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

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

(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