# Official Journal C 249/30 J

| | ISSN 1977-091X |
| --- | --- |
| Official Journal
  of the European Union | C 249 |
| | |
| English edition | Information and Notices | Volume 6530 June 2022 |

ISSN 1977-091X

Official Journal

of the European Union

C 249

English edition

Information and Notices

Volume 6530 June 2022

---

| Contents | page |
| --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2022/C 249/01 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2022 to 31 May 2022(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council) | 1 |
| 2022/C 249/02 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2022 to 31 May 2022(Decisions taken pursuant to Article 34 of Directive 2001/83/EC, Article 38 of Directive 2001/82/EC or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council) | 9 |

Contents

page

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2022/C 249/01

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2022 to 31 May 2022(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council or Article 5 of Regulation (EU) 2019/6 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 or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council)

1

2022/C 249/02

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2022 to 31 May 2022(Decisions taken pursuant to Article 34 of Directive 2001/83/EC, Article 38 of Directive 2001/82/EC or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council)

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC, Article 38 of Directive 2001/82/EC or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council)

9

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

EN

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IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 30.6.2022 | EN | Official Journal of the European Union | C 249/1 |
| --- | --- | --- | --- |

30.6.2022

EN

Official Journal of the European Union

C 249/1

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2022 to 31 May 2022

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1)
  or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council (2)
  )

(2022/C 249/01)

—   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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 5.5.2022 | Amversio | betaine anhydrous | SERB S.A. |
| Avenue Louise 480, 1050 Bruxelles, Belgique / Louizalaan 480, 1050 Brussel, België |

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

5.5.2022

Amversio

betaine anhydrous

SERB S.A.

Avenue Louise 480, 1050 Bruxelles, Belgique / Louizalaan 480, 1050 Brussel, België

EU/1/22/1640

Powder for oral solution

A16AA06

6.5.2022

13.5.2022

Dimethyl fumarate Mylan

dimethyl fumarate

| Mylan Ireland Limited |
| --- |
| Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland |

Mylan Ireland Limited

Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

EU/1/22/1634

Gastro-resistant capsule, hard

L04AX07

16.5.2022

13.5.2022

Dimethyl fumarate Neuraxpharm

dimethyl fumarate

| Laboratorios Lesvi, S.L. |
| --- |
| Avda. Barcelona 69, 08970 Sant Joan Despí — Barcelona, España |

Laboratorios Lesvi, S.L.

Avda. Barcelona 69, 08970 Sant Joan Despí — Barcelona, España

EU/1/22/1637

Gastro-resistant capsule, hard

L04AX07

16.5.2022

13.5.2022

Dimethyl fumarate Polpharma

dimethyl fumarate

| Zakłady Farmaceutyczne POLPHARMA S.A. |
| --- |
| ul. Pelplińska 19, 83-200 Starogard Gdański, Polska |

Zakłady Farmaceutyczne POLPHARMA S.A.

ul. Pelplińska 19, 83-200 Starogard Gdański, Polska

EU/1/22/1635

Gastro-resistant capsule, hard

L04AX07

13.5.2022

17.5.2022

Zolgensma

onasemnogene abeparvovec

| Novartis Gene Therapies EU Limited |
| --- |
| Block B, The Crescent Building, Northwood, Santry, Dublin 9, D09 C6X8, Ireland |

Novartis Gene Therapies EU Limited

Block B, The Crescent Building, Northwood, Santry, Dublin 9, D09 C6X8, Ireland

EU/1/20/1443

Solution for infusion

M09AX09

18.5.2022

19.5.2022

Amifampridine SERB

amifampridine

| SERB S.A. |
| --- |
| Avenue Louise 480, 1050 Bruxelles, Belgique / Louizalaan 480, 1050 Brussel, België |

SERB S.A.

Avenue Louise 480, 1050 Bruxelles, Belgique / Louizalaan 480, 1050 Brussel, België

EU/1/22/1646

Tablet

N07XX05

23.5.2022

24.5.2022

ADCETRIS

Brentuximab vedotin

| Takeda Pharma A/S |
| --- |
| Delta Park 45, 2665 Vallensbaek Strand, Danmark |

Takeda Pharma A/S

Delta Park 45, 2665 Vallensbaek Strand, Danmark

EU/1/12/794

Powder for concentrate for solution for infusion

L01FX05

25.5.2022

24.5.2022

Camcevi

leuprorelin

| Accord Healthcare S.L.U. |
| --- |
| World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España |

Accord Healthcare S.L.U.

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

EU/1/22/1647

Prolonged-release suspension for injection

L02AE02

26.5.2022

24.5.2022

Polivy

polatuzumab vedotin

| Roche Registration GmbH |
| --- |
| Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland |

Roche Registration GmbH

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

EU/1/19/1388

Powder for concentrate for solution for infusion

L01FX14

25.5.2022

25.5.2022

CARVYKTI

ciltacabtagene autoleucel

| Janssen-Cilag International NV |
| --- |
| Turnhoutseweg 30, 2340 Beerse, België |

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/22/1648

Dispersion for infusion

Pending

30.5.2022

31.5.2022

ZOLSKETIL pegylated liposomal

doxorubicin

| Accord Healthcare S.L.U. |
| --- |
| World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España |

Accord Healthcare S.L.U.

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

EU/1/22/1629

Concentrate for dispersion for infusion

L01DB01

2.6.2022

—   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 |
| --- | --- | --- | --- | --- |
| 4.5.2022 | Comirnaty | BioNTech Manufacturing GmbH |
| An der Goldgrube 12, 55131 Mainz, Deutschland |

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

4.5.2022

Comirnaty

BioNTech Manufacturing GmbH

An der Goldgrube 12, 55131 Mainz, Deutschland

EU/1/20/1528

4.5.2022

4.5.2022

Rubraca

| Clovis Oncology Ireland Limited |
| --- |
| Regus Dublin Airport, Skybridge House — Dublin Airport, Swords, Co. Dublin, K67 P6K2, Ireland |

Clovis Oncology Ireland Limited

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

EU/1/17/1250

4.5.2022

5.5.2022

Enerzair Breezhaler

| Novartis Europharm Limited |
| --- |
| Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |

Novartis Europharm Limited

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

EU/1/20/1438

6.5.2022

5.5.2022

Hepsera

| Gilead Sciences Ireland UC |
| --- |
| Carrigtohill, County Cork, T45 DP77, Ireland |

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/03/251

6.5.2022

5.5.2022

Invega

| Janssen-Cilag International NV |
| --- |
| Turnhoutseweg 30, 2340 Beerse, België |

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/07/395

6.5.2022

5.5.2022

Opsumit

| Janssen-Cilag International NV |
| --- |
| Turnhoutseweg 30, 2340 Beerse, België |

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/13/893

6.5.2022

5.5.2022

Pazenir

| ratiopharm GmbH |
| --- |
| Graf-Arco-Straße 3, 89079 Ulm, Deutschland |

ratiopharm GmbH

Graf-Arco-Straße 3, 89079 Ulm, Deutschland

EU/1/18/1317

6.5.2022

5.5.2022

Prolia

| Amgen Europe B.V. |
| --- |
| Minervum 7061, 4817 ZK Breda, Nederland |

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/10/618

9.5.2022

5.5.2022

Ravicti

| Immedica Pharma AB |
| --- |
| SE-113 29 Stockholm, Sverige |

Immedica Pharma AB

SE-113 29 Stockholm, Sverige

EU/1/15/1062

10.5.2022

5.5.2022

Sapropterin Dipharma

| Dipharma B.V. |
| --- |
| Prins Bernhardplein 200, 1097 JB Amsterdam, Nederland |

Dipharma B.V.

Prins Bernhardplein 200, 1097 JB Amsterdam, Nederland

EU/1/21/1620

6.5.2022

5.5.2022

Ziextenzo

| Sandoz GmbH |
| --- |
| Biochemiestrasse 10, 6250 Kundl, Österreich |

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/18/1327

9.5.2022

13.5.2022

Buccolam

| Laboratorios Lesvi, S.L. |
| --- |
| Avda. Barcelona 69, 08970 Sant Joan Despí — Barcelona, España |

Laboratorios Lesvi, S.L.

Avda. Barcelona 69, 08970 Sant Joan Despí — Barcelona, España

EU/1/11/709

18.5.2022

13.5.2022

Genvoya

| Gilead Sciences Ireland UC |
| --- |
| Carrigtohill, County Cork, T45 DP77, Ireland |

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/15/1061

16.5.2022

13.5.2022

Imatinib Actavis

| Actavis Group PTC ehf. |
| --- |
| Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland |

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland

EU/1/13/825

17.5.2022

13.5.2022

Lumigan

| AbbVie Deutschland GmbH & Co. KG |
| --- |
| Knollstrasse, 67061 Ludwigshafen, Deutschland |

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/02/205

20.5.2022

13.5.2022

NEXPOVIO

| Karyopharm Europe GmbH |
| --- |
| Franziska-Bilek-Weg 9, 80339 München, Deutschland |

Karyopharm Europe GmbH

Franziska-Bilek-Weg 9, 80339 München, Deutschland

EU/1/21/1537

17.5.2022

13.5.2022

Odomzo

| Sun Pharmaceutical Industries Europe BV |
| --- |
| Polarisavenue 87, 2132 JH Hoofddorp, Nederland |

Sun Pharmaceutical Industries Europe BV

Polarisavenue 87, 2132 JH Hoofddorp, Nederland

EU/1/15/1030

19.5.2022

13.5.2022

Tecfidera

| Biogen Netherlands B.V. |
| --- |
| Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland |

Biogen Netherlands B.V.

Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland

EU/1/13/837

13.5.2022

17.5.2022

Cinryze

| Takeda Manufacturing Austria AG |
| --- |
| Industriestraße 67, 1221 Wien, Österreich |

Takeda Manufacturing Austria AG

Industriestraße 67, 1221 Wien, Österreich

EU/1/11/688

18.5.2022

17.5.2022

COVID-19 Vaccine Janssen

| Janssen-Cilag International NV |
| --- |
| Turnhoutseweg 30, 2340 Beerse, België |

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/20/1525

18.5.2022

17.5.2022

Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva

| Zentiva, k.s. |
| --- |
| U Kabelovny 130, 102 37 Praha 10, Česká republika |

Zentiva, k.s.

U Kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/17/1210

18.5.2022

17.5.2022

Revestive

| Takeda Pharmaceuticals International AG Ireland Branch |
| --- |
| 50-58 Baggot Street Lower, Block 3 Miesian Plaza, Dublin 2, Co Dublin, D02 Y754, Ireland |

Takeda Pharmaceuticals International AG Ireland Branch

50-58 Baggot Street Lower, Block 3 Miesian Plaza, Dublin 2, Co Dublin, D02 Y754, Ireland

EU/1/12/787

18.5.2022

19.5.2022

Adcirca

| Eli Lilly Nederland B.V. |
| --- |
| Papendorpseweg 83, 3528 BJ Utrecht, Nederland |

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/08/476

23.5.2022

19.5.2022

Aranesp

| Amgen Europe B.V. |
| --- |
| Minervum 7061, 4817 ZK Breda, Nederland |

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/01/185

23.5.2022

19.5.2022

Azarga

| Novartis Europharm Limited |
| --- |
| Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |

Novartis Europharm Limited

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

EU/1/08/482

20.5.2022

19.5.2022

Bronchitol

| Pharmaxis Europe Limited |
| --- |
| 108 Q House, Furze Road, Sandyford Dublin 18, D18AY29, Ireland |

Pharmaxis Europe Limited

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

EU/1/12/760

24.5.2022

19.5.2022

Comtess

| Orion Corporation |
| --- |
| Orionintie 1, 02200 Espoo, Suomi |

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/1/98/082

20.5.2022

19.5.2022

Cresemba

| Basilea Pharmaceutica Deutschland GmbH |
| --- |
| Marie-Curie-Strasse 8, 79539 Loerrach, Deutschland |

Basilea Pharmaceutica Deutschland GmbH

Marie-Curie-Strasse 8, 79539 Loerrach, Deutschland

EU/1/15/1036

23.5.2022

19.5.2022

DuoTrav

| Novartis Europharm Limited |
| --- |
| Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |

Novartis Europharm Limited

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

EU/1/06/338

20.5.2022

19.5.2022

Epclusa

| Gilead Sciences Ireland UC |
| --- |
| Carrigtohill, County Cork, T45 DP77, Ireland |

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/16/1116

20.5.2022

19.5.2022

Glubrava

| Takeda Pharma A/S |
| --- |
| Delta Park 45, 2665 Vallensbaek Strand, Danmark |

Takeda Pharma A/S

Delta Park 45, 2665 Vallensbaek Strand, Danmark

EU/1/07/421

25.5.2022

19.5.2022

KEYTRUDA

| Merck Sharp & Dohme B.V. |
| --- |
| Waarderweg 39, 2031 BN Haarlem, Nederland |

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/15/1024

23.5.2022

19.5.2022

Maviret

| AbbVie Deutschland GmbH & Co. KG |
| --- |
| Knollstrasse, 67061 Ludwigshafen, Deutschland |

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/17/1213

20.5.2022

19.5.2022

Pelmeg

| Mundipharma Corporation (Ireland) Limited |
| --- |
| Millbank House, Arkle Road, Sandyford Industrial Estate, Dublin 18, Ireland |

Mundipharma Corporation (Ireland) Limited

Millbank House, Arkle Road, Sandyford Industrial Estate, Dublin 18, Ireland

EU/1/18/1328

23.5.2022

19.5.2022

Peyona

| Chiesi Farmaceutici S.p.A. |
| --- |
| Via Palermo 26/A, 43122 Parma, Italia |

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A, 43122 Parma, Italia

EU/1/09/528

6.6.2022

19.5.2022

Toujeo

| Sanofi-Aventis Deutschland GmbH |
| --- |
| D-65926 Frankfurt am Main, Deutschland |

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/00/133

2.6.2022

19.5.2022

Trogarzo

| Theratechnologies Europe Limited |
| --- |
| 4th Floor, 2 Hume Street, Dublin 2, D02 DV24, Ireland |

Theratechnologies Europe Limited

4th Floor, 2 Hume Street, Dublin 2, D02 DV24, Ireland

EU/1/19/1359

2.6.2022

19.5.2022

Zimbus Breezhaler

| Novartis Europharm Limited |
| --- |
| Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |

Novartis Europharm Limited

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

EU/1/20/1440

20.5.2022

20.5.2022

Vaxzevria

| AstraZeneca AB |
| --- |
| 151 85 Södertälje, Sverige |

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/21/1529

20.5.2022

24.5.2022

Adjupanrix

| GlaxoSmithKline Biologicals S.A. |
| --- |
| rue de l'Institut 89, 1330 Rixensart, Belgique |

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, 1330 Rixensart, Belgique

EU/1/09/578

31.5.2022

24.5.2022

Cabazitaxel Accord

| Accord Healthcare S.L.U. |
| --- |
| World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España |

Accord Healthcare S.L.U.

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

EU/1/20/1448

26.5.2022

24.5.2022

Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan

| Mylan Pharmaceuticals Limited |
| --- |
| Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland |

Mylan Pharmaceuticals Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland

EU/1/17/1222

25.5.2022

24.5.2022

Kesimpta

| Novartis Ireland Limited |
| --- |
| Vista Building, Elm Park, Merrion Road, Ballsbridge, Dublin 4, Ireland |

Novartis Ireland Limited

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

EU/1/21/1532

25.5.2022

24.5.2022

NovoSeven

| Novo Nordisk A/S |
| --- |
| Novo Allé, 2880 Bagsvaerd, Danmark |

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/96/006

25.5.2022

24.5.2022

Symtuza

| Janssen-Cilag International NV |
| --- |
| Turnhoutseweg 30, 2340 Beerse, België |

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/17/1225

25.5.2022

25.5.2022

JCOVDEN

| Janssen-Cilag International NV |
| --- |
| Turnhoutseweg 30, 2340 Beerse, België |

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/20/1525

25.5.2022

25.5.2022

Regkirona

| Celltrion Healthcare Hungary Kft. |
| --- |
| Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország |

Celltrion Healthcare Hungary Kft.

Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország

EU/1/21/1597

25.5.2022

30.5.2022

Aerinaze

| N.V. Organon |
| --- |
| Kloosterstraat 6, 5349 AB Oss, Nederland |

N.V. Organon

Kloosterstraat 6, 5349 AB Oss, Nederland

EU/1/07/399

31.5.2022

30.5.2022

Aerius

| N.V. Organon |
| --- |
| Kloosterstraat 6, 5349 AB Oss, Nederland |

N.V. Organon

Kloosterstraat 6, 5349 AB Oss, Nederland

EU/1/00/160

31.5.2022

30.5.2022

Azomyr

| N.V. Organon |
| --- |
| Kloosterstraat 6, 5349 AB Oss, Nederland |

N.V. Organon

Kloosterstraat 6, 5349 AB Oss, Nederland

EU/1/00/157

31.5.2022

30.5.2022

BLENREP

| GlaxoSmithKline (Ireland) Limited |
| --- |
| 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland |

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/20/1474

31.5.2022

30.5.2022

Bydureon

| AstraZeneca AB |
| --- |
| 151 85 Södertälje, Sverige |

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/11/696

31.5.2022

30.5.2022

Dasselta

| KRKA d d., Novo mesto |
| --- |
| Šmarješka cesta 6, 8501 Novo mesto, Slovenija |

KRKA d d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/11/739

1.6.2022

30.5.2022

Desloratadine ratiopharm

| ratiopharm GmbH |
| --- |
| Graf-Arco-Straße 3, 89079 Ulm, Deutschland |

ratiopharm GmbH

Graf-Arco-Straße 3, 89079 Ulm, Deutschland

EU/1/11/746

31.5.2022

30.5.2022

Desloratadine Teva

| Teva B.V. |
| --- |
| Swensweg 5, 2031 GA Haarlem, Nederland |

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/11/732

31.5.2022

30.5.2022

Harvoni

| Gilead Sciences Ireland UC |
| --- |
| Carrigtohill, County Cork, T45 DP77, Ireland |

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/14/958

31.5.2022

30.5.2022

JEVTANA

| Sanofi-Aventis groupe |
| --- |
| 54 rue La Boétie, 75008 Paris, France |

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/11/676

31.5.2022

30.5.2022

Neoclarityn

| N.V. Organon |
| --- |
| Kloosterstraat 6, 5349 AB Oss, Nederland |

N.V. Organon

Kloosterstraat 6, 5349 AB Oss, Nederland

EU/1/00/161

31.5.2022

30.5.2022

Rinvoq

| AbbVie Deutschland GmbH & Co. KG |
| --- |
| Knollstrasse, 67061 Ludwigshafen, Deutschland |

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/19/1404

31.5.2022

30.5.2022

Rozlytrek

| Roche Registration GmbH |
| --- |
| Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland |

Roche Registration GmbH

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

EU/1/20/1460

31.5.2022

30.5.2022

Rydapt

| Novartis Europharm Limited |
| --- |
| Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |

Novartis Europharm Limited

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

EU/1/17/1218

31.5.2022

30.5.2022

Sovaldi

| Gilead Sciences Ireland UC |
| --- |
| Carrigtohill, County Cork, T45 DP77, Ireland |

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/13/894

31.5.2022

30.5.2022

Tysabri

| Biogen Netherlands B.V. |
| --- |
| Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland |

Biogen Netherlands B.V.

Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland

EU/1/06/346

31.5.2022

30.5.2022

Vosevi

| Gilead Sciences Ireland UC |
| --- |
| Carrigtohill, County Cork, T45 DP77, Ireland |

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/17/1223

31.5.2022

30.5.2022

Zejula

| GlaxoSmithKline (Ireland) Limited |
| --- |
| 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland |

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/17/1235

31.5.2022

—   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 |
| --- | --- | --- | --- | --- |
| 16.5.2022 | Imatinib Actavis | Actavis Group PTC ehf. |
| Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland |

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

16.5.2022

Imatinib Actavis

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland

EU/1/13/825

17.5.2022

24.5.2022

Glubrava

| Takeda Pharma A/S |
| --- |
| Delta Park 45, 2665 Vallensbaek Strand, Danmark |

Takeda Pharma A/S

Delta Park 45, 2665 Vallensbaek Strand, Danmark

EU/1/07/421

25.5.2022

—   Modification of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council; Article 5 of Regulation (EU) 2019/6 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 |
| --- | --- | --- | --- | --- |
| 5.5.2022 | Advocate | Bayer Animal Health GmbH |
| D-51368 Leverkusen, Deutschland |

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

5.5.2022

Advocate

Bayer Animal Health GmbH

D-51368 Leverkusen, Deutschland

EU/2/03/039

6.5.2022

5.5.2022

Zeleris

| Ceva Santé Animale |
| --- |
| 10 avenue de La Ballastière, 33500 Libourne, France |

Ceva Santé Animale

10 avenue de La Ballastière, 33500 Libourne, France

EU/2/17/210

10.5.2022

18.5.2022

Hydrocortisone aceponate Ecuphar

| Ecuphar NV |
| --- |
| Legeweg 157-i, 8020 Oostkamp, België |

Ecuphar NV

Legeweg 157-i, 8020 Oostkamp, België

EU/2/18/230

23.5.2022

18.5.2022

Locatim

| Biokema Anstalt |
| --- |
| Pflugstrasse 12, 9490 Vaduz, Fürstentum Liechtenstein |

Biokema Anstalt

Pflugstrasse 12, 9490 Vaduz, Fürstentum Liechtenstein

EU/2/99/011

23.5.2022

30.5.2022

Pirsue

| Zoetis Belgium S.A. |
| --- |
| rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |

Zoetis Belgium S.A.

rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique

EU/2/00/027

31.5.2022

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 |
| --- |
| Domenico Scarlattilaan 6 |
| 1083 HS Amsterdam |
| NETHERLANDS |

European Medicines Agency

Domenico Scarlattilaan 6

1083 HS Amsterdam

NETHERLANDS

---

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

(2)  OJ L 4, 7.1.2019, p. 43.

---

| 30.6.2022 | EN | Official Journal of the European Union | C 249/9 |
| --- | --- | --- | --- |

30.6.2022

EN

Official Journal of the European Union

C 249/9

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2022 to 31 May 2022

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1)
  , Article 38 of Directive 2001/82/EC (2)
  or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council (3)
  )

(2022/C 249/02)

—   Suspension 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 |
| --- | --- | --- | --- | --- | --- |
| 24.5.2022 | HES (hydroxyethyl starch) | hydroxyethyl starch (HES), solutions for infusion | See Annex | See Annex | 25.5.2022 |

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

24.5.2022

HES (hydroxyethyl starch)

hydroxyethyl starch (HES), solutions for infusion

See Annex

See Annex

25.5.2022

---

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

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

(3)  OJ L 4, 7.1.2019, p. 43.

---

ANNEX

List of medicinal products and presentations

| Member State in EEA | Marketing authorisation holder | Product Name (in authorisation country) | INN + Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | Fresenius Kabi Austria GmbH | Volulyte 6 % infusionslösung | Magnesium chloride hexahydrate, potassium chloride, sodium chloride, sodium acetate trihydrate, hydroxyethyl starch 130/0,4 | Solution For Infusion | Intravenous Use |
| Austria | Fresenius Kabi Austria GmbH | Voluven (HES 130/0,4 ) 6 % infusionslösung | Sodium chloride, hetastarch | Solution For Infusion | Intravenous Use |
| Belgium | Fresenius Kabi nv/sa | Volulyte 6 % infusionslösung/6 % oplossing voor
  Infusie/ 6 %
  solution pour perfusion | Magnesium chloride hexahydrate, potassium chloride, sodium chloride, sodium acetate trihydrate, hydroxyethyl starch 130/0,4 | Solution For Infusion | Intravenous Use |
| Belgium | Fresenius Kabi nv/sa | Voluven, 6 % (60 mg/ml) Infusionslösung, Voluven, 6 % (60 mg/ml) oplossing voor infusie, Voluven, 6 % (60 mg/ml) solution
  pour perfusion | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4 | Solution For Infusion | Intravenous Use |
| Belgium | Fresenius Kabi nv/sa | Voluven, 10 % (100 mg/ml) Infusionslösung, Voluven, 10 % (100 mg/ml) oplossing voor infusie, Voluven,
  10 % (100 mg/ml) solution
  pour perfusion | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4  100gl | Solution For Infusion | Intravenous Use |
| Belgium | B. Braun Melsungen AG | Tetraspan 6 % oplossing
  voor infusie | 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 60g/1000ml, Sodium Acetate Trihydrate 3,27 g/1000ml, L-Malic Acid 0,67 g/1000ml | Solution For Infusion | Intravenous Use |
| Bulgaria | Fresenius Kabi Bulgaria EOOD | Волулайт 6 % инфузионен разтвор | 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 60g/1000ml | Solution For Infusion | Intravenous Use |
| Bulgaria | Fresenius Kabi Deutschland GmbH | ВОЛУВЕН 6 % инфузионен разтвор | Sodium chloride, hetastarch | Solution For Infusion | Intravenous Use |
| Croatia | Fresenius Kabi d.o.o. | Volulyte 6 % otopina za infuziju | 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 60g/1000ml | Solution For Infusion | Intravenous Use |
| Croatia | Fresenius Kabi d.o.o. | Voluven 6 % otopina za infuziju | Sodium chloride, hetastarch | Solution For Infusion | Intravenous Use |
| Cyprus | Fresenius Kabi Deutschland GmbH | Volulyte 6 %, Διάλυμα για έγχυση | 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 60g/1000ml | Solution For Infusion | Intravenous Use |
| Czechia | Fresenius Kabi Deutschland GmbH | Volulyte 6 % infuzní roztok | 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 60g/1000ml | Solution For Infusion | Intravenous Use |
| Czechia | Fresenius Kabi s.r.o. | VOLUVEN 6 % INFUZNÍ ROZTOK | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4  100gl | Solution For Infusion | Intravenous Use |
| Czechia | Fresenius Kabi s.r.o. | Voluven 10 %, infuzní roztok | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4  100gl | Solution For Infusion | Intravenous Use |
| Denmark | Fresenius Kabi AB | Volulyte, infusionsvæske,
  opløsning | Magnesium Chloride Hexahydrate 0,3 gl, Potassium Chloride 0,3 gl, Sodium Chloride 6,02 gl, Sodium Acetate Trihydrate 4,63 gl, 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 | Fresenius Kabi Deutschland GmbH | Volulyte | Magnesium Chloride Hexahydrate 0,3 gl, Potassium Chloride 0,3 gl, Sodium Chloride 6,02 gl, Sodium Acetate Trihydrate 4,63 gl, 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 |
| Estonia | Fresenius Kabi Deutschland GmbH | Voluven | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4 60gl | Solution For Infusion | Intravenous Use |
| Finland | Fresenius Kabi AB | Volulyte 60 mg/ml infuusioneste, liuos | 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.) 60g/1000ml | Solution For Infusion | Intravenous Use |
| Finland | Fresenius Kabi AB | Voluven 100 mg/ml infuusioneste, liuos | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4  100gl | Solution For Infusion | Intravenous Use |
| Finland | Fresenius Kabi AB | Voluven 60 mg/ml infuusioneste, liuos | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4 60gl | Solution For Infusion | Intravenous Use |
| France | Fresenius Kabi France S.A.S. | Volulyte 6 %, solution pour perfusion | 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 60g/1000ml | Solution For Infusion | Intravenous Use |
| France | Fresenius Kabi France S.A.S. | Voluven, solution pour perfusion | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4 60gl | Solution For Infusion | Intravenous Use |
| France | B. Braun Melsungen AG | ISOVOL 6 %, solution pour perfusion | 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 60g/1000ml | Solution For Infusion | Intravenous Use |
| France | B. Braun Melsungen AG | Restorvol perfusion 6 % solution pour | Sodium Chloride 9g/1000ml, Hetastarch 60g/1000ml | Solution For Infusion | Intravenous Use |
| Germany | Fresenius Kabi Deutschland GmbH | Volulyte 6 % Infusionslösung | 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.) 60g/1000ml | Solution For Infusion | Intravenous Use |
| Germany | Fresenius Kabi Deutschland GmbH | Volulyte 6 % Infusionslösung | Magnesium Chloride Hexahydrate 0,3 gl, Potassium Chloride 0,3 gl, Sodium Chloride 6,02 gl, Sodium Acetate Trihydrate 4,63 gl, Hydroxyethyl Starch 130/0,4 60gl | Solution For Infusion | Intravenous Use |
| Germany | Fresenius Kabi Deutschland GmbH | Voluven 10 % Infusionslösung | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4  100gl | Solution For Infusion | Intravenous Use |
| Germany | Fresenius Kabi Deutschland GmbH | Voluven 6 %; Infusionslösung | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4 60gl | Solution For Infusion | Intravenous Use |
| Germany | Fresenius Kabi Deutschland GmbH | Voluven 6 % Infusionslösung | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4 60gl | Solution For Infusion | Intravenous Use |
| Germany | Fresenius Kabi Deutschland GmbH | Voluven Fresenius; 6 % Infusionslösung | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4 60gl | Solution For Infusion | Intravenous Use |
| Germany | B. Braun Melsungen AG | Tetraspan 6 %
  Infusionslösung | 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 60g/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 10 % Infusionslösung | 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 100g/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 60 mg/ml Infusionslösung | Sodium Chloride 9g/1000ml, Hetastarch 60g/1000ml | Solution For Infusion | Intravenous Use |
| Greece | Fresenius Kabi Hellas A.E. | Volulyte 6 %W/V,
  Διάλυμα για έγχυση | 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 60g/1000ml | Solution For Infusion | Intravenous Use |
| Greece | Fresenius Kabi Hellas A.E. | Voluven 6 % διάλυμα για έγχυση | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4 60gl | Solution For Infusion | Intravenous Use |
| Hungary | Fresenius Kabi Deutschland GmbH | Volulyte 6 % oldatos infúzió | 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.) 60g/1000ml | Solution For Infusion | Intravenous Use |
| Hungary | Fresenius Kabi Deutschland GmbH | Volulyte 6 % oldatos infúzió | 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.) 60g/1000ml | Solution For Infusion | Intravenous Use |
| Hungary | Fresenius Kabi Deutschland GmbH | Voluven 10 % oldatos infúzió | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4  100gl | Solution For Infusion | Intravenous Use |
| Hungary | Fresenius Kabi Deutschland GmbH | Voluven 6 % oldatos infúzió | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4 60gl | Solution For Infusion | Intravenous Use |
| Iceland | Fresenius Kabi AB | Volulyte 60 mg/ml innrennslislyf, lausn | 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 60g/1000ml | Solution For Infusion | Intravenous Use |
| Iceland | Fresenius Kabi AB | Volulyte 60 mg/ml innrennslislyf, lausn | 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 60g/1000ml | Solution For Infusion | Intravenous Use |
| Iceland | Fresenius Kabi AB | Voluven 6 %. Innrennslislyf, lausn. | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4 60gl | Solution For Infusion | Intravenous Use |
| Italy | Fresenius Kabi Italia S.r.l. | Volulyte 6 % Soluzione per infusione | 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 60g/1000ml | Solution For Infusion | Intravenous Use |
| Italy | Fresenius Kabi Italia S.r.l. | Volulyte 6 % Soluzione per infusione | Magnesium Chloride Hexahydrate 0,3 gl, Potassium Chloride 0,3 gl, Sodium Chloride 6,02 gl, Sodium Acetate Trihydrate 4,63 gl, Hydroxyethyl Starch 130/0,4 60gl | Solution For Infusion | Intravenous Use |
| Italy | Fresenius Kabi Italia S.r.l. | Voluven soluzione per infusione al 6 % | Sodium Chloride 9g/1000ml, Poly (O-2-Hydroxyethyl) Starch 130/0,4 (Ph.Eur.) 60g/1000ml | Solution For Infusion | Intravenous Use |
| Italy | Fresenius Kabi Italia S.r.l. | Voluven soluzione per infusione al 6 % | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4 60gl | Solution For Infusion | Intravenous Use |
| Latvia | Fresenius Kabi Deutschland GmbH | Volulyte 6 % šķīdums infūzijām | 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 60g/1000ml | Solution For Infusion | Intravenous Use |
| Latvia | Fresenius Kabi Deutschland GmbH | Volulyte 6 % šķīdums infūzijām | 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 60g/1000ml | Solution For Infusion | Intravenous Use |
| Latvia | Fresenius Kabi Deutschland GmbH | Voluven 6 % šķīdums infūzijām | Sodium Chloride 9g/1000ml, Hydroxyethyl Starch 130/0,4 60g/1000ml | Solution For Infusion | Intravenous Use |
| Lithuania | Fresenius Kabi Deutschland GmbH | Volulyte 6 % infuzinis tirpalas | Magnesium Chloride Hexahydrate 0,3 gl, Potassium Chloride 0,3 gl, Sodium Chloride 6,02 gl, Sodium Acetate Trihydrate 4,63 gl, Hydroxyethyl Starch 130/0,4 60gl | Solution For Infusion | Intravenous Use |
| Lithuania | Fresenius Kabi Polska Sp. z o.o. | Voluforte 10 % infuzinis tirpalas | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4  100gl | Solution For Infusion | Intravenous Use |
| Lithuania | Fresenius Kabi Deutschland GmbH | Voluven 6 % infuzinis tirpalas | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4 60gl | Solution For Infusion | Intravenous Use |
| Luxembourg | Fresenius Kabi Deutschland GmbH | Volulyte 6 % Infusionslösung | Magnesium Chloride Hexahydrate 0,3 gl, Potassium Chloride 0,3 gl, Sodium Chloride 6,02 gl, Sodium Acetate Trihydrate 4,63 gl, Hydroxyethyl Starch 130/0,4 60gl | Solution For Infusion | Intravenous Use |
| Luxembourg | Fresenius Kabi Deutschland GmbH | Voluven 6 % Infusionslösung | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4 60gl | Solution For Infusion | Intravenous Use |
| Malta | Fresenius Kabi Italia S.r.l. | Volulyte 6 % Solution for Infusion | 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 60g/1000ml | Solution For Infusion | Intravenous Use |
| Netherlands | Fresenius Kabi Nederland b.v. | Volulyte 6 % oplossing voor infusie | 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 60g/1000ml | Solution For Infusion | Intravenous Use |
| Netherlands | Fresenius Kabi Nederland b.v. | Voluven, 10 % (100 mg/ml) oplossing voor infusie | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4 100gl | Solution For Infusion | Intravenous Use |
| Netherlands | Fresenius Kabi Nederland b.v. | Voluven, 6 % (60 mg/ml) oplossing voor infusie | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4 60gl | Solution For Infusion | Intravenous Use |
| Norway | Fresenius Kabi Norge AS | Volulyte 60 mg/ml infusjonsvæske,
  oppløsning | Magnesium Chloride Hexahydrate 0,3 gl, Potassium Chloride 0,3 gl, Sodium Chloride 6,02 gl, Sodium Acetate Trihydrate 4,63 gl, Hydroxyethyl Starch 130/0,4 60gl | Solution For Infusion | Intravenous Use |
| Norway | Fresenius Kabi Norge AS
  P | Voluven 60 mg/ml infusjonsvæske,
  oppløsning | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0.4 60gl | Solution For Infusion | Intravenous Use |
| Poland | Fresenius Kabi Deutschland GmbH | Volulyte 6 %, roztwór do infuzji | 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 60g/1000ml | Solution For Infusion | Intravenous Use |
| Poland | Fresenius Kabi Polska Sp. z o.o. | Voluven 10 %, 10 % + 0,9  %, roztwór do infuzji | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4  100gl | Solution For Infusion | Intravenous Use |
| Poland | Fresenius Kabi Deutschland GmbH | VOLUVEN, (60 mg + 9 mg)/ml, roztwór do infuzji | Sodium Chloride 9g/1000ml, Hydroxyethyl Starch 130/0,4 60g/1000ml | Solution For Infusion | Intravenous Use |
| Poland | B. Braun Melsungen AG | Tetraspan 60 mg/ml HES roztwór do infuzji | 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 60g/1000ml, L-Malic Acid 0,67 g/1000ml | Solution For Infusion | Intravenous Use |
| Portugal | Fresenius Kabi Pharma Portugal, Lda. | Volulyte 60 mg/ml Solução para Perfusão | 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.) 60g/1000ml | Solution For Infusion | Intravenous Use |
| Portugal | Fresenius Kabi Pharma Portugal, Lda. | Voluven Fresenius 100 mg/ml + 9 mg/ml solução para perfusão | Magnesium Chloride Hexahydrate 0,3 gl, Potassium Chloride 0,3 gl, Sodium Chloride 6,02 gl, Sodium Acetate Trihydrate 4,63 gl, Hydroxyethyl Starch 130/0,4 60gl | Solution For Infusion | Intravenous Use |
| Portugal | Fresenius Kabi Pharma Portugal, Lda. | Voluven Fresenius 60 mg/ml + 9 mg/ml solução para perfusão | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4 60gl | Solution For Infusion | Intravenous Use |
| Portugal | B. Braun Melsungen AG | Tetraspan 60 mg/ml solução para perfusão | 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 100g/1000ml, Malic Acid 0,67 g/1000ml, Sodium Acetate Trihydrate 3,27 g/1000ml | Solution For Infusion | Intravenous Use |
| Romania | Fresenius Kabi Romania srl | Volulyte 6 %, soluţie perfuzabilă | 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 60g/1000ml | Solution For Infusion | Intravenous Use |
| Romania | Fresenius Kabi Deutschland GmbH | Voluven 60 g/1000 ml soluţie perfuzabilă | Sodium Chloride 9g/1000ml, Hydroxyethyl Starch 130/0,4 60g/1000ml | Solution For Infusion | Intravenous Use |
| Romania | B. Braun Melsungen AG | Tetraspan 60 mg/ml | 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 60g/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 100g/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 6 %, infúzny roztok | 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 60g/1000ml | Solution For Infusion | Intravenous Use |
| Slovakia | Fresenius Kabi s.r.o. | Voluven 10 %, infúzny roztok | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4  100gl | Solution For Infusion | Intravenous Use |
| Slovakia | Fresenius Kabi Deutschland GmbH | Voluven, 6 % infúzny
  roztok | Sodium Chloride 9g/1000ml, Hydroxyethyl Starch 130/0,4 60g/1000ml | Solution For Infusion | Intravenous Use |
| Slovenia | Fresenius Kabi Austria GmbH | Volulyte 60 mg/ml raztopina za infundiranje | 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 60g/1000ml | Solution For Infusion | Intravenous Use |
| Slovenia | Fresenius Kabi Deutschland GmbH | Voluven 100 mg/ml raztopina za infundiranje | Sodium Chloride 9g/1000ml, Hydroxyethyl Starch 130/0,4 100g/1000ml | Solution For Infusion | Intravenous Use |
| Slovenia | Fresenius Kabi Austria GmbH | VOLUVEN 60 mg/ml
  raztopina za infundiranje | Sodium Chloride 9g/1000ml, Hydroxyethyl Starch 130/0,4 60g/1000ml | Solution For Infusion | Intravenous Use |
| Spain | Fresenius Kabi Deutschland GmbH | Volulyte 6 % solución para perfusión | 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 60g/1000ml | Solution For Infusion | Intravenous Use |
| Spain | Fresenius Kabi Austria GmbH | Voluven 6 % Solución
  para perfusion | Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4 60gl | Solution For Infusion | Intravenous Use |
| Spain | B. Braun Melsungen AG | Isohes 6 % Solución para perfusión | 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 60g/1000ml, Sodium Acetate Trihydrate 3,27 g/1000ml, L-Malic Acid 0,67 g/1000ml | Solution For Infusion | Intravenous Use |

Member State in EEA

Marketing authorisation holder

Product Name (in authorisation country)

INN + Strength

Pharmaceutical form

Route of administration

Austria

Fresenius Kabi Austria GmbH

Volulyte 6 % infusionslösung

Magnesium chloride hexahydrate, potassium chloride, sodium chloride, sodium acetate trihydrate, hydroxyethyl starch 130/0,4

Solution For Infusion

Intravenous Use

Austria

Fresenius Kabi Austria GmbH

Voluven (HES 130/0,4 ) 6 % infusionslösung

Sodium chloride, hetastarch

Solution For Infusion

Intravenous Use

Belgium

Fresenius Kabi nv/sa

Volulyte 6 % infusionslösung/6 % oplossing voor

Infusie/ 6 %

solution pour perfusion

Magnesium chloride hexahydrate, potassium chloride, sodium chloride, sodium acetate trihydrate, hydroxyethyl starch 130/0,4

Solution For Infusion

Intravenous Use

Belgium

Fresenius Kabi nv/sa

Voluven, 6 % (60 mg/ml) Infusionslösung, Voluven, 6 % (60 mg/ml) oplossing voor infusie, Voluven, 6 % (60 mg/ml) solution

pour perfusion

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4

Solution For Infusion

Intravenous Use

Belgium

Fresenius Kabi nv/sa

Voluven, 10 % (100 mg/ml) Infusionslösung, Voluven, 10 % (100 mg/ml) oplossing voor infusie, Voluven,

10 % (100 mg/ml) solution

pour perfusion

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4  100gl

Solution For Infusion

Intravenous Use

Belgium

B. Braun Melsungen AG

Tetraspan 6 % oplossing

voor infusie

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 60g/1000ml, Sodium Acetate Trihydrate 3,27 g/1000ml, L-Malic Acid 0,67 g/1000ml

Solution For Infusion

Intravenous Use

Bulgaria

Fresenius Kabi Bulgaria EOOD

Волулайт 6 % инфузионен разтвор

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 60g/1000ml

Solution For Infusion

Intravenous Use

Bulgaria

Fresenius Kabi Deutschland GmbH

ВОЛУВЕН 6 % инфузионен разтвор

Sodium chloride, hetastarch

Solution For Infusion

Intravenous Use

Croatia

Fresenius Kabi d.o.o.

Volulyte 6 % otopina za infuziju

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 60g/1000ml

Solution For Infusion

Intravenous Use

Croatia

Fresenius Kabi d.o.o.

Voluven 6 % otopina za infuziju

Sodium chloride, hetastarch

Solution For Infusion

Intravenous Use

Cyprus

Fresenius Kabi Deutschland GmbH

Volulyte 6 %, Διάλυμα για έγχυση

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 60g/1000ml

Solution For Infusion

Intravenous Use

Czechia

Fresenius Kabi Deutschland GmbH

Volulyte 6 % infuzní roztok

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 60g/1000ml

Solution For Infusion

Intravenous Use

Czechia

Fresenius Kabi s.r.o.

VOLUVEN 6 % INFUZNÍ ROZTOK

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4  100gl

Solution For Infusion

Intravenous Use

Czechia

Fresenius Kabi s.r.o.

Voluven 10 %, infuzní roztok

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4  100gl

Solution For Infusion

Intravenous Use

Denmark

Fresenius Kabi AB

Volulyte, infusionsvæske,

opløsning

Magnesium Chloride Hexahydrate 0,3 gl, Potassium Chloride 0,3 gl, Sodium Chloride 6,02 gl, Sodium Acetate Trihydrate 4,63 gl, 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

Fresenius Kabi Deutschland GmbH

Volulyte

Magnesium Chloride Hexahydrate 0,3 gl, Potassium Chloride 0,3 gl, Sodium Chloride 6,02 gl, Sodium Acetate Trihydrate 4,63 gl, 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

Estonia

Fresenius Kabi Deutschland GmbH

Voluven

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4 60gl

Solution For Infusion

Intravenous Use

Finland

Fresenius Kabi AB

Volulyte 60 mg/ml infuusioneste, liuos

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.) 60g/1000ml

Solution For Infusion

Intravenous Use

Finland

Fresenius Kabi AB

Voluven 100 mg/ml infuusioneste, liuos

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4  100gl

Solution For Infusion

Intravenous Use

Finland

Fresenius Kabi AB

Voluven 60 mg/ml infuusioneste, liuos

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4 60gl

Solution For Infusion

Intravenous Use

France

Fresenius Kabi France S.A.S.

Volulyte 6 %, solution pour perfusion

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 60g/1000ml

Solution For Infusion

Intravenous Use

France

Fresenius Kabi France S.A.S.

Voluven, solution pour perfusion

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4 60gl

Solution For Infusion

Intravenous Use

France

B. Braun Melsungen AG

ISOVOL 6 %, solution pour perfusion

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 60g/1000ml

Solution For Infusion

Intravenous Use

France

B. Braun Melsungen AG

Restorvol perfusion 6 % solution pour

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

Solution For Infusion

Intravenous Use

Germany

Fresenius Kabi Deutschland GmbH

Volulyte 6 % Infusionslösung

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.) 60g/1000ml

Solution For Infusion

Intravenous Use

Germany

Fresenius Kabi Deutschland GmbH

Volulyte 6 % Infusionslösung

Magnesium Chloride Hexahydrate 0,3 gl, Potassium Chloride 0,3 gl, Sodium Chloride 6,02 gl, Sodium Acetate Trihydrate 4,63 gl, Hydroxyethyl Starch 130/0,4 60gl

Solution For Infusion

Intravenous Use

Germany

Fresenius Kabi Deutschland GmbH

Voluven 10 % Infusionslösung

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4  100gl

Solution For Infusion

Intravenous Use

Germany

Fresenius Kabi Deutschland GmbH

Voluven 6 %; Infusionslösung

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4 60gl

Solution For Infusion

Intravenous Use

Germany

Fresenius Kabi Deutschland GmbH

Voluven 6 % Infusionslösung

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4 60gl

Solution For Infusion

Intravenous Use

Germany

Fresenius Kabi Deutschland GmbH

Voluven Fresenius; 6 % Infusionslösung

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4 60gl

Solution For Infusion

Intravenous Use

Germany

B. Braun Melsungen AG

Tetraspan 6 %

Infusionslösung

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 60g/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 10 % Infusionslösung

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 100g/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 60 mg/ml Infusionslösung

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

Solution For Infusion

Intravenous Use

Greece

Fresenius Kabi Hellas A.E.

Volulyte 6 %W/V,

Διάλυμα για έγχυση

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 60g/1000ml

Solution For Infusion

Intravenous Use

Greece

Fresenius Kabi Hellas A.E.

Voluven 6 % διάλυμα για έγχυση

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4 60gl

Solution For Infusion

Intravenous Use

Hungary

Fresenius Kabi Deutschland GmbH

Volulyte 6 % oldatos infúzió

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.) 60g/1000ml

Solution For Infusion

Intravenous Use

Hungary

Fresenius Kabi Deutschland GmbH

Volulyte 6 % oldatos infúzió

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.) 60g/1000ml

Solution For Infusion

Intravenous Use

Hungary

Fresenius Kabi Deutschland GmbH

Voluven 10 % oldatos infúzió

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4  100gl

Solution For Infusion

Intravenous Use

Hungary

Fresenius Kabi Deutschland GmbH

Voluven 6 % oldatos infúzió

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4 60gl

Solution For Infusion

Intravenous Use

Iceland

Fresenius Kabi AB

Volulyte 60 mg/ml innrennslislyf, lausn

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 60g/1000ml

Solution For Infusion

Intravenous Use

Iceland

Fresenius Kabi AB

Volulyte 60 mg/ml innrennslislyf, lausn

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 60g/1000ml

Solution For Infusion

Intravenous Use

Iceland

Fresenius Kabi AB

Voluven 6 %. Innrennslislyf, lausn.

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4 60gl

Solution For Infusion

Intravenous Use

Italy

Fresenius Kabi Italia S.r.l.

Volulyte 6 % Soluzione per infusione

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 60g/1000ml

Solution For Infusion

Intravenous Use

Italy

Fresenius Kabi Italia S.r.l.

Volulyte 6 % Soluzione per infusione

Magnesium Chloride Hexahydrate 0,3 gl, Potassium Chloride 0,3 gl, Sodium Chloride 6,02 gl, Sodium Acetate Trihydrate 4,63 gl, Hydroxyethyl Starch 130/0,4 60gl

Solution For Infusion

Intravenous Use

Italy

Fresenius Kabi Italia S.r.l.

Voluven soluzione per infusione al 6 %

Sodium Chloride 9g/1000ml, Poly (O-2-Hydroxyethyl) Starch 130/0,4 (Ph.Eur.) 60g/1000ml

Solution For Infusion

Intravenous Use

Italy

Fresenius Kabi Italia S.r.l.

Voluven soluzione per infusione al 6 %

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4 60gl

Solution For Infusion

Intravenous Use

Latvia

Fresenius Kabi Deutschland GmbH

Volulyte 6 % šķīdums infūzijām

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 60g/1000ml

Solution For Infusion

Intravenous Use

Latvia

Fresenius Kabi Deutschland GmbH

Volulyte 6 % šķīdums infūzijām

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 60g/1000ml

Solution For Infusion

Intravenous Use

Latvia

Fresenius Kabi Deutschland GmbH

Voluven 6 % šķīdums infūzijām

Sodium Chloride 9g/1000ml, Hydroxyethyl Starch 130/0,4 60g/1000ml

Solution For Infusion

Intravenous Use

Lithuania

Fresenius Kabi Deutschland GmbH

Volulyte 6 % infuzinis tirpalas

Magnesium Chloride Hexahydrate 0,3 gl, Potassium Chloride 0,3 gl, Sodium Chloride 6,02 gl, Sodium Acetate Trihydrate 4,63 gl, Hydroxyethyl Starch 130/0,4 60gl

Solution For Infusion

Intravenous Use

Lithuania

Fresenius Kabi Polska Sp. z o.o.

Voluforte 10 % infuzinis tirpalas

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4  100gl

Solution For Infusion

Intravenous Use

Lithuania

Fresenius Kabi Deutschland GmbH

Voluven 6 % infuzinis tirpalas

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4 60gl

Solution For Infusion

Intravenous Use

Luxembourg

Fresenius Kabi Deutschland GmbH

Volulyte 6 % Infusionslösung

Magnesium Chloride Hexahydrate 0,3 gl, Potassium Chloride 0,3 gl, Sodium Chloride 6,02 gl, Sodium Acetate Trihydrate 4,63 gl, Hydroxyethyl Starch 130/0,4 60gl

Solution For Infusion

Intravenous Use

Luxembourg

Fresenius Kabi Deutschland GmbH

Voluven 6 % Infusionslösung

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4 60gl

Solution For Infusion

Intravenous Use

Malta

Fresenius Kabi Italia S.r.l.

Volulyte 6 % Solution for Infusion

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 60g/1000ml

Solution For Infusion

Intravenous Use

Netherlands

Fresenius Kabi Nederland b.v.

Volulyte 6 % oplossing voor infusie

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 60g/1000ml

Solution For Infusion

Intravenous Use

Netherlands

Fresenius Kabi Nederland b.v.

Voluven, 10 % (100 mg/ml) oplossing voor infusie

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4 100gl

Solution For Infusion

Intravenous Use

Netherlands

Fresenius Kabi Nederland b.v.

Voluven, 6 % (60 mg/ml) oplossing voor infusie

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4 60gl

Solution For Infusion

Intravenous Use

Norway

Fresenius Kabi Norge AS

Volulyte 60 mg/ml infusjonsvæske,

oppløsning

Magnesium Chloride Hexahydrate 0,3 gl, Potassium Chloride 0,3 gl, Sodium Chloride 6,02 gl, Sodium Acetate Trihydrate 4,63 gl, Hydroxyethyl Starch 130/0,4 60gl

Solution For Infusion

Intravenous Use

Norway

Fresenius Kabi Norge AS

P

Voluven 60 mg/ml infusjonsvæske,

oppløsning

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

Solution For Infusion

Intravenous Use

Poland

Fresenius Kabi Deutschland GmbH

Volulyte 6 %, roztwór do infuzji

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 60g/1000ml

Solution For Infusion

Intravenous Use

Poland

Fresenius Kabi Polska Sp. z o.o.

Voluven 10 %, 10 % + 0,9  %, roztwór do infuzji

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4  100gl

Solution For Infusion

Intravenous Use

Poland

Fresenius Kabi Deutschland GmbH

VOLUVEN, (60 mg + 9 mg)/ml, roztwór do infuzji

Sodium Chloride 9g/1000ml, Hydroxyethyl Starch 130/0,4 60g/1000ml

Solution For Infusion

Intravenous Use

Poland

B. Braun Melsungen AG

Tetraspan 60 mg/ml HES roztwór do infuzji

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 60g/1000ml, L-Malic Acid 0,67 g/1000ml

Solution For Infusion

Intravenous Use

Portugal

Fresenius Kabi Pharma Portugal, Lda.

Volulyte 60 mg/ml Solução para Perfusão

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.) 60g/1000ml

Solution For Infusion

Intravenous Use

Portugal

Fresenius Kabi Pharma Portugal, Lda.

Voluven Fresenius 100 mg/ml + 9 mg/ml solução para perfusão

Magnesium Chloride Hexahydrate 0,3 gl, Potassium Chloride 0,3 gl, Sodium Chloride 6,02 gl, Sodium Acetate Trihydrate 4,63 gl, Hydroxyethyl Starch 130/0,4 60gl

Solution For Infusion

Intravenous Use

Portugal

Fresenius Kabi Pharma Portugal, Lda.

Voluven Fresenius 60 mg/ml + 9 mg/ml solução para perfusão

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4 60gl

Solution For Infusion

Intravenous Use

Portugal

B. Braun Melsungen AG

Tetraspan 60 mg/ml solução para perfusão

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 100g/1000ml, Malic Acid 0,67 g/1000ml, Sodium Acetate Trihydrate 3,27 g/1000ml

Solution For Infusion

Intravenous Use

Romania

Fresenius Kabi Romania srl

Volulyte 6 %, soluţie perfuzabilă

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 60g/1000ml

Solution For Infusion

Intravenous Use

Romania

Fresenius Kabi Deutschland GmbH

Voluven 60 g/1000 ml soluţie perfuzabilă

Sodium Chloride 9g/1000ml, Hydroxyethyl Starch 130/0,4 60g/1000ml

Solution For Infusion

Intravenous Use

Romania

B. Braun Melsungen AG

Tetraspan 60 mg/ml

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 60g/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 100g/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 6 %, infúzny roztok

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 60g/1000ml

Solution For Infusion

Intravenous Use

Slovakia

Fresenius Kabi s.r.o.

Voluven 10 %, infúzny roztok

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4  100gl

Solution For Infusion

Intravenous Use

Slovakia

Fresenius Kabi Deutschland GmbH

Voluven, 6 % infúzny

roztok

Sodium Chloride 9g/1000ml, Hydroxyethyl Starch 130/0,4 60g/1000ml

Solution For Infusion

Intravenous Use

Slovenia

Fresenius Kabi Austria GmbH

Volulyte 60 mg/ml raztopina za infundiranje

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 60g/1000ml

Solution For Infusion

Intravenous Use

Slovenia

Fresenius Kabi Deutschland GmbH

Voluven 100 mg/ml raztopina za infundiranje

Sodium Chloride 9g/1000ml, Hydroxyethyl Starch 130/0,4 100g/1000ml

Solution For Infusion

Intravenous Use

Slovenia

Fresenius Kabi Austria GmbH

VOLUVEN 60 mg/ml

raztopina za infundiranje

Sodium Chloride 9g/1000ml, Hydroxyethyl Starch 130/0,4 60g/1000ml

Solution For Infusion

Intravenous Use

Spain

Fresenius Kabi Deutschland GmbH

Volulyte 6 % solución para perfusión

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 60g/1000ml

Solution For Infusion

Intravenous Use

Spain

Fresenius Kabi Austria GmbH

Voluven 6 % Solución

para perfusion

Sodium Chloride 9gl, Hydroxyethyl Starch 130/0,4 60gl

Solution For Infusion

Intravenous Use

Spain

B. Braun Melsungen AG

Isohes 6 % Solución para perfusión

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 60g/1000ml, Sodium Acetate Trihydrate 3,27 g/1000ml, L-Malic Acid 0,67 g/1000ml

Solution For Infusion

Intravenous Use

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