Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2017 to 31 March 2017 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)
Date: 2017-04-28
Institutions: European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, medicinal product, veterinary drug








C_2017135EN.01000701.xml










28.4.2017   


EN


Official Journal of the European Union


C 135/7





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2017 to 31 March 2017
(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2))
(2017/C 135/02)






—



Issuing, maintenance or modification of a national marketing authorisation















Date of the decision


Name(s) of the medicinal product


INN (International Non-Proprietary Name)


Holder(s) of the marketing authorization


Member State concerned


Date of notification




9.3.2017


Lovenox and associated names


enoxaparin


See Annex I


See Annex I


10.3.2017




22.3.2017


dienogest/ethinylestradiol


dienogest/ethinylestradiol


See Annex II


See Annex II


23.3.2017




13.9.2017


Iron IV
Corrigendum


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


See Annex III


See Annex III


20.3.2017






(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 311, 28.11.2001, p. 1.


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











Member State EU/EEA


Marketing authorisation holder
company name, address


(Invented) Name


Strength


Pharmaceutical form


Route of administration


Content
(concentration)




Austria


sanofi-aventis GmbH,
Leonard-Bernstein-Straße 10, A-1220 Vienna, Austria


Lovenox 20 mg Spritzampullen


20 mg


Solution for injection


Subcutaneous use


0,2  ml (100 mg/ml)




Austria


sanofi-aventis GmbH,
Leonard-Bernstein-Straße 10, A-1220 Vienna, Austria


Lovenox 40 mg Spritzampullen


40 mg


Solution for injection


Subcutaneous use


0,4  ml (100 mg/ml)




Austria


sanofi-aventis GmbH,
Leonard-Bernstein-Straße 10, A-1220 Vienna, Austria


Lovenox 60 mg Spritzampullen


60 mg


Solution for injection


Subcutaneous use


0,6  ml (100 mg/ml)




Austria


sanofi-aventis GmbH,
Leonard-Bernstein-Straße 10, A-1220 Vienna, Austria


Lovenox 80 mg Spritzampullen


80 mg


Solution for injection


Subcutaneous use


0,8  ml (100 mg/ml)




Austria


sanofi-aventis GmbH,
Leonard-Bernstein-Straße 10, A-1220 Vienna, Austria


Lovenox 100 mg Spritzampullen


100 mg


Solution for injection


Subcutaneous use


1 ml (100 mg/ml)




Austria


sanofi-aventis GmbH,
Leonard-Bernstein-Straße 10, A-1220 Vienna, Austria


Lovenox 120 mg Spritzampullen


120 mg


Solution for injection


Subcutaneous use


0,8  ml (150 mg/ml)




Austria


sanofi-aventis GmbH,
Leonard-Bernstein-Straße 10, A-1220 Vienna, Austria


Lovenox 150 mg Spritzampullen


150 mg


Solution for injection


Subcutaneous use


1 ml (150 mg/ml)




Austria


sanofi-aventis GmbH,
Leonard-Bernstein-Straße 10, A-1220 Vienna, Austria


Lovenox 100 mg/ml Durchstichflasche


300 mg


Solution for injection


Subcutaneous use;
Intravenous use


3 ml (100 mg/ml)




Austria


sanofi-aventis GmbH,
Leonard-Bernstein-Straße 10, A-1220 Vienna, Austria


Lovenox 100 mg/1 ml Ampullen


100 mg


Solution for injection


Subcutaneous use;
Intravenous use


100 mg/1,0  ml




Austria


sanofi-aventis GmbH,
Leonard-Bernstein-Straße 10, A-1220 Vienna, Austria


Lovenox 100 mg/10 ml Stechampullen


100 mg


Solution for injection


Extracorporeal use


100 mg/10 ml




Austria


sanofi-aventis GmbH,
Leonard-Bernstein-Straße 10, A-1220 Vienna, Austria


Lovenox 10 x 40 mg Pen


40 mg


Solution for injection


Subcutaneous use


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




Belgium


Sanofi Belgium
Leonardo Da Vincilaan 19
1831 Diegem, Belgium


Clexane


20 mg/0,2  ml


Solution for injection


Subcutaneous use;
Intravenous use


0,2  ml (100 mg/ml)




Belgium


Sanofi Belgium
Leonardo Da Vincilaan 19
1831 Diegem, Belgium


Clexane


40 mg/0,4  ml


Solution for injection


Subcutaneous use;
Intravenous use


0,4  ml (100 mg/ml)




Belgium


Sanofi Belgium
Leonardo Da Vincilaan 19
1831 Diegem, Belgium


Clexane


60 mg/0,6  ml


Solution for injection


Subcutaneous use;
Intravenous use


0,6  ml (100 mg/ml)




Belgium


Sanofi Belgium
Leonardo Da Vincilaan 19
1831 Diegem, Belgium


Clexane


80 mg/0,8  ml


Solution for injection


Subcutaneous use;
Intravenous use


0,8  ml (100 mg/ml)




Belgium


Sanofi Belgium
Leonardo Da Vincilaan 19
1831 Diegem, Belgium


Clexane


100 mg/1,0  ml


Solution for injection


Subcutaneous use;
Intravenous use


1 ml (100 mg/ml)




Belgium


Sanofi Belgium
Leonardo Da Vincilaan 19
1831 Diegem, Belgium


Clexane


120 mg/0,8  ml


Solution for injection


Subcutaneous use;
Intravenous use


0,8  ml (150 mg/ml)




Belgium


Sanofi Belgium
Leonardo Da Vincilaan 19
1831 Diegem, Belgium


Clexane


150 mg/1,0  ml


Solution for injection


Subcutaneous use;
Intravenous use


1 ml (150 mg/ml)




Belgium


Sanofi Belgium
Leonardo Da Vincilaan 19
1831 Diegem, Belgium


Clexane


300 mg/3 ml


Solution for injection


Subcutaneous use;
Intravenous use


3 ml (100 mg/ml)




Bulgaria


SANOFI BULGARIA EOOD
90 Tsarigradsko chaussee Blvd. Office building Capital Fort, section A, 10th floor
Sofia 1784, Bulgaria


Clexane


100 mg/ml


Solution for injection


Subcutaneous use;
Intravenous use;
Extracorporeal use


0,2  ml; 0,4  ml (100 mg/ml)




Bulgaria


SANOFI BULGARIA EOOD
90 Tsarigradsko chaussee Blvd. Office building Capital Fort, section A, 10th floor
Sofia 1784, Bulgaria


Clexane


60 mg/0,6  ml


Solution for injection


Subcutaneous use;
Intravenous use;
Extracorporeal use


0,6  ml (100 mg/ml)




Bulgaria


SANOFI BULGARIA EOOD
90 Tsarigradsko chaussee Blvd. Office building Capital Fort, section A, 10th floor
Sofia 1784, Bulgaria


Clexane


80 mg/0,8  ml


Solution for injection


Subcutaneous use;
Intravenous use;
Extracorporeal use


0,8  ml (100 mg/ml)




Bulgaria


SANOFI BULGARIA EOOD
90 Tsarigradsko chaussee Blvd. Office building Capital Fort, section A, 10th floor
Sofia 1784, Bulgaria


Clexane


300 mg/3 ml


Solution for injection


Subcutaneous use;
Intravenous use;
Extracorporeal use


3 ml (100 mg/ml)




Croatia


sanofi-aventis Croatia d.o.o.
Heinzelova 70, 10000 Zagreb, Croatia


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


2 000  anti-Xa IU/0,2  ml


Solution for injection


Subcutaneous use;
Intravenous use;
Extracorporeal use


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




Croatia


sanofi-aventis Croatia d.o.o.
Heinzelova 70, 10000 Zagreb, Croatia


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


4 000  anti-Xa IU/0,4  ml


Solution for injection


Subcutaneous use;
Intravenous use;
Extracorporeal use


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




Croatia


sanofi-aventis Croatia d.o.o.
Heinzelova 70, 10000 Zagreb, Croatia


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


6 000  anti-Xa IU/0,6  ml


Solution for injection


Subcutaneous use;
Intravenous use;
Extracorporeal use


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




Croatia


sanofi-aventis Croatia d.o.o.
Heinzelova 70, 10000 Zagreb, Croatia


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


8 000  anti-Xa IU/0,8  ml


Solution for injection


Subcutaneous use;
Intravenous use;
Extracorporeal use


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




Croatia


sanofi-aventis Croatia d.o.o.
Heinzelova 70, 10000 Zagreb, Croatia


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


10 000  anti-Xa IU/1,0  ml


Solution for injection


Subcutaneous use;
Intravenous use;
Extracorporeal use


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




Croatia


sanofi-aventis Croatia d.o.o.
Heinzelova 70, 10000 Zagreb, Croatia


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


30 000  anti-Xa IU/3 ml


Solution for injection


Subcutaneous use;
Intravenous use;
Extracorporeal use


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




Cyprus


Sanofi-aventis Cyprus Ltd
14, Charalambou Mouskou
Strovolos, 2015
Nicosia
Cyprus


Clexane


2 000  anti-Xa IU/0,2  ml


Solution for injection


Subcutaneous use;
Intravenous use


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




Cyprus


Sanofi-aventis Cyprus Ltd
14, Charalambou Mouskou
Strovolos, 2015
Nicosia
Cyprus


Clexane


4 000  anti-Xa IU/0,4  ml


Solution for injection


Subcutaneous use;
Intravenous use


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




Cyprus


Sanofi-aventis Cyprus Ltd
14, Charalambou Mouskou
Strovolos, 2015
Nicosia
Cyprus


Clexane


6 000  anti-Xa IU/0,6  ml


Solution for injection


Subcutaneous use;
Intravenous use


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




Cyprus


Sanofi-aventis Cyprus Ltd
14, Charalambou Mouskou
Strovolos, 2015
Nicosia
Cyprus


Clexane


8 000  anti-Xa IU/0,8  ml


Solution for injection


Subcutaneous use;
Intravenous use


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




Cyprus


Sanofi-aventis Cyprus Ltd
14, Charalambou Mouskou
Strovolos, 2015
Nicosia
Cyprus


Clexane


150 mg/1,0  ml


Solution for injection


Subcutaneous use;
Intravenous use


1 ml
(150 mg/ml)




Czech Republic


sanofi-aventis, s.r.o.
Evropská 846/176a
160 00 Praha 6
Czech Republic


Clexane


100 mg/ml


Solution for injection


Subcutaneous use;
Intravenous use;
Extracorporeal use


0,2  ml; 0,4  ml;
0,6  ml; 0,8  ml; 1,0  ml (100 mg/ml equivalent to 10 000  anti-Xa IU/ml)




Czech Republic


sanofi-aventis, s.r.o.
Evropská 846/176a
160 00 Praha 6
Czech Republic


Clexane Forte


150 mg/ml


Solution for injection


Subcutaneous use;
Extracorporeal use


0,8  ml; 1,0  ml
(150 mg/ml equivalent to 15 000  anti-Xa IU/ml)




Denmark


sanofi-aventis Denmark A/S
Slotsmarken 13
2970 Hørsholm
Denmark


Klexane


100 mg/ml


Solution for injection


Subcutaneous use; Intravenous use


3 ml (100 mg/ml)




Denmark


sanofi-aventis Denmark A/S
Slotsmarken 13
2970 Hørsholm
Denmark


Klexane


100 mg/ml


Solution for injection


Subcutaneous use


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




Estonia


sanofi-aventis Estonia OÜ
Pärnu mnt. 139 E/2
11317 Tallinn,
Estonia


Clexane


10 000  anti-Xa IU/ml


Solution for injection


Subcutaneous use;
Intravenous use;
Extracorporeal use


0,2  ml; 0,4  ml;
0,6  ml; 0,8  ml;
1,0  ml
(100 mg/ml equivalent to 10 000  anti-Xa IU/ml)




Finland


Sanofi Oy
Huopalahdentie 24
00350 Helsinki
Finland


Klexane


100 mg/ml


Solution for injection


Subcutaneous use


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




Finland


Sanofi Oy
Huopalahdentie 24
00350 Helsinki
Finland


Klexane Cum Conservans


100 mg/ml


Solution for injection


Subcutaneous use;
Intravenous use


3 ml; 10 ml
(100 mg/ml)




France


Sanofi-aventis France
82 avenue Raspail
94250 Gentilly
FRANCE


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


2 000  anti-Xa IU/0,2  ml


Solution for injection


Subcutaneous use; Extracorporeal use


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




France


Sanofi-aventis France
82 avenue Raspail
94250 Gentilly
FRANCE


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


4 000  anti-Xa IU/0,4  ml


Solution for injection


Subcutaneous use;
Extracorporeal use


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




France


Sanofi-aventis France
82 avenue Raspail
94250 Gentilly
FRANCE


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


6 000  anti-Xa IU/0,6  ml


Solution for injection


Subcutaneous use;
Intravenous use


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




France


Sanofi-aventis France
82 avenue Raspail
94250 Gentilly
FRANCE


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


8 000  anti-Xa IU/0,8  ml


Solution for injection


Subcutaneous use;
Intravenous use


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




France


Sanofi-aventis France
82 avenue Raspail
94250 Gentilly
FRANCE


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


10 000  anti-Xa IU/1 ml


Solution for injection


Subcutaneous use;
Intravenous use


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




France


Sanofi-aventis France
82 avenue Raspail
94250 Gentilly
FRANCE


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


30 000  anti-Xa IU/3 ml


Solution for injection


Subcutaneous use;
Intravenous use; Extracorporeal use


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




France


Sanofi-aventis France
82 avenue Raspail
94250 Gentilly
FRANCE


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


2 000  anti-Xa IU/0,2  ml


Solution for injection


Subcutaneous use; Extracorporeal use


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




France


Sanofi-aventis France
82 avenue Raspail
94250 Gentilly
FRANCE


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


4 000  anti-Xa IU/0,4  ml


Solution for injection


Subcutaneous use; Extracorporeal use


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




France


Sanofi-aventis France
82 avenue Raspail
94250 Gentilly
FRANCE


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


6 000  anti-Xa IU/0,6  ml


Solution for injection


Subcutaneous use;
Intravenous use


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




France


Sanofi-aventis France
82 avenue Raspail
94250 Gentilly
FRANCE


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


8 000  anti-Xa IU/0,8  ml


Solution for injection


Subcutaneous use;
Intravenous use


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




France


Sanofi-aventis France
82 avenue Raspail
94250 Gentilly
FRANCE


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


10 000  anti-Xa IU/1 ml


Solution for injection


Subcutaneous use;
Intravenous use


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




Germany


Sanofi-Aventis Deutschland GmbH
Industriepark Höchst
Gebäude K703
65926 Frankfurt am Main
Germany


Clexane 20 mg


20 mg


Solution for injection


Subcutaneous use


0,2  ml (100 mg/ml)




Germany


Sanofi-Aventis Deutschland GmbH
Industriepark Höchst
Gebäude K703
65926 Frankfurt am Main
Germany


Clexane 20 mg Klinik


20 mg


Solution for injection


Subcutaneous use


0,2  ml (100 mg/ml)




Germany


Sanofi-Aventis Deutschland GmbH
Industriepark Höchst
Gebäude K703
65926 Frankfurt am Main
Germany


Clexane 20 mg Praxis


20 mg


Solution for injection


Subcutaneous use


0,2  ml (100 mg/ml)




Germany


Sanofi-Aventis Deutschland GmbH
Industriepark Höchst
Gebäude K703
65926 Frankfurt am Main
Germany


Enoxaparin Sanofi
20 mg


20 mg


Solution for injection


Subcutaneous use


0,2  ml (100 mg/ml)




Germany


Sanofi-Aventis Deutschland GmbH
Industriepark Höchst
Gebäude K703
65926 Frankfurt am Main
Germany


Clexane 40 mg


40 mg


Solution for injection


Subcutaneous use


0,4  ml (100 mg/ml)




Germany


Sanofi-Aventis Deutschland GmbH
Industriepark Höchst
Gebäude K703
65926 Frankfurt am Main
Germany


Clexane 40 mg Praxis


40 mg


Solution for injection


Subcutaneous use


0,4  ml (100 mg/ml)




Germany


Sanofi-Aventis Deutschland GmbH
Industriepark Höchst
Gebäude K703
65926 Frankfurt am Main
Germany


Clexane 40 mg Klinik


40 mg


Solution for injection


Subcutaneous use


0,4  ml (100 mg/ml)




Germany


Sanofi-Aventis Deutschland GmbH
Industriepark Höchst
Gebäude K703
65926 Frankfurt am Main
Germany


Enoxaparin Sanofi 40 mg


40 mg


Solution for injection


Subcutaneous use


0,4  ml (100 mg/ml)




Germany


Sanofi-Aventis Deutschland GmbH
Industriepark Höchst
Gebäude K703
65926 Frankfurt am Main
Germany


Enoxaparin Sanofi 60 mg


60 mg


Solution for injection


Subcutaneous use


0,6  ml (100 mg/ml)




Germany


Sanofi-Aventis Deutschland GmbH
Industriepark Höchst
Gebäude K703
65926 Frankfurt am Main
Germany


Clexane 60 mg
Fertigspritzen


60 mg


Solution for injection


Subcutaneous use


0,6  ml (100 mg/ml)




Germany


Sanofi-Aventis Deutschland GmbH
Industriepark Höchst
Gebäude K703
65926 Frankfurt am Main
Germany


Enoxaparin Sanofi 80 mg


80 mg


Solution for injection


Subcutaneous use


0,8  ml (100 mg/ml)




Germany


Sanofi-Aventis Deutschland GmbH
Industriepark Höchst
Gebäude K703
65926 Frankfurt am Main
Germany


Clexane 80 mg
Fertigspritzen


80 mg


Solution for injection


Subcutaneous use


0,8  ml (100 mg/ml)




Germany


Sanofi-Aventis Deutschland GmbH
Industriepark Höchst
Gebäude K703
65926 Frankfurt am Main
Germany


Enoxaparin Sanofi 100 mg


100 mg


Solution for injection


Subcutaneous use


1 ml (100 mg/ml)




Germany


Sanofi-Aventis Deutschland GmbH
Industriepark Höchst
Gebäude K703
65926 Frankfurt am Main
Germany


Clexane 100 mg Fertigspritzen


100 mg


Solution for injection


Subcutaneous use


1 ml (100 mg/ml)




Germany


Sanofi-Aventis Deutschland GmbH
Industriepark Höchst
Gebäude K703
65926 Frankfurt am Main
Germany


Enoxaparin Sanofi
multidose 100 mg/ml


100 mg/ml


Solution for injection


Subcutaneous use;
Intravenous use; Extracorporeal use


3 ml; 5 ml; 10 ml (100 mg/ml)




Germany


Sanofi-Aventis Deutschland GmbH
Industriepark Höchst
Gebäude K703
65926 Frankfurt am Main
Germany


Clexane multidose 100 mg/ml


100 mg/ml


Solution for injection


Subcutaneous use;
Intravenous use; Extracorporeal use


3 ml; 5 ml; 10 ml (100 mg/ml)




Germany


Sanofi-Aventis Deutschland GmbH
Industriepark Höchst
Gebäude K703
65926 Frankfurt am Main
Germany


Clexane Multidose 100 mg/ml Praxis


100 mg/ml


Solution for injection


Subcutaneous use;
Intravenous use; Extracorporeal use


3 ml; 5 ml; 10 ml (100 mg/ml)




Germany


Sanofi-Aventis Deutschland GmbH
Industriepark Höchst
Gebäude K703
65926 Frankfurt am Main
Germany


Qualiop multidose 100 mg/ml


100 mg/ml


Solution for injection


Subcutaneous use;
Extracorporeal use


3 ml; 5 ml; 10 ml (100 mg/ml)




Germany


Sanofi-Aventis Deutschland GmbH
Industriepark Höchst
Gebäude K703
65926 Frankfurt am Main
Germany


Qualiop Klinik 100 mg/ml


100 mg/ml


Solution for injection


Subcutaneous use;
Extracorporeal use


3 ml; 5 ml; 10 ml (100 mg/ml)




Greece


sanofi-aventis AEBE
348, Syngrou Av. — Building A, 176 74 Kallithea — Athens
Greece


Clexane


2 000  anti-Xa IU/0,2  ml


Solution for injection


Subcutaneous use
Intravenous use;
Extracorporeal use


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




Greece


sanofi-aventis AEBE
348, Syngrou Av. — Building A, 176 74 Kallithea — Athens
Greece


Clexane


4 000  anti-Xa IU/0,4  ml


Solution for injection


Subcutaneous use
Intravenous use;
Extracorporeal use


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




Greece


sanofi-aventis AEBE
348, Syngrou Av. — Building A, 176 74 Kallithea — Athens
Greece


Clexane


6 000  anti-Xa IU/0,6  ml


Solution for injection


Subcutaneous use
Intravenous use;
Extracorporeal use


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




Greece


sanofi-aventis AEBE
348, Syngrou Av. — Building A, 176 74 Kallithea — Athens
Greece


Clexane


8 000  anti-Xa IU/0,8  ml


Solution for injection


Subcutaneous use
Intravenous use;
Extracorporeal use


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




Greece


sanofi-aventis AEBE
348, Syngrou Av. — Building A, 176 74 Kallithea — Athens
Greece


Clexane


12 000  anti-Xa IU/0,8  ml


Solution for injection


Subcutaneous use
Intravenous use;
Extracorporeal use


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




Greece


sanofi-aventis AEBE
348, Syngrou Av. — Building A, 176 74 Kallithea — Athens
Greece


Clexane


15 000  anti-Xa IU/1,0  ml


Solution for injection


Subcutaneous use
Intravenous use;
Extracorporeal use


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




Hungary


SANOFI-AVENTIS Zrt.

1045. BUDAPEST TÓ U. 1-5
Hungary


Clexane


20 mg (2 000  NE/0,2  ml)


Solution for injection


Subcutaneous use


0,2  ml (100 mg/ml)




Hungary


SANOFI-AVENTIS Zrt.

1045. BUDAPEST TÓ U. 1-5
Hungary


Clexane


40 mg (4 000  NE/0,4  ml)


Solution for injection


Subcutaneous use


0,4  ml (100 mg/ml)




Hungary


SANOFI-AVENTIS Zrt.

1045. BUDAPEST TÓ U. 1-5
Hungary


Clexane


60 mg (6 000  NE/0,6  ml)


Solution for injection


Subcutaneous use


0,6  ml (100 mg/ml)




Hungary


SANOFI-AVENTIS Zrt.

1045. BUDAPEST TÓ U. 1-5
Hungary


Clexane


80 mg (8 000  NE/0,8  ml)


Solution for injection


Subcutaneous use


0,8  ml (100 mg/ml)




Hungary


SANOFI-AVENTIS Zrt.

1045. BUDAPEST TÓ U. 1-5
Hungary


Clexane


100 mg (10 000  NE/1 ml)


Solution for injection


Subcutaneous use


1 ml (100 mg/ml)




Hungary


SANOFI-AVENTIS Zrt.

1045. BUDAPEST TÓ U. 1-5
Hungary


Clexane


300 mg (30 000  NE/3 ml


Solution for injection


Subcutaneous use;
Intravenous use


3 ml (100 mg/ml)




Hungary


SANOFI-AVENTIS Zrt.

1045. BUDAPEST TÓ U. 1-5
Hungary


Clexane Forte


120 mg/0,8  ml


Solution for injection


Subcutaneous use


0,8  ml (150 mg/ml)




Hungary


SANOFI-AVENTIS Zrt.

1045. BUDAPEST TÓ U. 1-5
Hungary


Clexane Forte


150 mg/1,0  ml


Solution for injection


Subcutaneous use


1,0  ml (150 mg/ml)




Iceland


Sanofi-aventis Norge AS
P.O. Box 133
1325 Lysaker
Norway


Klexane


100 mg/ml


Solution for injection


Subcutaneous use;
Intravenous use; Extracorporeal use


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




Iceland


Sanofi-aventis Norge AS
P.O. Box 133
1325 Lysaker
Norway


Klexane


100 mg/ml


Solution for injection


Subcutaneous use;
Intravenous use; Extracorporeal use


3 ml
(100 mg/ml)




Ireland


Sanofi-aventis Ireland Ltd T/A SANOFI
Citywest Business Campus
Dublin 24
Ireland


Clexane Syringes


100 mg/ml


Solution for injection


Subcutaneous use;
Intravenous use


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




Ireland


Sanofi-aventis Ireland Ltd T/A SANOFI
Citywest Business Campus
Dublin 24
Ireland


Clexane Forte Syringe


150 mg/ml


Solution for injection


Subcutaneous use;
Intravenous use


0,8  ml; 1 ml (150 mg/ml)




Italy


Sanofi S.p.A.
Viale L. Bodio 37/b
20158 Milan, Italy


Clexane


2 000  anti-Xa IU/0,2  ml


Solution for injection


Subcutaneous use; Extracorporeal use


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




Italy


Sanofi S.p.A.
Viale L. Bodio 37/b
20158 Milan, Italy


Clexane


4 000  anti-Xa IU/0,4  ml


Solution for injection


Subcutaneous use; Extracorporeal use


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




Italy


Sanofi S.p.A.
Viale L. Bodio 37/b
20158 Milan, Italy


Clexane T


6 000  anti-Xa IU/0,6  ml


Solution for injection


Subcutaneous use


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




Italy


Sanofi S.p.A.
Viale L. Bodio 37/b
20158 Milan, Italy


Clexane T


8 000  anti-Xa IU/0,8  ml


Solution for injection


Subcutaneous use


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




Italy


Sanofi S.p.A.
Viale L. Bodio 37/b
20158 Milan, Italy


Clexane T


10 000  anti-Xa IU/1,0  ml


Solution for injection


Subcutaneous use


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




Italy


Sanofi S.p.A.
Viale L. Bodio 37/b
20158 Milan, Italy


Clexane T


30 000  anti-Xa IU/3,0  ml


Solution for injection


Intravenous use


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




Latvia


sanofi — aventis Latvia SIA
33 — 8 Kr. Valdemāra Street
Rīga, LV — 1010
Latvia


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


2 000  anti-Xa IU/0,2  ml


Solution for injection


Subcutaneous use;
Intravenous use; Extracorporeal use


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




Latvia


sanofi — aventis Latvia SIA
33 — 8 Kr. Valdemāra Street
Rīga, LV — 1010
Latvia


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


4 000  anti-Xa IU/0,4  ml


Solution for injection


Subcutaneous use;
Intravenous use; Extracorporeal use


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




Latvia


sanofi — aventis Latvia SIA
33 — 8 Kr. Valdemāra Street
Rīga, LV — 1010
Latvia


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


6 000  anti-Xa IU/0,6  ml


Solution for injection


Subcutaneous use;
Intravenous use; Extracorporeal use


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




Latvia


sanofi — aventis Latvia SIA
33 — 8 Kr. Valdemāra Street
Rīga, LV — 1010
Latvia


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


8 000  anti-Xa IU/0,8  ml


Solution for injection


Subcutaneous use;
Intravenous use; Extracorporeal use


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




Lithuania


UAB ‘SANOFI-AVENTIS LIETUVA’
A.Juozapaviciaus 6/2,
LT-09310 Vilnius, Lithuania


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


2 000  anti-Xa IU/0,2  ml


Solution for injection


Subcutaneous use;
Extracorporeal use


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




Lithuania


UAB ‘SANOFI-AVENTIS LIETUVA’
A.Juozapaviciaus 6/2,
LT-09310 Vilnius, Lithuania


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


4 000  anti-Xa IU/0,4  ml


Solution for injection


Subcutaneous use;
Extracorporeal use


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




Lithuania


UAB ‘SANOFI-AVENTIS LIETUVA’
A.Juozapaviciaus 6/2,
LT-09310 Vilnius, Lithuania


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


6 000  anti-Xa IU/0,6  ml


Solution for injection


Subcutaneous use;
Intravenous use; Extracorporeal use


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




Lithuania


UAB ‘SANOFI-AVENTIS LIETUVA’
A.Juozapaviciaus 6/2,
LT-09310 Vilnius, Lithuania


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


8 000  anti-Xa IU/0,8  ml


Solution for injection


Subcutaneous use;
Intravenous use; Extracorporeal use


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




Lithuania


UAB ‘SANOFI-AVENTIS LIETUVA’
A.Juozapaviciaus 6/2,
LT-09310 Vilnius, Lithuania


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


10 000  anti-Xa IU/1,0  ml


Solution for injection


Subcutaneous use;
Intravenous use; Extracorporeal use


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




Luxembourg


Sanofi Belgium
Leonardo Da Vincilaan 19
1831 Diegem, Belgium


Clexane


20 mg/0,2  ml


Solution for injection


Subcutaneous use;
Intravenous use


0,2  ml (100 mg/ml)




Luxembourg


Sanofi Belgium
Leonardo Da Vincilaan 19
1831 Diegem, Belgium


Clexane


40 mg/0,4  ml


Solution for injection


Subcutaneous use;
Intravenous use


0,4  ml (100 mg/ml)




Luxembourg


Sanofi Belgium
Leonardo Da Vincilaan 19
1831 Diegem, Belgium


Clexane


60 mg/0,6  ml


Solution for injection


Subcutaneous use;
Intravenous use


0,6  ml (100 mg/ml)




Luxembourg


Sanofi Belgium
Leonardo Da Vincilaan 19
1831 Diegem, Belgium


Clexane


80 mg/0,8  ml


Solution for injection


Subcutaneous use;
Intravenous use


0,8  ml (100 mg/ml)




Luxembourg


Sanofi Belgium
Leonardo Da Vincilaan 19
1831 Diegem, Belgium


Clexane


100 mg/1,0  ml


Solution for injection


Subcutaneous use;
Intravenous use


1 ml (100 mg/ml)




Luxembourg


Sanofi Belgium
Leonardo Da Vincilaan 19
1831 Diegem, Belgium


Clexane


120 mg/0,8  ml


Solution for injection


Subcutaneous use;
Intravenous use


0,8  ml (150 mg/ml)




Luxembourg


Sanofi Belgium
Leonardo Da Vincilaan 19
1831 Diegem, Belgium


Clexane


150 mg/1,0  ml


Solution for injection


Subcutaneous use;
Intravenous use


1 ml (150 mg/ml)




Malta


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


Clexane


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


Solution for Injection


Subcutaneous use;
Intravenous use


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




Malta


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


Clexane


4 000  anti-Xa IU/0,4  ml
(40 mg/0,4  ml)


Solution for Injection


Subcutaneous use;
Intravenous use


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




Malta


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


Clexane


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


Solution for Injection


Subcutaneous use;
Intravenous use


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




Malta


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


Clexane


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


Solution for Injection


Subcutaneous use;
Intravenous use


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




Malta


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


Clexane


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


Solution for Injection


Subcutaneous use;
Intravenous use


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




Malta


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


Clexane Forte Syringes


120 mg/0,8  ml


Solution for Injection


Subcutaneous use;
Intravenous use


0,8  ml (150 mg/ml)




Malta


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


Clexane Forte Syringes


150 mg/1,0  ml


Solution for Injection


Subcutaneous use;
Intravenous use


1 ml (150 mg/ml)




Malta


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


Clexane Multidose vial


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


Solution for Injection


Subcutaneous use;
Intravenous use


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




Netherlands


sanofi-aventis Netherlands B.V.
Kampenringweg 45 D-E
2803 PE Gouda
The Netherlands


Clexane 100 mg/ml


100 mg/ml


Solution for Injection


Subcutaneous use


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




Netherlands


sanofi-aventis Netherlands B.V.
Kampenringweg 45 D-E
2803 PE Gouda
The Netherlands


Clexane 300 mg/3 ml


300 mg/3 ml


Solution for Injection


Subcutaneous use;
Intravenous use


3 ml (100 mg/ml)




Netherlands


sanofi-aventis Netherlands B.V.
Kampenringweg 45 D-E
2803 PE Gouda
The Netherlands


Clexane 150 mg/ml


150 mg/ml


Solution for Injection


Subcutaneous use


0,8  ml; 1,0  ml (150 mg/ml)




Norway


Sanofi-aventis Norge AS
P.O. Box 133
1325 Lysaker
Norway


Klexane


100 mg/ml


Solution for Injection


Subcutaneous use;
Intravenous use; Extracorporeal use


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




Norway


Sanofi-aventis Norge AS
P.O. Box 133
1325 Lysaker
Norway


Klexane


100 mg/ml


Solution for Injection


Subcutaneous use;
Intravenous use; Extracorporeal use


3 ml (100 mg/ml)




Norway


Sanofi-aventis Norge AS
P.O. Box 133
1325 Lysaker
Norway


Klexane


150 mg/ml


Solution for Injection


Subcutaneous use;
Intravenous use; Extracorporeal use


0,8  ml; 1,0  ml (150 mg/ml)




Poland


Sanofi-Aventis France
82, Avenue Raspail
94250 Gentilly
France


Clexane


20 mg/0,2  ml


Solution for injection


Subcutaneous use;
Extracorporeal use


0,2  ml
(100 mg/ml)




Poland


Sanofi-Aventis France
82, Avenue Raspail
94250 Gentilly
France


Clexane


40 mg/0,4  ml


Solution for injection


Subcutaneous use;
Extracorporeal use


0,4  ml
(100 mg/ml)




Poland


Sanofi-Aventis France
82, Avenue Raspail
94250 Gentilly
France


Clexane


60 mg/0,6  ml


Solution for injection


Subcutaneous use;
Extracorporeal use


0,6  ml
(100 mg/ml)




Poland


Sanofi-Aventis France
82, Avenue Raspail
94250 Gentilly
France


Clexane


80 mg/0,8  ml


Solution for injection


Subcutaneous use;
Extracorporeal use


0,8  ml
(100 mg/ml)




Poland


Sanofi-Aventis France
82, Avenue Raspail
94250 Gentilly
France


Clexane


100 mg/1 ml


Solution for injection


Subcutaneous use;
Extracorporeal use


1 ml
(100 mg/ml)




Poland


Sanofi-Aventis France
82, Avenue Raspail
94250 Gentilly
France


Clexane


300 mg/3 ml


Solution for injection


Subcutaneous use;
Intravenous use;
Extracorporeal use


3 ml (100 mg/ml)




Poland


Aventis Pharma Limited
One Onslow Street
Guildford, Surrey GU1 4YS
United Kingdom


Clexane forte


120 mg/0,8  ml


Solution for injection


Subcutaneous use;
Extracorporeal use


0,8  ml (150 mg/ml)




Poland


Aventis Pharma Limited
One Onslow Street
Guildford, Surrey GU1 4YS
United Kingdom


Clexane forte


150 mg/1 ml


Solution for injection


Subcutaneous use;
Extracorporeal use


1 ml (150 mg/ml)




Portugal


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


Lovenox


100 mg/1 ml


Solution for injection


Subcutaneous use


1 ml
(100 mg/ml)




Portugal


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


Lovenox


100 mg/ml


Solution for injection


Subcutaneous use;
Intravenous use


3 ml (100 mg/ml)




Portugal


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


Lovenox


150 mg/1 ml


Solution for injection


Subcutaneous use


1 ml
(150 mg/ml)




Portugal


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


Lovenox


80 mg/0,8  ml


Solution for injection


Subcutaneous use


0,8  ml (100 mg/ml)




Portugal


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


Lovenox


60 mg/0,6  ml


Solution for injection


Subcutaneous use


0,6  ml (100 mg/ml)




Portugal


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


Lovenox


40 mg/0,4  ml


Solution for injection


Subcutaneous use


0,4  ml (100 mg/ml)




Portugal


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


Lovenox


20 mg/0,2  ml


Solution for injection


Subcutaneous use


0,2  ml (100 mg/ml)




Portugal


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


Lovenox


120 mg/0,8  ml


Solution for injection


Subcutaneous use


0,8  ml (120 mg/ml)




Romania


Sanofi Romania SRL,
Strada Gara Herăstrău, nr. 4, Clădirea B, etajele 8-9, Sector 2,
Bucureşti, Romania


Clexane


2 000  anti-Xa IU/0,2  ml


Solution for injection


Subcutaneous use;
Intravenous use;
Extracorporeal use


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




Romania


Sanofi Romania SRL,
Strada Gara Herăstrău, nr. 4, Clădirea B, etajele 8-9, Sector 2,
Bucureşti, Romania


Clexane


4 000  anti-Xa IU/0,4  ml


Solution for injection


Subcutaneous use;
Intravenous use;
Extracorporeal use


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




Romania


Sanofi Romania SRL,
Strada Gara Herăstrău, nr. 4, Clădirea B, etajele 8-9, Sector 2,
Bucureşti, Romania


Clexane


6 000  anti-Xa IU/0,6  ml


Solution for injection


Subcutaneous use;
Intravenous use;
Extracorporeal use


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




Romania


Sanofi Romania SRL,
Strada Gara Herăstrău, nr. 4, Clădirea B, etajele 8-9, Sector 2,
Bucureşti, Romania


Clexane


8 000  anti-Xa IU/0,8  ml


Solution for injection


Subcutaneous use;
Intravenous use;
Extracorporeal use


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




Slovak Republic


sanofi-aventis Slovakia s.r.o.
Einsteinova 24,
85101 Bratislava
Slovak Republic


Clexane


2 000  anti-Xa IU/0,2  ml


Solution for injection


Subcutaneous use;
Intravenous use;
Extracorporeal use


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




Slovak Republic


sanofi-aventis Slovakia s.r.o.
Einsteinova 24,
85101 Bratislava
Slovak Republic


Clexane


4 000  anti-Xa IU/0,4  ml


Solution for injection


Subcutaneous use;
Intravenous use;
Extracorporeal use


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




Slovak Republic


sanofi-aventis Slovakia s.r.o.
Einsteinova 24,
85101 Bratislava
Slovak Republic


Clexane


6 000  anti-Xa IU/0,6  ml


Solution for injection


Subcutaneous use;
Intravenous use;
Extracorporeal use


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




Slovak Republic


sanofi-aventis Slovakia s.r.o.
Einsteinova 24,
85101 Bratislava
Slovak Republic


Clexane


8 000  anti-Xa IU/0,8  ml


Solution for injection


Subcutaneous use;
Intravenous use;
Extracorporeal use


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




Slovak Republic


sanofi-aventis Slovakia s.r.o.
Einsteinova 24,
85101 Bratislava
Slovak Republic


Clexane


10 000  anti-Xa IU/1 ml


Solution for injection


Subcutaneous use;
Intravenous use;
Extracorporeal use


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




Slovak Republic


sanofi-aventis Slovakia s.r.o.
Einsteinova 24,
85101 Bratislava
Slovak Republic


Clexane


30 000  anti-Xa IU/3 ml


Solution for injection


Subcutaneous use;
Intravenous use;
Extracorporeal use


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




Slovak Republic


sanofi-aventis Slovakia s.r.o.
Einsteinova 24,
85101 Bratislava
Slovak Republic


Clexane forte


12 000  anti-Xa IU/0,8  ml


solution for injection


Subcutaneous use


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




Slovak Republic


sanofi-aventis Slovakia s.r.o.
Einsteinova 24,
85101 Bratislava
Slovak Republic


Clexane forte


15 000  anti-Xa IU/1,0  ml


solution for injection


Subcutaneous use


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




Slovenia


sanofi-aventis d.o.o.
Letališka 29 A
1000 Ljubljana
Slovenia


Clexane


2 000  anti-Xa IU/0,2  ml


Solution for injection


Subcutaneous use


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




Slovenia


sanofi-aventis d.o.o.
Letališka 29 A
1000 Ljubljana
Slovenia


Clexane


4 000  anti-Xa IU/0,4  ml


Solution for injection


Subcutaneous use


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




Slovenia


sanofi-aventis d.o.o.
Letališka 29 A
1000 Ljubljana
Slovenia


Clexane


6 000  anti-Xa IU/0,6  ml


Solution for injection


Subcutaneous use


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




Slovenia


sanofi-aventis d.o.o.
Letališka 29 A
1000 Ljubljana
Slovenia


Clexane


8 000  anti-Xa IU/0,8  ml


Solution for injection


Subcutaneous use


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




Slovenia


sanofi-aventis d.o.o.
Letališka 29 A
1000 Ljubljana
Slovenia


Clexane


10 000  anti-Xa IU/1 ml


Solution for injection


Subcutaneous use


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




Slovenia


sanofi-aventis d.o.o.
Letališka 29 A
1000 Ljubljana
Slovenia


Clexane


10 000  anti-Xa IU/ml


Solution for injection


Subcutaneous use;
Intravenous use


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




Slovenia


sanofi-aventis d.o.o.
Letališka 29 A
1000 Ljubljana
Slovenia


Clexane


12 000  anti-Xa IU/0,8  ml


Solution for injection


Subcutaneous use


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




Slovenia


sanofi-aventis d.o.o.
Letališka 29 A
1000 Ljubljana
Slovenia


Clexane


15 000  anti-Xa IU/1 ml


Solution for injection


Subcutaneous use


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




Spain


sanofi-aventis, S.A.
C/Josep Pla, 2
08019 Barcelona
Spain


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


20 mg (2 000  IU)


Solution for injection


Subcutaneous use;
Intravenous use;
Extracorporeal use


0,2  ml (100 mg/ml)




Spain


sanofi-aventis, S.A.
C/Josep Pla, 2
08019 Barcelona
Spain


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


40 mg (4 000  IU)


Solution for injection


Subcutaneous use;
Intravenous use;
Extracorporeal use


0,4  ml (100 mg/ml)




Spain


sanofi-aventis, S.A.
C/Josep Pla, 2
08019 Barcelona
Spain


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


60 mg (6 000  IU)


Solution for injection


Subcutaneous use;
Intravenous use;
Extracorporeal use


0,6  ml (100 mg/ml)




Spain


sanofi-aventis, S.A.
C/Josep Pla, 2
08019 Barcelona
Spain


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


80 mg (8 000  IU)


Solution for injection


Subcutaneous use;
Intravenous use;
Extracorporeal use


0,8  ml (100 mg/ml)




Spain


sanofi-aventis, S.A.
C/Josep Pla, 2
08019 Barcelona
Spain


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


100 mg (10 000  IU)


Solution for injection


Subcutaneous use;
Intravenous use;
Extracorporeal use


1 ml (100 mg/ml)




Spain


sanofi-aventis, S.A.
C/Josep Pla, 2
08019 Barcelona
Spain


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


120 mg (12 000  IU)


Solution for injection


Subcutaneous use;
Extracorporeal use


0,8  ml (150 mg/ml)




Spain


sanofi-aventis, S.A.
C/Josep Pla, 2
08019 Barcelona
Spain


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


150 mg (15 000  IU)


Solution for injection


Subcutaneous use;
Extracorporeal use


1 ml (150 mg/ml)




Sweden


Sanofi AB
Box 30052
104 25 Stockholm
Sweden


Klexane


100 mg/ml


Solution for injection


Subcutaneous use;
Intravenous use;
Extracorporeal use


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




Sweden


Sanofi AB
Box 30052
104 25 Stockholm
Sweden


Klexane (med konserveringsmedel)


100 mg/ml


Solution for injection


Subcutaneous use;
Intravenous use;
Extracorporeal use


3 ml; 10 ml
(100 mg/ml)




Sweden


Sanofi AB
Box 30052
104 25 Stockholm
Sweden


Klexane


150 mg/ml


Solution for injection


Subcutaneous use;
Intravenous use;
Extracorporeal use


0,6  ml; 0,8  ml;
1,0  ml
(150 mg/ml)




United Kingdom


Aventis Pharma Limited
One Onslow Street
Guildford
Surrey
GU1 4YS
United-Kingdom


Clexane Syringes


20 mg/0,2  ml


Solution for injection


Subcutaneous use;
Extracorporeal use


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




United Kingdom


Aventis Pharma Limited
One Onslow Street
Guildford
Surrey
GU1 4YS
United-Kingdom


Clexane Syringes


40 mg/0,4  ml


Solution for injection


Subcutaneous use;
Extracorporeal use


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




United Kingdom


Aventis Pharma Limited
One Onslow Street
Guildford
Surrey
GU1 4YS
United-Kingdom


Clexane Syringes


60 mg/0,6  ml


Solution for injection


Subcutaneous use;
Intravenous use;
Extracorporeal use


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




United Kingdom


Aventis Pharma Limited
One Onslow Street
Guildford
Surrey
GU1 4YS
United-Kingdom


Clexane Syringes


80 mg/0,8  ml


Solution for injection


Subcutaneous use;
Intravenous use;
Extracorporeal use


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




United Kingdom


Aventis Pharma Limited
One Onslow Street
Guildford
Surrey
GU1 4YS
United-Kingdom


Clexane Syringes


100 mg/1,0  ml


Solution for injection


Subcutaneous use;
Intravenous use;
Extracorporeal use


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




United Kingdom


Aventis Pharma Limited
One Onslow Street
Guildford
Surrey
GU1 4YS
United-Kingdom


Clexane Forte Syringes


120 mg/0,8  ml


Solution for injection


Subcutaneous use;
Extracorporeal use


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




United Kingdom


Aventis Pharma Limited
One Onslow Street
Guildford
Surrey
GU1 4YS
United-Kingdom


Clexane Forte Syringes


150 mg/1,0  ml


Solution for injection


Subcutaneous use;
Extracorporeal use


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




United Kingdom


Aventis Pharma Limited
One Onslow Street
Guildford
Surrey
GU1 4YS
United-Kingdom


Clexane Multidose vial


300 mg/3 ml


Solution for injection


Subcutaneous use;
Intravenous use;
Extracorporeal use


3 ml (100 mg/ml)







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







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