# C_2017135EN.01000701.xml

| 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

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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))

1

2

(2017/C 135/02)

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

—

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

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

1

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

2

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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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