I lisa. Ravimi nimetuste nimekiri, ravimvorm, ravimpreparaadi tugevus, manustamisviis, müügiloa hoidjad liikmesriikides

Átírás

1 I lisa Ravimi nimette nimekiri, ravimvorm, ravimpreparaadi tugev, mantamisviis, müügiloa hoidjad liikmesriikides

2 Belgia Belgia Belgia Belgia Bulgaaria Baxter Healthcare GmbH Stella-Klein-Löw-Weg 15, A-1020 Wien Baxter Healthcare GmbH Stella-Klein-Löw-Weg 15, A-1020 Wien Baxter Healthcare GmbH Stella-Klein-Löw-Weg 15, A-1020 Wien Baxter Healthcare GmbH Stella-Klein-Löw-Weg 15, A-1020 Wien Baxter S.A. Boulevard R. Branquart Lessines Belgium Baxter S.A. Boulevard R. Branquart Lessines Belgium Baxter S.A. Boulevard R. Branquart Lessines Belgium Baxter S.A. Boulevard R. Branquart Lessines Belgium BAXTER d.o.o.,zelezna cesta 18, 1000 Ljubljana, Slovenia 1,36% w/v/13,6 mg/ml- Peritonealdialyselösung 2,27% w/v/22,7 mg/ml- Peritonealdialyselösung 3,86% w/v/38,6 mg/ml- Peritonealdialyselösung EXTRANEAL- Peritonealdialyselösung 1,36% (13,6 mg/ml), solution pour dialyse péritonéale 2.27% (22,7 mg/ml). solution pour dialyse péritonéale 3,86% (38,6 mg/ml), solution pour dialyse péritonéale Extraneal 7,5 % solution pour dialyse péritonéale 1.36% w/v/ 13.6mg/ml Veevaba glükoos 13.6 g/l, Naatriumkloriid 5.38 g/l, Naatrium(S)-laktaat 4.48 g/l, Kaltsiumkloriid 0,184 g/l, Magneesiumkloriid 0,051 g/l Veevaba glükoos 22.7 g/l, Naatriumkloriid 5.38 g/l, Naatrium(S)-laktaat 4.48 g/l, Kaltsiumkloriid 0,184 g/l, Magneesiumkloriid 0,051 g/l Veevaba glükoos 38.6 g/l, Naatriumkloriid 5.38 g/l, Naatrium(S)-laktaat 4.48 g/l, Kaltsiumkloriid 0,184 g/l, Magneesiumkloriid 0,051 g/l 75 g/l 13.6 g/l Veevaba glükoos 22.7 g/l Veevaba glükoos 38.6 g/l Veevaba glükoos g/l Ikodekstriin 1.36% w/v/ 13.6 mg/ml Bulgaaria BAXTER d.o.o.,zelezna cesta 18, 1000 Ljubljana, Slovenia 2.27% w/v/ 22.7 mg/ml 2

3 Bulgaaria BAXTER d.o.o.,zelezna cesta 18, 1000 Ljubljana, Slovenia 3.86% w/v/ 38.6mg/ml Bulgaaria BAXTER d.o.o.,zelezna cesta 18, 1000 Ljubljana, Slovenia Extraneal 7.50% Tšehhi Vabariik Tšehhi Vabariik Tšehhi Vabariik Tšehhi Vabariik Taani Taani Taani Taani Eesti County Mayo lreland County Mayo lreland County Mayo lreland County Mayo lreland Baxter A/S Gydevang Allerød Denmark Baxter A/S Gydevang Allerød Denmark Baxter A/S Gydevang Allerød Denmark Baxter A/S Gydevang Allerød Denmark Baxter Oy P.O. Box 270 Valimotie 15A Helsinski Finland 1,36% w/v/13,6 mg/ml 2,27% w/v/22,7 mg/ml 3,86% w/v/38,6 mg/ml EXTRANEAL Dianeal PD4 med Glucos Dianeal PD4 med Glucos Dianeal PD4 med Glucos Extraneal 1,36% w/v/13,6 mg/ml 2,27% w/v/22,7 mg/ml 3,86% w/v/38,6 mg/ml 7,5 % 75 g/1000 ml 13,6 mg/ml 22,7 mg/ml 38,6 mg/ml 75 mg/ml EXTRANEAL 7.50% 3

4 Soome Soome Soome Soome Prantsmaa Prantsmaa Prantsmaa Prantsmaa CO. Mayo lreland CO. Mayo lreland CO. Mayo lreland Baxter Oy P.O. Box 270 Valimotie 15A Helsinski Finland Baxter S.A.S Avenue louis Pasteur ZA de Coigneres Maurepas France Baxter S.A.S Avenue louis Pasteur ZA de Coigneres Maurepas France Baxter S.A.S Avenue louis Pasteur ZA de Coigneres Maurepas France Baxter S.A.S Avenue louis Pasteur ZA de Coigneres Maurepas France Extraneal 7,5% DIANEAL PD4 GLUCOSE 1,36 %, solution pour dialyse péritonéale en poche DIANEAL PD4 GLUCOSE 2.27 %, solution pour dialyse péritonéale en poche DIANEAL PD4 GLUCOSE 3.86 %, solution pour dialyse péritonéale en poche EXTRANEAL, solution pour dialyse péritonéale 1.36% w/v 13,6 mg/ml 22,7 mg/ml 38,6 mg/ml 1.36% 2.27% 3.86% 7.50% 13.6 g/l 5.4 g/l 4.5 g/l g/l 4

5 Kreeka Kreeka Diophar SA Kifissias 368 Halandri Greece Diophar SA Kifissias 368 Halandri Greece 2.27% w/v 3.86% w/v Dianeal PDG4 1.36% Dianeal PDG4 2.27% Dianeal PDG4 3.86% Extraneal 22.7 g/l 5.4 g/l 4.5 g/l g/l 38.6 g/l 5.4 g/l 4.5 g/l g/l 13.6 g/l 5.38 g/l 4.48 g/l g/l 22.7 g/l 5.38 g/l 4.48 g/l g/l 38.6 g/l 5.38 g/l 4.48 g/l g/l 75 g/l 5.4 g/l 4.5 g/l g/l DIANEAL PD4 1.36% Extraneal (7,5+0,54+0,45+0,0257+0,0051)% w/v 5

6 Ungari Ungari Ungari Ungari Island Island Island Iirimaa Baxter Hungary Kft. Népfürdö u , Budapest Hungary Baxter Hungary Kft. Népfürdö u , Budapest Hungary Baxter Hungary Kft. Népfürdö u , Budapest Hungary Baxter Hungary Kft. Népfürdö u , Budapest Hungary Baxter Healthcare SA Baxter Healthcare SA Baxter Healthcare SA Thetford, Norfolk, IP24 3SE DIANEAL PD 4 Glucose 1,36% peritoneális dializáló oldat DIANEAL PD 4 Glucose 2,27% peritoneális dializáló oldat DIANEAL PD 4 Glucose 3,86% peritoneális dializáló oldat EXTRANEAL peritoneális dializáló oldat 1,36% w/v (13,6 mg/ml) Solution for 1,36% 2,27% 3,86% 7,5% (Ikodekstriin) 13,6 mg/ml 22,7 mg/ml 38,6 mg/ml 1.36% w/v (13.6 mg/ml) Iirimaa Iirimaa Thetford, Norfolk, IP24 3SE Thetford, Norfolk, IP24 3SE 2.27% w/v (22,7 mg/ml) Solution for 3,86% w/v (38,6 mg/ml) Solution for 2.27% w/v (22.7 mg/ml) 3.86% w/v (38.6 mg/ml) 6

7 Iirimaa Itaalia Itaalia Läti Läti Läti Läti Leedu Leedu Leedu Thetford, Norfolk, IP24 3SE Baxter S.p.A. Piazzale dell Indtria Roma Italy Baxter S.p.A. Piazzale dell Indtria Roma Italy Baxter Oy P.O. Box 270 Valimotie 15A Helsinski Finland EXTRANEAL Solution for EXTRANEAL 7,5% SOLUZIONI PER DIALISI PERITONEALE BAXTER 2.27% w/v/22,7 mg/ml- solution for 3,86% w/v/38,6 mg/ml- solution for 1,36% w/v/13,6 mg/ml- solution for Extraneal solution for 4,95 g/l 49,54 g/l 2,27 % w/v 0,538% w/v 0,448% w/v 0,0184% w/v 0,0051% w/v 3,86% w/v 0,538% w/v 0,448% w/v 0,0184% w/v 0,0051% w/v 1,36% w/v 0,538% w/v 0,448% w/v 0,0184% w/v 0,0051% w/v 75g/L 5,4g/L 4,5g/L 0,257g/L 0,051g/L 13,6g+5,38g+4,48g+0,184g+0,051 g/l 22,7g+5,38g+4,48g+0,184g+0,051 g/l 38,6g+5,38g+4,48g+0,184g+0,051 g/l 7

8 Leedu Luksemburg Luksemburg Malta Malta Malta Malta Norra Baxter Oy P.O. Box 270 Valimotie 15A Helsinski Finland Baxter S.A. Bd René Branquart 80 B-7860 Lessines Belgium Baxter S.A. Bd René Branquart 80 B-7860 Lessines Belgium Baxter Healthcare Ltd Thetford, Norfolk, IP24 3SE Baxter Healthcare Ltd Thetford, Norfolk, IP24 3SE Baxter Healthcare Ltd Thetford, Norfolk, IP24 3SE Baxter Healthcare Ltd Thetford, Norfolk, IP24 3SE Baxter AS Gjerdrumsvei Oslo, Norway EXTRANEAL Extraneal 1.36%w/v 13.6mg/ml 2.27%w/v 22.7mg/ml 3.86%w/v 38.6mg/ml Extraneal (Icodextrin 7.5%) Extraneal 75g+5,4g+4,5g+0,257g+0,051g/10 00ml 1,36%/2,27%/3,86% Veevaba glükoos g/l Ikodekstriin 1.36%w/v 13.6mg/ml 2.27%w/v 22.7mg/ml 3.86%w/v 38.6mg/ml N/A 75 mg/ml 8

9 Poola Poola Poola Poola Baxter Polska SP. z.o.o. Kruczkowskiego 8 st., Warszawa, Poland Baxter Polska SP. z.o.o. Kruczkowskiego 8 st., Warszawa, Poland Baxter Polska SP. z.o.o. Kruczkowskiego 8 st., Warszawa, Poland Baxter Polska SP. z.o.o. Kruczkowskiego 8 st., Warszawa, Poland Baxter Médico Farmacêutica Lda Zona Indtrial da Abrunheira, Edificio 10 Sintra Biness Park, Sintra Baxter Médico Farmacêutica Lda Zona Indtrial da Abrunheira, Edificio 10 Sintra Biness Park, Sintra Baxter Médico Farmacêutica Lda Zona Indtrial da Abrunheira, Edificio 10 Sintra Biness Park, Sintra Dianeal PD4 (glukoza 1,36%). Zestaw do dializy otrzewnowej Dianeal PD4 (glukoza 2,27%). Zestaw do dializy otrzewnowej Dianeal PD4 (glukoza 3,86%). Zestaw do dializy otrzewnowej Extraneal Zestaw do dializy otrzewnowej Dianeal Pd4 Dianeal Pd4 Dianeal Pd4 Association Association Association 9

10 Rumeenia Rumeenia Rumeenia Rumeenia Slovaki Vabariigi Slovaki Vabariigi Slovaki Vabariigi Slovaki Vabariigi Sloveenia Baxter Médico Farmacêutica Lda Zona Indtrial da Abrunheira, Edificio 10 Sintra Biness Park, Sintra Extraneal 75 mg/ml Baxter Healthcare SA, Moneen DIANEAL PD4 GLUCOSE 13,6 mg/ml Road, Castlebar, Co. Mayo, 1,36% m/v (13,6 Ireland mg/ml) Baxter Healthcare SA, Moneen DIANEAL PD4 GLUCOSE 22,7 mg/ml Road, Castlebar, Co. Mayo, 2,27% m/v (22,7 Ireland mg/ml) Baxter Healthcare SA, Moneen DIANEAL PD4 GLUCOSE 38,6 mg/ml Road, Castlebar, Co. Mayo, 3,86% m/v (38,6 Ireland mg/ml) Baxter Healthcare Ltd EXTRANEAL 75 mg/ml, Thetford, Norfolk, IP24 3SE, Baxter Healthcare SA, Moneen Dianeal PD4 glucose 13,6 mg/1 ml Rd, Castlebar, Co. Mayo, 1,36% w/v /13,6 Ireland mg/ml Baxter Healthcare SA, Moneen Dianeal PD4 glucose 22,7 mg/1 ml Rd, Castlebar, Co. Mayo, 2,27% w/v /22,7 Ireland mg/ml Baxter Healthcare SA, Moneen Dianeal PD4 glucose 38,6 mg/1 ml Rd, Castlebar, Co. Mayo, 3,86% w/v /38,6 Ireland mg/ml Baxter Healthcare Ltd EXTRANEAL 7.5%, Thetford, Norfolk, IP24 3SE Baxter d.o.o., Zelezna cesta 18, Ljubljana, SI -1000, Slovenia Dianeal PD4 13,6 mg/ml glukoze raztopina za peritonelano dializo 13,6 mg/ml 10

11 Sloveenia Sloveenia Sloveenia Baxter d.o.o., Zelezna cesta 18, Ljubljana, SI -1000, Slovenia Baxter d.o.o., Zelezna cesta 18, Ljubljana, SI -1000, Slovenia Baxter d.o.o., Zelezna cesta 18,Ljubljana, SI-1000, Slovenia Dianeal PD4 22,7 mg/ml glukoze raztopina za peritonelano dializo Dianeal PD4 38,6 mg/ml glukoze raztopina za peritonelano dializo Extraneal 75 mg/ml ikodekstrina raztopina za peritonealno dializo Dianeal PD4 Glucosa 1,36% Dianeal PD4 Glucosa 1,36% con sistema de desconexión integrado Dianeal PD4 Glucosa 2,27% Dianeal PD4 Glucosa 2,27% con sistema de desconexión integrado Dianeal PD4 Glucosa 3,86% Dianeal PD4 Glucosa 3,86% con sistema de desconexión integrado 22,7 mg/ml 38,6 mg/ml 75 mg/ml 11

12 Rootsi Rootsi Rootsi Rootsi Holland Holland Holland Holland Baxter Healthare SA Moneen Road Castlebar County Mayo Irland Baxter Healthare SA Moneen Road Castlebar County Mayo Irland Baxter Healthare SA Moneen Road Castlebar County Mayo Irland Baxter AB Box Kista Sverige Baxter B.V Kobaltweg CE Utrecht The Netherlands Baxter B.V Kobaltweg CE Utrecht The Netherlands Baxter B.V Kobaltweg CE Utrecht The Netherlands Baxter B.V Kobaltweg CE Utrecht The Netherlands EXTRANEAL Solución para diálisis peritoneal Dianeal PD4 med glucos 13,6 mg/ml Dianeal PD4 med glucos 22,7 mg/ml Dianeal PD4 med glucos 38,6 mg/ml Extraneal 7.5% 1.36%/13,6 mg/ml, peritoneaaldialysevloeis t of 2.27%/22,7 mg/ml, peritoneaaldialysevloeis t of 3.86%/38,6 mg/ml, peritoneaaldialysevloeis t of EXTRANEAL 7,5 %, oplossing voor peritoneale dialyse 13,6 mg/ml 22,7 mg/ml 38,6 mg/ml 13.6 g/l Veevaba glükoos 22.7 g/l Veevaba glükoos 38.6 g/l Veevaba glükoos 75 g/l Ikodekstriin 12

13 Ühendkuningri ik Ühendkuningri ik Ühendkuningri ik Ühendkuningri ik, Thetford IP24 3SE, Thetford IP24 3SE, Thetford IP24 3SE, Thetford IP24 3SE 1.36% w/v /13.6mg/ml 2.27% w/v /22.7mg/ml 3.86% w/v /38.6mg/ml Extraneal (lcodextrin 7.5%) Solution for 1.36% w/v /13.6mg/ml 2.27% w/v /22.7mg/ml 3.86% w/v /38.6mg/ml 13