexahydrate 0.3 g/1000ml, Potassium Chloride 0.3gl, Sodium Chloride 6.02 g/1000ml, Sodium Acetate Trihydrate 4.63 g/1000ml, Poly (O-2-Hydroxyethyl) Starch 130/0.4 (Ph.Eur.) 60 g/1000ml

Solution For Infusion

Intravenous Use

Hungary

Fresenius Kabi Deutschland Gmbh

Volulyte

Magnesium Chloride Hexahydrate 0.3gl, Potassium Chloride 0.3gl, Sodium Chloride 6.02gl, Sodium Acetate Trihydrate 4.63gl, Hydroxyethyl Starch 130/0.4 60gl

Solution For Infusion

Intravenous Use

Hungary

Fresenius Kabi Deutschland Gmbh

Voluven

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 100gl

Solution For Infusion

Intravenous Use

Hungary

Fresenius Kabi Deutschland Gmbh

Voluven

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 60gl

Solution For Infusion

Intravenous Use

Iceland

B.Braun Melsungen Ag

Tetraspan

Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Hetastarch 60 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml

Solution For Infusion

Intravenous Use

Iceland

Fresenius Kabi Ab

Volulyte

Magnesium Chloride Hexahydrate 0.3 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.02 g/1000ml, Sodium Acetate Trihydrate 4.63 g/1000ml, Hydroxyethyl Starch 130/0.4 60 g/1000ml

Solution For Infusion

Intravenous Use

Iceland

Fresenius Kabi Ab

Voluven

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 60gl

Solution For Infusion

Intravenous Use

Ireland

B.Braun Melsungen Ag

Equihes Ecobag

Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Hetastarch 100 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml

Solution For Infusion

Intravenous Use

Ireland

B.Braun Melsungen Ag

Equihes Ecobag

Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Hetastarch 60 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml

Solution For Infusion

Intravenous Use

Ireland

B.Braun Melsungen Ag

Equihes Ecoflac Plus

Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Hetastarch 100 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml

Solution For Infusion

Intravenous Use

Ireland

B.Braun Melsungen Ag

Equihes Ecoflac Plus

Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Hetastarch 60 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml

Solution For Infusion

Intravenous Use

Ireland

Fresenius Kabi Limited

Volulyte

Magnesium Chloride Hexahydrate 0.3 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.02 g/1000ml, Sodium Acetate Trihydrate 4.63 g/1000ml, Poly (O-2-Hydroxyethyl) Starch 130/0.4 (Ph.Eur.) 60 g/1000ml

Solution For Infusion

Intravenous Use

Ireland

Fresenius Kabi Limited

Voluven

Sodium Chloride 9 g/1000ml, Hydroxyethyl Starch 130/0.4 100 g/1000ml

Solution For Infusion

Intravenous Use

Ireland

Fresenius Kabi Limited

Voluven

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 100gl

Solution For Infusion

Intravenous Use

Ireland

Fresenius Kabi Limited

Voluven

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 60gl

Solution For Infusion

Intravenous Use

Italy

B.Braun Melsungen Ag

Amidolite

Sodium Chloride 9 g/1000ml, Hetastarch 60 g/1000ml

Solution For Infusion

Intravenous Use

Italy

B.Braun Melsungen Ag

Tetraspan

Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Hetastarch 100 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml

Solution For Infusion

Intravenous Use

Italy

B.Braun Melsungen Ag

Tetraspan

Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Hetastarch 60 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml

Solution For Infusion

Intravenous Use

Italy

Fresenius Kabi Italia S.R.L.

Volulyte

Magnesium Chloride Hexahydrate 0.3 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.02 g/1000ml, Sodium Acetate Trihydrate 4.63 g/1000ml, Hydroxyethyl Starch 130/0.4 60 g/1000ml

Solution For Infusion

Intravenous Use

Italy

Fresenius Kabi Italia S.R.L.

Volulyte

Magnesium Chloride Hexahydrate 0.3gl, Potassium Chloride 0.3gl, Sodium Chloride 6.02gl, Sodium Acetate Trihydrate 4.63gl, Hydroxyethyl Starch 130/0.4 60gl

Solution For Infusion

Intravenous Use

Italy

Fresenius Kabi Italia S.R.L.

Voluven

Sodium Chloride 9 g/1000ml, Poly (O-2-Hydroxyethyl) Starch 130/0.4 (Ph.Eur.) 60 g/1000ml

Solution For Infusion

Intravenous Use

Italy

Fresenius Kabi Italia S.R.L.

Voluven

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 60gl

Solution For Infusion

Intravenous Use

Italy

Fresenius Kabi Italia S.R.L.

Vonten

Sodium Chloride 9 g/1000ml, Poly (O-2-Hydroxyethyl) Starch 130/0.4 (Ph.Eur.) 100 g/1000ml

Solution For Infusion

Intravenous Use

Italy

Fresenius Kabi Italia S.R.L.

Vonten

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 100gl

Solution For Infusion

Intravenous Use

Latvia

B.Braun Melsungen Ag

Tetraspan

Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Hetastarch 100 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml

Solution For Infusion

Intravenous Use

Latvia

B.Braun Melsungen Ag

Tetraspan

Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Hetastarch 100 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml

Solution For Infusion

Intravenous Use

Latvia

B.Braun Melsungen Ag

Tetraspan

Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Hetastarch 60 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml

Solution For Infusion

Intravenous Use

Latvia

Fresenius Kabi Deutschland Gmbh

Volulyte

Magnesium Chloride Hexahydrate 0.3 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.02 g/1000ml, Sodium Acetate Trihydrate 4.63 g/1000ml, Hydroxyethyl Starch 130/0.4 60 g/1000ml

Solution For Infusion

Intravenous Use

Latvia

Fresenius Kabi Deutschland Gmbh

Voluven

Sodium Chloride 9 g/1000ml, Hydroxyethyl Starch 130/0.4 60 g/1000ml

Solution For Infusion

Intravenous Use

Lithuania

B.Braun Melsungen Ag

Tetraspan

Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Hetastarch 60 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml

Solution For Infusion

Intravenous Use

Lithuania

Fresenius Kabi Deutschland Gmbh

Volulyte

Magnesium Chloride Hexahydrate 0.3gl, Potassium Chloride 0.3gl, Sodium Chloride 6.02gl, Sodium Acetate Trihydrate 4.63gl, Hydroxyethyl Starch 130/0.4 60gl

Solution For Infusion

Intravenous Use

Lithuania

Fresenius Kabi Deutschland Gmbh

Voluven

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 60gl

Solution For Infusion

Intravenous Use

Lithuania

Fresenius Kabi Polska Sp. Z O.O.

Voluforte

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 100gl

Solution For Infusion

Intravenous Use

Luxembourg

B.Braun Melsungen Ag

Tetraspan

Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Hetastarch 100 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml

Solution For Infusion

Intravenous Use

Luxembourg

B.Braun Melsungen Ag

Tetraspan

Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Hetastarch 60 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml

Solution For Infusion

Intravenous Use

Luxembourg

B.Braun Melsungen Ag

Venofundin

Sodium Chloride 9 g/1000ml, Hetastarch 60 g/1000ml

Solution For Infusion

Intravenous Use

Luxembourg

Fresenius Kabi Deutschland Gmbh

Volulyte

Magnesium Chloride Hexahydrate 0.3gl, Potassium Chloride 0.3gl, Sodium Chloride 6.02gl, Sodium Acetate Trihydrate 4.63gl, Hydroxyethyl Starch 130/0.4 60gl

Solution For Infusion

Intravenous Use

Luxembourg

Fresenius Kabi Deutschland Gmbh

Voluven

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 60gl

Solution For Infusion

Intravenous Use

Malta

Fresenius Kabi Limited

Volulyte

Magnesium Chloride Hexahydrate 0.3 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.02 g/1000ml, Sodium Acetate Trihydrate 4.63 g/1000ml, Hydroxyethyl Starch 130/0.4 60 g/1000ml

Solution For Infusion

Intravenous Use

Netherlands

B.Braun Melsungen Ag

Tetraspan

Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Hetastarch 100 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml

Solution For Infusion

Intravenous Use

Netherlands

B.Braun Melsungen Ag

Tetraspan

Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Hetastarch 60 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml

Solution For Infusion

Intravenous Use

Netherlands

B.Braun Melsungen Ag

Venofundin

Sodium Chloride 9 g/1000ml, Hetastarch 60 g/1000ml

Solution For Infusion

Intravenous Use

Netherlands

Fresenius Kabi Nederland B.V.

Volulyte

Magnesium Chloride Hexahydrate 0.3 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.02 g/1000ml, Sodium Acetate Trihydrate 4.63 g/1000ml, Hydroxyethyl Starch 130/0.4 60 g/1000ml

Solution For Infusion

Intravenous Use

Netherlands

Fresenius Kabi Nederland B.V.

Voluven

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 100gl

Solution For Infusion

Intravenous Use

Netherlands

Fresenius Kabi Nederland B.V.

Voluven

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 60gl

Solution For Infusion

Intravenous Use

Norway

B.Braun Melsungen Ag

Tetraspan

Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml

Solution For Infusion

Intravenous Use

Norway

B.Braun Melsungen Ag

Venofundin

Sodium Chloride 9 g/1000ml, Hetastarch 60 g/1000ml

Solution For Infusion

Intravenous Use

Norway

Fresenius Kabi Norge As

Volulyte

Magnesium Chloride Hexahydrate 0.3gl, Potassium Chloride 0.3gl, Sodium Chloride 6.02gl, Sodium Acetate Trihydrate 4.63gl, Hydroxyethyl Starch 130/0.4 60gl

Solution For Infusion

Intravenous Use

Norway

Fresenius Kabi Norge As

Voluven

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 60gl

Solution For Infusion

Intravenous Use

Poland

B.Braun Melsungen Ag

Tetraspan

Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, Poly (0 2 Hydroxyethyl) Starch 60 g/1000ml, L-Malic Acid 0.67 g/1000ml

Solution For Infusion

Intravenous Use

Poland

B.Braun Melsungen Ag

Tetraspan Hes

Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Malic Acid 0.67 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, Poly (0 2 Hydroxyethyl) Starch 100 g/1000ml

Solution For Infusion

Intravenous Use

Poland

Fresenius Kabi Deutschland Gmbh

Volulyte

Magnesium Chloride Hexahydrate 0.3 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.02 g/1000ml, Sodium Acetate Trihydrate 4.63 g/1000ml, Hydroxyethyl Starch 130/0.4 60 g/1000ml

Solution For Infusion

Intravenous Use

Poland

Fresenius Kabi Deutschland Gmbh

Voluven

Sodium Chloride 9 g/1000ml, Hydroxyethyl Starch 130/0.4 60 g/1000ml

Solution For Infusion

Intravenous Use

Poland

Fresenius Kabi Polska Sp. Z O.O.

Voluven

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 100gl

Solution For Infusion

Intravenous Use

Portugal

B.Braun Melsungen Ag

Tetraspan

Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Hetastarch 100 g/1000ml, Malic Acid 0.67 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml

Solution For Infusion

Intravenous Use

Portugal

B.Braun Melsungen Ag

Tetraspan

Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Hetastarch 60 g/1000ml, Malic Acid 0.67 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml

Solution For Infusion

Intravenous Use

Portugal

B.Braun Melsungen Ag

Venofundin

Sodium Chloride 9 g/1000ml, Hetastarch 60 g/1000ml

Solution For Infusion

Intravenous Use

Portugal

Fresenius Kabi Pharma Portugal Lda.

Volulyte

Magnesium Chloride Hexahydrate 0.3 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.02 g/1000ml, Sodium Acetate Trihydrate 4.63 g/1000ml, Poly (O-2-Hydroxyethyl) Starch 130/0.4 (Ph.Eur.) 60 g/1000ml

Solution For Infusion

Intravenous Use

Portugal

Fresenius Kabi Pharma Portugal Lda.

Volulyte

Magnesium Chloride Hexahydrate 0.3gl, Potassium Chloride 0.3gl, Sodium Chloride 6.02gl, Sodium Acetate Trihydrate 4.63gl, Hydroxyethyl Starch 130/0.4 60gl

Solution For Infusion

Intravenous Use

Portugal

Fresenius Kabi Pharma Portugal Lda.

Voluven

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 100gl

Solution For Infusion

Intravenous Use

Portugal

Fresenius Kabi Pharma Portugal Lda.

Voluven

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 60gl

Solution For Infusion

Intravenous Use

Romania

B.Braun Melsungen Ag

Tetraspan

Magnesium Chloride Hexahydrate 0.203 g/1000ml, Potassium Chloride 0.298 g/1000ml, Sodium Chloride 6.252 g/1000ml, Calcium Chloride Dihydrate 0.367 g/1000ml, Sodium Acetate Trihydrate 3.266 g/1000ml, L-Malic Acid 0.671 g/1000ml, Hydroxyethyl Starch 130/0.4 60 g/1000ml

Solution For Infusion

Intravenous Use

Romania

B.Braun Melsungen Ag

Tetraspan

Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Hetastarch 100 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml

Solution For Infusion

Intravenous Use

Romania

B.Braun Melsungen Ag

Venofundin

Sodium Chloride 9 g/1000ml, Hetastarch 60 g/1000ml

Solution For Infusion

Intravenous Use

Romania

Fresenius Kabi Deutschland Gmbh

Voluven

Sodium Chloride 9 g/1000ml, Hydroxyethyl Starch 130/0.4 60 g/1000ml

Solution For Infusion

Intravenous Use

Romania

Infomed Fluids Srl

Vitafusal

Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.4 g/1000ml, Sodium Chloride 6 g/1000ml, Calcium Chloride Dihydrate 0.134 g/1000ml, Hetastarch 60 g/1000ml, Sodium Acetate Trihydrate 3.7 g/1000ml

Solution For Infusion

Intravenous Use

Romania

S.C. Fresenius Kabi România S.R.L.

Volulyte

Magnesium Chloride Hexahydrate 0.3 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.02 g/1000ml, Sodium Acetate Trihydrate 4.63 g/1000ml, Hydroxyethyl Starch 130/0.4 60 g/1000ml

Solution For Infusion

Intravenous Use

Romania

S.C. Fresenius Kabi România S.R.L.

Volulyte

Magnesium Chloride Hexahydrate 0.3 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.02 g/1000ml, Sodium Acetate Trihydrate 4.63 g/1000ml, Poly (0 2 Hydroxyethyl) Starch 60 g/1000ml

Solution For Infusion

Intravenous Use

Romania

S.C. Fresenius Kabi România S.R.L.

Volulyte

Magnesium Chloride Hexahydrate 0.3 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.02 g/1000ml, Sodium Acetate Trihydrate 4.63 g/1000ml, Poly (0 2 Hydroxyethyl) Starch 60 g/1000μl

Solution For Infusion

Intravenous Use

Slovakia

B.Braun Melsungen Ag

Tetraspan

Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Hetastarch 100 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml

Solution For Infusion

Intravenous Use

Slovakia

B.Braun Melsungen Ag

Tetraspan

Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Hetastarch 60 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml

Solution For Infusion

Intravenous Use

Slovakia

Fresenius Kabi Deutschland Gmbh

Volulyte

Magnesium Chloride Hexahydrate 0.3 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.02 g/1000ml, Sodium Acetate Trihydrate 4.63 g/1000ml, Hydroxyethyl Starch 130/0.4 60 g/1000ml

Solution For Infusion

Intravenous Use

Slovakia

Fresenius Kabi Deutschland Gmbh

Voluven

Sodium Chloride 9 g/1000ml, Hydroxyethyl Starch 130/0.4 60 g/1000ml

Solution For Infusion

Intravenous Use

Slovakia

Fresenius Kabi S.R.O

Voluven

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 100gl

Solution For Infusion

Intravenous Use

Slovenia

B.Braun Melsungen Ag

Tetraspan

Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Hetastarch 100 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml

Solution For Infusion

Intravenous Use

Slovenia

B.Braun Melsungen Ag

Tetraspan

Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Hetastarch 60 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml

Solution For Infusion

Intravenous Use

Slovenia

Fresenius Kabi Deutschland Gmbh

Voluven

Sodium Chloride 9 g/1000ml, Hydroxyethyl Starch 130/0.4 100 g/1000ml

Solution For Infusion

Intravenous Use

Slovenia

Medias International D.O.O.

Volulyte

Magnesium Chloride Hexahydrate 0.3 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.02 g/1000ml, Sodium Acetate Trihydrate 4.63 g/1000ml, Hydroxyethyl Starch 130/0.4 60 g/1000ml

Solution For Infusion

Intravenous Use

Slovenia

Medias International D.O.O.

Voluven

Sodium Chloride 4.5 g/500ml, Hydroxyethyl Starch 130/0.4 30 g/500ml

Solution For Infusion

Intravenous Use

Slovenia

Medias International D.O.O.

Voluven

Sodium Chloride 9 g/1000ml, Hydroxyethyl Starch 130/0.4 60 g/1000ml

Solution For Infusion

Intravenous Use

Spain

B.Braun Melsungen Ag

Isohes

Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Hetastarch 60 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml

Solution For Infusion

Intravenous Use

Spain

Fresenius Kabi Deutschland Gmbh

Hes Hipertónico

Sodium Chloride 72 g/1000ml, Hydroxyethyl Starch 200/0.5 60 g/1000ml

Solution For Infusion

Intravenous Use

Spain

Fresenius Kabi Deutschland Gmbh

Volulyte

Magnesium Chloride Hexahydrate 0.3 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.02 g/1000ml, Sodium Acetate Trihydrate 4.63 g/1000ml, Hydroxyethyl Starch 130/0.4 60 g/1000ml

Solution For Infusion

Intravenous Use

Spain

Fresenius Kabi Deutschland Gmbh

Voluven

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 60gl

Solution For Infusion

Intravenous Use

Spain

Fresenius Kabi España S.A.U.

Voluven

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 100gl

Solution For Infusion

Intravenous Use

Sweden

B.Braun Melsungen Ag

Tetraspan

Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Hetastarch 100 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml

Solution For Infusion

Intravenous Use

Sweden

B.Braun Melsungen Ag

Tetraspan

Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Hetastarch 60 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml

Solution For Infusion

Intravenous Use

Sweden

B.Braun Melsungen Ag

Venofundin

Sodium Chloride 9 g/1000ml, Hetastarch 60 g/1000ml

Solution For Infusion

Intravenous Use

Sweden

Fresenius Kabi Ab

Volulyte

Magnesium Chloride Hexahydrate 0.3 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.02 g/1000ml, Sodium Acetate Trihydrate 4.63 g/1000ml, Hydroxyethyl Starch 130/0.4 60 g/1000ml

Solution For Infusion

Intravenous Use

Sweden

Fresenius Kabi Ab

Voluven

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 100gl

Solution For Infusion

Intravenous Use

Sweden

Fresenius Kabi Ab

Voluven

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 60gl

Solution For Infusion

Intravenous Use

United Kingdom

B.Braun Melsungen Ag

Tetraspan

Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Hetastarch 100 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml

Solution For Infusion

Intravenous Use

United Kingdom

B.Braun Melsungen Ag

Tetraspan

Magnesium Chloride Hexahydrate 0.2 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.25 g/1000ml, Calcium Chloride Dihydrate 0.37 g/1000ml, Hetastarch 60 g/1000ml, Sodium Acetate Trihydrate 3.27 g/1000ml, L-Malic Acid 0.67 g/1000ml

Solution For Infusion

Intravenous Use

United Kingdom

Fresenius Kabi Limited

Volulyte

Magnesium Chloride Hexahydrate 0.3 g/1000ml, Potassium Chloride 0.3 g/1000ml, Sodium Chloride 6.02 g/1000ml, Sodium Acetate Trihydrate 4.63 g/1000ml, Hydroxyethyl Starch 130/0.4 60 g/1000ml

Solution For Infusion

Intravenous Use

United Kingdom

Fresenius Kabi Limited

Voluven

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 100gl

Solution For Infusion

Intravenous Use

United Kingdom

Fresenius Kabi Limited

Voluven

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 60gl

Solution For Infusion

Intravenous Use

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