# Den Europæiske Unions C 29/2014

| | ISSN 1977-0871
  doi:10.3000/19770871.C_2014.029.dan |
| --- | --- |
| Den Europæiske Unions
  Tidende | C 29 |
| | |
| Dansk udgave | Meddelelser og oplysninger | 57. årgang31. januar 2014 |

ISSN 1977-0871

doi:10.3000/19770871.C_2014.029.dan

Den Europæiske Unions

Tidende

C 29

Dansk udgave

Meddelelser og oplysninger

57. årgang31. januar 2014

---

| Informationsnummer | Indhold | Side |
| --- | --- | --- |
| | IV   Oplysninger |
| | OPLYSNINGER FRA DEN EUROPÆISKE UNIONS INSTITUTIONER, ORGANER, KONTORER OG AGENTURER |
| | Europa-Kommissionen |
| 2014/C 029/01 | Oversigt over EU-afgørelser om tilladelse til markedsføring af lægemidler fra 1. december 2013 til 31. december 2013(Offentliggjort i henhold til artikel 13 eller artikel 38 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004) | 1 |
| 2014/C 029/02 | Oversigt over EU-afgørelser om tilladelse til markedsføring af lægemidler fra 1. december 2013 til 31. december 2013(Afgørelser truffet i henhold til artikel 34 i direktiv 2001/83/EF eller artikel 38 i direktiv 2001/82/EF) | 13 |

Informationsnummer

Indhold

Side

IV   Oplysninger

OPLYSNINGER FRA DEN EUROPÆISKE UNIONS INSTITUTIONER, ORGANER, KONTORER OG AGENTURER

Europa-Kommissionen

2014/C 029/01

Oversigt over EU-afgørelser om tilladelse til markedsføring af lægemidler fra 1. december 2013 til 31. december 2013(Offentliggjort i henhold til artikel 13 eller artikel 38 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004)

(Offentliggjort i henhold til artikel 13 eller artikel 38 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004)

1

2014/C 029/02

Oversigt over EU-afgørelser om tilladelse til markedsføring af lægemidler fra 1. december 2013 til 31. december 2013(Afgørelser truffet i henhold til artikel 34 i direktiv 2001/83/EF eller artikel 38 i direktiv 2001/82/EF)

(Afgørelser truffet i henhold til artikel 34 i direktiv 2001/83/EF eller artikel 38 i direktiv 2001/82/EF)

13

| DA | |
| --- | --- |

DA

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IV Oplysninger

OPLYSNINGER FRA DEN EUROPÆISKE UNIONS INSTITUTIONER, ORGANER, KONTORER OG AGENTURER

Europa-Kommissionen

| 31.1.2014 | DA | Den Europæiske Unions Tidende | C 29/1 |
| --- | --- | --- | --- |

31.1.2014

DA

Den Europæiske Unions Tidende

C 29/1

---

Oversigt over EU-afgørelser om tilladelse til markedsføring af lægemidler fra 1. december 2013 til 31. december 2013

(Offentliggjort i henhold til artikel 13 eller artikel 38 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004
   (1)
  )

2014/C 29/01

—   Udstedelse af markedsføringstilladelse (artikel 13 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004): Godkendt

| Dato for afgørelser | Lægemidlets navn | INN-navn (International Non-Proprietary Name) | Indehaver af markedsføringstilladelsen | Nummer i EF-registret | Lægemiddelform | ATC-kode (Anatomical Therapeutic Chemical Code) | Dato for notifikation |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 4.12.2013 | Fluenz Tetra | Influenza Virus Type A, H1N1 / Influenza Virus Type A, H3N2 / Influenza Virus Type B (Victoria lineage) / Influenza Virus, Type B (Yamagata lineage) | MedImmune, LLC |
| Lagelandseweg 78, |
| NL-6545 CG Nijmegen, |
| Nederland |

Dato for afgørelser

Lægemidlets navn

INN-navn (International Non-Proprietary Name)

Indehaver af markedsføringstilladelsen

Nummer i EF-registret

Lægemiddelform

ATC-kode (Anatomical Therapeutic Chemical Code)

Dato for notifikation

4.12.2013

Fluenz Tetra

Influenza Virus Type A, H1N1 / Influenza Virus Type A, H3N2 / Influenza Virus Type B (Victoria lineage) / Influenza Virus, Type B (Yamagata lineage)

MedImmune, LLC

Lagelandseweg 78,

NL-6545 CG Nijmegen,

Nederland

EU/1/13/887

Næsespray, suspension

J07BB03

6.12.2013

4.12.2013

Memantin Accord

memantin

| Accord Healthcare Limited |
| --- |
| Sage House, |
| 319 Pinner Road, North Harrow, |
| Middlesex, |
| HA1 4HF, |
| United Kingdom |

Accord Healthcare Limited

Sage House,

319 Pinner Road, North Harrow,

Middlesex,

HA1 4HF,

United Kingdom

EU/1/13/880

Filmovertrukket tablet

N06DX01

6.12.2013

18.12.2013

Brintellix

vortioxetin

| H. Lundbeck A/S |
| --- |
| Ottiliavej 9, |
| DK-2500 Valby, |
| Danmark |

H. Lundbeck A/S

Ottiliavej 9,

DK-2500 Valby,

Danmark

EU/1/13/891

Filmovertrukket tablet

Orale dråber, opløsning

N06AX26

20.12.2013

20.12.2013

Opsumit

macitentan

| Actelion Registration Ltd |
| --- |
| Cheswick Tower, 13th floor, |
| 389 Cheswick High Road, |
| London |
| W4 4AL, |
| United Kingdom |

Actelion Registration Ltd

Cheswick Tower, 13th floor,

389 Cheswick High Road,

London

W4 4AL,

United Kingdom

EU/1/13/893

Filmovertrukket tablet

C02KX04

27.12.2013

—   Ændring af markedsføringstilladelse (artikel 13 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004): Godkendt

| Dato for afgørelser | Lægemidlets navn | Indehaver af markedsføringstilladelsen | Nummer i EF-registret | Dato for notifikation |
| --- | --- | --- | --- | --- |
| 3.12.2013 | Abraxane | Celgene Europe Limited |
| 1 Longwalk Road, Stockley Park, |
| Uxbridge |
| UB11 1DB, |
| United Kingdom |

Dato for afgørelser

Lægemidlets navn

Indehaver af markedsføringstilladelsen

Nummer i EF-registret

Dato for notifikation

3.12.2013

Abraxane

Celgene Europe Limited

1 Longwalk Road, Stockley Park,

Uxbridge

UB11 1DB,

United Kingdom

EU/1/07/428

6.12.2013

3.12.2013

Bondronat

| Roche Registration Limited |
| --- |
| 6 Falcon Way, Shire Park, Welwyn Garden City, |
| AL7 1TW, |
| United Kingdom |

Roche Registration Limited

6 Falcon Way, Shire Park, Welwyn Garden City,

AL7 1TW,

United Kingdom

EU/1/96/012

6.12.2013

3.12.2013

Cubicin

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex |
| RH12 5AB, |
| United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex

RH12 5AB,

United Kingdom

EU/1/05/328

6.12.2013

3.12.2013

Dynastat

| Pfizer Limited |
| --- |
| Ramsgate Road, Sandwich, Kent |
| CT13 9NJ, |
| United Kingdom |

Pfizer Limited

Ramsgate Road, Sandwich, Kent

CT13 9NJ,

United Kingdom

EU/1/02/209

6.12.2013

3.12.2013

Orencia

| Bristol-Myers Squibb Pharma EEIG |
| --- |
| Uxbridge Business Park, Sanderson Road, Uxbridge |
| UB8 1DH, |
| United Kingdom |

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park, Sanderson Road, Uxbridge

UB8 1DH,

United Kingdom

EU/1/07/389

6.12.2013

3.12.2013

Rasilamlo

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex |
| RH12 5AB, |
| United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex

RH12 5AB,

United Kingdom

EU/1/11/686

6.12.2013

3.12.2013

Rasilez

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex |
| RH12 5AB, |
| United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex

RH12 5AB,

United Kingdom

EU/1/07/405

6.12.2013

3.12.2013

Rasilez HCT

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex |
| RH12 5AB, |
| United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex

RH12 5AB,

United Kingdom

EU/1/08/491

6.12.2013

3.12.2013

Xeplion

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

Janssen-Cilag International NV

Turnhoutseweg 30,

B-2340 Beerse,

België

EU/1/11/672

6.12.2013

3.12.2013

Zoledronsyre medac

| medac Gesellschaft für klinische Spezialpräparate mbH |
| --- |
| Theaterstr. 6, |
| D-22880 Wedel, |
| Deutschland |

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstr. 6,

D-22880 Wedel,

Deutschland

EU/1/12/779

6.12.2013

4.12.2013

Synagis

| AbbVie Ltd |
| --- |
| Maidenhead, |
| SL6 4XE, |
| United Kingdom |

AbbVie Ltd

Maidenhead,

SL6 4XE,

United Kingdom

EU/1/99/117

6.12.2013

4.12.2013

Tamiflu

| Roche Registration Limited |
| --- |
| 6 Falcon Way, Shire Park, Welwyn Garden City, |
| AL7 1TW, |
| United Kingdom |

Roche Registration Limited

6 Falcon Way, Shire Park, Welwyn Garden City,

AL7 1TW,

United Kingdom

EU/1/02/222

6.12.2013

9.12.2013

Sildenafil ratiopharm

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

ratiopharm GmbH

Graf-Arco-Straße 3,

D-89079 Ulm,

Deutschland

EU/1/09/603

11.12.2013

13.12.2013

Dificlir

| Astellas Pharma Europe B.V. |
| --- |
| Sylviusweg 62, |
| NL-2333 BE Leiden, |
| Nederland |

Astellas Pharma Europe B.V.

Sylviusweg 62,

NL-2333 BE Leiden,

Nederland

EU/1/11/733

16.12.2013

13.12.2013

Inovelon

| Eisai Limited |
| --- |
| European Knowledge Centre, Mosquito Way, Hatfield, Herts |
| AL10 9SN, |
| United Kingdom |

Eisai Limited

European Knowledge Centre, Mosquito Way, Hatfield, Herts

AL10 9SN,

United Kingdom

EU/1/06/378

17.12.2013

13.12.2013

Irbesartan / Hydrochlorthiazid Teva

| Teva Pharma B.V. |
| --- |
| Computerweg 10, |
| NL-3542 DR Utrecht, |
| Nederland |

Teva Pharma B.V.

Computerweg 10,

NL-3542 DR Utrecht,

Nederland

EU/1/09/583

18.12.2013

13.12.2013

JEVTANA

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

Sanofi-Aventis groupe

54 rue La Boétie,

F-75008 Paris,

France

EU/1/11/676

17.12.2013

13.12.2013

Mimpara

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

Amgen Europe B.V.

Minervum 7061,

NL-4817 ZK Breda,

Nederland

EU/1/04/292

17.12.2013

13.12.2013

Revatio

| Pfizer Limited |
| --- |
| Ramsgate Road, Sandwich, Kent |
| CT13 9NJ, |
| United Kingdom |

Pfizer Limited

Ramsgate Road, Sandwich, Kent

CT13 9NJ,

United Kingdom

EU/1/05/318

17.12.2013

13.12.2013

Temozolomide HEXAL

| Hexal AG |
| --- |
| Industriestrasse 25, |
| D-83607 Holzkirchen, |
| Deutschland |

Hexal AG

Industriestrasse 25,

D-83607 Holzkirchen,

Deutschland

EU/1/10/616

17.12.2013

13.12.2013

Tracleer

| Actelion Registration Ltd |
| --- |
| Cheswick Tower, 13th floor, 389 Cheswick High Road, |
| London |
| W4 4AL, |
| United Kingdom |

Actelion Registration Ltd

Cheswick Tower, 13th floor, 389 Cheswick High Road,

London

W4 4AL,

United Kingdom

EU/1/02/220

17.12.2013

17.12.2013

Benlysta

| Glaxo Group Ltd |
| --- |
| 980 Great West Road, Brentford, Middlesex, |
| TW8 9GS, |
| United Kingdom |

Glaxo Group Ltd

980 Great West Road, Brentford, Middlesex,

TW8 9GS,

United Kingdom

EU/1/11/700

19.12.2013

17.12.2013

Esbriet

| InterMune UK Limited |
| --- |
| Grove House, 2nd Floor, 248A Marylebone Road, |
| London |
| NW1 6JZ, |
| United Kingdom |

InterMune UK Limited

Grove House, 2nd Floor, 248A Marylebone Road,

London

NW1 6JZ,

United Kingdom

EU/1/11/667

19.12.2013

17.12.2013

Glybera

| uniQure biopharma B.V. |
| --- |
| Meibergdreef 61, |
| NL-1105 BA Amsterdam, |
| Nederland |

uniQure biopharma B.V.

Meibergdreef 61,

NL-1105 BA Amsterdam,

Nederland

EU/1/12/791

19.12.2013

17.12.2013

Isentress

| Merck Sharp & Dohme Limited |
| --- |
| Hertford Road, Hoddesdon, Hertfordshire |
| EN11 9BU, |
| United Kingdom |

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire

EN11 9BU,

United Kingdom

EU/1/07/436

19.12.2013

17.12.2013

Ovitrelle

| Merck Serono Europe Limited |
| --- |
| 56, Marsh Wall, |
| London |
| E14 9TP, |
| United Kingdom |

Merck Serono Europe Limited

56, Marsh Wall,

London

E14 9TP,

United Kingdom

EU/1/00/165

20.12.2013

18.12.2013

Actraphane

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

Novo Nordisk A/S

Novo Allé,

DK-2880 Bagsvaerd,

Danmark

EU/1/02/229

20.12.2013

18.12.2013

Actrapid

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

Novo Nordisk A/S

Novo Allé,

DK-2880 Bagsvaerd,

Danmark

EU/1/02/230

20.12.2013

18.12.2013

Aflunov

| Novartis Vaccines and Diagnostics S.r.l. |
| --- |
| Via Fiorentina, 1, |
| 53100 Siena, |
| Italia |

Novartis Vaccines and Diagnostics S.r.l.

Via Fiorentina, 1,

53100 Siena,

Italia

EU/1/10/658

20.12.2013

18.12.2013

Aldurazyme

| Genzyme Europe B.V. |
| --- |
| Gooimeer 10, |
| NL-1411 DD Naarden, |
| Nederland |

Genzyme Europe B.V.

Gooimeer 10,

NL-1411 DD Naarden,

Nederland

EU/1/03/253

23.12.2013

18.12.2013

APTIVUS

| Boehringer Ingelheim International GmbH |
| --- |
| Binger Straße 173, |
| D-55216 Ingelheim am Rhein, |
| Deutschland |

Boehringer Ingelheim International GmbH

Binger Straße 173,

D-55216 Ingelheim am Rhein,

Deutschland

EU/1/05/315

2.1.2014

18.12.2013

Bonviva

| Roche Registration Limited |
| --- |
| 6 Falcon Way, Shire Park, Welwyn Garden City, |
| AL7 1TW, |
| United Kingdom |

Roche Registration Limited

6 Falcon Way, Shire Park, Welwyn Garden City,

AL7 1TW,

United Kingdom

EU/1/03/265

20.12.2013

18.12.2013

Bronchitol

| Pharmaxis Pharmaceuticals Limited |
| --- |
| The Priory, Stomp Road, Burnham, Buckinghamshire |
| SL1 7LW, |
| United Kingdom |

Pharmaxis Pharmaceuticals Limited

The Priory, Stomp Road, Burnham, Buckinghamshire

SL1 7LW,

United Kingdom

EU/1/12/760

23.12.2013

18.12.2013

Buccolam

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

ViroPharma SPRL-BVBA rue Montoyer 47,

1000 Bruxelles, Belgique / Montoyerstraat 47,

1000 Brussel,

België

EU/1/11/709

19.12.2013

18.12.2013

Cervarix

| 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/1/07/419

23.12.2013

18.12.2013

Corlentor

| Les Laboratoires Servier |
| --- |
| 50 rue Carnot, |
| F-92284 Suresnes CEDEX, |
| France |

Les Laboratoires Servier

50 rue Carnot,

F-92284 Suresnes CEDEX,

France

EU/1/05/317

23.12.2013

18.12.2013

Dexdor

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

Orion Corporation

Orionintie 1,

FI-02200

Espoo,

Suomi

EU/1/11/718

23.12.2013

18.12.2013

Efient

| Eli Lilly Nederland B.V. |
| --- |
| Grootslag 1-5, |
| NL-3991 RA Houten, |
| Nederland |

Eli Lilly Nederland B.V.

Grootslag 1-5,

NL-3991 RA Houten,

Nederland

EU/1/08/503

23.12.2013

18.12.2013

Emend

| Merck Sharp & Dohme Limited |
| --- |
| Hertford Road, Hoddesdon, Hertfordshire |
| EN11 9BU, |
| United Kingdom |

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire

EN11 9BU,

United Kingdom

EU/1/03/262

20.12.2013

18.12.2013

Eporatio

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

ratiopharm GmbH

Graf-Arco-Straße 3,

D-89079 Ulm,

Deutschland

EU/1/09/573

20.12.2013

18.12.2013

Erbitux

| Merck KGaA |
| --- |
| 64271 Darmstadt |

Merck KGaA

64271 Darmstadt

EU/1/04/281

23.12.2013

18.12.2013

Esmya

| Gedeon Richter Plc. |
| --- |
| Gyömrői út 19-21., |
| H-1103 Budapest, |
| Magyarország |

Gedeon Richter Plc.

Gyömrői út 19-21.,

H-1103 Budapest,

Magyarország

EU/1/12/750

23.12.2013

18.12.2013

Extavia

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex |
| RH12 5AB, |
| United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex

RH12 5AB,

United Kingdom

EU/1/08/454

20.12.2013

18.12.2013

Faslodex

| AstraZeneca UK Limited |
| --- |
| Alderley Park, Macclesfield, Cheshire, |
| SK10 4TG |
| United Kingdom |

AstraZeneca UK Limited

Alderley Park, Macclesfield, Cheshire,

SK10 4TG

United Kingdom

EU/1/03/269

23.12.2013

18.12.2013

GILENYA

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex |
| RH12 5AB, |
| United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex

RH12 5AB,

United Kingdom

EU/1/11/677

23.12.2013

18.12.2013

Herceptin

| Roche Registration Limited |
| --- |
| 6 Falcon Way, Shire Park, Welwyn Garden City, |
| AL7 1TW, |
| United Kingdom |

Roche Registration Limited

6 Falcon Way, Shire Park, Welwyn Garden City,

AL7 1TW,

United Kingdom

EU/1/00/145

23.12.2013

18.12.2013

Hizentra

| CSL Behring GmbH |
| --- |
| Emil-von-Behring-Straße 76, |
| D-35041 |
| Marburg, |
| Deutschland |

CSL Behring GmbH

Emil-von-Behring-Straße 76,

D-35041

Marburg,

Deutschland

EU/1/11/687

23.12.2013

18.12.2013

Incivo

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

Janssen-Cilag International NV

Turnhoutseweg 30,

B-2340 Beerse,

België

EU/1/11/720

20.12.2013

18.12.2013

Kaletra

| AbbVie Ltd |
| --- |
| Maidenhead, |
| SL6 4XE, |
| United Kingdom |

AbbVie Ltd

Maidenhead,

SL6 4XE,

United Kingdom

EU/1/01/172

23.12.2013

18.12.2013

Levetiracetam SUN

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

Sun Pharmaceutical Industries Europe BV

Polarisavenue 87,

NL-2132 JH

Hoofddorp,

Nederland

EU/1/11/741

23.12.2013

18.12.2013

Lojuxta

| Aegerion Pharmaceuticals Limited |
| --- |
| Lakeside House, 1 Furzeground Way, Stockley Park East, Uxbridge |
| UB11 1BD, |
| United Kingdom |

Aegerion Pharmaceuticals Limited

Lakeside House, 1 Furzeground Way, Stockley Park East, Uxbridge

UB11 1BD,

United Kingdom

EU/1/13/851

23.12.2013

18.12.2013

Luveris

| Merck Serono Europe Limited |
| --- |
| 56, Marsh Wall, |
| London |
| E14 9TP, |
| United Kingdom |

Merck Serono Europe Limited

56, Marsh Wall,

London

E14 9TP,

United Kingdom

EU/1/00/155

23.12.2013

18.12.2013

Mepact

| Takeda France SAS |
| --- |
| Immeuble Pacific, |
| 11-13 cours Valmy, |
| 92800 Puteaux, |
| France |

Takeda France SAS

Immeuble Pacific,

11-13 cours Valmy,

92800 Puteaux,

France

EU/1/08/502

23.12.2013

18.12.2013

Myozyme

| Genzyme Europe B.V. |
| --- |
| Gooimeer 10, |
| NL-1411 DD Naarden, |
| Nederland |

Genzyme Europe B.V.

Gooimeer 10,

NL-1411 DD Naarden,

Nederland

EU/1/06/333

23.12.2013

18.12.2013

Nivestim

| Hospira UK Limited |
| --- |
| Queensway, Royal Leamington Spa, Warwickshire |
| CV31 3RW, |
| United Kingdom |

Hospira UK Limited

Queensway, Royal Leamington Spa, Warwickshire

CV31 3RW,

United Kingdom

EU/1/10/631

20.12.2013

18.12.2013

Norvir

| AbbVie Ltd |
| --- |
| Maidenhead, |
| SL6 4XE, |
| United Kingdom |

AbbVie Ltd

Maidenhead,

SL6 4XE,

United Kingdom

EU/1/96/016

20.12.2013

18.12.2013

NovoSeven

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

Novo Nordisk A/S

Novo Allé,

DK-2880 Bagsvaerd,

Danmark

EU/1/96/006

23.12.2013

18.12.2013

Pradaxa

| Boehringer Ingelheim International GmbH |
| --- |
| Binger Straße 173, |
| D-55216 Ingelheim am Rhein, |
| Deutschland |

Boehringer Ingelheim International GmbH

Binger Straße 173,

D-55216 Ingelheim am Rhein,

Deutschland

EU/1/08/442

2.1.2014

18.12.2013

Procoralan

| Les Laboratoires Servier |
| --- |
| 50 rue Carnot, |
| F-92284 Suresnes CEDEX, |
| France |

Les Laboratoires Servier

50 rue Carnot,

F-92284 Suresnes CEDEX,

France

EU/1/05/316

23.12.2013

18.12.2013

ProQuad

| Sanofi Pasteur MSD, SNC |
| --- |
| 8 rue Jonas Salk, |
| F-69007 Lyon, |
| France |

Sanofi Pasteur MSD, SNC

8 rue Jonas Salk,

F-69007 Lyon,

France

EU/1/05/323

20.12.2013

18.12.2013

Protopic

| Astellas Pharma Europe B.V. |
| --- |
| Sylviusweg 62, |
| NL-2333 BE Leiden, |
| Nederland |

Astellas Pharma Europe B.V.

Sylviusweg 62,

NL-2333 BE Leiden,

Nederland

EU/1/02/201

23.12.2013

18.12.2013

Removab

| Fresenius Biotech GmbH |
| --- |
| Am Haag 6-7, |
| D-82166 Graefelfing, |
| Deutschland |

Fresenius Biotech GmbH

Am Haag 6-7,

D-82166 Graefelfing,

Deutschland

EU/1/09/512

20.12.2013

18.12.2013

Repaglinide Teva

| Teva Pharma B.V. |
| --- |
| Computerweg 10, |
| NL-3542 DR Utrecht, |
| Nederland |

Teva Pharma B.V.

Computerweg 10,

NL-3542 DR Utrecht,

Nederland

EU/1/09/530

24.12.2013

18.12.2013

Ribavirin Mylan

| Generics [UK] Limited |
| --- |
| Station Close, Potters Bar, Hertfordshire, |
| EN6 1TL, |
| United Kingdom |

Generics [UK] Limited

Station Close, Potters Bar, Hertfordshire,

EN6 1TL,

United Kingdom

EU/1/10/634

20.12.2013

18.12.2013

Soliris

| Alexion Europe SAS |
| --- |
| 25 boulevard de l'Amiral Bruix, |
| F-75016 Paris, |
| France |

Alexion Europe SAS

25 boulevard de l'Amiral Bruix,

F-75016 Paris,

France

EU/1/07/393

23.12.2013

18.12.2013

Temodal

| Merck Sharp & Dohme Limited |
| --- |
| Hertford Road, Hoddesdon, Hertfordshire |
| EN11 9BU, |
| United Kingdom |

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire

EN11 9BU,

United Kingdom

EU/1/98/096

23.12.2013

18.12.2013

VELCADE

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

Janssen-Cilag International NV

Turnhoutseweg 30,

B-2340 Beerse,

België

EU/1/04/274

23.12.2013

18.12.2013

Xeloda

| Roche Registration Limited |
| --- |
| 6 Falcon Way, Shire Park, Welwyn Garden City, |
| AL7 1TW, |
| United Kingdom |

Roche Registration Limited

6 Falcon Way, Shire Park, Welwyn Garden City,

AL7 1TW,

United Kingdom

EU/1/00/163

23.12.2013

18.12.2013

Xgeva

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

Amgen Europe B.V.

Minervum 7061,

NL-4817 ZK Breda,

Nederland

EU/1/11/703

23.12.2013

18.12.2013

Yervoy

| Bristol-Myers Squibb Pharma EEIG |
| --- |
| Uxbridge Business Park, Sanderson Road, Uxbridge |
| UB8 1DH, |
| United Kingdom |

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park, Sanderson Road, Uxbridge

UB8 1DH,

United Kingdom

EU/1/11/698

23.12.2013

18.12.2013

Yondelis

| Pharma Mar S.A. |
| --- |
| Polígono Industrial La Mina, |
| Avda de los Reyes 1, |
| E-28770 Colmenar Viejo, Madrid, |
| España |

Pharma Mar S.A.

Polígono Industrial La Mina,

Avda de los Reyes 1,

E-28770 Colmenar Viejo, Madrid,

España

EU/1/07/417

23.12.2013

18.12.2013

Zelboraf

| Roche Registration Limited |
| --- |
| 6 Falcon Way, Shire Park, Welwyn Garden City, |
| AL7 1TW, |
| United Kingdom |

Roche Registration Limited

6 Falcon Way, Shire Park, Welwyn Garden City,

AL7 1TW,

United Kingdom

EU/1/12/751

23.12.2013

20.12.2013

Abraxane

| Celgene Europe Limited |
| --- |
| 1 Longwalk Road, Stockley Park, Uxbridge |
| UB11 1DB, |
| United Kingdom |

Celgene Europe Limited

1 Longwalk Road, Stockley Park, Uxbridge

UB11 1DB,

United Kingdom

EU/1/07/428

30.12.2013

20.12.2013

Advate

| Baxter AG |
| --- |
| Industriestraße 67, |
| A-1221 Wien, |
| Österreich |

Baxter AG

Industriestraße 67,

A-1221 Wien,

Österreich

EU/1/03/271

6.01.2014

20.12.2013

Atriance

| Glaxo Group Ltd |
| --- |
| 980 Great West Road, Brentford, Middlesex, |
| TW8 9GS, |
| United Kingdom |

Glaxo Group Ltd

980 Great West Road, Brentford, Middlesex,

TW8 9GS,

United Kingdom

EU/1/07/403

2.1.2014

20.12.2013

Caprelsa

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

AstraZeneca AB

SE-151 85 Södertälje,

Sverige

EU/1/11/749

27.12.2013

20.12.2013

Comtan

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex |
| RH12 5AB, |
| United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex

RH12 5AB,

United Kingdom

EU/1/98/081

2.1.2014

20.12.2013

ellaOne

| Laboratoire HRA Pharma |
| --- |
| 15 rue Béranger, |
| F-75003 Paris, |
| France |

Laboratoire HRA Pharma

15 rue Béranger,

F-75003 Paris,

France

EU/1/09/522

24.12.2013

20.12.2013

Iclusig

| ARIAD Pharma Ltd |
| --- |
| Brooklands Business Park, Wellington Way, Weybridge, |
| KT13 0TT, |
| United Kingdom |

ARIAD Pharma Ltd

Brooklands Business Park, Wellington Way, Weybridge,

KT13 0TT,

United Kingdom

EU/1/13/839

27.12.2013

20.12.2013

Ivemend

| Merck Sharp & Dohme Limited |
| --- |
| Hertford Road, Hoddesdon, Hertfordshire |
| EN11 9BU, |
| United Kingdom |

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire

EN11 9BU,

United Kingdom

EU/1/07/437

2.1.2014

20.12.2013

Lantus

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

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main,

Deutschland

EU/1/00/134

27.12.2013

20.12.2013

Lumigan

| Allergan Pharmaceuticals Ireland |
| --- |
| Castlebar Road, Westport, County Mayo, |
| Ireland |

Allergan Pharmaceuticals Ireland

Castlebar Road, Westport, County Mayo,

Ireland

EU/1/02/205

2.1.2014

20.12.2013

Mixtard

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

Novo Nordisk A/S

Novo Allé,

DK-2880 Bagsvaerd,

Danmark

EU/1/02/231

27.12.2013

20.12.2013

Nplate

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

Amgen Europe B.V.

Minervum 7061,

NL-4817 ZK Breda,

Nederland

EU/1/08/497

24.12.2013

20.12.2013

Optisulin

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

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main,

Deutschland

EU/1/00/133

27.12.2013

20.12.2013

Pioglitazone Accord

| Accord Healthcare Limited |
| --- |
| Sage House, 319 Pinner Road, North Harrow, Middlesex, |
| HA1 4HF, |
| United Kingdom |

Accord Healthcare Limited

Sage House, 319 Pinner Road, North Harrow, Middlesex,

HA1 4HF,

United Kingdom

EU/1/11/722

24.12.2013

20.12.2013

Prolia

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

Amgen Europe B.V.

Minervum 7061,

NL-4817 ZK Breda,

Nederland

EU/1/10/618

24.12.2013

20.12.2013

Sabervel

| Pharmathen S.A. |
| --- |
| 6 Dervenakion, |
| 15351 Pallini Attiki, |
| Ελλάδα |

Pharmathen S.A.

6 Dervenakion,

15351 Pallini Attiki,

Ελλάδα

EU/1/12/765

24.12.2013

20.12.2013

Tasigna

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex |
| RH12 5AB, |
| United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex

RH12 5AB,

United Kingdom

EU/1/07/422

2.1.2014

20.12.2013

Vizarsin

| 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/1/09/551

24.12.2013

20.12.2013

VPRIV

| Shire Pharmaceuticals Ireland Limited |
| --- |
| 5 River Walk, Citywest Business Campus, Dublin 24, |
| Ireland |

Shire Pharmaceuticals Ireland Limited

5 River Walk, Citywest Business Campus, Dublin 24,

Ireland

EU/1/10/646

24.12.2013

20.12.2013

Xaluprine

| Nova Laboratories Limited |
| --- |
| Martin House, Gloucester Crescent, Wigston Leicester, |
| LE18 4YL, |
| United Kingdom |

Nova Laboratories Limited

Martin House, Gloucester Crescent, Wigston Leicester,

LE18 4YL,

United Kingdom

EU/1/11/727

24.12.2013

—   Udstedelse af markedsføringstilladelse (artikel 38 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004
   (2)
  ): Godkendt

| Dato for afgørelser | Lægemidlets navn | INN-navn (International Non-Proprietary Name) | Indehaver af markedsføringstilladelsen | Nummer i EF-registret | Lægemiddelform | ATC-kode (Anatomical Therapeutic Chemical Code) | Dato for notifikation |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 4.12.2013 | BROADLINE | Fipronil/ S-methopren/ Eprinomectin/ Praziquantel | Merial |
| 29 avenue Tony Garnier, |
| F-69007 Lyon, |
| France |

Dato for afgørelser

Lægemidlets navn

INN-navn (International Non-Proprietary Name)

Indehaver af markedsføringstilladelsen

Nummer i EF-registret

Lægemiddelform

ATC-kode (Anatomical Therapeutic Chemical Code)

Dato for notifikation

4.12.2013

BROADLINE

Fipronil/ S-methopren/ Eprinomectin/ Praziquantel

Merial

29 avenue Tony Garnier,

F-69007 Lyon,

France

EU/2/13/157

Spot-on, opløsning

QP54AA54

6.12.2013

4.12.2013

Vectra 3D

dinotefuran, pyriproxyfen, permethrin

| CEVA SANTE ANIMALE |
| --- |
| 10 avenue de la Ballastière, |
| F-33500 Libourne, |
| France |

CEVA SANTE ANIMALE

10 avenue de la Ballastière,

F-33500 Libourne,

France

EU/2/13/156

Spot-on, opløsning

QP53AC54

6.12.2013

—   Ændring af markedsføringstilladelse (artikel 38 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004): Godkendt

| Dato for afgørelser | Lægemidlets navn | Indehaver af markedsføringstilladelsen | Nummer i EF-registret | Dato for notifikation |
| --- | --- | --- | --- | --- |
| 3.12.2013 | Emdocam | Emdoka bvba |
| J. Lijsenstraat 16, |
| B-2321 Hoogstraten, |
| België |

Dato for afgørelser

Lægemidlets navn

Indehaver af markedsføringstilladelsen

Nummer i EF-registret

Dato for notifikation

3.12.2013

Emdocam

Emdoka bvba

J. Lijsenstraat 16,

B-2321 Hoogstraten,

België

EU/2/11/128

6.12.2013

3.12.2013

Meloxidolor

| Le Vet Beheer B.V. |
| --- |
| Wilgenweg 7, |
| NL-3421 TV Oudewater, |
| Nederland |

Le Vet Beheer B.V.

Wilgenweg 7,

NL-3421 TV Oudewater,

Nederland

EU/2/13/148

6.12.2013

4.12.2013

Aivlosin

| ECO Animal Health Ltd |
| --- |
| 78 Coombe Road, New Malden, Surrey |
| KT3 4QS |
| United Kingdom |

ECO Animal Health Ltd

78 Coombe Road, New Malden, Surrey

KT3 4QS

United Kingdom

EU/2/04/044

6.12.2013

9.12.2013

Acticam

| Ecuphar NV |
| --- |
| Legeweg 157-I, |
| B-8020 Oostkamp, |
| België |

Ecuphar NV

Legeweg 157-I,

B-8020 Oostkamp,

België

EU/2/08/088

11.12.2013

13.12.2013

Porcilis PCV

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35, |
| NL-5831 AN Boxmeer, |
| Nederland |

Intervet International B.V.

Wim de Körverstraat 35,

NL-5831 AN Boxmeer,

Nederland

EU/2/08/091

17.12.2013

13.12.2013

Prac-Tic

| Novartis Sanidad Animal S.L. |
| --- |
| Calle de la Marina, 206, |
| E-08013 Barcelona, |
| España |

Novartis Sanidad Animal S.L.

Calle de la Marina, 206,

E-08013 Barcelona,

España

EU/2/06/066

17.12.2013

18.12.2013

Meloxidyl

| CEVA SANTE ANIMALE |
| --- |
| 10 avenue de la Ballastière, |
| F-33500 Libourne, |
| France |

CEVA SANTE ANIMALE

10 avenue de la Ballastière,

F-33500 Libourne,

France

EU/2/06/070

20.12.2013

Alle interesserede kan ved henvendelse på nedenstående adresse få tilsendt den offentlige evalueringsrapport om de pågældende lægemidler og de afgørelser, der er truffet vedrørende disse:

| The European Medicines Agency |
| --- |
| 7, Westferry Circus, |
| Canary Wharf |
| UK-LONDON E14 4H |

The European Medicines Agency

7, Westferry Circus,

Canary Wharf

UK-LONDON E14 4H

---

(1)  EUT L 136 af 30.4.2004, s. 1.

(2)  EUT L 136, 30.4.2004, p. 1.

---

| 31.1.2014 | DA | Den Europæiske Unions Tidende | C 29/13 |
| --- | --- | --- | --- |

31.1.2014

DA

Den Europæiske Unions Tidende

C 29/13

---

Oversigt over EU-afgørelser om tilladelse til markedsføring af lægemidler fra 1. december 2013 til 31. december 2013

(Afgørelser truffet i henhold til artikel 34 i direktiv 2001/83/EF
   (1)
  eller artikel 38 i direktiv 2001/82/EF
   (2)
  )

2014/C 29/02

—   Udstedelse, videreførsel eller ændring af en national markedsføringstilladelse

| Dato for afgørelser | Lægemidlets navn/navne | Indehaver/indehavere af markedsføringstilladelsen | Medlemsstat | Dato for notifikation |
| --- | --- | --- | --- | --- |
| 20.12.2013 | Nicardipine | Se bilaget I | Se bilaget I | 6.1.2014 |
| 19.12.2013 | Hydroxyethyl starch | Se bilaget II | Se bilaget II | 20.12.2013 |
| 20.12.2013 | Metoclopramide only containing products | Se bilaget III | Se bilaget III | 6.1.2014 |
| 18.12.2013 | Ergot derivatives - (dihydroergotoxine) | Se bilaget IV | Se bilaget IV | 20.12.2013 |

Dato for afgørelser

Lægemidlets navn/navne

Indehaver/indehavere af markedsføringstilladelsen

Medlemsstat

Dato for notifikation

20.12.2013

Nicardipine

Se bilaget I

Se bilaget I

6.1.2014

19.12.2013

Hydroxyethyl starch

Se bilaget II

Se bilaget II

20.12.2013

20.12.2013

Metoclopramide only containing products

Se bilaget III

Se bilaget III

6.1.2014

18.12.2013

Ergot derivatives - (dihydroergotoxine)

Se bilaget IV

Se bilaget IV

20.12.2013

—   Suspension af en national markedsføringstilladelse

| Dato for afgørelser | Lægemidlets navn/navne | Indehaver/indehavere af markedsføringstilladelsen | Medlemsstat | Dato for notifikation |
| --- | --- | --- | --- | --- |
| 18.12.2013 | Ergot derivatives - (dihydroergotoxine) | Se bilaget IV | Se bilaget IV | 20.12.2013 |

Dato for afgørelser

Lægemidlets navn/navne

Indehaver/indehavere af markedsføringstilladelsen

Medlemsstat

Dato for notifikation

18.12.2013

Ergot derivatives - (dihydroergotoxine)

Se bilaget IV

Se bilaget IV

20.12.2013

---

(1)  EUT L 311 af 28.11.2001, s. 67.

(2)  EUT L 311 af 28.11.2001, s. 1.

---

BILAG I

LISTE OVER LÆGEMIDLETS NAVNE, LÆGEMIDDELFORMER, STYRKER, INDGIVELSESVEJ SAMT INDEHAVERE AF MARKEDSFØRINGSTILLADELSE I MEDLEMSSTATERNE

| Medlemsstat
  EU/EAA | Ansøger | Indehaver af markedsføringstilladelse | INN | Navn | Styrke | Lægemiddelform | Indgivelsesvej |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Belgien | | Astellas Pharma BV, Erasmus Park, |
| Square Marie Curie 50, Building 5, 1st floor |
| 1070 Brussels |
| Belgium |

Medlemsstat

EU/EAA

Ansøger

Indehaver af markedsføringstilladelse

INN

Navn

Styrke

Lægemiddelform

Indgivelsesvej

Belgien

Astellas Pharma BV, Erasmus Park,

Square Marie Curie 50, Building 5, 1st floor

1070 Brussels

Belgium

Nicardipin hydrochlorid

Rydene

1 mg/ml

Injektionsvæske, opløsning

Intravenøs anvendelse

Belgien

| Magenta Pharma Consulting |
| --- |
| Ericapark 38 |
| 2403 EG Alphen aan den Rijn |
| The Netherlands |

Magenta Pharma Consulting

Ericapark 38

2403 EG Alphen aan den Rijn

The Netherlands

Nicardipin hydrochlorid

Nicardipine Aguettant

10 mg/10 ml

Injektionsvæske, opløsning

Intravenøs anvendelse

Frankrig

| NOVARTIS PHARMA SAS |
| --- |
| 2-4, rue Lionel Terray |
| 92500 Rueil-Malmaison |
| FRANCE |

NOVARTIS PHARMA SAS

2-4, rue Lionel Terray

92500 Rueil-Malmaison

FRANCE

Nicardipin (hydrochlorid)

LOXEN 10 mg/10 ml, solution injectable (I.V.)

10 mg/10 ml

Injektionsvæske, opløsning

Intravenøs anvendelse

Frankrig

| LABORATOIRE AGUETTANT |
| --- |
| 1, rue Alexander Fleming |
| 69007 Lyon |
| FRANCE |

LABORATOIRE AGUETTANT

1, rue Alexander Fleming

69007 Lyon

FRANCE

nicardipin (hydrochlorid)

NICARDIPINE AGUETTANT 10 mg/10 ml, solution injectable

10 mg/10 ml

Injektionsvæske, opløsning

Intravenøs anvendelse

Frankrig

| ARROW GENERIQUES |
| --- |
| 26, avenue Tony Garnier |
| 69007 Lyon |
| FRANCE |

ARROW GENERIQUES

26, avenue Tony Garnier

69007 Lyon

FRANCE

nicardipin (hydrochlorid)

NICARDIPINE ARROW 10 mg/10 ml, solution injectable

10 mg/10 ml

Injektionsvæske, opløsning

Intravenøs anvendelse

Luxembourg

| ASTELLAS PHARMA |
| --- |
| Square Marie Curie 50 1 |
| Building 5 |
| 1070 Brussels |
| Belgium |

ASTELLAS PHARMA

Square Marie Curie 50 1

Building 5

1070 Brussels

Belgium

Nicardipin

Rydene

1 mg/ml (5 ml)

Injektionsvæske, opløsning

Intravenøs anvendelse

Spanien

| ASTELLAS PHARMA, S.A. |
| --- |
| Paseo del Club Deportivo, 1 |
| bloque 14 |
| 28223 Pozuelo de Alarcón |
| (Madrid) |

ASTELLAS PHARMA, S.A.

Paseo del Club Deportivo, 1

bloque 14

28223 Pozuelo de Alarcón

(Madrid)

Nicardipin hydrochlorid

VASONASE 1 mg/ml solución para perfusión

1 mg/ml

Injektionsvæske, opløsning

Intravenøs anvendelse

Holland

| Astellas Pharma B.V. |
| --- |
| Sylviusweg 62 |
| 2333 BE Leiden |
| The Netherlands |

Astellas Pharma B.V.

Sylviusweg 62

2333 BE Leiden

The Netherlands

nicardipin

Cardene IV

5 mg/5 ml

Koncentrat till infusionsvæske, opløsning

Intravenøs anvendelse

England

| Mercury Pharmaceuticals Limited |
| --- |
| No. 1 Croydon, |
| 12-16 Addiscombe Road, |
| Croydon, Surrey |
| CR0 0XT, |
| United Kingdom |

Mercury Pharmaceuticals Limited

No. 1 Croydon,

12-16 Addiscombe Road,

Croydon, Surrey

CR0 0XT,

United Kingdom

Nicardipin hydrochlorid

Nicardipine 10 mg/10 ml solution for injection

1 mg/1 ml

Injektionsvæske, opløsning

Intravenøs anvendelse

---

BILAG II

FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORMER, STYRKER, ADMINISTRATIONSVEJE, INDEHAVERE AF MARKEDSFØRINGSTILLADELSER I MEDLEMSSTATERNE

| Medlemsstat
  EU/EAA | Indehaver af markedsføringstilladelse | INN | Særnavn Navn | Styrke | Lægemiddelform | Administrationsvej |
| --- | --- | --- | --- | --- | --- | --- |
| Østrig | Fresenius Kabi Austria GmbH |
| Hafnerstraße 36 |
| 8055 Graz |
| Austria |

Medlemsstat

EU/EAA

Indehaver af markedsføringstilladelse

INN

Særnavn Navn

Styrke

Lægemiddelform

Administrationsvej

Østrig

Fresenius Kabi Austria GmbH

Hafnerstraße 36

8055 Graz

Austria

Hydroxyethylstivelse, natriumchlorid

HAES-steril »Fresenius« (HES 200/0,5) 6 % - Infusionsloesung

60 g/l, 9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Østrig

| Fresenius Kabi Austria GmbH |
| --- |
| Hafnerstraße 36 |
| 8055 Graz |
| Austria |

Fresenius Kabi Austria GmbH

Hafnerstraße 36

8055 Graz

Austria

Hydroxyethylstivelse, natriumchlorid

HyperHAES 6 % in 7,2 % NaCl – Infusionsloesung

60 g/l, 72 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Østrig

| Baxter Healthcare GmbH |
| --- |
| Stella-Klein-Loew-Weg 15 |
| 1020 Vienna |
| Austria |

Baxter Healthcare GmbH

Stella-Klein-Loew-Weg 15

1020 Vienna

Austria

Hydroxyethylstivelse, natriumchlorid, kaliumchlorid, calciumchloriddihydrat, magnesiumchloridhexahydrat, natriumacetattrihydrat

PlasmaHES Redibag – Infusionsloesung

60 g/l, 6 g/l, 0,4 g/l, 0,134 g/l, 0,200 g/l, 3,70 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Østrig

| Fresenius Kabi Austria GmbH |
| --- |
| Hafnerstraße 36 |
| 055 Graz |
| Austria |

Fresenius Kabi Austria GmbH

Hafnerstraße 36

055 Graz

Austria

Hydroxyethylstivelse, natriumchlorid

Refortan 6 % Infusionsflasche

60 g/l, 9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Østrig

| Fresenius Kabi Austria GmbH |
| --- |
| Hafnerstraße 36 |
| 8055 Graz |
| Austria |

Fresenius Kabi Austria GmbH

Hafnerstraße 36

8055 Graz

Austria

Hydroxyethylstivelse, natriumchlorid

Refortan plus 10 % Infusionsflasche

100 g/l, 9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Østrig

| Fresenius Kabi Austria GmbH |
| --- |
| Hafnerstraße 36 |
| 8055 Graz |
| Austria |

Fresenius Kabi Austria GmbH

Hafnerstraße 36

8055 Graz

Austria

Hydroxyethylstivelse, natriumchlorid

Stabisol 6 % Infusionsflasche

60 g/l, 9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Østrig

| B. Braun Melsungen AG |
| --- |
| Carl-Braun-Strasse 1 |
| 34212 Melsungen |
| Germany |

B. Braun Melsungen AG

Carl-Braun-Strasse 1

34212 Melsungen

Germany

Hydroxyethylstivelse, natriumchlorid, kaliumchlorid, calciumchloriddihydrat, magnesiumchloridhexahydrat, natriumacetattrihydrat, æblesyre

Tetraspan 100 mg/ml Infusionsloesung

100,0 g/l, 6,25 g/l, 0,30 g/l, 0,37 g/l, 0,20 g/l, 3,27 g/l, 0,67 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Østrig

| B. Braun Melsungen AG |
| --- |
| Carl-Braun-Strasse 1 |
| 34212 Melsungen |
| Germany |

B. Braun Melsungen AG

Carl-Braun-Strasse 1

34212 Melsungen

Germany

Hydroxyethylstivelse, natriumchlorid, kaliumchlorid, calciumchloriddihydrat, magnesiumchloridhexahydrat, natriumacetattrihydrat, æblesyre

Tetraspan 60 mg/ml Infusionsloesung

60,0 g/l, 6,25 g/l, 0,30 g/l, 0,37 g/l, 0,20 g/l, 3,27 g/l, 0,67 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Østrig

| B. Braun Melsungen AG |
| --- |
| Carl-Braun-Strasse 1 |
| 34212 Melsungen |
| Germany |

B. Braun Melsungen AG

Carl-Braun-Strasse 1

34212 Melsungen

Germany

Hydroxyethylstivelse, natriumchlorid

VENOFUNDIN 60 mg/ml Infusionsloesung

60 g/l, 9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Østrig

| Fresenius Kabi Austria GmbH |
| --- |
| Hafnerstraße 36 |
| 8055 Graz |
| Austria |

Fresenius Kabi Austria GmbH

Hafnerstraße 36

8055 Graz

Austria

Hydroxyethylstivelse, natriumacetattrihydrat, natriumchlorid, kaliumchlorid, magnesiumchloridhexahydrat

Volulyte 6 % Infusionsloesung

60,00 g/l, 4,63 g/l, 6,02 g/l, 0,30 g/l, 0,30 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Østrig

| Fresenius Kabi Austria GmbH |
| --- |
| Hafnerstraße 36 |
| 8055 Graz |
| Austria |

Fresenius Kabi Austria GmbH

Hafnerstraße 36

8055 Graz

Austria

Hydroxyethylstivelse, natriumchlorid

Voluven (HES 130/0,4) 6 % - Infusionsloesung

60 g/l, 9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Belgien

| Fresenius Kabi NV |
| --- |
| Molenberglei 7 |
| 2627 Schelle |
| Belgium |

Fresenius Kabi NV

Molenberglei 7

2627 Schelle

Belgium

Hydroxyethylstivelse

Haes-Steril 10 %

100 mg/ml

infusionsvæske, opløsning

intravenøs anvendelse

Belgien

| Fresenius Kabi NV |
| --- |
| Molenberglei 7 |
| 2627 Schelle |
| Belgium |

Fresenius Kabi NV

Molenberglei 7

2627 Schelle

Belgium

Hydroxyethylstivelse

Haes-Steril 6 %

60 mg/ml

infusionsvæske, opløsning

intravenøs anvendelse

Belgien

| Baxter SA |
| --- |
| Bd Rene Branquart, 80 |
| 7860 Lessines |
| Belgium |

Baxter SA

Bd Rene Branquart, 80

7860 Lessines

Belgium

Natriumacetat (trihydrat), kaliumchlorid, magnesiumchloridhexahydrat, natriumchlorid, calciumchlorid (dihydrat), hydroxyethylstivelse

Plasmavolume Redibag 6 %

3,70 mg/ml, 0,40 mg/ml, 0,20 mg/ml, 6 mg/ml, 0,13 mg/ml, 60 mg/ml

infusionsvæske, opløsning

intravenøs anvendelse

Belgien

| B. Braun Melsungen AG |
| --- |
| Carl-Braun-Strasse 1 |
| 34212 Melsugen |
| Germany |

B. Braun Melsungen AG

Carl-Braun-Strasse 1

34212 Melsugen

Germany

Natriumacetat (trihydrat), kaliumchlorid, magnesiumchloridhexahydrat, natriumchlorid, calciumchlorid (dihydrat), Hydroxyethylstivelse, æblesyre

Tetraspan 10 %

3,27 mg/ml, 0,30 mg/ml, 0,20 mg/ml, 6,25 mg/ml, 0,37 mg/ml, 100 mg/ml, 0,67 mg/ml

infusionsvæske, opløsning

intravenøs anvendelse

Belgien

| B. Braun Melsungen AG |
| --- |
| Carl-Braun-Strasse 1 |
| 34212 Melsugen |
| Germany |

B. Braun Melsungen AG

Carl-Braun-Strasse 1

34212 Melsugen

Germany

Natriumacetat (trihydrat), kaliumchlorid, magnesiumchloridhexahydrat, natriumchlorid, calciumchlorid (dihydrat), hydroxyethylstivelse, æblesyre

Tetraspan 6 %

3,27 mg/ml, 0,30 mg/ml, 0,20 mg/ml, 6,25 mg/ml, 0,37 mg/ml, 60 mg/ml, 0,67 mg/ml

infusionsvæske, opløsning

intravenøs anvendelse

Belgien

| B. Braun Melsungen AG |
| --- |
| Carl-Braun-Strasse 1 |
| 34212 Melsugen |
| Germany |

B. Braun Melsungen AG

Carl-Braun-Strasse 1

34212 Melsugen

Germany

Natriumchlorid, hydroxyethylstivelse

Venohes 6 %

9 mg/ml, 60 mg/ml

infusionsvæske, opløsning

intravenøs anvendelse

Belgien

| Fresenius Kabi NV |
| --- |
| Molenberglei 7 |
| 2627 Schelle |
| Belgium |

Fresenius Kabi NV

Molenberglei 7

2627 Schelle

Belgium

Natriumacetat (trihydrat), kaliumchlorid, magnesiumchloridhexahydrat, natriumchlorid, Hydroxyethylstivelse

Volulyte 6 %

4,63 mg/ml, 0,30 mg/ml, 0,30 mg/ml, 6,02 mg/ml, 60 mg/ml

infusionsvæske, opløsning

intravenøs anvendelse

Belgien

| Fresenius Kabi NV |
| --- |
| Molenberglei 7 |
| 2627 Schelle |
| Belgium |

Fresenius Kabi NV

Molenberglei 7

2627 Schelle

Belgium

Natriumchlorid, hydroxyethylstivelse

Voluven 10 %

9 mg/ml, 100 mg/ml

infusionsvæske, opløsning

intravenøs anvendelse

Belgien

| Fresenius Kabi NV |
| --- |
| Molenberglei 7 |
| 2627 Schelle |
| Belgium |

Fresenius Kabi NV

Molenberglei 7

2627 Schelle

Belgium

Natriumchlorid, hydroxyethylstivelse

Voluven 6 %

9 mg/ml, 60 mg/ml

infusionsvæske, opløsning

intravenøs anvendelse

Bulgarien

| B.Braun Melsungen AG |
| --- |
| Carl-Braun-Strasse 1 |
| D-34212 Melsungen |
| Germany |

B.Braun Melsungen AG

Carl-Braun-Strasse 1

D-34212 Melsungen

Germany

Poly(O-2-Hydroxyethyl)-stivelse, natriumchlorid

Hemohes 6 %

60 g/l, 9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Bulgarien

| Fresenius Kabi Deutschland GmbH |
| --- |
| Else-Kröner-Straße 1 |
| 61352 Bad Homburg v.d.Höhe |
| Germany |

Fresenius Kabi Deutschland GmbH

Else-Kröner-Straße 1

61352 Bad Homburg v.d.Höhe

Germany

Poly(O-2-Hydroxyethyl)-stivelse, natriumchlorid

Voluven 6 %

60 g/l, 9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Bulgarien

| Fresenius Kabi EOOD |
| --- |
| 1 »Alexander Jendov« str. |
| 6th floor, ap 37 +Sofia |
| 1113 |
| Bulgaria |

Fresenius Kabi EOOD

1 »Alexander Jendov« str.

6th floor, ap 37 +Sofia

1113

Bulgaria

Poly(O-2-Hydroxyethyl)-stivelse, natriumchlorid

Voluven 10 %

100 g/l, 9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Bulgarien

| Fresenius Kabi EOOD |
| --- |
| 1 »Alexander Jendov« str. |
| 6th floor, ap 37 +Sofia |
| 1113 |
| Bulgaria |

Fresenius Kabi EOOD

1 »Alexander Jendov« str.

6th floor, ap 37 +Sofia

1113

Bulgaria

Poly(O-2-Hydroxyethyl)-stivelse, natriumchlorid, natriumacetattrihydrat, kaliumchlorid, magnesiumchloridhexahydrat

Volulyte 6 %

60 g/l, 6,02 g/l, 4,63 g/l, 0,3 g/l, 0,3 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Bulgarien

| Baxter Deutschland GmbH, |
| --- |
| Edissonstrasse 4 +Unterschleissheim, 85716 |
| Germany |

Baxter Deutschland GmbH,

Edissonstrasse 4 +Unterschleissheim, 85716

Germany

Hydroxyethylstivelse 130/0,42, natriumchlorid, kaliumchlorid, calciumchloriddihydrat, magnesiumchloridhexahydrat, natriumacetattrihydrat

Plasma volume Redibag

60,0 g/l, 6 g/l, 0,400 g/l, 0,134 g/l, 0,2 g/l, 3,70 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Kroatien

| B. Braun Adria d.o.o |
| --- |
| Hondlova 2/9k |
| 10000 Zagreb |
| Croatia |

B. Braun Adria d.o.o

Hondlova 2/9k

10000 Zagreb

Croatia

Calciumchloriddihydrat, hydroxyethylstivelse (HES), kaliumchlorid, magnesiumchloridhexahydrat, natriumchlorid, natriumacetattrihydrat, æblesyre

TETRASPAN 60 mg/ml SOLUTION FOR INFUSION

0,37 g/l, 60,0 g/l, 0,30 g/l, 0,2 g/l, 6,25 g/l, 3,27 g/l, 0,67 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Kroatien

| B. Braun Adria d.o.o |
| --- |
| Hondlova 2/9 |
| 10000 Zagreb |
| Croatia |

B. Braun Adria d.o.o

Hondlova 2/9

10000 Zagreb

Croatia

Calciumchloriddihydrat, hydroxyethylstivelse (HES), kaliumchlorid, magnesiumchloridhexahydrat, natriumchlorid, natriumacetattrihydrat, æblesyre

TETRASPAN 100 mg/ml SOLUTION FOR INFUSION

0,37 g/l, 100,0 g/l, 0,30 g/l, 0,2 g/l, 6,25 g/l, 3,27 g/l, 0,67 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Kroatien

| Fresenius Kabi d.o.o. |
| --- |
| Trg J.F. Kennedya 6b |
| 10000 Zagreb |
| Croatia |

Fresenius Kabi d.o.o.

Trg J.F. Kennedya 6b

10000 Zagreb

Croatia

Hydroxyethylstivelse, natriumchlorid, natriumacetattrihydrat, kaliumchlorid, magnesiumchloridhexahydrat

VOLULYTE 6 % SOLUTION FOR INFUSION

60,0 g/l, 6,02 g/l, 4,63 g/l, 0,30 g/l 0,30 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Kroatien

| Fresenius Kabi d.o.o. |
| --- |
| Trg J.F. Kennedya 6b |
| 10000 Zagreb |
| Croatia |

Fresenius Kabi d.o.o.

Trg J.F. Kennedya 6b

10000 Zagreb

Croatia

Hydroxyethylstivelse, natriumchlorid

VOLUVEN 6 % SOLUTION FOR INFUSION

60,0 g/l, 9,0 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Cypern

| FRESENIUS KABI HELLAS AE |
| --- |
| Mesogeion Avenue 354, |
| Agia Paraskevi 15341, Athens |
| Greece |

FRESENIUS KABI HELLAS AE

Mesogeion Avenue 354,

Agia Paraskevi 15341, Athens

Greece

Hydroxyethylstivelse + natriumchlorid+natriumacetat trihydrat+kaliumchlorid+magnesiumchloridhexahydrat

VOLULYTE SOLUTION FOR INFUSION 6 %

60 g/l, 6,02 g/l, 4,63 g/l, 0,3 g/l, 0,3 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Cypern

| FRESENIUS KABI HELLAS AE |
| --- |
| Mesogeion Avenue 354, |
| Agia Paraskevi 15341, Athens |
| Greece |

FRESENIUS KABI HELLAS AE

Mesogeion Avenue 354,

Agia Paraskevi 15341, Athens

Greece

Hydroxyethylstivelse + natriumchlorid

VOLUVEN SOLUTION FOR INFUSION 10 %

100 g/l, 9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Tjekkiet

| BAXTER CZECH spol. s r.o. |
| --- |
| Karla Engliše 3201/6 |
| 150 00 Praha 5 |
| Czech Republic |

BAXTER CZECH spol. s r.o.

Karla Engliše 3201/6

150 00 Praha 5

Czech Republic

Hydroxyethylstivelse 130 000, natriumchlorid, kaliumchlorid, calciumchloriddihydrat, magnesiumchloridhexahydrat, natriumacetattrihydrat

PLASMA VOLUME REDIBAG 6 %

60,0 g/l, 6,0 g/l, 0,4 g/l, 0,134 g/l, 0,2 g/l, 3,7 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Tjekkiet

| B. Braun Melsungen AG |
| --- |
| Carl-Braun Strasse 1 |
| 342 12 Melsungen |
| Germany |

B. Braun Melsungen AG

Carl-Braun Strasse 1

342 12 Melsungen

Germany

Hydroxyethylstivelse 130 000, natriumchlorid, kaliumchlorid, calciumchloriddihydrat, magnesiumchloridhexahydrat, natriumacetattrihydrat, L-æblesyre

TETRASPAN 10 %

100,0 g/l, 6,25 g/l, 0,3 g/l, 0,37 g/l, 0,2 g/l, 3,27 g/l, 0,67 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Tjekkiet

| B. Braun Melsungen AG |
| --- |
| Carl-Braun Strasse 1 |
| 342 12 Melsungen |
| Germany |

B. Braun Melsungen AG

Carl-Braun Strasse 1

342 12 Melsungen

Germany

Hydroxyethylstivelse 130 000, natriumchlorid, kaliumchlorid, calciumchloriddihydrat, magnesiumchloridhexahydrat, natriumacetattrihydrat, L-æblesyre

TETRASPAN 6 %

60,0 g/l, 6,25 g/l, 0,30 g/l, 0,37 g/l, 0,2 g/l, 3,27 g/l, 0,67 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Tjekkiet

| Fresenius Kabi Deutschland GmbH |
| --- |
| Else-Kröner-Straße 1 |
| 61352 Bad Homburg v.d.Höhe |
| Germany |

Fresenius Kabi Deutschland GmbH

Else-Kröner-Straße 1

61352 Bad Homburg v.d.Höhe

Germany

Hydroxyethylstivelse, natriumacetattrihydrat, natriumchlorid, kaliumchlorid, magnesiumchloridhexahydrat

VOLULYTE 6 %

60,0 g/l, 4,63 g/l, 6,02 g/l, 0,3 g/l, 0,3 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Tjekkiet

| Fresenius Kabi s.r.o. |
| --- |
| Želetavská 1525/1 |
| 140 00 Praha 4 – Michle |
| Czech Republic |

Fresenius Kabi s.r.o.

Želetavská 1525/1

140 00 Praha 4 – Michle

Czech Republic

Hydroxyethylstivelse, natriumchlorid

VOLUVEN 10 %

100 g/l, 9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Tjekkiet

| Fresenius Kabi Deutschland GmbH |
| --- |
| Else-Kröner-Straße 1 |
| 61352 Bad Homburg v.d.Höhe |
| Germany |

Fresenius Kabi Deutschland GmbH

Else-Kröner-Straße 1

61352 Bad Homburg v.d.Höhe

Germany

Hydroxyethylstivelse, natriumchlorid

HYPERHAES

60 g/l, 72 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Tjekkiet

| Fresenius Kabi Deutschland GmbH |
| --- |
| Else-Kröner-Straße 1 |
| 61352 Bad Homburg v.d.Höhe |
| Germany |

Fresenius Kabi Deutschland GmbH

Else-Kröner-Straße 1

61352 Bad Homburg v.d.Höhe

Germany

Hydroxyethylstivelse, natriumchlorid

VOLUVEN

60 g/l, 9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Danmark

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

Baxter A/S,

Gydevang 43,

DK-3450 Allerød,

Denmark

Calciumchloriddihydrat, hydroxyethylstivelse (HES), kaliumchlorid, magnesiumchlorid hexahydrat, natriumchlorid, natriumacetattrihydrat, vand

Hesra

0,134 g/l, 60 g/l, 0,4 g/l, 0,2 g/l, 6 g/l, 3,7 g/l, vand ad 1 000 ml

infusionsvæske, opløsning

intravenøs anvendelse

Danmark

| Fresenius Kabi AB, |
| --- |
| Rapsgatan 7, |
| SE-751 74 Uppsala, |
| Sweden |

Fresenius Kabi AB,

Rapsgatan 7,

SE-751 74 Uppsala,

Sweden

Hydroxyethylstivelse (HES), natriumchlorid, vand

HyperHAES

60 g/l, 72 g/l, vand ad 1 000 ml

infusionsvæske, opløsning

intravenøs anvendelse

Danmark

| B. Braun Melsungen, |
| --- |
| Carl-Braun-Strasse 1, |
| DE-34212 Melsungen, |
| Germany |

B. Braun Melsungen,

Carl-Braun-Strasse 1,

DE-34212 Melsungen,

Germany

Calciumchloriddihydrat, hydroxyethylstivelse (HES), kaliumchlorid, magnesiumchloridhexahydrat, natriumchlorid, natriumacetattrihydrat, æblesyre, natriumhydroxid, vand

Tetraspan

0,37 g/l, 60 g/l, 0,3 g/l, 0,2 g/l, 6,25 g/l, 3,27 g/l, 0,67 g/l, 1,197 g/l, vand ad 1 000 ml

infusionsvæske, opløsning

intravenøs anvendelse

Danmark

| B. Braun Melsungen, |
| --- |
| Carl-Braun-Strasse 1, |
| DE-34212 Melsungen, |
| Germany |

B. Braun Melsungen,

Carl-Braun-Strasse 1,

DE-34212 Melsungen,

Germany

Calciumchloriddihydrat, Hydroxyethylstivelse (HES), kaliumchlorid, magnesiumchloridhexahydrat, natriumchlorid, natriumacetattrihydrat, æblesyre, natriumhydroxid, vand

Tetraspan

0,37 g/l, 100 g/l, 0,3 g/l, 0,2 g/l, 6,25 g/l, 3,27 g/l, 0,67 g/l, 1,197 g/l, vand ad 1 000 ml

infusionsvæske, opløsning

intravenøs anvendelse

Danmark

| B. Braun Melsungen, |
| --- |
| Carl-Braun-Strasse 1, |
| DE-34212 Melsungen, |
| Germany |

B. Braun Melsungen,

Carl-Braun-Strasse 1,

DE-34212 Melsungen,

Germany

Hydroxyethylstivelse (HES), natriumchlorid, vand

Venofundin

60 g/l, 9 g/l, vand ad 1 000 ml

infusionsvæske, opløsning

intravenøs anvendelse

Danmark

| Fresenius Kabi AB |
| --- |
| Rapsgatan 7 |
| SE-751 74 Uppsala |
| Sweden |

Fresenius Kabi AB

Rapsgatan 7

SE-751 74 Uppsala

Sweden

Hydroxyethylstivelse (HES), kaliumchlorid, magnesiumchloridhexahydrat, natriumchlorid, natriumacetattrihydrat, vand

Volulyte

60 g/l, 0,3 g/l, 0,3 g/l, 6,02 g/l, 4,63 g/l, vand ad 1 000 ml

infusionsvæske, opløsning

intravenøs anvendelse

Danmark

| Fresenius Kabi AB |
| --- |
| Rapsgatan 7 |
| SE-751 74 Uppsala |
| Sweden |

Fresenius Kabi AB

Rapsgatan 7

SE-751 74 Uppsala

Sweden

Hydroxyethylstivelse (HES), natriumchlorid, vand

Voluven

60 g/l, 9 g/l, vand ad 1 000 ml

infusionsvæske, opløsning

intravenøs anvendelse

Danmark

| Fresenius Kabi AB |
| --- |
| Rapsgatan 7 |
| SE-751 74 Uppsala |
| Sweden |

Fresenius Kabi AB

Rapsgatan 7

SE-751 74 Uppsala

Sweden

Hydroxyethylstivelse (HES), natriumchlorid, vand

Voluven

100 g/l, 9 g/l, vand ad 1 000 ml

infusionsvæske, opløsning

intravenøs anvendelse

Estland

| B.Braun Melsungen AG |
| --- |
| Carl-Braun-Strasse 1 |
| Melsungen D-34212 |
| Germany |

B.Braun Melsungen AG

Carl-Braun-Strasse 1

Melsungen D-34212

Germany

Hydroxyethylstivelse, natriumchlorid, kaliumchlorid, calciumchloriddihydrat, magnesiumchlorid, natriumacetattrihydrat, æblesyre

TETRASPAN 60 MG/ML

60 g/l, 6,25 g/l, 0,3 g/l, 0,37g/l, 0,2 g/l, 3,27 g/l, 0,67 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Estland

| B.Braun Melsungen AG |
| --- |
| Carl-Braun-Strasse 1 |
| Melsungen D-34212 |
| Germany |

B.Braun Melsungen AG

Carl-Braun-Strasse 1

Melsungen D-34212

Germany

Hydroxyethylstivelse, natriumchlorid, kaliumchlorid, calciumchloriddihydrat, magnesiumchlorid, natriumacetattrihydrat, æblesyre

TETRASPAN 100 MG/ML

100 g/l, 6,25 g/l, 0,3 g/l, 0,37 g/l, 0,2 g/l, 3,27 g/l, 0,67 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Estland

| Fresenius Kabi Deutschland GmbH |
| --- |
| 61346 Bad Homburg v.d.H. |
| Germany |

Fresenius Kabi Deutschland GmbH

61346 Bad Homburg v.d.H.

Germany

Hydroxyethylstivelse, natriumchlorid

VOLUVEN

60 g/l, 9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Estland

| Fresenius Kabi Deutschland GmbH |
| --- |
| 61346 Bad Homburg v.d.H. |
| Germany |

Fresenius Kabi Deutschland GmbH

61346 Bad Homburg v.d.H.

Germany

Hydroxyethylstivelse, natriumacetattrihydrat, natriumchlorid, natriumchlorid, magnesiumchlorid

VOLULYTE

60 g/l, 4,63 g/l, 6,02 g/l, 0,3 g/l, 0,3 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Estland

| Fresenius Kabi Polska Sp.z o.o |
| --- |
| Crown Tower |
| ul.Hrubieszowska 2 |
| Warszawa |
| 01-209 |
| Poland |

Fresenius Kabi Polska Sp.z o.o

Crown Tower

ul.Hrubieszowska 2

Warszawa

01-209

Poland

Hydroxyethylstivelse, natriumchlorid

VOLUFORTE

100 g/l, 9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Finland

| Baxter Oy |
| --- |
| Tammasaarenkatu 1 |
| P.O.Box 119 |
| 00181 Helsinki, |
| Finland |

Baxter Oy

Tammasaarenkatu 1

P.O.Box 119

00181 Helsinki,

Finland

Poly(o-2-hydroxyethyl)-stivelse, natriumchlorid, kaliumchlorid, calciumchloriddihydrat, magnesiumchloriddihydrat, natriumacetattrihydrat

HESRA

60,0 g/l, 6,000 g/l, 0,400 g/l, 0,134 g/l, 0,200 g/l, 3,700 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Finland

| Fresenius Kabi Ab |
| --- |
| Rapsgatan 7 |
| 75174 Uppsala, |
| Sweden |

Fresenius Kabi Ab

Rapsgatan 7

75174 Uppsala,

Sweden

Poly(o-2-hydroxyethyl)-stivelse, natriumchlorid

HYPERHAES

60,0 g/l, 72 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Finland

| B. Braun Melsungen AG |
| --- |
| Carl-Braun-Strasse 1 |
| 34209 Melsungen, |
| Germany |

B. Braun Melsungen AG

Carl-Braun-Strasse 1

34209 Melsungen,

Germany

Poly(o-2-hydroxyethyl)-stivelse, natriumchlorid, kaliumchlorid, calciumchloriddihydrat, magnesiumchloridhexahydrat, natriumacetattrihydrat, æblesyre

TETRASPAN

100,0 g/l, 6,252 g/l, 0,2984 g/l, 0,3675 g/l, 0,2033 g/l, 3,266 g/l, 0,671 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Finland

| B. Braun Melsungen AG |
| --- |
| Carl-Braun-Strasse 1 |
| 34209 Melsungen, |
| Germany |

B. Braun Melsungen AG

Carl-Braun-Strasse 1

34209 Melsungen,

Germany

Poly(o-2-hydroxyethyl)-stivelse, natriumchlorid, kaliumchlorid, calciumchloriddihydrat, magnesiumchloriddihydrate, natriumacetattrihydrat, æblesyre

TETRASPAN

60,0 g/l, 6,252 g/l, 0,2984 g/l, 0,3675 g/l, 0,2033 g/l, 3,266 g/l, 0,671 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Finland

| B. Braun Melsungen AG |
| --- |
| Carl-Braun-Strasse 1 |
| 34209 Melsungen, |
| Germany |

B. Braun Melsungen AG

Carl-Braun-Strasse 1

34209 Melsungen,

Germany

Poly(o-2-hydroxyethyl)-stivelse, natriumchlorid

VENOFUNDIN

60,0 g/l, 9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Finland

| Fresenius Kabi Ab |
| --- |
| Rapsgatan 7 |
| 75174 Uppsala, |
| Sweden |

Fresenius Kabi Ab

Rapsgatan 7

75174 Uppsala,

Sweden

Poly(o-2-hydroxyethyl)-stivelse, natriumacetattrihydrid, natriumchlorid, kaliumchlorid, magnesiumchloridhexahydrat

VOLULYTE

60 g/l, 4,63 g/l, 6,02 g/l, 0,3 g/l, 0,3 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Finland

| Fresenius Kabi Ab |
| --- |
| Rapsgatan 7 |
| 75174 Uppsala, |
| Sweden |

Fresenius Kabi Ab

Rapsgatan 7

75174 Uppsala,

Sweden

Poly(o-2-hydroxyethyl)-stivelse, natriumchlorid

VOLUVEN

60 g/l, 9,0 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Finland

| Fresenius Kabi Ab |
| --- |
| Rapsgatan 7 |
| 75174 Uppsala, |
| Sweden |

Fresenius Kabi Ab

Rapsgatan 7

75174 Uppsala,

Sweden

Hydroxyethylstivelse, natriumchlorid

VOLUVEN

100 g/l, 9,0 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Frankrig

| B BRAUN MELSUNGEN |
| --- |
| Carl-Braun Strasse 1 |
| 34212 Melsungen |
| Germany |

B BRAUN MELSUNGEN

Carl-Braun Strasse 1

34212 Melsungen

Germany

Hydroxyethylstivelse 130 000 calciumchloriddehydrat magnesiumchloridhexahydrat æblesyre kaliumchlorid natriumacetattrihydrat natriumchlorid

ISOVOL 6 %, solution pour perfusion

60 g / l 0,367 g / l 0,203 g / l 0,671 g / l 0,298 g / l 3,266 g / l 6,252 g / l

infusionsvæske, opløsning

intravenøs anvendelse

Frankrig

| BAXTER S.A.S. |
| --- |
| Avenue Louis Pasteur |
| ZA de Coignères Maurepas |
| 78310 Maurepas |
| France |

BAXTER S.A.S.

Avenue Louis Pasteur

ZA de Coignères Maurepas

78310 Maurepas

France

Hydroxyethylstivelse 130 000 calciumchloriddihydrat magnesiumchloridhexahydrat kaliumchlorid natriumacetattrihydrat natriumchlorid

PLASMAVOLUME 6 %, solution pour perfusion

60 g / l 0,134 g / l 0,2 g / l 0,4 g / l 3,7 g / l 6 g / l

infusionsvæske, opløsning

intravenøs anvendelse

Frankrig

| FRESENIUS KABI FRANCE |
| --- |
| 5, place du Marivel |
| 92316 Sèvres Cedex |
| France |

FRESENIUS KABI FRANCE

5, place du Marivel

92316 Sèvres Cedex

France

Hydroxyethylstivelse 130 000 magnesiumchloridhexahydrat kaliumchlorid natriumacetattrihydrat natriumchlorid

VOLULYTE 6 %, solution pour perfusion

60 g / l 0,3 g / l 0,3 g / l 4,63 g / l 6,02 g / l

infusionsvæske, opløsning

intravenøs anvendelse

Frankrig

| B BRAUN MELSUNGEN |
| --- |
| Carl-Braun Strasse 1 |
| 34212 Melsungen |
| Germany |

B BRAUN MELSUNGEN

Carl-Braun Strasse 1

34212 Melsungen

Germany

Hydroxyethylstivelse 130 000 natriumchlorid

RESTORVOL 6 %, solution pour perfusion

60 g / l 9 g / l

infusionsvæske, opløsning

intravenøs anvendelse

Frankrig

| FRESENIUS KABI FRANCE |
| --- |
| 5, place du Marivel |
| 92316 Sèvres Cedex |
| France |

FRESENIUS KABI FRANCE

5, place du Marivel

92316 Sèvres Cedex

France

Hydroxyethylstivelse 130 000 natriumchlorid

VOLUVEN, solution pour perfusion

60 g / l 9 g / l

infusionsvæske, opløsning

intravenøs anvendelse

Frankrig

| FRESENIUS KABI FRANCE |
| --- |
| 5, place du Marivel |
| 92316 Sèvres Cedex |
| France |

FRESENIUS KABI FRANCE

5, place du Marivel

92316 Sèvres Cedex

France

Hydroxyethylstivelse 200 000

ELOHES 6 %, solution pour perfusion en poche

6 g / 100 ml

infusionsvæske, opløsning

intravenøs anvendelse

Frankrig

| FRESENIUS KABI FRANCE |
| --- |
| 5, place du Marivel |
| 92316 Sèvres Cedex |
| France |

FRESENIUS KABI FRANCE

5, place du Marivel

92316 Sèvres Cedex

France

Hydroxyethylstivelse 200 000

ELOHES 6 %, solution injectable pour perfusion en flacon

6 g / 100 ml

infusionsvæske, opløsning

intravenøs anvendelse

Frankrig

| AGUETTANT |
| --- |
| 1, rue Alexander Fleming |
| 69007 Lyon |
| France |

AGUETTANT

1, rue Alexander Fleming

69007 Lyon

France

Hydroxyethylstivelse 200 000

PLASMOHES 6 %, solution pour perfusion

6 g / 100 ml

infusionsvæske, opløsning

intravenøs anvendelse

Frankrig

| B BRAUN MELSUNGEN |
| --- |
| Carl-Braun Strasse 1 |
| 34212 Melsungen |
| Germany |

B BRAUN MELSUNGEN

Carl-Braun Strasse 1

34212 Melsungen

Germany

Hydroxyethylstivelse 200 000 natriumchlorid

HEAFUSINE 10 %, solution pour perfusion en poche

10 g / 100 ml 0,90 g / 100 ml

infusionsvæske, opløsning

intravenøs anvendelse

Frankrig

| B BRAUN MELSUNGEN |
| --- |
| Carl-Braun Strasse 1 |
| 34212 Melsungen |
| Germany |

B BRAUN MELSUNGEN

Carl-Braun Strasse 1

34212 Melsungen

Germany

Hydroxyethylstivelse 200 000 natriumchlorid

HEAFUSINE 6 %, solution pour perfusion en poche

6 g / 100 ml 0,90 g / 100 ml

infusionsvæske, opløsning

intravenøs anvendelse

Frankrig

| FRESENIUS KABI FRANCE |
| --- |
| 5, place du Marivel |
| 92316 Sèvres Cedex |
| France |

FRESENIUS KABI FRANCE

5, place du Marivel

92316 Sèvres Cedex

France

Hydroxyethylstivelse 200 000 natriumchlorid

HYPERHES, solution pour perfusion

60 g / l 72 g / l

infusionsvæske, opløsning

intravenøs anvendelse

Frankrig

| FRESENIUS KABI FRANCE |
| --- |
| 5, place du Marivel |
| 92316 Sèvres Cedex |
| France |

FRESENIUS KABI FRANCE

5, place du Marivel

92316 Sèvres Cedex

France

Hydroxyethylstivelse 240 000

HESTERIL 10 %, solution pour perfusion

10 g / 100 ml

infusionsvæske, opløsning

intravenøs anvendelse

Frankrig

| FRESENIUS KABI FRANCE |
| --- |
| 5, place du Marivel |
| 92316 Sèvres Cedex |
| France |

FRESENIUS KABI FRANCE

5, place du Marivel

92316 Sèvres Cedex

France

Hydroxyethylstivelse 240 000

HESTERIL 6 %, solution pour perfusion

6 g / 100 ml

infusionsvæske, opløsning

intravenøs anvendelse

Frankrig

| FRESENIUS KABI FRANCE |
| --- |
| 5, place du Marivel |
| 92316 Sèvres Cedex |
| France |

FRESENIUS KABI FRANCE

5, place du Marivel

92316 Sèvres Cedex

France

Hydroxyethylstivelse 250 000

LOMOL, solution injectable pour perfusion en poche

10 g / 100 ml

infusionsvæske, opløsning

intravenøs anvendelse

Tyskland

| B. Braun Melsungen AG |
| --- |
| Carl-Braun-Str. 1 |
| 34212 Melsungen |
| Germany |

B. Braun Melsungen AG

Carl-Braun-Str. 1

34212 Melsungen

Germany

Hydroxyethylstivelse natriumchlorid

Hemohes 6 %

60 g/l, 9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Tyskland

| B. Braun Melsungen AG |
| --- |
| Carl-Braun-Str. 1 |
| 34212 Melsungen |
| Germany |

B. Braun Melsungen AG

Carl-Braun-Str. 1

34212 Melsungen

Germany

Hydroxyethylstivelse natriumchlorid

Hemohes 10 %

100 g/l, 9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Tyskland

| B. Braun Melsungen AG |
| --- |
| Carl-Braun-Str. 1 |
| 34212 Melsungen |
| Germany |

B. Braun Melsungen AG

Carl-Braun-Str. 1

34212 Melsungen

Germany

Hydroxyethylstivelse natriumchlorid

VENOFUNDIN 60 mg/ml Infusionslösung

60 g/l, 9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Tyskland

| B. Braun Melsungen AG |
| --- |
| Carl-Braun-Str. 1 |
| 34212 Melsungen |
| Germany |

B. Braun Melsungen AG

Carl-Braun-Str. 1

34212 Melsungen

Germany

Hydroxyethylstivelse, natriumchlorid, kaliumchlorid, calciumchloriddihydrat, magnesiumchloridhexahydrat, natriumacetattrihydrat, æblesyre

Tetraspan 6 % Infusionslösung

60 g/l, 6,25 g/l, 0,3 g/l, 0,37 g/l, 0,2 g/l, 3,27 g/l, 0,67 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Tyskland

| B. Braun Melsungen AG |
| --- |
| Carl-Braun-Str. 1 |
| 34212 Melsungen |
| Germany |

B. Braun Melsungen AG

Carl-Braun-Str. 1

34212 Melsungen

Germany

Hydroxyethylstivelse, natriumchlorid, kaliumchlorid, calciumchloriddihydrat, magnesiumchloridhexahydrat natriumacetattrihydrat, æblesyre

Tetraspan 10 % Infusionslösung

100 g/l, 6,25 g/l, 0,3 g/l, 0,37 g/l, 0,2 g/l, 3,27 g/l, 0,67 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Tyskland

| Baxter Deutschland GmBh |
| --- |
| Edisonstr. 4 |
| 85716 Unterschleißheim |
| Germany |

Baxter Deutschland GmBh

Edisonstr. 4

85716 Unterschleißheim

Germany

Hydroxyethylstivelse, natriumchlorid, kaliumchlorid, calciumchloriddihydrat, magnesiumchloridhexahydrat natriumacetattrihydrat

Plasma Volume Redibag

60 g/l, 6 g/l, 0,4 g/l, 0,134 g/l, 0,2 g/l, 3,7 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Tyskland

| Berlin-Chemie AG |
| --- |
| Glienicker Weg 125 |
| 12489 Berlin |
| Germany |

Berlin-Chemie AG

Glienicker Weg 125

12489 Berlin

Germany

Natriumchlorid, hydroxyethylstivelse

Refortan 6 %

9 g/l, 60 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Tyskland

| Berlin-Chemie AG |
| --- |
| Glienicker Weg 125 |
| 12489 Berlin |
| Germany |

Berlin-Chemie AG

Glienicker Weg 125

12489 Berlin

Germany

Natriumchlorid, hydroxyethylstivelse

Refortan 10 %

9 g/l, 100 g/l

infusionsvæske, opløsning

intravenøs anvendelse

yskland

| Fresenius Kabi Deutschland GmbH |
| --- |
| Else-Kröner-Str. 1 |
| 61352 Bad Homburg v.d.H. |
| Germany |

Fresenius Kabi Deutschland GmbH

Else-Kröner-Str. 1

61352 Bad Homburg v.d.H.

Germany

Hydroxyethylstivelse, natriumacetattrihydrat, natriumchlorid, kaliumchlorid, magnesiumchloridhexahydrat

Volulyte 6 % Infusionslösung

60 g/l, 4,63 g/l, 6,02 g/l, 0,3 g/l, 0,3 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Tyskland

| Fresenius Kabi Deutschland GmbH |
| --- |
| Else-Kröner-Str. 1 |
| 61352 Bad Homburg v.d.H. |
| Germany |

Fresenius Kabi Deutschland GmbH

Else-Kröner-Str. 1

61352 Bad Homburg v.d.H.

Germany

Natriumchlorid, hydroxyethylstivelse

Voluven 6 % Infusionslösung

9 g/l, 60 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Tyskland

| Fresenius Kabi Deutschland GmbH |
| --- |
| Else-Kröner-Str. 1 |
| 61352 Bad Homburg v.d.H. |
| Germany |

Fresenius Kabi Deutschland GmbH

Else-Kröner-Str. 1

61352 Bad Homburg v.d.H.

Germany

Natriumchlorid, hydroxyethylstivelse

Voluven 10 % Infusionslösung

9 g/l, 100 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Tyskland

| Fresenius Kabi Deutschland GmbH |
| --- |
| Else-Kröner-Str. 1 |
| 61352 Bad Homburg v.d.H. |
| Germany |

Fresenius Kabi Deutschland GmbH

Else-Kröner-Str. 1

61352 Bad Homburg v.d.H.

Germany

Natriumchlorid, hydroxyethylstivelse

Elohäst 6 %

9 g/l, 60 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Tyskland

| Fresenius Kabi Deutschland GmbH |
| --- |
| Else-Kröner-Str. 1 |
| 61352 Bad Homburg v.d.H. |
| Germany |

Fresenius Kabi Deutschland GmbH

Else-Kröner-Str. 1

61352 Bad Homburg v.d.H.

Germany

Natriumchlorid, hydroxyethylstivelse

HyperHAES Infusionslösung

72 g/l, 60 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Tyskland

| Fresenius Kabi Deutschland GmbH |
| --- |
| Else-Kröner-Str. 1 |
| 61352 Bad Homburg v.d.H. |
| Germany |

Fresenius Kabi Deutschland GmbH

Else-Kröner-Str. 1

61352 Bad Homburg v.d.H.

Germany

Natriumchlorid, hydroxyethylstivelse

HAES-steril 3 %

9 g/l, 30 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Tyskland

| Fresenius Kabi Deutschland GmbH |
| --- |
| Else-Kröner-Str. 1 |
| 61352 Bad Homburg v.d.H. |
| Germany |

Fresenius Kabi Deutschland GmbH

Else-Kröner-Str. 1

61352 Bad Homburg v.d.H.

Germany

Natriumchlorid, hydroxyethylstivelse

Voluven Fresenius 6 % Infusionslösung

9 g/l, 60 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Tyskland

| Fresenius Kabi Deutschland GmbH |
| --- |
| Else-Kröner-Str. 1 |
| 61352 Bad Homburg v.d.H. |
| Germany |

Fresenius Kabi Deutschland GmbH

Else-Kröner-Str. 1

61352 Bad Homburg v.d.H.

Germany

Natriumchlorid, hydroxyethylstivelse

Haes-steril 10 %

9 g/l, 100 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Tyskland

| Fresenius Kabi Deutschland GmbH |
| --- |
| Else-Kröner-Str. 1 |
| 61352 Bad Homburg v.d.H. |
| Germany |

Fresenius Kabi Deutschland GmbH

Else-Kröner-Str. 1

61352 Bad Homburg v.d.H.

Germany

Hydroxyethylstivelse, natriumacetattrihydrat, natriumchlorid, kaliumchlorid, magnesiumchloridhexahydrat

Volulyte 6 % Infusionslösung

60 g/l, 4,63 g/l, 6,02 g/l, 0,3 g/l, 0,3 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Tyskland

| Fresenius Kabi Deutschland GmbH |
| --- |
| Else-Kröner-Str. 1 |
| 61352 Bad Homburg v.d.H. |
| Germany |

Fresenius Kabi Deutschland GmbH

Else-Kröner-Str. 1

61352 Bad Homburg v.d.H.

Germany

Hydroxyethylstivelse, natriumchlorid

Haes-steril 6 %

60 g/l, 9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Tyskland

| Fresenius Kabi Deutschland GmbH |
| --- |
| Else-Kröner-Str. 1 |
| 61352 Bad Homburg v.d.H. |
| Germany |

Fresenius Kabi Deutschland GmbH

Else-Kröner-Str. 1

61352 Bad Homburg v.d.H.

Germany

Hydroxyethylstivelse, natriumchlorid

Voluven 6 % Infusionslösung

60 g/l, 9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Tyskland

| Fresenius Kabi Deutschland GmbH |
| --- |
| Else-Kröner-Str. 1 |
| 61352 Bad Homburg v.d.H. |
| Germany |

Fresenius Kabi Deutschland GmbH

Else-Kröner-Str. 1

61352 Bad Homburg v.d.H.

Germany

Hydroxyethylstivelse, natriumchlorid

Voluven 10 % Infusionslösung

100 g/l, 9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Tyskland

| Fresenius Kabi Deutschland GmbH |
| --- |
| Else-Kröner-Str. 1 |
| 61352 Bad Homburg v.d.H. |
| Germany |

Fresenius Kabi Deutschland GmbH

Else-Kröner-Str. 1

61352 Bad Homburg v.d.H.

Germany

Hydroxyethylstivelse, natriumchlorid

HyperHAES Infusionslösung

60 g/l, 72 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Tyskland

| Serumwerk Bernburg AG |
| --- |
| Hallesche Landstr. 105b |
| 06406 Bernburg |
| Germany |

Serumwerk Bernburg AG

Hallesche Landstr. 105b

06406 Bernburg

Germany

Hydroxyethylstivelse, natriumchlorid

Infukoll HES 6 %

60 g/l, 9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Tyskland

| Serumwerk Bernburg AG |
| --- |
| Hallesche Landstr. 105b |
| 06406 Bernburg |
| Germany |

Serumwerk Bernburg AG

Hallesche Landstr. 105b

06406 Bernburg

Germany

Hydroxyethylstivelse, natriumchlorid, kaliumchlorid, calciumchloriddihydrat, magnesiumchloridhexahydrat natriumacetattrihydrat

Vitafusal 10 %

100 g/l, 6 g/l, 0,4 g/l, 0,134 g/l, 0,2 g/l, 3,7 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Tyskland

| Serumwerk Bernburg AG |
| --- |
| Hallesche Landstr. 105b |
| 06406 Bernburg |
| Germany |

Serumwerk Bernburg AG

Hallesche Landstr. 105b

06406 Bernburg

Germany

Hydroxyethylstivelse, natriumchlorid, kaliumchlorid, calciumchloriddihydrat, magnesiumchloridhexahydrat natriumacetattrihydrat

Vitakoll 10 %

100 g/l, 6 g/l, 0,4 g/l, 0,134 g/l, 0,2 g/l, 3,7 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Tyskland

| Serumwerk Bernburg AG |
| --- |
| Hallesche Landstr. 105b |
| 06406 Bernburg |
| Germany |

Serumwerk Bernburg AG

Hallesche Landstr. 105b

06406 Bernburg

Germany

Hydroxyethylstivelse, natriumchlorid

Infukoll HES 10 %

100 g/l, 9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Tyskland

| Serumwerk Bernburg AG |
| --- |
| Hallesche Landstr. 105b |
| 06406 Bernburg |
| Germany |

Serumwerk Bernburg AG

Hallesche Landstr. 105b

06406 Bernburg

Germany

Hydroxyethylstivelse, natriumchlorid, kaliumchlorid, calciumchloriddihydrat, magnesiumchloridhexahydrat natriumacetattrihydrat

Vitafusal 6 %

60 g/l, 6 g/l, 0,4 g/l, 0,134 g/l, 0,2 g/l, 3,7 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Tyskland

| Serumwerk Bernburg AG |
| --- |
| Hallesche Landstr. 105b |
| 06406 Bernburg |
| Germany |

Serumwerk Bernburg AG

Hallesche Landstr. 105b

06406 Bernburg

Germany

Hydroxyethylstivelse, natriumchlorid, kaliumchlorid, calciumchloriddihydrat, magnesiumchloridhexahydrat natriumacetattrihydrat

Vitafusal

60 g/l, 6 g/l, 0,4 g/l, 0,134 g/l, 0,2 g/l, 3,7 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Tyskland

| Serumwerk Bernburg AG |
| --- |
| Hallesche Landstr. 105b |
| 06406 Bernburg |
| Germany |

Serumwerk Bernburg AG

Hallesche Landstr. 105b

06406 Bernburg

Germany

Hydroxyethylstivelse, natriumchlorid

VitaHES Infusionslösung

60 g/l, 9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Grækenland

| FRESENIUS KABI HELLAS AE |
| --- |
| Mesogeion Avenue 354, |
| Agia Paraskevi 15341, |
| Athens |
| Greece |

FRESENIUS KABI HELLAS AE

Mesogeion Avenue 354,

Agia Paraskevi 15341,

Athens

Greece

Poly-(o-2 hydroxyethyl)-stivelse (M.W 200 000) + natriumchlorid

HAES-STERIL

60 g/l + 9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Grækenland

| FRESENIUS KABI HELLAS AE |
| --- |
| Mesogeion Avenue 354, |
| Agia Paraskevi 15341, |
| Athens |
| Greece |

FRESENIUS KABI HELLAS AE

Mesogeion Avenue 354,

Agia Paraskevi 15341,

Athens

Greece

Hydroxyethylstivelse + natriumchlorid

VOLUVEN

60 g/l + 9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Grækenland

| FRESENIUS KABI HELLAS AE |
| --- |
| Mesogeion Avenue 354, |
| Agia Paraskevi 15341, |
| Athens |
| Greece |

FRESENIUS KABI HELLAS AE

Mesogeion Avenue 354,

Agia Paraskevi 15341,

Athens

Greece

Hydroxyethylstivelse + natriumchlorid

VOLUVEN

100 g/l + 9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Grækenland

| VIOSER SA, |
| --- |
| 9th Km National Highway Trikala- Larissis, |
| P.O. Box 35, Taxiarhes, Trikala |
| Trikala 42100 |
| Greece |

VIOSER SA,

9th Km National Highway Trikala- Larissis,

P.O. Box 35, Taxiarhes, Trikala

Trikala 42100

Greece

Hydroxyethylstivelse + natriumchlorid

VENOFUNDIN

60 g/l + 9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Grækenland

| FRESENIUS KABI HELLAS AE |
| --- |
| Mesogeion Avenue 354, |
| Agia Paraskevi 15341, |
| Athens |
| Greece |

FRESENIUS KABI HELLAS AE

Mesogeion Avenue 354,

Agia Paraskevi 15341,

Athens

Greece

Poly-(o-2-hydroxyethyl)-stivelse (M.W 200 000) + natriumacetattrihydrat + natriumchlorid + kaliumchlorid + magnesiumchloridhexahydrat

VOLULYTE

60 g/l, 4,63 g/l, 6,02 g/l, 0,3 g/l, 0,3 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Grækenland

| BAXTER HELLAS Ltd, Metsovou 3, |
| --- |
| Neo Irakleion 14121, |
| Athens |
| Greece |

BAXTER HELLAS Ltd, Metsovou 3,

Neo Irakleion 14121,

Athens

Greece

Hydroxyethylstivelse + natriumchlorid + kaliumchlorid + calciumchloriddihydrat + magnesiumchloridhexahydrat + natriumacetattrihydrat

PLASMAVOLUME REDIBAG

60 g/l, 6 g/l, 0,4 g/l, 0,134 g/l, 0,2 g/l, 3,7 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Grækenland

| VIOSER SA |
| --- |
| 9th Km National Highway Trikal-Larissa, |
| P.O. Box 35, Taksiarhes Trikalon, |
| Trikala 42100 |
| Greece |

VIOSER SA

9th Km National Highway Trikal-Larissa,

P.O. Box 35, Taksiarhes Trikalon,

Trikala 42100

Greece

Poly(o-2-hydroxyethyl)-stivelse (M.W 200 000) + natriumchlorid + kaliumchlorid + calciumchloriddihydrat + magnesiumchloridhexahydrat + natriumacetattrihydrat + æblesyre

TETRASPAN

60 g/l, 6,25 g/l, 0,3 g/l, 0,37 g/l, 0,2 g/l, 3,27 g/l, 0,67 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Grækenland

| VIOSER SA |
| --- |
| 9th Km National Highway Trikal-Larissa, |
| P.O. Box 35, Taksiarhes Trikalon, |
| Trikala 42100 |
| Greece |

VIOSER SA

9th Km National Highway Trikal-Larissa,

P.O. Box 35, Taksiarhes Trikalon,

Trikala 42100

Greece

Poly-(o-2-hydroxyethyl)-stivelse (MW 200 000) + natriumchlorid + kaliumchlorid + calciumchloriddihydrat + magnesiumchloridhexahydrat + natriumacetattrihydrat + æblesyre

TETRASPAN

100 g/l, 6,25 g/l, 0,3 g/l, 0,37 g/l, 0,2 g/l, 3,27 g/l, 0,67 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Ungarn

| Fresenius Kabi Deutschland GmbH |
| --- |
| Else-Kröner-Str. 1 |
| 61352 Bad Homburg v.d.H. |
| Germany |

Fresenius Kabi Deutschland GmbH

Else-Kröner-Str. 1

61352 Bad Homburg v.d.H.

Germany

Hydroxyethylstivelse, natriumchlorid

VOLUVEN 10 % oldatos infúzió

100 g/l, 9,0 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Ungarn

| Fresenius Kabi Deutschland GmbH |
| --- |
| Else-Kröner-Str. 1 |
| 61352 Bad Homburg v.d.H. |
| Germany |

Fresenius Kabi Deutschland GmbH

Else-Kröner-Str. 1

61352 Bad Homburg v.d.H.

Germany

Hydroxyethylstivelse, natriumchlorid

VOLUVEN 6 % oldatos infúzió

60,0 g/l, 9,0 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Ungarn

| Fresenius Kabi Deutschland GmbH |
| --- |
| Else-Kröner-Str. 1 |
| 61352 Bad Homburg v.d.H. |
| Germany |

Fresenius Kabi Deutschland GmbH

Else-Kröner-Str. 1

61352 Bad Homburg v.d.H.

Germany

Hydroxyethylstivelse, natriumchlorid

HAES-STERIL 10 % oldatos infúzió

100 g/l, 9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Ungarn

| Fresenius Kabi Deutschland GmbH |
| --- |
| Else-Kröner-Str. 1 |
| 61352 Bad Homburg v.d.H. |
| Germany |

Fresenius Kabi Deutschland GmbH

Else-Kröner-Str. 1

61352 Bad Homburg v.d.H.

Germany

Hydroxyethylstivelse, natriumchlorid

HYPERHAES oldatos infúzió

101 g/l, 9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Ungarn

| B.Braun Melsungen AG |
| --- |
| Carl Braun Strasse 1 |
| Melsungen |
| Germany |

B.Braun Melsungen AG

Carl Braun Strasse 1

Melsungen

Germany

HES, natriumchlorid, kaliumchlorid, calciumchloriddihydrat, magnesiumchloridhexahydrat, natriumacetattrihydrat, æblesyre

Tetraspan 60 mg/ml

60 g/l, 6,252 g/l, 0,2984 g/l, 0,3675 g/l, 0,2033 g/l, 3,266 g/l, 0,67 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Ungarn

| B.Braun Melsungen AG |
| --- |
| Carl Braun Strasse 1 |
| Melsungen |
| Germany |

B.Braun Melsungen AG

Carl Braun Strasse 1

Melsungen

Germany

HES, natriumchlorid, kaliumchlorid, calciumchloriddihydrat, magnesiumchloridhexahydrat, natriumacetattrihydrat, æblesyre

Tetraspan 100 mg/ml

100 g/l, 6,252 g/l, 0,2984 g/l, 0,3675 g/l, 0,2033 g/l, 3,266 g/l, 0,67 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Ungarn

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

Baxter Hungary Kft

Népfürdő u. 22.

Budapest H-1138

Hungary

HES, natriumchlorid, kaliumchlorid, calciumchloriddihydrat, magnesiumchloridhexahydrat, natriumacetattrihydrat

HesRa

60 g/l, 6 g/l, 0,4 g/l, 0,134 g/l, 0,2 g/l. 3,7 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Island

| Fresenius Kabi AB – |
| --- |
| Rapsgatan 7 – |
| 751 74 Uppsala |
| Sweden |

Fresenius Kabi AB –

Rapsgatan 7 –

751 74 Uppsala

Sweden

Hydroxyethylstivelse, natriumchlorid

HyperHAES

60 g/l, 72 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Island

| B.Braun Melsungen AG |
| --- |
| Carl Braun Strasse 1 |
| Melsungen |
| Germany |

B.Braun Melsungen AG

Carl Braun Strasse 1

Melsungen

Germany

Hydroxyethylstivelse, natriumchlorid, kaliumchlorid, calciumchlorid, magnesiumchlorid, natriumacetat, æblesyre

Tetraspan

60 g/l, 6,25 g/l, 0,30 g/l, 0,37 g/l, 0,20 g/l, 3,27 g/l, 0,67 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Island

| Fresenius Kabi Deutschland GmBh |
| --- |
| - 61346 Bad Homburg v.d.H |
| Germany |

Fresenius Kabi Deutschland GmBh

- 61346 Bad Homburg v.d.H

Germany

Hydroxyethylstivelse, natriumacetat, natriumchlorid, kaliumchlorid, magnesiumchlorid

Volulyte

60 g/l, 4,63 g/l, 6,02 g/l, 0,30 g/l, 0,30 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Island

| Fresenius Kabi AB |
| --- |
| Rapsgatan 7 |
| 751 74 Uppsala |
| Sweden |

Fresenius Kabi AB

Rapsgatan 7

751 74 Uppsala

Sweden

Hydroxyethylstivelse, natriumchlorid

Voluven

60 g/l, 9,0 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Irland

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

Baxter Healthcare Limited

Caxton Way

Thetford

Norfolk

IP24 3SE

United Kingdom

Hydroxyethylstivelse, natriumchlorid, kaliumchlorid, calciumchloriddihydrat, magnesiumchloridhexahydrat, natriumacetattrihydrat

Plasma Volume Redibag 6 % Solution for Infusion

60 g/l, 6 g/l, 0,4 g/l, 0,134 g/l, 0,200 g/l, 3,7 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Irland

| B. Braun Melsungen AG, |
| --- |
| Harald Weis, |
| Carl-Braun Strasse 1, |
| 34212 Melsungen, |
| Germany |

B. Braun Melsungen AG,

Harald Weis,

Carl-Braun Strasse 1,

34212 Melsungen,

Germany

Poly (O-2-hydroxyethyl)-stivelse (HES), natriumchlorid, kaliumchlorid, calciumchloriddihydrat, magnesiumchloridhexahydrat, natriumacetattrihydrat, L-æblesyre DAB

EquiHes 60 mg/ml solution for infusion, Ecoflac Plus

60 g/l, 6,25 g/l, 0,3 g/l, 0,37 g/l, 0,2 g/l, 3,27 g/l, 0,67 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Irland

| B. Braun Melsungen AG, |
| --- |
| Harald Weis, |
| Carl-Braun Strasse 1, |
| 34212 Melsungen, |
| Germany |

B. Braun Melsungen AG,

Harald Weis,

Carl-Braun Strasse 1,

34212 Melsungen,

Germany

Poly (O-2-hydroxyethyl)-stivelse (HES), natriumchlorid, kaliumchlorid, calciumchloriddihydrat, magnesiumchloridhexahydrat, natriumacetattrihydrat, æblesyre DAB

EquiHes 100 mg/ml solution for infusion, Ecoflac Plus

100 g/l, 6,25 g/l, 0,3 g/l, 0,37 g/l, 0,2g/l, 3,27 g/l, 0,67 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Irland

| B. Braun Melsungen AG, |
| --- |
| Harald Weis, |
| Carl-Braun Strasse 1, |
| 34212 Melsungen, |
| Germany |

B. Braun Melsungen AG,

Harald Weis,

Carl-Braun Strasse 1,

34212 Melsungen,

Germany

Poly (O-2-hydroxyethyl)-stivelse (HES), natriumchlorid, kaliumchlorid, calciumchloriddihydrat, magnesiumchloridhexahydrat, natriumacetattrihydrat, æblesyre DAB

EquiHes 60 mg/ml solution for infusion, Ecobag

60 g/l, 6,25 g/l, 0,3 g/l, 0,37 g/l, 0,2 g/l, 3,27 g/l, 0,67 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Irland

| B. Braun Melsungen AG, |
| --- |
| Harald Weis, |
| Carl-Braun Strasse 1, |
| 34212 Melsungen, |
| Germany |

B. Braun Melsungen AG,

Harald Weis,

Carl-Braun Strasse 1,

34212 Melsungen,

Germany

Poly (O-2-hydroxyethyl)-stivelse (HES), natriumchlorid, kaliumchlorid, calciumchloriddihydrat, magnesiumchloridhexahydrat, natriumacetattrihydrat, æblesyre DAB

EquiHes 100 mg/ml solution for infusion, Ecobag

100 g/l, 6,25 g/l, 0,30 g/l, 0,37 g/l, 0,20 g/l, 3,27 g/l, 0,67 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Irland

| Fresenius Kabi Limited |
| --- |
| Cestrian Court, |
| Eastgate way |
| Manor Park, |
| Runcorn,Cheshire, |
| WA7 1NT |
| United Kingdom |

Fresenius Kabi Limited

Cestrian Court,

Eastgate way

Manor Park,

Runcorn,Cheshire,

WA7 1NT

United Kingdom

poly (0-2-hydroxyethyl)-stivelse natriumchlorid

HyperHAES

60 g/l, 72 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Irland

| Fresenius Kabi Limited |
| --- |
| Cestrian Court |
| Eastgate way |
| Manor Park |
| Runcorn,Cheshire |
| WA7 1NT |
| United Kingdom |

Fresenius Kabi Limited

Cestrian Court

Eastgate way

Manor Park

Runcorn,Cheshire

WA7 1NT

United Kingdom

poly (0-2-hydroxyethyl)-stivelse natriumchlorid

Voluven 10 % Solution for Infusion (Polyolefine Bag)

100 g/l 9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Irland

| Fresenius Kabi Limited |
| --- |
| Cestrian Court |
| Eastgate way |
| Manor Park |
| Runcorn,Cheshire |
| WA7 1NT |
| United Kingdom |

Fresenius Kabi Limited

Cestrian Court

Eastgate way

Manor Park

Runcorn,Cheshire

WA7 1NT

United Kingdom

poly (o-2-hydroxyethyl)-stivelse natriumchlorid

Voluven 10 % Solution for Infusion (PE Bottle)

100 g/l 9,00 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Irland

| Fresenius Kabi Limited |
| --- |
| Cestrian Court |
| Eastgate way |
| Manor Park |
| Runcorn,Cheshire |
| WA7 1NT |
| United Kingdom |

Fresenius Kabi Limited

Cestrian Court

Eastgate way

Manor Park

Runcorn,Cheshire

WA7 1NT

United Kingdom

poly (o-2-hydroxyethyl)-stivelse natriumchlorid

Voluven 6 % Solution for Infusion (Glass bottle)

60 g/l 9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Irland

| Fresenius Kabi Limited |
| --- |
| Cestrian Court |
| Eastgate way |
| Manor Park |
| Runcorn,Cheshire |
| WA7 1NT |
| United Kingdom |

Fresenius Kabi Limited

Cestrian Court

Eastgate way

Manor Park

Runcorn,Cheshire

WA7 1NT

United Kingdom

poly (o-2-hydroxyethyl)-stivelse natriumchlorid

Voluven 6 % Solution for Infusion (Polyolefine/Freeflex Bag

60 g/l 9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Irland

| Fresenius Kabi Limited |
| --- |
| Cestrian Court |
| Eastgate way |
| Manor Park |
| Runcorn, Cheshire |
| WA7 1NT |
| United Kingdom |

Fresenius Kabi Limited

Cestrian Court

Eastgate way

Manor Park

Runcorn, Cheshire

WA7 1NT

United Kingdom

poly (o-2-hydroxyethyl)-stivelse natriumchlorid

Voluven 6 % Solution for Infusion (PVC Bag)

60 g/l 9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Irland

| Fresenius Kabi Limited |
| --- |
| Cestrian Court |
| Eastgate way |
| Manor Park |
| Runcorn, Cheshire |
| WA7 1NT |
| United Kingdom |

Fresenius Kabi Limited

Cestrian Court

Eastgate way

Manor Park

Runcorn, Cheshire

WA7 1NT

United Kingdom

poly(o-2-hydroxyethyl)-stivelse natriumacetattrihydrat natriumchlorid kaliumchlorid magnesiumchloridhexahydrat

Volulyte 6 % Solution for Infusion, polyoelfine bags

60 g/l, 4,63 g/l, 6,02 g/l, 0,3 g/l, 0,3 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Irland

| Fresenius Kabi Limited |
| --- |
| Cestrian Court |
| Eastgate way |
| Manor Park |
| Runcorn, Cheshire |
| WA7 1NT |
| United Kingdom |

Fresenius Kabi Limited

Cestrian Court

Eastgate way

Manor Park

Runcorn, Cheshire

WA7 1NT

United Kingdom

poly(o-2-hydroxyethyl)-stivelse natriumacetattrihydrat natriumchlorid kaliumchlorid magnesiumchloridhexahydrat

Volulyte 6 % Solution for Infusion, glass bottle

60 g/l, 4,63 g/l, 6,02 g/l, 0,3 g/l, 0,3 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Italien

| FRESENIUS KABI ITALIA Srl |
| --- |
| Via Camagre, 41-43 |
| Isola della Scala (Verona) 37063 |
| Italy |

FRESENIUS KABI ITALIA Srl

Via Camagre, 41-43

Isola della Scala (Verona) 37063

Italy

Hydroxyethylstivelse, natriumchlorid

Vonten

100 g/l, 9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Italien

| FRESENIUS KABI ITALIA Srl |
| --- |
| Via Camagre, 41-43 |
| Isola della Scala (Verona) 37063 |
| Italy |

FRESENIUS KABI ITALIA Srl

Via Camagre, 41-43

Isola della Scala (Verona) 37063

Italy

Hydroxyethylstivelse, natriumchlorid

HyperHAES

60 g/l, 72 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Italien

| FRESENIUS KABI ITALIA Srl |
| --- |
| Via Camagre, 41-43 |
| Isola della Scala (Verona) 37063 |
| Italy |

FRESENIUS KABI ITALIA Srl

Via Camagre, 41-43

Isola della Scala (Verona) 37063

Italy

Hydroxyethylstivelse, natriumchlorid

Voluven

60 g/l, 9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Italien

| B. Braun Melsungen AG |
| --- |
| Carl-Braun-Straße 1 |
| 34209 Melsungen |
| Germany |

B. Braun Melsungen AG

Carl-Braun-Straße 1

34209 Melsungen

Germany

Hydroxyethylstivelse, natriumchlorid

Amidolite

60 g/l, 9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Italien

| B. Braun Melsungen AG |
| --- |
| Carl-Braun-Straße 1 |
| 34209 Melsungen |
| Germany |

B. Braun Melsungen AG

Carl-Braun-Straße 1

34209 Melsungen

Germany

Hydroxyethylstivelse, natriumchlorid, kaliumchlorid, calciumchloriddihydrat, magnesiumchloridhexahydrat, natriumacetattrihydrat, æblesyre

Tetraspan

60 g/l, 6,25 g/l, 0,30 g/l, 0,37 g/l, 0,20 g/l, 3,27 g/l, 0,67 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Italien

| B. Braun Melsungen AG |
| --- |
| Carl-Braun-Straße 1 |
| 34209 Melsungen |
| Germany |

B. Braun Melsungen AG

Carl-Braun-Straße 1

34209 Melsungen

Germany

Hydroxyethylstivelse, natriumchlorid, kaliumchlorid, calciumchloriddihydrat, magnesiumchloridhexahydrat, natriumacetattrihydrat, æblesyre

Tetraspan

100 g/l, 6,25 g/l, 0,30 g/l, 0,37 g/l, 0,20 g/l, 3,27 g/l, 0,67 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Italien

| Baxter S.p.A. |
| --- |
| Piazzale dell industria, 20 |
| 00144 Rome |
| Italy |

Baxter S.p.A.

Piazzale dell industria, 20

00144 Rome

Italy

Hydroxyethylstivelse, natriumchlorid, kaliumchlorid, calciumchloriddihydrat, magnesiumchloridhexahydrat, natriumacetattrihydrat

Plasmavolume

60 g/l, 6 g/l, 0,4 g/l, 0,134 g/l, 0,2 g/l, 3,7 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Italien

| FRESENIUS KABI ITALIA Srl |
| --- |
| Via Camagre, 41-43 |
| Isola della Scala (Verona) 37063 |
| Italy |

FRESENIUS KABI ITALIA Srl

Via Camagre, 41-43

Isola della Scala (Verona) 37063

Italy

Hydroxyethylstivelse, natriumchlorid, kaliumchlorid, magnesiumchloridhexahydrat, natriumacetattrihydrat

Volulyte

60 g/l, 6,02 g/l, 0,3 g/l, 0,3 g/l, 4,63 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Italien

| Fresenius Kabi Deutschland GMBH |
| --- |
| Else-Kröner-Straße 1 |
| 61352 Bad Homburg v.d.H. |
| Germany |

Fresenius Kabi Deutschland GMBH

Else-Kröner-Straße 1

61352 Bad Homburg v.d.H.

Germany

Hydroxyethylstivelse, natriumchlorid

HAES-STERIL

60 g/l, 9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Italien

| Fresenius Kabi Deutschland GMBH |
| --- |
| Else-Kröner-Straße 1 |
| 61352 Bad Homburg v.d.H. |
| Germany |

Fresenius Kabi Deutschland GMBH

Else-Kröner-Straße 1

61352 Bad Homburg v.d.H.

Germany

Hydroxyethylstivelse, natriumchlorid

HAES-STERIL

100 g/l, 9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Letland

| Fresenius Kabi Deutschland GMBH |
| --- |
| Else-Kröner-Straße 1 61346 Bad Homburg v.d.H. |
| Germany |

Fresenius Kabi Deutschland GMBH

Else-Kröner-Straße 1 61346 Bad Homburg v.d.H.

Germany

Poly(O-2-hydroxyethyl)-stivelse, natriumchlorid

Voluven 6 % solution for infusion

60 g, 9 g

infusionsvæske, opløsning

intravenøs anvendelse

Letland

| Fresenius Kabi Polska Sp.z.o.o. |
| --- |
| Ul. Hrubieszowska 2 |
| 01-209 Warszawa |
| Poland |

Fresenius Kabi Polska Sp.z.o.o.

Ul. Hrubieszowska 2

01-209 Warszawa

Poland

Poly(O-2-hydroxyethyl)-stivelse, natriumchlorid

Voluforte solution for infusion

100 g, 9 g

infusionsvæske, opløsning

intravenøs anvendelse

Letland

| Fresenius Kabi Deutschland GmbH |
| --- |
| 61346 Bad Homburg v.d.H. |
| Germany |

Fresenius Kabi Deutschland GmbH

61346 Bad Homburg v.d.H.

Germany

Poly(O-2-hydroxyethyl)-stivelse, natriumacetattrihydrat, natriumchlorid, kaliumchlorid, magnesiumchloridhexahydrat

Volulyte 6 % solution for infusion

60 g, 4,63 g, 6,02 g, 0,30 g, 0,30 g

infusionsvæske, opløsning

intravenøs anvendelse

Letland

| B. Braun Melsungen AG |
| --- |
| Carl-Braun-Strasse 1 |
| 34212 Melsungen |
| Germany |

B. Braun Melsungen AG

Carl-Braun-Strasse 1

34212 Melsungen

Germany

Poly(O-2-hydroxyethyl)-stivelse, natriumchlorid, kaliumchlorid, calciumchloriddihydrat, magnesiumchloridhexahydrat, natriumacetattrihydrat, æblesyre

Tetraspan 60 mg/ml solution for infusion

60 g, 6,25 g, 0,30 g, 0,37 g, 0,20 g, 3,27 g, 0,67 g

infusionsvæske, opløsning

intravenøs anvendelse

Letland

| B. Braun Melsungen AG |
| --- |
| Carl-Braun-Strasse 1 |
| 34212 Melsungen |
| Germany |

B. Braun Melsungen AG

Carl-Braun-Strasse 1

34212 Melsungen

Germany

Poly(O-2-hydroxyethyl)-stivelse, natriumchlorid, kaliumchlorid, calciumchloriddihydrat, magnesiumchloridhexahydrat, natriumacetattrihydrat, æblesyre

Tetraspan 100 mg/ml solution for infusion

100 g, 6,25 g, 0,30 g, 0,37 g, 0,20 g, 3,27 g, 0,67 g

infusionsvæske, opløsning

intravenøs anvendelse

Litauen

| UAB »BERLIN CHEMIE MENARINI BALTIC« |
| --- |
| Jasinskio 16a, |
| LT-01112 Vilnius, |
| Lithuania |

UAB »BERLIN CHEMIE MENARINI BALTIC«

Jasinskio 16a,

LT-01112 Vilnius,

Lithuania

Hydroxyethylstivelse

Refortan

60 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Litauen

| UAB »BERLIN CHEMIE MENARINI BALTIC« |
| --- |
| Jasinskio 16a, |
| LT-01112 Vilnius, |
| Lithuania |

UAB »BERLIN CHEMIE MENARINI BALTIC«

Jasinskio 16a,

LT-01112 Vilnius,

Lithuania

Hydroxyethylstivelse

Refortan Plus

100 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Litauen

| UAB »BERLIN CHEMIE MENARINI BALTIC« |
| --- |
| Jasinskio 16a, |
| LT-01112 Vilnius, |
| Lithuania |

UAB »BERLIN CHEMIE MENARINI BALTIC«

Jasinskio 16a,

LT-01112 Vilnius,

Lithuania

Hydroxyethylstivelse

Stabisol

60 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Litauen

| Fresenius Kabi Polska Sp.zo.o. |
| --- |
| ul.Hrubieszowska 2 |
| 01-209 Warszawa, |
| Poland |

Fresenius Kabi Polska Sp.zo.o.

ul.Hrubieszowska 2

01-209 Warszawa,

Poland

Poli(O-2-hydroxyethyl)-stivelse, natriumchlorid

Voluforte

100 g + 9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Litauen

| Fresenius Kabi Deutchland GmBh |
| --- |
| 61346 Bad Homburg v.d. H. |
| Germany |

Fresenius Kabi Deutchland GmBh

61346 Bad Homburg v.d. H.

Germany

Poli(O-2-hydroxyethyl)-stivelse

Volulyte

60 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Litauen

| Fresenius Kabi Deutschland GmBh |
| --- |
| 61346 Bad Homburg v.d. H. |
| Germany |

Fresenius Kabi Deutschland GmBh

61346 Bad Homburg v.d. H.

Germany

Poli(O-2-hydroxyethyl)-stivelse, natriumchlorid

Voluven

60 g+ 9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Litauen

| B. Braun Melsungen AG |
| --- |
| Carl-Braun-Strasse 1 |
| 34212 Melsungen |
| Germany |

B. Braun Melsungen AG

Carl-Braun-Strasse 1

34212 Melsungen

Germany

Poli(0-2-hydroxyethyl)-stivelse(HEK), natriumchlorid, kaliumchlorid, calciumchloriddihydrat, magnesiumchloridhexahydrat, natriumacetattrihydrat, æblesyre

Tetraspan

60 g, 6,25 g, 0,3 g, 0,37 g, 0,2 g, 3,27 g, 0,67 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Litauen

| B. Braun Melsungen AG |
| --- |
| Carl-Braun-Strasse 1 |
| 34212 Melsungen |
| Germany |

B. Braun Melsungen AG

Carl-Braun-Strasse 1

34212 Melsungen

Germany

Poli(0-2-hydroxyethyl)-stivelse(HEK), natriumchlorid, kaliumchlorid, calciumchloriddihydrat, magnesiumchloridhexahydrat, natriumacetattrihydrat, æblesyre

Tetraspan

100 g, 6,25 g, 0,3 g 0,37g, 0,2 g, 3,27g, 0,67 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Luxembourg

| Fresenius kabi deutschland G.m.b.H. |
| --- |
| 64346 Bad Homburg v.d.H. |
| Germany |

Fresenius kabi deutschland G.m.b.H.

64346 Bad Homburg v.d.H.

Germany

Poly(0-2-hydroxyethyl)-stivelse 200 kDa mol. substitution 0,43-0,55, natriumchlorid

Haes-steril 6 %

60 g/l, 9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Luxembourg

| Fresenius kabi deutschland G.m.b.H. |
| --- |
| 64346 Bad Homburg v.d.H. |
| Germany |

Fresenius kabi deutschland G.m.b.H.

64346 Bad Homburg v.d.H.

Germany

Poly(0-2-hydroxyethyl)-stivelse 200 kDa mol. substitution 0,43-0,55, natriumchlorid

Haes-steril 10 %

100 g/l, 9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Luxembourg

| B.Braun Melsungen A.G. |
| --- |
| Carl-Braun-Straße 1 |
| D-34212 Melsungen |
| Germany |

B.Braun Melsungen A.G.

Carl-Braun-Straße 1

D-34212 Melsungen

Germany

Poly(0-2-hydroxyethyl)-stivelse 200 kDa mol. substitution 0,45-0,55, natriumchlorid

Hemohes 6 %

60 g/l, 9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Luxembourg

| B.Braun Melsungen A.G. |
| --- |
| Carl-Braun-Straße 1 |
| D-34212 Melsungen |
| Germany |

B.Braun Melsungen A.G.

Carl-Braun-Straße 1

D-34212 Melsungen

Germany

Poly(0-2-hydroxyethyl)-stivelse 200 kDa mol. substitution 0,45-0,55, natriumchlorid

Hemohes 10 %

100 g/l, 9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Luxembourg

| Fresenius kabi deutschland G.m.b.H. |
| --- |
| 61346 Bad Homburg v.d.H. |
| Germany |

Fresenius kabi deutschland G.m.b.H.

61346 Bad Homburg v.d.H.

Germany

Poly(0-2-hydroxyethyl)-stivelse 200 kDa mol. substitution 0,43-0,55, natriumchlorid

Hyperhaes

60 g/l, 72 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Luxembourg

| Baxter S.A. |
| --- |
| Boulevard René Branquart 80 |
| B-7860 Lessines |
| Belgium |

Baxter S.A.

Boulevard René Branquart 80

B-7860 Lessines

Belgium

Poly(0-2-hydroxyethyl)-stivelse 130 kDa mol. substitution 0,42, natriumchlorid, kaliumchlorid, calciumchloridtrihydrat, magnesiumchloridhexahydrat, natriumacetattrihydrat

Plasma Volume Redibag 6 %

60 g/l, 6 g/l, 0,4 g/l, 0,134 g/l, 0,2 g/l, 3,7 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Luxembourg

| B.Braun Melsungen A.G. |
| --- |
| Carl-Braun-Straße 1 |
| D-34212 Melsungen |
| Germany |

B.Braun Melsungen A.G.

Carl-Braun-Straße 1

D-34212 Melsungen

Germany

Poly(0-2-hydroxyethyl)-stivelse 130 kDa mol. substitution 0,42, natriumchlorid, kaliumchlorid, calciumchloriddihydrat, magnesiumchloridhexahydrat, natriumacetattrihydrat, æblesyre

Tetraspan 6 %

60 g/l, 6,25 g/l, 0,3 g/l, 0,37 g/l, 0,2 g/l, 3,27 g/l, 0,67 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Luxembourg

| B.Braun Melsungen A.G. |
| --- |
| Carl-Braun-Straße 1 |
| D-34212 Melsungen |
| Germany |

B.Braun Melsungen A.G.

Carl-Braun-Straße 1

D-34212 Melsungen

Germany

Poly(0-2-hydroxyethyl)-stivelse 130 kDa mol. substitution 0,42, natriumchlorid, kaliumchlorid, calciumchloriddihydrat, magnesiumchloridhexahydrat, natriumacetattrihydrat, æblesyre

Tetraspan 10 %

100 g/l, 6,25 g/l, 0,3 g/l, 0,37 g/l, 0,2 g/l, 3,27 g/l, 0,67 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Luxembourg

| B.Braun Melsungen A.G. |
| --- |
| Carl-Braun-Straße 1 |
| D-34212 Melsungen |
| Germany |

B.Braun Melsungen A.G.

Carl-Braun-Straße 1

D-34212 Melsungen

Germany

Poly(0-2-hydroxyethyl)-stivelse 130 kDa mol. substitution 0,42, natriumchlorid

Venofundin 60 mg/ml

60 g/l, 9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Luxembourg

| Fresenius kabi deutschland G.m.b.H. |
| --- |
| 61346 Bad Homburg v.d.H. |
| Germany |

Fresenius kabi deutschland G.m.b.H.

61346 Bad Homburg v.d.H.

Germany

Poly(0-2-hydroxyethyl)-stivelse 130 kDa mol. substitution 0,38-0,45, natriumacetattrihydrat, natriumchlorid, kaliumchlorid, magnesiumchloridhexahydrat

Volulyte 6 %

60 g/l, 4,63 g/l, 6,02 g/l, 0,3 g/l 0,3 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Luxembourg

| Fresenius kabi deutschland G.m.b.H. |
| --- |
| 61346 Bad Homburg v.d.H. |
| Germany |

Fresenius kabi deutschland G.m.b.H.

61346 Bad Homburg v.d.H.

Germany

Poly(0-2-hydroxyethyl)-stivelse 130 kDa mol. substitution 0,38-0,45, natriumchlorid

Voluven 6 %

60 g/l, 9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Luxembourg

| Fresenius kabi deutschland G.m.b.H. |
| --- |
| 61346 Bad Homburg v.d.H. |
| Germany |

Fresenius kabi deutschland G.m.b.H.

61346 Bad Homburg v.d.H.

Germany

Poly(0-2-hydroxyethyl)-stivelse 130 kDa mol. substitution 0,38-0,45, natriumchlorid

Voluven 10 %

100 g/l, 9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Malta

| Fresenius Kabi Limited |
| --- |
| Cestrian Court |
| Eastgate Way |
| Manor Park |
| Runcorn |
| Cheshire |
| WA7 1NT |
| United Kingdom |

Fresenius Kabi Limited

Cestrian Court

Eastgate Way

Manor Park

Runcorn

Cheshire

WA7 1NT

United Kingdom

Natriumacetattrihydrat, natriumchlorid, kaliumchlorid, magnesiumchloridhexahydrat, hydroxyethylstivelse 130/0,4

Volulyte 6 % solution for infusion

4,63 g/l, 6,02 g/l, 0,3 g/l, 0,3 g/l, 60 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Malta

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

Baxter Healthcare Limited

Caxton Way

Thetford

Norfolk

IP24 3SE

United Kingdom

Poly (O-2-hydroxyethylstivelse (HES), natriumchlorid, kaliumchlorid, calciumchloriddihydrat, magnesiumchloridhexahydrat, natriumacetattrihydrat

Plasma Volume Redibag 6 % solution for infusion

60 g/l, 6 g/l, 0,4 g/l, 0,134 g/l, 0,200 g/l, 3,7 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Norge

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

Baxter AS

Gjerdumsvei 11

0484 Oslo

Norway

Poly(O-2-hydroxyethyl)-stivelse (HES), natriumchlorid, kaliumchlorid, calciumchloriddihydrat, magnesiumchloridhexahydrat, natriumacetattrihydrat

Hesra

60 g/l, 6,00 g/l, 0,400 g/l, 0,134 g/l, 0,200 g/l, 3,70 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Norge

| Fresenius Kabi Norge AS |
| --- |
| Postboks 430 |
| 1753 Halden |
| Norway |

Fresenius Kabi Norge AS

Postboks 430

1753 Halden

Norway

Poly(O-2-hydroxyethyl)-stivelse (HES), natriumchlorid

HyperHAES

60 g/l, 72 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Norge

| B. Braun Melsungen AG |
| --- |
| Carl-Braun-Straße 1 |
| 34212 Melsungen |
| Germany |

B. Braun Melsungen AG

Carl-Braun-Straße 1

34212 Melsungen

Germany

Poly(O-2-hydroxyethyl)-stivelse (HES), natriumchlorid, kaliumchlorid, calciumchloriddihydrat, magnesiumchloridhexahydrat, natriumacetattrihydrat, æblesyre

Tetraspan

60 g/l, 6,25 g/l, 0,30 g/l, 0,37 g/l, 0,20 g/l, 3, 27 g/l, 0,67 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Norge

| B. Braun Melsungen AG |
| --- |
| Carl-Braun-Straße 1 |
| 34212 Melsungen |
| Germany |

B. Braun Melsungen AG

Carl-Braun-Straße 1

34212 Melsungen

Germany

Poly(O-2-hydroxyethyl)-stivelse (HES), natriumchlorid

Venofundin

60 g/l, 9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Norge

| Fresenius Kabi Norge AS |
| --- |
| Postboks 430 |
| 1753 Halden |
| Norway |

Fresenius Kabi Norge AS

Postboks 430

1753 Halden

Norway

Poly(O-2-hydroxyethyl)-stivelse (HES), natriumacetattrihydrat, natriumchlorid, kaliumchlorid, magnesiumchloridhexahydrat

Volulyte

60 g/l, 4,63 g/l, 6,02 g/l, 0,30 g/l, 0,30 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Norge

| Fresenius Kabi Norge AS |
| --- |
| Postboks 430 |
| 1753 Halden |
| Norway |

Fresenius Kabi Norge AS

Postboks 430

1753 Halden

Norway

Poly(O-2-hydroxyethyl)-stivelse (HES), natriumchlorid

Voluven

100 g/l, 9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Norge

| Fresenius Kabi Norge AS |
| --- |
| Postboks 430 |
| 1753 Halden |
| Norway |

Fresenius Kabi Norge AS

Postboks 430

1753 Halden

Norway

Poly(O-2-hydroxyethyl)-stivelse (HES), natriumchlorid

Voluven

60 g/l, 9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Polen

| Fresenius Kabi Deutschland GmbH |
| --- |
| 61346 Bad Homburg v.d.H. |
| Germany |

Fresenius Kabi Deutschland GmbH

61346 Bad Homburg v.d.H.

Germany

Hydroxyethylstivelse

HAES - steril 10 %

100 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Polen

| Berlin-Chemie AG |
| --- |
| Glienicker Weg 125 |
| 12489 Berlin |
| Germany |

Berlin-Chemie AG

Glienicker Weg 125

12489 Berlin

Germany

Hydroxyethylstivelse, natriumchlorid

Refortan

60 g/l 9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Polen

| Baxter Polska Sp. z o.o. |
| --- |
| ul. Kruczkowskiego 8 |
| 00-380 Warszawa |
| Poland |

Baxter Polska Sp. z o.o.

ul. Kruczkowskiego 8

00-380 Warszawa

Poland

Hydroxyethylstivelse,

6 % Hydroksyetyloskrobia 200/0,5 Baxter

60 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Polen

| Baxter Polska Sp. z o.o. |
| --- |
| ul. Kruczkowskiego 8 |
| 00-380 Warszawa |
| Poland |

Baxter Polska Sp. z o.o.

ul. Kruczkowskiego 8

00-380 Warszawa

Poland

Hydroxyethylstivelse

10 % Hydroksyetyloskrobia 200/0,5 Baxter

100 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Polen

| Berlin-Chemie AG |
| --- |
| Glienicker Weg 125 |
| 12489 Berlin |
| Germany |

Berlin-Chemie AG

Glienicker Weg 125

12489 Berlin

Germany

Hydroxyethylstivelse, natriumchlorid

Refortan Forte

100 g/l 9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Polen

| B. Braun Melsungen AG |
| --- |
| Carl-Braun Strasse 1 |
| 34212 Melsungen |
| Germany |

B. Braun Melsungen AG

Carl-Braun Strasse 1

34212 Melsungen

Germany

Hydroxyethylstivelse, natriumchlorid

Hemohes 6 %

60 g/l 9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Polen

| B. Braun Melsungen AG |
| --- |
| Carl-Braun Strasse 1 |
| 34212 Melsungen |
| Germany |

B. Braun Melsungen AG

Carl-Braun Strasse 1

34212 Melsungen

Germany

Hydroxyethylstivelse, natriumchlorid

Hemohes 10 %

100 g/l 9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Polen

| B. Braun Melsungen AG |
| --- |
| Carl-Braun Strasse 1 |
| 34212 Melsungen |
| Germany |

B. Braun Melsungen AG

Carl-Braun Strasse 1

34212 Melsungen

Germany

Hydroxyethylstivelse, natriumchlorid, kaliumchlorid, calciumchloridhydrat, magnesiumchloridhydrat, natriumacetathydrat, hydroxysuccinat

Tetraspan 60 mg/ml HES roztwór do infuzji

60 g/l 6,25 g/l 0,30 g/l 0,37 g/l 0,20 g/l 3,27 g/l 0,67 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Polen

| B. Braun Melsungen AG |
| --- |
| Carl-Braun Strasse 1 |
| 34212 Melsungen |
| Germany |

B. Braun Melsungen AG

Carl-Braun Strasse 1

34212 Melsungen

Germany

Hydroxyethylstivelse, natriumchlorid, kaliumchlorid, calciumchloridhydrat, magnesiumchloridhydrat, natriumacetathydrat, hydroxysuccinat (hydroxyl ravsyre)

Tetraspan 100 mg/ml HES roztwór do infuzji

100 g/l 6,252 g/l 0,2984 g/l 0,3675 g/l 0,2033 g/l 3,266 g/l 0,6710 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Polen

| Baxter Polska Sp. z o.o. |
| --- |
| ul. Kruczkowskiego 8 |
| 00-380 Warszawa |
| Poland |

Baxter Polska Sp. z o.o.

ul. Kruczkowskiego 8

00-380 Warszawa

Poland

Hydroxyethylstivelse, natriumchlorid, kaliumchlorid, calciumchloridhydrat, magnesiumchloridhydrat, natriumacetathydrat

PlasmaVolume Redibag

60 g/l 6,0 g/l 0,4 g/l 0,134 g/l 0,2 g/l 3,70 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Polen

| Fresenius Kabi Polska Sp. z o.o. |
| --- |
| ul. Hrubieszowska 2 |
| 01-209 Warszawa |
| Poland |

Fresenius Kabi Polska Sp. z o.o.

ul. Hrubieszowska 2

01-209 Warszawa

Poland

Hydroxyethylstivelse, natriumchlorid

Voluven 10 %

100 g/l 9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Polen

| Fresenius Kabi Deutschland GmBh |
| --- |
| 61346 Bad Homburg v.d.H. |
| Germany |

Fresenius Kabi Deutschland GmBh

61346 Bad Homburg v.d.H.

Germany

Polyhydroxyethylstivelse, natriumchlorid

HyperHAES

60 g/l, 72 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Polen

| Fresenius Kabi Deutschland GmBh |
| --- |
| D-61346 Bad Homburg v.d.H |
| Germany |

Fresenius Kabi Deutschland GmBh

D-61346 Bad Homburg v.d.H

Germany

Hydroxyethylstivelse, natriumchlorid

VOLUVEN

60 g/l 9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Polen

| Fresenius Kabi Deutschland GmBh |
| --- |
| D-61346 Bad Homburg v.d.H |
| Germany |

Fresenius Kabi Deutschland GmBh

D-61346 Bad Homburg v.d.H

Germany

Poly(O-2-hydoxyethyl)-stivelse 130/0,4, natriumchlorid, natriumacetattrihydrat, kaliumchlorid, magnesiumchloridhexahydrat

Volulyte 6 %

60 g/l, 6,02 g/l, 4,63 g/l, 0,30 g/l, 0,30 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Portugal

| Fresenius Kabi Pharma Portugal, Lda |
| --- |
| Av. do Forte, 3 |
| Edifício Suécia III - Piso 2 |
| 2790-073 Carnaxide |
| Portugal |

Fresenius Kabi Pharma Portugal, Lda

Av. do Forte, 3

Edifício Suécia III - Piso 2

2790-073 Carnaxide

Portugal

Hydroxyethylstivelse + natriumchlorid

Haes-Steril 10 %

100 mg/ml + 9 mg/ml

infusionsvæske, opløsning

intravenøs anvendelse

Portugal

| Fresenius Kabi Pharma Portugal, Lda |
| --- |
| Av. do Forte, 3 |
| Edifício Suécia III - Piso 2 |
| 2790-073 Carnaxide |
| Portugal |

Fresenius Kabi Pharma Portugal, Lda

Av. do Forte, 3

Edifício Suécia III - Piso 2

2790-073 Carnaxide

Portugal

Hydroxyethylstivelse + natriumchlorid

Haes-Steril 6 %

60 mg/ml + 9 mg/ml

infusionsvæske, opløsning

intravenøs anvendelse

Portugal

| Fresenius Kabi Pharma Portugal, Lda |
| --- |
| Av. do Forte, 3 |
| Edifício Suécia III - Piso 2 |
| 2790-073 Carnaxide |
| Portugal |

Fresenius Kabi Pharma Portugal, Lda

Av. do Forte, 3

Edifício Suécia III - Piso 2

2790-073 Carnaxide

Portugal

Hydroxyethylstivelse + natriumchlorid

Voluven Fresenius

60 mg/ml + 9 mg/ml

infusionsvæske, opløsning

intravenøs anvendelse

Portugal

| Fresenius Kabi Pharma Portugal, Lda |
| --- |
| Av. do Forte, 3 |
| Edifício Suécia III - Piso 2 |
| 2790-073 Carnaxide |
| Ptl |

Fresenius Kabi Pharma Portugal, Lda

Av. do Forte, 3

Edifício Suécia III - Piso 2

2790-073 Carnaxide

Ptl

Hydroxyethylstivelse + natriumchlorid

HyperHAES

60 mg/ml + 72 mg/ml

infusionsvæske, opløsning

intravenøs anvendelse

Portugal

| B. Braun Melsungen A.G. |
| --- |
| Carl-Braun Strasse, 1 |
| D-34212 Melsungen |
| Germany |

B. Braun Melsungen A.G.

Carl-Braun Strasse, 1

D-34212 Melsungen

Germany

Hydroxyethylstivelse + natriumchlorid

Venofundin

60 mg/ml + 9 mg/ml

infusionsvæske, opløsning

intravenøs anvendelse

Portugal

| Fresenius Kabi Pharma Portugal, Lda |
| --- |
| Av. do Forte, 3 |
| Edifício Suécia III - Piso 2 |
| 2790-073 Carnaxide |
| Portugal |

Fresenius Kabi Pharma Portugal, Lda

Av. do Forte, 3

Edifício Suécia III - Piso 2

2790-073 Carnaxide

Portugal

Kaliumchlorid + natriumacetattrihydrat + magnesiumchloridhexahydrat + hydroxyethylstivelse + natriumchlorid

Volulyte

0,3 mg/ml, 4,63 mg/ml, 0,3 mg/ml, 60 mg/ml, 6,02 mg/ml

infusionsvæske, opløsning

intravenøs anvendelse

Portugal

| B. Braun Melsungen A.G. |
| --- |
| Carl-Braun Strasse, 1 |
| D-34212 Melsungen |
| Germany |

B. Braun Melsungen A.G.

Carl-Braun Strasse, 1

D-34212 Melsungen

Germany

Kaliumchlorid + natriumacetattrihydrat + æblesyre + magnesiumchloridhexahydrat + natriumchlorid + hydroxyethylstivelse + calciumchloriddihydrat

Tetraspan

0,3 mg/ml, 3,27 mg/ml 0,67 mg/ml, 0,2 mg/ml 6,25 mg/ml, 60 mg/ml, 0,37 mg/ml

infusionsvæske, opløsning

intravenøs anvendelse

Portugal

| B. Braun Melsungen A.G. |
| --- |
| Carl-Braun Strasse, 1 |
| D-34212 Melsungen |
| Germany |

B. Braun Melsungen A.G.

Carl-Braun Strasse, 1

D-34212 Melsungen

Germany

Kaliumchlorid + natriumacetattrihydrat + æblesyre + magnesiumchloridhexahydrat + natriumchlorid + hydroxyethylstivelse + calciumchloriddihydrat

Tetraspan

0,3 mg/ml, 3,27 mg/ml, 0,67 mg/ml, 0,2 mg/ml, 6,25 mg/ml,100 mg/ml, 0,37 mg/ml

infusionsvæske, opløsning

intravenøs anvendelse

Portugal

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

Baxter Médico-Farmacêutica, Lda.

Zona Industrial da Abrunheira - Edifício 10 - Sintra Business Park

2710-089 Sintra

Portugal

Natriumacetattrihydrat + kaliumchlorid + magnesiumchloridhexahydrat + hydroxyethylstivelse + calciumchloriddihydrat + natriumchlorid

PlasmaVolume Redibag

3,7 mg/ml, 0,4 mg/ml, 0,2 mg/ml, 60 mg/ml, 0,134 mg/ml, 6 mg/ml

infusionsvæske, opløsning

intravenøs anvendelse

Portugal

| Fresenius Kabi Pharma Portugal, Lda |
| --- |
| Av. do Forte, 3 |
| Edifício Suécia III - Piso 2 |
| 2790-073 Carnaxide |
| Portugal |

Fresenius Kabi Pharma Portugal, Lda

Av. do Forte, 3

Edifício Suécia III - Piso 2

2790-073 Carnaxide

Portugal

Hydroxyethylstivelse + natriumchlorid

Voluven Fresenius

100 mg/ml, 9 mg/ml

infusionsvæske, opløsning

intravenøs anvendelse

Rumænien

| S.C. INFOMED FLUIDS S.R.L., |
| --- |
| B-dul Theodor Pallady nr. 50, sector 3, București, |
| 032266 |
| Romania |

S.C. INFOMED FLUIDS S.R.L.,

B-dul Theodor Pallady nr. 50, sector 3, București,

032266

Romania

Hydroxyethylstivelse natriumchlorid kaliumchlorid calciumchloriddihydrat magnesiumchloridhexahydrat natriumacetattrihydrat

VITAFUSAL

60 g/l, 6 g/l, 0,40 g/l, 0,134 g/l, 0,20 g/l, 3,70 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Rumænien

| Fresenius Kabi Deutschland GmbH, |
| --- |
| 61346 Bad Homburg v.d.H., |
| Germany |

Fresenius Kabi Deutschland GmbH,

61346 Bad Homburg v.d.H.,

Germany

Hydroxyethylstivelse natriumchlorid

Voluven 60 g/1 000 ml

60 g/l, 9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Rumænien

| S.C. FRESENIUS KABI ROMÂNIA S.R.L. |
| --- |
| Strada Fânarului nr. 2A, |
| 500464 Brașov, |
| Romania |

S.C. FRESENIUS KABI ROMÂNIA S.R.L.

Strada Fânarului nr. 2A,

500464 Brașov,

Romania

Hydroxyethylstivelse natriumchlorid

VOLUVEN 10 %

100 g/l, 9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Rumænien

| S.C. INFOMED FLUIDS S.R.L. |
| --- |
| B-dul Theodor Pallady nr. 50, sector 3, București, |
| 032266 |
| Romania |

S.C. INFOMED FLUIDS S.R.L.

B-dul Theodor Pallady nr. 50, sector 3, București,

032266

Romania

Hydroxyethylstivelse natriumchlorid

INFOHES 60 g/L

60 g/l, 9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Rumænien

| S.C. INFOMED FLUIDS S.R.L. |
| --- |
| B-dul Theodor Pallady nr. 50, sector 3, |
| București, |

S.C. INFOMED FLUIDS S.R.L.

B-dul Theodor Pallady nr. 50, sector 3,

București,

Hydroxyethylstivelse natriumchlorid

INFOHES 100 g/L

100 g/l, 9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Rumænien

| B. BRAUN MELSUNGEN AG |
| --- |
| Carl – Braun str. 1, D – 34212 Melsungen, |
| Germany |

B. BRAUN MELSUNGEN AG

Carl – Braun str. 1, D – 34212 Melsungen,

Germany

Hydroxyethylstivelse natriumchlorid

HEMOHES 6 %

60 g/l, 9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Rumænien

| B. BRAUN MELSUNGEN AG |
| --- |
| Carl – Braun str. 1, |
| D – 34212 Melsungen, |
| Germany |

B. BRAUN MELSUNGEN AG

Carl – Braun str. 1,

D – 34212 Melsungen,

Germany

Hydroxyethylstivelse natriumchlorid

HEMOHES 10 %

100 g/l, 9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Rumænien

| Fresenius Kabi Deutschland GmbH, |
| --- |
| 61346 Bad Homburg v.d.H., |
| Germany |

Fresenius Kabi Deutschland GmbH,

61346 Bad Homburg v.d.H.,

Germany

Hydroxyethylstivelse natriumchlorid

HAES-steril 60 g/1 000 ml

60 g/l, 9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Rumænien

| Fresenius Kabi Deutschland GmbH, |
| --- |
| 61346 Bad Homburg v.d.H., |
| Germany |

Fresenius Kabi Deutschland GmbH,

61346 Bad Homburg v.d.H.,

Germany

Hydroxyethylstivelse natriumchlorid

HAES-steril 100 g/1 000 ml

100 g/l, 9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Rumænien

| B. BRAUN MELSUNGEN AG, |
| --- |
| Carl-Braun-Strasse 1 |
| 34212 Melsungen, |
| Germany |

B. BRAUN MELSUNGEN AG,

Carl-Braun-Strasse 1

34212 Melsungen,

Germany

Hydroxyethylstivelse natriumchlorid

Venofundin 6 g/100 ml

60 g/l, 9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Rumænien

| S.C. Fresenius Kabi Romania S.R.L, |
| --- |
| strada Fanarului nr. 2A, |
| 500464 Brasov, |
| Romania |

S.C. Fresenius Kabi Romania S.R.L,

strada Fanarului nr. 2A,

500464 Brasov,

Romania

Hydroxyethylstivelse, natriumacetattrihydrat, kaliumchlorid, magnesiumchloridhexahydrat, natriumchlorid

Volulyte 6 %

60 g/l, 4,63 g/l, 6,02 g/l, 0,30 g/l, 0,30 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Rumænien

| B. BRAUN MELSUNGEN AG |
| --- |
| Carl-Braun. Str.1, |
| D-34212 Melsungen, |
| Germany |

B. BRAUN MELSUNGEN AG

Carl-Braun. Str.1,

D-34212 Melsungen,

Germany

Hidroxietilamidon, natriumchlorid, kaliumchlorid, magnesiumchloridhexahydrat, calciumchloriddihydrat, natriumacetattrihydrat, æblesyre

TETRASPAN 60 mg/ml

60 g/l, 6,252 g/l, 0,298 g/l, 0,203 g/l, 0,367 g/l, 3,266 g/l, 0,671 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Rumænien

| B. BRAUN MELSUNGEN AG |
| --- |
| Carl-Braun. Str.1, |
| D-34212 Melsungen, |
| Germany |

B. BRAUN MELSUNGEN AG

Carl-Braun. Str.1,

D-34212 Melsungen,

Germany

Hidroxietilamidon, natriumchlorid, kaliumchlorid, magnesiumchloridhexahydrat, calciumchloriddihydrat, natriumacetattrihydrat, æblesyre

TETRASPAN 100 mg/ml

100 g/l, 6,252 g/l, 0,298 g/l, 0,203 g/l, 0,367 g/l, 3,266 g/l, 0,671 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Slovakiet

| Fresenius Kabi Deutschland GmbH |
| --- |
| Else-Kröner-Straße 1 |
| 61352 Bad Homburg v.d.H. |
| Germany |

Fresenius Kabi Deutschland GmbH

Else-Kröner-Straße 1

61352 Bad Homburg v.d.H.

Germany

Hydroxyethylstivelse, natriumchlorid

HAES-steril 10 %

100 g/l, 9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Slovakiet

| Fresenius Kabi Deutschland GmbH |
| --- |
| Else-Kröner-Straße 1 |
| 61352 Bad Homburg v.d.H. |
| Germany |

Fresenius Kabi Deutschland GmbH

Else-Kröner-Straße 1

61352 Bad Homburg v.d.H.

Germany

Hydroxyethylstivelse, natriumchlorid

HyperHAES

60 g/l, 72 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Slovakiet

| BAXTER CZECH spol. s r.o. |
| --- |
| Karla Engliše 3201/6 |
| 150 00 Praha 5 |
| Czech Republic |

BAXTER CZECH spol. s r.o.

Karla Engliše 3201/6

150 00 Praha 5

Czech Republic

Hydroxyethylstivelse, natriumchlorid, kaliumchlorid, calciumchloriddihydrat, magnesiumchloridhexahydrat, natriumacetattrihydrat

PlasmaVolume Redibag

60 g/l, 6 g/l, 0,4 g/l, 0,134 g/l, 0,2 g/l,3,70 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Slovakiet

| B. Braun Melsungen AG |
| --- |
| Carl-Braun-Straße 1 |
| 34212 Melsungen |
| Germany |

B. Braun Melsungen AG

Carl-Braun-Straße 1

34212 Melsungen

Germany

Hydroxyethylstivelse, natriumchlorid, kaliumchlorid, calciumchlorid, magnesiumchloridhexahydrat, sodium acetate, æblesyre

Tetraspan 10 %

100 g/l, 6,25 g/l, 0,30 g/l, 0,37 g/l, 0,20 g/l, 3,27 g /l, 0,67 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Slovakiet

| B. Braun Melsungen AG |
| --- |
| Carl-Braun-Straße 1 |
| 34212 Melsungen |
| Germany |

B. Braun Melsungen AG

Carl-Braun-Straße 1

34212 Melsungen

Germany

Hydroxyethylstivelse, natriumchlorid, kaliumchlorid, calciumchlorid, magnesiumchloridhexahydrat, sodium acetate, æblesyre

Tetraspan 6 %

60 g/l, 6,25 g/l, 0,30 g/l, 0,37 g/l, 0,20 g/l, 3,27 g/l, 0,67 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Slovakiet

| Fresenius Kabi Deutschland GmbH |
| --- |
| Else-Kröner-Straße 1 |
| 61352 Bad Homburg |
| Germany |

Fresenius Kabi Deutschland GmbH

Else-Kröner-Straße 1

61352 Bad Homburg

Germany

Hydroxyethylstivelse, natriumacetattrihydrat, natriumchlorid, kaliumchlorid, magnesiumchloridhexahydrat

Volulyte 6 %, infúzny roztok

60 g/l, 4,63 g/l, 6,02 g/l, 0,30 g/l, 0,30 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Slovakiet

| Fresenius Kabi Deutschland GmbH |
| --- |
| Else-Kröner-Straße 1 |
| 61352 Bad Homburg |
| Germany |

Fresenius Kabi Deutschland GmbH

Else-Kröner-Straße 1

61352 Bad Homburg

Germany

Hydroxyethylstivelse, natriumchlorid

VOLUVEN

60 g/l, 9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Slovakiet

| Fresenius Kabi s.r.o. |
| --- |
| Želetavská 1525/1 |
| 140 00 Praha 4 – Michle |
| Czech Republic |

Fresenius Kabi s.r.o.

Želetavská 1525/1

140 00 Praha 4 – Michle

Czech Republic

Hydroxyethylstivelse, natriumchlorid

Voluven 10 %

100 g/l, 9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Slovenien

| Medias International d.o.o. |
| --- |
| Leskoškova cesta 9D |
| 1000 Ljubljana |
| Slovenia |

Medias International d.o.o.

Leskoškova cesta 9D

1000 Ljubljana

Slovenia

Hydroxyethylstivelse, natriumchlorid

HAES-steril 60 mg/ml raztopina za infundiranje

60,0 g/l, 9,0 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Slovenien

| Baxter d.o.o. |
| --- |
| Železna cesta 18 |
| 1000 Ljubljana |
| Slovenija |

Baxter d.o.o.

Železna cesta 18

1000 Ljubljana

Slovenija

Hydroxyethylstivelse, natriumchlorid, kaliumchlorid, calciumchloriddihydrat, magnesiumchloridhexahydrat, natriumacetattrihydrat

Plasma Volume Redibag 60 mg/ml raztopina za infundiranje

60,0 g/l, 6,0 g/l, 0,4 g/l, 0,134 g/l, 0,2 g/l, 3,7 g/l,

infusionsvæske, opløsning

intravenøs anvendelse

Slovenien

| B.Braun Melsungen AG |
| --- |
| Carl-Braun-Strasse 1 |
| 34212 Melsungen |
| Germany |

B.Braun Melsungen AG

Carl-Braun-Strasse 1

34212 Melsungen

Germany

Hydroxyethylstivelse, natriumchlorid, kaliumchlorid, calciumchloriddihydrat, magnesiumchloridhexahydrat, natriumacetattrihydrat, æblesyre

Tetraspan 60 mg/ml raztopina za infundiranje

60,0 g/l, 6,25 g/l, 0,30 g/l, 0,37 g/l, 0,20 g/l, 3,27 g/l, 0,67 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Slovenien

| B.Braun Melsungen AG |
| --- |
| Carl-Braun-Strasse 1 |
| 34212 Melsungen |
| Germany |

B.Braun Melsungen AG

Carl-Braun-Strasse 1

34212 Melsungen

Germany

Hydroxyethylstivelse, natriumchlorid, kaliumchlorid, calciumchloriddihydrat, magnesiumchloridhexahydrat, natriumacetattrihydrat, æblesyre

Tetraspan 100 mg/ml raztopina za infundiranje

100,0 g/l, 6,25 g/l, 0,30 g/l, 0,37 g/l, 0,20 g/l, 3,27 g/l, 0,67 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Slovenien

| Medias International d.o.o. |
| --- |
| Leskoškova cesta 9D |
| 1000 Ljubljana |
| Slovenia |

Medias International d.o.o.

Leskoškova cesta 9D

1000 Ljubljana

Slovenia

Hydroxyethylstivelse, natriumchlorid, kaliumchlorid, magnesiumchloridhexahydrat, natriumacetattrihydrat

Volulyte 60 mg/ml raztopina za infundiranje

60,0 g/l, 6,02 g/l, 0,30 g/l, 0,30 g/l, 4,63 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Slovenien

| Fresenius Kabi Deutschland GmBh |
| --- |
| 61346 Bad Homburg v.d.H. |
| Germany |

Fresenius Kabi Deutschland GmBh

61346 Bad Homburg v.d.H.

Germany

Hydroxyethylstivelse, natriumchlorid

VOLUVEN 100 mg/ml raztopina za infundiranje

100,0 g/l, 9,0 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Slovenien

| Medias International d.o.o. |
| --- |
| Leskoškova cesta 9D |
| 1000 Ljubljana |
| Slovenia |

Medias International d.o.o.

Leskoškova cesta 9D

1000 Ljubljana

Slovenia

Hydroxyethylstivelse, natriumchlorid

VOLUVEN 60 mg/ml raztopina za infundiranje

60,0 g/, 9,0 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Spanien

| B. BRAUN MELSUNGEN AG |
| --- |
| Carl-Braun Strasse, 1 |
| Melsungen D-34212 |
| Germany |

B. BRAUN MELSUNGEN AG

Carl-Braun Strasse, 1

Melsungen D-34212

Germany

Hydroxyethylstivelse + natriumchlorid

HEMOES 6 % SOLUCIÓN

60 g/l + 9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Spanien

| B. BRAUN MELSUNGEN AG |
| --- |
| Carl-Braun Strasse, 1 |
| Melsungen D-34212 |
| Germany |

B. BRAUN MELSUNGEN AG

Carl-Braun Strasse, 1

Melsungen D-34212

Germany

Hydroxyethylstivelse + natriumchlorid

HEMOES 10 % SOLUCIÓN

100 g/l + 9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Spanien

| Fresenius Kabi Deutschland GmbH |
| --- |
| Else-Kröner Strasse, 1 |
| 61352 Bad Homburg |
| Germany |

Fresenius Kabi Deutschland GmbH

Else-Kröner Strasse, 1

61352 Bad Homburg

Germany

Hydroxyethylstivelse + natriumchlorid

VOLUVEN 6 % SOLUCIÓN PARA PERFUSIÓN

60 g/l + 9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Spanien

| FRESENIUS KABI ESPAÑA S.A. |
| --- |
| Marina, 16-18-17 |
| 08005 Barcelona |
| Spain |

FRESENIUS KABI ESPAÑA S.A.

Marina, 16-18-17

08005 Barcelona

Spain

Hydroxyethylstivelse + natriumchlorid

VOLUVEN 10 % SOLUCIÓN PARA PERFUSIÓN

100 g/l + 9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Spanien

| Fresenius Kabi Deutschland GmbH |
| --- |
| Else-Kröner Strasse, 1 |
| 61352 Bad Homburg |
| Germany |

Fresenius Kabi Deutschland GmbH

Else-Kröner Strasse, 1

61352 Bad Homburg

Germany

Hydroxyethylstivelse + natriumchlorid

HES HIPERTONICO FRESENIUS SOLUCIÓN PARA PERFUSIÓN

60 g/l + 72 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Spanien

| Fresenius Kabi Deutschland GmbH |
| --- |
| Else-Kröner Strasse, 1 |
| 61352 Bad Homburg |
| Germany |

Fresenius Kabi Deutschland GmbH

Else-Kröner Strasse, 1

61352 Bad Homburg

Germany

Hydroxyethylstivelse + natriumacetattrihydrat + natriumchlorid + kaliumchlorid + magnesiumchloridhexahydrat

VOLULYTE 6 % SOLUCIÓN PARA PERFUSIÓN

60 g/l, 4,63 g/l, 6,02 g/l, 0,30 g/l, 0,30 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Spanien

| B. BRAUN MELSUNGEN AG |
| --- |
| Carl-Braun Strasse, 1 |
| Melsungen D-34212 |
| Germany |

B. BRAUN MELSUNGEN AG

Carl-Braun Strasse, 1

Melsungen D-34212

Germany

Hydroxyethylstivelse + natriumchlorid + kaliumchlorid + calciumchloriddihydrat + magnesiumchloridhexahydrat + natriumacetattrihydrat + æblesyre

ISOHES 6 % SOLUCIÓN PARA PERFUSIÓN

60 g/, 6,25 g/l, 0,30 g/l, 0,37 g/l, 0,20 g/l, 3,27 g/l, 0,67 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Spanien

| B. Braun Melsungen AG |
| --- |
| Carl-Braun Strasse, 1 |
| Melsungen D-34212 |
| Germany |

B. Braun Melsungen AG

Carl-Braun Strasse, 1

Melsungen D-34212

Germany

Hydroxyethylstivelse + natriumchlorid + kaliumchlorid + calciumchloriddihydrat + magnesiumchloridhexahydrat + natriumacetattrihydrat + æblesyre

ISOHES 10 % SOLUCIÓN PARA PERFUSIÓN

100 g/l, 6,25 g/l 0,30 g/, 0,37 g/l, 0,20 g/l, 3,27 g/l, 0,67 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Spanien

| BAXTER S.L. |
| --- |
| Polígono Industrial Sector 14 |
| ouet de Camilo, 2 |
| 46394 Ribarroja del Turia (Valencia) |
| Spain |

BAXTER S.L.

Polígono Industrial Sector 14

ouet de Camilo, 2

46394 Ribarroja del Turia (Valencia)

Spain

Hydroxyethylstivelse + natriumchlorid + kaliumchlorid + calciumchloriddihydrat + magnesiumchloridhexahydrat + natriumacetattrihydrat

PLASMAVOLUME REDIBAG SOLUCIÓN PARA PERFUSIÓN

60 g/l, 6 g/l, 0,4 g/l 0,134 g/l, 0,2 g/l, 3,70 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Sverige

| Fresenius Kabi AB, |
| --- |
| 751 74 Uppsala |
| Sweden |

Fresenius Kabi AB,

751 74 Uppsala

Sweden

Hydroxyethylstivelse, 130/0,4, natriumchlorid

Voluven

60 g/l, 9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Sverige

| Fresenius Kabi AB, |
| --- |
| 751 74 Uppsala |
| Sweden |

Fresenius Kabi AB,

751 74 Uppsala

Sweden

Hydroxyethylstivelse, 200/0,5, natriumchlorid

HyperHAES

60 g/l, 72 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Sverige

| B. Braun Melsungen AG |
| --- |
| P.O. Box 1110 +1120 |
| DE-34209 Melsungen |
| Germany |

B. Braun Melsungen AG

P.O. Box 1110 +1120

DE-34209 Melsungen

Germany

Hydroxyethylstivelse, 130/0,4, natriumchlorid

Venofundin®

60 g/l, 9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Sverige

| B. Braun Melsungen AG |
| --- |
| Carl-Braun-Strasse 1 |
| 34212 Melsungen |
| Germany |

B. Braun Melsungen AG

Carl-Braun-Strasse 1

34212 Melsungen

Germany

Hydroxyethylstivelse, 130/0,4, natriumchlorid, natriumacetattrihydrat, æblesyre, calciumchloriddihydrat, kaliumchlorid, magnesiumchloridhexahydrat

Tetraspan

60 g/l, 6,252 g/l, 3,266 g/l, 0,671 g/l, 0,368 g/l, 0,298 g/l, 0,203 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Sverige

| B. Braun Melsungen AG |
| --- |
| Carl-Braun-Strasse 1 |
| 34212 Melsungen |
| Germany |

B. Braun Melsungen AG

Carl-Braun-Strasse 1

34212 Melsungen

Germany

Hydroxyethylstivelse, 130/0,4, natriumchlorid, natriumacetattrihydrat, æblesyre, calciumchloridihydrat, kaliumchlorid, magnesiumchloridhexahydrat

Tetraspan

100 g/l, 6,252 g/l, 3,266 g/l, 0,671 g/l, 0,368 g/l, 0,298 g/l, 0,203 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Sverige

| Fresenius Kabi AB, |
| --- |
| 751 74 Uppsala |
| Sweden |

Fresenius Kabi AB,

751 74 Uppsala

Sweden

Hydroxyethylstivelse, 130/0,4, natriumchlorid, natriumacetattrihydrat, magnesiumchloridhexahydrat, kaliumchlorid

Volulyte

60 g/l, 6,020 g/l, 4,630 g/l, 0,300 g/l, 0,300 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Sverige

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

Baxter Medical AB

Box 63

164 94 Kista

Sweden

Hydroxyethylstivelse, 130/0,4, natriumchlorid, natriumacetattrihydrat, kaliumchlorid, magnesiumchloridhexahydrat, calciumchloriddihydrat

Hesra

60 g/l, 6,000 g/l, 3,700 g/l, 0,400 g/l, 0,200 g/l, 0,134 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Sverige

| Fresenius Kabi AB, |
| --- |
| 751 74 Uppsala |
| Sweden |

Fresenius Kabi AB,

751 74 Uppsala

Sweden

Hydroxyethylstivelse, 130/0,4, natriumchlorid

Voluven

100 g/l, 9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Holland

| Fresenius Kabi Nederland B.V. |
| --- |
| Molenberglei 7 |
| 2627 Schelle |
| Belgium |

Fresenius Kabi Nederland B.V.

Molenberglei 7

2627 Schelle

Belgium

aktivt stof: Hydroxyethylstivelse (MR 200.000), natriumchlorid

EloHAES, infusievloeistof

60,0 g/l, 9,0 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Holland

| Fresenius Kabi Nederland B.V. |
| --- |
| Molenberglei 7 |
| 2627 Schelle |
| Belgium |

Fresenius Kabi Nederland B.V.

Molenberglei 7

2627 Schelle

Belgium

aktivt stof: Hydroxyethylstivelse (MR 200.000)

HyperHAES, oplossing voor intraveneuze infusie 60 g/l

60,0 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Holland

| B. Braun Melsungen AG (Melsungen) |
| --- |
| Carl-Braun-Strasse 1 |
| 34212 Melsungen |
| Germany |

B. Braun Melsungen AG (Melsungen)

Carl-Braun-Strasse 1

34212 Melsungen

Germany

aktivt stof: Hydroxyethylstivelse (MR 130.000) natriumchlorid, æblesyre, calciumchlorid, kaliumchlorid, magnesiumchlorid, natriumacetat

Tetraspan 10 % g/v, oplossing voor infusie 100 g/l

100,0 g/l, 9 g/l, 0,67 g/l, 0,37 g/l, 0,3 g/l, 0,2 g/l, 3,27 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Holland

| B. Braun Melsungen AG (Melsungen) |
| --- |
| Carl-Braun-Strasse 1 |
| 34212 Melsungen |
| Germany |

B. Braun Melsungen AG (Melsungen)

Carl-Braun-Strasse 1

34212 Melsungen

Germany

aktivt stof: Hydroxyethylstivelse (MR 130.000) natriumchlorid, æblesyre, calciumchlorid, kaliumchlorid, magnesiumchlorid, natriumacetat

Tetraspan 6 % g/v, oplossing voor infusie 60 g/l

60,0 g/l, 6,25 g/l, 0,67 g/l, 0,37 g/l, 0,3 g/l, 0,2 g/l, 3,27 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Holland

| B. Braun Melsungen AG (Melsungen) |
| --- |
| Carl-Braun-Strasse 1 |
| 34212 Melsungen |
| Germany |

B. Braun Melsungen AG (Melsungen)

Carl-Braun-Strasse 1

34212 Melsungen

Germany

aktivt stof: Hydroxyethylstivelse (MR 130.000), natriumchlorid

Venofundin 60 mg/ml, oplossing voor intraveneuze infusie

60,0 g/l, 9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Holland

| Fresenius Kabi Nederland B.V. |
| --- |
| Molenberglei 7 |
| 2627 Schelle |
| Belgium |

Fresenius Kabi Nederland B.V.

Molenberglei 7

2627 Schelle

Belgium

aktivt stof: Hydroxyethylstivelse (MR 130.000), natriumchlorid, kaliumchlorid, magnesiumchlorid, natriumacetat, saltsyre

Volulyte 6 % oplossing voor infusie

60,0 g/l, 6,02 g/l, 0,3 g/l, 0,3 g/l, 4,63 g/l, 0,3 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Holland

| Fresenius Kabi Nederland B.V. |
| --- |
| Molenberglei 7 |
| 2627 Schelle |
| Belgium |

Fresenius Kabi Nederland B.V.

Molenberglei 7

2627 Schelle

Belgium

aktivt stof: Hydroxyethylstivelse (MR 130.000), natriumchlorid

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

60,0 g/l, 0,9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Holland

| Fresenius Kabi Nederland B.V. |
| --- |
| Molenberglei 7 |
| 2627 Schelle |
| Belgium |

Fresenius Kabi Nederland B.V.

Molenberglei 7

2627 Schelle

Belgium

aktivt stof: Hydroxyethylstivelse (polymere 130/0,4) og natriumchlorid

Voluven 10 % (100 mg/ml)

100 g/l, 9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Holland

| Baxter B.V. |
| --- |
| Kobaltweg 49 |
| 3542 CE UTRECHT/The Netherlands |

Baxter B.V.

Kobaltweg 49

3542 CE UTRECHT/The Netherlands

Natriumchlorid, kaliumchlorid, calciumchloriddihydrat, magnesiumchloridhexahydrat, natriumacetattrihydrat, Hydroxyethylstivelse 130/0,42

Plasma Volume Redibag 6 %, solution for infusion

6 g/l, 0,4 g/l, 0,134 g/l, 0,2 g/l, 3,7 g/l, 60 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Storbritannien

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

Baxter Healthcare Limited,

Caxton Way,

Thetford,

Norfolk IP24 3SE

United Kingdom

Natriumchlorid, kaliumchlorid, calciumchloriddihydrat, magnesiumchloridhexahydrat, natriumacetattrihydrat, hydroxyethylstivelse 130/0,42

Plasma Volume Redibag 6 % Solution for Infusion

6 g/l, 0,4 g/l, 0,134 g/l, 0,2 g/l, 3,7 g/l, 60 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Storbritannien

| Fresenius Kabi Limited, |
| --- |
| Cestrian Court, |
| Eastgate Way, |
| Manor Park, |
| Runcorn, Cheshire |
| WA7 1NT |
| United Kingdom |

Fresenius Kabi Limited,

Cestrian Court,

Eastgate Way,

Manor Park,

Runcorn, Cheshire

WA7 1NT

United Kingdom

Hydroxyethylstivelse 130/0,4, natriumchlorid

Voluven 6 % solution for injection

60 g/l, 9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Storbritannien

| Fresenius Kabi Limited, |
| --- |
| Cestrian Court, |
| Eastgate Way, |
| Manor Park, |
| Runcorn, Cheshire |
| WA7 1NT |
| United Kingdom |

Fresenius Kabi Limited,

Cestrian Court,

Eastgate Way,

Manor Park,

Runcorn, Cheshire

WA7 1NT

United Kingdom

Hydroxyethylstivelse 200/0,5, natriumchlorid

Hyperhaes Solution for Injection

72 g/l, 60 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Storbritannien

| Fresenius Kabi Limited, |
| --- |
| Cestrian Court, |
| Eastgate Way, |
| Manor Park, |
| Runcorn, Cheshire |
| WA7 1NT |
| United Kingdom |

Fresenius Kabi Limited,

Cestrian Court,

Eastgate Way,

Manor Park,

Runcorn, Cheshire

WA7 1NT

United Kingdom

Natriumacetattrihydrat, natriumchlorid, kaliumchlorid, magnesiumchloridhexahydrat, hydroxyethylstivelse 130/0,4

Volulyte 6 % solution for infusion

4,63 g/l, 6,02 g/l, 0,3 g/l, 0,3 g/l, 60 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Storbritannien

| Fresenius Kabi Limited, |
| --- |
| Cestrian Court, |
| Eastgate Way, |
| Manor Park, |
| Runcorn, Cheshire |
| WA7 1NT |
| United Kingdom |

Fresenius Kabi Limited,

Cestrian Court,

Eastgate Way,

Manor Park,

Runcorn, Cheshire

WA7 1NT

United Kingdom

Hydroxyethylstivelse 130/0,4, natriumchlorid

Voluven 6 % solution for infusion

60 g/l, 9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Storbritannien

| Fresenius Kabi Limited, |
| --- |
| Cestrian Court, |
| Eastgate Way, |
| Manor Park, |
| Runcorn, Cheshire |
| WA7 1NT |
| United Kingdom |

Fresenius Kabi Limited,

Cestrian Court,

Eastgate Way,

Manor Park,

Runcorn, Cheshire

WA7 1NT

United Kingdom

Natriumchlorid, Hydroxyethylstivelse 130/0,4

Voluven 10 % solution for infusion

9 g/l, 100 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Storbritannien

| B Braun Melsungen AG |
| --- |
| Carl-Braun-Strasse 1 |
| Melsungen, D-34212 |
| Germany |

B Braun Melsungen AG

Carl-Braun-Strasse 1

Melsungen, D-34212

Germany

Poly(O-2-hydroxyethyl)-stivelse mol. sub. 0,45-0,55 gns. MW 200 K, natriumchlorid

Venofundin 6 % solution for infusion

60 g/l, 9 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Storbritannien

| B Braun Melsungen AG |
| --- |
| Carl-Braun-Strasse 1 |
| Melsungen, D-34212 |
| Germany |

B Braun Melsungen AG

Carl-Braun-Strasse 1

Melsungen, D-34212

Germany

Natriumchlorid, kaliumchlorid, magnesiumchloridhexahydrat, natriumacetattrihydrat, æblesyre, poly(0-2-hydroxyethyl)-stivelse, calciumchloriddihydrat

Tetraspan 6 % solution for infusion

6,25 g/l, 0,3 g/l, 0,2 g/l, 3,27 g/l, 0,67 g/l, 60 g/l, 0/37 g/l

infusionsvæske, opløsning

intravenøs anvendelse

Storbritannien

| B Braun Melsungen AG |
| --- |
| Carl-Braun-Strasse 1 |
| Melsungen, D-34212 |
| Germany |

B Braun Melsungen AG

Carl-Braun-Strasse 1

Melsungen, D-34212

Germany

Natriumchlorid, kaliumchlorid, calciumchloriddihydrat, magnesiumchloridhexahydrat, natriumacetattrihydrat, æblesyre, poly(0-2-hydroxyethyl)-stivelse

Tetraspan 10 % solution for infusion

6,25 g/l, 0,3 g/l, 0,37 g/l, 0,2 g/l, 3,27 g/l, 0,67 g/l, 100 g/l

infusionsvæske, opløsning

intravenøs anvendelse

---

BILAG III

FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM(ER), STYRKE(R), ADMINISTRATIONSVEJ(E), INDEHAVER(E) AF MARKEDSFØRINGSTILLADELSE(R) I MEDLEMSSTATERNE

| Medlemsstat
  EU/EAA | Indehaver af markedsføringstilladelse | Særnavn | Styrke | Lægemiddelform | Indgivelsesvej |
| --- | --- | --- | --- | --- | --- |
| Østrig | Hexal Pharma GmbH |
| Stella-Klein-Löw-Weg 17 |
| 1020 Wien |
| Austria |

Medlemsstat

EU/EAA

Indehaver af markedsføringstilladelse

Særnavn

Styrke

Lægemiddelform

Indgivelsesvej

Østrig

Hexal Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Wien

Austria

Metogastron 10 mg - Ampullen

10 mg/2 ml

Injektionsvæske, opløsning

Intramuskulær anvendelse

Intravenøs anvendelse

Østrig

| Hexal Pharma GmbH |
| --- |
| Stella-Klein-Löw-Weg 17 |
| 1020 Wien |
| Austria |

Hexal Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Wien

Austria

Metogastron 4 mg/ml - Tropfen

4 mg/ml

Orale dråber, opløsning

Oral anvendelse

Østrig

| Abbott Products GmbH |
| --- |
| Perfektastraße 84A |
| 1230 Wien |
| Austria |

Abbott Products GmbH

Perfektastraße 84A

1230 Wien

Austria

Paspertin - Filmtabletten

10 mg

Film-coated tablet

Oral anvendelse

Østrig

| Abbott Products GmbH |
| --- |
| Perfektastraße 84A |
| 1230 Wien |
| Austria |

Abbott Products GmbH

Perfektastraße 84A

1230 Wien

Austria

Paspertin 10 mg - Ampullen

10 mg/2 ml

Injektionsvæske, opløsning

Intramuskulær anvendelse

Intravenøs anvendelse

Østrig

| Abbott Products GmbH |
| --- |
| Perfektastraße 84A |
| 1230 Wien |
| Austria |

Abbott Products GmbH

Perfektastraße 84A

1230 Wien

Austria

Paspertin 50 mg - Konzentrat zur Infusionsbereitung

50 mg/10 ml

Koncentrat til infusion, opløsning

Intravenøs anvendelse

Østrig

| Abbott Products GmbH |
| --- |
| Perfektastraße 84A |
| 1230 Wien |
| Austria |

Abbott Products GmbH

Perfektastraße 84A

1230 Wien

Austria

Paspertin 4 mg/ml - Tropfen

4 mg/ml

Orale dråber, opløsning

Oral anvendelse

Belgien

| Sanofi-Aventis Belgium N.V. |
| --- |
| Culliganlaan 1 C |
| 1831 Diegem |
| Belgium |

Sanofi-Aventis Belgium N.V.

Culliganlaan 1 C

1831 Diegem

Belgium

Primperan

10 mg

Tablet

Oral anvendelse

Belgien

| Sanofi-Aventis Belgium N.V. |
| --- |
| Culliganlaan 1 C |
| 1831 Diegem |
| Belgium |

Sanofi-Aventis Belgium N.V.

Culliganlaan 1 C

1831 Diegem

Belgium

Primperan

1 mg/ml

Oral opløsning

Oral anvendelse

Belgien

| Sanofi-Aventis Belgium N.V. |
| --- |
| Culliganlaan 1 C |
| 1831 Diegem |
| Belgium |

Sanofi-Aventis Belgium N.V.

Culliganlaan 1 C

1831 Diegem

Belgium

Primperan

10 mg/2 ml

Injektionsvæske, opløsning

Intramuskulær anvendelse

Intravenøs anvendelse

Belgien

| Sanofi-Aventis Belgium N.V. |
| --- |
| Culliganlaan 1 C |
| 1831 Diegem |
| Belgium |

Sanofi-Aventis Belgium N.V.

Culliganlaan 1 C

1831 Diegem

Belgium

Primperan 20 mg

20 mg

Suppositorium

Rektal anvendelse

Belgien

| Takeda Belgium |
| --- |
| Gentsesteenweg 615 |
| 1080 Brussel |
| Belgium |

Takeda Belgium

Gentsesteenweg 615

1080 Brussel

Belgium

Dibertil

5 mg

Kapsel, blød

Oral anvendelse

Belgien

| Takeda Belgium |
| --- |
| Gentsesteenweg 615 |
| 1080 Brussel |
| Belgium |

Takeda Belgium

Gentsesteenweg 615

1080 Brussel

Belgium

Dibertil

10 mg

Kapsel, blød

Oral anvendelse

Bulgarien

| Sopharma PLC |
| --- |
| 16 Iliensko Shosse Str. |
| Sofia |
| 1220 |
| Bulgaria |

Sopharma PLC

16 Iliensko Shosse Str.

Sofia

1220

Bulgaria

Antiemetin

5 mg/ml

Injektionsvæske, opløsning

Intramuskulær anvendelse

Intravenøs anvendelse

Bulgarien

| Sopharma PLC |
| --- |
| 16 Iliensko Shosse Str. |
| Sofia |
| 1220 |
| Bulgaria |

Sopharma PLC

16 Iliensko Shosse Str.

Sofia

1220

Bulgaria

Antiemetin

5 mg/ml

Sirup

Oral anvendelse

Bulgarien

| AWD.pharma GmbH&Co.KG |
| --- |
| Wasastrasse 50 |
| Radebeul |
| 01445 |
| Germany |

AWD.pharma GmbH&Co.KG

Wasastrasse 50

Radebeul

01445

Germany

Cerucal

10 mg

Tablet

Oral anvendelse

Bulgarien

| Lek Pharmaceuticals d.d. |
| --- |
| Verovskova 57 |
| Ljubljana |
| 1526 |
| Slovenia |

Lek Pharmaceuticals d.d.

Verovskova 57

Ljubljana

1526

Slovenia

Degan

10 mg/2 ml

Injektionsvæske, opløsning

Intramuskulær anvendelse

Intravenøs anvendelse

Bulgarien

| Lek Pharmaceuticals d.d. |
| --- |
| Verovskova 57 |
| Ljubljana |
| 1526 |
| Slovenia |

Lek Pharmaceuticals d.d.

Verovskova 57

Ljubljana

1526

Slovenia

Degan

10 mg

Tablet

Oral anvendelse

Bulgarien

| CSC Pharmaceuticals Ltd. |
| --- |
| 10 Assen Yordanov str. |
| Sofia |
| 1592 |
| Bulgaria |

CSC Pharmaceuticals Ltd.

10 Assen Yordanov str.

Sofia

1592

Bulgaria

Pramidin 10

10 mg/spray

Næsespray, opløsning

Nasal anvendelse

Bulgarien

| CSC Pharmaceuticals Ltd. |
| --- |
| 10 Assen Yordanov str. |
| Sofia |
| 1592 |
| Bulgaria |

CSC Pharmaceuticals Ltd.

10 Assen Yordanov str.

Sofia

1592

Bulgaria

Pramidin 20

20 mg/spray

Næsespray, opløsning

Nasal anvendelse

Bulgarien

| Alkaloid Ltd |
| --- |
| 2 Ricardo Vakarini str. |
| Sofia |
| 1404 |
| Bulgaria |

Alkaloid Ltd

2 Ricardo Vakarini str.

Sofia

1404

Bulgaria

Reglan

10 mg

Tablet

Oral anvendelse

Cypern

| Sanofi Aventis Cyprus ltd |
| --- |
| Charalambou Mouskou 14 |
| 2015 Strovolos Nicosia |
| Cyprus |

Sanofi Aventis Cyprus ltd

Charalambou Mouskou 14

2015 Strovolos Nicosia

Cyprus

Primperan for adults suppository 20 mg

20 mg

Suppositorium

Rektal anvendelse

Cypern

| Sanofi Aventis Cyprus ltd |
| --- |
| Charalambou Mouskou 14 |
| 2015 Strovolos Nicosia |
| Cyprus |

Sanofi Aventis Cyprus ltd

Charalambou Mouskou 14

2015 Strovolos Nicosia

Cyprus

Primperan solution for injection 10 mg/2 ml

10 mg/2 ml

Injektionsvæske, opløsning

Intramuskulær anvendelse

Intravenøs anvendelse

Cypern

| Sanofi Aventis Cyprus ltd |
| --- |
| Charalambou Mouskou 14 |
| 2015 Strovolos Nicosia |
| Cyprus |

Sanofi Aventis Cyprus ltd

Charalambou Mouskou 14

2015 Strovolos Nicosia

Cyprus

Primperan tablets 10 mg

10 mg

Tablet

Oral anvendelse

Cypern

| Medochemie ltd |
| --- |
| 1-10 Constantinoupoleos street |
| P.O.BOX 51409 |
| 3505 Lemesos |
| Cyprus |

Medochemie ltd

1-10 Constantinoupoleos street

P.O.BOX 51409

3505 Lemesos

Cyprus

Elitan tablets 10 mg

10 mg

Tablet

Oral anvendelse

Cypern

| Medochemie ltd |
| --- |
| 1-10 Constantinoupoleos street |
| P.O.BOX 51409 |
| 3505 Lemesos |
| Cyprus |

Medochemie ltd

1-10 Constantinoupoleos street

P.O.BOX 51409

3505 Lemesos

Cyprus

Elitan injection 10 mg/2 ml

10 mg/2 ml

Injektion

Intramuskulær anvendelse

Intravenøs anvendelse

Cypern

| Remedica ltd |
| --- |
| Aharnon street |
| P.O.Box 51706 |
| 3508 Lemesos |
| Cyprus |

Remedica ltd

Aharnon street

P.O.Box 51706

3508 Lemesos

Cyprus

Cloperan tablets 10 mg

10 mg

Tablet

Oral anvendelse

Cypern

| Accord Healthcare Ltd |
| --- |
| Sage House |
| 319 Pinner Road |
| North Harrow |
| Middlesex HA1 4HF |
| United Kingdom |

Accord Healthcare Ltd

Sage House

319 Pinner Road

North Harrow

Middlesex HA1 4HF

United Kingdom

Metoclopramide Accord 10 mg tablet

10 mg

Tablet

Oral anvendelse

Tjekkiet

| Lek Pharmaceuticals d.d. |
| --- |
| Verovškova 57 |
| 1526 Ljubljana |
| Slovenia |

Lek Pharmaceuticals d.d.

Verovškova 57

1526 Ljubljana

Slovenia

Degan 10 mg tablety

10 mg

Tablet

Oral anvendelse

Tjekkiet

| Lek Pharmaceuticals d.d. |
| --- |
| Verovškova 57 |
| 1526 Ljubljana |
| Slovenia |

Lek Pharmaceuticals d.d.

Verovškova 57

1526 Ljubljana

Slovenia

Degan 10 mg roztok pro injekci

5 mg/ml

Injektionsvæske, opløsning

Intramuskulær anvendelse

Intravenøs anvendelse

Tjekkiet

| Hexal AG |
| --- |
| Industriestrasse 25 |
| 83607 Holzkirchen |
| Germany |

Hexal AG

Industriestrasse 25

83607 Holzkirchen

Germany

Mcp hexal 10

10 mg

Tablet

Oral anvendelse

Tjekkiet

| Teva Pharmaceuticals CR, s.r.o. |
| --- |
| Radlická 3185/1c |
| 150 00 Prague |
| Czech Republic |

Teva Pharmaceuticals CR, s.r.o.

Radlická 3185/1c

150 00 Prague

Czech Republic

Cerucal

10 mg

Tablet

Oral anvendelse

Tjekkiet

| Teva Pharmaceuticals CR, s.r.o. |
| --- |
| Radlická 3185/1c |
| 150 00 Prague |
| Czech Republic |

Teva Pharmaceuticals CR, s.r.o.

Radlická 3185/1c

150 00 Prague

Czech Republic

Cerucal

5 mg/ml

Injektionsvæske, opløsning

Intramuskulær anvendelse

Intravenøs anvendelse

Danmark

| Sanofi-aventis Denmark A/S |
| --- |
| Slotsmarken 13 |
| DK-2970 Hørsholm |
| Denmark |

Sanofi-aventis Denmark A/S

Slotsmarken 13

DK-2970 Hørsholm

Denmark

Primperan

10 mg/2 ml

Injektionsvæske, opløsning

Intramuskulær anvendelse

Intravenøs anvendelse

Danmark

| Sanofi-aventis Denmark A/S |
| --- |
| Slotsmarken 13 |
| DK-2970 Hørsholm |
| Denmark |

Sanofi-aventis Denmark A/S

Slotsmarken 13

DK-2970 Hørsholm

Denmark

Primperan

20 mg

Suppositorium

Rektal anvendelse

Danmark

| Orion Corporation |
| --- |
| Orionintie 1A |
| FI-02200 Espoo |
| Finland |

Orion Corporation

Orionintie 1A

FI-02200 Espoo

Finland

Emperal

10 mg

Tablet

Oral anvendelse

Danmark

| Temmler Pharma GmbH & Co |
| --- |
| KG, Temmlerstrasse 2 |
| DE-35039 Marburg |
| Germany |

Temmler Pharma GmbH & Co

KG, Temmlerstrasse 2

DE-35039 Marburg

Germany

Gasto-Timelets

30 mg

Depotkapsel, hård

Oral anvendelse

Estland

| Teva Pharma B.V. |
| --- |
| Computerweg 10 |
| 3542 DR Utrecht |
| The Netherlands |

Teva Pharma B.V.

Computerweg 10

3542 DR Utrecht

The Netherlands

CERUCAL

10 mg

Tablet

Oral anvendelse

Finland

| sanofi-aventis Oy |
| --- |
| Huopalahdentie 24 |
| 00350 Helsinki |
| Finland |

sanofi-aventis Oy

Huopalahdentie 24

00350 Helsinki

Finland

Primperan

20 mg

Suppositorium

Rektal anvendelse

Finland

| sanofi-aventis Oy |
| --- |
| Huopalahdentie 24 |
| 00350 Helsinki |
| Finland |

sanofi-aventis Oy

Huopalahdentie 24

00350 Helsinki

Finland

Primperan

10 mg

Tablet

Oral anvendelse

Finland

| sanofi-aventis Oy |
| --- |
| Huopalahdentie 24 |
| 00350 Helsinki |
| Finland |

sanofi-aventis Oy

Huopalahdentie 24

00350 Helsinki

Finland

Primperan

5 mg/ml

Injektionsvæske, opløsning

Intramuskulær anvendelse

Intravenøs anvendelse

Frankrig

| Sanofi Aventis France |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| France |

Sanofi Aventis France

1-13, boulevard Romain Rolland

75014 Paris

France

PRIMPERAN 10 mg, comprimé sécable

10 mg

Tablet

Oral anvendelse

Frankrig

| Sanofi Aventis France |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| France |

Sanofi Aventis France

1-13, boulevard Romain Rolland

75014 Paris

France

PRIMPERAN 10 mg, suppositoire sécable

10 mg

Suppositorium

Rektal anvendelse

Frankrig

| Sanofi Aventis France |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| France |

Sanofi Aventis France

1-13, boulevard Romain Rolland

75014 Paris

France

PRIMPERAN 20 mg, suppositoire

20 mg

Suppositorium

Rektal anvendelse

Frankrig

| Sanofi Aventis France |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| France |

Sanofi Aventis France

1-13, boulevard Romain Rolland

75014 Paris

France

PRIMPERAN ENFANTS 2,6 mg/ml, solution buvable

2,6 mg/ml

Oral opløsning

Oral anvendelse

Frankrig

| Sanofi Aventis France |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| France |

Sanofi Aventis France

1-13, boulevard Romain Rolland

75014 Paris

France

PRIMPERAN NOURRISSONS ET ENFANTS 2,6 mg/ml, solution buvable

2,6 mg/ml

Orale dråber, opløsning

Oral anvendelse

Frankrig

| Sanofi Aventis France |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| France |

Sanofi Aventis France

1-13, boulevard Romain Rolland

75014 Paris

France

PRIMPERAN 0,1 % ADULTES, solution buvable édulcorée au cyclamate de sodium et à la saccharine sodique

0,10 %

Orale dråber, opløsning

Oral anvendelse

Frankrig

| Sanofi Aventis France |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| France |

Sanofi Aventis France

1-13, boulevard Romain Rolland

75014 Paris

France

PRIMPERAN 0,1 %, solution buvable édulcorée à la saccharine sodique

0,10 %

Oral opløsning

Oral anvendelse

Frankrig

| Sanofi Aventis France |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| France |

Sanofi Aventis France

1-13, boulevard Romain Rolland

75014 Paris

France

PRIMPERAN 10 mg/2 ml, solution injectable en ampoule

10 mg/2 ml

Injektionsvæske, opløsning

Intramuskulær anvendelse

Intravenøs anvendelse

Frankrig

| Sanofi Aventis France |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| France |

Sanofi Aventis France

1-13, boulevard Romain Rolland

75014 Paris

France

PRIMPERAN 100 mg, solution injectable

100 mg/5 ml

Injektionsvæske, opløsning

Intramuskulær anvendelse

Intravenøs anvendelse

Frankrig

| Laboratoire Renaudin |
| --- |
| Z A. Errobi |
| Itxassou |
| 64250 Cambo les Bains |
| France |

Laboratoire Renaudin

Z A. Errobi

Itxassou

64250 Cambo les Bains

France

CHLORHYDRATE DE METOCLOPRAMIDE RENAUDIN 10 mg/2 ml, solution injectable en ampoule

10 mg/2 ml

Injektionsvæske, opløsning

Intramuskulær anvendelse

Intravenøs anvendelse

Frankrig

| Laboratoire Renaudin |
| --- |
| Z A. Errobi |
| Itxassou |
| 64250 Cambo les Bains |
| France |

Laboratoire Renaudin

Z A. Errobi

Itxassou

64250 Cambo les Bains

France

CHLORHYDRATE DE METOCLOPRAMIDE RENAUDIN 20 mg/ml, solution injectable

20 mg/ml

Injektionsvæske, opløsning

Intramuskulær anvendelse

Intravenøs anvendelse

Frankrig

| Panpharma |
| --- |
| ZI du Clairay Luitré |
| 35133 Fougères |
| France |

Panpharma

ZI du Clairay Luitré

35133 Fougères

France

DICHLORHYDRATE DE METOCLOPRAMIDE PANPHARMA 100 mg/5 ml, solution injectable (IM, IV) en ampoule

100 mg/100 ml

Injektionsvæske, opløsning

Intramuskulær anvendelse

Intravenøs anvendelse

Frankrig

| Laboratoires Richard |
| --- |
| rue du Progrès |
| ZI des Reys de Saulce |
| 26270 Saulce sur Rhone |
| France |

Laboratoires Richard

rue du Progrès

ZI des Reys de Saulce

26270 Saulce sur Rhone

France

CHLORHYDRATE DE METOCLOPRAMIDE RICHARD 1 mg/ml, solution buvable

1 mg/ml

Oral opløsning

Oral anvendelse

Frankrig

| Mylan SAS |
| --- |
| 117, allée des Parcs |
| 69800 Saint-Priest |
| France |

Mylan SAS

117, allée des Parcs

69800 Saint-Priest

France

METOCLOPRAMIDE MYLAN 10 mg, comprimé sécable

10 mg

Tablet

Oral anvendelse

Frankrig

| Sandoz |
| --- |
| 49, avenue Georges Pompidou |
| 92300 Levallois-Perret |
| France |

Sandoz

49, avenue Georges Pompidou

92300 Levallois-Perret

France

METOCLOPRAMIDE SANDOZ 10 mg, comprimé sécable

10 mg

Tablet

Oral anvendelse

Frankrig

| Meda Pharma France |
| --- |
| 25, boulevard de l'Amiral Bruix |
| 75016 Paris |
| France |

Meda Pharma France

25, boulevard de l'Amiral Bruix

75016 Paris

France

ANAUSIN METOCLOPRAMIDE 15 mg, comprimé à libération prolongée

15 mg

Depottablet

Oral anvendelse

Frankrig

| Techni-Pharma |
| --- |
| 7, rue de l'Industrie |
| BP 717 |
| 98014 Monaco Cedex |
| Monaco |

Techni-Pharma

7, rue de l'Industrie

BP 717

98014 Monaco Cedex

Monaco

PROKINYL L.P. 15 mg, gélule à libération prolongée

15 mg

Depotkapsel, hård

Oral anvendelse

Tyskland

| 1 A Pharma GmbH |
| --- |
| Keltenring 1 + 3 |
| D-82041 Oberhaching |
| Germany |

1 A Pharma GmbH

Keltenring 1 + 3

D-82041 Oberhaching

Germany

MCP Tropfen-1 A-Pharma

4,21 mg/1 g

Oral opløsning

Oral anvendelse

Tyskland

| Abbott Arzneimittel GmbH |
| --- |
| Freundallee 9A |
| 30173 Hannover |
| Germany |

Abbott Arzneimittel GmbH

Freundallee 9A

30173 Hannover

Germany

Paspertin 10 mg/2 ml Ampullen

10 mg/2 ml

Injektionsvæske, opløsning

Intramuskulær anvendelse

Intravenøs anvendelse

Tyskland

| Abbott Arzneimittel GmbH |
| --- |
| Freundallee 9A |
| 30173 Hannover |
| Germany |

Abbott Arzneimittel GmbH

Freundallee 9A

30173 Hannover

Germany

Paspertin 50 mg/10 ml Ampullen

50 mg/10 ml

Koncentrat til infusion, opløsning

Intravenøs anvendelse

Tyskland

| Abbott Arzneimittel GmbH |
| --- |
| Freundallee 9A |
| 30173 Hannover |
| Germany |

Abbott Arzneimittel GmbH

Freundallee 9A

30173 Hannover

Germany

Paspertin Filmtabletten

10 mg

Film-coated tablet

Oral anvendelse

Tyskland

| Abbott Arzneimittel GmbH |
| --- |
| Freundallee 9A |
| 30173 Hannover |
| Germany |

Abbott Arzneimittel GmbH

Freundallee 9A

30173 Hannover

Germany

Paspertin Tropfen

4 mg/ml

Oral opløsning

Oral anvendelse

Tyskland

| AbZ-Pharma GmbH |
| --- |
| Graf-Arco-Str. 3 |
| 89079 Ulm |
| Germany |

AbZ-Pharma GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

MCP AbZ 5 mg/ml Tropfen

5,91 mg/ml

Oral opløsning

Oral anvendelse

Tyskland

| ALIUD PHARMA GmbH |
| --- |
| Gottlieb-Daimler-Str. 19 |
| D-89150 Laichingen |
| Germany |

ALIUD PHARMA GmbH

Gottlieb-Daimler-Str. 19

D-89150 Laichingen

Germany

MCP AL 10

10,53 mg

Tablet

Oral anvendelse

Tyskland

| ALIUD PHARMA GmbH |
| --- |
| Gottlieb-Daimler-Str. 19 |
| D-89150 Laichingen |
| Germany |

ALIUD PHARMA GmbH

Gottlieb-Daimler-Str. 19

D-89150 Laichingen

Germany

MCP AL retard

30 mg

Depotkapsel, hård

Oral anvendelse

Tyskland

| ALIUD PHARMA GmbH |
| --- |
| Gottlieb-Daimler-Str. 19 |
| D-89150 Laichingen |
| Germany |

ALIUD PHARMA GmbH

Gottlieb-Daimler-Str. 19

D-89150 Laichingen

Germany

MCP AL Tropfen

4,21 mg/1 ml

Oral opløsning

Oral anvendelse

Tyskland

| AWD.pharma GmbH & Co.KG |
| --- |
| Wasastr. 50 |
| D-01445 Radebeul |
| Germany |

AWD.pharma GmbH & Co.KG

Wasastr. 50

D-01445 Radebeul

Germany

Cerucal inject

10,54 mg/2 ml

Injektionsvæske, opløsning

Intramuskulær anvendelse

Intravenøs anvendelse

Tyskland

| AWD.pharma GmbH & Co.KG |
| --- |
| Wasastr. 50 |
| D-01445 Radebeul |
| Germany |

AWD.pharma GmbH & Co.KG

Wasastr. 50

D-01445 Radebeul

Germany

Metoclopramid AWD 10 mg Tabletten

10,53 mg

Tablet

Oral anvendelse

Tyskland

| axcount Generika AG |
| --- |
| Max-Planck-Str. 36b |
| D-61381 Friedrichsdorf |
| Germany |

axcount Generika AG

Max-Planck-Str. 36b

D-61381 Friedrichsdorf

Germany

MCP axcount Tropfen

4,21 mg/ml

Oral opløsning

Oral anvendelse

Tyskland

| betapharm Arzneimittel GmbH |
| --- |
| Kobelweg 95 |
| D-86156 Augsburg |
| Germany |

betapharm Arzneimittel GmbH

Kobelweg 95

D-86156 Augsburg

Germany

MCP-beta Tropfen

4,21 mg/ml

Oral opløsning

Oral anvendelse

Tyskland

| CT Arzneimittel GmbH |
| --- |
| Graf-Arco-Str. 3 |
| 79079 Ulm |
| Germany |

CT Arzneimittel GmbH

Graf-Arco-Str. 3

79079 Ulm

Germany

MCP-CT 10 mg/2 ml Ampullen

10 mg/2 ml

Injektionsvæske, opløsning

Intramuskulær anvendelse

Intravenøs anvendelse

Tyskland

| CT Arzneimittel GmbH |
| --- |
| Graf-Arco-Str. 3 |
| 79079 Ulm |
| Germany |

CT Arzneimittel GmbH

Graf-Arco-Str. 3

79079 Ulm

Germany

MCP-CT 30 mg Retardkapseln

30 mg

Depotkapsel, hård

Oral anvendelse

Tyskland

| CT Arzneimittel GmbH |
| --- |
| Graf-Arco-Str. 3 |
| 79079 Ulm |
| Germany |

CT Arzneimittel GmbH

Graf-Arco-Str. 3

79079 Ulm

Germany

MCP-CT 4 mg/1 ml Tropfen

5,2 mg/ml

Oral opløsning

Oral anvendelse

Tyskland

| DOCPHARM Arzneimittelvertrieb GmbH & Co |
| --- |
| Greschbachstr. 7 |
| D-76229 Karlsruhe |
| Germany |

DOCPHARM Arzneimittelvertrieb GmbH & Co

Greschbachstr. 7

D-76229 Karlsruhe

Germany

Metoclopramid Injektionslösung 10 ml PB

52,65 mg/10 ml

Injektionsvæske, opløsning

Intravenøs anvendelse

Tyskland

| Dolorgiet GmbH & Co.KG |
| --- |
| Otto-von-Guericke-Str. 1 |
| D-53757 Sankt Augustin |
| Tyskland |

Dolorgiet GmbH & Co.KG

Otto-von-Guericke-Str. 1

D-53757 Sankt Augustin

Tyskland

Gastronerton

465 mg/100 ml

Oral opløsning

Oral anvendelse

Tyskland

| Dolorgiet GmbH & Co.KG |
| --- |
| Otto-von-Guericke-Str. 1 |
| D-53757 Sankt Augustin |
| Germany |

Dolorgiet GmbH & Co.KG

Otto-von-Guericke-Str. 1

D-53757 Sankt Augustin

Germany

Gastronerton

8,92 mg

Tablet

Oral anvendelse

Tyskland

| hameln pharmaceuticals GmbH |
| --- |
| Langes Feld 13 |
| D-31789 Hameln |
| Germany |

hameln pharmaceuticals GmbH

Langes Feld 13

D-31789 Hameln

Germany

Metoclo-hameln 5 mg/ml, Injektionslösung

10,53 mg/2 ml

Injektionsvæske, opløsning

Intramuskulær anvendelse

Intravenøs anvendelse

Tyskland

| Heumann Pharma GmbH & Co. Generica KG |
| --- |
| Südwestpark 50 |
| D-90449 Nürnberg |
| Germany |

Heumann Pharma GmbH & Co. Generica KG

Südwestpark 50

D-90449 Nürnberg

Germany

Gastrosil 10 mg Amp.

10 mg/2 ml

Injektionsvæske, opløsning

Intramuskulær anvendelse

Intravenøs anvendelse

Tyskland

| Heumann Pharma GmbH & Co. Generica KG |
| --- |
| Südwestpark 50 |
| D-90449 Nürnberg |
| Germany |

Heumann Pharma GmbH & Co. Generica KG

Südwestpark 50

D-90449 Nürnberg

Germany

Gastrosil 20 mg Supp.

20 mg

Suppositorium

Rektal anvendelse

Tyskland

| Heumann Pharma GmbH & Co. Generica KG |
| --- |
| Südwestpark 50 |
| D-90449 Nürnberg |
| Germany |

Heumann Pharma GmbH & Co. Generica KG

Südwestpark 50

D-90449 Nürnberg

Germany

Gastrosil 50 mg Amp.

52,7 mg/10 ml

Injektionsvæske, opløsning

Intravenøs anvendelse

Tyskland

| Heumann Pharma GmbH & Co. Generica KG |
| --- |
| Südwestpark 50 |
| D-90449 Nürnberg |
| Germany |

Heumann Pharma GmbH & Co. Generica KG

Südwestpark 50

D-90449 Nürnberg

Germany

Gastrosil akut Tropfen

5,97 mg/ml

Oral opløsning

Oral anvendelse

Tyskland

| Heumann Pharma GmbH & Co. Generica KG |
| --- |
| Südwestpark 50 |
| D-90449 Nürnberg |
| Germany |

Heumann Pharma GmbH & Co. Generica KG

Südwestpark 50

D-90449 Nürnberg

Germany

Gastrosil retard

31,6 mg

Depotkapsel, hård

Oral anvendelse

Tyskland

| Heumann Pharma GmbH & Co. Generica KG |
| --- |
| Südwestpark 50 |
| D-90449 Nürnberg |
| Germany |

Heumann Pharma GmbH & Co. Generica KG

Südwestpark 50

D-90449 Nürnberg

Germany

Gastrosil retard mite

15,8 mg

Depotkapsel, hård

Oral anvendelse

Tyskland

| Heumann Pharma GmbH & Co. Generica KG |
| --- |
| Südwestpark 50 |
| D-90449 Nürnberg |
| Germany |

Heumann Pharma GmbH & Co. Generica KG

Südwestpark 50

D-90449 Nürnberg

Germany

Gastrosil Tabletten

10,54 mg

Tablet

Oral anvendelse

Tyskland

| Heumann Pharma GmbH & Co. Generica KG |
| --- |
| Südwestpark 50 |
| D-90449 Nürnberg |
| Germany |

Heumann Pharma GmbH & Co. Generica KG

Südwestpark 50

D-90449 Nürnberg

Germany

Gastrsosil Tropfen

5,97 mg/ml

Oral opløsning

Oral anvendelse

Tyskland

| Heumann Pharma GmbH & Co. Generica KG |
| --- |
| Südwestpark 50 |
| D-90449 Nürnberg |
| Germany |

Heumann Pharma GmbH & Co. Generica KG

Südwestpark 50

D-90449 Nürnberg

Germany

MCP Heumann 10 mg Tabletten

10,53 mg

Tablet

Oral anvendelse

Tyskland

| HEXAL AG |
| --- |
| Industriestr. 25 |
| D-83607 Holzkirchen |
| Germany |

HEXAL AG

Industriestr. 25

D-83607 Holzkirchen

Germany

MCP Hexal 10

10,53 mg

Tablet

Oral anvendelse

Tyskland

| HEXAL AG |
| --- |
| Industriestr. 25 |
| D-83607 Holzkirchen |
| Germany |

HEXAL AG

Industriestr. 25

D-83607 Holzkirchen

Germany

MCP Hexal injekt

10,53 mg/2 ml

Injektionsvæske, opløsning

Intramuskulær anvendelse

Intravenøs anvendelse

Tyskland

| HEXAL AG |
| --- |
| Industriestr. 25 |
| D-83607 Holzkirchen |
| Germany |

HEXAL AG

Industriestr. 25

D-83607 Holzkirchen

Germany

MCP Hexal Tropfen

4,21 mg/ml

Oral opløsning

Oral anvendelse

Tyskland

| Mylan dura GmbH |
| --- |
| Wittichstr. 6 |
| D-64295 Darmstadt |
| Germany |

Mylan dura GmbH

Wittichstr. 6

D-64295 Darmstadt

Germany

MCP dura 4 mg/ml Tropfen zum Einnehmen

4,21 mg/ml

Oral opløsning

Oral anvendelse

Tyskland

| ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Germany

MCP-ratiopharm 10 mg Tabletten

11,82 mg

Tablet

Oral anvendelse

Tyskland

| ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Germany

MCP-ratiopharm 10 mg Zäpfchen

10 mg

Suppositorium

Rektal anvendelse

Tyskland

| ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Germany

MCP-Ratiopharm 30 mg Retardkapseln

30 mg

Depotkapsel

Oral anvendelse

Tyskland

| ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Germany

MCP-ratiopharm 4 mg/ml Tropfen

5,2 mg/ml

Oral opløsning

Oral anvendelse

Tyskland

| ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Germany

MCP-ratiopharm SF 10 mg/2 ml Injektionslösung

10 mg/2 ml

Injektionsvæske, opløsning

Intramuskulær anvendelse

Intravenøs anvendelse

Tyskland

| ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Germany

MCP-ratiopharm SF 50 mg/10 ml Konzentrat zur Herstellung einer Infusionslösung

50 mg/10 ml

Koncentrat til infusion, opløsning

Intravenøs anvendelse

Tyskland

| Sandoz Pharmaceuticals GmbH |
| --- |
| Raiffeisenstr. 11 |
| D-83607 Holzkirchen |
| Germany |

Sandoz Pharmaceuticals GmbH

Raiffeisenstr. 11

D-83607 Holzkirchen

Germany

MCP Sandoz 10 mg Tabletten

10,53 mg

Tablet

Oral anvendelse

Tyskland

| Sandoz Pharmaceuticals GmbH |
| --- |
| Raiffeisenstr. 11 |
| D-83607 Holzkirchen |
| Germany |

Sandoz Pharmaceuticals GmbH

Raiffeisenstr. 11

D-83607 Holzkirchen

Germany

MCP Sandoz 4 mg/ml Tropfen zum Einnehmen, Lösung

4,21 mg/ml

Oral opløsning

Oral anvendelse

Tyskland

| Stadapharm GmbH |
| --- |
| Stadastr. 2 - 18 |
| D-61118 Bad Vilbel |
| Germany |

Stadapharm GmbH

Stadastr. 2 - 18

D-61118 Bad Vilbel

Germany

MCP STADA 10 mg Tabletten

10,53 mg

Tablet

Oral anvendelse

Tyskland

| Stadapharm GmbH |
| --- |
| Stadastr. 2 - 18 |
| D-61118 Bad Vilbel |
| Germany |

Stadapharm GmbH

Stadastr. 2 - 18

D-61118 Bad Vilbel

Germany

MCP STADA 4 mg/1 ml Tropfen zum Einnehmen, Lösung

4,21 mg/ml

Oral opløsning

Oral anvendelse

Tyskland

| Temmler Pharma GmbH & Co.KG |
| --- |
| Temmlerstr. 2 |
| D-35039 Marburg |
| Germany |

Temmler Pharma GmbH & Co.KG

Temmlerstr. 2

D-35039 Marburg

Germany

Cerucal

10,54 mg

Tablet

Oral anvendelse

Tyskland

| Temmler Pharma GmbH & Co.KG |
| --- |
| Temmlerstr. 2 |
| D-35039 Marburg |
| Germany |

Temmler Pharma GmbH & Co.KG

Temmlerstr. 2

D-35039 Marburg

Germany

Cerucal retard

30 mg

Depotkapsel, hård

Oral anvendelse

Grækenland

| Sanofi Aventis AEBE |
| --- |
| 348 Syngrou avenue |
| Building A |
| 176 74 Kalithea – Athens |
| Greece |

Sanofi Aventis AEBE

348 Syngrou avenue

Building A

176 74 Kalithea – Athens

Greece

PRIMPERAN

10 mg

Suppositorium

Rektal anvendelse

Grækenland

| Sanofi Aventis AEBE |
| --- |
| 348 Syngrou avenue |
| Building A |
| 176 74 Kalithea – Athens |
| Greece |

Sanofi Aventis AEBE

348 Syngrou avenue

Building A

176 74 Kalithea – Athens

Greece

PRIMPERAN

20 mg

Suppositorium

Rektal anvendelse

Grækenland

| Sanofi Aventis AEBE |
| --- |
| 348 Syngrou avenue |
| Building A |
| 176 74 Kalithea – Athens |
| Greece |

Sanofi Aventis AEBE

348 Syngrou avenue

Building A

176 74 Kalithea – Athens

Greece

PRIMPERAN

10 mg/2 ml

Injektionsvæske, opløsning

Intramuskulær anvendelse

Intravenøs anvendelse

Grækenland

| Sanofi Aventis AEBE |
| --- |
| 348 Syngrou avenue |
| Building A |
| 176 74 Kalithea – Athens |
| Greece |

Sanofi Aventis AEBE

348 Syngrou avenue

Building A

176 74 Kalithea – Athens

Greece

PRIMPERAN

5 mg/5 ml

Sirup

Oral anvendelse

Grækenland

| Sanofi Aventis AEBE |
| --- |
| 348 Syngrou avenue |
| Building A |
| 176 74 Kalithea – Athens |
| Greece |

Sanofi Aventis AEBE

348 Syngrou avenue

Building A

176 74 Kalithea – Athens

Greece

PRIMPERAN

10 mg

Tablet

Oral anvendelse

Ungarn

| AWD Pharma GmbH&Co. KG |
| --- |
| Wasastrasse 50 |
| Radebeul 1445 |
| Germany |

AWD Pharma GmbH&Co. KG

Wasastrasse 50

Radebeul 1445

Germany

CERUCAL 5 mg/ml oldatos injekció

5 mg/ml

Injektionsvæske, opløsning

Parenteral anvendelse

Ungarn

| AWD Pharma GmbH&Co. KG |
| --- |
| Wasastrasse 50 |
| Radebeul 1445 |
| Germany |

AWD Pharma GmbH&Co. KG

Wasastrasse 50

Radebeul 1445

Germany

CERUCAL tabletta

10 mg

Tablet

Oral anvendelse

Island

| Nycomed Pharma AS |
| --- |
| P.O Box 205 |
| NO-1375, Asker |
| Norway |

Nycomed Pharma AS

P.O Box 205

NO-1375, Asker

Norway

Afipran

10 mg

Tablet

Oral anvendelse

Island

| Nycomed Pharma AS |
| --- |
| P.O Box 205 |
| NO-1375, Asker |
| Norway |

Nycomed Pharma AS

P.O Box 205

NO-1375, Asker

Norway

Afipran

20 mg

Suppositorium

Rektal anvendelse

Island

| Nycomed Pharma AS |
| --- |
| P.O Box 205 |
| NO-1375, Asker |
| Norway |

Nycomed Pharma AS

P.O Box 205

NO-1375, Asker

Norway

Afipran

5 mg/ml

Injektionsvæske, opløsning

Intramuskulær anvendelse

Intravenøs anvendelse

Irland

| Mercury Pharmacuticals (Ireland) Ltd |
| --- |
| 4045 Kingswood Road |
| Citywest Business Park |
| Co. Dublin |
| Ireland |

Mercury Pharmacuticals (Ireland) Ltd

4045 Kingswood Road

Citywest Business Park

Co. Dublin

Ireland

Metoclopramide

10 mg/2 ml

Injektionsvæske, opløsning

Intramuskulær anvendelse

Intravenøs anvendelse

Irland

| Amdipharm Limited |
| --- |
| Regency House |
| Miles Gray Road |
| Basildon |
| Essex, SS14 3AF |
| United Kingdom |

Amdipharm Limited

Regency House

Miles Gray Road

Basildon

Essex, SS14 3AF

United Kingdom

Maxolon

5 mg/ml

Injektionsvæske, opløsning

Intramuskulær anvendelse

Intravenøs anvendelse

Irland

| Amdipharm Limited |
| --- |
| Regency House |
| Miles Gray Road |
| Basildon |
| Essex, SS14 3AF |
| United Kingdom |

Amdipharm Limited

Regency House

Miles Gray Road

Basildon

Essex, SS14 3AF

United Kingdom

Maxolon

10 mg

Tablet

Oral anvendelse

Italien

| Sanofi-Aventis spa |
| --- |
| Viale Luigi BODIO, 37/B |
| 20158 Milano |
| Italien |

Sanofi-Aventis spa

Viale Luigi BODIO, 37/B

20158 Milano

Italien

PLASIL

10 mg/2 ml

Injektionsvæske, opløsning

Intramuskulær anvendelse

Intravenøs anvendelse

Italien

| Sanofi-Aventis spa |
| --- |
| Viale Luigi BODIO, 37/B |
| 20158 Milano |
| Italy |

Sanofi-Aventis spa

Viale Luigi BODIO, 37/B

20158 Milano

Italy

PLASIL

1 mg/ml

Sirup

Oral anvendelse

Italien

| Sanofi-Aventis spa |
| --- |
| Viale Luigi BODIO, 37/B |
| 20158 Milano |
| Italy |

Sanofi-Aventis spa

Viale Luigi BODIO, 37/B

20158 Milano

Italy

PLASIL

4 mg/ml

Orale dråber, opløsning

Oral anvendelse

Italien

| Sanofi-Aventis spa |
| --- |
| Viale Luigi BODIO, 37/B |
| 20158 Milano |
| Italy |

Sanofi-Aventis spa

Viale Luigi BODIO, 37/B

20158 Milano

Italy

PLASIL

10 mg

Tablet

Oral anvendelse

Italien

| Teofarma srl |
| --- |
| Via Fratelli Cervi, 8 |
| 27010 Valle Salimbene Pavia |
| Italy |

Teofarma srl

Via Fratelli Cervi, 8

27010 Valle Salimbene Pavia

Italy

RANDUM

10 mg

Tablet

Oral anvendelse

Italien

| F.I.R.M.A. spa |
| --- |
| Via Scandicci, 37 |
| 50143 Firenze |
| Italy |

F.I.R.M.A. spa

Via Scandicci, 37

50143 Firenze

Italy

CLOPAN

10 mg

Injektionsvæske, opløsning

Intramuskulær anvendelse

Intravenøs anvendelse

Italien

| Sirton Medicare spa |
| --- |
| Piazza XX Settembre, 2 |
| 22079 Villa Guardia - COMO |
| Italy |

Sirton Medicare spa

Piazza XX Settembre, 2

22079 Villa Guardia - COMO

Italy

PRAMIDIN

10 mg/spray

Næsespray, opløsning

Nasal anvendelse

Italien

| Sirton Medicare spa |
| --- |
| Piazza XX Settembre, 2 |
| 22079 Villa Guardia - COMO |
| Italy |

Sirton Medicare spa

Piazza XX Settembre, 2

22079 Villa Guardia - COMO

Italy

PRAMIDIN

20 mg/spray

Næsespray, opløsning

Nasal anvendelse

Italien

| Sanofi-Aventis spa |
| --- |
| Viale Luigi BODIO, 37/B |
| 20158 Milano |
| Italy |

Sanofi-Aventis spa

Viale Luigi BODIO, 37/B

20158 Milano

Italy

DIGESTIVO S.PELLEGRINO

5 mg

Brusetablet

Oral anvendelse

Italien

| Sanofi-Aventis spa |
| --- |
| Viale Luigi BODIO, 37/B |
| 20158 Milano |
| Italy |

Sanofi-Aventis spa

Viale Luigi BODIO, 37/B

20158 Milano

Italy

DIGESTIVO S.PELLEGRINO

5 mg

Effervescent granules

Oral anvendelse

Italien

| Hospira Italia srl |
| --- |
| Via Orazio, 20/22 |
| 80122 NAPOLI |
| Italy |

Hospira Italia srl

Via Orazio, 20/22

80122 NAPOLI

Italy

METOCLOPRAMIDE CLORIDRATO HOSPIRA

10 mg

Injektionsvæske, opløsning

Intramuskulær anvendelse

Intravenøs anvendelse

Italien

| Farmakopea spa |
| --- |
| Via Cavriana, 14 |
| 20134 MILANO |
| Italy |

Farmakopea spa

Via Cavriana, 14

20134 MILANO

Italy

ISAPRANDIL

5 mg

Brusetablet

Oral anvendelse

Italien

| Farmakopea spa |
| --- |
| Via Cavriana, 14 |
| 20134 MILANO |
| Italy |

Farmakopea spa

Via Cavriana, 14

20134 MILANO

Italy

ISAPRANDIL

5 mg

Brusegranulat

Oral anvendelse

Letland

| Pharmaceutical Works POLPHARMA SA |
| --- |
| 19 Pelplińska Street |
| 83-200 Starogard Gdański |
| Poland |

Pharmaceutical Works POLPHARMA SA

19 Pelplińska Street

83-200 Starogard Gdański

Poland

Metoclopramid Polpharma 10 mg tablets

10 mg

Tablet

Oral anvendelse

Letland

| Pharmaceutical Works POLPHARMA SA |
| --- |
| 19 Pelplińska Street |
| 83-200 Starogard Gdański |
| Poland |

Pharmaceutical Works POLPHARMA SA

19 Pelplińska Street

83-200 Starogard Gdański

Poland

Metoclopramid Polpharma 10 mg/2 ml solution for injection

10 mg/2 ml

Injektionsvæske, opløsning

Intramuskulær anvendelse

Intravenøs anvendelse

Letland

| Teva Pharma B.V. |
| --- |
| Computerweg 10 |
| 3542 DR Utrecht |
| The Netherlands |

Teva Pharma B.V.

Computerweg 10

3542 DR Utrecht

The Netherlands

Cerucal 10 mg tablets

10 mg

Tablet

Oral anvendelse

Litauen

| Teva Pharma B.V. |
| --- |
| Computerweg 10 |
| 3542 DR Utrecht |
| The Netherlands |

Teva Pharma B.V.

Computerweg 10

3542 DR Utrecht

The Netherlands

Cerucal

10 mg

Tablet

Oral anvendelse

Litauen

| Medochemie Ltd. |
| --- |
| p.o box 51409 |
| CY-3505, Limassol |
| Cyprus |

Medochemie Ltd.

p.o box 51409

CY-3505, Limassol

Cyprus

ELITAN

5 mg/ml

Injektionsvæske, opløsning

Intramuskulær anvendelse

Intravenøs anvendelse

Litauen

| Pharmaceutical Works POLPHARMA SA |
| --- |
| 19 Pelplińska Street |
| 83-200 Starogard Gdański |
| Poland |

Pharmaceutical Works POLPHARMA SA

19 Pelplińska Street

83-200 Starogard Gdański

Poland

Metoclopramid Polpharma

10 mg

Tablet

Oral anvendelse

Litauen

| Pharmaceutical Works POLPHARMA SA |
| --- |
| 19 Pelplińska Street |
| 83-200 Starogard Gdański |
| Poland |

Pharmaceutical Works POLPHARMA SA

19 Pelplińska Street

83-200 Starogard Gdański

Poland

Metoclopramid Polpharma

10 mg/2 ml

Injektionsvæske, opløsning

Intramuskulær anvendelse

Intravenøs anvendelse

Luxembourg

| Nycomed Belgium s.a. |
| --- |
| 615, chaussee de Gand |
| B-1080 Bruxelles |
| Belgium |

Nycomed Belgium s.a.

615, chaussee de Gand

B-1080 Bruxelles

Belgium

Dibertil

10 mg

Kapsel, blød

Oral anvendelse

Luxembourg

| Nycomed Belgium s.a. |
| --- |
| 615, chaussee de Gand |
| B-1080 Bruxelles |
| Belgium |

Nycomed Belgium s.a.

615, chaussee de Gand

B-1080 Bruxelles

Belgium

Dibertil

5 mg

Kapsel, blød

Oral anvendelse

Luxembourg

| Dolorgiet Gmbh&Co |
| --- |
| Otto-von-Guericke-Str. 1 |
| D-53757 Sankt Augustin |
| Germany |

Dolorgiet Gmbh&Co

Otto-von-Guericke-Str. 1

D-53757 Sankt Augustin

Germany

Gastronerton

4,65 mg/ml

Orale dråber

Oral anvendelse

Luxembourg

| Dolorgiet Gmbh&Co |
| --- |
| Otto-von-Guericke-Str. 1 |
| D-53757 Sankt Augustin |
| Germany |

Dolorgiet Gmbh&Co

Otto-von-Guericke-Str. 1

D-53757 Sankt Augustin

Germany

Gastronerton

8,92 mg

Tablet

Oral anvendelse

Luxembourg

| Ratiopharm GMBH Arzneimittel |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |
| Germany |

Ratiopharm GMBH Arzneimittel

Graf-Arco-Str. 3

D-89079 Ulm

Germany

MCP Ratiopharm

5,2 mg

Orale dråber

Oral anvendelse

Luxembourg

| Ratiopharm GMBH Arzneimittel |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |
| Germany |

Ratiopharm GMBH Arzneimittel

Graf-Arco-Str. 3

D-89079 Ulm

Germany

MCP Ratiopharm

10 mg

Suppositorium

Rektal anvendelse

Luxembourg

| Ratiopharm GMBH Arzneimittel |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |
| Germany |

Ratiopharm GMBH Arzneimittel

Graf-Arco-Str. 3

D-89079 Ulm

Germany

MCP Ratiopharm

10 mg

Tablet

Oral anvendelse

Luxembourg

| Ratiopharm GMBH Arzneimittel |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |
| Germany |

Ratiopharm GMBH Arzneimittel

Graf-Arco-Str. 3

D-89079 Ulm

Germany

mcP Ratiopharm SF

10 mg/2 ml

Injektionsvæske, opløsning

Intramuskulær anvendelse

Intravenøs anvendelse

Luxembourg

| Ratiopharm GMBH Arzneimittel |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |
| Germany |

Ratiopharm GMBH Arzneimittel

Graf-Arco-Str. 3

D-89079 Ulm

Germany

MCP Ratiopharm-30

30 mg

Kapsel med modificeret udløsning, blød

Oral anvendelse

Luxembourg

| Eurogenerics s.a. |
| --- |
| Heizel Esplanade B22 |
| 1020 Laeken |
| Belgium |

Eurogenerics s.a.

Heizel Esplanade B22

1020 Laeken

Belgium

Metoclopramide EG-10

10 mg

Kapsel, blød

Oral anvendelse

Luxembourg

| Sanofi-Aventis Belgium |
| --- |
| Culliganlaan 1 C |
| 1831 Diegem |
| Belgium |

Sanofi-Aventis Belgium

Culliganlaan 1 C

1831 Diegem

Belgium

Primperan adultes

20 mg

Suppositorium

Rektal anvendelse

Luxembourg

| Hexal AG |
| --- |
| Industriestr. 25 |
| D-83607 Holzkirchen |
| Germany |

Hexal AG

Industriestr. 25

D-83607 Holzkirchen

Germany

MCP Hexal-10

10 mg

Tablet

Oral anvendelse

Luxembourg

| Hexal AG |
| --- |
| Industriestr. 25 |
| D-83607 Holzkirchen |
| Germany |

Hexal AG

Industriestr. 25

D-83607 Holzkirchen

Germany

MCP Hexal Injekt

10 mg/2 ml

Injektionsvæske, opløsning

Intramuskulær anvendelse

Intravenøs anvendelse

Luxembourg

| Hexal AG |
| --- |
| Industriestr. 25 |
| D-83607 Holzkirchen |
| Germany |

Hexal AG

Industriestr. 25

D-83607 Holzkirchen

Germany

MCP Hexal Tropfen

4 mg/ml

Orale dråber

Oral anvendelse

Luxembourg

| Sanofi-Aventis Belgium |
| --- |
| Culliganlaan 1 C |
| 1831 Diegem |
| Belgium |

Sanofi-Aventis Belgium

Culliganlaan 1 C

1831 Diegem

Belgium

Primperan

10 mg

Tablet

Oral anvendelse

Luxembourg

| Sanofi-Aventis Belgium |
| --- |
| Culliganlaan 1 C |
| 1831 Diegem |
| Belgium |

Sanofi-Aventis Belgium

Culliganlaan 1 C

1831 Diegem

Belgium

Primperan

10 mg/2 ml

Injektionsvæske, opløsning

Intramuskulær anvendelse

Intravenøs anvendelse

Luxembourg

| Sanofi-Aventis Belgium |
| --- |
| Culliganlaan 1 C |
| 1831 Diegem |
| Belgium |

Sanofi-Aventis Belgium

Culliganlaan 1 C

1831 Diegem

Belgium

Primperan

1 mg/ml

Oral opløsning

Oral anvendelse

Malta

| Accord Healthcare Ltd |
| --- |
| Sage House |
| 319 Pinner Road |
| North Harrow |
| Middlesex HA1 4HF |
| United Kingdom |

Accord Healthcare Ltd

Sage House

319 Pinner Road

North Harrow

Middlesex HA1 4HF

United Kingdom

Metoclopramide 10 mg tablets

10 mg

Tablet

Oral anvendelse

Malta

| Antigen International Limited |
| --- |
| Chandler House |
| Castle Street, Roscrea |
| County Tipperary |
| Ireland |

Antigen International Limited

Chandler House

Castle Street, Roscrea

County Tipperary

Ireland

Metoclopramide Injection BP 10 mg/2 ml Solution for Injection

10 mg/2 ml

Injektionsvæske, opløsning

Intramuskulær anvendelse

Intravenøs anvendelse

Malta

| Hameln Pharmaceuticals Ltd. |
| --- |
| Nexus, Gloucester Business Park |
| Gloucester GL3 4AG |
| United Kingdom |

Hameln Pharmaceuticals Ltd.

Nexus, Gloucester Business Park

Gloucester GL3 4AG

United Kingdom

Metoclopramide 5 mg/ml Injection

5 mg/ml

Injektionsvæske, opløsning

Intramuskulær anvendelse

Intravenøs anvendelse

Malta

| Medochemie Limited |
| --- |
| 1-10 Constantinoupleos Str |
| 3011 Limassol |
| Cyprus |

Medochemie Limited

1-10 Constantinoupleos Str

3011 Limassol

Cyprus

Elitan 10 mg tablet

10 mg

Tablet

Oral anvendelse

Malta

| Medochemie Ltd. |
| --- |
| 1-10, Constantinoupleos Street |
| 3011 Limassol |
| Cyprus |

Medochemie Ltd.

1-10, Constantinoupleos Street

3011 Limassol

Cyprus

Elitan Injection, 10 mg/2 ml, Injektionsvæske, opløsning

10 mg

Injektionsvæske, opløsning

Intramuskulær anvendelse

Intravenøs anvendelse

Malta

| Remedica Ltd. |
| --- |
| Limassol Industrial Estate |
| Aharnon Street |
| P.O. Box 51706 |
| 3508 Limassol |
| Cyprus |

Remedica Ltd.

Limassol Industrial Estate

Aharnon Street

P.O. Box 51706

3508 Limassol

Cyprus

Cloperan 10

10 mg

Tablet

Oral anvendelse

Holland

| Sanofi-Aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| 2803 PE GOUDA |
| The Netherlands |

Sanofi-Aventis Netherlands B.V.

Kampenringweg 45 D-E

2803 PE GOUDA

The Netherlands

Primperan injectie 10/2 ml, oplossing voor injection 10 mg/2 ml

10 mg/2 ml

Injektionsvæske, opløsning

Intravenøs anvendelse

Holland

| Sanofi-Aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| 2803 PE GOUDA |
| The Netherlands |

Sanofi-Aventis Netherlands B.V.

Kampenringweg 45 D-E

2803 PE GOUDA

The Netherlands

Primperan drank, drank

1 mg/ml

1 mg/ml

Oral opløsning

Oral anvendelse

Holland

| Sanofi-Aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| 2803 PE GOUDA |
| The Netherlands |

Sanofi-Aventis Netherlands B.V.

Kampenringweg 45 D-E

2803 PE GOUDA

The Netherlands

Primperan 10, zetpillen 10 mg

10 mg

Suppositorium

Rektal anvendelse

Holland

| Sanofi-Aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| 2803 PE GOUDA |
| The Netherlands |

Sanofi-Aventis Netherlands B.V.

Kampenringweg 45 D-E

2803 PE GOUDA

The Netherlands

Primperan 20, zetpillen 20 mg

20 mg

Suppositorium

Rektal anvendelse

Holland

| Pharmachemie B.V. |
| --- |
| Swensweg 5 |
| 2031 GA HAARLEM |
| The Netherlands |

Pharmachemie B.V.

Swensweg 5

2031 GA HAARLEM

The Netherlands

Metoclopramide HCl 10 PCH, tabletten 10 mg

10 mg

Tablet

Oral anvendelse

Holland

| Centrafarm B.V. |
| --- |
| Nieuwe Donk 3 |
| 4879 AC Etten Leur |
| The Netherlands |

Centrafarm B.V.

Nieuwe Donk 3

4879 AC Etten Leur

The Netherlands

Metoclopramide HCl CF 10 mg, tabletten

10 mg

Tablet

Oral anvendelse

Holland

| Accord Healthcare B.V. |
| --- |
| De Waterman 15 A |
| 4891 TL Rijsbergen |
| The Netherlands |

Accord Healthcare B.V.

De Waterman 15 A

4891 TL Rijsbergen

The Netherlands

Metoclopramidemonohydrochloride Accord 10 mg Tabletten

10 mg

Tablet

Oral anvendelse

Norge

| Nycomed Pharma AS |
| --- |
| Postboks 205 |
| 1372 Asker |
| Norway |

Nycomed Pharma AS

Postboks 205

1372 Asker

Norway

Afipran

5 mg/ml

Injektionsvæske, opløsning

Intramuskulær anvendelse

Intravenøs anvendelse

Norge

| Nycomed Pharma AS |
| --- |
| Postboks 205 |
| 1372 Asker |
| Norway |

Nycomed Pharma AS

Postboks 205

1372 Asker

Norway

Afipran

20 mg

Suppositorium

Rektal anvendelse

Norge

| Nycomed Pharma AS |
| --- |
| Postboks 205 |
| 1372 Asker |
| Norway |

Nycomed Pharma AS

Postboks 205

1372 Asker

Norway

Afipran

100 mg/ml

Koncentrat til infusion, opløsning

Intravenøs anvendelse

Norge

| Nycomed Pharma AS |
| --- |
| Postboks 205 |
| 1372 Asker |
| Norway |

Nycomed Pharma AS

Postboks 205

1372 Asker

Norway

Afipran

1 mg/ml

Oral opløsning

Oral anvendelse

Norge

| Nycomed Pharma AS |
| --- |
| Postboks 205 |
| 1372 Asker |
| Norway |

Nycomed Pharma AS

Postboks 205

1372 Asker

Norway

Afipran

10 mg

Tablet

Oral anvendelse

Polen

| Zakłady Farmaceutyczne Polpharma SA |
| --- |
| ul. Pelplińska 19 |
| 83-200 Starogard Gdański |
| Poland |

Zakłady Farmaceutyczne Polpharma SA

ul. Pelplińska 19

83-200 Starogard Gdański

Poland

Metoclopramidum 0,5 % Polpharma

5 mg/ml

Injektionsvæske, opløsning

Intramuskulær anvendelse

Intravenøs anvendelse

Polen

| Zakłady Farmaceutyczne Polpharma SA |
| --- |
| ul. Pelplińska 19 |
| 83-200 Starogard Gdański |
| Poland |

Zakłady Farmaceutyczne Polpharma SA

ul. Pelplińska 19

83-200 Starogard Gdański

Poland

Metoclopramidum Polpharma

10 mg

Tablet

Oral anvendelse

Portugal

| Sanofi - Produtos Farmacêuticos, Lda. |
| --- |
| Empreendimento Lagoas Park |
| Edifício 7 - 3o Piso |
| 2740-244 Porto Salvo |
| Portugal |

Sanofi - Produtos Farmacêuticos, Lda.

Empreendimento Lagoas Park

Edifício 7 - 3o Piso

2740-244 Porto Salvo

Portugal

Primperan

10 mg/2 ml

Injektionsvæske, opløsning

Intramuskulær anvendelse

Intravenøs anvendelse

Portugal

| Labesfal - Laboratórios Almiro, S.A. |
| --- |
| Zona Industrial do Lagedo |
| 3465-157 Santiago de Besteiros |
| Portugal |

Labesfal - Laboratórios Almiro, S.A.

Zona Industrial do Lagedo

3465-157 Santiago de Besteiros

Portugal

Metoclopramida Labesfal

10 mg/2 ml

Injektionsvæske, opløsning

Intramuskulær anvendelse

Intravenøs anvendelse

Portugal

| Labesfal - Laboratórios Almiro, S.A. |
| --- |
| Zona Industrial do Lagedo |
| 3465-157 Santiago de Besteiros |
| Portugal |

Labesfal - Laboratórios Almiro, S.A.

Zona Industrial do Lagedo

3465-157 Santiago de Besteiros

Portugal

Metoclopramida Labesfal

10 mg

Tablet

Oral anvendelse

Portugal

| Sanofi - Produtos Farmacêuticos, Lda. |
| --- |
| Empreendimento Lagoas Park |
| Edifício 7 - 3o Piso |
| 2740-244 Porto Salvo |
| Portugal |

Sanofi - Produtos Farmacêuticos, Lda.

Empreendimento Lagoas Park

Edifício 7 - 3o Piso

2740-244 Porto Salvo

Portugal

Primperan

1 mg/ml

Oral opløsning

Oral anvendelse

Portugal

| Sanofi - Produtos Farmacêuticos, Lda. |
| --- |
| Empreendimento Lagoas Park |
| Edifício 7 - 3o Piso |
| 2740-244 Porto Salvo |
| Portugal |

Sanofi - Produtos Farmacêuticos, Lda.

Empreendimento Lagoas Park

Edifício 7 - 3o Piso

2740-244 Porto Salvo

Portugal

Primperan

10 mg

Tablet

Oral anvendelse

Portugal

| Laboratório Medinfar - Produtos Farmacêuticos, S.A. |
| --- |
| l Ribeiro de Pavia, 1 - 1o - Venda Nova 2700-547 Amadora |
| Portugal |

Laboratório Medinfar - Produtos Farmacêuticos, S.A.

l Ribeiro de Pavia, 1 - 1o - Venda Nova 2700-547 Amadora

Portugal

Metoclopramida Medinfar

10 mg/2 ml

Injektionsvæske, opløsning

Intramuskulær anvendelse

Intravenøs anvendelse

Portugal

| Laboratório Medinfar - Produtos Farmacêuticos, S.A. |
| --- |
| Rua Manuel Ribeiro de Pavia |
| 1 - 1 - Venda Nova |
| 2700-547 Amadora |
| Portugal |

Laboratório Medinfar - Produtos Farmacêuticos, S.A.

Rua Manuel Ribeiro de Pavia

1 - 1 - Venda Nova

2700-547 Amadora

Portugal

Metoclopramida Medinfar

10 mg

Tablet

Oral anvendelse

Portugal

| Laboratório Medinfar - Produtos Farmacêuticos, S.A. |
| --- |
| Rua Manuel Ribeiro de Pavia |
| 1 - 1 - Venda Nova |
| 2700-547 Amadora |
| Portugal |

Laboratório Medinfar - Produtos Farmacêuticos, S.A.

Rua Manuel Ribeiro de Pavia

1 - 1 - Venda Nova

2700-547 Amadora

Portugal

Metoclopramida Medinfar

2,6 mg/ml

Orale dråber, opløsning

Oral anvendelse

Portugal

| Laboratório Medinfar - Produtos Farmacêuticos, S.A. |
| --- |
| Rua Manuel Ribeiro de Pavia |
| 1 - 1 - Venda Nova |
| 2700-547 Amadora |
| Portugal |

Laboratório Medinfar - Produtos Farmacêuticos, S.A.

Rua Manuel Ribeiro de Pavia

1 - 1 - Venda Nova

2700-547 Amadora

Portugal

Metoclopramida Medinfar

1 mg/ml

Oral opløsning

Oral anvendelse

Rumænien

| S.C. LAROPHARM S.R.L. |
| --- |
| Șos. Alexandriei, nr 145 A |
| B07-Bragadiru, jud Ilfov |
| Romania |

S.C. LAROPHARM S.R.L.

Șos. Alexandriei, nr 145 A

B07-Bragadiru, jud Ilfov

Romania

METOCLOPRAMID LAROPHARM

10 mg

Tablet

Oral anvendelse

Rumænien

| S.C. SLAVIA PHARM S.R.L. |
| --- |
| B-dul Theodor Pallady nr. 44C |
| Sector 3, București 032266 |
| Romania |

S.C. SLAVIA PHARM S.R.L.

B-dul Theodor Pallady nr. 44C

Sector 3, București 032266

Romania

METOCLOPRAMID

10 mg

Tablet

Oral anvendelse

Rumænien

| S.C. MEDUMAN S.A. |
| --- |
| Str. Aleea Eroilor nr. 28, Vișeu de Sus, |
| Județul Maramureș 435700 |
| Romania |

S.C. MEDUMAN S.A.

Str. Aleea Eroilor nr. 28, Vișeu de Sus,

Județul Maramureș 435700

Romania

N - METOCLOPRAMID

10 mg

Tablet

Oral anvendelse

Rumænien

| S.C. ARENA GROUP S.A |
| --- |
| Str. Stefan Mihaileanu, nr.31 |
| sector 2; Bucuresti 024022 |
| Romania |

S.C. ARENA GROUP S.A

Str. Stefan Mihaileanu, nr.31

sector 2; Bucuresti 024022

Romania

METOCLOPRAMID ARENA 10 mg

10 mg

Tablet

Oral anvendelse

Rumænien

| S.C. TERAPIA S.A. |
| --- |
| Str. Fabricii nr. 124 |
| Cluj - Napoca 400632 |
| Romania |

S.C. TERAPIA S.A.

Str. Fabricii nr. 124

Cluj - Napoca 400632

Romania

METOCLOPRAMID 10 mg

10 mg

Tablet

Oral anvendelse

Rumænien

| S.C. BIOFARM S.A. |
| --- |
| Str. Logofăt Tăutu, nr. 99 |
| sector 3, București 031212 |
| Romania |

S.C. BIOFARM S.A.

Str. Logofăt Tăutu, nr. 99

sector 3, București 031212

Romania

METOCLOPRAMID BIOFARM 1 mg/5 ml

1 mg/5 ml

Sirup

Oral anvendelse

Rumænien

| S.C. BIOFARM S.A. |
| --- |
| Str. Logofăt Tăutu, nr. 99 |
| sector 3, București 031212 |
| Romania |

S.C. BIOFARM S.A.

Str. Logofăt Tăutu, nr. 99

sector 3, București 031212

Romania

METOCLOPRAMID

7 mg/ml

Orale dråber, opløsning

Oral anvendelse

Rumænien

| S.C. TERAPIA S.A. |
| --- |
| Str. Fabricii nr. 124 |
| Cluj - Napoca 400632 |
| Romania |

S.C. TERAPIA S.A.

Str. Fabricii nr. 124

Cluj - Napoca 400632

Romania

METOCLOPRAMID 10 mg

10 mg/2 ml

Injektionsvæske, opløsning

Intramuskulær anvendelse

Intravenøs anvendelse

Rumænien

| Accord Healthcar |
| --- |
| Ltd Sage House |
| 319 Pinner Road |
| North Harrow |
| Middlesex HA1 4HF |
| United Kingdom |

Accord Healthcar

Ltd Sage House

319 Pinner Road

North Harrow

Middlesex HA1 4HF

United Kingdom

Metoclopramid Accord 10 mg comprimate

10 mg

Tablet

Oral anvendelse

Slovakiet

| TEVA Pharmaceuticals Slovakia s.r.o. |
| --- |
| Teslova 26 |
| 82102 Bratislava |
| Slovakia |

TEVA Pharmaceuticals Slovakia s.r.o.

Teslova 26

82102 Bratislava

Slovakia

Cerucal

10 mg

Tablet

Oral anvendelse

Slovakiet

| AWD. pharma GmbH & Co.KG |
| --- |
| Wasastr. 50 |
| 01445 Radebeul |
| Germany |

AWD. pharma GmbH & Co.KG

Wasastr. 50

01445 Radebeul

Germany

Cerucal

10 mg/2 ml

Injektionsvæske, opløsning

Intramuskulær anvendelse

Intravenøs anvendelse

Slovakiet

| Sandoz Pharmaceuticals d.d. |
| --- |
| Verovškova 57 |
| 1000 Ljubljana |
| Slovenia |

Sandoz Pharmaceuticals d.d.

Verovškova 57

1000 Ljubljana

Slovenia

DEGAN 10 mg

10 mg

Tablet

Oral anvendelse

Slovakiet

| Sandoz Pharmaceuticals d.d. |
| --- |
| Verovškova 57 |
| 1000 Ljubljana |
| Slovenia |

Sandoz Pharmaceuticals d.d.

Verovškova 57

1000 Ljubljana

Slovenia

DEGAN 10 mg/2 ml

10 mg/2 ml

Injektionsvæske, opløsning

Intramuskulær anvendelse

Intravenøs anvendelse

Slovenien

| Alkaloid-INT d.o.o. Ljubljana |
| --- |
| Slandrova ulica 4 |
| 1231 Ljubljana- Crnuce |
| Slovenia |

Alkaloid-INT d.o.o. Ljubljana

Slandrova ulica 4

1231 Ljubljana- Crnuce

Slovenia

Reglan 1 mg/1 ml peroralna raztopina

1 mg/ml

Oral opløsning

Oral anvendelse

Slovenien

| Alkaloid-INT d.o.o. Ljubljana |
| --- |
| Slandrova ulica 4 |
| 1231 Ljubljana- Crnuce |
| Slovenia |

Alkaloid-INT d.o.o. Ljubljana

Slandrova ulica 4

1231 Ljubljana- Crnuce

Slovenia

Reglan 10 mg tablete

10 mg

Tablet

Oral anvendelse

Spanien

| Sanofi Aventis, S.A. |
| --- |
| Josep Plá, 2 |
| 08019 Barcelona |
| Spain |

Sanofi Aventis, S.A.

Josep Plá, 2

08019 Barcelona

Spain

PRIMPERAN 10 mg/2 ml SOLUCION INYECTABLE

10 mg/2 ml

Injektionsvæske, opløsning

Intramuskulær anvendelse

Intravenøs anvendelse

Spanien

| Sanofi Aventis, S.A. |
| --- |
| Josep Plá, 2 |
| 08019 Barcelona |
| Spain |

Sanofi Aventis, S.A.

Josep Plá, 2

08019 Barcelona

Spain

PRIMPERAN 1 mg/1 ml SOLUCION ORAL

1 mg/ml

Oral opløsning

Oral anvendelse

Spanien

| Sanofi Aventis, S.A. |
| --- |
| Josep Plá, 2 |
| 08019 Barcelona |
| Spain |

Sanofi Aventis, S.A.

Josep Plá, 2

08019 Barcelona

Spain

PRIMPERAN 10 mg COMPRIMIDOS

10 mg

Tablet

Oral anvendelse

Spanien

| Sanofi Aventis, S.A. |
| --- |
| Josep Plá, 2 |
| 08019 Barcelona |
| Spain |

Sanofi Aventis, S.A.

Josep Plá, 2

08019 Barcelona

Spain

PRIMPERAN 260mg/100 ml GOTAS

2,6 mg/ml

Orale dråber, opløsning

Oral anvendelse

Spanien

| Sanofi Aventis, S.A. |
| --- |
| Josep Plá, 2 |
| 08019 Barcelona |
| Spain |

Sanofi Aventis, S.A.

Josep Plá, 2

08019 Barcelona

Spain

PRIMPERAN 100 mg/5 ml SOLUCION INYECTABLE

100 mg/5 ml

Injektionsvæske, opløsning

Intramuskulær anvendelse

Intravenøs anvendelse

Spanien

| Kern Pharma, S.L. |
| --- |
| Venus, 72. |
| Poligono Industrial Colon II. |
| 08228 Tarrasa |
| Spain |

Kern Pharma, S.L.

Venus, 72.

Poligono Industrial Colon II.

08228 Tarrasa

Spain

METOCLOPRAMIDA KERN PHARMA 1 mg/ml SOLUCION ORAL

1 mg/ml

Oral opløsning

Oral anvendelse

Spanien

| Pensa Pharma, S.A.U |
| --- |
| Jorge Comín (médico pediatra) |
| 3 - 46015 Valencia |
| Spain |

Pensa Pharma, S.A.U

Jorge Comín (médico pediatra)

3 - 46015 Valencia

Spain

METOCLOPRAMIDA PENSA 1 mg/ml SOLUCION ORAL

1 mg/ml

Oral opløsning

Oral anvendelse

Spanien

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

Accord Healthcare, S.L.U.

Moll de Barcelona s/n

World Trade Centre

Edifici Est 6a planta

08039 Barcelona

Spain

METOCLOPRAMIDA ACCORD 10 mg COMPRIMIDOS

10 mg

Tablet

Oral anvendelse

Sverige

| sanofi-aventis AB |
| --- |
| Box 14142 |
| 167 14 Bromma |
| Sweden |

sanofi-aventis AB

Box 14142

167 14 Bromma

Sweden

Primperan

10 mg

Tablet

Oral anvendelse

Sverige

| sanofi-aventis AB |
| --- |
| Box 14142 |
| 167 14 Bromma |
| Sweden |

sanofi-aventis AB

Box 14142

167 14 Bromma

Sweden

Primperan

10 mg/2 ml

Injektionsvæske, opløsning

Intramuskulær anvendelse

Intravenøs anvendelse

Sverige

| sanofi-aventis AB |
| --- |
| Box 14142 |
| 167 14 Bromma |
| Sweden |

sanofi-aventis AB

Box 14142

167 14 Bromma

Sweden

Primperan

20 mg

Suppositorium

Rektal anvendelse

Storbritanien

| Actavis UK Limited |
| --- |
| Whiddon Valley |
| Barnstaple |
| North evon EX32 8NS |
| United Kingdom |

Actavis UK Limited

Whiddon Valley

Barnstaple

North evon EX32 8NS

United Kingdom

Metoclopramide Tablets BP 10 mg

10 mg

Tablet

Oral anvendelse

Storbritanien

| Amdipharm plc |
| --- |
| Regency House |
| Miles Gray Road, Basildon |
| Essex SS14 3AF |
| United Kingdom |

Amdipharm plc

Regency House

Miles Gray Road, Basildon

Essex SS14 3AF

United Kingdom

Maxolon SR

15 mg

Kapsler med modificeret udløsning, hård

Oral anvendelse

Storbritanien

| Amdipharm plc |
| --- |
| Regency House |
| Miles Gray Road, Basildon |
| Essex SS14 3AF |
| United Kingdom |

Amdipharm plc

Regency House

Miles Gray Road, Basildon

Essex SS14 3AF

United Kingdom

Maxolon Tablets 10 mg

10 mg

Tablet

Oral anvendelse

Storbritanien

| Amdipharm plc |
| --- |
| Regency House |
| Miles Gray Road, Basildon |
| Essex SS14 3AF |
| United Kingdom |

Amdipharm plc

Regency House

Miles Gray Road, Basildon

Essex SS14 3AF

United Kingdom

Maxolon Injection 5 mg/ml

0,5 % w/v

Injektionsvæske, opløsning

Intramuskulær anvendelse

Intravenøs anvendelse

Storbritanien

| Amdipharm plc |
| --- |
| Regency House |
| Miles Gray Road, Basildon |
| Essex SS14 3AF |
| United Kingdom |

Amdipharm plc

Regency House

Miles Gray Road, Basildon

Essex SS14 3AF

United Kingdom

Maxolon High Dose 100 mg/20 ml

0,5 % w/v

Injektionsvæske, opløsning

Intravenøs anvendelse

Storbritanien

| Chelonia Healthcare Limited |
| --- |
| Boumpoulinas 11, 3rd Floor |
| Nicosia, CY-1060 |
| Cyprus |

Chelonia Healthcare Limited

Boumpoulinas 11, 3rd Floor

Nicosia, CY-1060

Cyprus

Metoclopramide 10 mg Tablets

10 mg

Tablet

Oral anvendelse

Storbritanien

| Crescent Pharma Limited |
| --- |
| Units 3 & 4 |
| Quidhampton Business Units |
| Polhampton Lane, Overton |
| Hampshire RG25 3ED |
| United Kingdom |

Crescent Pharma Limited

Units 3 & 4

Quidhampton Business Units

Polhampton Lane, Overton

Hampshire RG25 3ED

United Kingdom

Metoclopramide 10 mg Tablets

10 mg

Tablet

Oral anvendelse

Storbritanien

| Ennogen Limited |
| --- |
| 78 York Street |
| London W1H 1DP |
| United Kingdom |

Ennogen Limited

78 York Street

London W1H 1DP

United Kingdom

Metoclopramide 10 mg Tablets

10 mg

Tablet

Oral anvendelse

Storbritanien

| Ennogen Limited |
| --- |
| 78 York Street |
| London W1H 1DP |
| United Kingdom |

Ennogen Limited

78 York Street

London W1H 1DP

United Kingdom

Metoclopramide 5 mg/ml Injection

0,5 % w/v

Injektionsvæske, opløsning

Intramuskulær anvendelse

Intravenøs anvendelse

Storbritanien

| Generics (United Kingdom) Limited |
| --- |
| Station Close, Potters Bar |
| Hertfordshire EN6 1TL |
| United Kingdom |

Generics (United Kingdom) Limited

Station Close, Potters Bar

Hertfordshire EN6 1TL

United Kingdom

Metoclopramide Tablets 10 mg

10 mg

Tablet

Oral anvendelse

Storbritanien

| Hameln Pharmaceuticals Limited |
| --- |
| Nexus, Gloucester Business Park |
| Gloucester GL3 4AG |
| United Kingdom |

Hameln Pharmaceuticals Limited

Nexus, Gloucester Business Park

Gloucester GL3 4AG

United Kingdom

Metoclopramide Injection BP 5 mg/ml

0,526 % w/v

Injektionsvæske, opløsning

Intramuskulær anvendelse

Intravenøs anvendelse

Storbritanien

| Metwest Pharmaceuticals Limited |
| --- |
| 15 Runnelfield |
| Harrow on the Hill |
| Middlesex HA1 3NY |
| United Kingdom |

Metwest Pharmaceuticals Limited

15 Runnelfield

Harrow on the Hill

Middlesex HA1 3NY

United Kingdom

Metoclopramide 10 mg Tablets

10 mg

Tablet

Oral anvendelse

Storbritanien

| Pharmvit Limited |
| --- |
| 177 Bilton Road, Perivale |
| Middlesex UB6 7HQ |
| United Kingdom |

Pharmvit Limited

177 Bilton Road, Perivale

Middlesex UB6 7HQ

United Kingdom

Metoclopramide Tablets BP 10 mg

10 mg

Tablet

Oral anvendelse

Storbritanien

| Rosemont Pharmaceuticals Limited |
| --- |
| Rosemont House |
| Yorkdale Industrial Park |
| Braithwaite Street |
| Leeds, W Yorkshire LS11 9XE |
| United Kingdom |

Rosemont Pharmaceuticals Limited

Rosemont House

Yorkdale Industrial Park

Braithwaite Street

Leeds, W Yorkshire LS11 9XE

United Kingdom

Metoclopramide Hydrochloride 5 mg/5 ml Oral opløsning

5 mg/5 ml

Oral opløsning

Oral anvendelse

Storbritanien

| Rosemont Pharmaceuticals Limited |
| --- |
| Rosemont House |
| Yorkdale Industrial Park |
| Braithwaite Street |
| Leeds, W Yorkshire LS11 9XE |
| United Kingdom |

Rosemont Pharmaceuticals Limited

Rosemont House

Yorkdale Industrial Park

Braithwaite Street

Leeds, W Yorkshire LS11 9XE

United Kingdom

Maxolon Paediatric Liquid

5 mg/5 ml

Oral opløsning

Oral anvendelse

Storbritanien

| Teva United Kingdom Limted |
| --- |
| Brampton Road |
| Hampden Park, Eastbourne |
| East Sussex BN22 9AG |
| United Kingdom |

Teva United Kingdom Limted

Brampton Road

Hampden Park, Eastbourne

East Sussex BN22 9AG

United Kingdom

Primperan; Metoclopramide Tablets BP 10 mg

10 mg

Tablet

Oral anvendelse

Storbritanien

| Accord Healthcare Ltd |
| --- |
| Sage House |
| 319 Pinner Road |
| North Harrow |
| Middlesex HA1 4HF |
| United Kingdom |

Accord Healthcare Ltd

Sage House

319 Pinner Road

North Harrow

Middlesex HA1 4HF

United Kingdom

Metoclopramide Hydrochloride 10 mg tablets

10 mg

Tablet

Oral anvendelse

Storbritanien

| Mercury Pharma International Limited |
| --- |
| 4045 Kingswood Raod |
| City West Business Park |
| County Dublin |
| Ireland |

Mercury Pharma International Limited

4045 Kingswood Raod

City West Business Park

County Dublin

Ireland

Metoclopramide 5 mg/ml solution for injection

5 mg/ml

Injektionsvæske, opløsning

Intramuskulær anvendelse

Intravenøs anvendelse

---

BILAG IV

FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM(ER), STYRKE(R), ADMINISTRATIONSVEJ(E), INDEHAVER(E) AF MARKEDSFØRINGSTILLADELSE(R) I MEDLEMSSTATERNE

| Medlemsstat
  (EØS) | Indehaver af markedsføringstilladelse | Særnavn | Styrke | Lægemiddelform | Indgivelsesvej |
| --- | --- | --- | --- | --- | --- |
| Østrig | Defiante Farmaceutica S.A., |
| Rua dos Ferreiros 260, |
| 9000-082 Funchal/Madeira, |
| Portugal |

Medlemsstat

(EØS)

Indehaver af markedsføringstilladelse

Særnavn

Styrke

Lægemiddelform

Indgivelsesvej

Østrig

Defiante Farmaceutica S.A.,

Rua dos Ferreiros 260,

9000-082 Funchal/Madeira,

Portugal

Hydergin Fas 4,5 mg Filmtabletten

4,5 mg (1:1:1)

Filmovertrukket tablet

Oral anvendelse

Østrig

| Defiante Farmaceutica S.A., |
| --- |
| Rua dos Ferreiros 260, |
| 9000-082 Funchal/Madeira, |
| Portugal |

Defiante Farmaceutica S.A.,

Rua dos Ferreiros 260,

9000-082 Funchal/Madeira,

Portugal

Hydergin 1 mg/ml Tropfen

1 mg/ml (1:1:1)

orale dråber, opløsning

Oral anvendelse

Østrig

| Defiante Farmaceutica S.A., |
| --- |
| Rua dos Ferreiros 260, |
| 9000-082 Funchal/Madeira, |
| Portugal |

Defiante Farmaceutica S.A.,

Rua dos Ferreiros 260,

9000-082 Funchal/Madeira,

Portugal

Hydergin 3 mg/ml Tropfen

3 mg/ml (1:1:1)

orale dråber, opløsning

Oral anvendelse

Østrig

| Defiante Farmaceutica S.A., |
| --- |
| Rua dos Ferreiros 260, |
| 9000-082 Funchal/Madeira, |
| Portugal |

Defiante Farmaceutica S.A.,

Rua dos Ferreiros 260,

9000-082 Funchal/Madeira,

Portugal

Hydergin 1 mg Tabletten

1 mg (1:1:1)

tablet

Oral anvendelse

Østrig

| Defiante Farmaceutica S.A., |
| --- |
| Rua dos Ferreiros 260, |
| 9000-082 Funchal/Madeira, |
| Portugal |

Defiante Farmaceutica S.A.,

Rua dos Ferreiros 260,

9000-082 Funchal/Madeira,

Portugal

Hydergin 2 mg Tabletten

2 mg (1:1:1)

tablet

Oral anvendelse

Østrig

| Defiante Farmaceutica S.A., |
| --- |
| Rua dos Ferreiros 260, |
| 9000-082 Funchal/Madeira, |
| Portugal |

Defiante Farmaceutica S.A.,

Rua dos Ferreiros 260,

9000-082 Funchal/Madeira,

Portugal

Hydergin SRO 6 mg Kapseln

6 mg (1:1:1)

modificeret udløsning, hårde

Oral anvendelse

Belgien

| Defiante Farmacêutica S.A., |
| --- |
| Rua dos Ferreiros 260, |
| 9000-082 Funchal, |
| Portugal |

Defiante Farmacêutica S.A.,

Rua dos Ferreiros 260,

9000-082 Funchal,

Portugal

Hydergine

1 mg-ml

orale opløsning

Oral anvendelse

Belgien

| Defiante Farmacêutica S.A., |
| --- |
| Rua dos Ferreiros 260, |
| 9000-082 Funchal, |
| Portugal |

Defiante Farmacêutica S.A.,

Rua dos Ferreiros 260,

9000-082 Funchal,

Portugal

Hydergine

1,5 mg

Tablet

Oral anvendelse

Belgien

| Defiante Farmacêutica S.A., |
| --- |
| Rua dos Ferreiros 260, |
| 9000-082 Funchal, |
| Portugal |

Defiante Farmacêutica S.A.,

Rua dos Ferreiros 260,

9000-082 Funchal,

Portugal

Hydergine

4,5 mg

Tablet

Oral anvendelse

Belgien

| Defiante Farmacêutica S.A., |
| --- |
| Rua dos Ferreiros 260, |
| 9000-082 Funchal, |
| Portugal |

Defiante Farmacêutica S.A.,

Rua dos Ferreiros 260,

9000-082 Funchal,

Portugal

Hydergine FAS

4,5 mg

Enterotablet

Oral anvendelse

Belgien

| Nycomed Belgien N.V. |
| --- |
| Gentsesteenweg 615 |
| 1080 Brussels |
| Belgien |

Nycomed Belgien N.V.

Gentsesteenweg 615

1080 Brussels

Belgien

Ibexone

1,5 mg

Tablets

Oral anvendelse

Belgien

| Nycomed Belgien N.V. |
| --- |
| Gentsesteenweg 615 |
| 1080 Brussels |
| Belgien |

Nycomed Belgien N.V.

Gentsesteenweg 615

1080 Brussels

Belgien

Ibexone

1 mg-ml

orale opløsning

Oral anvendelse

Belgien

| Nycomed Belgien N.V. |
| --- |
| Gentsesteenweg 615 |
| 1080 Brussels |
| Belgien |

Nycomed Belgien N.V.

Gentsesteenweg 615

1080 Brussels

Belgien

Ibexone

3 mg-ml

orale opløsning

Oral anvendelse

Belgien

| Nycomed Belgien N.V. |
| --- |
| Gentsesteenweg 615 |
| 1080 Brussels |
| Belgien |

Nycomed Belgien N.V.

Gentsesteenweg 615

1080 Brussels

Belgien

Ibexone

4,5 mg

Tablets

Oral anvendelse

Belgien

| Nycomed Belgien N.V. |
| --- |
| Gentsesteenweg 615 |
| 1080 Brussels |
| Belgien |

Nycomed Belgien N.V.

Gentsesteenweg 615

1080 Brussels

Belgien

STOFILAN

1,5 mg

Tablets

Oral anvendelse

Belgien

| Nycomed Belgien N.V. |
| --- |
| Gentsesteenweg 615 |
| 1080 Brussels |
| Belgien |

Nycomed Belgien N.V.

Gentsesteenweg 615

1080 Brussels

Belgien

STOFILAN

1 mg-ml

orale dråber, opløsning

Oral anvendelse

Belgien

| Nycomed Belgien N.V. |
| --- |
| Gentsesteenweg 615 |
| 1080 Brussels |
| Belgien |

Nycomed Belgien N.V.

Gentsesteenweg 615

1080 Brussels

Belgien

STOFILAN FORTE

4,5 mg

Tablets

Oral anvendelse

Tjekkiet

| TEVA Czech Industries s.r.o. |
| --- |
| Ostravská 29 |
| 747 70 Opava-Komárov |
| Czech Republic |

TEVA Czech Industries s.r.o.

Ostravská 29

747 70 Opava-Komárov

Czech Republic

SECATOXIN FORTE

2,5 MG/ML

Orale dråber, opløsning

Oral anvendelse

Finland

| Defiante Farmacêutica, S.A. |
| --- |
| Rua dos Ferreiros, 260 |
| 9000-082 Funchal |
| Portugal |

Defiante Farmacêutica, S.A.

Rua dos Ferreiros, 260

9000-082 Funchal

Portugal

Hydergin

1,5 mg

Tablets

Oral anvendelse

Finland

| Defiante Farmacêutica, S.A. |
| --- |
| Rua dos Ferreiros, 260 |
| 9000-082 Funchal |
| Portugal |

Defiante Farmacêutica, S.A.

Rua dos Ferreiros, 260

9000-082 Funchal

Portugal

Hydergin

1 mg

Tablets

Oral anvendelse

Frankrig

| THERICA |
| --- |
| 15, avenue Henry Dunant |
| 27400 Louviers |
| France |

THERICA

15, avenue Henry Dunant

27400 Louviers

France

CAPERGYL 4,5 mg DOSE QUOTIDIENNE UNIQUE, capsule

4,5 mg

blød kapsel

Oral anvendelse

Frankrig

| DEFIANTE FARMACEUTICA SA (PORTUGAL) |
| --- |
| Rua dos Ferreiros, 260 |
| 9000-082 Funchal |
| Portugal |

DEFIANTE FARMACEUTICA SA (PORTUGAL)

Rua dos Ferreiros, 260

9000-082 Funchal

Portugal

HYDERGINE 1 mg/ml, solution buvable en gouttes

1 mg/ml

orale dråber, opløsning

Oral anvendelse

Frankrig

| DEFIANTE FARMACEUTICA SA (PORTUGAL) |
| --- |
| Rua dos Ferreiros, 260 |
| 9000-082 Funchal |
| Portugal |

DEFIANTE FARMACEUTICA SA (PORTUGAL)

Rua dos Ferreiros, 260

9000-082 Funchal

Portugal

HYDERGINE 4,5 mg DOSE QUOTIDIENNE UNIQUE, comprimé

4,5 mg

tablet

Oral anvendelse

Tyskland

| Defiante Farmacêutica, S.A. |
| --- |
| Rua dos Ferreiros, 260 |
| 9000-082 Funchal |
| Portugal |

Defiante Farmacêutica, S.A.

Rua dos Ferreiros, 260

9000-082 Funchal

Portugal

Hydergin

2 mg

Tablets

Oral anvendelse

Tyskland

| Defiante Farmacêutica, S.A. |
| --- |
| Rua dos Ferreiros, 260 |
| 9000-082 Funchal |
| Portugal |

Defiante Farmacêutica, S.A.

Rua dos Ferreiros, 260

9000-082 Funchal

Portugal

Hydergin

1 mg/ml

Orale dråber

Oral anvendelse

Tyskland

| Defiante Farmacêutica, S.A. |
| --- |
| Rua dos Ferreiros, 260 |
| 9000-082 Funchal |
| Portugal |

Defiante Farmacêutica, S.A.

Rua dos Ferreiros, 260

9000-082 Funchal

Portugal

Hydergin

2 mg/ml

Orale dråber

Oral anvendelse

Grækenland

| Defiante Farmacêutica, S.A. |
| --- |
| Rua dos Ferreiros, 260 |
| 9000-082 Funchal |
| Portugal |

Defiante Farmacêutica, S.A.

Rua dos Ferreiros, 260

9000-082 Funchal

Portugal

Hydergine

1 mg/ml

Orale dråber

Oral anvendelse

Italien

| Defiante Farmaceutica sa |
| --- |
| Rua dos Ferreiros, 260 |
| Funchal Madeira - |
| Portugal |

Defiante Farmaceutica sa

Rua dos Ferreiros, 260

Funchal Madeira -

Portugal

HYDERGINA

1,5 mg

tablet

Oral anvendelse

Italien

| Defiante Farmaceutica sa |
| --- |
| Rua dos Ferreiros, 260 |
| Funchal Madeira - |
| Portugal |

Defiante Farmaceutica sa

Rua dos Ferreiros, 260

Funchal Madeira -

Portugal

HYDERGINA

1 mg/ml

orale opløsning

Oral anvendelse

Luxembourg

| Defiante Farmacêutica, S.A. |
| --- |
| Rua dos Ferreiros, 260 |
| 9000-082 Funchal |
| Portugal |

Defiante Farmacêutica, S.A.

Rua dos Ferreiros, 260

9000-082 Funchal

Portugal

Hydergin

1 mg/ml

Orale dråber

Oral anvendelse

Luxembourg

| Defiante Farmacêutica, S.A. |
| --- |
| Rua dos Ferreiros, 260 |
| 9000-082 Funchal |
| Portugal |

Defiante Farmacêutica, S.A.

Rua dos Ferreiros, 260

9000-082 Funchal

Portugal

Hydergin

2 mg/ml

Orale dråber

Oral anvendelse

Polen

| Farmaceutyczna |
| --- |
| Spółdzielnia Pracy |
| FILOFARM |
| ul. Pułaskiego 39 |
| 85-619 Bydgoszcz |
| Poland |

Farmaceutyczna

Spółdzielnia Pracy

FILOFARM

ul. Pułaskiego 39

85-619 Bydgoszcz

Poland

Dihydroergotoxinum Filofarm

1 mg/ml

orale opløsning

Oral anvendelse

Portugal

| Defiante Farmacêutica, S.A. PRT |
| --- |
| Rua dos Ferreiros, 260 |
| 9000-082 Funchal - Madeira |
| Portugal |

Defiante Farmacêutica, S.A. PRT

Rua dos Ferreiros, 260

9000-082 Funchal - Madeira

Portugal

Hydergine

1,5 mg

tablet

Oral anvendelse

Portugal

| Defiante Farmacêutica, S.A. PRT |
| --- |
| Rua dos Ferreiros, 260 |
| 9000-082 Funchal - Madeira |
| Portugal |

Defiante Farmacêutica, S.A. PRT

Rua dos Ferreiros, 260

9000-082 Funchal - Madeira

Portugal

Hydergine

4,5 mg

tablet

Oral anvendelse

Portugal

| Defiante Farmacêutica, S.A. PRT |
| --- |
| Rua dos Ferreiros, 260 |
| 9000-082 Funchal - Madeira |
| Portugal |

Defiante Farmacêutica, S.A. PRT

Rua dos Ferreiros, 260

9000-082 Funchal - Madeira

Portugal

Hydergine

1 mg/ml

Orale dråber, opløsning

Oral anvendelse

Portugal

| Defiante Farmacêutica, S.A. PRT |
| --- |
| Rua dos Ferreiros, 260 |
| 9000-082 Funchal - Madeira |
| Portugal |

Defiante Farmacêutica, S.A. PRT

Rua dos Ferreiros, 260

9000-082 Funchal - Madeira

Portugal

Hydergine

3 mg/ml

Orale dråber, opløsning

Oral anvendelse

Rumænien

| LEK PHARMACEUTICALS d.d. |
| --- |
| Verovskova 57, |
| 1526 Ljubljana, |
| Slovenia |

LEK PHARMACEUTICALS d.d.

Verovskova 57,

1526 Ljubljana,

Slovenia

REDERGIN

1 mg/ml

Orale dråber, opløsning

Oral anvendelse

Slovakiet

| Teva Czech Industries s.r.o. |
| --- |
| Ostravská 29, |
| č. p. 305 747 70 Opava- Komárov |
| Czech republic |

Teva Czech Industries s.r.o.

Ostravská 29,

č. p. 305 747 70 Opava- Komárov

Czech republic

SECATOXIN FORTE

2,5 mg / 1 ml

Orale dråber, opløsning

Oral anvendelse

Slovenien

| LEK farmacevtska družba d.d., |
| --- |
| Verovskova 57, |
| SI-1526 Ljubljana, |
| Slovenia |

LEK farmacevtska družba d.d.,

Verovskova 57,

SI-1526 Ljubljana,

Slovenia

Redergin 1,5 mg tablete

1,5 mg

tablet

Oral anvendelse

Slovenien

| LEK farmacevtska družba d.d., |
| --- |
| Verovskova 57, |
| SI-1526 Ljubljana, |
| Slovenia |

LEK farmacevtska družba d.d.,

Verovskova 57,

SI-1526 Ljubljana,

Slovenia

Redergin 4,5 mg tablete

4,5 mg

tablet

Oral anvendelse

Slovenien

| LEK farmacevtska družba d.d., |
| --- |
| Verovskova 57, |
| SI-1526 Ljubljana, |
| Slovenia |

LEK farmacevtska družba d.d.,

Verovskova 57,

SI-1526 Ljubljana,

Slovenia

Redergin 1 mg/ ml peroralna raztopina

1 mg/ml

orale opløsning

Oral anvendelse

Spanien

| DEFIANTE FARMACEUTICA, S.A. |
| --- |
| Rua dos Ferreiros, 260 |
| 9000-082 Funchal |
| PORTUGAL |

DEFIANTE FARMACEUTICA, S.A.

Rua dos Ferreiros, 260

9000-082 Funchal

PORTUGAL

HYDERGINA SOLUCIÓN GOTAS

1 mg/ml

orale dråber, opløsning

Oral anvendelse

Spanien

| DEFIANTE FARMACEUTICA, S.A. |
| --- |
| Rua dos Ferreiros, 260 |
| 9000-082 Funchal |
| PORTUGAL |

DEFIANTE FARMACEUTICA, S.A.

Rua dos Ferreiros, 260

9000-082 Funchal

PORTUGAL

HYDERGINA 4,5 mg COMPRIMIDOS

4,5 mg

tablet

Oral anvendelse

Sverige

| Defiante Farmacêutica, S.A. |
| --- |
| Rua dos Ferreiros, 260 |
| 9000-082 Funchal |
| Portugal |

Defiante Farmacêutica, S.A.

Rua dos Ferreiros, 260

9000-082 Funchal

Portugal

Hydergin

1 mg

Tablets

Oral anvendelse

---