# Official Journal C 135/28 A

| | ISSN 1977-091X |
| --- | --- |
| Official Journal
  of the European Union | C 135 |
| | |
| English edition | Information and Notices | Volume 6028 April 2017 |

ISSN 1977-091X

Official Journal

of the European Union

C 135

English edition

Information and Notices

Volume 6028 April 2017

---

| Notice No | Contents | page |
| --- | --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2017/C 135/01 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2017 to 31 March 2017(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) | 1 |
| 2017/C 135/02 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2017 to 31 March 2017(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC) | 7 |

Notice No

Contents

page

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2017/C 135/01

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2017 to 31 March 2017(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

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

1

2017/C 135/02

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2017 to 31 March 2017(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)

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

7

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

EN

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IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 28.4.2017 | EN | Official Journal of the European Union | C 135/1 |
| --- | --- | --- | --- |

28.4.2017

EN

Official Journal of the European Union

C 135/1

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2017 to 31 March 2017

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

(2017/C 135/01)

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

—

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

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorisation | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 3.3.2017 | Ledaga | chlormethine | Actelion Registration Ltd
  Chiswick Tower, 13th Floor, 389 Chiswick High Road, London W4 4AL, United Kingdom | EU/1/16/1171 | Gel | L01AA05 | 7.3.2017 |
| 20.3.2017 | Rolufta | umeclidinium | GlaxoSmithKline Trading Services Limited
  Currabinny, Carrigaline, County Cork, Ireland | EU/1/17/1174 | Inhalation powder, pre-dispensed | R03BB07 | 22.3.2017 |
| 22.3.2017 | AMGEVITA | adalimumab | Amgen Europe B.V.
  Minervum 7061, NL-4817 ZK Breda, Nederland | EU/1/16/1164 | Solution for injection | L04AB04 | 24.3.2017 |
| 22.3.2017 | Daptomycin Hospira | daptomycin | Hospira UK Limited
  Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom | EU/1/17/1175 | Powder for solution for injection or infusion | J01XX09 | 24.3.2017 |
| 22.3.2017 | SOLYMBIC | adalimumab | Amgen Europe B.V.
  Minervum 7061, NL-4817 ZK Breda, Nederland | EU/1/16/1163 | Solution for injection | L04AB04 | 24.3.2017 |
| 22.3.2017 | Tadalafil Lilly | tadalafil | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/17/1177 | Film-coated tablet | G04BE08 | 24.3.2017 |
| 22.3.2017 | Xeljanz | Tofacitinib | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/17/1178 | Film-coated tablet | L04AA29 | 24.3.2017 |
| 22.3.2017 | Yargesa | miglustat | JensonR+ Limited
  Fishleigh Court, Fishleigh Road, Barnstaple, Devon, EX31 3UD, United Kingdom | EU/1/17/1176 | Capsule, hard | A16AX06 | 24.3.2017 |
| 29.3.2017 | Jylamvo | methotrexate | Therakind Ltd
  314 Regents Park Road, London N3 2JX, United Kingdom | EU/1/17/1172 | Oral solution | L01BA01 | 31.3.2017 |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorisation

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

3.3.2017

Ledaga

chlormethine

Actelion Registration Ltd

Chiswick Tower, 13th Floor, 389 Chiswick High Road, London W4 4AL, United Kingdom

EU/1/16/1171

Gel

L01AA05

7.3.2017

20.3.2017

Rolufta

umeclidinium

GlaxoSmithKline Trading Services Limited

Currabinny, Carrigaline, County Cork, Ireland

EU/1/17/1174

Inhalation powder, pre-dispensed

R03BB07

22.3.2017

22.3.2017

AMGEVITA

adalimumab

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/16/1164

Solution for injection

L04AB04

24.3.2017

22.3.2017

Daptomycin Hospira

daptomycin

Hospira UK Limited

Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom

EU/1/17/1175

Powder for solution for injection or infusion

J01XX09

24.3.2017

22.3.2017

SOLYMBIC

adalimumab

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/16/1163

Solution for injection

L04AB04

24.3.2017

22.3.2017

Tadalafil Lilly

tadalafil

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/17/1177

Film-coated tablet

G04BE08

24.3.2017

22.3.2017

Xeljanz

Tofacitinib

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

EU/1/17/1178

Film-coated tablet

L04AA29

24.3.2017

22.3.2017

Yargesa

miglustat

JensonR+ Limited

Fishleigh Court, Fishleigh Road, Barnstaple, Devon, EX31 3UD, United Kingdom

EU/1/17/1176

Capsule, hard

A16AX06

24.3.2017

29.3.2017

Jylamvo

methotrexate

Therakind Ltd

314 Regents Park Road, London N3 2JX, United Kingdom

EU/1/17/1172

Oral solution

L01BA01

31.3.2017

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

—

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

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 3.3.2017 | Baraclude | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/06/343 | 7.3.2017 |
| 3.3.2017 | Combivir | ViiV Healthcare UK Limited
  980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | EU/1/98/058 | 7.3.2017 |
| 3.3.2017 | Deltyba | Otsuka Novel Products GmbH
  Erika-Mann-Straße 21, D-80636 München, Deutschland | EU/1/13/875 | 7.3.2017 |
| 3.3.2017 | Gardasil 9 | MSD VACCINS
  162 avenue Jean Jaurès, 69007 Lyon, France | EU/1/15/1007 | 7.3.2017 |
| 3.3.2017 | Synjardy | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/15/1003 | 7.3.2017 |
| 9.3.2017 | Ziagen | ViiV Healthcare UK Limited
  980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | EU/1/99/112 | 13.3.2017 |
| 17.3.2017 | Fortacin | Plethora Solutions Limited
  Hampden House, Monument Business Park, Chalgrove, OX44 7RW United Kingdom | EU/1/13/881 | 21.3.2017 |
| 17.3.2017 | Tybost | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/13/872 | 21.3.2017 |
| 20.3.2017 | Benlysta | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/11/700 | 22.3.2017 |
| 20.3.2017 | Entacapone Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/10/665 | 22.3.2017 |
| 20.3.2017 | Repso | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/11/674 | 22.3.2017 |
| 20.3.2017 | Telmisartan Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/09/610 | 22.3.2017 |
| 20.3.2017 | Unituxin | United Therapeutics Europe Ltd
  Unither House, Curfew Bell Road, Chertsey, Surrey KT16 9FG, United Kingdom | EU/1/15/1022 | 22.3.2017 |
| 20.3.2017 | Xiapex | Swedish Orphan Biovitrum AB (publ)
  SE-112 76 Stockholm, Sverige | EU/1/11/671 | 22.3.2017 |
| 22.3.2017 | BeneFIX | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/97/047 | 23.3.2017 |
| 22.3.2017 | Betaferon | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/95/003 | 24.3.2017 |
| 22.3.2017 | Briviact | UCB Pharma S.A.
  Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België | EU/1/15/1073 | 24.3.2017 |
| 22.3.2017 | Cosentyx | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/14/980 | 24.3.2017 |
| 22.3.2017 | Fluenz Tetra | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/13/887 | 24.3.2017 |
| 22.3.2017 | Ilaris | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/09/564 | 24.3.2017 |
| 22.3.2017 | Jentadueto | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/12/780 | 24.3.2017 |
| 22.3.2017 | Latuda | Sunovion Pharmaceuticals Europe Ltd
  First Floor, Southside, 97-105 Victoria Street, London SW1E 6QT, United Kingdom | EU/1/14/913 | 24.3.2017 |
| 22.3.2017 | Pixuvri | CTI Life Sciences Ltd
  Highland House, Basingstoke Road, Spencers Wood, Reading, Berkshire RG7 1NT, United Kingdom | EU/1/12/764 | 24.3.2017 |
| 22.3.2017 | TAGRISSO | AstraZeneca AB
  Gärtunavägen, SE-151 85 Södertälje, Sverige | EU/1/16/1086 | 24.3.2017 |
| 22.3.2017 | Zyclara | Meda AB
  Pipers väg 2A, SE-170 73 Solna, Sverige | EU/1/12/783 | 24.3.2017 |
| 24.3.2017 | Bosulif | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/13/818 | 28.3.2017 |
| 24.3.2017 | Caelyx | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/96/011 | 28.3.2017 |
| 24.3.2017 | Genvoya | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/15/1061 | 28.3.2017 |
| 24.3.2017 | Humira | AbbVie Ltd
  Maidenhead, SL6 4UB, United Kingdom | EU/1/03/256 | 28.3.2017 |
| 24.3.2017 | JEVTANA | Sanofi-Aventis groupe
  54 rue La Boétie, F-75008 Paris, France | EU/1/11/676 | 28.3.2017 |
| 24.3.2017 | Nemdatine | Actavis Group PTC ehf.
  Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland | EU/1/13/824 | 28.3.2017 |
| 24.3.2017 | Nevirapine Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/09/598 | 28.3.2017 |
| 24.3.2017 | NULOJIX | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/11/694 | 28.3.2017 |
| 24.3.2017 | Odefsey | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/16/1112 | 28.3.2017 |
| 24.3.2017 | Opdivo | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/15/1014 | 28.3.2017 |
| 24.3.2017 | Pandemic influenza vaccine H5N1 BAXTER | Nanotherapeutics UK Limited
  10 Chiswell Street, London, EC1Y 4UQ, United Kingdom | EU/1/09/571 | 28.3.2017 |
| 24.3.2017 | Truvada | Gilead Sciences International Ltd
  Cambridge, CB21 6GT, United Kingdom | EU/1/04/305 | 28.3.2017 |
| 24.3.2017 | Vimpat | UCB Pharma S.A.
  Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België | EU/1/08/470 | 28.3.2017 |
| 27.3.2017 | Mekinist | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/14/931 | 29.3.2017 |
| 29.3.2017 | Clopidogrel/Acetylsalicylic acid Zentiva | Sanofi-Aventis groupe
  54 rue La Boétie, F-75008 Paris, France | EU/1/10/623 | 31.3.2017 |
| 29.3.2017 | Descovy | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/16/1099 | 31.3.2017 |
| 29.3.2017 | EVARREST | Omrix Biopharmaceuticals N.V.
  Leonardo Da Vincilaan 15, B-1831 Diegem, België | EU/1/13/868 | 31.3.2017 |
| 29.3.2017 | Iressa | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/09/526 | 31.3.2017 |
| 29.3.2017 | Levitra | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/03/248 | 31.3.2017 |
| 29.3.2017 | Plavix | Sanofi Clir SNC
  54 rue La Boétie, F-75008 Paris, France | EU/1/98/069 | 31.3.2017 |
| 29.3.2017 | Tafinlar | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/13/865 | 31.3.2017 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

3.3.2017

Baraclude

Bristol-Myers Squibb Pharma EEIG

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

EU/1/06/343

7.3.2017

3.3.2017

Combivir

ViiV Healthcare UK Limited

980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom

EU/1/98/058

7.3.2017

3.3.2017

Deltyba

Otsuka Novel Products GmbH

Erika-Mann-Straße 21, D-80636 München, Deutschland

EU/1/13/875

7.3.2017

3.3.2017

Gardasil 9

MSD VACCINS

162 avenue Jean Jaurès, 69007 Lyon, France

EU/1/15/1007

7.3.2017

3.3.2017

Synjardy

Boehringer Ingelheim International GmbH

Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland

EU/1/15/1003

7.3.2017

9.3.2017

Ziagen

ViiV Healthcare UK Limited

980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom

EU/1/99/112

13.3.2017

17.3.2017

Fortacin

Plethora Solutions Limited

Hampden House, Monument Business Park, Chalgrove, OX44 7RW United Kingdom

EU/1/13/881

21.3.2017

17.3.2017

Tybost

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/13/872

21.3.2017

20.3.2017

Benlysta

Glaxo Group Ltd

980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

EU/1/11/700

22.3.2017

20.3.2017

Entacapone Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/10/665

22.3.2017

20.3.2017

Repso

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/11/674

22.3.2017

20.3.2017

Telmisartan Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/610

22.3.2017

20.3.2017

Unituxin

United Therapeutics Europe Ltd

Unither House, Curfew Bell Road, Chertsey, Surrey KT16 9FG, United Kingdom

EU/1/15/1022

22.3.2017

20.3.2017

Xiapex

Swedish Orphan Biovitrum AB (publ)

SE-112 76 Stockholm, Sverige

EU/1/11/671

22.3.2017

22.3.2017

BeneFIX

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

EU/1/97/047

23.3.2017

22.3.2017

Betaferon

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/95/003

24.3.2017

22.3.2017

Briviact

UCB Pharma S.A.

Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België

EU/1/15/1073

24.3.2017

22.3.2017

Cosentyx

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/14/980

24.3.2017

22.3.2017

Fluenz Tetra

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/13/887

24.3.2017

22.3.2017

Ilaris

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/09/564

24.3.2017

22.3.2017

Jentadueto

Boehringer Ingelheim International GmbH

Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland

EU/1/12/780

24.3.2017

22.3.2017

Latuda

Sunovion Pharmaceuticals Europe Ltd

First Floor, Southside, 97-105 Victoria Street, London SW1E 6QT, United Kingdom

EU/1/14/913

24.3.2017

22.3.2017

Pixuvri

CTI Life Sciences Ltd

Highland House, Basingstoke Road, Spencers Wood, Reading, Berkshire RG7 1NT, United Kingdom

EU/1/12/764

24.3.2017

22.3.2017

TAGRISSO

AstraZeneca AB

Gärtunavägen, SE-151 85 Södertälje, Sverige

EU/1/16/1086

24.3.2017

22.3.2017

Zyclara

Meda AB

Pipers väg 2A, SE-170 73 Solna, Sverige

EU/1/12/783

24.3.2017

24.3.2017

Bosulif

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

EU/1/13/818

28.3.2017

24.3.2017

Caelyx

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/96/011

28.3.2017

24.3.2017

Genvoya

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/15/1061

28.3.2017

24.3.2017

Humira

AbbVie Ltd

Maidenhead, SL6 4UB, United Kingdom

EU/1/03/256

28.3.2017

24.3.2017

JEVTANA

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/11/676

28.3.2017

24.3.2017

Nemdatine

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland

EU/1/13/824

28.3.2017

24.3.2017

Nevirapine Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/598

28.3.2017

24.3.2017

NULOJIX

Bristol-Myers Squibb Pharma EEIG

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

EU/1/11/694

28.3.2017

24.3.2017

Odefsey

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/16/1112

28.3.2017

24.3.2017

Opdivo

Bristol-Myers Squibb Pharma EEIG

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

EU/1/15/1014

28.3.2017

24.3.2017

Pandemic influenza vaccine H5N1 BAXTER

Nanotherapeutics UK Limited

10 Chiswell Street, London, EC1Y 4UQ, United Kingdom

EU/1/09/571

28.3.2017

24.3.2017

Truvada

Gilead Sciences International Ltd

Cambridge, CB21 6GT, United Kingdom

EU/1/04/305

28.3.2017

24.3.2017

Vimpat

UCB Pharma S.A.

Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België

EU/1/08/470

28.3.2017

27.3.2017

Mekinist

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/14/931

29.3.2017

29.3.2017

Clopidogrel/Acetylsalicylic acid Zentiva

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/10/623

31.3.2017

29.3.2017

Descovy

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/16/1099

31.3.2017

29.3.2017

EVARREST

Omrix Biopharmaceuticals N.V.

Leonardo Da Vincilaan 15, B-1831 Diegem, België

EU/1/13/868

31.3.2017

29.3.2017

Iressa

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/09/526

31.3.2017

29.3.2017

Levitra

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/03/248

31.3.2017

29.3.2017

Plavix

Sanofi Clir SNC

54 rue La Boétie, F-75008 Paris, France

EU/1/98/069

31.3.2017

29.3.2017

Tafinlar

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/13/865

31.3.2017

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

—

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

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 20.3.2017 | Unituxin | United Therapeutics Europe Ltd
  Unither House, Curfew Bell Road, Chertsey, Surrey KT16 9FG, United Kingdom | EU/1/15/1022 | 22.3.2017 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

20.3.2017

Unituxin

United Therapeutics Europe Ltd

Unither House, Curfew Bell Road, Chertsey, Surrey KT16 9FG, United Kingdom

EU/1/15/1022

22.3.2017

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

—

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

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 6.3.2017 | Rabigen SAG2 | VIRBAC S.A.
  1ère Avenue — 2065 m — L.I.D., F-06516 Carros Cedex, France | EU/2/00/021 | 8.3.2017 |
| 13.3.2017 | Nobivac L4 | Intervet International B.V.
  Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | EU/2/12/143 | 15.3.2017 |
| 29.3.2017 | Dexdomitor | Orion Corporation
  Orionintie 1, FI-02200 Espoo, Suomi | EU/2/02/033 | 31.3.2017 |
| 29.3.2017 | Porcilis ColiClos | Intervet International B.V.
  Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | EU/2/12/141 | 31.3.2017 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

6.3.2017

Rabigen SAG2

VIRBAC S.A.

1ère Avenue — 2065 m — L.I.D., F-06516 Carros Cedex, France

EU/2/00/021

8.3.2017

13.3.2017

Nobivac L4

Intervet International B.V.

Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland

EU/2/12/143

15.3.2017

29.3.2017

Dexdomitor

Orion Corporation

Orionintie 1, FI-02200 Espoo, Suomi

EU/2/02/033

31.3.2017

29.3.2017

Porcilis ColiClos

Intervet International B.V.

Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland

EU/2/12/141

31.3.2017

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

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

European Medicines Agency

30 Churchill Place

Canary Wharf

London E14 5EU

United Kingdom

---

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

---

| 28.4.2017 | EN | Official Journal of the European Union | C 135/7 |
| --- | --- | --- | --- |

28.4.2017

EN

Official Journal of the European Union

C 135/7

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2017 to 31 March 2017

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

(2017/C 135/02)

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

—

Issuing, maintenance or modification of a national marketing authorisation

| Date of the decision | Name(s) of the medicinal product | INN (International Non-Proprietary Name) | Holder(s) of the marketing authorization | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- | --- |
| 9.3.2017 | Lovenox and associated names | enoxaparin | See Annex I | See Annex I | 10.3.2017 |
| 22.3.2017 | dienogest/ethinylestradiol | dienogest/ethinylestradiol | See Annex II | See Annex II | 23.3.2017 |
| 13.9.2017 | Iron IV
  Corrigendum | ferric carboxymaltose, iron sucrose complex, sodium ferric gluconate complex, iron(III) isomaltoside complex, iron(III)-hydroxide dextran complex | See Annex III | See Annex III | 20.3.2017 |

Date of the decision

Name(s) of the medicinal product

INN (International Non-Proprietary Name)

Holder(s) of the marketing authorization

Member State concerned

Date of notification

9.3.2017

Lovenox and associated names

enoxaparin

See Annex I

See Annex I

10.3.2017

22.3.2017

dienogest/ethinylestradiol

dienogest/ethinylestradiol

See Annex II

See Annex II

23.3.2017

13.9.2017

Iron IV

Corrigendum

ferric carboxymaltose, iron sucrose complex, sodium ferric gluconate complex, iron(III) isomaltoside complex, iron(III)-hydroxide dextran complex

See Annex III

See Annex III

20.3.2017

---

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

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

---

ANNEX I

List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, Marketing Authorisation Holders in the Member States

| Member State EU/EEA | Marketing authorisation holder
  company name, address | (Invented) Name | Strength | Pharmaceutical form | Route of administration | Content
  (concentration) |
| --- | --- | --- | --- | --- | --- | --- |
| Austria | sanofi-aventis GmbH,
  Leonard-Bernstein-Straße 10, A-1220 Vienna, Austria | Lovenox 20 mg Spritzampullen | 20 mg | Solution for injection | Subcutaneous use | 0,2  ml (100 mg/ml) |
| Austria | sanofi-aventis GmbH,
  Leonard-Bernstein-Straße 10, A-1220 Vienna, Austria | Lovenox 40 mg Spritzampullen | 40 mg | Solution for injection | Subcutaneous use | 0,4  ml (100 mg/ml) |
| Austria | sanofi-aventis GmbH,
  Leonard-Bernstein-Straße 10, A-1220 Vienna, Austria | Lovenox 60 mg Spritzampullen | 60 mg | Solution for injection | Subcutaneous use | 0,6  ml (100 mg/ml) |
| Austria | sanofi-aventis GmbH,
  Leonard-Bernstein-Straße 10, A-1220 Vienna, Austria | Lovenox 80 mg Spritzampullen | 80 mg | Solution for injection | Subcutaneous use | 0,8  ml (100 mg/ml) |
| Austria | sanofi-aventis GmbH,
  Leonard-Bernstein-Straße 10, A-1220 Vienna, Austria | Lovenox 100 mg Spritzampullen | 100 mg | Solution for injection | Subcutaneous use | 1 ml (100 mg/ml) |
| Austria | sanofi-aventis GmbH,
  Leonard-Bernstein-Straße 10, A-1220 Vienna, Austria | Lovenox 120 mg Spritzampullen | 120 mg | Solution for injection | Subcutaneous use | 0,8  ml (150 mg/ml) |
| Austria | sanofi-aventis GmbH,
  Leonard-Bernstein-Straße 10, A-1220 Vienna, Austria | Lovenox 150 mg Spritzampullen | 150 mg | Solution for injection | Subcutaneous use | 1 ml (150 mg/ml) |
| Austria | sanofi-aventis GmbH,
  Leonard-Bernstein-Straße 10, A-1220 Vienna, Austria | Lovenox 100 mg/ml Durchstichflasche | 300 mg | Solution for injection | Subcutaneous use;
  Intravenous use | 3 ml (100 mg/ml) |
| Austria | sanofi-aventis GmbH,
  Leonard-Bernstein-Straße 10, A-1220 Vienna, Austria | Lovenox 100 mg/1 ml Ampullen | 100 mg | Solution for injection | Subcutaneous use;
  Intravenous use | 100 mg/1,0  ml |
| Austria | sanofi-aventis GmbH,
  Leonard-Bernstein-Straße 10, A-1220 Vienna, Austria | Lovenox 100 mg/10 ml Stechampullen | 100 mg | Solution for injection | Extracorporeal use | 100 mg/10 ml |
| Austria | sanofi-aventis GmbH,
  Leonard-Bernstein-Straße 10, A-1220 Vienna, Austria | Lovenox 10 x 40 mg Pen | 40 mg | Solution for injection | Subcutaneous use | 400,00  mg/3 ml (equiv. 10 single doses of 40 mg) |
| Belgium | Sanofi Belgium
  Leonardo Da Vincilaan 19
  1831 Diegem, Belgium | Clexane | 20 mg/0,2  ml | Solution for injection | Subcutaneous use;
  Intravenous use | 0,2  ml (100 mg/ml) |
| Belgium | Sanofi Belgium
  Leonardo Da Vincilaan 19
  1831 Diegem, Belgium | Clexane | 40 mg/0,4  ml | Solution for injection | Subcutaneous use;
  Intravenous use | 0,4  ml (100 mg/ml) |
| Belgium | Sanofi Belgium
  Leonardo Da Vincilaan 19
  1831 Diegem, Belgium | Clexane | 60 mg/0,6  ml | Solution for injection | Subcutaneous use;
  Intravenous use | 0,6  ml (100 mg/ml) |
| Belgium | Sanofi Belgium
  Leonardo Da Vincilaan 19
  1831 Diegem, Belgium | Clexane | 80 mg/0,8  ml | Solution for injection | Subcutaneous use;
  Intravenous use | 0,8  ml (100 mg/ml) |
| Belgium | Sanofi Belgium
  Leonardo Da Vincilaan 19
  1831 Diegem, Belgium | Clexane | 100 mg/1,0  ml | Solution for injection | Subcutaneous use;
  Intravenous use | 1 ml (100 mg/ml) |
| Belgium | Sanofi Belgium
  Leonardo Da Vincilaan 19
  1831 Diegem, Belgium | Clexane | 120 mg/0,8  ml | Solution for injection | Subcutaneous use;
  Intravenous use | 0,8  ml (150 mg/ml) |
| Belgium | Sanofi Belgium
  Leonardo Da Vincilaan 19
  1831 Diegem, Belgium | Clexane | 150 mg/1,0  ml | Solution for injection | Subcutaneous use;
  Intravenous use | 1 ml (150 mg/ml) |
| Belgium | Sanofi Belgium
  Leonardo Da Vincilaan 19
  1831 Diegem, Belgium | Clexane | 300 mg/3 ml | Solution for injection | Subcutaneous use;
  Intravenous use | 3 ml (100 mg/ml) |
| Bulgaria | SANOFI BULGARIA EOOD
  90 Tsarigradsko chaussee Blvd. Office building Capital Fort, section A, 10th floor
  Sofia 1784, Bulgaria | Clexane | 100 mg/ml | Solution for injection | Subcutaneous use;
  Intravenous use;
  Extracorporeal use | 0,2  ml; 0,4  ml (100 mg/ml) |
| Bulgaria | SANOFI BULGARIA EOOD
  90 Tsarigradsko chaussee Blvd. Office building Capital Fort, section A, 10th floor
  Sofia 1784, Bulgaria | Clexane | 60 mg/0,6  ml | Solution for injection | Subcutaneous use;
  Intravenous use;
  Extracorporeal use | 0,6  ml (100 mg/ml) |
| Bulgaria | SANOFI BULGARIA EOOD
  90 Tsarigradsko chaussee Blvd. Office building Capital Fort, section A, 10th floor
  Sofia 1784, Bulgaria | Clexane | 80 mg/0,8  ml | Solution for injection | Subcutaneous use;
  Intravenous use;
  Extracorporeal use | 0,8  ml (100 mg/ml) |
| Bulgaria | SANOFI BULGARIA EOOD
  90 Tsarigradsko chaussee Blvd. Office building Capital Fort, section A, 10th floor
  Sofia 1784, Bulgaria | Clexane | 300 mg/3 ml | Solution for injection | Subcutaneous use;
  Intravenous use;
  Extracorporeal use | 3 ml (100 mg/ml) |
| Croatia | sanofi-aventis Croatia d.o.o.
  Heinzelova 70, 10000 Zagreb, Croatia | Clexane 2 000 IU anti-Xa/0,2  ml otopina za injekciju u napunjenoj štrcaljki | 2 000 anti-Xa IU/0,2  ml | Solution for injection | Subcutaneous use;
  Intravenous use;
  Extracorporeal use | 0,2  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml) |
| Croatia | sanofi-aventis Croatia d.o.o.
  Heinzelova 70, 10000 Zagreb, Croatia | Clexane 4 000 IU anti-Xa/0,4  ml otopina za injekciju u napunjenoj štrcaljki | 4 000 anti-Xa IU/0,4  ml | Solution for injection | Subcutaneous use;
  Intravenous use;
  Extracorporeal use | 0,4  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml) |
| Croatia | sanofi-aventis Croatia d.o.o.
  Heinzelova 70, 10000 Zagreb, Croatia | Clexane 6 000 IU anti-Xa/0,6  ml otopina za injekciju u napunjenoj štrcaljki | 6 000 anti-Xa IU/0,6  ml | Solution for injection | Subcutaneous use;
  Intravenous use;
  Extracorporeal use | 0,6  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml) |
| Croatia | sanofi-aventis Croatia d.o.o.
  Heinzelova 70, 10000 Zagreb, Croatia | Clexane 8 000 IU anti-Xa/0,8  ml otopina za injekciju u napunjenoj štrcaljki | 8 000 anti-Xa IU/0,8  ml | Solution for injection | Subcutaneous use;
  Intravenous use;
  Extracorporeal use | 0,8  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml) |
| Croatia | sanofi-aventis Croatia d.o.o.
  Heinzelova 70, 10000 Zagreb, Croatia | Clexane 10 000 IU anti-Xa/1,0  ml otopina za injekciju u napunjenoj štrcaljki | 10 000 anti-Xa IU/1,0  ml | Solution for injection | Subcutaneous use;
  Intravenous use;
  Extracorporeal use | 1 ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml) |
| Croatia | sanofi-aventis Croatia d.o.o.
  Heinzelova 70, 10000 Zagreb, Croatia | Clexane 30 000 IU anti-Xa/3,0  ml otopina za injekciju u višedoznom spremniku | 30 000 anti-Xa IU/3 ml | Solution for injection | Subcutaneous use;
  Intravenous use;
  Extracorporeal use | 3 ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml) |
| Cyprus | Sanofi-aventis Cyprus Ltd
  14, Charalambou Mouskou
  Strovolos, 2015
  Nicosia
  Cyprus | Clexane | 2 000 anti-Xa IU/0,2  ml | Solution for injection | Subcutaneous use;
  Intravenous use | 0,2  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml) |
| Cyprus | Sanofi-aventis Cyprus Ltd
  14, Charalambou Mouskou
  Strovolos, 2015
  Nicosia
  Cyprus | Clexane | 4 000 anti-Xa IU/0,4  ml | Solution for injection | Subcutaneous use;
  Intravenous use | 0,4  ml;
  (100 mg/ml equivalent to 10 000 anti-Xa IU/ml) |
| Cyprus | Sanofi-aventis Cyprus Ltd
  14, Charalambou Mouskou
  Strovolos, 2015
  Nicosia
  Cyprus | Clexane | 6 000 anti-Xa IU/0,6  ml | Solution for injection | Subcutaneous use;
  Intravenous use | 0,6  ml
  (100 mg/ml equivalent to 10 000 anti-Xa IU/ml) |
| Cyprus | Sanofi-aventis Cyprus Ltd
  14, Charalambou Mouskou
  Strovolos, 2015
  Nicosia
  Cyprus | Clexane | 8 000 anti-Xa IU/0,8  ml | Solution for injection | Subcutaneous use;
  Intravenous use | 0,8  ml
  (100 mg/ml equivalent to 10 000 anti-Xa IU/ml) |
| Cyprus | Sanofi-aventis Cyprus Ltd
  14, Charalambou Mouskou
  Strovolos, 2015
  Nicosia
  Cyprus | Clexane | 150 mg/1,0  ml | Solution for injection | Subcutaneous use;
  Intravenous use | 1 ml
  (150 mg/ml) |
| Czech Republic | sanofi-aventis, s.r.o.
  Evropská 846/176a
  160 00 Praha 6
  Czech Republic | Clexane | 100 mg/ml | Solution for injection | Subcutaneous use;
  Intravenous use;
  Extracorporeal use | 0,2  ml; 0,4  ml;
  0,6  ml; 0,8  ml; 1,0  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml) |
| Czech Republic | sanofi-aventis, s.r.o.
  Evropská 846/176a
  160 00 Praha 6
  Czech Republic | Clexane Forte | 150 mg/ml | Solution for injection | Subcutaneous use;
  Extracorporeal use | 0,8  ml; 1,0  ml
  (150 mg/ml equivalent to 15 000 anti-Xa IU/ml) |
| Denmark | sanofi-aventis Denmark A/S
  Slotsmarken 13
  2970 Hørsholm
  Denmark | Klexane | 100 mg/ml | Solution for injection | Subcutaneous use; Intravenous use | 3 ml (100 mg/ml) |
| Denmark | sanofi-aventis Denmark A/S
  Slotsmarken 13
  2970 Hørsholm
  Denmark | Klexane | 100 mg/ml | Solution for injection | Subcutaneous use | 0,2  ml; 0,4  ml;
  0,6  ml; 0,8  ml;
  1,0  ml
  (100 mg/ml) |
| Estonia | sanofi-aventis Estonia OÜ
  Pärnu mnt. 139 E/2
  11317 Tallinn,
  Estonia | Clexane | 10 000 anti-Xa IU/ml | Solution for injection | Subcutaneous use;
  Intravenous use;
  Extracorporeal use | 0,2  ml; 0,4  ml;
  0,6  ml; 0,8  ml;
  1,0  ml
  (100 mg/ml equivalent to 10 000 anti-Xa IU/ml) |
| Finland | Sanofi Oy
  Huopalahdentie 24
  00350 Helsinki
  Finland | Klexane | 100 mg/ml | Solution for injection | Subcutaneous use | 0,2  ml; 0,4  ml;
  0,6  ml; 0,8  ml;
  1,0  ml
  (100 mg/ml) |
| Finland | Sanofi Oy
  Huopalahdentie 24
  00350 Helsinki
  Finland | Klexane Cum Conservans | 100 mg/ml | Solution for injection | Subcutaneous use;
  Intravenous use | 3 ml; 10 ml
  (100 mg/ml) |
| France | Sanofi-aventis France
  82 avenue Raspail
  94250 Gentilly
  FRANCE | LOVENOX 2 000  UI anti-Xa/0,2  ml, solution injectable en seringue préremplie | 2 000 anti-Xa IU/0,2  ml | Solution for injection | Subcutaneous use; Extracorporeal use | 0,2  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml) |
| France | Sanofi-aventis France
  82 avenue Raspail
  94250 Gentilly
  FRANCE | LOVENOX 4 000  UI anti-Xa/0,4  ml, solution injectable en seringue préremplie | 4 000 anti-Xa IU/0,4  ml | Solution for injection | Subcutaneous use;
  Extracorporeal use | 0,4  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml) |
| France | Sanofi-aventis France
  82 avenue Raspail
  94250 Gentilly
  FRANCE | LOVENOX 6 000  UI anti-Xa/0,6  ml, solution injectable en seringue préremplie | 6 000 anti-Xa IU/0,6  ml | Solution for injection | Subcutaneous use;
  Intravenous use | 0,6  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml) |
| France | Sanofi-aventis France
  82 avenue Raspail
  94250 Gentilly
  FRANCE | LOVENOX 8 000  UI anti-Xa/0,8  ml, solution injectable en seringue préremplie | 8 000 anti-Xa IU/0,8  ml | Solution for injection | Subcutaneous use;
  Intravenous use | 0,8  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml) |
| France | Sanofi-aventis France
  82 avenue Raspail
  94250 Gentilly
  FRANCE | LOVENOX 10 000  UI anti-Xa/1 ml, solution injectable en seringue préremplie | 10 000 anti-Xa IU/1 ml | Solution for injection | Subcutaneous use;
  Intravenous use | 1 ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml) |
| France | Sanofi-aventis France
  82 avenue Raspail
  94250 Gentilly
  FRANCE | LOVENOX 30 000  UI Anti-Xa/3 ml, solution injectable en flacon multidose | 30 000 anti-Xa IU/3 ml | Solution for injection | Subcutaneous use;
  Intravenous use; Extracorporeal use | 3 ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml) |
| France | Sanofi-aventis France
  82 avenue Raspail
  94250 Gentilly
  FRANCE | ENOXAPARINE SANOFI 2 000  UI anti-Xa/0,2  ml, solution injectable en seringue préremplie | 2 000 anti-Xa IU/0,2  ml | Solution for injection | Subcutaneous use; Extracorporeal use | 0,2  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml) |
| France | Sanofi-aventis France
  82 avenue Raspail
  94250 Gentilly
  FRANCE | ENOXAPARINE SANOFI 4 000  UI anti-Xa/0,4  ml, solution injectable en seringue préremplie | 4 000 anti-Xa IU/0,4  ml | Solution for injection | Subcutaneous use; Extracorporeal use | 0,4  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml) |
| France | Sanofi-aventis France
  82 avenue Raspail
  94250 Gentilly
  FRANCE | ENOXAPARINE SANOFI 6 000  UI anti-Xa/0,6  ml, solution injectable en seringue préremplie | 6 000 anti-Xa IU/0,6  ml | Solution for injection | Subcutaneous use;
  Intravenous use | 0,6  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml) |
| France | Sanofi-aventis France
  82 avenue Raspail
  94250 Gentilly
  FRANCE | ENOXAPARINE SANOFI 8 000  UI anti-Xa/0,8  ml, solution injectable en seringue préremplie | 8 000 anti-Xa IU/0,8  ml | Solution for injection | Subcutaneous use;
  Intravenous use | 0,8  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml) |
| France | Sanofi-aventis France
  82 avenue Raspail
  94250 Gentilly
  FRANCE | ENOXAPARINE SANOFI 10 000  UI anti-Xa/1 ml, solution injectable en seringue préremplie | 10 000 anti-Xa IU/1 ml | Solution for injection | Subcutaneous use;
  Intravenous use | 1 ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml) |
| Germany | Sanofi-Aventis Deutschland GmbH
  Industriepark Höchst
  Gebäude K703
  65926 Frankfurt am Main
  Germany | Clexane 20 mg | 20 mg | Solution for injection | Subcutaneous use | 0,2  ml (100 mg/ml) |
| Germany | Sanofi-Aventis Deutschland GmbH
  Industriepark Höchst
  Gebäude K703
  65926 Frankfurt am Main
  Germany | Clexane 20 mg Klinik | 20 mg | Solution for injection | Subcutaneous use | 0,2  ml (100 mg/ml) |
| Germany | Sanofi-Aventis Deutschland GmbH
  Industriepark Höchst
  Gebäude K703
  65926 Frankfurt am Main
  Germany | Clexane 20 mg Praxis | 20 mg | Solution for injection | Subcutaneous use | 0,2  ml (100 mg/ml) |
| Germany | Sanofi-Aventis Deutschland GmbH
  Industriepark Höchst
  Gebäude K703
  65926 Frankfurt am Main
  Germany | Enoxaparin Sanofi
  20 mg | 20 mg | Solution for injection | Subcutaneous use | 0,2  ml (100 mg/ml) |
| Germany | Sanofi-Aventis Deutschland GmbH
  Industriepark Höchst
  Gebäude K703
  65926 Frankfurt am Main
  Germany | Clexane 40 mg | 40 mg | Solution for injection | Subcutaneous use | 0,4  ml (100 mg/ml) |
| Germany | Sanofi-Aventis Deutschland GmbH
  Industriepark Höchst
  Gebäude K703
  65926 Frankfurt am Main
  Germany | Clexane 40 mg Praxis | 40 mg | Solution for injection | Subcutaneous use | 0,4  ml (100 mg/ml) |
| Germany | Sanofi-Aventis Deutschland GmbH
  Industriepark Höchst
  Gebäude K703
  65926 Frankfurt am Main
  Germany | Clexane 40 mg Klinik | 40 mg | Solution for injection | Subcutaneous use | 0,4  ml (100 mg/ml) |
| Germany | Sanofi-Aventis Deutschland GmbH
  Industriepark Höchst
  Gebäude K703
  65926 Frankfurt am Main
  Germany | Enoxaparin Sanofi 40 mg | 40 mg | Solution for injection | Subcutaneous use | 0,4  ml (100 mg/ml) |
| Germany | Sanofi-Aventis Deutschland GmbH
  Industriepark Höchst
  Gebäude K703
  65926 Frankfurt am Main
  Germany | Enoxaparin Sanofi 60 mg | 60 mg | Solution for injection | Subcutaneous use | 0,6  ml (100 mg/ml) |
| Germany | Sanofi-Aventis Deutschland GmbH
  Industriepark Höchst
  Gebäude K703
  65926 Frankfurt am Main
  Germany | Clexane 60 mg
  Fertigspritzen | 60 mg | Solution for injection | Subcutaneous use | 0,6  ml (100 mg/ml) |
| Germany | Sanofi-Aventis Deutschland GmbH
  Industriepark Höchst
  Gebäude K703
  65926 Frankfurt am Main
  Germany | Enoxaparin Sanofi 80 mg | 80 mg | Solution for injection | Subcutaneous use | 0,8  ml (100 mg/ml) |
| Germany | Sanofi-Aventis Deutschland GmbH
  Industriepark Höchst
  Gebäude K703
  65926 Frankfurt am Main
  Germany | Clexane 80 mg
  Fertigspritzen | 80 mg | Solution for injection | Subcutaneous use | 0,8  ml (100 mg/ml) |
| Germany | Sanofi-Aventis Deutschland GmbH
  Industriepark Höchst
  Gebäude K703
  65926 Frankfurt am Main
  Germany | Enoxaparin Sanofi 100 mg | 100 mg | Solution for injection | Subcutaneous use | 1 ml (100 mg/ml) |
| Germany | Sanofi-Aventis Deutschland GmbH
  Industriepark Höchst
  Gebäude K703
  65926 Frankfurt am Main
  Germany | Clexane 100 mg Fertigspritzen | 100 mg | Solution for injection | Subcutaneous use | 1 ml (100 mg/ml) |
| Germany | Sanofi-Aventis Deutschland GmbH
  Industriepark Höchst
  Gebäude K703
  65926 Frankfurt am Main
  Germany | Enoxaparin Sanofi
  multidose 100 mg/ml | 100 mg/ml | Solution for injection | Subcutaneous use;
  Intravenous use; Extracorporeal use | 3 ml; 5 ml; 10 ml (100 mg/ml) |
| Germany | Sanofi-Aventis Deutschland GmbH
  Industriepark Höchst
  Gebäude K703
  65926 Frankfurt am Main
  Germany | Clexane multidose 100 mg/ml | 100 mg/ml | Solution for injection | Subcutaneous use;
  Intravenous use; Extracorporeal use | 3 ml; 5 ml; 10 ml (100 mg/ml) |
| Germany | Sanofi-Aventis Deutschland GmbH
  Industriepark Höchst
  Gebäude K703
  65926 Frankfurt am Main
  Germany | Clexane Multidose 100 mg/ml Praxis | 100 mg/ml | Solution for injection | Subcutaneous use;
  Intravenous use; Extracorporeal use | 3 ml; 5 ml; 10 ml (100 mg/ml) |
| Germany | Sanofi-Aventis Deutschland GmbH
  Industriepark Höchst
  Gebäude K703
  65926 Frankfurt am Main
  Germany | Qualiop multidose 100 mg/ml | 100 mg/ml | Solution for injection | Subcutaneous use;
  Extracorporeal use | 3 ml; 5 ml; 10 ml (100 mg/ml) |
| Germany | Sanofi-Aventis Deutschland GmbH
  Industriepark Höchst
  Gebäude K703
  65926 Frankfurt am Main
  Germany | Qualiop Klinik 100 mg/ml | 100 mg/ml | Solution for injection | Subcutaneous use;
  Extracorporeal use | 3 ml; 5 ml; 10 ml (100 mg/ml) |
| Greece | sanofi-aventis AEBE
  348, Syngrou Av. — Building A, 176 74 Kallithea — Athens
  Greece | Clexane | 2 000 anti-Xa IU/0,2  ml | Solution for injection | Subcutaneous use
  Intravenous use;
  Extracorporeal use | 0,2  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml) |
| Greece | sanofi-aventis AEBE
  348, Syngrou Av. — Building A, 176 74 Kallithea — Athens
  Greece | Clexane | 4 000 anti-Xa IU/0,4  ml | Solution for injection | Subcutaneous use
  Intravenous use;
  Extracorporeal use | 0,4  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml) |
| Greece | sanofi-aventis AEBE
  348, Syngrou Av. — Building A, 176 74 Kallithea — Athens
  Greece | Clexane | 6 000 anti-Xa IU/0,6  ml | Solution for injection | Subcutaneous use
  Intravenous use;
  Extracorporeal use | 0,6  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml) |
| Greece | sanofi-aventis AEBE
  348, Syngrou Av. — Building A, 176 74 Kallithea — Athens
  Greece | Clexane | 8 000 anti-Xa IU/0,8  ml | Solution for injection | Subcutaneous use
  Intravenous use;
  Extracorporeal use | 0,8  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml) |
| Greece | sanofi-aventis AEBE
  348, Syngrou Av. — Building A, 176 74 Kallithea — Athens
  Greece | Clexane | 12 000 anti-Xa IU/0,8  ml | Solution for injection | Subcutaneous use
  Intravenous use;
  Extracorporeal use | 0,8  ml (150 mg/ml equivalent to 15 000 anti-Xa IU/ml) |
| Greece | sanofi-aventis AEBE
  348, Syngrou Av. — Building A, 176 74 Kallithea — Athens
  Greece | Clexane | 15 000 anti-Xa IU/1,0  ml | Solution for injection | Subcutaneous use
  Intravenous use;
  Extracorporeal use | 1 ml (150 mg/ml equivalent to 15 000 anti-Xa IU/ml) |
| Hungary | SANOFI-AVENTIS Zrt.

  1045. BUDAPEST TÓ U. 1-5
  Hungary | Clexane | 20 mg (2 000 NE/0,2  ml) | Solution for injection | Subcutaneous use | 0,2  ml (100 mg/ml) |
| Hungary | SANOFI-AVENTIS Zrt.

  1045. BUDAPEST TÓ U. 1-5
  Hungary | Clexane | 40 mg (4 000 NE/0,4  ml) | Solution for injection | Subcutaneous use | 0,4  ml (100 mg/ml) |
| Hungary | SANOFI-AVENTIS Zrt.

  1045. BUDAPEST TÓ U. 1-5
  Hungary | Clexane | 60 mg (6 000 NE/0,6  ml) | Solution for injection | Subcutaneous use | 0,6  ml (100 mg/ml) |
| Hungary | SANOFI-AVENTIS Zrt.

  1045. BUDAPEST TÓ U. 1-5
  Hungary | Clexane | 80 mg (8 000 NE/0,8  ml) | Solution for injection | Subcutaneous use | 0,8  ml (100 mg/ml) |
| Hungary | SANOFI-AVENTIS Zrt.

  1045. BUDAPEST TÓ U. 1-5
  Hungary | Clexane | 100 mg (10 000 NE/1 ml) | Solution for injection | Subcutaneous use | 1 ml (100 mg/ml) |
| Hungary | SANOFI-AVENTIS Zrt.

  1045. BUDAPEST TÓ U. 1-5
  Hungary | Clexane | 300 mg (30 000 NE/3 ml | Solution for injection | Subcutaneous use;
  Intravenous use | 3 ml (100 mg/ml) |
| Hungary | SANOFI-AVENTIS Zrt.

  1045. BUDAPEST TÓ U. 1-5
  Hungary | Clexane Forte | 120 mg/0,8  ml | Solution for injection | Subcutaneous use | 0,8  ml (150 mg/ml) |
| Hungary | SANOFI-AVENTIS Zrt.

  1045. BUDAPEST TÓ U. 1-5
  Hungary | Clexane Forte | 150 mg/1,0  ml | Solution for injection | Subcutaneous use | 1,0  ml (150 mg/ml) |
| Iceland | Sanofi-aventis Norge AS
  P.O. Box 133
  1325 Lysaker
  Norway | Klexane | 100 mg/ml | Solution for injection | Subcutaneous use;
  Intravenous use; Extracorporeal use | 0,2  ml; 0,4  ml;
  0,6  ml; 0,8  ml;
  1,0  ml
  (100 mg/ml) |
| Iceland | Sanofi-aventis Norge AS
  P.O. Box 133
  1325 Lysaker
  Norway | Klexane | 100 mg/ml | Solution for injection | Subcutaneous use;
  Intravenous use; Extracorporeal use | 3 ml
  (100 mg/ml) |
| Ireland | Sanofi-aventis Ireland Ltd T/A SANOFI
  Citywest Business Campus
  Dublin 24
  Ireland | Clexane Syringes | 100 mg/ml | Solution for injection | Subcutaneous use;
  Intravenous use | 0,2  ml; 0,4  ml; 0,6  ml; 0,8  ml; 1 ml (100 mg/ml) |
| Ireland | Sanofi-aventis Ireland Ltd T/A SANOFI
  Citywest Business Campus
  Dublin 24
  Ireland | Clexane Forte Syringe | 150 mg/ml | Solution for injection | Subcutaneous use;
  Intravenous use | 0,8  ml; 1 ml (150 mg/ml) |
| Italy | Sanofi S.p.A.
  Viale L. Bodio 37/b
  20158 Milan, Italy | Clexane | 2 000 anti-Xa IU/0,2  ml | Solution for injection | Subcutaneous use; Extracorporeal use | 0,2  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml) |
| Italy | Sanofi S.p.A.
  Viale L. Bodio 37/b
  20158 Milan, Italy | Clexane | 4 000 anti-Xa IU/0,4  ml | Solution for injection | Subcutaneous use; Extracorporeal use | 0,4  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml) |
| Italy | Sanofi S.p.A.
  Viale L. Bodio 37/b
  20158 Milan, Italy | Clexane T | 6 000 anti-Xa IU/0,6  ml | Solution for injection | Subcutaneous use | 0,6  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml) |
| Italy | Sanofi S.p.A.
  Viale L. Bodio 37/b
  20158 Milan, Italy | Clexane T | 8 000 anti-Xa IU/0,8  ml | Solution for injection | Subcutaneous use | 0,8  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml) |
| Italy | Sanofi S.p.A.
  Viale L. Bodio 37/b
  20158 Milan, Italy | Clexane T | 10 000 anti-Xa IU/1,0  ml | Solution for injection | Subcutaneous use | 1 ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml) |
| Italy | Sanofi S.p.A.
  Viale L. Bodio 37/b
  20158 Milan, Italy | Clexane T | 30 000 anti-Xa IU/3,0  ml | Solution for injection | Intravenous use | 3 ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml) |
| Latvia | sanofi — aventis Latvia SIA
  33 — 8 Kr. Valdemāra Street
  Rīga, LV — 1010
  Latvia | Clexane 2 000 anti-Xa SV/0,2  ml šķīdums injekcijām pilnšļircē | 2 000 anti-Xa IU/0,2  ml | Solution for injection | Subcutaneous use;
  Intravenous use; Extracorporeal use | 0,2  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml) |
| Latvia | sanofi — aventis Latvia SIA
  33 — 8 Kr. Valdemāra Street
  Rīga, LV — 1010
  Latvia | Clexane 4 000 anti-Xa SV/0,4  ml šķīdums injekcijām pilnšļircē | 4 000 anti-Xa IU/0,4  ml | Solution for injection | Subcutaneous use;
  Intravenous use; Extracorporeal use | 0,4  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml) |
| Latvia | sanofi — aventis Latvia SIA
  33 — 8 Kr. Valdemāra Street
  Rīga, LV — 1010
  Latvia | Clexane 6 000 anti-Xa SV/0,6  ml šķīdums injekcijām pilnšļircē | 6 000 anti-Xa IU/0,6  ml | Solution for injection | Subcutaneous use;
  Intravenous use; Extracorporeal use | 0,6  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml) |
| Latvia | sanofi — aventis Latvia SIA
  33 — 8 Kr. Valdemāra Street
  Rīga, LV — 1010
  Latvia | Clexane 8 000 anti-Xa SV/0,8  ml šķīdums injekcijai pilnšļircē | 8 000 anti-Xa IU/0,8  ml | Solution for injection | Subcutaneous use;
  Intravenous use; Extracorporeal use | 0,8  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml) |
| Lithuania | UAB ‘SANOFI-AVENTIS LIETUVA’
  A.Juozapaviciaus 6/2,
  LT-09310 Vilnius, Lithuania | Clexane 2 000 anti-Xa TV/0,2  ml injekcinis tirpalas užpildytame švirkšte | 2 000 anti-Xa IU/0,2  ml | Solution for injection | Subcutaneous use;
  Extracorporeal use | 0,2  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml) |
| Lithuania | UAB ‘SANOFI-AVENTIS LIETUVA’
  A.Juozapaviciaus 6/2,
  LT-09310 Vilnius, Lithuania | Clexane 4 000 anti-Xa TV/0,4  ml injekcinis tirpalas užpildytame švirkšte | 4 000 anti-Xa IU/0,4  ml | Solution for injection | Subcutaneous use;
  Extracorporeal use | 0,4  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml) |
| Lithuania | UAB ‘SANOFI-AVENTIS LIETUVA’
  A.Juozapaviciaus 6/2,
  LT-09310 Vilnius, Lithuania | Clexane 6 000 anti-Xa TV/0,6  ml injekcinis tirpalas užpildytame švirkšte | 6 000 anti-Xa IU/0,6  ml | Solution for injection | Subcutaneous use;
  Intravenous use; Extracorporeal use | 0,6  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml) |
| Lithuania | UAB ‘SANOFI-AVENTIS LIETUVA’
  A.Juozapaviciaus 6/2,
  LT-09310 Vilnius, Lithuania | Clexane 8 000 anti-Xa TV/0,8  ml injekcinis tirpalas užpildytame švirkšte | 8 000 anti-Xa IU/0,8  ml | Solution for injection | Subcutaneous use;
  Intravenous use; Extracorporeal use | 0,8  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml) |
| Lithuania | UAB ‘SANOFI-AVENTIS LIETUVA’
  A.Juozapaviciaus 6/2,
  LT-09310 Vilnius, Lithuania | Clexane 10 000 anti-Xa TV/1,0  ml injekcinis tirpalas užpildytame švirkšte | 10 000 anti-Xa IU/1,0  ml | Solution for injection | Subcutaneous use;
  Intravenous use; Extracorporeal use | 1 ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml) |
| Luxembourg | Sanofi Belgium
  Leonardo Da Vincilaan 19
  1831 Diegem, Belgium | Clexane | 20 mg/0,2  ml | Solution for injection | Subcutaneous use;
  Intravenous use | 0,2  ml (100 mg/ml) |
| Luxembourg | Sanofi Belgium
  Leonardo Da Vincilaan 19
  1831 Diegem, Belgium | Clexane | 40 mg/0,4  ml | Solution for injection | Subcutaneous use;
  Intravenous use | 0,4  ml (100 mg/ml) |
| Luxembourg | Sanofi Belgium
  Leonardo Da Vincilaan 19
  1831 Diegem, Belgium | Clexane | 60 mg/0,6  ml | Solution for injection | Subcutaneous use;
  Intravenous use | 0,6  ml (100 mg/ml) |
| Luxembourg | Sanofi Belgium
  Leonardo Da Vincilaan 19
  1831 Diegem, Belgium | Clexane | 80 mg/0,8  ml | Solution for injection | Subcutaneous use;
  Intravenous use | 0,8  ml (100 mg/ml) |
| Luxembourg | Sanofi Belgium
  Leonardo Da Vincilaan 19
  1831 Diegem, Belgium | Clexane | 100 mg/1,0  ml | Solution for injection | Subcutaneous use;
  Intravenous use | 1 ml (100 mg/ml) |
| Luxembourg | Sanofi Belgium
  Leonardo Da Vincilaan 19
  1831 Diegem, Belgium | Clexane | 120 mg/0,8  ml | Solution for injection | Subcutaneous use;
  Intravenous use | 0,8  ml (150 mg/ml) |
| Luxembourg | Sanofi Belgium
  Leonardo Da Vincilaan 19
  1831 Diegem, Belgium | Clexane | 150 mg/1,0  ml | Solution for injection | Subcutaneous use;
  Intravenous use | 1 ml (150 mg/ml) |
| Malta | Sanofi Malta Ltd
  3rd Floor, Avantech Building, St.Julian’s Road, San Gwann SGN 2805, Malta | Clexane | 2 000 anti-Xa IU/0,2  ml (20 mg/0,2  ml) | Solution for Injection | Subcutaneous use;
  Intravenous use | 0,2  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml) |
| Malta | Sanofi Malta Ltd
  3rd Floor, Avantech Building, St.Julian’s Road, San Gwann SGN 2805, Malta | Clexane | 4 000 anti-Xa IU/0,4  ml
  (40 mg/0,4  ml) | Solution for Injection | Subcutaneous use;
  Intravenous use | 0,4  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml) |
| Malta | Sanofi Malta Ltd
  3rd Floor, Avantech Building, St.Julian’s Road, San Gwann SGN 2805, Malta | Clexane | 6 000 anti-Xa IU/0,6  ml (60 mg/0,6  ml) | Solution for Injection | Subcutaneous use;
  Intravenous use | 0,6  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml) |
| Malta | Sanofi Malta Ltd
  3rd Floor, Avantech Building, St.Julian’s Road, San Gwann SGN 2805, Malta | Clexane | 8 000 anti-Xa IU/0,8  ml (80 mg/0,8  ml) | Solution for Injection | Subcutaneous use;
  Intravenous use | 0,8  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml) |
| Malta | Sanofi Malta Ltd
  3rd Floor, Avantech Building, St.Julian’s Road, San Gwann SGN 2805, Malta | Clexane | 10 000 anti-Xa IU/1,0  ml (100 mg/1 ml) | Solution for Injection | Subcutaneous use;
  Intravenous use | 1 ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml) |
| Malta | Sanofi Malta Ltd
  3rd Floor, Avantech Building, St.Julian’s Road, San Gwann SGN 2805, Malta | Clexane Forte Syringes | 120 mg/0,8  ml | Solution for Injection | Subcutaneous use;
  Intravenous use | 0,8  ml (150 mg/ml) |
| Malta | Sanofi Malta Ltd
  3rd Floor, Avantech Building, St.Julian’s Road, San Gwann SGN 2805, Malta | Clexane Forte Syringes | 150 mg/1,0  ml | Solution for Injection | Subcutaneous use;
  Intravenous use | 1 ml (150 mg/ml) |
| Malta | Sanofi Malta Ltd
  3rd Floor, Avantech Building, St.Julian’s Road, San Gwann SGN 2805, Malta | Clexane Multidose vial | 30 000 anti-Xa IU/3,0  ml (300 mg/3 ml) | Solution for Injection | Subcutaneous use;
  Intravenous use | 3 ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml) |
| Netherlands | sanofi-aventis Netherlands B.V.
  Kampenringweg 45 D-E
  2803 PE Gouda
  The Netherlands | Clexane 100 mg/ml | 100 mg/ml | Solution for Injection | Subcutaneous use | 0,2  ml; 0,4  ml; 0,6  ml; 0,8  ml; 1,0  ml (100 mg/ml) |
| Netherlands | sanofi-aventis Netherlands B.V.
  Kampenringweg 45 D-E
  2803 PE Gouda
  The Netherlands | Clexane 300 mg/3 ml | 300 mg/3 ml | Solution for Injection | Subcutaneous use;
  Intravenous use | 3 ml (100 mg/ml) |
| Netherlands | sanofi-aventis Netherlands B.V.
  Kampenringweg 45 D-E
  2803 PE Gouda
  The Netherlands | Clexane 150 mg/ml | 150 mg/ml | Solution for Injection | Subcutaneous use | 0,8  ml; 1,0  ml (150 mg/ml) |
| Norway | Sanofi-aventis Norge AS
  P.O. Box 133
  1325 Lysaker
  Norway | Klexane | 100 mg/ml | Solution for Injection | Subcutaneous use;
  Intravenous use; Extracorporeal use | 0,2  ml; 0,4  ml; 0,6  ml; 0,8  ml; 1,0  ml (100 mg/ml) |
| Norway | Sanofi-aventis Norge AS
  P.O. Box 133
  1325 Lysaker
  Norway | Klexane | 100 mg/ml | Solution for Injection | Subcutaneous use;
  Intravenous use; Extracorporeal use | 3 ml (100 mg/ml) |
| Norway | Sanofi-aventis Norge AS
  P.O. Box 133
  1325 Lysaker
  Norway | Klexane | 150 mg/ml | Solution for Injection | Subcutaneous use;
  Intravenous use; Extracorporeal use | 0,8  ml; 1,0  ml (150 mg/ml) |
| Poland | Sanofi-Aventis France
  82, Avenue Raspail
  94250 Gentilly
  France | Clexane | 20 mg/0,2  ml | Solution for injection | Subcutaneous use;
  Extracorporeal use | 0,2  ml
  (100 mg/ml) |
| Poland | Sanofi-Aventis France
  82, Avenue Raspail
  94250 Gentilly
  France | Clexane | 40 mg/0,4  ml | Solution for injection | Subcutaneous use;
  Extracorporeal use | 0,4  ml
  (100 mg/ml) |
| Poland | Sanofi-Aventis France
  82, Avenue Raspail
  94250 Gentilly
  France | Clexane | 60 mg/0,6  ml | Solution for injection | Subcutaneous use;
  Extracorporeal use | 0,6  ml
  (100 mg/ml) |
| Poland | Sanofi-Aventis France
  82, Avenue Raspail
  94250 Gentilly
  France | Clexane | 80 mg/0,8  ml | Solution for injection | Subcutaneous use;
  Extracorporeal use | 0,8  ml
  (100 mg/ml) |
| Poland | Sanofi-Aventis France
  82, Avenue Raspail
  94250 Gentilly
  France | Clexane | 100 mg/1 ml | Solution for injection | Subcutaneous use;
  Extracorporeal use | 1 ml
  (100 mg/ml) |
| Poland | Sanofi-Aventis France
  82, Avenue Raspail
  94250 Gentilly
  France | Clexane | 300 mg/3 ml | Solution for injection | Subcutaneous use;
  Intravenous use;
  Extracorporeal use | 3 ml (100 mg/ml) |
| Poland | Aventis Pharma Limited
  One Onslow Street
  Guildford, Surrey GU1 4YS
  United Kingdom | Clexane forte | 120 mg/0,8  ml | Solution for injection | Subcutaneous use;
  Extracorporeal use | 0,8  ml (150 mg/ml) |
| Poland | Aventis Pharma Limited
  One Onslow Street
  Guildford, Surrey GU1 4YS
  United Kingdom | Clexane forte | 150 mg/1 ml | Solution for injection | Subcutaneous use;
  Extracorporeal use | 1 ml (150 mg/ml) |
| Portugal | Sanofi — Produtos Farmacêuticos, Lda. Empreendimento Lagoas Park, Edifício 7 — 3o Piso 2740-244 Porto Salvo Portugal | Lovenox | 100 mg/1 ml | Solution for injection | Subcutaneous use | 1 ml
  (100 mg/ml) |
| Portugal | Sanofi — Produtos Farmacêuticos, Lda. Empreendimento Lagoas Park, Edifício 7 — 3o Piso 2740-244 Porto Salvo Portugal | Lovenox | 100 mg/ml | Solution for injection | Subcutaneous use;
  Intravenous use | 3 ml (100 mg/ml) |
| Portugal | Sanofi — Produtos Farmacêuticos, Lda. Empreendimento Lagoas Park, Edifício 7 — 3o Piso 2740-244 Porto Salvo Portugal | Lovenox | 150 mg/1 ml | Solution for injection | Subcutaneous use | 1 ml
  (150 mg/ml) |
| Portugal | Sanofi — Produtos Farmacêuticos, Lda. Empreendimento Lagoas Park, Edifício 7 — 3o Piso 2740-244 Porto Salvo Portugal | Lovenox | 80 mg/0,8  ml | Solution for injection | Subcutaneous use | 0,8  ml (100 mg/ml) |
| Portugal | Sanofi — Produtos Farmacêuticos, Lda. Empreendimento Lagoas Park, Edifício 7 — 3o Piso 2740-244 Porto Salvo Portugal | Lovenox | 60 mg/0,6  ml | Solution for injection | Subcutaneous use | 0,6  ml (100 mg/ml) |
| Portugal | Sanofi — Produtos Farmacêuticos, Lda. Empreendimento Lagoas Park, Edifício 7 — 3o Piso 2740-244 Porto Salvo Portugal | Lovenox | 40 mg/0,4  ml | Solution for injection | Subcutaneous use | 0,4  ml (100 mg/ml) |
| Portugal | Sanofi — Produtos Farmacêuticos, Lda. Empreendimento Lagoas Park, Edifício 7 — 3o Piso 2740-244 Porto Salvo Portugal | Lovenox | 20 mg/0,2  ml | Solution for injection | Subcutaneous use | 0,2  ml (100 mg/ml) |
| Portugal | Sanofi — Produtos Farmacêuticos, Lda. Empreendimento Lagoas Park, Edifício 7 — 3o Piso 2740-244 Porto Salvo Portugal | Lovenox | 120 mg/0,8  ml | Solution for injection | Subcutaneous use | 0,8  ml (120 mg/ml) |
| Romania | Sanofi Romania SRL,
  Strada Gara Herăstrău, nr. 4, Clădirea B, etajele 8-9, Sector 2,
  Bucureşti, Romania | Clexane | 2 000 anti-Xa IU/0,2  ml | Solution for injection | Subcutaneous use;
  Intravenous use;
  Extracorporeal use | 0,2  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml) |
| Romania | Sanofi Romania SRL,
  Strada Gara Herăstrău, nr. 4, Clădirea B, etajele 8-9, Sector 2,
  Bucureşti, Romania | Clexane | 4 000 anti-Xa IU/0,4  ml | Solution for injection | Subcutaneous use;
  Intravenous use;
  Extracorporeal use | 0,4  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml) |
| Romania | Sanofi Romania SRL,
  Strada Gara Herăstrău, nr. 4, Clădirea B, etajele 8-9, Sector 2,
  Bucureşti, Romania | Clexane | 6 000 anti-Xa IU/0,6  ml | Solution for injection | Subcutaneous use;
  Intravenous use;
  Extracorporeal use | 0,6  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml) |
| Romania | Sanofi Romania SRL,
  Strada Gara Herăstrău, nr. 4, Clădirea B, etajele 8-9, Sector 2,
  Bucureşti, Romania | Clexane | 8 000 anti-Xa IU/0,8  ml | Solution for injection | Subcutaneous use;
  Intravenous use;
  Extracorporeal use | 0,8  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml) |
| Slovak Republic | sanofi-aventis Slovakia s.r.o.
  Einsteinova 24,
  85101 Bratislava
  Slovak Republic | Clexane | 2 000 anti-Xa IU/0,2  ml | Solution for injection | Subcutaneous use;
  Intravenous use;
  Extracorporeal use | 0,2  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml) |
| Slovak Republic | sanofi-aventis Slovakia s.r.o.
  Einsteinova 24,
  85101 Bratislava
  Slovak Republic | Clexane | 4 000 anti-Xa IU/0,4  ml | Solution for injection | Subcutaneous use;
  Intravenous use;
  Extracorporeal use | 0,4  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml) |
| Slovak Republic | sanofi-aventis Slovakia s.r.o.
  Einsteinova 24,
  85101 Bratislava
  Slovak Republic | Clexane | 6 000 anti-Xa IU/0,6  ml | Solution for injection | Subcutaneous use;
  Intravenous use;
  Extracorporeal use | 0,6  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml) |
| Slovak Republic | sanofi-aventis Slovakia s.r.o.
  Einsteinova 24,
  85101 Bratislava
  Slovak Republic | Clexane | 8 000 anti-Xa IU/0,8  ml | Solution for injection | Subcutaneous use;
  Intravenous use;
  Extracorporeal use | 0,8  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml) |
| Slovak Republic | sanofi-aventis Slovakia s.r.o.
  Einsteinova 24,
  85101 Bratislava
  Slovak Republic | Clexane | 10 000 anti-Xa IU/1 ml | Solution for injection | Subcutaneous use;
  Intravenous use;
  Extracorporeal use | 1 ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml) |
| Slovak Republic | sanofi-aventis Slovakia s.r.o.
  Einsteinova 24,
  85101 Bratislava
  Slovak Republic | Clexane | 30 000 anti-Xa IU/3 ml | Solution for injection | Subcutaneous use;
  Intravenous use;
  Extracorporeal use | 3 ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml) |
| Slovak Republic | sanofi-aventis Slovakia s.r.o.
  Einsteinova 24,
  85101 Bratislava
  Slovak Republic | Clexane forte | 12 000 anti-Xa IU/0,8  ml | solution for injection | Subcutaneous use | 0,8  ml (150 mg/ml equivalent to 15 000 anti-Xa IU/ml) |
| Slovak Republic | sanofi-aventis Slovakia s.r.o.
  Einsteinova 24,
  85101 Bratislava
  Slovak Republic | Clexane forte | 15 000 anti-Xa IU/1,0  ml | solution for injection | Subcutaneous use | 1 ml (150 mg/ml equivalent to 15 000 anti-Xa IU/ml) |
| Slovenia | sanofi-aventis d.o.o.
  Letališka 29 A
  1000 Ljubljana
  Slovenia | Clexane | 2 000 anti-Xa IU/0,2  ml | Solution for injection | Subcutaneous use | 0,2  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml) |
| Slovenia | sanofi-aventis d.o.o.
  Letališka 29 A
  1000 Ljubljana
  Slovenia | Clexane | 4 000 anti-Xa IU/0,4  ml | Solution for injection | Subcutaneous use | 0,4  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml) |
| Slovenia | sanofi-aventis d.o.o.
  Letališka 29 A
  1000 Ljubljana
  Slovenia | Clexane | 6 000 anti-Xa IU/0,6  ml | Solution for injection | Subcutaneous use | 0,6  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml) |
| Slovenia | sanofi-aventis d.o.o.
  Letališka 29 A
  1000 Ljubljana
  Slovenia | Clexane | 8 000 anti-Xa IU/0,8  ml | Solution for injection | Subcutaneous use | 0,8  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml) |
| Slovenia | sanofi-aventis d.o.o.
  Letališka 29 A
  1000 Ljubljana
  Slovenia | Clexane | 10 000 anti-Xa IU/1 ml | Solution for injection | Subcutaneous use | 1 ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml) |
| Slovenia | sanofi-aventis d.o.o.
  Letališka 29 A
  1000 Ljubljana
  Slovenia | Clexane | 10 000 anti-Xa IU/ml | Solution for injection | Subcutaneous use;
  Intravenous use | 3 ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml) |
| Slovenia | sanofi-aventis d.o.o.
  Letališka 29 A
  1000 Ljubljana
  Slovenia | Clexane | 12 000 anti-Xa IU/0,8  ml | Solution for injection | Subcutaneous use | 0,8  ml (150 mg/ml equivalent to 15 000 anti-Xa IU/ml) |
| Slovenia | sanofi-aventis d.o.o.
  Letališka 29 A
  1000 Ljubljana
  Slovenia | Clexane | 15 000 anti-Xa IU/1 ml | Solution for injection | Subcutaneous use | 1 ml (150 mg/ml equivalent to 15 000 anti-Xa IU/ml) |
| Spain | sanofi-aventis, S.A.
  C/Josep Pla, 2
  08019 Barcelona
  Spain | Clexane 20 mg (2 000  UI) solución inyectable en jeringa precargada | 20 mg (2 000 IU) | Solution for injection | Subcutaneous use;
  Intravenous use;
  Extracorporeal use | 0,2  ml (100 mg/ml) |
| Spain | sanofi-aventis, S.A.
  C/Josep Pla, 2
  08019 Barcelona
  Spain | Clexane 40 mg (4 000  UI) solución inyectable en jeringa precargada | 40 mg (4 000 IU) | Solution for injection | Subcutaneous use;
  Intravenous use;
  Extracorporeal use | 0,4  ml (100 mg/ml) |
| Spain | sanofi-aventis, S.A.
  C/Josep Pla, 2
  08019 Barcelona
  Spain | Clexane 60 mg (6 000  UI) solución inyectable en jeringa precargada | 60 mg (6 000 IU) | Solution for injection | Subcutaneous use;
  Intravenous use;
  Extracorporeal use | 0,6  ml (100 mg/ml) |
| Spain | sanofi-aventis, S.A.
  C/Josep Pla, 2
  08019 Barcelona
  Spain | Clexane 80 mg (8 000  UI) solución inyectable en jeringa precargada | 80 mg (8 000 IU) | Solution for injection | Subcutaneous use;
  Intravenous use;
  Extracorporeal use | 0,8  ml (100 mg/ml) |
| Spain | sanofi-aventis, S.A.
  C/Josep Pla, 2
  08019 Barcelona
  Spain | Clexane 100 mg (10 000  UI) solución inyectable en jeringa precargada | 100 mg (10 000 IU) | Solution for injection | Subcutaneous use;
  Intravenous use;
  Extracorporeal use | 1 ml (100 mg/ml) |
| Spain | sanofi-aventis, S.A.
  C/Josep Pla, 2
  08019 Barcelona
  Spain | Clexane 120 mg (12 000  UI) solución inyectable en jeringa precargada | 120 mg (12 000 IU) | Solution for injection | Subcutaneous use;
  Extracorporeal use | 0,8  ml (150 mg/ml) |
| Spain | sanofi-aventis, S.A.
  C/Josep Pla, 2
  08019 Barcelona
  Spain | Clexane 150 mg (15 000  UI) solución inyectable en jeringa precargada | 150 mg (15 000 IU) | Solution for injection | Subcutaneous use;
  Extracorporeal use | 1 ml (150 mg/ml) |
| Sweden | Sanofi AB
  Box 30052
  104 25 Stockholm
  Sweden | Klexane | 100 mg/ml | Solution for injection | Subcutaneous use;
  Intravenous use;
  Extracorporeal use | 0,2  ml; 0,4  ml;
  0,6  ml; 0,8  ml;
  1,0  ml
  (100 mg/ml) |
| Sweden | Sanofi AB
  Box 30052
  104 25 Stockholm
  Sweden | Klexane (med konserveringsmedel) | 100 mg/ml | Solution for injection | Subcutaneous use;
  Intravenous use;
  Extracorporeal use | 3 ml; 10 ml
  (100 mg/ml) |
| Sweden | Sanofi AB
  Box 30052
  104 25 Stockholm
  Sweden | Klexane | 150 mg/ml | Solution for injection | Subcutaneous use;
  Intravenous use;
  Extracorporeal use | 0,6  ml; 0,8  ml;
  1,0  ml
  (150 mg/ml) |
| United Kingdom | Aventis Pharma Limited
  One Onslow Street
  Guildford
  Surrey
  GU1 4YS
  United-Kingdom | Clexane Syringes | 20 mg/0,2  ml | Solution for injection | Subcutaneous use;
  Extracorporeal use | 0,2  ml (100 mg/ml equivalent to 10 000 IU anti-Xa activity/ml) |
| United Kingdom | Aventis Pharma Limited
  One Onslow Street
  Guildford
  Surrey
  GU1 4YS
  United-Kingdom | Clexane Syringes | 40 mg/0,4  ml | Solution for injection | Subcutaneous use;
  Extracorporeal use | 0,4  ml (100 mg/ml equivalent to 10 000 IU anti-Xa activity/ml) |
| United Kingdom | Aventis Pharma Limited
  One Onslow Street
  Guildford
  Surrey
  GU1 4YS
  United-Kingdom | Clexane Syringes | 60 mg/0,6  ml | Solution for injection | Subcutaneous use;
  Intravenous use;
  Extracorporeal use | 0,6  ml (100 mg/ml equivalent to 10 000 IU anti-Xa activity/ml) |
| United Kingdom | Aventis Pharma Limited
  One Onslow Street
  Guildford
  Surrey
  GU1 4YS
  United-Kingdom | Clexane Syringes | 80 mg/0,8  ml | Solution for injection | Subcutaneous use;
  Intravenous use;
  Extracorporeal use | 0,8  ml (100 mg/ml equivalent to 10 000 IU anti-Xa activity/ml) |
| United Kingdom | Aventis Pharma Limited
  One Onslow Street
  Guildford
  Surrey
  GU1 4YS
  United-Kingdom | Clexane Syringes | 100 mg/1,0  ml | Solution for injection | Subcutaneous use;
  Intravenous use;
  Extracorporeal use | 1 ml (100 mg/ml equivalent to 10 000 IU anti-Xa activity/ml) |
| United Kingdom | Aventis Pharma Limited
  One Onslow Street
  Guildford
  Surrey
  GU1 4YS
  United-Kingdom | Clexane Forte Syringes | 120 mg/0,8  ml | Solution for injection | Subcutaneous use;
  Extracorporeal use | 0,8  ml (150 mg/ml equivalent to 15 000 IU anti-Xa activity/ml) |
| United Kingdom | Aventis Pharma Limited
  One Onslow Street
  Guildford
  Surrey
  GU1 4YS
  United-Kingdom | Clexane Forte Syringes | 150 mg/1,0  ml | Solution for injection | Subcutaneous use;
  Extracorporeal use | 1 ml (150 mg/ml equivalent to 15 000 IU anti-Xa activity/ml) |
| United Kingdom | Aventis Pharma Limited
  One Onslow Street
  Guildford
  Surrey
  GU1 4YS
  United-Kingdom | Clexane Multidose vial | 300 mg/3 ml | Solution for injection | Subcutaneous use;
  Intravenous use;
  Extracorporeal use | 3 ml (100 mg/ml) |

Member State EU/EEA

Marketing authorisation holder

company name, address

(Invented) Name

Strength

Pharmaceutical form

Route of administration

Content

(concentration)

Austria

sanofi-aventis GmbH,

Leonard-Bernstein-Straße 10, A-1220 Vienna, Austria

Lovenox 20 mg Spritzampullen

20 mg

Solution for injection

Subcutaneous use

0,2  ml (100 mg/ml)

Austria

sanofi-aventis GmbH,

Leonard-Bernstein-Straße 10, A-1220 Vienna, Austria

Lovenox 40 mg Spritzampullen

40 mg

Solution for injection

Subcutaneous use

0,4  ml (100 mg/ml)

Austria

sanofi-aventis GmbH,

Leonard-Bernstein-Straße 10, A-1220 Vienna, Austria

Lovenox 60 mg Spritzampullen

60 mg

Solution for injection

Subcutaneous use

0,6  ml (100 mg/ml)

Austria

sanofi-aventis GmbH,

Leonard-Bernstein-Straße 10, A-1220 Vienna, Austria

Lovenox 80 mg Spritzampullen

80 mg

Solution for injection

Subcutaneous use

0,8  ml (100 mg/ml)

Austria

sanofi-aventis GmbH,

Leonard-Bernstein-Straße 10, A-1220 Vienna, Austria

Lovenox 100 mg Spritzampullen

100 mg

Solution for injection

Subcutaneous use

1 ml (100 mg/ml)

Austria

sanofi-aventis GmbH,

Leonard-Bernstein-Straße 10, A-1220 Vienna, Austria

Lovenox 120 mg Spritzampullen

120 mg

Solution for injection

Subcutaneous use

0,8  ml (150 mg/ml)

Austria

sanofi-aventis GmbH,

Leonard-Bernstein-Straße 10, A-1220 Vienna, Austria

Lovenox 150 mg Spritzampullen

150 mg

Solution for injection

Subcutaneous use

1 ml (150 mg/ml)

Austria

sanofi-aventis GmbH,

Leonard-Bernstein-Straße 10, A-1220 Vienna, Austria

Lovenox 100 mg/ml Durchstichflasche

300 mg

Solution for injection

Subcutaneous use;

Intravenous use

3 ml (100 mg/ml)

Austria

sanofi-aventis GmbH,

Leonard-Bernstein-Straße 10, A-1220 Vienna, Austria

Lovenox 100 mg/1 ml Ampullen

100 mg

Solution for injection

Subcutaneous use;

Intravenous use

100 mg/1,0  ml

Austria

sanofi-aventis GmbH,

Leonard-Bernstein-Straße 10, A-1220 Vienna, Austria

Lovenox 100 mg/10 ml Stechampullen

100 mg

Solution for injection

Extracorporeal use

100 mg/10 ml

Austria

sanofi-aventis GmbH,

Leonard-Bernstein-Straße 10, A-1220 Vienna, Austria

Lovenox 10 x 40 mg Pen

40 mg

Solution for injection

Subcutaneous use

400,00  mg/3 ml (equiv. 10 single doses of 40 mg)

Belgium

Sanofi Belgium

Leonardo Da Vincilaan 19

1831 Diegem, Belgium

Clexane

20 mg/0,2  ml

Solution for injection

Subcutaneous use;

Intravenous use

0,2  ml (100 mg/ml)

Belgium

Sanofi Belgium

Leonardo Da Vincilaan 19

1831 Diegem, Belgium

Clexane

40 mg/0,4  ml

Solution for injection

Subcutaneous use;

Intravenous use

0,4  ml (100 mg/ml)

Belgium

Sanofi Belgium

Leonardo Da Vincilaan 19

1831 Diegem, Belgium

Clexane

60 mg/0,6  ml

Solution for injection

Subcutaneous use;

Intravenous use

0,6  ml (100 mg/ml)

Belgium

Sanofi Belgium

Leonardo Da Vincilaan 19

1831 Diegem, Belgium

Clexane

80 mg/0,8  ml

Solution for injection

Subcutaneous use;

Intravenous use

0,8  ml (100 mg/ml)

Belgium

Sanofi Belgium

Leonardo Da Vincilaan 19

1831 Diegem, Belgium

Clexane

100 mg/1,0  ml

Solution for injection

Subcutaneous use;

Intravenous use

1 ml (100 mg/ml)

Belgium

Sanofi Belgium

Leonardo Da Vincilaan 19

1831 Diegem, Belgium

Clexane

120 mg/0,8  ml

Solution for injection

Subcutaneous use;

Intravenous use

0,8  ml (150 mg/ml)

Belgium

Sanofi Belgium

Leonardo Da Vincilaan 19

1831 Diegem, Belgium

Clexane

150 mg/1,0  ml

Solution for injection

Subcutaneous use;

Intravenous use

1 ml (150 mg/ml)

Belgium

Sanofi Belgium

Leonardo Da Vincilaan 19

1831 Diegem, Belgium

Clexane

300 mg/3 ml

Solution for injection

Subcutaneous use;

Intravenous use

3 ml (100 mg/ml)

Bulgaria

SANOFI BULGARIA EOOD

90 Tsarigradsko chaussee Blvd. Office building Capital Fort, section A, 10th floor

Sofia 1784, Bulgaria

Clexane

100 mg/ml

Solution for injection

Subcutaneous use;

Intravenous use;

Extracorporeal use

0,2  ml; 0,4  ml (100 mg/ml)

Bulgaria

SANOFI BULGARIA EOOD

90 Tsarigradsko chaussee Blvd. Office building Capital Fort, section A, 10th floor

Sofia 1784, Bulgaria

Clexane

60 mg/0,6  ml

Solution for injection

Subcutaneous use;

Intravenous use;

Extracorporeal use

0,6  ml (100 mg/ml)

Bulgaria

SANOFI BULGARIA EOOD

90 Tsarigradsko chaussee Blvd. Office building Capital Fort, section A, 10th floor

Sofia 1784, Bulgaria

Clexane

80 mg/0,8  ml

Solution for injection

Subcutaneous use;

Intravenous use;

Extracorporeal use

0,8  ml (100 mg/ml)

Bulgaria

SANOFI BULGARIA EOOD

90 Tsarigradsko chaussee Blvd. Office building Capital Fort, section A, 10th floor

Sofia 1784, Bulgaria

Clexane

300 mg/3 ml

Solution for injection

Subcutaneous use;

Intravenous use;

Extracorporeal use

3 ml (100 mg/ml)

Croatia

sanofi-aventis Croatia d.o.o.

Heinzelova 70, 10000 Zagreb, Croatia

Clexane 2 000 IU anti-Xa/0,2  ml otopina za injekciju u napunjenoj štrcaljki

2 000 anti-Xa IU/0,2  ml

Solution for injection

Subcutaneous use;

Intravenous use;

Extracorporeal use

0,2  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml)

Croatia

sanofi-aventis Croatia d.o.o.

Heinzelova 70, 10000 Zagreb, Croatia

Clexane 4 000 IU anti-Xa/0,4  ml otopina za injekciju u napunjenoj štrcaljki

4 000 anti-Xa IU/0,4  ml

Solution for injection

Subcutaneous use;

Intravenous use;

Extracorporeal use

0,4  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml)

Croatia

sanofi-aventis Croatia d.o.o.

Heinzelova 70, 10000 Zagreb, Croatia

Clexane 6 000 IU anti-Xa/0,6  ml otopina za injekciju u napunjenoj štrcaljki

6 000 anti-Xa IU/0,6  ml

Solution for injection

Subcutaneous use;

Intravenous use;

Extracorporeal use

0,6  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml)

Croatia

sanofi-aventis Croatia d.o.o.

Heinzelova 70, 10000 Zagreb, Croatia

Clexane 8 000 IU anti-Xa/0,8  ml otopina za injekciju u napunjenoj štrcaljki

8 000 anti-Xa IU/0,8  ml

Solution for injection

Subcutaneous use;

Intravenous use;

Extracorporeal use

0,8  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml)

Croatia

sanofi-aventis Croatia d.o.o.

Heinzelova 70, 10000 Zagreb, Croatia

Clexane 10 000 IU anti-Xa/1,0  ml otopina za injekciju u napunjenoj štrcaljki

10 000 anti-Xa IU/1,0  ml

Solution for injection

Subcutaneous use;

Intravenous use;

Extracorporeal use

1 ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml)

Croatia

sanofi-aventis Croatia d.o.o.

Heinzelova 70, 10000 Zagreb, Croatia

Clexane 30 000 IU anti-Xa/3,0  ml otopina za injekciju u višedoznom spremniku

30 000 anti-Xa IU/3 ml

Solution for injection

Subcutaneous use;

Intravenous use;

Extracorporeal use

3 ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml)

Cyprus

Sanofi-aventis Cyprus Ltd

14, Charalambou Mouskou

Strovolos, 2015

Nicosia

Cyprus

Clexane

2 000 anti-Xa IU/0,2  ml

Solution for injection

Subcutaneous use;

Intravenous use

0,2  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml)

Cyprus

Sanofi-aventis Cyprus Ltd

14, Charalambou Mouskou

Strovolos, 2015

Nicosia

Cyprus

Clexane

4 000 anti-Xa IU/0,4  ml

Solution for injection

Subcutaneous use;

Intravenous use

0,4  ml;

(100 mg/ml equivalent to 10 000 anti-Xa IU/ml)

Cyprus

Sanofi-aventis Cyprus Ltd

14, Charalambou Mouskou

Strovolos, 2015

Nicosia

Cyprus

Clexane

6 000 anti-Xa IU/0,6  ml

Solution for injection

Subcutaneous use;

Intravenous use

0,6  ml

(100 mg/ml equivalent to 10 000 anti-Xa IU/ml)

Cyprus

Sanofi-aventis Cyprus Ltd

14, Charalambou Mouskou

Strovolos, 2015

Nicosia

Cyprus

Clexane

8 000 anti-Xa IU/0,8  ml

Solution for injection

Subcutaneous use;

Intravenous use

0,8  ml

(100 mg/ml equivalent to 10 000 anti-Xa IU/ml)

Cyprus

Sanofi-aventis Cyprus Ltd

14, Charalambou Mouskou

Strovolos, 2015

Nicosia

Cyprus

Clexane

150 mg/1,0  ml

Solution for injection

Subcutaneous use;

Intravenous use

1 ml

(150 mg/ml)

Czech Republic

sanofi-aventis, s.r.o.

Evropská 846/176a

160 00 Praha 6

Czech Republic

Clexane

100 mg/ml

Solution for injection

Subcutaneous use;

Intravenous use;

Extracorporeal use

0,2  ml; 0,4  ml;

0,6  ml; 0,8  ml; 1,0  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml)

Czech Republic

sanofi-aventis, s.r.o.

Evropská 846/176a

160 00 Praha 6

Czech Republic

Clexane Forte

150 mg/ml

Solution for injection

Subcutaneous use;

Extracorporeal use

0,8  ml; 1,0  ml

(150 mg/ml equivalent to 15 000 anti-Xa IU/ml)

Denmark

sanofi-aventis Denmark A/S

Slotsmarken 13

2970 Hørsholm

Denmark

Klexane

100 mg/ml

Solution for injection

Subcutaneous use; Intravenous use

3 ml (100 mg/ml)

Denmark

sanofi-aventis Denmark A/S

Slotsmarken 13

2970 Hørsholm

Denmark

Klexane

100 mg/ml

Solution for injection

Subcutaneous use

0,2  ml; 0,4  ml;

0,6  ml; 0,8  ml;

1,0  ml

(100 mg/ml)

Estonia

sanofi-aventis Estonia OÜ

Pärnu mnt. 139 E/2

11317 Tallinn,

Estonia

Clexane

10 000 anti-Xa IU/ml

Solution for injection

Subcutaneous use;

Intravenous use;

Extracorporeal use

0,2  ml; 0,4  ml;

0,6  ml; 0,8  ml;

1,0  ml

(100 mg/ml equivalent to 10 000 anti-Xa IU/ml)

Finland

Sanofi Oy

Huopalahdentie 24

00350 Helsinki

Finland

Klexane

100 mg/ml

Solution for injection

Subcutaneous use

0,2  ml; 0,4  ml;

0,6  ml; 0,8  ml;

1,0  ml

(100 mg/ml)

Finland

Sanofi Oy

Huopalahdentie 24

00350 Helsinki

Finland

Klexane Cum Conservans

100 mg/ml

Solution for injection

Subcutaneous use;

Intravenous use

3 ml; 10 ml

(100 mg/ml)

France

Sanofi-aventis France

82 avenue Raspail

94250 Gentilly

FRANCE

LOVENOX 2 000  UI anti-Xa/0,2  ml, solution injectable en seringue préremplie

2 000 anti-Xa IU/0,2  ml

Solution for injection

Subcutaneous use; Extracorporeal use

0,2  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml)

France

Sanofi-aventis France

82 avenue Raspail

94250 Gentilly

FRANCE

LOVENOX 4 000  UI anti-Xa/0,4  ml, solution injectable en seringue préremplie

4 000 anti-Xa IU/0,4  ml

Solution for injection

Subcutaneous use;

Extracorporeal use

0,4  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml)

France

Sanofi-aventis France

82 avenue Raspail

94250 Gentilly

FRANCE

LOVENOX 6 000  UI anti-Xa/0,6  ml, solution injectable en seringue préremplie

6 000 anti-Xa IU/0,6  ml

Solution for injection

Subcutaneous use;

Intravenous use

0,6  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml)

France

Sanofi-aventis France

82 avenue Raspail

94250 Gentilly

FRANCE

LOVENOX 8 000  UI anti-Xa/0,8  ml, solution injectable en seringue préremplie

8 000 anti-Xa IU/0,8  ml

Solution for injection

Subcutaneous use;

Intravenous use

0,8  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml)

France

Sanofi-aventis France

82 avenue Raspail

94250 Gentilly

FRANCE

LOVENOX 10 000  UI anti-Xa/1 ml, solution injectable en seringue préremplie

10 000 anti-Xa IU/1 ml

Solution for injection

Subcutaneous use;

Intravenous use

1 ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml)

France

Sanofi-aventis France

82 avenue Raspail

94250 Gentilly

FRANCE

LOVENOX 30 000  UI Anti-Xa/3 ml, solution injectable en flacon multidose

30 000 anti-Xa IU/3 ml

Solution for injection

Subcutaneous use;

Intravenous use; Extracorporeal use

3 ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml)

France

Sanofi-aventis France

82 avenue Raspail

94250 Gentilly

FRANCE

ENOXAPARINE SANOFI 2 000  UI anti-Xa/0,2  ml, solution injectable en seringue préremplie

2 000 anti-Xa IU/0,2  ml

Solution for injection

Subcutaneous use; Extracorporeal use

0,2  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml)

France

Sanofi-aventis France

82 avenue Raspail

94250 Gentilly

FRANCE

ENOXAPARINE SANOFI 4 000  UI anti-Xa/0,4  ml, solution injectable en seringue préremplie

4 000 anti-Xa IU/0,4  ml

Solution for injection

Subcutaneous use; Extracorporeal use

0,4  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml)

France

Sanofi-aventis France

82 avenue Raspail

94250 Gentilly

FRANCE

ENOXAPARINE SANOFI 6 000  UI anti-Xa/0,6  ml, solution injectable en seringue préremplie

6 000 anti-Xa IU/0,6  ml

Solution for injection

Subcutaneous use;

Intravenous use

0,6  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml)

France

Sanofi-aventis France

82 avenue Raspail

94250 Gentilly

FRANCE

ENOXAPARINE SANOFI 8 000  UI anti-Xa/0,8  ml, solution injectable en seringue préremplie

8 000 anti-Xa IU/0,8  ml

Solution for injection

Subcutaneous use;

Intravenous use

0,8  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml)

France

Sanofi-aventis France

82 avenue Raspail

94250 Gentilly

FRANCE

ENOXAPARINE SANOFI 10 000  UI anti-Xa/1 ml, solution injectable en seringue préremplie

10 000 anti-Xa IU/1 ml

Solution for injection

Subcutaneous use;

Intravenous use

1 ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml)

Germany

Sanofi-Aventis Deutschland GmbH

Industriepark Höchst

Gebäude K703

65926 Frankfurt am Main

Germany

Clexane 20 mg

20 mg

Solution for injection

Subcutaneous use

0,2  ml (100 mg/ml)

Germany

Sanofi-Aventis Deutschland GmbH

Industriepark Höchst

Gebäude K703

65926 Frankfurt am Main

Germany

Clexane 20 mg Klinik

20 mg

Solution for injection

Subcutaneous use

0,2  ml (100 mg/ml)

Germany

Sanofi-Aventis Deutschland GmbH

Industriepark Höchst

Gebäude K703

65926 Frankfurt am Main

Germany

Clexane 20 mg Praxis

20 mg

Solution for injection

Subcutaneous use

0,2  ml (100 mg/ml)

Germany

Sanofi-Aventis Deutschland GmbH

Industriepark Höchst

Gebäude K703

65926 Frankfurt am Main

Germany

Enoxaparin Sanofi

20 mg

20 mg

Solution for injection

Subcutaneous use

0,2  ml (100 mg/ml)

Germany

Sanofi-Aventis Deutschland GmbH

Industriepark Höchst

Gebäude K703

65926 Frankfurt am Main

Germany

Clexane 40 mg

40 mg

Solution for injection

Subcutaneous use

0,4  ml (100 mg/ml)

Germany

Sanofi-Aventis Deutschland GmbH

Industriepark Höchst

Gebäude K703

65926 Frankfurt am Main

Germany

Clexane 40 mg Praxis

40 mg

Solution for injection

Subcutaneous use

0,4  ml (100 mg/ml)

Germany

Sanofi-Aventis Deutschland GmbH

Industriepark Höchst

Gebäude K703

65926 Frankfurt am Main

Germany

Clexane 40 mg Klinik

40 mg

Solution for injection

Subcutaneous use

0,4  ml (100 mg/ml)

Germany

Sanofi-Aventis Deutschland GmbH

Industriepark Höchst

Gebäude K703

65926 Frankfurt am Main

Germany

Enoxaparin Sanofi 40 mg

40 mg

Solution for injection

Subcutaneous use

0,4  ml (100 mg/ml)

Germany

Sanofi-Aventis Deutschland GmbH

Industriepark Höchst

Gebäude K703

65926 Frankfurt am Main

Germany

Enoxaparin Sanofi 60 mg

60 mg

Solution for injection

Subcutaneous use

0,6  ml (100 mg/ml)

Germany

Sanofi-Aventis Deutschland GmbH

Industriepark Höchst

Gebäude K703

65926 Frankfurt am Main

Germany

Clexane 60 mg

Fertigspritzen

60 mg

Solution for injection

Subcutaneous use

0,6  ml (100 mg/ml)

Germany

Sanofi-Aventis Deutschland GmbH

Industriepark Höchst

Gebäude K703

65926 Frankfurt am Main

Germany

Enoxaparin Sanofi 80 mg

80 mg

Solution for injection

Subcutaneous use

0,8  ml (100 mg/ml)

Germany

Sanofi-Aventis Deutschland GmbH

Industriepark Höchst

Gebäude K703

65926 Frankfurt am Main

Germany

Clexane 80 mg

Fertigspritzen

80 mg

Solution for injection

Subcutaneous use

0,8  ml (100 mg/ml)

Germany

Sanofi-Aventis Deutschland GmbH

Industriepark Höchst

Gebäude K703

65926 Frankfurt am Main

Germany

Enoxaparin Sanofi 100 mg

100 mg

Solution for injection

Subcutaneous use

1 ml (100 mg/ml)

Germany

Sanofi-Aventis Deutschland GmbH

Industriepark Höchst

Gebäude K703

65926 Frankfurt am Main

Germany

Clexane 100 mg Fertigspritzen

100 mg

Solution for injection

Subcutaneous use

1 ml (100 mg/ml)

Germany

Sanofi-Aventis Deutschland GmbH

Industriepark Höchst

Gebäude K703

65926 Frankfurt am Main

Germany

Enoxaparin Sanofi

multidose 100 mg/ml

100 mg/ml

Solution for injection

Subcutaneous use;

Intravenous use; Extracorporeal use

3 ml; 5 ml; 10 ml (100 mg/ml)

Germany

Sanofi-Aventis Deutschland GmbH

Industriepark Höchst

Gebäude K703

65926 Frankfurt am Main

Germany

Clexane multidose 100 mg/ml

100 mg/ml

Solution for injection

Subcutaneous use;

Intravenous use; Extracorporeal use

3 ml; 5 ml; 10 ml (100 mg/ml)

Germany

Sanofi-Aventis Deutschland GmbH

Industriepark Höchst

Gebäude K703

65926 Frankfurt am Main

Germany

Clexane Multidose 100 mg/ml Praxis

100 mg/ml

Solution for injection

Subcutaneous use;

Intravenous use; Extracorporeal use

3 ml; 5 ml; 10 ml (100 mg/ml)

Germany

Sanofi-Aventis Deutschland GmbH

Industriepark Höchst

Gebäude K703

65926 Frankfurt am Main

Germany

Qualiop multidose 100 mg/ml

100 mg/ml

Solution for injection

Subcutaneous use;

Extracorporeal use

3 ml; 5 ml; 10 ml (100 mg/ml)

Germany

Sanofi-Aventis Deutschland GmbH

Industriepark Höchst

Gebäude K703

65926 Frankfurt am Main

Germany

Qualiop Klinik 100 mg/ml

100 mg/ml

Solution for injection

Subcutaneous use;

Extracorporeal use

3 ml; 5 ml; 10 ml (100 mg/ml)

Greece

sanofi-aventis AEBE

348, Syngrou Av. — Building A, 176 74 Kallithea — Athens

Greece

Clexane

2 000 anti-Xa IU/0,2  ml

Solution for injection

Subcutaneous use

Intravenous use;

Extracorporeal use

0,2  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml)

Greece

sanofi-aventis AEBE

348, Syngrou Av. — Building A, 176 74 Kallithea — Athens

Greece

Clexane

4 000 anti-Xa IU/0,4  ml

Solution for injection

Subcutaneous use

Intravenous use;

Extracorporeal use

0,4  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml)

Greece

sanofi-aventis AEBE

348, Syngrou Av. — Building A, 176 74 Kallithea — Athens

Greece

Clexane

6 000 anti-Xa IU/0,6  ml

Solution for injection

Subcutaneous use

Intravenous use;

Extracorporeal use

0,6  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml)

Greece

sanofi-aventis AEBE

348, Syngrou Av. — Building A, 176 74 Kallithea — Athens

Greece

Clexane

8 000 anti-Xa IU/0,8  ml

Solution for injection

Subcutaneous use

Intravenous use;

Extracorporeal use

0,8  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml)

Greece

sanofi-aventis AEBE

348, Syngrou Av. — Building A, 176 74 Kallithea — Athens

Greece

Clexane

12 000 anti-Xa IU/0,8  ml

Solution for injection

Subcutaneous use

Intravenous use;

Extracorporeal use

0,8  ml (150 mg/ml equivalent to 15 000 anti-Xa IU/ml)

Greece

sanofi-aventis AEBE

348, Syngrou Av. — Building A, 176 74 Kallithea — Athens

Greece

Clexane

15 000 anti-Xa IU/1,0  ml

Solution for injection

Subcutaneous use

Intravenous use;

Extracorporeal use

1 ml (150 mg/ml equivalent to 15 000 anti-Xa IU/ml)

Hungary

SANOFI-AVENTIS Zrt.

1045. BUDAPEST TÓ U. 1-5

Hungary

Clexane

20 mg (2 000 NE/0,2  ml)

Solution for injection

Subcutaneous use

0,2  ml (100 mg/ml)

Hungary

SANOFI-AVENTIS Zrt.

1045. BUDAPEST TÓ U. 1-5

Hungary

Clexane

40 mg (4 000 NE/0,4  ml)

Solution for injection

Subcutaneous use

0,4  ml (100 mg/ml)

Hungary

SANOFI-AVENTIS Zrt.

1045. BUDAPEST TÓ U. 1-5

Hungary

Clexane

60 mg (6 000 NE/0,6  ml)

Solution for injection

Subcutaneous use

0,6  ml (100 mg/ml)

Hungary

SANOFI-AVENTIS Zrt.

1045. BUDAPEST TÓ U. 1-5

Hungary

Clexane

80 mg (8 000 NE/0,8  ml)

Solution for injection

Subcutaneous use

0,8  ml (100 mg/ml)

Hungary

SANOFI-AVENTIS Zrt.

1045. BUDAPEST TÓ U. 1-5

Hungary

Clexane

100 mg (10 000 NE/1 ml)

Solution for injection

Subcutaneous use

1 ml (100 mg/ml)

Hungary

SANOFI-AVENTIS Zrt.

1045. BUDAPEST TÓ U. 1-5

Hungary

Clexane

300 mg (30 000 NE/3 ml

Solution for injection

Subcutaneous use;

Intravenous use

3 ml (100 mg/ml)

Hungary

SANOFI-AVENTIS Zrt.

1045. BUDAPEST TÓ U. 1-5

Hungary

Clexane Forte

120 mg/0,8  ml

Solution for injection

Subcutaneous use

0,8  ml (150 mg/ml)

Hungary

SANOFI-AVENTIS Zrt.

1045. BUDAPEST TÓ U. 1-5

Hungary

Clexane Forte

150 mg/1,0  ml

Solution for injection

Subcutaneous use

1,0  ml (150 mg/ml)

Iceland

Sanofi-aventis Norge AS

P.O. Box 133

1325 Lysaker

Norway

Klexane

100 mg/ml

Solution for injection

Subcutaneous use;

Intravenous use; Extracorporeal use

0,2  ml; 0,4  ml;

0,6  ml; 0,8  ml;

1,0  ml

(100 mg/ml)

Iceland

Sanofi-aventis Norge AS

P.O. Box 133

1325 Lysaker

Norway

Klexane

100 mg/ml

Solution for injection

Subcutaneous use;

Intravenous use; Extracorporeal use

3 ml

(100 mg/ml)

Ireland

Sanofi-aventis Ireland Ltd T/A SANOFI

Citywest Business Campus

Dublin 24

Ireland

Clexane Syringes

100 mg/ml

Solution for injection

Subcutaneous use;

Intravenous use

0,2  ml; 0,4  ml; 0,6  ml; 0,8  ml; 1 ml (100 mg/ml)

Ireland

Sanofi-aventis Ireland Ltd T/A SANOFI

Citywest Business Campus

Dublin 24

Ireland

Clexane Forte Syringe

150 mg/ml

Solution for injection

Subcutaneous use;

Intravenous use

0,8  ml; 1 ml (150 mg/ml)

Italy

Sanofi S.p.A.

Viale L. Bodio 37/b

20158 Milan, Italy

Clexane

2 000 anti-Xa IU/0,2  ml

Solution for injection

Subcutaneous use; Extracorporeal use

0,2  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml)

Italy

Sanofi S.p.A.

Viale L. Bodio 37/b

20158 Milan, Italy

Clexane

4 000 anti-Xa IU/0,4  ml

Solution for injection

Subcutaneous use; Extracorporeal use

0,4  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml)

Italy

Sanofi S.p.A.

Viale L. Bodio 37/b

20158 Milan, Italy

Clexane T

6 000 anti-Xa IU/0,6  ml

Solution for injection

Subcutaneous use

0,6  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml)

Italy

Sanofi S.p.A.

Viale L. Bodio 37/b

20158 Milan, Italy

Clexane T

8 000 anti-Xa IU/0,8  ml

Solution for injection

Subcutaneous use

0,8  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml)

Italy

Sanofi S.p.A.

Viale L. Bodio 37/b

20158 Milan, Italy

Clexane T

10 000 anti-Xa IU/1,0  ml

Solution for injection

Subcutaneous use

1 ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml)

Italy

Sanofi S.p.A.

Viale L. Bodio 37/b

20158 Milan, Italy

Clexane T

30 000 anti-Xa IU/3,0  ml

Solution for injection

Intravenous use

3 ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml)

Latvia

sanofi — aventis Latvia SIA

33 — 8 Kr. Valdemāra Street

Rīga, LV — 1010

Latvia

Clexane 2 000 anti-Xa SV/0,2  ml šķīdums injekcijām pilnšļircē

2 000 anti-Xa IU/0,2  ml

Solution for injection

Subcutaneous use;

Intravenous use; Extracorporeal use

0,2  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml)

Latvia

sanofi — aventis Latvia SIA

33 — 8 Kr. Valdemāra Street

Rīga, LV — 1010

Latvia

Clexane 4 000 anti-Xa SV/0,4  ml šķīdums injekcijām pilnšļircē

4 000 anti-Xa IU/0,4  ml

Solution for injection

Subcutaneous use;

Intravenous use; Extracorporeal use

0,4  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml)

Latvia

sanofi — aventis Latvia SIA

33 — 8 Kr. Valdemāra Street

Rīga, LV — 1010

Latvia

Clexane 6 000 anti-Xa SV/0,6  ml šķīdums injekcijām pilnšļircē

6 000 anti-Xa IU/0,6  ml

Solution for injection

Subcutaneous use;

Intravenous use; Extracorporeal use

0,6  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml)

Latvia

sanofi — aventis Latvia SIA

33 — 8 Kr. Valdemāra Street

Rīga, LV — 1010

Latvia

Clexane 8 000 anti-Xa SV/0,8  ml šķīdums injekcijai pilnšļircē

8 000 anti-Xa IU/0,8  ml

Solution for injection

Subcutaneous use;

Intravenous use; Extracorporeal use

0,8  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml)

Lithuania

UAB ‘SANOFI-AVENTIS LIETUVA’

A.Juozapaviciaus 6/2,

LT-09310 Vilnius, Lithuania

Clexane 2 000 anti-Xa TV/0,2  ml injekcinis tirpalas užpildytame švirkšte

2 000 anti-Xa IU/0,2  ml

Solution for injection

Subcutaneous use;

Extracorporeal use

0,2  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml)

Lithuania

UAB ‘SANOFI-AVENTIS LIETUVA’

A.Juozapaviciaus 6/2,

LT-09310 Vilnius, Lithuania

Clexane 4 000 anti-Xa TV/0,4  ml injekcinis tirpalas užpildytame švirkšte

4 000 anti-Xa IU/0,4  ml

Solution for injection

Subcutaneous use;

Extracorporeal use

0,4  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml)

Lithuania

UAB ‘SANOFI-AVENTIS LIETUVA’

A.Juozapaviciaus 6/2,

LT-09310 Vilnius, Lithuania

Clexane 6 000 anti-Xa TV/0,6  ml injekcinis tirpalas užpildytame švirkšte

6 000 anti-Xa IU/0,6  ml

Solution for injection

Subcutaneous use;

Intravenous use; Extracorporeal use

0,6  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml)

Lithuania

UAB ‘SANOFI-AVENTIS LIETUVA’

A.Juozapaviciaus 6/2,

LT-09310 Vilnius, Lithuania

Clexane 8 000 anti-Xa TV/0,8  ml injekcinis tirpalas užpildytame švirkšte

8 000 anti-Xa IU/0,8  ml

Solution for injection

Subcutaneous use;

Intravenous use; Extracorporeal use

0,8  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml)

Lithuania

UAB ‘SANOFI-AVENTIS LIETUVA’

A.Juozapaviciaus 6/2,

LT-09310 Vilnius, Lithuania

Clexane 10 000 anti-Xa TV/1,0  ml injekcinis tirpalas užpildytame švirkšte

10 000 anti-Xa IU/1,0  ml

Solution for injection

Subcutaneous use;

Intravenous use; Extracorporeal use

1 ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml)

Luxembourg

Sanofi Belgium

Leonardo Da Vincilaan 19

1831 Diegem, Belgium

Clexane

20 mg/0,2  ml

Solution for injection

Subcutaneous use;

Intravenous use

0,2  ml (100 mg/ml)

Luxembourg

Sanofi Belgium

Leonardo Da Vincilaan 19

1831 Diegem, Belgium

Clexane

40 mg/0,4  ml

Solution for injection

Subcutaneous use;

Intravenous use

0,4  ml (100 mg/ml)

Luxembourg

Sanofi Belgium

Leonardo Da Vincilaan 19

1831 Diegem, Belgium

Clexane

60 mg/0,6  ml

Solution for injection

Subcutaneous use;

Intravenous use

0,6  ml (100 mg/ml)

Luxembourg

Sanofi Belgium

Leonardo Da Vincilaan 19

1831 Diegem, Belgium

Clexane

80 mg/0,8  ml

Solution for injection

Subcutaneous use;

Intravenous use

0,8  ml (100 mg/ml)

Luxembourg

Sanofi Belgium

Leonardo Da Vincilaan 19

1831 Diegem, Belgium

Clexane

100 mg/1,0  ml

Solution for injection

Subcutaneous use;

Intravenous use

1 ml (100 mg/ml)

Luxembourg

Sanofi Belgium

Leonardo Da Vincilaan 19

1831 Diegem, Belgium

Clexane

120 mg/0,8  ml

Solution for injection

Subcutaneous use;

Intravenous use

0,8  ml (150 mg/ml)

Luxembourg

Sanofi Belgium

Leonardo Da Vincilaan 19

1831 Diegem, Belgium

Clexane

150 mg/1,0  ml

Solution for injection

Subcutaneous use;

Intravenous use

1 ml (150 mg/ml)

Malta

Sanofi Malta Ltd

3rd Floor, Avantech Building, St.Julian’s Road, San Gwann SGN 2805, Malta

Clexane

2 000 anti-Xa IU/0,2  ml (20 mg/0,2  ml)

Solution for Injection

Subcutaneous use;

Intravenous use

0,2  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml)

Malta

Sanofi Malta Ltd

3rd Floor, Avantech Building, St.Julian’s Road, San Gwann SGN 2805, Malta

Clexane

4 000 anti-Xa IU/0,4  ml

(40 mg/0,4  ml)

Solution for Injection

Subcutaneous use;

Intravenous use

0,4  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml)

Malta

Sanofi Malta Ltd

3rd Floor, Avantech Building, St.Julian’s Road, San Gwann SGN 2805, Malta

Clexane

6 000 anti-Xa IU/0,6  ml (60 mg/0,6  ml)

Solution for Injection

Subcutaneous use;

Intravenous use

0,6  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml)

Malta

Sanofi Malta Ltd

3rd Floor, Avantech Building, St.Julian’s Road, San Gwann SGN 2805, Malta

Clexane

8 000 anti-Xa IU/0,8  ml (80 mg/0,8  ml)

Solution for Injection

Subcutaneous use;

Intravenous use

0,8  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml)

Malta

Sanofi Malta Ltd

3rd Floor, Avantech Building, St.Julian’s Road, San Gwann SGN 2805, Malta

Clexane

10 000 anti-Xa IU/1,0  ml (100 mg/1 ml)

Solution for Injection

Subcutaneous use;

Intravenous use

1 ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml)

Malta

Sanofi Malta Ltd

3rd Floor, Avantech Building, St.Julian’s Road, San Gwann SGN 2805, Malta

Clexane Forte Syringes

120 mg/0,8  ml

Solution for Injection

Subcutaneous use;

Intravenous use

0,8  ml (150 mg/ml)

Malta

Sanofi Malta Ltd

3rd Floor, Avantech Building, St.Julian’s Road, San Gwann SGN 2805, Malta

Clexane Forte Syringes

150 mg/1,0  ml

Solution for Injection

Subcutaneous use;

Intravenous use

1 ml (150 mg/ml)

Malta

Sanofi Malta Ltd

3rd Floor, Avantech Building, St.Julian’s Road, San Gwann SGN 2805, Malta

Clexane Multidose vial

30 000 anti-Xa IU/3,0  ml (300 mg/3 ml)

Solution for Injection

Subcutaneous use;

Intravenous use

3 ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml)

Netherlands

sanofi-aventis Netherlands B.V.

Kampenringweg 45 D-E

2803 PE Gouda

The Netherlands

Clexane 100 mg/ml

100 mg/ml

Solution for Injection

Subcutaneous use

0,2  ml; 0,4  ml; 0,6  ml; 0,8  ml; 1,0  ml (100 mg/ml)

Netherlands

sanofi-aventis Netherlands B.V.

Kampenringweg 45 D-E

2803 PE Gouda

The Netherlands

Clexane 300 mg/3 ml

300 mg/3 ml

Solution for Injection

Subcutaneous use;

Intravenous use

3 ml (100 mg/ml)

Netherlands

sanofi-aventis Netherlands B.V.

Kampenringweg 45 D-E

2803 PE Gouda

The Netherlands

Clexane 150 mg/ml

150 mg/ml

Solution for Injection

Subcutaneous use

0,8  ml; 1,0  ml (150 mg/ml)

Norway

Sanofi-aventis Norge AS

P.O. Box 133

1325 Lysaker

Norway

Klexane

100 mg/ml

Solution for Injection

Subcutaneous use;

Intravenous use; Extracorporeal use

0,2  ml; 0,4  ml; 0,6  ml; 0,8  ml; 1,0  ml (100 mg/ml)

Norway

Sanofi-aventis Norge AS

P.O. Box 133

1325 Lysaker

Norway

Klexane

100 mg/ml

Solution for Injection

Subcutaneous use;

Intravenous use; Extracorporeal use

3 ml (100 mg/ml)

Norway

Sanofi-aventis Norge AS

P.O. Box 133

1325 Lysaker

Norway

Klexane

150 mg/ml

Solution for Injection

Subcutaneous use;

Intravenous use; Extracorporeal use

0,8  ml; 1,0  ml (150 mg/ml)

Poland

Sanofi-Aventis France

82, Avenue Raspail

94250 Gentilly

France

Clexane

20 mg/0,2  ml

Solution for injection

Subcutaneous use;

Extracorporeal use

0,2  ml

(100 mg/ml)

Poland

Sanofi-Aventis France

82, Avenue Raspail

94250 Gentilly

France

Clexane

40 mg/0,4  ml

Solution for injection

Subcutaneous use;

Extracorporeal use

0,4  ml

(100 mg/ml)

Poland

Sanofi-Aventis France

82, Avenue Raspail

94250 Gentilly

France

Clexane

60 mg/0,6  ml

Solution for injection

Subcutaneous use;

Extracorporeal use

0,6  ml

(100 mg/ml)

Poland

Sanofi-Aventis France

82, Avenue Raspail

94250 Gentilly

France

Clexane

80 mg/0,8  ml

Solution for injection

Subcutaneous use;

Extracorporeal use

0,8  ml

(100 mg/ml)

Poland

Sanofi-Aventis France

82, Avenue Raspail

94250 Gentilly

France

Clexane

100 mg/1 ml

Solution for injection

Subcutaneous use;

Extracorporeal use

1 ml

(100 mg/ml)

Poland

Sanofi-Aventis France

82, Avenue Raspail

94250 Gentilly

France

Clexane

300 mg/3 ml

Solution for injection

Subcutaneous use;

Intravenous use;

Extracorporeal use

3 ml (100 mg/ml)

Poland

Aventis Pharma Limited

One Onslow Street

Guildford, Surrey GU1 4YS

United Kingdom

Clexane forte

120 mg/0,8  ml

Solution for injection

Subcutaneous use;

Extracorporeal use

0,8  ml (150 mg/ml)

Poland

Aventis Pharma Limited

One Onslow Street

Guildford, Surrey GU1 4YS

United Kingdom

Clexane forte

150 mg/1 ml

Solution for injection

Subcutaneous use;

Extracorporeal use

1 ml (150 mg/ml)

Portugal

Sanofi — Produtos Farmacêuticos, Lda. Empreendimento Lagoas Park, Edifício 7 — 3o Piso 2740-244 Porto Salvo Portugal

Lovenox

100 mg/1 ml

Solution for injection

Subcutaneous use

1 ml

(100 mg/ml)

Portugal

Sanofi — Produtos Farmacêuticos, Lda. Empreendimento Lagoas Park, Edifício 7 — 3o Piso 2740-244 Porto Salvo Portugal

Lovenox

100 mg/ml

Solution for injection

Subcutaneous use;

Intravenous use

3 ml (100 mg/ml)

Portugal

Sanofi — Produtos Farmacêuticos, Lda. Empreendimento Lagoas Park, Edifício 7 — 3o Piso 2740-244 Porto Salvo Portugal

Lovenox

150 mg/1 ml

Solution for injection

Subcutaneous use

1 ml

(150 mg/ml)

Portugal

Sanofi — Produtos Farmacêuticos, Lda. Empreendimento Lagoas Park, Edifício 7 — 3o Piso 2740-244 Porto Salvo Portugal

Lovenox

80 mg/0,8  ml

Solution for injection

Subcutaneous use

0,8  ml (100 mg/ml)

Portugal

Sanofi — Produtos Farmacêuticos, Lda. Empreendimento Lagoas Park, Edifício 7 — 3o Piso 2740-244 Porto Salvo Portugal

Lovenox

60 mg/0,6  ml

Solution for injection

Subcutaneous use

0,6  ml (100 mg/ml)

Portugal

Sanofi — Produtos Farmacêuticos, Lda. Empreendimento Lagoas Park, Edifício 7 — 3o Piso 2740-244 Porto Salvo Portugal

Lovenox

40 mg/0,4  ml

Solution for injection

Subcutaneous use

0,4  ml (100 mg/ml)

Portugal

Sanofi — Produtos Farmacêuticos, Lda. Empreendimento Lagoas Park, Edifício 7 — 3o Piso 2740-244 Porto Salvo Portugal

Lovenox

20 mg/0,2  ml

Solution for injection

Subcutaneous use

0,2  ml (100 mg/ml)

Portugal

Sanofi — Produtos Farmacêuticos, Lda. Empreendimento Lagoas Park, Edifício 7 — 3o Piso 2740-244 Porto Salvo Portugal

Lovenox

120 mg/0,8  ml

Solution for injection

Subcutaneous use

0,8  ml (120 mg/ml)

Romania

Sanofi Romania SRL,

Strada Gara Herăstrău, nr. 4, Clădirea B, etajele 8-9, Sector 2,

Bucureşti, Romania

Clexane

2 000 anti-Xa IU/0,2  ml

Solution for injection

Subcutaneous use;

Intravenous use;

Extracorporeal use

0,2  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml)

Romania

Sanofi Romania SRL,

Strada Gara Herăstrău, nr. 4, Clădirea B, etajele 8-9, Sector 2,

Bucureşti, Romania

Clexane

4 000 anti-Xa IU/0,4  ml

Solution for injection

Subcutaneous use;

Intravenous use;

Extracorporeal use

0,4  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml)

Romania

Sanofi Romania SRL,

Strada Gara Herăstrău, nr. 4, Clădirea B, etajele 8-9, Sector 2,

Bucureşti, Romania

Clexane

6 000 anti-Xa IU/0,6  ml

Solution for injection

Subcutaneous use;

Intravenous use;

Extracorporeal use

0,6  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml)

Romania

Sanofi Romania SRL,

Strada Gara Herăstrău, nr. 4, Clădirea B, etajele 8-9, Sector 2,

Bucureşti, Romania

Clexane

8 000 anti-Xa IU/0,8  ml

Solution for injection

Subcutaneous use;

Intravenous use;

Extracorporeal use

0,8  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml)

Slovak Republic

sanofi-aventis Slovakia s.r.o.

Einsteinova 24,

85101 Bratislava

Slovak Republic

Clexane

2 000 anti-Xa IU/0,2  ml

Solution for injection

Subcutaneous use;

Intravenous use;

Extracorporeal use

0,2  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml)

Slovak Republic

sanofi-aventis Slovakia s.r.o.

Einsteinova 24,

85101 Bratislava

Slovak Republic

Clexane

4 000 anti-Xa IU/0,4  ml

Solution for injection

Subcutaneous use;

Intravenous use;

Extracorporeal use

0,4  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml)

Slovak Republic

sanofi-aventis Slovakia s.r.o.

Einsteinova 24,

85101 Bratislava

Slovak Republic

Clexane

6 000 anti-Xa IU/0,6  ml

Solution for injection

Subcutaneous use;

Intravenous use;

Extracorporeal use

0,6  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml)

Slovak Republic

sanofi-aventis Slovakia s.r.o.

Einsteinova 24,

85101 Bratislava

Slovak Republic

Clexane

8 000 anti-Xa IU/0,8  ml

Solution for injection

Subcutaneous use;

Intravenous use;

Extracorporeal use

0,8  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml)

Slovak Republic

sanofi-aventis Slovakia s.r.o.

Einsteinova 24,

85101 Bratislava

Slovak Republic

Clexane

10 000 anti-Xa IU/1 ml

Solution for injection

Subcutaneous use;

Intravenous use;

Extracorporeal use

1 ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml)

Slovak Republic

sanofi-aventis Slovakia s.r.o.

Einsteinova 24,

85101 Bratislava

Slovak Republic

Clexane

30 000 anti-Xa IU/3 ml

Solution for injection

Subcutaneous use;

Intravenous use;

Extracorporeal use

3 ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml)

Slovak Republic

sanofi-aventis Slovakia s.r.o.

Einsteinova 24,

85101 Bratislava

Slovak Republic

Clexane forte

12 000 anti-Xa IU/0,8  ml

solution for injection

Subcutaneous use

0,8  ml (150 mg/ml equivalent to 15 000 anti-Xa IU/ml)

Slovak Republic

sanofi-aventis Slovakia s.r.o.

Einsteinova 24,

85101 Bratislava

Slovak Republic

Clexane forte

15 000 anti-Xa IU/1,0  ml

solution for injection

Subcutaneous use

1 ml (150 mg/ml equivalent to 15 000 anti-Xa IU/ml)

Slovenia

sanofi-aventis d.o.o.

Letališka 29 A

1000 Ljubljana

Slovenia

Clexane

2 000 anti-Xa IU/0,2  ml

Solution for injection

Subcutaneous use

0,2  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml)

Slovenia

sanofi-aventis d.o.o.

Letališka 29 A

1000 Ljubljana

Slovenia

Clexane

4 000 anti-Xa IU/0,4  ml

Solution for injection

Subcutaneous use

0,4  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml)

Slovenia

sanofi-aventis d.o.o.

Letališka 29 A

1000 Ljubljana

Slovenia

Clexane

6 000 anti-Xa IU/0,6  ml

Solution for injection

Subcutaneous use

0,6  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml)

Slovenia

sanofi-aventis d.o.o.

Letališka 29 A

1000 Ljubljana

Slovenia

Clexane

8 000 anti-Xa IU/0,8  ml

Solution for injection

Subcutaneous use

0,8  ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml)

Slovenia

sanofi-aventis d.o.o.

Letališka 29 A

1000 Ljubljana

Slovenia

Clexane

10 000 anti-Xa IU/1 ml

Solution for injection

Subcutaneous use

1 ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml)

Slovenia

sanofi-aventis d.o.o.

Letališka 29 A

1000 Ljubljana

Slovenia

Clexane

10 000 anti-Xa IU/ml

Solution for injection

Subcutaneous use;

Intravenous use

3 ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml)

Slovenia

sanofi-aventis d.o.o.

Letališka 29 A

1000 Ljubljana

Slovenia

Clexane

12 000 anti-Xa IU/0,8  ml

Solution for injection

Subcutaneous use

0,8  ml (150 mg/ml equivalent to 15 000 anti-Xa IU/ml)

Slovenia

sanofi-aventis d.o.o.

Letališka 29 A

1000 Ljubljana

Slovenia

Clexane

15 000 anti-Xa IU/1 ml

Solution for injection

Subcutaneous use

1 ml (150 mg/ml equivalent to 15 000 anti-Xa IU/ml)

Spain

sanofi-aventis, S.A.

C/Josep Pla, 2

08019 Barcelona

Spain

Clexane 20 mg (2 000  UI) solución inyectable en jeringa precargada

20 mg (2 000 IU)

Solution for injection

Subcutaneous use;

Intravenous use;

Extracorporeal use

0,2  ml (100 mg/ml)

Spain

sanofi-aventis, S.A.

C/Josep Pla, 2

08019 Barcelona

Spain

Clexane 40 mg (4 000  UI) solución inyectable en jeringa precargada

40 mg (4 000 IU)

Solution for injection

Subcutaneous use;

Intravenous use;

Extracorporeal use

0,4  ml (100 mg/ml)

Spain

sanofi-aventis, S.A.

C/Josep Pla, 2

08019 Barcelona

Spain

Clexane 60 mg (6 000  UI) solución inyectable en jeringa precargada

60 mg (6 000 IU)

Solution for injection

Subcutaneous use;

Intravenous use;

Extracorporeal use

0,6  ml (100 mg/ml)

Spain

sanofi-aventis, S.A.

C/Josep Pla, 2

08019 Barcelona

Spain

Clexane 80 mg (8 000  UI) solución inyectable en jeringa precargada

80 mg (8 000 IU)

Solution for injection

Subcutaneous use;

Intravenous use;

Extracorporeal use

0,8  ml (100 mg/ml)

Spain

sanofi-aventis, S.A.

C/Josep Pla, 2

08019 Barcelona

Spain

Clexane 100 mg (10 000  UI) solución inyectable en jeringa precargada

100 mg (10 000 IU)

Solution for injection

Subcutaneous use;

Intravenous use;

Extracorporeal use

1 ml (100 mg/ml)

Spain

sanofi-aventis, S.A.

C/Josep Pla, 2

08019 Barcelona

Spain

Clexane 120 mg (12 000  UI) solución inyectable en jeringa precargada

120 mg (12 000 IU)

Solution for injection

Subcutaneous use;

Extracorporeal use

0,8  ml (150 mg/ml)

Spain

sanofi-aventis, S.A.

C/Josep Pla, 2

08019 Barcelona

Spain

Clexane 150 mg (15 000  UI) solución inyectable en jeringa precargada

150 mg (15 000 IU)

Solution for injection

Subcutaneous use;

Extracorporeal use

1 ml (150 mg/ml)

Sweden

Sanofi AB

Box 30052

104 25 Stockholm

Sweden

Klexane

100 mg/ml

Solution for injection

Subcutaneous use;

Intravenous use;

Extracorporeal use

0,2  ml; 0,4  ml;

0,6  ml; 0,8  ml;

1,0  ml

(100 mg/ml)

Sweden

Sanofi AB

Box 30052

104 25 Stockholm

Sweden

Klexane (med konserveringsmedel)

100 mg/ml

Solution for injection

Subcutaneous use;

Intravenous use;

Extracorporeal use

3 ml; 10 ml

(100 mg/ml)

Sweden

Sanofi AB

Box 30052

104 25 Stockholm

Sweden

Klexane

150 mg/ml

Solution for injection

Subcutaneous use;

Intravenous use;

Extracorporeal use

0,6  ml; 0,8  ml;

1,0  ml

(150 mg/ml)

United Kingdom

Aventis Pharma Limited

One Onslow Street

Guildford

Surrey

GU1 4YS

United-Kingdom

Clexane Syringes

20 mg/0,2  ml

Solution for injection

Subcutaneous use;

Extracorporeal use

0,2  ml (100 mg/ml equivalent to 10 000 IU anti-Xa activity/ml)

United Kingdom

Aventis Pharma Limited

One Onslow Street

Guildford

Surrey

GU1 4YS

United-Kingdom

Clexane Syringes

40 mg/0,4  ml

Solution for injection

Subcutaneous use;

Extracorporeal use

0,4  ml (100 mg/ml equivalent to 10 000 IU anti-Xa activity/ml)

United Kingdom

Aventis Pharma Limited

One Onslow Street

Guildford

Surrey

GU1 4YS

United-Kingdom

Clexane Syringes

60 mg/0,6  ml

Solution for injection

Subcutaneous use;

Intravenous use;

Extracorporeal use

0,6  ml (100 mg/ml equivalent to 10 000 IU anti-Xa activity/ml)

United Kingdom

Aventis Pharma Limited

One Onslow Street

Guildford

Surrey

GU1 4YS

United-Kingdom

Clexane Syringes

80 mg/0,8  ml

Solution for injection

Subcutaneous use;

Intravenous use;

Extracorporeal use

0,8  ml (100 mg/ml equivalent to 10 000 IU anti-Xa activity/ml)

United Kingdom

Aventis Pharma Limited

One Onslow Street

Guildford

Surrey

GU1 4YS

United-Kingdom

Clexane Syringes

100 mg/1,0  ml

Solution for injection

Subcutaneous use;

Intravenous use;

Extracorporeal use

1 ml (100 mg/ml equivalent to 10 000 IU anti-Xa activity/ml)

United Kingdom

Aventis Pharma Limited

One Onslow Street

Guildford

Surrey

GU1 4YS

United-Kingdom

Clexane Forte Syringes

120 mg/0,8  ml

Solution for injection

Subcutaneous use;

Extracorporeal use

0,8  ml (150 mg/ml equivalent to 15 000 IU anti-Xa activity/ml)

United Kingdom

Aventis Pharma Limited

One Onslow Street

Guildford

Surrey

GU1 4YS

United-Kingdom

Clexane Forte Syringes

150 mg/1,0  ml

Solution for injection

Subcutaneous use;

Extracorporeal use

1 ml (150 mg/ml equivalent to 15 000 IU anti-Xa activity/ml)

United Kingdom

Aventis Pharma Limited

One Onslow Street

Guildford

Surrey

GU1 4YS

United-Kingdom

Clexane Multidose vial

300 mg/3 ml

Solution for injection

Subcutaneous use;

Intravenous use;

Extracorporeal use

3 ml (100 mg/ml)

---

ANNEX II

List of nationally authorised medicinal products

| Member State EU/EEA | Marketing authorisation holder | Product name | INN + Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | Actavis Group Ptc Ehf. | Sienima | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral use |
| Austria | Dermapharm Gmbh | Dienovel | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral use |
| Austria | Exeltis Germany Gmbh | Dienorette | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral use |
| Austria | Exeltis Germany Gmbh | Viola | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral use |
| Austria | Madaus Gmbh | Kappanogest | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral use |
| Austria | Ratiopharm Arzneimittel Vertriebs-Gmbh | Motion | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral use |
| Austria | Ratiopharm Arzneimittel Vertriebs-Gmbh | Motion Ratiopharm | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral use |
| Belgium | Effik Benelux | Dienobel | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral use |
| Belgium | Exeltis Germany Gmbh | Serisima Continu | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet $ Placebo 0 mg Tablet | Film-Coated Tablet | Oral use |
| Bulgaria | Pharmaswiss česká Republika S.R.O. | диенил | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral use |
| Czech Republic | Actavis Group Ptc Ehf. | Sienima | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral use |
| Czech Republic | Bayer Pharma Ag | Jeanine | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Coated Tablet | Oral use |
| Czech Republic | Egis Pharmaceuticals Plc | Omisson | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral use |
| Czech Republic | Egis Pharmaceuticals Plc | Omisson Daily | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet $ Lactose Monohydrate 55 mg Tablet | Film-Coated Tablet | Oral use |
| Czech Republic | Exeltis Czech S.R.O. | Diecyclen | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet $ Placebo 0 mg Tablet | Film-Coated Tablet | Oral use |
| Czech Republic | Exeltis Magyarország Kft. | Dienille | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral use |
| Czech Republic | Gedeon Richter Plc. | Mistra | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral use |
| Czech Republic | Genericon, S.R.O. | Paoletta | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral use |
| Czech Republic | Sandoz S.R.O. | Foxinette Neo | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral use |
| Czech Republic | Teva Pharmaceuticals Cr, S.R.O. | Verezana | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral use |
| Czech Republic | Zentiva, K.S. | Bonadea | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral use |
| Estonia | Bayer Pharma Ag | Jeanine | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Coated Tablet | Oral use |
| Estonia | Gedeon Richter Plc. | Sibilla Plus | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet $ Lactose Anhydrous 37.26 mg Tablet | Film-Coated Tablet | Oral use |
| Estonia | Laboratorios León Farma, S.A. | Diener | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral use |
| Estonia | Ladee Pharma Baltics Uab | Lasca | Dienogest 2 mg, Ethinylestradiol 0,03  mg | Film-Coated Tablet | Oral use |
| Estonia | Uab ‘exeltis Baltics’ | Diecyclen | Dienogest 2 mg, Ethinylestradiol 0,03  mg | Film-Coated Tablet | Oral use |
| Germany | 1 A Pharma Gmbh | Amelie | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral use |
| Germany | Acis Arzneimittel Gmbh | Dienogenance | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral use |
| Germany | Actavis Group Ptc Ehf. | Aurovida | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral use |
| Germany | Aristo Pharma Gmbh (Art 57) | Aristelle | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral use |
| Germany | Dr Kade — Besins Pharma Gmbh | Finic | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Tablet | Oral use |
| Germany | Egis Pharmaceuticals Plc | Omisson | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral use |
| Germany | Emra-Med Arzneimittel Gmbh | Valette | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Coated Tablet | Oral use |
| Germany | Eurimpharm Arzneimittel Gmbh | Valette | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Coated Tablet | Oral use |
| Germany | Exeltis Germany Gmbh | Velafee | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral use |
| Germany | Exeltis Germany Gmbh | Velafee 21 + 7 | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet $ Lactose Monohydrate 55,5  mg Tablet | Film-Coated Tablet | Oral use |
| Germany | Hexal Ag | Starletta | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral use |
| Germany | Hormosan Pharma Gmbh | Luvyna | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral use |
| Germany | Jenapharm Gmbh & Co Kg | Maxim | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Coated Tablet | Oral use |
| Germany | Jenapharm Gmbh & Co Kg | Valette | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Coated Tablet | Oral use |
| Germany | Kohlpharma Gmbh | Valette | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Coated Tablet | Oral use |
| Germany | Laboratorios León Farma, S.A. | Dande | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral use |
| Germany | Laboratorios León Farma, S.A. | Lasca | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral use |
| Germany | Laboratorios León Farma, S.A. | Raener | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral use |
| Germany | Meda Pharma Gmbh & Co. Kg | Kappanogest | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral use |
| Germany | Mibe Gmbh Arzneimittel | Dienovel | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral use |
| Germany | Mibe Gmbh Arzneimittel | Ethinylestradiol/Dienogest Mibe | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral use |
| Germany | Mithra Pharmaceuticals Sa | Midien | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral use |
| Germany | Orifarm Gmbh | Valette | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Coated Tablet | Oral use |
| Germany | Pharma Gerke Arzneimittelvertriebs Gmbh | Valette | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Coated Tablet | Oral use |
| Germany | Ratiopharm Gmbh | Velvet | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral use |
| Germany | Ratiopharm Gmbh | Velvet-Ratiopharm | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral use |
| Germany | Teva Gmbh | Laviola | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral use |
| Germany | Zentiva Pharma | Bonadea | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral use |
| Hungary | Actavis Group Ptc Ehf. | Sienima | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral use |
| Hungary | Alvogen Ipco S.Ar.L | Dande | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral use |
| Hungary | Alvogen Ipco S.Ar.L | Diedita | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet $ Lactose Monohydrate 60,9  mg Tablet | Film-Coated Tablet | Oral use |
| Hungary | Egis Pharmaceuticals Plc | Omisson | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral use |
| Hungary | Egis Pharmaceuticals Plc | Omisson Daily | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral use |
| Hungary | Exeltis Magyarország Kft. | Dienille | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral use |
| Hungary | Gedeon Richter Plc. | Mistral | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral use |
| Hungary | Gedeon Richter Plc. | Mistral Continuous | Dienogest 2 mg, Ethinylestradiol 0,03  mg $ Lactose Anhydrous 37,26  mg | Film-Coated Tablet | Oral use |
| Hungary | Pharmaswiss česká Republika S.R.O. | Combipat | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral use |
| Latvia | Bayer Pharma Ag | Jeanine | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Coated Tablet | Oral use |
| Latvia | Exeltis Baltics Uab, Lithuania | Diecyclen | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral use |
| Latvia | Exeltis Baltics Uab, Lithuania | Diecyclen | Dienogest 2 mg, Ethynylestradiol 0,03  mg | Film-Coated Tablet | Oral use |
| Latvia | Laboratorios Leon Farma, S.A., Spain | Diener | Dienogest 2 mg, Ethinylestradiol 0,03  mg | Film-Coated Tablet | Oral use |
| Latvia | Ladee Pharma Baltics Uab, Lithuania | Lasca | Dienogest 2 mg, Ethynylestradiol 0,03  mg | Film-Coated Tablet | Oral use |
| Latvia | Zentiva, K.S. | Zenadea | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral use |
| Lithuania | Bayer Pharma Ag | Jeanine | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Coated Tablet | Oral use |
| Lithuania | Zentiva, K.S. | Zenadea | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral use |
| Luxembourg | Mithra Pharmaceuticals Sa | Deltanogest | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral use |
| Luxembourg | Ratiopharm Gmbh | Velvet | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral use |
| Luxembourg | Ratiopharm Gmbh | Velvet-Ratiopharm | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral use |
| Poland | Alvogen Ipco S.Ar.L | Diener | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral use |
| Poland | Dr Kade Pharmazeutische Fabrik Gmbh | Dionelle | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Tablet | Oral use |
| Poland | Egis Pharmaceuticals Plc | Omisson | Dienogest 2 mg, Ethinylestradiol 0,03  mg | Film-Coated Tablet | Oral use |
| Poland | Egis Pharmaceuticals Plc | Omisson Daily | Dienogest 2 mg, Ethinylestradiol 0,03  mg | Film-Coated Tablet | Oral use |
| Poland | Exeltis Poland Sp. Z O.O. | Atywia | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral use |
| Poland | Gedeon Richter Polska Sp. Z. O.O. | Sibilla | Dienogest 2 mg, Ethinylestradiol 0,03  mg | Film-Coated Tablet | Oral use |
| Poland | Sun-Farm Sp. Z.O.O. | Dorin | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral use |
| Poland | Zentiva, K.S. | Bonadea | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral use |
| Portugal | Aurovitas Unipessoal, Lda. | Sienima | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral use |
| Romania | Gedeon Richter România S.A. | Sibilla | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral use |
| Romania | Gedeon Richter România S.A. | Sibilla Zilnic | Dienogest 2 mg, Ethinylestradiol 0,03  mg $ Lactose Anhydrous 37,26  mg | Film-Coated Tablet | Oral use |
| Romania | Pharmaswiss česká Republika S.R.O. | Dienille | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral use |
| Romania | Zentiva, K.S. | Zenadea | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral use |
| Slovakia | Bayer Pharma Ag | Jeanine | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Coated Tablet | Oral use |
| Slovakia | Egis Pharmaceuticals Plc | Omisson | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral use |
| Slovakia | Exeltis Slovakia S.R.O. | Diecyclen | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral use |
| Slovakia | Gedeon Richter Plc. | Mistra | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral use |
| Slovakia | Genericon, S.R.O. | Paoletta | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral use |
| Slovakia | Ladeepharma Slovakia, S.R.O. | Dienorette | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral use |
| Slovakia | Sandoz Pharmaceuticals D.D. | Foxinette Neo | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral use |
| Slovakia | Zentiva, K.S. | Zenadea | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral use |
| Slovenia | Exeltis Magyarország Kft. | Dienille | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral use |
| Slovenia | Gedeon Richter Plc. | Sibilla | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet $ Lactose 37,26  mg Tablet | Film-Coated Tablet | Oral use |
| Spain | Laboratorios Aurobindo S.L.U. | Dienogest/Etinilestradiol Aurobindo | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral use |
| Spain | Laboratorios Cinfa, S.A. | Dienogest/Etinilestradiol Cinfa | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral use |
| Spain | Sandoz Farmacéutica, S.A. | Ceciliana | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral use |
| Spain | Sandoz Farmacéutica, S.A. | Ceciliana Diario | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral use |
| Spain | Teva Pharma S.L.U | Verezana | Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral use |

Member State EU/EEA

Marketing authorisation holder

Product name

INN + Strength

Pharmaceutical form

Route of administration

Austria

Actavis Group Ptc Ehf.

Sienima

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral use

Austria

Dermapharm Gmbh

Dienovel

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral use

Austria

Exeltis Germany Gmbh

Dienorette

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral use

Austria

Exeltis Germany Gmbh

Viola

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral use

Austria

Madaus Gmbh

Kappanogest

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral use

Austria

Ratiopharm Arzneimittel Vertriebs-Gmbh

Motion

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral use

Austria

Ratiopharm Arzneimittel Vertriebs-Gmbh

Motion Ratiopharm

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral use

Belgium

Effik Benelux

Dienobel

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral use

Belgium

Exeltis Germany Gmbh

Serisima Continu

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet $ Placebo 0 mg Tablet

Film-Coated Tablet

Oral use

Bulgaria

Pharmaswiss česká Republika S.R.O.

диенил

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral use

Czech Republic

Actavis Group Ptc Ehf.

Sienima

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral use

Czech Republic

Bayer Pharma Ag

Jeanine

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Coated Tablet

Oral use

Czech Republic

Egis Pharmaceuticals Plc

Omisson

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral use

Czech Republic

Egis Pharmaceuticals Plc

Omisson Daily

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet $ Lactose Monohydrate 55 mg Tablet

Film-Coated Tablet

Oral use

Czech Republic

Exeltis Czech S.R.O.

Diecyclen

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet $ Placebo 0 mg Tablet

Film-Coated Tablet

Oral use

Czech Republic

Exeltis Magyarország Kft.

Dienille

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral use

Czech Republic

Gedeon Richter Plc.

Mistra

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral use

Czech Republic

Genericon, S.R.O.

Paoletta

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral use

Czech Republic

Sandoz S.R.O.

Foxinette Neo

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral use

Czech Republic

Teva Pharmaceuticals Cr, S.R.O.

Verezana

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral use

Czech Republic

Zentiva, K.S.

Bonadea

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral use

Estonia

Bayer Pharma Ag

Jeanine

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Coated Tablet

Oral use

Estonia

Gedeon Richter Plc.

Sibilla Plus

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet $ Lactose Anhydrous 37.26 mg Tablet

Film-Coated Tablet

Oral use

Estonia

Laboratorios León Farma, S.A.

Diener

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral use

Estonia

Ladee Pharma Baltics Uab

Lasca

Dienogest 2 mg, Ethinylestradiol 0,03  mg

Film-Coated Tablet

Oral use

Estonia

Uab ‘exeltis Baltics’

Diecyclen

Dienogest 2 mg, Ethinylestradiol 0,03  mg

Film-Coated Tablet

Oral use

Germany

1 A Pharma Gmbh

Amelie

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral use

Germany

Acis Arzneimittel Gmbh

Dienogenance

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral use

Germany

Actavis Group Ptc Ehf.

Aurovida

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral use

Germany

Aristo Pharma Gmbh (Art 57)

Aristelle

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral use

Germany

Dr Kade — Besins Pharma Gmbh

Finic

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Tablet

Oral use

Germany

Egis Pharmaceuticals Plc

Omisson

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral use

Germany

Emra-Med Arzneimittel Gmbh

Valette

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Coated Tablet

Oral use

Germany

Eurimpharm Arzneimittel Gmbh

Valette

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Coated Tablet

Oral use

Germany

Exeltis Germany Gmbh

Velafee

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral use

Germany

Exeltis Germany Gmbh

Velafee 21 + 7

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet $ Lactose Monohydrate 55,5  mg Tablet

Film-Coated Tablet

Oral use

Germany

Hexal Ag

Starletta

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral use

Germany

Hormosan Pharma Gmbh

Luvyna

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral use

Germany

Jenapharm Gmbh & Co Kg

Maxim

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Coated Tablet

Oral use

Germany

Jenapharm Gmbh & Co Kg

Valette

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Coated Tablet

Oral use

Germany

Kohlpharma Gmbh

Valette

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Coated Tablet

Oral use

Germany

Laboratorios León Farma, S.A.

Dande

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral use

Germany

Laboratorios León Farma, S.A.

Lasca

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral use

Germany

Laboratorios León Farma, S.A.

Raener

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral use

Germany

Meda Pharma Gmbh & Co. Kg

Kappanogest

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral use

Germany

Mibe Gmbh Arzneimittel

Dienovel

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral use

Germany

Mibe Gmbh Arzneimittel

Ethinylestradiol/Dienogest Mibe

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral use

Germany

Mithra Pharmaceuticals Sa

Midien

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral use

Germany

Orifarm Gmbh

Valette

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Coated Tablet

Oral use

Germany

Pharma Gerke Arzneimittelvertriebs Gmbh

Valette

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Coated Tablet

Oral use

Germany

Ratiopharm Gmbh

Velvet

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral use

Germany

Ratiopharm Gmbh

Velvet-Ratiopharm

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral use

Germany

Teva Gmbh

Laviola

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral use

Germany

Zentiva Pharma

Bonadea

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral use

Hungary

Actavis Group Ptc Ehf.

Sienima

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral use

Hungary

Alvogen Ipco S.Ar.L

Dande

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral use

Hungary

Alvogen Ipco S.Ar.L

Diedita

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet $ Lactose Monohydrate 60,9  mg Tablet

Film-Coated Tablet

Oral use

Hungary

Egis Pharmaceuticals Plc

Omisson

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral use

Hungary

Egis Pharmaceuticals Plc

Omisson Daily

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral use

Hungary

Exeltis Magyarország Kft.

Dienille

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral use

Hungary

Gedeon Richter Plc.

Mistral

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral use

Hungary

Gedeon Richter Plc.

Mistral Continuous

Dienogest 2 mg, Ethinylestradiol 0,03  mg $ Lactose Anhydrous 37,26  mg

Film-Coated Tablet

Oral use

Hungary

Pharmaswiss česká Republika S.R.O.

Combipat

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral use

Latvia

Bayer Pharma Ag

Jeanine

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Coated Tablet

Oral use

Latvia

Exeltis Baltics Uab, Lithuania

Diecyclen

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral use

Latvia

Exeltis Baltics Uab, Lithuania

Diecyclen

Dienogest 2 mg, Ethynylestradiol 0,03  mg

Film-Coated Tablet

Oral use

Latvia

Laboratorios Leon Farma, S.A., Spain

Diener

Dienogest 2 mg, Ethinylestradiol 0,03  mg

Film-Coated Tablet

Oral use

Latvia

Ladee Pharma Baltics Uab, Lithuania

Lasca

Dienogest 2 mg, Ethynylestradiol 0,03  mg

Film-Coated Tablet

Oral use

Latvia

Zentiva, K.S.

Zenadea

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral use

Lithuania

Bayer Pharma Ag

Jeanine

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Coated Tablet

Oral use

Lithuania

Zentiva, K.S.

Zenadea

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral use

Luxembourg

Mithra Pharmaceuticals Sa

Deltanogest

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral use

Luxembourg

Ratiopharm Gmbh

Velvet

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral use

Luxembourg

Ratiopharm Gmbh

Velvet-Ratiopharm

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral use

Poland

Alvogen Ipco S.Ar.L

Diener

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral use

Poland

Dr Kade Pharmazeutische Fabrik Gmbh

Dionelle

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Tablet

Oral use

Poland

Egis Pharmaceuticals Plc

Omisson

Dienogest 2 mg, Ethinylestradiol 0,03  mg

Film-Coated Tablet

Oral use

Poland

Egis Pharmaceuticals Plc

Omisson Daily

Dienogest 2 mg, Ethinylestradiol 0,03  mg

Film-Coated Tablet

Oral use

Poland

Exeltis Poland Sp. Z O.O.

Atywia

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral use

Poland

Gedeon Richter Polska Sp. Z. O.O.

Sibilla

Dienogest 2 mg, Ethinylestradiol 0,03  mg

Film-Coated Tablet

Oral use

Poland

Sun-Farm Sp. Z.O.O.

Dorin

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral use

Poland

Zentiva, K.S.

Bonadea

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral use

Portugal

Aurovitas Unipessoal, Lda.

Sienima

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral use

Romania

Gedeon Richter România S.A.

Sibilla

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral use

Romania

Gedeon Richter România S.A.

Sibilla Zilnic

Dienogest 2 mg, Ethinylestradiol 0,03  mg $ Lactose Anhydrous 37,26  mg

Film-Coated Tablet

Oral use

Romania

Pharmaswiss česká Republika S.R.O.

Dienille

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral use

Romania

Zentiva, K.S.

Zenadea

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral use

Slovakia

Bayer Pharma Ag

Jeanine

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Coated Tablet

Oral use

Slovakia

Egis Pharmaceuticals Plc

Omisson

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral use

Slovakia

Exeltis Slovakia S.R.O.

Diecyclen

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral use

Slovakia

Gedeon Richter Plc.

Mistra

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral use

Slovakia

Genericon, S.R.O.

Paoletta

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral use

Slovakia

Ladeepharma Slovakia, S.R.O.

Dienorette

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral use

Slovakia

Sandoz Pharmaceuticals D.D.

Foxinette Neo

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral use

Slovakia

Zentiva, K.S.

Zenadea

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral use

Slovenia

Exeltis Magyarország Kft.

Dienille

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral use

Slovenia

Gedeon Richter Plc.

Sibilla

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet $ Lactose 37,26  mg Tablet

Film-Coated Tablet

Oral use

Spain

Laboratorios Aurobindo S.L.U.

Dienogest/Etinilestradiol Aurobindo

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral use

Spain

Laboratorios Cinfa, S.A.

Dienogest/Etinilestradiol Cinfa

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral use

Spain

Sandoz Farmacéutica, S.A.

Ceciliana

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral use

Spain

Sandoz Farmacéutica, S.A.

Ceciliana Diario

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral use

Spain

Teva Pharma S.L.U

Verezana

Dienogest 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral use

---

ANNEX III

List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the Member States

| Member State
  (in EEA) | Marketing authorisation holder | INN | Invented name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- | --- |
| Austria | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron (III) hydroxide dextran complex | CosmoFer 50 mg/ml Injektionslösung und Infusionslösung | 50 mg/ml | Solution for injection/infusion | Intravenous use
  intramuscular use |
| Austria | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92200 Neuilly-sur-Seine
  France | Ferric carboxymaltose | Ferinject 50 mg Eisen/ml Injektionslösung oder Konzentrat zur Herstellung einer Infusionslösung | 50 mg/ml | Solution for injection/infusion | Intravenous use |
| Austria | Medice Arzneimittel Pütter GmbH & Co KG
  Kuhloweg 37
  DE-58638 Iserlohn
  Germany | Iron sucrose complex | FerMed 100 mg/5 ml Injektionslösung oder Konzentrat zur Herstellung einer Infusionslösung | 100 mg/5 ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| Austria | Fresenius Medical Care Nephrologica Deutschland GmbH
  Else-Kröner-Strasse 1
  61352 Bad Homburg
  Germany | Iron sucrose complex | Ferrologic 20 mg/ml Injektionslösung oder Konzentrat zur Herstellung einer Infusionslösung | 20 mg/ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| Austria | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron(III) isomaltoside complex | Monofer 100 mg/ml Injektions- oder Infusionslösung | 100 mg/ml | Solution for injection/infusion | Intravenous use |
| Austria | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92200 Neuilly-sur-Seine
  France | Iron sucrose complex | Venofer 20 mg/ml — Injektionslösung oder Konzentrat zur Herstellung einer Infusionslösung | 20 mg/ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| Belgium | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron (III) hydroxide dextran complex | Cosmofer | 50 mg/ml | Solution for injection/infusion | Intravenous use |
| Belgium | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron(III) isomaltoside complex | Monover | 100 mg/ml | Solution for injection/infusion | Intravenous use |
| Belgium | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | Iron sucrose complex | Venofer | 20 mg/ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| Belgium | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | Ferric Carboxymaltose | Injectafer | 50,00  mg/ml | Solution for injection/infusion | Intravenous use |
| Bulgaria | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | Ferric carboxymaltose | Ferinject | 50 mg/ml | Solution for injection/infusion | Intravenous use |
| Bulgaria | Pharmalog AG,
  33 Cherni vrah blvd.,
  1421 Sofia
  Bulgaria | Iron sucrose complex | Idafer | 20 mg/ml | Solution for injection | Intravenous use |
| Bulgaria | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron (III) hydroxide dextran complex | Cosmofer | 50 mg/ml | Solution for injection | Intravenous use |
| Bulgaria | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron(III) isomaltoside complex | Monofer | 100 mg/ml | Solution for injection/infusion | Intravenous use |
| Cyprus | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | ferric carboxymaltose | FERINJECT SOLUTION FOR INJECTION OR INFUSION 50 MG IRON/ML | 50 mg/ml | Solution for injection/infusion | Intravenous use |
| Cyprus | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron(III) isomaltoside complex | MONOFER SOLUTION FOR INJECTION OR INFUSION 100 MG/ML | 100 mg/ml | Solution for injection/infusion | Intravenous use |
| Cyprus | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron (III) hydroxide dextran complex | COSMOFER SOLUTION FOR INJECTION OR INFUSION 50 MG IRON/ML | 50 mg/ml | Solution for injection/infusion | Intravenous use |
| Cyprus | The Star Medicines Importers & co ltd,
  9A Loukis Akritas Street,
  P.O. box 50151,
  3601 Lemesos, Cyprus | Iron sucrose complex | VENOFER INJECTION 100 MG IRON/5 ML | 100 mg/5 ml | Solution for injection | Intravenous use |
| Cyprus | Fresenius Medical Care Nephrologica Deutschland GmbH
  Else-Kröner-Strasse 1
  61352 Bad Homburg
  Germany | Iron sucrose complex | FERROLOGIC SOLUTION FOR INJECTION/CONCENTRATE FOR SOLUTION FOR INFUSION 20 MG/ML | 20 mg/ml | Solution for injection/infusion | Intravenous use |
| Czech Republic | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | Iron sucrose complex | VENOFER | 20 mg/ml | Solution for injection | Intravenous use |
| Czech Republic | Fresenius Medical Care Nephrologica Deutschland GmbH
  Else-Kröner-Strasse 1
  61352 Bad Homburg
  Germany | Iron sucrose complex | FERROLOGIC 20 MG/ML | 20 mg/ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| Czech Republic | PHARMABIDE LTD
  20, Lakonias str,
  15234 Halandri
  Athens — Greece | Iron sucrose complex | IRON SUCROSE PHARMABIDE 20 MG/ML | 20 mg/ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| Czech Republic | Orion Corporation,
  Orionintie 1,
  FI-02200 Espoo,
  Finland | Iron sucrose complex | FERION 20 MG/ML | 20 mg/ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| Czech Republic | Sanofi-Aventis, s.r.o.
  Evropská 846/176a
  160 00 Praha 6
  Czech Republic | sodium ferric gluconate complex | FERRLECIT | 12,5  mg/ml | Solution for injection | Intravenous use |
| Czech Republic | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | ferric carboxymaltose | FERINJECT | 50 mg/ml | Solution for injection/infusion | Intravenous use |
| Denmark | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron (III) hydroxide dextran complex | Cosmofer | 50 mg/ml | Solution for injection/infusion | Intravenous use |
| Denmark | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | Ferric carboxymaltose | Ferinject | 50 mg/ml | Solution for injection/infusion | Intravenous use |
| Denmark | Orion Corporation,
  Orionintie 1,
  FI-02200 Espoo,
  Finland | Iron sucrose complex | Ferion | 20 mg/ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| Denmark | Fresenius Medical Care Nephrologica Deutschland GmbH
  Else-Kröner-Strasse 1
  61352 Bad Homburg
  Germany | Iron sucrose complex | Ferrologic | 20 mg/ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| Denmark | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron (III) hydroxide dextran complex | Jerndextran ‘Pharmacosmos’ | 50 mg/ml | Solution for injection/infusion | Intravenous use |
| Denmark | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron(III) isomaltoside complex | MonoFer | 100 mg/ml | Solution for injection/infusion | Intravenous use |
| Denmark | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | Iron sucrose complex | Venofer | 20 mg/ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| Estonia | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | Iron sucrose complex | Venofer | 20 mg/ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| Estonia | Fresenius Medical Care Nephrologica Deutschland GmbH
  Else-Kröner-Strasse 1
  61352 Bad Homburg
  Germany | Iron sucrose complex | Ferrologic 20 mg/ml | 20 mg/ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| Estonia | Orion Corporation,
  Orionintie 1,
  FI-02200 Espoo,
  Finland | Iron sucrose complex | Ferion | 20 mg/ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| Estonia | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron (III) hydroxide dextran complex | Cosmofer | 50 mg/ml | Solution for injection/infusion | Intravenous use
  intramuscular use |
| Estonia | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron(III) isomaltoside complex | Monofer | 100 mg/ml | Solution for injection/infusion | Intravenous use |
| Estonia | Lek Pharmaceuticals d.d.
  Verovškova 57
  1526 Ljubljana
  Slovenia | Iron (III) hydroxide dextran complex | Ferrum Lek | 50 mg/ml | Solution for injection | Intramuscular use |
| Finland | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | Ferric carboxymaltose | Ferinject | 50 mg/ml | Solution for injection/infusion | Intravenous use |
| Finland | Fresenius Medical Care Nephrologica Deutschland GmbH
  Else-Kröner-Strasse 1
  61352 Bad Homburg
  Germany | Iron sucrose complex | Ferrologic | 20 mg/ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| Finland | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | Iron sucrose complex | Venofer | 20 mg/ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| Finland | Alternova A/S
  Lodshusvej 11
  4230 Skaelskoer
  Denmark | Iron sucrose complex | Venotrix | 20 mg/ml | Concentrate for solution for infusion/solution for injection | Intravenous use |
| Finland | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron (III) hydroxide dextran complex | Cosmofer | 50 mg/ml | Solution for injection/infusion | Intravenous use |
| Finland | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron(III) isomaltoside complex | Monofer | 100 mg/ml | Solution for injection/infusion | Intravenous use |
| France | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | Ferric Carboxymaltose | FERINJECT 50 mg/ml, solution injectable/pour perfusion | 50 mg/ml | Solution for injection/infusion | Intravenous use |
| France | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | Iron sucrose complex | VENOFER 20 mg/ml, solution injectable | 20 mg/ml | Solution for injection | Intravenous use |
| France | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron (III) hydroxide dextran complex | FERRISAT 50 mg/ml, solution injectable ou pour perfusion | 50 mg/ml | Solution for injection/infusion | Intravenous use |
| France | Pharmaki Generics Ltd
  5 Bourlet Close
  W1W 7BL London
  United Kingdom | Iron sucrose complex | FER ACTAVIS 100 mg/5 ml, solution injectable | 100 mg/5 ml | Solution for injection | Intravenous use |
| France | IBD3 Pharma Consulting
  Immeuble l’Orient
  10, place Charles Béraudier
  69003 Lyon
  France | Iron sucrose complex | FER IBD3 PHARMA CONSULTING 100 mg/5 ml, solution à diluer pour perfusion | 100 mg/5 ml | Concentrate for solution for infusion | Intravenous use |
| France | Mylan SAS
  117, allée des Parcs
  69800 Saint-Priest
  France | Iron sucrose complex | FER MYLAN 100 mg/5 ml, solution à diluer pour perfusion | 100 mg/5 ml | Concentrate for solution for infusion | Intravenous use |
| France | SANDOZ
  49, avenue Georges Pompidou
  92300 Levallois-Perret France | Iron sucrose complex | FER SANDOZ 100 mg/5 ml, solution à diluer pour perfusion | 100 mg/5 ml | Concentrate for solution for infusion | Intravenous use |
| France | TEVA SANTE
  110, Esplanade du Général de Gaulle
  92931 Paris La Défense Cedex
  FRANCE | Iron sucrose complex | FER TEVA PHARMA 100 mg/5 ml, solution injectable (IV) | 100 mg/5 ml | Solution for injection | Intravenous use |
| Germany | Fresenius Medical Care Nephrologica Deutschland GmbH
  Else-Kröner-Strasse 1
  61352 Bad Homburg
  Germany | Iron sucrose complex | Ferrologic 20 mg/ml Injektionslösung/Konzentrat zur Herstellung einer Infusionslösung | 1 709  mg/5 ml | Concentrate for solution for infusion/solution for injection | Intravenous use |
| Germany | Medice Arzneimittel Pütter GmbH & Co KG
  Kuhloweg 37
  DE-58638 Iserlohn
  Germany | Iron sucrose complex | FerMed | 1 563  — 1 887  mg/5 ml | Concentrate for solution for infusion/solution for injection | Intravenous use |
| Germany | Medice Arzneimittel Pütter GmbH & Co KG
  Kuhloweg 37
  DE-58638 Iserlohn
  Germany | Iron sucrose complex | Nefro-Fer | 1 563  — 1 887  mg/5 ml | Solution for injection | Intravenous use |
| Germany | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron(III) isomaltoside complex | Monofer 100 mg/ml Lösung zur Injektion/Infusion | 377-465 mg/ml | Solution for injection/infusion | Intravenous use |
| Germany | Sanofi-Aventis Deutschland GmbH
  Brüningstrasse 50,
  D-65926 Frankfurt am Main Germany | sodium ferric gluconate complex | Ferrlecit 40 mg | 1 288,9  mg/3,2  ml | Solution for injection | Intravenous use |
| Germany | Sanofi-Aventis Deutschland GmbH
  Brüningstrasse 50,
  D-65926 Frankfurt am Main Germany | sodium ferric gluconate complex | Ferrlecit 62,5  mg | 2 013,9  mg/5 ml | Solution for injection | Intravenous use |
| Germany | Pharmacosmos A/S
  Roervangsvei 30
  Holbaek DK-4300
  Denmark | Iron (III) hydroxide dextran complex | CosmoFer 50 mg/ml Injektionslösong und Infusionslösung | 312,5  mg/ml | Solution for injection/infusion | Intravenous use
  intramuscular use |
| Germany | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | Ferric carboxymaltose complex | FERINJECT 50 mg Eisen/ml Injektions- und Infusionslösung | 180 mg/ml | Solution for injection/infusion | Intravenous use |
| Germany | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | Iron sucrose complex | Venofer 20 mg FR/ml Injektionslösung | 2 700  mg/5 ml | Concentrate for solution for infusion/solution for injection | Intravenous use |
| Greece | Medicus SA
  Valaoritou 10
  Metamorfosi
  Attikis 14452
  Greece | Iron sucrose complex | REOXYL | 100 mg/5 ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| Greece | Vianex S.A.
  Tatoiou Street
  Nea Erythrea 14671
  Greece | Iron sucrose complex | INTRAFER | 100 mg/5 ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| Greece | Alapis ABEE
  Aftokratoros Nikolaou 2
  Athens 17671
  Greece | Iron sucrose complex | FAREMIO | 100 mg/5 ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| Greece | Intermed ABEE
  Kalyftaki 27
  Athens 14564
  Greece | Iron sucrose complex | DEXTRIFER-S | 100 mg/5 ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| Greece | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | Iron sucrose complex | VENOFER | 100 mg/5 ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| Greece | Demo ABEE
  21ST Km National Highway
  Athens-Lamia, 14565
  Greece | Iron (III) hydroxide dextran | COSMOFER | 50 mg/ml | Solution for injection/infusion | Intravenous use
  intramuscular use |
| Greece | Rafarm AEBE
  Korinthou 12,
  N. Psychiko, 15451
  Greece | Iron sucrose complex | FERROVIN | 100 mg/5 ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| Greece | Nephrotech S.A.
  Parnithos 44
  Metamorfosi Attikis 14452
  Greece | Iron sucrose complex | SUCRO-FER | 100 mg/5 ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| Greece | Uni-Pharma Kleon Tseitis
  Pharmaceutical Laboratories
  14KM National Highway
  Athens-Lamia
  Kifissia 14564
  Greece | Iron sucrose complex | HEMAFER-S | 100 mg/5 ml | Concentrate for solution for infusion | Intravenous use |
| Greece | Verisfield (UK) Ltd, U.K.
  41 Chalton street
  London, NW1 1JD
  United Kingdom | Iron sucrose complex | NEPHROFEROL | 100 mg/5 ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| Greece | HELP ABEE
  Valaoritou 10
  Metamorfosi
  Attikis, 14452
  Greece | Iron sucrose complex | FERRINEMIA | 100 mg/5 ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| Greece | Specifar AEBE
  28th October Street 1
  Agia Barbara 12351
  Greece | Iron sucrose complex | ALVOFER | 100 mg/5 ml | Concentrate for solution for infusion | Intravenous use |
| Greece | Alet Pharmaceuticals
  M. Alexander 121,
  Agia Varvara, 12351
  Greece | Iron sucrose complex | SUCROVEN | 100 mg/5 ml | Concentrate for solution for infusion | Intravenous use |
| Greece | Target Pharma Ltd
  Menandrou 54
  Athens 10431
  Greece | Iron sucrose complex | IRONCROSE | 20 mg/ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| Greece | HELP ABEE
  Valaoritou 10
  Metamorfosi
  Attikis, 14452
  Greece | Iron (III) hydroxide dextran complex | IRONATE | 50 mg/ml | Solution for injection/infusion | Intravenous use
  intramuscular use |
| Greece | Demo ABEE
  21st km National Highway
  Athens-Lamia, 14565
  Greece | Iron(III) isomaltoside complex | MONOFER | 100 mg/ml | Solution for injection/infusion | Intravenous use
  intramuscular use |
| Greece | Viofar EPE
  Ethnikis Antistaseos & Trifyllias,
  Aharnai, 13671
  Greece | Iron sucrose complex | VENIRON | 100 mg/5 ml | Concentrate for solution for infusion | Intravenous use |
| Greece | Medicus SA
  Valaoritou 10
  Metamorfosi
  Attikis 14452
  Greece | Iron (III) hydroxide dextran complex | IRON (III)-HYDROXIDE DEXTRAN COMPLEX/BIOMEDIC LABORATORIES | 50 mg/ml | Solution for injection/infusion | Intravenous use
  intramuscular use |
| Hungary | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | Ferric carboxymaltose | Ferinject | 50 mg/ml | Solution for injection/infusion | Intravenous use |
| Hungary | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | Iron sucrose complex | Venofer | 20 mg/ml | Solution for injection/infusion | Intravenous use |
| Hungary | Fresenius Medical Care Nephrologica Deutschland GmbH
  Else-Kröner-Strasse 1
  61352 Bad Homburg
  Germany | Iron sucrose complex | Ferrologic | 20 mg/ml | Solution for injection/infusion | Intravenous use |
| Hungary | Sanofi-Aventis Zrt
  Tó utca 1-5,
  1045 Budapest
  Hungary | Sodium ferric gluconate complex | Ferrlecit | 12,5  mg/ml | Solution for injection | Intravenous use |
| Iceland | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | ferric carboxymaltose | Ferinject | 50 mg/ml | Solution for injection/infusion | Intravenous use |
| Iceland | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron(III) isomaltoside complex | Monofer | 100 mg/ml | Solution for infusion | Intravenous use |
| Iceland | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | Iron sucrose complex | Venofer | 20 mg/ml | Solution for injection | Intravenous use |
| Ireland | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron (III) hydroxide dextran complex | CosmoFer 50 mg/ml solution for infusion and injection | 50 mg/ml | Solution for injection/infusion | Intravenous use |
| Ireland | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron(III) isomaltoside complex | Monover 100 mg/ml solution for injection/infusion (ampoules) | 100 mg/ml | Solution for injection/infusion | Intravenous use |
| Ireland | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron(III) isomaltoside complex | Monover 100 mg/ml solution for injection/infusion (vials) | 100 mg/ml | Solution for injection/infusion | Intravenous use |
| Ireland | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | Iron sucrose complex | Venofer 20 mg iron/ml solution for injection or concentrate for solution for infusion, ampoule | 20 mg/ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| Ireland | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | ferric carboxymaltose | FERINJECT 50 mg iron/ml solution for injection/infusion | 50 mg/ml | Solution for injection/infusion | Intravenous use |
| Ireland | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | Iron sucrose complex | Venofer 20 mg iron/ml solution for injection or concentrate for solution for infusion, vial | 20 mg/ml | Solution for injection/infusion | Intravenous use |
| Ireland | Fresenius Medical Care Nephrologica Deutschland GmbH
  Else-Kröner-Strasse 1
  61352 Bad Homburg
  Germany | Iron sucrose complex | FerroLogic 20 mg/ml solution for injection/concentrate for solution for infusion | 20 mg/ml | Solution for injection | Intravenous use |
| Italy | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | ferric carboxymaltose | FERINJECT | 50 mg/ml | Solution for injection/infusion | Intravenous use |
| Italy | Fresenius Medical Care Nephrologica Deutschland GmbH
  Else-Kröner-Strasse 1
  61352 Bad Homburg
  Germany | Iron sucrose complex | FERRO SACCARATO FME | 20 mg/ml | Concentrate for solution for infusion/solution for injection | Intravenous use |
| Italy | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | Iron sucrose complex | VENOFER | 20 mg/ml | Solution for injection | Intravenous use |
| Italy | Sanofi-Aventis SPA
  Viale Luigi Bodio, 37/B
  20158 Milano
  Italy | sodium ferric gluconate complex | FERLIXIT | 62,5  mg/5 ml | Oral solution or solution for infusion | Oral use
  Intravenous use |
| Latvia | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | Ferric carboxymaltose | Ferinject | 50 mg/ml | Solution for injection/infusion | Intravenous use |
| Latvia | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | Iron sucrose complex | Venofer | 20 mg/ml | Solution for injection | Intravenous use |
| Latvia | Fresenius Medical Care Nephrologica Deutschland GmbH
  Else-Kröner-Strasse 1
  61352 Bad Homburg
  Germany | Iron sucrose complex | FerroLogic | 20 mg/ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| Latvia | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron (III) hydroxide dextran complex | CosmoFer | 50 mg/ml | Solution for injection/infusion | Intravenous use
  intramuscular use |
| Latvia | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron(III) isomaltoside complex | Monofer | 100 mg/ml | Solution for injection/infusion | Intravenous use |
| Lithuania | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | Ferric carboxymaltose | Ferinject | 50 mg/ml | Solution for injection/infusion | Intravenous use |
| Lithuania | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | Iron sucrose complex | Venofer | 20 mg/ml | Solution for injection | Intravenous use |
| Lithuania | Fresenius Medical Care Nephrologica Deutschland GmbH
  Else-Kröner-Strasse 1
  61352 Bad Homburg
  Germany | Iron sucrose complex | Ferrologic | 20 mg/ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| Lithuania | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron(III) isomaltoside complex | Monofer | 100 mg/ml | Solution for injection/infusion | Intravenous use |
| Lithuania | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Ferric (III) hydroxide dextran complex | CosmoFer | 50 mg/ml | Solution for injection/infusion | Intravenous use
  intramuscular use |
| Luxembourg | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | Ferric carboxymaltose | Injectafer-50 mg/l | 50 mg/ml | Solution for injection | Intravenous use |
| Luxembourg | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron (III) hydroxide dextran complex | Cosmofer-50 mg/ml | 50 mg/ml | Solution for injection | Intravenous use |
| Luxembourg | Medice Arzneimittel Pütter GmbH & Co KG
  Kuhloweg 37
  DE-58638 Iserlohn
  Germany | Iron sucrose complex | Fermed-100 mg/5 ml | 100 mg/5 ml | Solution for perfusion | Intravenous use |
| Luxembourg | Fresenius Medical Care Nephrologica Deutschland GmbH
  Else-Kröner-Strasse 1
  61352 Bad Homburg
  Germany | Iron sucrose complex | Ferrologic-20 mg/ml | 20 mg/ml | Solution for perfusion | Intravenous use |
| Malta | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92200 Neuilly-sur-Seine
  France | ferric carboxymaltose | FERINJECT 50 mg iron/ml solution for injection/infusion | 50 mg/ml | Solution for injection/infusion | Intravenous use |
| Malta | Fresenius Medical Care Nephrologica Deutschland GmbH
  Else-Kröner-Strasse 1
  61352 Bad Homburg
  Germany | Iron sucrose complex. | Ferrologic 20 mg/ml solution for injection/concentrate for solution for infusion | 20 mg/ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| Norway | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron (III) hydroxide dextran complex | Cosmofer | 50 mg/ml | Solution for injection/infusion | Parenteral use |
| Norway | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | Ferric carboxymaltose | Ferinject | 50 mg/ml | Solution for injection/infusion | Parenteral use |
| Norway | Orion Corporation,
  Orionintie 1,
  FI-02200 Espoo,
  Finland | Iron sucrose complex | Ferion | 20 mg/ml | Solution for injection
  Concentrate for solution for infusion | Parenteral use |
| Norway | Fresenius Medical Care Nephrologica Deutschland GmbH
  Else-Kröner-Strasse 1
  61352 Bad Homburg
  Germany | Iron sucrose complex | Ferrologic | 20 mg/ml | Solution for injection
  Concentrate for solution for infusion | Parenteral use |
| Norway | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron(III) isomaltoside complex | Monofer | 100 mg/ml | Solution for injection/infusion | Parenteral use |
| Norway | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron (III) hydroxide dextran complex | Uniferon | 200 mg/ml | Solution for injection | Parenteral use |
| Norway | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | Iron sucrose complex | Venofer | 20 mg/ml | Solution for injection
  Concentrate for solution for infusion | Parenteral use |
| Poland | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron (III) hydroxide dextran complex | CosmoFer | 50 mg/ml | Solution for injection/infusion | Intravenous use |
| Poland | VIFOR France SA
  123 Rue Jules Guesde
  92200 Neuilly-sur-Seine
  France | ferric carboxymaltose | Ferinject | 50 mg/ml | Solution for injection | Intravenous use |
| Poland | VIFOR France SA
  123 Rue Jules Guesde
  92200 Neuilly-sur-Seine
  France | Iron sucrose complex | Venofer | 20 mg/ml | Solution for injection/infusion | Intravenous use |
| Poland | Fresenius Medical Care Nephrologica Deutschland GmbH
  61346 Bad Homburg
  Germany | Iron sucrose complex | Ferrologic 20 mg/ml | 20 mg/ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| Poland | Sandoz GmbH
  Biochemiestrasse 10
  A-6250 Kundl
  Austria | Iron(III) isomaltoside complex | Ferrum-Lek | 50 mg/ml | Solution for injection | Intramuscular use |
| Poland | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron(III) isomaltoside complex | Monover | 100 mg/ml | Solution for injection/infusion | Intravenous use |
| Portugal | Fresenius Medical Care Nephrologica Deutschland GmbH
  Else-Kröner-Strasse 1
  61352 Bad Homburg
  Germany | Iron sucrose complex | Referen | 100 mg/5 ml | Solution for injection | Intravenous use |
| Portugal | Vifor France, SA
  7-13 Boulevard Paul Emile Victor
  92200 Neuilly-sur-Seine
  France | Iron sucrose complex | Venofer | 100 mg/5 ml | Solution for injection | Intravenous use |
| Portugal | Combino Pharm Portugal, Unipessoal, Lda.
  Lagoas Park
  Edifício 8
  Piso 0 2740-268 Porto Salvo
  Portugal | Iron sucrose complex | Óxido Férrico Sacarosado Combino | 100 mg/5 ml | Solution for injection | Intravenous use |
| Portugal | Farmoz — Sociedade Técnico Medicinal, S.A.
  Rua da Tapada Grande, 2,
  Abrunheira
  2710-089 Sintra
  Portugal | Iron sucrose complex | Óxido Férrico Sacarosado Farmoz | 100 mg/5 ml | Solution for injection | Intravenous use |
| Portugal | Generis Farmacêutica, S.A.
  Rua João de Deus, 19
  2700-487 Amadora
  Portugal | Iron sucrose complex | Óxido Férrico Sacarosado Generis | 100 mg/5 ml | Solution for injection | Intravenous use |
| Portugal | Laboratórios Normon, S.A.
  Rua Armando Villar,
  Lote 42 1o Dto. Quinta das Patinhas, Cobre
  2750 — 777 Cascais
  Portugal | Iron sucrose complex | Óxido Férrico Sacarosado Normon | 100 mg/5 ml | Solution for injection | Intravenous use |
| Portugal | Vifor France, SA
  7-13 Boulevard Paul Emile Victor
  92200 Neuilly-sur-Seine
  France | Ferric carboxymaltose | Ferinject | 50 mg/ml | Solution for injection/infusion | Intravenous use |
| Portugal | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron (III) hydroxide dextran complex | Cosmofer | 50 mg/ml | Solution for injection/infusion | Intravenous use
  intramuscular use |
| Portugal | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron (III) isomaltoside complex | Monofar | 100 mg/ml | Solution for injection/infusion | Intravenous use |
| Romania | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | Iron sucrose complex | VENOFER® | 20 mg/ml | Solution for injection/infusion | Intravenous use
  intramuscular use |
| Romania | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron(III) isomaltoside complex | MONOFER 100 mg/ml | 100 mg/ml | Solution for injection/infusion | Intravenous use
  intramuscular use |
| Romania | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | Ferric carboxymaltose | FERINJECT 50 mg fer/ml | 50 mg/ml | Solution for injection/infusion | Intravenous use
  intramuscular use |
| Slovak Republic | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | Ferric carboxymaltose | Ferinject | 50 mg/ml | Solution for injection/infusion | Intravenous use |
| Slovak Republic | Orion Corporation,
  Orionintie 1,
  FI-02200 Espoo,
  Finland | Iron sucrose complex | Ferion 20 mg/ml | 20 mg/ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| Slovak Republic | Fresenius Medical Care Nephrologica Deutschland GmbH
  Else-Kröner-Strasse 1
  61352 Bad Homburg
  Germany | Iron sucrose complex | Ferrologic 20 mg/ml | 20 mg/ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| Slovak Republic | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | Iron sucrose complex | Venofer | 20 mg/ml | Solution for injection | Intravenous use |
| Slovenia | Fresenius Medical Care Nephrologica Deutschland GmbH
  Else-Kröner-Strasse 1
  61352 Bad Homburg
  Germany | Iron sucrose complex | Ferrologic 20 mg/ml raztopina za injiciranje/koncentrat za raztopino za infundiranje | 20 mg/ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| Slovenia | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | carboxymaltose | Iroprem 50 mg/ml raztopina za iniciranje ali infundiranje | 50 mg/ml | Solution for injection/infusion | Intravenous use |
| Slovenia | Lek farmacevtska družba d.d.,
  Verovškova 57,
  1000 Ljubljana
  Slovenia | Iron sucrose complex | Venofer 20 mg/ml raztopina za injiciranje/koncentrat za raztopino za infundiranje | 20 mg/ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| Spain | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron (III) hydroxide dextran complex | COSMOFER 50 mg/ml SOLUCION PARA PERFUSION E INYECCION | 50 mg/ml | Solution for injection
  Solution for infusion | Intravenous use
  intramuscular use |
| Spain | GUERBET B.P.
  57400 ROISSY CdG
  Cedex F-95943
  France | Iron sucrose complex | ENDOREM 11,2  mg FE/ml CONCENTRADO PARA SUSPENSION PARA PERFUSION | 11,2  mg/ml | Concentrate for suspension for infusion | Intravenous use |
| Spain | G.E.S. Genericos Espanoles Laboratorio
  S.A.Cólquide, 6 — Portal 2, 1 Oficina F.Las Rozas
  28230 MADRID
  Spain | Iron sucrose complex | FERIV 20 mg/ml SOLUCION INYECTABLE O CONCENTRADO PARA SOLUCION PARA PERFUSION | 20 mg/ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| Spain | Fresenius Medical Care Nephrologica Deutschland GmbH
  Else-Kröner-Strasse 1
  61346 Bad Homburg
  Germany | Iron sucrose complex | HIERRO SACAROSA FME 20 mg/ml SOLUCION INYECTABLE O CONCENTRADO PARA SOLUCION PARA PERFUSION | 20 mg/ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| Spain | Laboratorios Normon S.A.
  Ronda de Valdecarrizo 6
  28760 Tres Cantos
  Madrid
  Spain | Iron sucrose complex | HIERRO SACAROSA NORMON 20 mg/ml SOLUCION INYECTABLE O CONCENTRADO PARA SOLUCION PARA PERFUSION | 20 mg/ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| Spain | Medice Arzneimittel Pütter GmbH & Co KG
  Kuhloweg 37
  DE-58638 Iserlohn
  Germany | Iron sucrose complex | FERMED 100 mg/5 ml SOLUCION INYECTABLE O CONCENTRADO PARA SOLUCION PARA PERFUSION | 100 mg/5 ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| Spain | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | Iron sucrose complex | VENOFER 20 mg/ml SOLUCION INYECTABLE O CONCENTRADO PARA SOLUCION PARA PERFUSION | 20 mg/ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| Spain | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | Ferric carboxymaltose | FERINJECT 50 mg/ml SOLUCION INYECTABLE Y PARA PERFUSION | 50 mg/ml | Solution for injection
  Solution for infusion | Intravenous use |
| Spain | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron(III) isomaltoside complex | MONOFERRO 100 mg/ml SOLUCIÓN INYECTABLE O PARA PERFUSIÓN | 100 mg/ml | Solution for injection
  Solution for infusion | Intravenous use |
| Sweden | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92200 Neuilly-sur-Seine
  France | Iron sucrose complex | Venofer® | 20 mg/ml | Concentrate for solution for injection | Intravenous use |
| Sweden | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron (III) hydroxide dextran complex | Cosmofer® | 50 mg/ml | Solution for injection | Intravenous use |
| Sweden | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92200 Neuilly-sur-Seine
  France | Ferric carboxymaltose | Ferinject | 50 mg/ml | Solution for injection | Intravenous use |
| Sweden | Fresenius Medical Care Nephrologica Deutschland GmbH
  Else-Kröner-Strasse 1
  61346 Bad Homburg
  Germany | Iron sucrose complex | Ferrologic | 20 mg/ml | Concentrate for solution for injection | Intravenous use |
| Sweden | Orion Corporation,
  Orionintie 1,
  FI-02200 Espoo,
  Finland | Iron sucrose complex | Ferion | 20 mg/ml | Concentrate for solution for injection | Intravenous use |
| Sweden | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron(III) isomaltoside complex | MonoFer® | 100 mg/ml | Solution for injection | Intravenous use |
| The Netherlands | Pharmamatch B.V.
  Egelenburg 2
  Amsterdam GK — 1081
  The Netherlands | Iron sucrose complex | IJzerhydroxide sacharose complex bevattende 20 mg/ml IJzer PHARMAMATCH, oplossing/concentraat voor oplossing voor injectie | 20 mg/ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| The Netherlands | Fresenius Medical Care Nephrologica Deutschland GmbH
  Else-Kröner-Strasse 1
  61352 Bad Homburg
  Germany | Iron sucrose complex | FerroLogic 20 mg/ml, oplossing voor injectie of concentraat voor oplossing voor infusie | 20 mg/ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| The Netherlands | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron(III) isomaltoside complex | MonoFer 100 mg/ml oplossing voor injectie/infusie | 100 mg/ml | Solution for injection/infusion | Intravenous use |
| The Netherlands | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | Iron sucrose complex | Venofer 20 mg/ml ijzer (III), oplossing voor injectie of concentraat voor oplossing voor intraveneuze infusie | 20 mg/ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| The Netherlands | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | Ferric carboxymaltose | FERINJECT 50 mg ijzer/ml, oplossing voor injectie/infusie | 50 mg/ml | Solution for injection/infusion | Intravenous use |
| The Netherlands | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron (III) hydroxide dextran complex | CosmoFer 50 mg/ml oplossing voor infusie en injectie | 50 mg/ml | Solution for injection/infusion | Intravenous use |
| The Netherlands | Pharmachemie B.V.
  Haarlem — 2031 GA
  The Netherlands | Iron sucrose complex | IJzerhydroxide sacharose complex 20 mg/ml PCH, oplossing voor injectie/concentraat voor oplossing voor infusie | 20 mg/ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| United Kingdom | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | Iron sucrose complex | Venofer | 20 mg/ml | Solution for injection/infusion | Intravenous use |
| United Kingdom | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron(III) isomaltoside complex | Monofer | 100 mg/ml | Solution for injection/infusion | Intravenous use |
| United Kingdom | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron(III) isomaltoside complex | Diafer | 50 mg/ml | Solution for injection | Intravenous use |
| United Kingdom | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron (III) hydroxide dextran complex | Cosmofer | 50 mg/ml | Solution for injection/infusion | Intravenous use
  intramuscular use |
| United Kingdom | Fresenius Medical Care Nephrologica Deutschland GmbH
  Else-Kröner-Strasse 1
  61352 Bad Homburg
  Germany | Iron sucrose complex | Ferrologic | 20 mg/ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| United Kingdom | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | Ferric carboxymaltose | Ferinject | 50 mg/ml | Solution for injection/infusion | Intravenous use |

Member State

(in EEA)

Marketing authorisation holder

INN

Invented name

Strength

Pharmaceutical form

Route of administration

Austria

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron (III) hydroxide dextran complex

CosmoFer 50 mg/ml Injektionslösung und Infusionslösung

50 mg/ml

Solution for injection/infusion

Intravenous use

intramuscular use

Austria

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92200 Neuilly-sur-Seine

France

Ferric carboxymaltose

Ferinject 50 mg Eisen/ml Injektionslösung oder Konzentrat zur Herstellung einer Infusionslösung

50 mg/ml

Solution for injection/infusion

Intravenous use

Austria

Medice Arzneimittel Pütter GmbH & Co KG

Kuhloweg 37

DE-58638 Iserlohn

Germany

Iron sucrose complex

FerMed 100 mg/5 ml Injektionslösung oder Konzentrat zur Herstellung einer Infusionslösung

100 mg/5 ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Austria

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron sucrose complex

Ferrologic 20 mg/ml Injektionslösung oder Konzentrat zur Herstellung einer Infusionslösung

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Austria

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

Monofer 100 mg/ml Injektions- oder Infusionslösung

100 mg/ml

Solution for injection/infusion

Intravenous use

Austria

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92200 Neuilly-sur-Seine

France

Iron sucrose complex

Venofer 20 mg/ml — Injektionslösung oder Konzentrat zur Herstellung einer Infusionslösung

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Belgium

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron (III) hydroxide dextran complex

Cosmofer

50 mg/ml

Solution for injection/infusion

Intravenous use

Belgium

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

Monover

100 mg/ml

Solution for injection/infusion

Intravenous use

Belgium

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex

Venofer

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Belgium

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Ferric Carboxymaltose

Injectafer

50,00  mg/ml

Solution for injection/infusion

Intravenous use

Bulgaria

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Ferric carboxymaltose

Ferinject

50 mg/ml

Solution for injection/infusion

Intravenous use

Bulgaria

Pharmalog AG,

33 Cherni vrah blvd.,

1421 Sofia

Bulgaria

Iron sucrose complex

Idafer

20 mg/ml

Solution for injection

Intravenous use

Bulgaria

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron (III) hydroxide dextran complex

Cosmofer

50 mg/ml

Solution for injection

Intravenous use

Bulgaria

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

Monofer

100 mg/ml

Solution for injection/infusion

Intravenous use

Cyprus

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

ferric carboxymaltose

FERINJECT SOLUTION FOR INJECTION OR INFUSION 50 MG IRON/ML

50 mg/ml

Solution for injection/infusion

Intravenous use

Cyprus

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

MONOFER SOLUTION FOR INJECTION OR INFUSION 100 MG/ML

100 mg/ml

Solution for injection/infusion

Intravenous use

Cyprus

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron (III) hydroxide dextran complex

COSMOFER SOLUTION FOR INJECTION OR INFUSION 50 MG IRON/ML

50 mg/ml

Solution for injection/infusion

Intravenous use

Cyprus

The Star Medicines Importers & co ltd,

9A Loukis Akritas Street,

P.O. box 50151,

3601 Lemesos, Cyprus

Iron sucrose complex

VENOFER INJECTION 100 MG IRON/5 ML

100 mg/5 ml

Solution for injection

Intravenous use

Cyprus

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron sucrose complex

FERROLOGIC SOLUTION FOR INJECTION/CONCENTRATE FOR SOLUTION FOR INFUSION 20 MG/ML

20 mg/ml

Solution for injection/infusion

Intravenous use

Czech Republic

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex

VENOFER

20 mg/ml

Solution for injection

Intravenous use

Czech Republic

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron sucrose complex

FERROLOGIC 20 MG/ML

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Czech Republic

PHARMABIDE LTD

20, Lakonias str,

15234 Halandri

Athens — Greece

Iron sucrose complex

IRON SUCROSE PHARMABIDE 20 MG/ML

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Czech Republic

Orion Corporation,

Orionintie 1,

FI-02200 Espoo,

Finland

Iron sucrose complex

FERION 20 MG/ML

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Czech Republic

Sanofi-Aventis, s.r.o.

Evropská 846/176a

160 00 Praha 6

Czech Republic

sodium ferric gluconate complex

FERRLECIT

12,5  mg/ml

Solution for injection

Intravenous use

Czech Republic

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

ferric carboxymaltose

FERINJECT

50 mg/ml

Solution for injection/infusion

Intravenous use

Denmark

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron (III) hydroxide dextran complex

Cosmofer

50 mg/ml

Solution for injection/infusion

Intravenous use

Denmark

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Ferric carboxymaltose

Ferinject

50 mg/ml

Solution for injection/infusion

Intravenous use

Denmark

Orion Corporation,

Orionintie 1,

FI-02200 Espoo,

Finland

Iron sucrose complex

Ferion

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Denmark

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron sucrose complex

Ferrologic

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Denmark

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron (III) hydroxide dextran complex

Jerndextran ‘Pharmacosmos’

50 mg/ml

Solution for injection/infusion

Intravenous use

Denmark

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

MonoFer

100 mg/ml

Solution for injection/infusion

Intravenous use

Denmark

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex

Venofer

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Estonia

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex

Venofer

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Estonia

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron sucrose complex

Ferrologic 20 mg/ml

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Estonia

Orion Corporation,

Orionintie 1,

FI-02200 Espoo,

Finland

Iron sucrose complex

Ferion

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Estonia

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron (III) hydroxide dextran complex

Cosmofer

50 mg/ml

Solution for injection/infusion

Intravenous use

intramuscular use

Estonia

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

Monofer

100 mg/ml

Solution for injection/infusion

Intravenous use

Estonia

Lek Pharmaceuticals d.d.

Verovškova 57

1526 Ljubljana

Slovenia

Iron (III) hydroxide dextran complex

Ferrum Lek

50 mg/ml

Solution for injection

Intramuscular use

Finland

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Ferric carboxymaltose

Ferinject

50 mg/ml

Solution for injection/infusion

Intravenous use

Finland

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron sucrose complex

Ferrologic

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Finland

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex

Venofer

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Finland

Alternova A/S

Lodshusvej 11

4230 Skaelskoer

Denmark

Iron sucrose complex

Venotrix

20 mg/ml

Concentrate for solution for infusion/solution for injection

Intravenous use

Finland

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron (III) hydroxide dextran complex

Cosmofer

50 mg/ml

Solution for injection/infusion

Intravenous use

Finland

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

Monofer

100 mg/ml

Solution for injection/infusion

Intravenous use

France

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Ferric Carboxymaltose

FERINJECT 50 mg/ml, solution injectable/pour perfusion

50 mg/ml

Solution for injection/infusion

Intravenous use

France

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex

VENOFER 20 mg/ml, solution injectable

20 mg/ml

Solution for injection

Intravenous use

France

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron (III) hydroxide dextran complex

FERRISAT 50 mg/ml, solution injectable ou pour perfusion

50 mg/ml

Solution for injection/infusion

Intravenous use

France

Pharmaki Generics Ltd

5 Bourlet Close

W1W 7BL London

United Kingdom

Iron sucrose complex

FER ACTAVIS 100 mg/5 ml, solution injectable

100 mg/5 ml

Solution for injection

Intravenous use

France

IBD3 Pharma Consulting

Immeuble l’Orient

10, place Charles Béraudier

69003 Lyon

France

Iron sucrose complex

FER IBD3 PHARMA CONSULTING 100 mg/5 ml, solution à diluer pour perfusion

100 mg/5 ml

Concentrate for solution for infusion

Intravenous use

France

Mylan SAS

117, allée des Parcs

69800 Saint-Priest

France

Iron sucrose complex

FER MYLAN 100 mg/5 ml, solution à diluer pour perfusion

100 mg/5 ml

Concentrate for solution for infusion

Intravenous use

France

SANDOZ

49, avenue Georges Pompidou

92300 Levallois-Perret France

Iron sucrose complex

FER SANDOZ 100 mg/5 ml, solution à diluer pour perfusion

100 mg/5 ml

Concentrate for solution for infusion

Intravenous use

France

TEVA SANTE

110, Esplanade du Général de Gaulle

92931 Paris La Défense Cedex

FRANCE

Iron sucrose complex

FER TEVA PHARMA 100 mg/5 ml, solution injectable (IV)

100 mg/5 ml

Solution for injection

Intravenous use

Germany

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron sucrose complex

Ferrologic 20 mg/ml Injektionslösung/Konzentrat zur Herstellung einer Infusionslösung

1 709  mg/5 ml

Concentrate for solution for infusion/solution for injection

Intravenous use

Germany

Medice Arzneimittel Pütter GmbH & Co KG

Kuhloweg 37

DE-58638 Iserlohn

Germany

Iron sucrose complex

FerMed

1 563  — 1 887  mg/5 ml

Concentrate for solution for infusion/solution for injection

Intravenous use

Germany

Medice Arzneimittel Pütter GmbH & Co KG

Kuhloweg 37

DE-58638 Iserlohn

Germany

Iron sucrose complex

Nefro-Fer

1 563  — 1 887  mg/5 ml

Solution for injection

Intravenous use

Germany

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

Monofer 100 mg/ml Lösung zur Injektion/Infusion

377-465 mg/ml

Solution for injection/infusion

Intravenous use

Germany

Sanofi-Aventis Deutschland GmbH

Brüningstrasse 50,

D-65926 Frankfurt am Main Germany

sodium ferric gluconate complex

Ferrlecit 40 mg

1 288,9  mg/3,2  ml

Solution for injection

Intravenous use

Germany

Sanofi-Aventis Deutschland GmbH

Brüningstrasse 50,

D-65926 Frankfurt am Main Germany

sodium ferric gluconate complex

Ferrlecit 62,5  mg

2 013,9  mg/5 ml

Solution for injection

Intravenous use

Germany

Pharmacosmos A/S

Roervangsvei 30

Holbaek DK-4300

Denmark

Iron (III) hydroxide dextran complex

CosmoFer 50 mg/ml Injektionslösong und Infusionslösung

312,5  mg/ml

Solution for injection/infusion

Intravenous use

intramuscular use

Germany

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Ferric carboxymaltose complex

FERINJECT 50 mg Eisen/ml Injektions- und Infusionslösung

180 mg/ml

Solution for injection/infusion

Intravenous use

Germany

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex

Venofer 20 mg FR/ml Injektionslösung

2 700  mg/5 ml

Concentrate for solution for infusion/solution for injection

Intravenous use

Greece

Medicus SA

Valaoritou 10

Metamorfosi

Attikis 14452

Greece

Iron sucrose complex

REOXYL

100 mg/5 ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Greece

Vianex S.A.

Tatoiou Street

Nea Erythrea 14671

Greece

Iron sucrose complex

INTRAFER

100 mg/5 ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Greece

Alapis ABEE

Aftokratoros Nikolaou 2

Athens 17671

Greece

Iron sucrose complex

FAREMIO

100 mg/5 ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Greece

Intermed ABEE

Kalyftaki 27

Athens 14564

Greece

Iron sucrose complex

DEXTRIFER-S

100 mg/5 ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Greece

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex

VENOFER

100 mg/5 ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Greece

Demo ABEE

21ST Km National Highway

Athens-Lamia, 14565

Greece

Iron (III) hydroxide dextran

COSMOFER

50 mg/ml

Solution for injection/infusion

Intravenous use

intramuscular use

Greece

Rafarm AEBE

Korinthou 12,

N. Psychiko, 15451

Greece

Iron sucrose complex

FERROVIN

100 mg/5 ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Greece

Nephrotech S.A.

Parnithos 44

Metamorfosi Attikis 14452

Greece

Iron sucrose complex

SUCRO-FER

100 mg/5 ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Greece

Uni-Pharma Kleon Tseitis

Pharmaceutical Laboratories

14KM National Highway

Athens-Lamia

Kifissia 14564

Greece

Iron sucrose complex

HEMAFER-S

100 mg/5 ml

Concentrate for solution for infusion

Intravenous use

Greece

Verisfield (UK) Ltd, U.K.

41 Chalton street

London, NW1 1JD

United Kingdom

Iron sucrose complex

NEPHROFEROL

100 mg/5 ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Greece

HELP ABEE

Valaoritou 10

Metamorfosi

Attikis, 14452

Greece

Iron sucrose complex

FERRINEMIA

100 mg/5 ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Greece

Specifar AEBE

28th October Street 1

Agia Barbara 12351

Greece

Iron sucrose complex

ALVOFER

100 mg/5 ml

Concentrate for solution for infusion

Intravenous use

Greece

Alet Pharmaceuticals

M. Alexander 121,

Agia Varvara, 12351

Greece

Iron sucrose complex

SUCROVEN

100 mg/5 ml

Concentrate for solution for infusion

Intravenous use

Greece

Target Pharma Ltd

Menandrou 54

Athens 10431

Greece

Iron sucrose complex

IRONCROSE

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Greece

HELP ABEE

Valaoritou 10

Metamorfosi

Attikis, 14452

Greece

Iron (III) hydroxide dextran complex

IRONATE

50 mg/ml

Solution for injection/infusion

Intravenous use

intramuscular use

Greece

Demo ABEE

21st km National Highway

Athens-Lamia, 14565

Greece

Iron(III) isomaltoside complex

MONOFER

100 mg/ml

Solution for injection/infusion

Intravenous use

intramuscular use

Greece

Viofar EPE

Ethnikis Antistaseos & Trifyllias,

Aharnai, 13671

Greece

Iron sucrose complex

VENIRON

100 mg/5 ml

Concentrate for solution for infusion

Intravenous use

Greece

Medicus SA

Valaoritou 10

Metamorfosi

Attikis 14452

Greece

Iron (III) hydroxide dextran complex

IRON (III)-HYDROXIDE DEXTRAN COMPLEX/BIOMEDIC LABORATORIES

50 mg/ml

Solution for injection/infusion

Intravenous use

intramuscular use

Hungary

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Ferric carboxymaltose

Ferinject

50 mg/ml

Solution for injection/infusion

Intravenous use

Hungary

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex

Venofer

20 mg/ml

Solution for injection/infusion

Intravenous use

Hungary

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron sucrose complex

Ferrologic

20 mg/ml

Solution for injection/infusion

Intravenous use

Hungary

Sanofi-Aventis Zrt

Tó utca 1-5,

1045 Budapest

Hungary

Sodium ferric gluconate complex

Ferrlecit

12,5  mg/ml

Solution for injection

Intravenous use

Iceland

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

ferric carboxymaltose

Ferinject

50 mg/ml

Solution for injection/infusion

Intravenous use

Iceland

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

Monofer

100 mg/ml

Solution for infusion

Intravenous use

Iceland

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex

Venofer

20 mg/ml

Solution for injection

Intravenous use

Ireland

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron (III) hydroxide dextran complex

CosmoFer 50 mg/ml solution for infusion and injection

50 mg/ml

Solution for injection/infusion

Intravenous use

Ireland

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

Monover 100 mg/ml solution for injection/infusion (ampoules)

100 mg/ml

Solution for injection/infusion

Intravenous use

Ireland

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

Monover 100 mg/ml solution for injection/infusion (vials)

100 mg/ml

Solution for injection/infusion

Intravenous use

Ireland

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex

Venofer 20 mg iron/ml solution for injection or concentrate for solution for infusion, ampoule

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Ireland

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

ferric carboxymaltose

FERINJECT 50 mg iron/ml solution for injection/infusion

50 mg/ml

Solution for injection/infusion

Intravenous use

Ireland

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex

Venofer 20 mg iron/ml solution for injection or concentrate for solution for infusion, vial

20 mg/ml

Solution for injection/infusion

Intravenous use

Ireland

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron sucrose complex

FerroLogic 20 mg/ml solution for injection/concentrate for solution for infusion

20 mg/ml

Solution for injection

Intravenous use

Italy

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

ferric carboxymaltose

FERINJECT

50 mg/ml

Solution for injection/infusion

Intravenous use

Italy

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron sucrose complex

FERRO SACCARATO FME

20 mg/ml

Concentrate for solution for infusion/solution for injection

Intravenous use

Italy

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex

VENOFER

20 mg/ml

Solution for injection

Intravenous use

Italy

Sanofi-Aventis SPA

Viale Luigi Bodio, 37/B

20158 Milano

Italy

sodium ferric gluconate complex

FERLIXIT

62,5  mg/5 ml

Oral solution or solution for infusion

Oral use

Intravenous use

Latvia

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Ferric carboxymaltose

Ferinject

50 mg/ml

Solution for injection/infusion

Intravenous use

Latvia

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex

Venofer

20 mg/ml

Solution for injection

Intravenous use

Latvia

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron sucrose complex

FerroLogic

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Latvia

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron (III) hydroxide dextran complex

CosmoFer

50 mg/ml

Solution for injection/infusion

Intravenous use

intramuscular use

Latvia

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

Monofer

100 mg/ml

Solution for injection/infusion

Intravenous use

Lithuania

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Ferric carboxymaltose

Ferinject

50 mg/ml

Solution for injection/infusion

Intravenous use

Lithuania

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex

Venofer

20 mg/ml

Solution for injection

Intravenous use

Lithuania

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron sucrose complex

Ferrologic

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Lithuania

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

Monofer

100 mg/ml

Solution for injection/infusion

Intravenous use

Lithuania

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Ferric (III) hydroxide dextran complex

CosmoFer

50 mg/ml

Solution for injection/infusion

Intravenous use

intramuscular use

Luxembourg

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Ferric carboxymaltose

Injectafer-50 mg/l

50 mg/ml

Solution for injection

Intravenous use

Luxembourg

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron (III) hydroxide dextran complex

Cosmofer-50 mg/ml

50 mg/ml

Solution for injection

Intravenous use

Luxembourg

Medice Arzneimittel Pütter GmbH & Co KG

Kuhloweg 37

DE-58638 Iserlohn

Germany

Iron sucrose complex

Fermed-100 mg/5 ml

100 mg/5 ml

Solution for perfusion

Intravenous use

Luxembourg

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron sucrose complex

Ferrologic-20 mg/ml

20 mg/ml

Solution for perfusion

Intravenous use

Malta

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92200 Neuilly-sur-Seine

France

ferric carboxymaltose

FERINJECT 50 mg iron/ml solution for injection/infusion

50 mg/ml

Solution for injection/infusion

Intravenous use

Malta

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron sucrose complex.

Ferrologic 20 mg/ml solution for injection/concentrate for solution for infusion

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Norway

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron (III) hydroxide dextran complex

Cosmofer

50 mg/ml

Solution for injection/infusion

Parenteral use

Norway

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Ferric carboxymaltose

Ferinject

50 mg/ml

Solution for injection/infusion

Parenteral use

Norway

Orion Corporation,

Orionintie 1,

FI-02200 Espoo,

Finland

Iron sucrose complex

Ferion

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Parenteral use

Norway

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron sucrose complex

Ferrologic

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Parenteral use

Norway

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

Monofer

100 mg/ml

Solution for injection/infusion

Parenteral use

Norway

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron (III) hydroxide dextran complex

Uniferon

200 mg/ml

Solution for injection

Parenteral use

Norway

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex

Venofer

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Parenteral use

Poland

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron (III) hydroxide dextran complex

CosmoFer

50 mg/ml

Solution for injection/infusion

Intravenous use

Poland

VIFOR France SA

123 Rue Jules Guesde

92200 Neuilly-sur-Seine

France

ferric carboxymaltose

Ferinject

50 mg/ml

Solution for injection

Intravenous use

Poland

VIFOR France SA

123 Rue Jules Guesde

92200 Neuilly-sur-Seine

France

Iron sucrose complex

Venofer

20 mg/ml

Solution for injection/infusion

Intravenous use

Poland

Fresenius Medical Care Nephrologica Deutschland GmbH

61346 Bad Homburg

Germany

Iron sucrose complex

Ferrologic 20 mg/ml

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Poland

Sandoz GmbH

Biochemiestrasse 10

A-6250 Kundl

Austria

Iron(III) isomaltoside complex

Ferrum-Lek

50 mg/ml

Solution for injection

Intramuscular use

Poland

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

Monover

100 mg/ml

Solution for injection/infusion

Intravenous use

Portugal

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron sucrose complex

Referen

100 mg/5 ml

Solution for injection

Intravenous use

Portugal

Vifor France, SA

7-13 Boulevard Paul Emile Victor

92200 Neuilly-sur-Seine

France

Iron sucrose complex

Venofer

100 mg/5 ml

Solution for injection

Intravenous use

Portugal

Combino Pharm Portugal, Unipessoal, Lda.

Lagoas Park

Edifício 8

Piso 0 2740-268 Porto Salvo

Portugal

Iron sucrose complex

Óxido Férrico Sacarosado Combino

100 mg/5 ml

Solution for injection

Intravenous use

Portugal

Farmoz — Sociedade Técnico Medicinal, S.A.

Rua da Tapada Grande, 2,

Abrunheira

2710-089 Sintra

Portugal

Iron sucrose complex

Óxido Férrico Sacarosado Farmoz

100 mg/5 ml

Solution for injection

Intravenous use

Portugal

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

Iron sucrose complex

Óxido Férrico Sacarosado Generis

100 mg/5 ml

Solution for injection

Intravenous use

Portugal

Laboratórios Normon, S.A.

Rua Armando Villar,

Lote 42 1o Dto. Quinta das Patinhas, Cobre

2750 — 777 Cascais

Portugal

Iron sucrose complex

Óxido Férrico Sacarosado Normon

100 mg/5 ml

Solution for injection

Intravenous use

Portugal

Vifor France, SA

7-13 Boulevard Paul Emile Victor

92200 Neuilly-sur-Seine

France

Ferric carboxymaltose

Ferinject

50 mg/ml

Solution for injection/infusion

Intravenous use

Portugal

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron (III) hydroxide dextran complex

Cosmofer

50 mg/ml

Solution for injection/infusion

Intravenous use

intramuscular use

Portugal

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron (III) isomaltoside complex

Monofar

100 mg/ml

Solution for injection/infusion

Intravenous use

Romania

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex

VENOFER®

20 mg/ml

Solution for injection/infusion

Intravenous use

intramuscular use

Romania

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

MONOFER 100 mg/ml

100 mg/ml

Solution for injection/infusion

Intravenous use

intramuscular use

Romania

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Ferric carboxymaltose

FERINJECT 50 mg fer/ml

50 mg/ml

Solution for injection/infusion

Intravenous use

intramuscular use

Slovak Republic

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Ferric carboxymaltose

Ferinject

50 mg/ml

Solution for injection/infusion

Intravenous use

Slovak Republic

Orion Corporation,

Orionintie 1,

FI-02200 Espoo,

Finland

Iron sucrose complex

Ferion 20 mg/ml

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Slovak Republic

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron sucrose complex

Ferrologic 20 mg/ml

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Slovak Republic

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex

Venofer

20 mg/ml

Solution for injection

Intravenous use

Slovenia

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron sucrose complex

Ferrologic 20 mg/ml raztopina za injiciranje/koncentrat za raztopino za infundiranje

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Slovenia

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

carboxymaltose

Iroprem 50 mg/ml raztopina za iniciranje ali infundiranje

50 mg/ml

Solution for injection/infusion

Intravenous use

Slovenia

Lek farmacevtska družba d.d.,

Verovškova 57,

1000 Ljubljana

Slovenia

Iron sucrose complex

Venofer 20 mg/ml raztopina za injiciranje/koncentrat za raztopino za infundiranje

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Spain

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron (III) hydroxide dextran complex

COSMOFER 50 mg/ml SOLUCION PARA PERFUSION E INYECCION

50 mg/ml

Solution for injection

Solution for infusion

Intravenous use

intramuscular use

Spain

GUERBET B.P.

57400 ROISSY CdG

Cedex F-95943

France

Iron sucrose complex

ENDOREM 11,2  mg FE/ml CONCENTRADO PARA SUSPENSION PARA PERFUSION

11,2  mg/ml

Concentrate for suspension for infusion

Intravenous use

Spain

G.E.S. Genericos Espanoles Laboratorio

S.A.Cólquide, 6 — Portal 2, 1 Oficina F.Las Rozas

28230 MADRID

Spain

Iron sucrose complex

FERIV 20 mg/ml SOLUCION INYECTABLE O CONCENTRADO PARA SOLUCION PARA PERFUSION

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Spain

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61346 Bad Homburg

Germany

Iron sucrose complex

HIERRO SACAROSA FME 20 mg/ml SOLUCION INYECTABLE O CONCENTRADO PARA SOLUCION PARA PERFUSION

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Spain

Laboratorios Normon S.A.

Ronda de Valdecarrizo 6

28760 Tres Cantos

Madrid

Spain

Iron sucrose complex

HIERRO SACAROSA NORMON 20 mg/ml SOLUCION INYECTABLE O CONCENTRADO PARA SOLUCION PARA PERFUSION

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Spain

Medice Arzneimittel Pütter GmbH & Co KG

Kuhloweg 37

DE-58638 Iserlohn

Germany

Iron sucrose complex

FERMED 100 mg/5 ml SOLUCION INYECTABLE O CONCENTRADO PARA SOLUCION PARA PERFUSION

100 mg/5 ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Spain

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex

VENOFER 20 mg/ml SOLUCION INYECTABLE O CONCENTRADO PARA SOLUCION PARA PERFUSION

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Spain

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Ferric carboxymaltose

FERINJECT 50 mg/ml SOLUCION INYECTABLE Y PARA PERFUSION

50 mg/ml

Solution for injection

Solution for infusion

Intravenous use

Spain

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

MONOFERRO 100 mg/ml SOLUCIÓN INYECTABLE O PARA PERFUSIÓN

100 mg/ml

Solution for injection

Solution for infusion

Intravenous use

Sweden

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92200 Neuilly-sur-Seine

France

Iron sucrose complex

Venofer®

20 mg/ml

Concentrate for solution for injection

Intravenous use

Sweden

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron (III) hydroxide dextran complex

Cosmofer®

50 mg/ml

Solution for injection

Intravenous use

Sweden

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92200 Neuilly-sur-Seine

France

Ferric carboxymaltose

Ferinject

50 mg/ml

Solution for injection

Intravenous use

Sweden

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61346 Bad Homburg

Germany

Iron sucrose complex

Ferrologic

20 mg/ml

Concentrate for solution for injection

Intravenous use

Sweden

Orion Corporation,

Orionintie 1,

FI-02200 Espoo,

Finland

Iron sucrose complex

Ferion

20 mg/ml

Concentrate for solution for injection

Intravenous use

Sweden

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

MonoFer®

100 mg/ml

Solution for injection

Intravenous use

The Netherlands

Pharmamatch B.V.

Egelenburg 2

Amsterdam GK — 1081

The Netherlands

Iron sucrose complex

IJzerhydroxide sacharose complex bevattende 20 mg/ml IJzer PHARMAMATCH, oplossing/concentraat voor oplossing voor injectie

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

The Netherlands

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron sucrose complex

FerroLogic 20 mg/ml, oplossing voor injectie of concentraat voor oplossing voor infusie

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

The Netherlands

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

MonoFer 100 mg/ml oplossing voor injectie/infusie

100 mg/ml

Solution for injection/infusion

Intravenous use

The Netherlands

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex

Venofer 20 mg/ml ijzer (III), oplossing voor injectie of concentraat voor oplossing voor intraveneuze infusie

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

The Netherlands

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Ferric carboxymaltose

FERINJECT 50 mg ijzer/ml, oplossing voor injectie/infusie

50 mg/ml

Solution for injection/infusion

Intravenous use

The Netherlands

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron (III) hydroxide dextran complex

CosmoFer 50 mg/ml oplossing voor infusie en injectie

50 mg/ml

Solution for injection/infusion

Intravenous use

The Netherlands

Pharmachemie B.V.

Haarlem — 2031 GA

The Netherlands

Iron sucrose complex

IJzerhydroxide sacharose complex 20 mg/ml PCH, oplossing voor injectie/concentraat voor oplossing voor infusie

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

United Kingdom

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex

Venofer

20 mg/ml

Solution for injection/infusion

Intravenous use

United Kingdom

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

Monofer

100 mg/ml

Solution for injection/infusion

Intravenous use

United Kingdom

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

Diafer

50 mg/ml

Solution for injection

Intravenous use

United Kingdom

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron (III) hydroxide dextran complex

Cosmofer

50 mg/ml

Solution for injection/infusion

Intravenous use

intramuscular use

United Kingdom

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron sucrose complex

Ferrologic

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

United Kingdom

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Ferric carboxymaltose

Ferinject

50 mg/ml

Solution for injection/infusion

Intravenous use

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