Tadim 1 Million I.E. Pulver zur Herstellung einer Infusionslösung. Tadim 1 Million I.E. Pulver zur Herstellung einer Lösung für einen Vernebler
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1 Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration and marketing authorisation s in the member states 1
2 Austria Forest Pharma B.V. Newtonlaan BH Utrecht The Netherlands Colistin Forest - Trockenstechampullen mit Lösungsmittel I.U. powder and solvent for suspension for injection, nebuliser intramuscular use,, Austria Tadim 1 Million I.E. Pulver zur Herstellung einer Infusionslösung I.U. powder for for infusion Austria Xellia Pharmaceuticals ApS Dalslandsgade 11 DK-2300 Copenhagen S Denmark Colistin Xellia 1 Million I.E. Pulver zur Herstellung einer Injektions-/Infusionslösung I.U. powder for for Austria Tadim 1 Million I.E. Pulver zur Herstellung einer Lösung für einen Vernebler I.U. powder for nebuliser Austria PARI Pharma GmbH Moosstrasse Starnberg ColiFin 1 Mio. I.E. Pulver zur Herstellung einer Lösung für einen Vernebler I.U. powder for nebuliser 2
3 Austria PARI Pharma GmbH Moosstrasse Starnberg ColiFin 2 Mio. I.E. Pulver zur Herstellung einer Lösung für einen Vernebler I.U. powder for nebuliser Belgium Forest Laboratories UK Ltd. Dartford Kent DA2 6SL Colistineb IE I.U. powder for for, Belgium Forest Laboratories UK Ltd. Dartford Kent DA2 6SL Colistineb IE I.U. powder for for, Bulgaria Alvogen IPCo.S.ar. I. 5 Rue Heienhaff Senningerberg L-1736 Luxembourg Colistin Alvogen I.U. powder for for 3
4 Bulgaria Alvogen IPCo.S.ar. I. 5 Rue Heienhaff Senningerberg L-1736 Luxembourg Colistin Alvogen I.U. powder for for Croatia Altamedics d.o.o. Karlovačka cesta 24a, Zagreb Croatia Colixin 1 milijun IU prašak za otopinu za injekciju I.U. powder for for injection Czech Republic Dartford Kent DA2 6SL Colomycin injekce IU I.U. powder for for or nebuliser, Denmark Promixin I.U. nebuliser 4
5 Denmark Promixin I.U. powder for for infusion Denmark Xellia Pharmaceuticals ApS Dalslandsgade 11 DK-2300 Copenhagen S Denmark Colistimethatnatrium "Xellia" I.U. powder for for France Sanofi-Aventis France 1-13 boulevard R. Rolland Paris France COLIMYCINE 1 MUI, poudre et solvant pour par nébuliseur I.U. powder and solvent for nebuliser France Sanofi-Aventis France 1-13 boulevard R. Rolland Paris France COLIMYCINE U.I., poudre et solvant pour injectable I.U. powder and solvent for for injection 5
6 France TADIM 1 million d'unités internationales (UI) poudre pour pour par nébuliseur I.U. powder for nebuliser Forest Laboratories Nederland B.V. Newtonlaan BH Utrecht The Netherlands Colistin CF I.U. powder and solvent for nebuliser InfectoPharm Arzneimittel und Consilium GmbH Von-Humboldt-Straße Heppenheim Colistimethat-Natrium Infectopharm I.E. Pulver zur Herstellung einer Injektionsoder Infusionslösung I.U. powder for for InfectoPharm Arzneimittel und Consilium GmbH Von-Humboldt-Straße Heppenheim Colistimethat-Natrium Infectopharm I.E. Pulver zur Herstellung einer Injektionsoder Infusionslösung I.U. powder for for 6
7 Bicentennial Building Southern Gate Chichester PO19 8EZ Promixin 1 MI.E. Pulver zur Herstellung einer Lösung für einen Vernebler I.U. powder for nebuliser Bicentennial Building Southern Gate Chichester PO19 8EZ Promixin 1 MI.E. Pulver zur Herstellung einer Lösung für einer Infusionslösung I.U. powder for for infusion NORMA HELLAS AE 54 Menandrou str Athens COLISTIN/NORMA I.U. powder for for injection intramuscular use NORMA HELLAS AE 54 Menandrou str Athens COLISTIN/NORMA I.U. powder and solvent for nebuliser NORMA HELLAS AE 54 Menandrou str Athens COLISTIN/NORMA I.U. powder for for infusion 7
8 NORMA HELLAS AE 54 Menandrou str Athens COLISTIN/NORMA I.U. powder for for infusion ALLERTEC HELLAS AE 74 Karamanli str , Kalamaria, Thessaloniki TADIM I.U. powder and solvent for nebuliser Hungary Dartford, Kent DA2 6SL COLOMYCIN I.U. powder for for, powder for nebuliser, Hungary Dartford, Kent DA2 6SL COLOMYCIN I.U. powder for for, powder for nebuliser, 8
9 Iceland Alvogen IPCo S.à.r.l., 5 Rue Heienhaff, L-1736 Senningerberg Luxembourg Colistimethate Alvogen I.U. powder for for injection or infusion Iceland Alvogen IPCo S.à.r.l., 5 Rue Heienhaff, L-1736 Senningerberg Luxembourg Colistimethate Alvogen I.U. powder for for injection or infusion Ireland Dartford, Kent DA2 6SL Colomycin Injection 1 million International Units. Powder for for injection, infusion or I.U. powder for for injection, infusion or, Ireland Dartford, Kent DA2 6SL Colomycin Injection 2 million International Units. Powder for for injection, infusion or I.U. powder for for injection, infusion or, 9
10 Ireland Promixin, 1 million International Units (IU), Powder for Nebuliser Solution I.U. powder for nebuliser Italy UCB Pharma S.p.A.Via Gadames Milano (MI) Italy COLIMICINA I.U. powder and solvent for for injection intramuscular use Italy PARI Pharma GmbH Moosstrasse Starnberg COLFINAIR I.U. powder for nebuliser Italy PARI Pharma GmbH Moosstrasse Starnberg COLFINAIR I.U. powder for nebuliser Inhalation use 10
11 Italy PROMIXIN I.U. powder for nebuliser Inhalation use Luxembourg Tadim I.U. powder for nebuliser Malta Dartford, Kent DA2 6SL Colomycin Injection 1million International Units powder for for injection, infusion or I.U. powder for for /, Norway Xellia Pharmaceuticals ApS Dalslandsgade 11 DK-2300 Copenhagen S Denmark Colistimethate Xellia I.U. powder for for infusion 11
12 Norway Promixin I.U. powder for nebuliser nasal use Norway Promixin I.U. powder for for infusion Poland Tarchomińskie Zakłady Farmaceutyczne "Polfa" S.A. 2, A. Fleminga Str Warsaw Poland Colistin TZF I.U. powder for for injection, injection or intramuscular use,, Poland Promixin I.U. powder for nebuliser 12
13 Portugal Generis Farmacêutica, S.A. Rua João de Deus Amadora Portugal Colistina Generis I.U. powder for for injection or for nebuliser, Portugal Pharmis Biofarmacêutica, Lda. Praceta do Farol, lote 101 Cascais Portugal Colixin I.U. powder for for injection or for nebuliser, Portugal Pharmis Biofarmacêutica, Lda. Praceta do Farol, lote 101 Cascais Portugal Colixin I.U. powder for for injection or for nebuliser, Portugal Promixin I.U. powder for nebuliser Romania S.C. ANTIBIOTICE S.A., Str. Valea Lupului nr Iaşi România COLISTINĂ ANTIBIOTICE UI, I.U. powder for for 13
14 Romania Xellia Pharmaceuticals ApS Dalslandsgade 11 DK-2300 Copenhagen S Denmark Colistimetat sodic Xellia 1 milion unităţi internaţionale (U.I.) I.U. powder for for Slovak Republic sanofi-aventis Slovakia s.r.o. Einsteinova Bratislava Slovak Republic Colimycine I.U. powder for for injection, intramuscular use Slovak Republic Dartford, Kent DA2 6SL KOLOMYCÍN INJEKCIA 1 milión IU I.U. powder for for /, Slovak Republic Dartford, Kent DA2 6SL KOLOMYCÍN INJEKCIA 2 milión IU I.U. powder for for /, 14
15 Spain GES GENÉRICOS ESPAÑOLES LABORATORIO, S.A. Cólquide, 6 - Portal 2, 1º-Oficina F Las Rozas (Madrid) Spain Colistimetato de sodio GES 1 MUI polvo para solución inyectable/para inhalación por nebulizador I.U. powder for for injection, powder for nebuliser, Spain Promixin 1 millón de Unidades Internacionales (UI) polvo para solución para inhalación por nebulizador I.U. powder for nebuliser Spain Pharmis Biofarmacêutica, Lda. Praceta do Farol, lote 101 Cascais Portugal Colixin 1 MUI polvo para solución inyectable o para solución para inhalación por nebulizador I.U. powder for for injection, powder for nebuliser, Sweden Bicentennial Building Southern Gate Chichester PO19 8EZ Tadim I.U. powder for nebuliser 15
16 Sweden Bicentennial Building Southern Gate Chichester PO19 8EZ Tadim I.U. powder for for infusion Sweden Xellia Pharmaceuticals ApS Dalslandsgade 11 DK-2300 Copenhagen S Denmark Colistin Xellia I.U. powder for for The Netherlands Forest Pharma B.V. Newtonlaan BH Utrecht The Netherlands Colistin, poeder voor verneveloplossing met oplosmiddel IE I.U. powder for nebuliser United Kingdom Dartford, Kent DA2 6SL Colomycin Injection 2 million international units powder for soln for inj, infusion or I.U. powder for for injection 16
17 United Kingdom Dartford, Kent DA2 6SL Colomycin Injection 1 million international units powder for soln for inj, infusion or I.U. powder for for injection, infusion or intramuscular use,, United Kingdom Xellia Pharmaceuticals ApS Dalslandsgade 11 DK-2300 Copenhagen S Denmark Colistimethate sodium 1 million international units powder for for injection or infusion I.U. powder for for United Kingdom Beacon Pharmaceuticals Limited, Tunbridge Wells, Kent TN1 1YG Colistimethate sodium 1 million I.U. powder for for injection I.U. powder for for injection, United Kingdom Promixin 1 million international units (IU) powder for nebuliser I.U. powder for nebuliser 17
18 United Kingdom Promixin 1 million international units (IU) powder for for infusion I.U. powder for for injection intramuscular use, United Kingdom PARI Pharma GmbH Moosstrasse Starnberg Colifin 1 MIU powder for nebuliser s I.U. powder for nebuliser United Kingdom PARI Pharma GmbH Moosstrasse Starnberg Colifin 2 MIU powder for nebuliser s I.U. powder for nebuliser 18
Tadim 1 Million I.E. Pulver zur Herstellung einer Infusionslösung. Tadim 1 Million I.E. Pulver zur Herstellung einer Lösung für einen Vernebler
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