Medlemsstat Indehaver af markedsføringstilladelse. Baxter Healthcare GmbH. Dianeal PD4 Glucose 1,36% w/v/13,6 mg/ml- Peritonealdialyselösung

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1 Bilag I Fortegnelse over lægemidlernes navne, lægemiddelform(er), styrke(r), indgivelsesvej(e), ansøger(e), indehaver(e) af markedsføringstilladelse(r) i medlemsstaterne 1

2 Medlemsstat Indehaver af markedsføringstilladelse Østrig Baxter Healthcare GmbH Stella-Klein-Löw-Weg 15, A-1020 Wien Østerrike Østrig Østrig Østrig Belgien Belgien Belgien Belgien Bulgarien Baxter Healthcare GmbH Stella-Klein-Löw-Weg 15, A-1020 Wien Østerrike Baxter Healthcare GmbH Stella-Klein-Löw-Weg 15, A-1020 Wien Østerrike Baxter Healthcare GmbH Stella-Klein-Löw-Weg 15, A-1020 Wien Østerrike Baxter S.A. Boulevard R. Branquart Lessines Belgia Baxter S.A. Boulevard R. Branquart Lessines Belgia Baxter S.A. Boulevard R. Branquart Lessines Belgia Baxter S.A. Boulevard R. Branquart Lessines Belgia BAXTER d.o.o.,zelezna cesta 18, 1000 Ljubljana, Særnavn 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% (), solution pour dialyse péritonéale 2.27% (). solution pour dialyse péritonéale 3,86% (), solution pour dialyse péritonéale Extraneal 7,5 % solution pour dialyse péritonéale 1.36% w/v/ 13.6mg/ml Styrke Glukose anhydrat 13.6 g/l, natriumchlorid 5.38 g/l, natrium -L (+) lactat 4.48 g/l, calciumchlorid dihydrat 0,184 g/l, magnesiumchlorid hexahydrat 0,051 g/l Glukose anhydrat 22.7 g/l, natriumklorid 5.38 g/l, natrium -L (+) lactat 4.48 g/l, calciumchlorid dihydrat 0,184 g/l, magnesiumchlorid hexahydrat 0,051 g/l Glukose anhydrat 38.6 g/l, natriumklorid 5.38 g/l, natrium -L (+) lactat 4.48 g/l, calciumchlorid dihydrat 0,184 g/l, magnesiumchlorid hexahydrat 0,051 g/l 75 g/l 13.6 g/l Glukose anhydrat 22.7 g/l Glukose anhydrat 38.6 g/l Glukose anhydrat g/l Icodextrin 1.36% w/v/ 13.6 mg/ml Lægemiddelform Indgivelsesvej 2

3 Bulgarien Bulgarien Bulgarien Tsjekkiet Tsjekkiet Tsjekkiet Tsjekkiet Estland BAXTER d.o.o.,zelezna cesta 18, 1000 Ljubljana, BAXTER d.o.o.,zelezna cesta 18, 1000 Ljubljana, BAXTER d.o.o.,zelezna cesta 18, 1000 Ljubljana, County Mayo lreland County Mayo lreland County Mayo lreland County Mayo lreland Baxter A/S Gydevang Allerød Baxter A/S Gydevang Allerød Baxter A/S Gydevang Allerød Baxter A/S Gydevang Allerød Baxter Oy P.O. Box 270 Valimotie 15A Helsinski CO. Mayo lreland Extraneal 7.50% 1,36% w/v/ 2,27% w/v/ 3,86% w/v/ EXTRANEAL Dianeal PD4 med Glucos Dianeal PD4 med Glucos Dianeal PD4 med Glucos Extraneal 2.27% w/v/ 22.7 mg/ml 38.6% w/v/ 38.6mg/ml 1,36% w/v/ 2,27% w/v/ 3,86% w/v/ 7,5 % 75 g / 1000 ml 75 mg/ml EXTRANEAL 7.50% 3

4 CO. Mayo lreland CO. Mayo lreland Baxter Oy P.O. Box 270 Valimotie 15A Helsinski Baxter S.A.S Avenue louis Pasteur ZA de Coigneres Maurepas Baxter S.A.S Avenue louis Pasteur ZA de Coigneres Maurepas Baxter S.A.S Avenue louis Pasteur ZA de Coigneres Maurepas Baxter S.A.S Avenue louis Pasteur ZA de Coigneres Maurepas 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 2.27% w/v 3.86% w/v 1.36% 2.27% 3.86% 7.50% 13.6 g/l 5.4 g/l 4.5 g/l g/l 22.7 g/l 5.4 g/l 4.5 g/l g/l 38.6 g/l 5.4 g/l 4

5 Grækenland Grækenland Diophar SA Kifissias 368 Halandri Grækenland Diophar SA Kifissias 368 Halandri Grækenland Baxter Kft. Népfürdö u , Budapest Baxter Kft. Népfürdö u , Budapest Baxter Kft. Népfürdö u , Budapest 4.5 g/l g/l Dianeal PDG4 1.36% 13.6 g/l 5.38 g/l 4.48 g/l g/l Dianeal PDG4 2.27% 22.7 g/l 5.38 g/l 4.48 g/l g/l Dianeal PDG4 3.86% 38.6 g/l 5.38 g/l 4.48 g/l g/l Extraneal 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 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 1,36% 2,27% 3,86% 5

6 Island Island Island Baxter Kft. Népfürdö u , Budapest Baxter Healthcare SA County Mayo Baxter Healthcare SA County Mayo Baxter Healthcare SA County Mayo Baxter Healthcare Limited Thetford, Norfolk, IP24 3SE EXTRANEAL peritoneális dializáló oldat 1,36% w/v (13,6 mg/ml) Solution for 7,5% (Icodextrin) 1.36% w/v (13.6 mg/ml) Italien Italien Letland Baxter Healthcare Limited Thetford, Norfolk, IP24 3SE Baxter Healthcare Limited Thetford, Norfolk, IP24 3SE Baxter Healthcare Limited Thetford, Norfolk, IP24 3SE Baxter S.p.A. Piazzale dell Industria Roma Italien Baxter S.p.A. Piazzale dell Industria Roma Italien County Mayo 2.27% w/v (22,7 mg/ml) Solution for 3,86% w/v (38,6 mg/ml) Solution for EXTRANEAL Solution for EXTRANEAL 7,5% SOLUZIONI PER DIALISI PERITONEALE BAXTER 2.27% w/v/22,7 mg/ml- solution for 2.27% w/v (22.7 mg/ml) 3.86% w/v (38.6 mg/ml) 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 6

7 Letland Letland Letland Litauen Litauen Litauen Litauen Luxembourg Luxembourg Malta Malta County Mayo County Mayo Baxter Oy P.O. Box 270 Valimotie 15A Helsinski County Mayo County Mayo County Mayo Baxter Oy P.O. Box 270 Valimotie 15A Helsinski Baxter S.A. Bd René Branquart 80 B-7860 Lessines Belgia Baxter S.A. Bd René Branquart 80 B-7860 Lessines Belgia Baxter Healthcare Ltd Thetford, Norfolk, IP24 3SE Baxter Healthcare Ltd 3,86% w/v/38,6 mg/ml- solution for 1,36% w/v/13,6 mg/ml- solution for Extraneal solution for EXTRANEAL Extraneal 1.36%w/v 13.6mg/ml 2.27%w/v 22.7mg/ml 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 75g+5,4g+4,5g+0,257g+0,051g/10 00ml 1,36%/2,27%/3,86% glukose anhydrat g/l Icodextrin 1.36%w/v 13.6mg/ml 2.27%w/v 22.7mg/ml 7

8 Malta Malta Norge Polen Polen Polen Polen Thetford, Norfolk, IP24 3SE Baxter Healthcare Ltd Thetford, Norfolk, IP24 3SE Baxter Healthcare Ltd Thetford, Norfolk, IP24 3SE Baxter AS Gjerdrumsvei Oslo, Norge Baxter Polska SP. z.o.o. Kruczkowskiego 8 st., Warszawa, Polen Baxter Polska SP. z.o.o. Kruczkowskiego 8 st., Warszawa, Polen Baxter Polska SP. z.o.o. Kruczkowskiego 8 st., Warszawa, Polen Baxter Polska SP. z.o.o. Kruczkowskiego 8 st., Warszawa, Polen Baxter Médico Farmacêutica Lda Zona Industrial da Abrunheira, Edificio 10 Sintra Business Park, Sintra Baxter Médico Farmacêutica Lda Zona Industrial da Abrunheira, 3.86%w/v 38.6mg/ml Extraneal (Icodextrin 7.5%) Extraneal 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 3.86%w/v 38.6mg/ml N/A 75 mg/ml Association Association 8

9 Rumænien Rumænien Rumænien Rumænien Slovakiet Slovakiet Slovakiet Edificio 10 Sintra Business Park, Sintra Baxter Médico Farmacêutica Dianeal Pd4 Lda Zona Industrial da Abrunheira, Edificio 10 Sintra Business Park, Sintra Baxter Médico Farmacêutica Extraneal Lda Zona Industrial da Abrunheira, Edificio 10 Sintra Business Park, Sintra Baxter Healthcare Ltd EXTRANEAL, Thetford, Norfolk, IP24 3SE, Baxter Healthcare SA, Moneen DIANEAL PD4 GLUCOSE Road, Castlebar, Co. Mayo, 1,36% m/v (13,6 mg/ml) Baxter Healthcare SA, Moneen DIANEAL PD4 GLUCOSE Road, Castlebar, Co. Mayo, 2,27% m/v (22,7 mg/ml) Baxter Healthcare SA, Moneen DIANEAL PD4 GLUCOSE Road, Castlebar, Co. Mayo, 3,86% m/v (38,6 mg/ml) Baxter Healthcare SA, Moneen Dianeal PD4 glucose Rd, Castlebar, Co. Mayo, 1,36% w/v /13,6 mg/ml Baxter Healthcare SA, Moneen Dianeal PD4 glucose Rd, Castlebar, Co. Mayo, 2,27% w/v /22,7 mg/ml Baxter Healthcare SA, Moneen Rd, Castlebar, Co. Mayo, Dianeal PD4 glucose 3,86% w/v /38,6 mg/ml Association 75 mg/ml 13,6 mg/1 ml 22,7 mg/1 ml 38,6 mg/1 ml 9

10 Slovakiet Baxter Healthcare Ltd, Thetford, Norfolk, IP24 3SE Baxter d.o.o., Zelezna cesta 18, Ljubljana, SI -1000, Baxter d.o.o., Zelezna cesta 18, Ljubljana, SI -1000, Baxter d.o.o., Zelezna cesta 18, Ljubljana, SI -1000, Baxter d.o.o., Zelezna cesta 18,Ljubljana, SI-1000, Baxter S.L Baxter S.L Baxter S.L Baxter S.L Baxter S.L EXTRANEAL Dianeal PD4 13,6 mg/ml glukoze raztopina za peritonelano dializo 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% 75 mg/ml 10

11 Baxter S.L Baxter S.L Sverige Baxter Healthare SA Moneen Road Castlebar County Mayo Sverige Baxter Healthare SA Moneen Road Castlebar County Mayo Sverige Baxter Healthare SA Moneen Road Castlebar County Mayo Sverige Baxter AB Box Kista Sverige Nederlandene Baxter B.V Kobaltweg CE Utrecht Nederlandene Nederlandene Baxter B.V Kobaltweg CE Utrecht Nederlandene Nederlandene Baxter B.V Kobaltweg CE Utrecht Nederlandene Nederlandene Baxter B.V Kobaltweg 49 Dianeal PD4 Glucosa 3,86% con sistema de desconexión integrado EXTRANEAL Solución para diálisis peritoneal Dianeal PD4 med glucos Dianeal PD4 med glucos Dianeal PD4 med glucos Extraneal 7.5% 1.36%/, peritoneaaldialysevloeis t of 2.27%/, peritoneaaldialysevloeis t of 3.86%/, peritoneaaldialysevloeis t of EXTRANEAL 7,5 %, oplossing voor 13.6 g/l glukose anhydrat 22.7 g/l glukose anhydrat 38.6 g/l glukose anhydrat 75 g/l Icodextrin 11

12 3542 CE Utrecht The Nederlandene Baxter Healthcare Limited, Thetford IP24 3SE Baxter Healthcare Limited, Thetford IP24 3SE Baxter Healthcare Limited, Thetford IP24 3SE Baxter Healthcare Limited, Thetford IP24 3SE peritoneale dialyse 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 12