Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2011 to 31 December 2011 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)
Date: 2012-02-24
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2012056EN.01002601.xml










24.2.2012   


EN


Official Journal of the European Union


C 56/26





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2011 to 31 December 2011

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC
 (1)
or Article 38 of Directive 2001/82/EC
 (2)
)

2012/C 56/02
—   Issuing, maintenance or modification of a national marketing authorization










Date of the decision


Name(s) of the medicinal product


Holder(s) of the marketing authorization


Member State concerned


Date of notification




16.12.2011


Dianeal, Extraneal, Nutrineal, Monosol and sodium chloride 0,9% solution for haemodialysis
(Baxter)


See Annex I


See Annex I


19.12.2011







—   Suspension of a national marketing authorization










Date of the decision


Name(s) of the medicinal product


Holder(s) of the marketing authorization


Member State concerned


Date of notification




3.11.2011


HIPRABOVIS PNEUMOS Emulsion for injection for cattle


See Annex II


See Annex II


7.11.2011






(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


Invented name


Strength


Pharmaceutical form


Route of administration




Austria







Baxter Healthcare GmbH,




Stella-Klein-Löw-Weg 15,




A-1020 Wien




Austria






EXTRANEAL - Peritonealdialyselösung


75 g/L


solution for peritoneal dialysis


intraperitoneal use




Austria







Baxter Healthcare GmbH,




Stella-Klein-Löw-Weg 15,




A-1020 Wien




Austria






Dianeal PD4 Glucose 1,36% w/v/13,6 mg/ml - Peritonealdialyselösung


Anhydrous glucose 13,6 g/L, sodium chloride 5,38 g/L, sodium-L(+) lactate 4,48 g/L, calcium chloride dihydrate 0,184 g/L, magnesium chloride hexahydrate 0,051 g/L


solution for peritoneal dialysis


intraperitoneal use




Austria







Baxter Healthcare GmbH,




Stella-Klein-Löw-Weg 15,




A-1020 Wien




Austria






Dianeal PD4 Glucose 2,27% w/v/22,7 mg/ml - Peritonealdialyselösung


Anhydrous glucose 22,7 g/L, sodium chloride 5,38 g/L, sodium-L(+) lactate 4,48 g/L, calcium chloride dihydrate 0,184 g/L, magnesium chloride hexahydrate 0,051 g/L


solution for peritoneal dialysis


intraperitoneal use




Austria







Baxter Healthcare GmbH,




Stella-Klein-Löw-Weg 15,




A-1020 Wien




Austria






Dianeal PD4 Glucose 3,86 % w/v/38,6 mg/ml - Peritonealdialyselösung


Anhydrous glucose 38,6 g/L, sodium chloride 5,38 g/L, sodium-L(+) lactate 4,48 g/L, calcium chloride dihydrate 0,184 g/L, magnesium chloride hexahydrate 0,051 g/L


solution for peritoneal dialysis


intraperitoneal use




Austria







Baxter Healthcare GmbH,




Stella-Klein-Löw-Weg 15,




A-1020 Wien




Austria






Nutrineal PD4 mit 1,1 % Aminosäuren - Peritonealdialyselösung


alanine 951 mg/L, arginine 1 071 mg/L, glycine 510 mg/L, histidine 714 mg/L, isoleucine 850 mg/L, leucine 1 020 mg/L, lysine hydrochloride 955 mg/L, methionine 850 mg/L, phenylalanine 570 mg/L, proline 595 mg/L, serine 510 mg/L, threonine 646 mg/L, tryptophan 270 mg/L, tyrosine 300 mg/L, valine 1 393 mg/L, sodium chloride 5 380 mg/L, calcium chloride dihydrate 184 mg/L, magnesium chloride hexahydrate 51 mg/L, sodium(s)-lactate 4 480 mg/L


solution for peritoneal dialysis


intraperitoneal use




Austria







Baxter Healthcare GmbH,




Stella-Klein-Löw-Weg 15,




A-1020 Wien




Austria






Monosol Hämodialyse-, Hämodiafiltrations- und Hämofiltrationslösung


Glucose monohydrate 1,1 g/L, sodium chloride 6,43 g/L, sodium lactate 3,36 g/L, calcium chloride dihydrate 0,257 g/L, magnesium chloride hexahydrate 0,152 g/L


solution for haemodialysis, haemodiafiltration and haemofiltration


intraarterial use, intravenous use, hemodialysis




Austria







Baxter Healthcare GmbH,




Stella-Klein-Löw-Weg 15,




A-1020 Wien




Austria






Monosol-K mit 2mEq Kalium/l Hämodialyse-, Hämodiafiltrations- und Hämofiltrationslösung


Glucose monohydrate 1,1 g/L, sodium chloride 6,43 g/L, sodium lactate 3,36 g/L, calcium chloride dihydrate 0,257 g/L, magnesium chloride hexahydrate 0,152 g/L, potassium chloride 0,149 g/L


solution for haemodialysis, haemodiafiltration and haemofiltration


intraarterial use, intravenous use, hemodialysis




Austria







Baxter Healthcare GmbH,




Stella-Klein-Löw-Weg 15,




A-1020 Wien




Austria






Monosol-K mit 4mEq Kalium/l Hämodialyse-, Hämodiafiltrations- und Hämofiltrationslösung


Glucose monohydrate 1,1 g/L, sodium chloride 6,43 g/L, sodium lactate 3,36 g/L, calcium chloride dihydrate 0,257 g/L, magnesium chloride hexahydrate 0,152 g/L, potassium chloride 0,298 g/L


solution for haemodialysis, haemodiafiltration and haemofiltration


intraarterial use, intravenous use, hemodialysis




Belgium







Baxter SA




Boulevard R. Branquart 80




7680 Lessines




Belgium






EXTRANEAL 7,5 %, solution pour dialyse péritonéale


75,00 g/l Icodextrine


solution for peritoneal dialysis


intraperitoneal use




Belgium







Baxter SA




Boulevard R. Branquart 80




7680 Lessines




Belgium






Dianeal PD1 Glucose 1,36 % (13,6 mg/ml), solution pour dialyse péritonéale


13,60 g/l glucose anhydrate


solution for peritoneal dialysis


intraperitoneal use




Belgium







Baxter SA




Boulevard R. Branquart 80




7680 Lessines




Belgium






Dianeal PD1 Glucose 2,27 % (22,7 mg/ml), solution pour dialyse péritonéale


22,7 g/l glucose anhydrate


solution for peritoneal dialysis


intraperitoneal use




Belgium







Baxter SA




Boulevard R. Branquart 80




7680 Lessines




Belgium






Dianeal PD1 Glucose 3,86 % (38,6 mg/ml), solution pour dialyse péritonéale


38,6 g/l glucose anhydrate


solution for peritoneal dialysis


intraperitoneal use




Belgium







Baxter SA




Boulevard R. Branquart 80




7680 Lessines




Belgium






Dianeal PD4 Glucose 1,36 % (13,6 mg/ml), solution pour dialyse péritonéale


13,6 g/l glucose anhydrate


solution for peritoneal dialysis


intraperitoneal use




Belgium







Baxter SA




Boulevard R. Branquart 80




7680 Lessines




Belgium






Dianeal PD4 Glucose 2,27 % (22,7 mg/ml), solution pour dialyse péritonéale


22,7 g/l glucose anhydrate


solution for peritoneal dialysis


intraperitoneal use




Belgium







Baxter SA




Boulevard R. Branquart 80




7680 Lessines




Belgium






Dianeal PD4 Glucose 3,86 % (38,6 mg/ml), solution pour dialyse péritonéale


38,6 g/l glucose anhydrate


solution for peritoneal dialysis


intraperitoneal use




Belgium







Baxter SA




Boulevard R. Branquart 80




7680 Lessines




Belgium






Nutrineal Peritoneal Dialysis 4 à 1,1 % d’acides aminés, solution pour dialyse péritonéale


4 to 1,1% acides aminés


solution for peritoneal dialysis


intraperitoneal use




Bulgaria







BAXTER d.o.o.,




Zelezna cesta 18,




1000 Ljubljana




Slovenia






Dianeal PD4 Glucose 1,36% w/v/ 13,6mg/ml


1,36% w/v/ 13,6mg/ml


solution for peritoneal dialysis


intraperitoneal use




Bulgaria







BAXTER d.o.o.,




Zelezna cesta 18,




1000 Ljubljana




Slovenia






Dianeal PD4 Glucose


2,27% w/v/ 22,7mg/ml


solution for peritoneal dialysis


intraperitoneal use




Bulgaria







BAXTER d.o.o.,




Zelezna cesta 18,




1000 Ljubljana




Slovenia






Dianeal PD4 Glucose


3,86% w/v/ 38,6mg/ml


solution for peritoneal dialysis


intraperitoneal use




Bulgaria







BAXTER d.o.o.,




Zelezna cesta 18,




1000 Ljubljana




Slovenia






Extraneal


7,50%


solution for peritoneal dialysis


intraperitoneal use




Bulgaria







BAXTER d.o.o.,




Zelezna cesta 18,




1000 Ljubljana




Slovenia






Nutrineal PD 4 with 1,1% Amino Acids


 


solution for peritoneal dialysis


intraperitoneal use




Czech Republic







Baxter Healthcare S.A.




Moneen Road Castlebar,




Co. Mayo




Ireland






EXTRANEAL


7,5 % 75 g / 1 000 ml


solution for peritoneal dialysis


peritoneal use




Czech Republic







Baxter Healthcare S.A.




Moneen Road Castlebar,




Co. Mayo




Ireland






Dianeal PD4 Glucose 1,36 % w/v / 13,6 mg/ml


1,36 % w/v / 13,6 mg/ml


solution for peritoneal dialysis


peritoneal use




Czech Republic







Baxter Healthcare S.A.




Moneen Road Castlebar,




Co. Mayo




Ireland






Dianeal PD4 Glucose 2,27 % w/v / 22,7 mg/ml


2,27 % w/v / 22,7 mg/ml


solution for peritoneal dialysis


peritoneal use




Czech Republic







Baxter Healthcare S.A.




Moneen Road Castlebar,




Co. Mayo




Ireland






Dianeal PD4 Glucose 3,86 % w/v / 38,6 mg/ml


3,86 % w/v / 38,6 mg/ml


solution for peritoneal dialysis


peritoneal use




Czech Republic







Baxter Healthcare S.A.




Moneen Road Castlebar,




Co. Mayo




Ireland






NUTRINEAL PD4 WITH 1,1% AMINOACIDS


1,10%


solution for peritoneal dialysis


peritoneal use




Denmark







Baxter A/S,




Gydevang 43,




DK-3450 Allerød




Denmark






Natriumklorid Baxter 9 mg/ml


9 mg/ml


solution for infusion


intravenous use




Denmark







Baxter A/S,




Gydevang 43,




DK-3450 Allerød




Denmark






Dianeal PD4 med Glucos


13,6 mg/ml


solution for peritoneal dialysis


intraperitoneal use




Denmark







Baxter A/S,




Gydevang 43,




DK-3450 Allerød




Denmark






Dianeal PD4 med Glucos


22,7 mg/ml


solution for peritoneal dialysis


intraperitoneal use




Denmark







Baxter A/S,




Gydevang 43,




DK-3450 Allerød




Denmark






Dianeal PD4 med Glucos


38,6 mg/ml


solution for peritoneal dialysis


intraperitoneal use




Denmark







Baxter A/S,




Gydevang 43,




DK-3450 Allerød




Denmark






Extraneal


75 mg/ml


solution for peritoneal dialysis


intraperitoneal use




Denmark







Baxter A/S,




Gydevang 43,




DK-3450 Allerød




Denmark






Nutrineal PD4 med 1,1 % aminosyrer


1,1 %/1 000 ml


solution for peritoneal dialysis


intraperitoneal use




Estonia







Baxter OY




P.O box 270,




Valimotie 15A,




Helsinki 00381




Finland






EXTRANEAL


7,50%


solution for peritoneal dialysis


intraperitoneal use




Finland







Baxter Healthcare S.A.




Moneen Road, Castlebar




County Mayo




Ireland






Natriumklorid Baxter 9 mg/ml


9 mg/ml


solution for infusion


intravenous use




Finland







Baxter Oy




Valimotie 15 A




00380 Helsinki




Finland






Extraneal


7,50%


solution for peritoneal dialysis


intraperitoneal use




Finland







Baxter Healthcare S.A.




Moneen Road, Castlebar




County Mayo




Ireland






Dianeal PD4 Glucose


13,6 mg/ml


solution for peritoneal dialysis


intraperitoneal use




Finland







Baxter Healthcare S.A.




Moneen Road, Castlebar




County Mayo




Ireland






Dianeal PD4 Glucose


22,7 mg/ml


solution for peritoneal dialysis


intraperitoneal use




Finland







Baxter Healthcare S.A.




Moneen Road, Castlebar




County Mayo




Ireland






Dianeal PD4 Glucose


38,6 mg/ml


solution for peritoneal dialysis


intraperitoneal use




France







Baxter SAS




Avenue louis Pasteur




ZA de Coignères Maurepas




78310 Maurepas




France






DIANEAL PD1 GLUCOSE 1,36 %, solution pour dialyse péritonéale en poche


1,36%


solution for peritoneal dialysis


intraperitoneal use




France







Baxter SAS




Avenue louis Pasteur




ZA de Coignères Maurepas




78310 Maurepas




France






DIANEAL PD1 GLUCOSE 3,86 %, solution pour dialyse péritonéale en poche


3,86%


solution for peritoneal dialysis


intraperitoneal use




France







Baxter SAS




Avenue louis Pasteur




ZA de Coignères Maurepas




78310 Maurepas




France






DIANEAL PD4 GLUCOSE 3,86 %, solution pour dialyse péritonéale en poche


3,86%


solution for peritoneal dialysis


intraperitoneal use




France







Baxter SAS




Avenue louis Pasteur




ZA de Coignères Maurepas




78310 Maurepas




France






DIANEAL PD1 GLUCOSE 2,27 %, solution pour dialyse péritonéale en poche


2,27%


solution for peritoneal dialysis


Intraperitoneal use




France







Baxter SAS




Avenue louis Pasteur




ZA de Coignères Maurepas




78310 Maurepas




France






DIANEAL PD4 GLUCOSE 2,27 %, solution pour dialyse péritonéale en poche


2,27%


solution for peritoneal dialysis


Intraperitoneal use




France







Baxter SAS




Avenue louis Pasteur




ZA de Coignères Maurepas




78310 Maurepas




France






DIANEAL PD4 GLUCOSE 1,36 %, solution pour dialyse péritonéale en poche


1,36%


solution for peritoneal dialysis


Intraperitoneal use




France







Baxter SAS




Avenue louis Pasteur




ZA de Coignères Maurepas




78310 Maurepas




France






EXTRANEAL, solution pour dialyse péritonéale


7,50%


solution for peritoneal dialysis


Intraperitoneal use




France







Baxter SAS




Avenue louis Pasteur




ZA de Coignères Maurepas




78310 Maurepas




France






NUTRINEAL PD4 A 1,1 % D'ACIDES AMINES, solution pour dialyse péritonéale


1,10%


solution for peritoneal dialysis


Intraperitoneal use




Germany







Baxter Deutschland GmbH




Edisonstr. 4




D-85716 Unterschleißheim




Germany






Dianeal PD1 Glucose 1,36% w/v


13,6 g / l
5,67 g / l
3,92 g / l
0,257 g / l
0,152 g / l


solution for peritoneal dialysis


Intraperitoneal use




Germany







Baxter Deutschland GmbH




Edisonstr. 4




D-85716 Unterschleißheim




Germany






Dianeal PD1 Glucose 2,27% w/v


22,7 g / l
5,67 g / l
3,92 g / l
0,257 g / l
0,152 g / l


solution for peritoneal dialysis


Intraperitoneal use




Germany







Baxter Deutschland GmbH




Edisonstr. 4




D-85716 Unterschleißheim




Germany






Dianeal PD1 Glucose 3,86% w/v


38,6 g / l
5,67 g / l
3,92 g / l
0,257 g / l
0,152 g / l


solution for peritoneal dialysis


Intraperitoneal use




Germany







Baxter Deutschland GmbH




Edisonstr. 4




D-85716 Unterschleißheim




Germany






Dianeal PD4 Glucose 1,36% w/v


13,6 g / l
5,4 g / l
4,5 g / l
0,184 g / l
0,051 g / l


solution for peritoneal dialysis


Intraperitoneal use




Germany







Baxter Deutschland GmbH




Edisonstr. 4




D-85716 Unterschleißheim




Germany






Dianeal PD4 Glucose 2,27% w/v


22,7 g / l
5,4 g / l
4,5 g / l
0,184 g / l
0,051 g / l


solution for peritoneal dialysis


intraperitoneal use




Germany







Baxter Deutschland GmbH




Edisonstr. 4




D-85716 Unterschleißheim




Germany






Dianeal PD4 Glucose 3,86% w/v


38,6 g / l
5,4 g / l
4,5 g / l
0,184 g / l
0,051 g / l


solution for peritoneal dialysis


intraperitoneal use




Germany







Baxter Deutschland GmbH




Edisonstr. 4




D-85716 Unterschleißheim




Germany






Dianeal PDG1 1,36 %


13,6 g / l
5,67 g / l
3,92 g / l
0,257 g / l
0,0152 g / l


solution for peritoneal dialysis


intraperitoneal use




Germany







Baxter Deutschland GmbH




Edisonstr. 4




D-85716 Unterschleißheim




Germany






Dianeal PDG1 2,27 %


22,7 g / l
5,67 g / l
3,92 g / l
0,257 g / l
0,0152 g / l


solution for peritoneal dialysis


intraperitoneal use




Germany







Baxter Deutschland GmbH




Edisonstr. 4




D-85716 Unterschleißheim




Germany






Dianeal PDG1 3,86 %


38,6 g / l
5,67 g / l
3,92 g / l
0,257 g / l
0,0152 g / l


solution for peritoneal dialysis


intraperitoneal use




Germany







Baxter Deutschland GmbH




Edisonstr. 4




D-85716 Unterschleißheim




Germany






Dianeal PDG4 1,36 %


13,6g / l
5,38 g / l
4,48 g/ l
0,184 g / l
0,051 g / l


solution for peritoneal dialysis


intraperitoneal use




Germany







Baxter Deutschland GmbH




Edisonstr. 4




D-85716 Unterschleißheim




Germany






Dianeal PDG4 2,27 %


22,7 g / l
5,38 g / l
4,48 g/ l
0,184 g / l
0,051 g / l


solution for peritoneal dialysis


intraperitoneal use




Germany







Baxter Deutschland GmbH




Edisonstr. 4




D-85716 Unterschleißheim




Germany






Dianeal PDG4 3,86 %


38,6 g /l
5,38 g / l
4,48 g/ l
0,184 g / l
0,051 g / l


solution for peritoneal dialysis


intraperitoneal use




Germany







Baxter Deutschland GmbH




Edisonstr. 4




D-85716 Unterschleißheim




Germany






Extraneal


75 g / l
5,4 g / l
4,5 g / l
0,257 g / l
0,051 g / l


solution for peritoneal dialysis


intraperitoneal use




Germany







Baxter Deutschland GmbH




Edisonstr. 4




D-85716 Unterschleißheim




Germany






Nutrineal PD4 mit 1,1 % Aminosäuren


11,205 g / l
5,38 g / l
0,184 g / l
0,0508 g / l
4,48 g / l


solution for peritoneal dialysis


intraperitoneal use




Germany







Baxter Deutschland GmbH




Edisonstr. 4




D-85716 Unterschleißheim




Germany






Monosol


1,1 g / l
6,43 g / l
0,257 g / l
0,152 g / l
3,36 g / l


solution for haemodialysis


hemodialysis




Germany







Baxter Deutschland GmbH




Edisonstr. 4




D-85716 Unterschleißheim




Germany






Monosol-K mit 2 mmol Kalium/l


1,1 g / l
6,43 g / l
0,257 g / l
0,149 g / l
0,152 g / l
3,36 g / l


solution for haemodialysis


hemodialysis




Germany







Baxter Deutschland GmbH




Edisonstr. 4




D-85716 Unterschleißheim




Germany






Monosol-K mit 4 mmol Kalium/l


1,1 g / l
6,43 g / l
0,257 g / l
0,298 g / l
0,152 g / l
3,36 g / l


solution for haemodialysis


hemodialysis




Greece







DIOPHAR S.A.




Kifissias Avenue 368,




Halandri, 152 33




Greece






DIANEAL PD1


1,36% W/V
2,27% W/V
3,86% W/V


solution for peritoneal dialysis


Intraperitoneal use




Greece







DIOPHAR S.A.




Kifissias Avenue 368,




152 33 Halandri,




Greece






DIANEAL PD4


1,36%
2,27% W/V
3,86% W/V


solution for peritoneal dialysis


intraperitoneal use




Greece







DIOPHAR S.A.




Kifissias Avenue 368,




152 33 Halandri,




Greece






EXTRANEAL


(7,5+0,54+0,45+0,0257+0,0051)% w/v


solution for peritoneal dialysis


intraperitoneal use




Greece







DIOPHAR S.A.




Kifissias Avenue 368,




152 33 Halandri,




Greece






Nutrineal PD4


1,1%


solution for peritoneal dialysis


intraperitoneal use




Hungary







Baxter Hungary Kft.




Népfürdő u. 22.




1138, Budapest




Hungary






EXTRANEAL peritoneális dializáló oldat


7,5% (icodextrin)


solution for peritoneal dialysis


intraperitoneal use




Hungary







Baxter Hungary Kft.




Népfürdő u. 22.




1138, Budapest




Hungary






DIANEAL PD 1 Glucose 1,36% peritoneális dializáló oldat


1,36%


solution for peritoneal dialysis


intraperitoneal use




Hungary







Baxter Hungary Kft.




Népfürdő u. 22.




1138, Budapest




Hungary






DIANEAL PD 1 Glucose 2,27% peritoneális dializáló oldat


2,27%


solution for peritoneal dialysis


intraperitoneal use




Hungary







Baxter Hungary Kft.




Népfürdő u. 22.




1138, Budapest




Hungary






DIANEAL PD 1 Glucose 3,86% peritoneális dializáló oldat


3,86%


solution for peritoneal dialysis


intraperitoneal use




Hungary







Baxter Hungary Kft.




Népfürdő u. 22.




1138, Budapest




Hungary






DIANEAL PD 4 Glucose 1,36% peritoneális dializáló oldat


1,36%


solution for peritoneal dialysis


intraperitoneal use




Hungary







Baxter Hungary Kft.




Népfürdő u. 22.




1138, Budapest




Hungary






DIANEAL PD 4 Glucose 2,27% peritoneális dializáló oldat


2,27%


solution for peritoneal dialysis


intraperitoneal use




Hungary







Baxter Hungary Kft.




Népfürdő u. 22.




1138, Budapest




Hungary






DIANEAL PD 4 Glucose 3,86% peritoneális dializáló oldat


3,86%


solution for peritoneal dialysis


intraperitoneal use




Iceland







Baxter Healthare SA




Moneen Road Castlebar




County Mayo




Ireland






Dianeal PD4 Glucose


13,6 mg/ml


solution for peritoneal dialysis


intraperitoneal use




Iceland







Baxter Healthare SA




Moneen Road Castlebar




County Mayo




Ireland






Dianeal PD4 Glucose


22,7 mg/ml


solution for peritoneal dialysis


intraperitoneal use




Iceland







Baxter Healthare SA




Moneen Road Castlebar




County Mayo




Ireland






Dianeal PD4 Glucose


38,6 mg/ml


solution for peritoneal dialysis


intraperitoneal use




Ireland







Baxter Healthcare Limited,




Caxton Way,




Thetford,




Norfolk,




IP24 3SE




United Kingdom






Monosol, Solution for haemodialysis, haemodiafiltration and haemofiltration


Glucose Monohydrate Ph. Eur.1,1, Sodium Chloride Ph. Eur. 6,43, Calcium Chloride Dihydrate Ph. Eur., 0,257, Magnesium Chloride Hexahydrate Ph. Eur.0,152, Sodium Lactate Ph. Eur. 3,36


solution for haemodialysis, haemodiafiltration and haemofiltration


hemodialysis




Ireland







Baxter Healthcare Limited,




Caxton Way,




Thetford,




Norfolk,




IP24 3SE




United Kingdom






Monosol-K with 2 mEq Potassium/l, Solution for haemodialysis, haemodiafiltration and haemofiltration


Glucose Monohydrate Ph. Eur. 1,1, Sodium Chloride Ph. Eur. 6,43, Calcium Chloride Dihydrate Ph. Eur. 0,257, Magnesium Chloride Hexahydrate Ph. Eur. 0,152, Sodium Lactate Ph. Eur. 3,36, Potassium Chloride Ph. Eur. 0,149


solution for haemodialysis, haemodiafiltration and haemofiltration


hemodialysis




Ireland







Baxter Healthcare Limited,




Caxton Way,




Thetford,




Norfolk,




IP24 3SE,




United Kingdom






Monosol-K with 4 mEq Potassium/l, Solution for haemodialysis, haemodiafiltration and haemofiltration


Glucose Monohydrate Ph. Eur. 1,1, Sodium Chloride Ph. Eur. 6,43, Calcium Chloride Dihydrate Ph. Eur. 0,257, Magnesium Chloride Hexahydrate Ph. Eur. 0,152, Sodium Lactate Ph. Eur. 3,36, Potassium Chloride Ph. Eur. 0,298


solution for haemodialysis, haemodiafiltration and haemofiltration


hemodialysis




Ireland







Baxter Healthcare Limited,




Caxton Way,




Thetford,




Norfolk,




IP24 3SE,




United Kingdom






Dianeal PD1 Glucose 1,36% w/v (13,6mg/ml) Solution for Peritoneal Dialysis


1,36% w/v


solution for peritoneal dialysis


intraperitoneal use




Ireland







Baxter Healthcare Limited,




Caxton Way,




Thetford,




Norfolk,




IP24 3SE,




United Kingdom






Dianeal PD1 Glucose 3,86% w/v (38,6 mg/ml) Solution for Peritoneal Dialysis


3,86% w/v (38,6 mg/ml)


solution for peritoneal dialysis


intraperitoneal use




Ireland







Baxter Healthcare Limited,




Caxton Way,




Thetford,




Norfolk,




IP24 3SE,




United Kingdom






Dianeal PD1 Glucose 2,27% w/v (22,7 mg/ml) Solution for Peritoneal Dialysis


2,27% w/v (22,7 mg/ml)


solution for peritoneal dialysis


intraperitoneal use




Ireland







Baxter Healthcare Limited,




Caxton Way,




Thetford,




Norfolk,




IP24 3SE,




United Kingdom






Dianeal PD4 Glucose 1,36 % w/v (13,6 mg/ml) Solution for peritoneal dialysis


1,36 % w/v (13,6 mg/ml)


solution for peritoneal dialysis


intraperitoneal use




Ireland







Baxter Healthcare Limited,




Caxton Way,




Thetford,




Norfolk,




IP24 3SE,




United Kingdom






Dianeal PD4 Glucose 2,27 % w/v (22,7 mg/ml) Solution for peritoneal dialysis


2,27 % w/v (22,7 mg/ml)


solution for peritoneal dialysis


intraperitoneal use




Ireland







Baxter Healthcare Limited,




Caxton Way,




Thetford,




Norfolk,




IP24 3SE,




United Kingdom






Dianeal PD4 Glucose 3,86 % w/v (38,6 mg/ml) Solution for peritoneal dialysis


3,86 % w/v (38,6 mg/ml)


solution for peritoneal dialysis


intraperitoneal use




Ireland







Baxter Healthcare Limited,




Caxton Way,




Thetford,




Norfolk,




IP24 3SE,




United Kingdom






Nutrineal Solution for Peritoneal Dialysis 4 with 1,1% Amino Acids


 


solution for peritoneal dialysis


intraperitoneal use




Ireland







Baxter Healthcare Limited,




Caxton Way,




Thetford,




Norfolk,




IP24 3SE,




United Kingdom






EXTRANEAL Solution for peritoneal dialysis


 


solution for peritoneal dialysis


intraperitoneal use




Italy







Baxter SPA




piazzale dell' industria 20 -




00144 Roma,




Italy






EXTRANEAL


7,5%


solution for dialysis peritoneal


intraperitoneal use




Italy







Baxter SPA




piazzale dell' industria 20 –




00144 Roma,




Italy






NUTRINEAL PD4


1,1%


solution for dialysis peritoneal


intraperitoneal use




Italy







Baxter SPA




piazzale dell' industria 20 –




00144 Roma,




Italy






SOLUZIONI PER DIALISI PERITONEALE BAXTER


4,95 g/l - 49,54 g/l;


solution for dialysis peritoneal


intraperitoneal use




Latvia







Baxter Oy




Valimotie 15 A




00381 Helsinki




Finland






Extraneal solution for peritoneal dialysis


75g/L 5,4g/L 4,5g/L 0,257g/L 0,051g/L


solution for peritoneal dialysis


intraperitoneal use




Latvia







Baxter Healthcare S.A.




Moneen Road Castlebar




County Mayo




Ireland






Dianeal PD4 Glucose 2,27% w/v//22,7 mg/ml solution for peritoneal dialysis


2,27 % w/v
0,538% w/v 0,448% w/v
0,0184% w/v 0,0051% w/v


solution for peritoneal dialysis


intraperitoneal use




Latvia







Baxter Healthcare S.A.




Moneen Road Castlebar




County Mayo




Ireland






Dianeal PD4 Glucose 3,86 % w/v/38,6 mg/ml solution for peritoneal dialysis


3,86% w/v 0,538% w/v 0,448% w/v 0,0184% w/v 0,0051% w/v


solution for peritoneal dialysis


intraperitoneal use




Latvia







Baxter Healthcare S.A.




Moneen Road Castlebar




County Mayo




Ireland






Dianeal PD4 Glucose 1,36 % w/v/13,6 mg/ml solution for peritoneal dialysis


1,36% w/v 0,538% w/v 0,448% w/v 0,0184% w/v 0,0051% w/v


solution for peritoneal dialysis


intraperitoneal use




Lithuania







Baxter Healthcare S.A.




Moneen Road Castlebar




County Mayo




Ireland






Dianeal PD4 Glucose


13,6g+5,38g+4,48g+0,184g+0,051g/l


solution for peritoneal dialysis


intraperitoneal use




Lithuania







Baxter Healthcare S.A.




Moneen Road Castlebar




County Mayo




Ireland






Dianeal PD4 Glucose


22,7g+5,38g+4,48g+0,184g+0,051g/l


solution for peritoneal dialysis


intraperitoneal use




Lithuania







Baxter Healthcare S.A.




Moneen Road Castlebar




County Mayo




Ireland






Dianeal PD4 Glucose


38,6g+5,38g+4,48g+0,184g+0,051g/l


solution for peritoneal dialysis


intraperitoneal use




Lithuania







Baxter Oy,




P.O. Box 270




Valimotie 15A




00381 Helsinki




Finland






EXTRANEAL


75g+5,4g+4,5g+0,257g+0,051g/1 000ml


solution for peritoneal dialysis


intraperitoneal use




Luxembourg







Baxter SA,




Bd René Branquart 80,




B-7860 Lessines




Belgium






Nutrineal PD4+A.A.1,1%


1,1% amino acids


solution for peritoneal dialysis


intraperitoneal use




Luxembourg







Baxter SA,




Bd René Branquart 80,




B-7860 Lessines




Belgium






Dianeal PD1 Glucose


1,36%/2,27%/3,86% dextrose anydre


solution for peritoneal dialysis


intraperitoneal use




Luxembourg







Baxter SA,




Bd René Branquart 80,




B-7860 Lessines




Belgium






Dianeal PD4 Glucose


1,36%/2,27%/3,86% dextrose anydre


solution for peritoneal dialysis


intraperitoneal use




Luxembourg







Baxter SA,




Bd René Branquart 80,




B-7860 Lessines




Belgium






Extraneal


75,00 g/l Icodextrine


solution for peritoneal dialysis


intraperitoneal use




Malta







Baxter Healthcare Ltd.,




Caxton Way,




Thetford,




Norfolk,




IP24 3SE




United Kingdom






Extraneal (Icodextrin 7,5%)


Icodextrin (75 g/l), Sodium chloride (5,4 g/l),
Calcium chloride (0,257 g/l), Magnesium chloride
(0,051 g/l), Sodium lactate solution (4,5 g/l)


solution for peritoneal dialysis


intraperitoneal use




Malta







Baxter Healthcare Ltd.,




Caxton Way,




Thetford,




Norfolk,




IP24 3SE




United Kingdom






Nutrineal PD4 with 1,1% amino acids


L-Tyrosine 0,300 g/l
L-Tryptophan 0,270 g/l
L-Phenylalanine 0,570 g/l
L-Threonine 0,646 g/l
L-Serine 0,510 g/l
L-Proline 0,595 g/l
Glycine 0,510 g/l
L-Alanine 0,951 g/l
L-Valine 1,393 g/l
L-Methionine 0,850 g/l
L-Isoleucine 0,850 g/l
L-Leucine 1,020 g/l
L-Lysine (chlorhydrate) 0,955 g/l
L-Histidine 0,714 g/l
L-Arginine 1,071 g/l
Calcium chloride dihydrate 0,184 g/l
Magnesium chloride hexahydrate 0,051 g/l
Sodium Lactate 4,48 g/l
Sodium Chloride 5,38 g/l
Quantitative Composition of Sodium Lactate
Lactic Acid 139 g
Sodium Hydroxide 52,25 g
Water for Injections to 100 ml


solution for peritoneal dialysis


intraperitoneal use




Malta







Baxter Healthcare Ltd.,




Caxton Way,




Thetford,




Norfolk,




IP24 3SE




United Kingdom






Dianeal PD1 Glucose 1,36%w/v 13,6mg/ml


Anhydrous Glucose Ph.Eur. 1,36 % w/v
or Glucose Monohydrate Ph.Eur. 1,50 % w/v
Sodium Chloride Ph.Eur. 0,57 % w/v
Sodium Lactate Ph.Eur. 0,39 % w/v
Calcium Chloride Ph.Eur. 0,0257 % w/v
Magnesium Chloride Ph.Eur. 0,0152 % w/v


solution for peritoneal dialysis


intraperitoneal use




Malta







Baxter Healthcare Ltd.,




Caxton Way,




Thetford,




Norfolk,




IP24 3SE




United Kingdom






Dianeal PD1 Glucose 2,27%w/v 22,7mg/ml


Anhydrous Glucose Ph.Eur. 2,27 % w/v
or Glucose Monohydrate Ph.Eur. 2,50 % w/v
Sodium Chloride Ph.Eur. 0,57 % w/v
Sodium Lactate Ph.Eur. 0,39 % w/v
Calcium Chloride Ph.Eur. 0,0257 % w/v
Magnesium Chloride Ph.Eur. 0,0152 % w/v


solution for peritoneal dialysis


intraperitoneal use




Malta







Baxter Healthcare Ltd.,




Caxton Way,




Thetford,




Norfolk,




IP24 3SE




United Kingdom






Dianeal PD1 Glucose 3,86%w/v 38.6mg/ml


Anhydrous Glucose Ph.Eur. 3,86 % w/v
or Glucose Monohydrate Ph.Eur. 4,25 % w/v
Sodium Chloride Ph.Eur. 0,57 % w/v
Sodium Lactate Ph.Eur. 0,39 % w/v
Calcium Chloride Ph.Eur. 0,0257 % w/v
Magnesium Chloride Ph.Eur. 0,0152 % w/v


solution for peritoneal dialysis


intraperitoneal use




Malta







Baxter Healthcare Ltd.,




Caxton Way,




Thetford,




Norfolk,




IP24 3SE




United Kingdom






Dianeal PD4 Glucose 1,36%w/v 13,6mg/ml


Anhydrous Glucose Ph.Eur. 1,36 % w/v
or Glucose Monohydrate Ph.Eur. 1,50 % w/v
Sodium Chloride Ph.Eur. 0,538 % w/v
Sodium Lactate Ph.Eur. 0,448 % w/v
Calcium Chloride Ph.Eur. 0,0184 % w/v
Magnesium Chloride Ph.Eur. 0,0051 % w/v


solution for peritoneal dialysis


intraperitoneal use




Malta







Baxter Healthcare Ltd.,




Caxton Way,




Thetford,




Norfolk,




IP24 3SE




United Kingdom






Dianeal PD4 Glucose 2,27%w/v 22,7mg/ml


Anhydrous Glucose Ph.Eur. 2,27 % w/v
or Glucose Monohydrate Ph.Eur. 2,50 % w/v
Sodium Chloride Ph.Eur. 0,538 % w/v
Sodium Lactate Ph.Eur. 0,448 % w/v
Calcium Chloride Ph.Eur. 0,0184 % w/v
Magnesium Chloride Ph.Eur. 0,0051 % w/v


solution for peritoneal dialysis


intraperitoneal use




Malta







Baxter Healthcare Ltd.,




Caxton Way,




Thetford,




Norfolk,




IP24 3SE




United Kingdom






Dianeal PD4 Glucose 3,86%w/v 38,6mg/ml


Anhydrous Glucose Ph.Eur. 3,86 % w/v
or Glucose Monohydrate Ph.Eur. 4,25 % w/v
Sodium Chloride Ph.Eur. 0,538 % w/v
Sodium Lactate Ph.Eur. 0,448 % w/v
Calcium Chloride Ph.Eur. 0,0184 % w/v
Magnesium Chloride Ph.Eur. 0,0051 % w/v


solution for peritoneal dialysis


intraperitoneal use




Malta







Baxter Healthcare Limited,




Caxton Way,




Thetford,




Norfolk




IP24 3SE,




UK






Monosol


Glucose Monohydrate 1,1 g/l,
Sodium Chloride 6,43 g/l,
Calcium Chloride Dihydrate 0,257 g/l,
Magnesium Chloride Hexahydrate 0,152 g/l,
Sodium Lactate 3,36 g/l


solution for haemodialysis/haemofiltration


intraarterial use, intravenous use




Malta







Baxter Healthcare Limited,




Caxton Way,




Thetford,




Norfolk




IP24 3SE,




UK






Monosol-K with 2MEQ Potassium/L


Glucose Monohydrate 1,1 g/l,
Sodium Chloride 6,43 g/l,
Calcium Chloride Dihydrate 0,257 g/l,
Magnesium Chloride Hexahydrate 0,152 g/l,
Potassium Chloride 0,149 g/l,
Sodium Lactate 3,36 g/l


solution for haemodialysis/haemofiltration


intra-arterial use, intravenous use




Netherlands







Baxter B.V.,




Kobaltweg 49,




3542 CE Utrecht




The Netherlands






Dianeal PD1 Glucose 1,36%/13,6 mg/ml, peritoneaaldialysevloeistof


13,6 g/l glucose anhydrate


solution for peritoneal dialysis


intraperitoneal use




Netherlands







Baxter B.V.,




Kobaltweg 49,




3542 CE Utrecht




The Netherlands






Dianeal PD1 Glucose 2,27%/22,7 mg/ml, peritoneaaldialysevloeistof


22,7 g/l glucose anhydrate


solution for peritoneal dialysis


intraperitoneal use




Netherlands







Baxter B.V.,




Kobaltweg 49,




3542 CE Utrecht




The Netherlands






Dianeal PD1 Glucose 3,86%/38,6 mg/ml, peritoneaaldialysevloeistof


38,6 g/l glucose anhydrate


solution for peritoneal dialysis


intraperitoneal use




Netherlands







Baxter B.V.,




Kobaltweg 49,




3542 CE Utrecht




The Netherlands






Dianeal PD4 Glucose 1,36%/13,6 mg/ml, peritoneaaldialysevloeistof


13,6 g/l glucose anhydrate


solution for peritoneal dialysis


intraperitoneal use




Netherlands







Baxter B.V.,




Kobaltweg 49,




3542 CE Utrecht




The Netherlands






Dianeal PD4 Glucose 2,27%/22,7 mg/ml, peritoneaaldialysevloeistof


22,7 g/l glucose anhydrate


solution for peritoneal dialysis


intraperitoneal use




Netherlands







Baxter B.V.,




Kobaltweg 49,




3542 CE Utrecht




The Netherlands






Dianeal PD4 Glucose 3,86%/38,6 mg/ml, peritoneaaldialysevloeistof


38,6 g/l glucose anhydrate


solution for peritoneal dialysis


intraperitoneal use




Netherlands







Baxter B.V.,




Kobaltweg 49,




3542 CE Utrecht




The Netherlands






Nutrineal PD4 met 11 g/l aminozuren en Ca 1,25 mmol/l, peritoneaaldialysevloeistof


11 g/l amino acids and 1,25 mmol/l Ca.


solution for peritoneal dialysis


intraperitoneal use




Netherlands







Baxter B.V.,




Kobaltweg 49,




3542 CE Utrecht




The Netherlands






EXTRANEAL 7,5 %, oplossing voor peritoneale dialyse


75 g/l icodextrine


solution for peritoneal dialysis


intraperitoneal use




Norway







Baxter AS




Gjerdrumsvei 11




0484 Oslo




Norway






Natriumklorid Baxter 9 mg/ml


9 mg/ml


solution for infusion


intravenous use




Norway







Baxter AS




Gjerdrumsvei 11




0484 Oslo




Norway






Nutrineal PD4 amino Acids 1,1 %


1,10%


solution for peritoneal dialysis


intraperitoneal use




Norway







Baxter AS




Gjerdrumsvei 11




0484 Oslo




Norway






Extraneal


75 mg/ml


solution for peritoneal dialysis


intraperitoneal use




Poland







Baxter Polska SP. z o.o.




Kruczkowskiego 8 st.,




00-380 Warszawa




Poland






Dianeal PD1 (glukoza 1,36%). Zestaw do dializy otrzewnowej


15 mg/ml Glucose Monohydrate; 5,67 mg/ml Sodium Chloride; 0,257 mg/ml Calcium Chloride Dihydrate; 0,152 mg/ml Magnesium Chloride Hexahydrate; 3,92 mg/ml Sodium Lactate


solution for peritoneal dialysis


intraperitoneal use




Poland







Baxter Polska SP. z o.o.




Kruczkowskiego 8 st.,




00-380 Warszawa




Poland






Dianeal PD1 (glukoza 2,27%). Zestaw do dializy otrzewnowej


25 mg/ml Glucose Monohydrate; 5,67 mg/ml Sodium Chloride; 0,257 mg/ml Calcium Chloride Dihydrate; 0,152 mg/ml Magnesium Chloride Hexahydrate; 3,92 mg/ml Sodium Lactate


solution for peritoneal dialysis


intraperitoneal use




Poland







Baxter Polska SP. z o.o.




Kruczkowskiego 8 st.,




00-380 Warszawa




Poland






Dianeal PD1 (glukoza 3,86%). Zestaw do dializy otrzewnowej


42,5 mg/ml Glucose Monohydrate; 5,67 mg/ml Sodium Chloride; 2,57 mg/ml Calcium Chloride Dihydrate; 0,152 mg/ml Magnesium Chloride Hexahydrate; 3,92 mg/ml Sodium Lactate


solution for peritoneal dialysis


intraperitoneal use




Poland







Baxter Polska SP. z o.o.




Kruczkowskiego 8 st.,




00-380 Warszawa




Poland






Dianeal PD4 (glukoza 1,36%). Zestaw do dializy otrzewnowej


15 mg/ml Glucose Monohydrate; 5,38 mg/ml Sodium Chloride; 0,184 mg/ml Calcium Chloride Dihydrate; 0,051 mg/ml Magnesium Chloride Hexahydrate; 4,48 mg/ml Sodium Lactate


solution for peritoneal dialysis


intraperitoneal use




Poland







Baxter Polska SP. z o.o.




Kruczkowskiego 8 st.,




00-380 Warszawa




Poland






Dianeal PD4 (glukoza 2,27%). Zestaw do dializy otrzewnowej


25 mg/ml Glucose Monohydrate; 5,38 mg/ml Sodium Chloride; 0,184 mg/ml Calcium Chloride Dihydrate; 0,051 mg/ml Magnesium Chloride Hexahydrate; 4,48 mg/ml Sodium Lactate


solution for peritoneal dialysis


intraperitoneal use




Poland







Baxter Polska SP. z o.o.




Kruczkowskiego 8 st.,




00-380 Warszawa




Poland






Dianeal PD4 (glukoza 3,86%). Zestaw do dializy otrzewnowej


42,5 mg/ml Glucose Monohydrate; 5,38 mg/ml Sodium Chloride; 0,184 mg/ml Calcium Chloride Dihydrate; 0,051 mg/ml Magnesium Chloride Hexahydrate; 4,48 mg/ml Sodium Lactate


solution for peritoneal dialysis


intraperitoneal use




Poland







Baxter Polska SP. z o.o.




Kruczkowskiego 8 st.,




00-380 Warszawa




Poland






Extraneal Zestaw do dializy otrzewnowej


75 mg/ml


solution for peritoneal dialysis


intraperitoneal use




Poland







Baxter Polska SP. z o.o.




Kruczkowskiego 8 st.,




00-380 Warszawa




Poland






Nutrineal PD4 (z 1,1% roztworem aminokwasów)


1,071 mg/ml Arginine; 0,714 mg/ml Histine; 0,955 mg/ml Lysine hydrochloride; 1,02 mg/ml Leucine; 0,85 mg/ml Isoleucine; 0,85 mg/ml Methionine; 1,393 mg/ml Valine; 0,951 mg/ml Alanine; 0,51 mg/ml Glycine; 0,595 mg/ml Proline; 0,51 mg/ml Serine; 0,646 mg/ml Threonine; 0,57 mg/ml Phenylalanine; 0,27 mg/ml Tryptophan; 0,3 mg/ml Tyrosine; 0,184 mg/ml Calcium Chloride Dihydrate; 0,051 mg/ml Magnesium Chloride Hexahydrate; 5,38 mg/ml Sodium Chloride; 4,48 mg/ml Sodium Lactate


solution for peritoneal dialysis


intraperitoneal use




Portugal







Baxter Médico-Farmacêutica, Lda.




Zona Industrial da Abrunheira –




Edifício 10 - Sintra Business Park,




2710-089 Sintra




Portugal






Extraneal


75 mg/ml Icodextrin; 5,4 mg/ml Sodium Chloride; 4,5 mg/ml Sodium (S) - lactate solution; 0,051 mg/ml Magnesium Chloride; 0,257 mg/ml Calcium Chloride


solution for peritoneal dialysis


intraperitoneal use




Portugal







Baxter Médico-Farmacêutica, Lda.




Zona Industrial da Abrunheira –




Edifício 10 - Sintra Business Park,




2710-089 Sintra




Portugal






Dianeal Pd1


42,5 mg/ml Glucose Monohydrate; 5,67 mg/ml Sodium Chloride; 2,57 mg/ml Calcium Chloride Dihydrate; 0,152 mg/ml Magnesium Chloride Hexahydrate; 3,92 mg/ml Sodium Lactate


solution for peritoneal dialysis


intraperitoneal use




Portugal







Baxter Médico-Farmacêutica, Lda.




Zona Industrial da Abrunheira –




Edifício 10 - Sintra Business Park,




2710-089 Sintra




Portugal






Dianeal Pd1


25 mg/ml Glucose Monohydrate; 5,67 mg/ml Sodium Chloride; 0,257 mg/ml Calcium Chloride Dihydrate; 0,152 mg/ml Magnesium Chloride Hexahydrate; 3,92 mg/ml Sodium Lactate


solution for peritoneal dialysis


intraperitoneal use




Portugal







Baxter Médico-Farmacêutica, Lda.




Zona Industrial da Abrunheira –




Edifício 10 - Sintra Business Park,




2710-089 Sintra




Portugal






Dianeal Pd1


15 mg/ml Glucose Monohydrate; 5,67 mg/ml Sodium Chloride; 0,257 mg/ml Calcium Chloride Dihydrate; 0,152 mg/ml Magnesium Hydroxide; 3,92 mg/ml Sodium Lactate


solution for peritoneal dialysis


intraperitoneal use




Portugal







Baxter Médico-Farmacêutica, Lda.




Zona Industrial da Abrunheira –




Edifício 10 - Sintra Business Park,




2710-089 Sintra




Portugal






Dianeal Pd4


42,5 mg/ml Glucose Monohydrate; 5,38 mg/ml Sodium Chloride; 0,184 mg/ml Calcium Chloride Dihydrate; 0,051 mg/ml Magnesium Chloride Hexahydrate; 4,48 mg/ml Sodium Lactate


solution for peritoneal dialysis


intraperitoneal use




Portugal







Baxter Médico-Farmacêutica, Lda.




Zona Industrial da Abrunheira –




Edifício 10 - Sintra Business Park,




2710-089 Sintra




Portugal






Dianeal Pd4


25 mg/ml Glucose Monohydrate; 5,38 mg/ml Sodium Chloride; 0,184 mg/ml Calcium Chloride Dihydrate; 0,051 mg/ml Magnesium Chloride Hexahydrate; 4,48 mg/ml Sodium Lactate


solution for peritoneal dialysis


intraperitoneal use




Portugal







Baxter Médico-Farmacêutica, Lda.




Zona Industrial da Abrunheira –




Edifício 10 - Sintra Business Park,




2710-089 Sintra




Portugal






Dianeal Pd4


15 mg/ml Glucose Monohydrate; 5,38 mg/ml Sodium Chloride; 0,184 mg/ml Calcium Chloride Dihydrate; 0,051 mg/ml Magnesium Chloride Hexahydrate; 4,48 mg/ml Sodium Lactate


solution for peritoneal dialysis


intraperitoneal use




Portugal







Baxter Médico-Farmacêutica, Lda.




Zona Industrial da Abrunheira –




Edifício 10 - Sintra Business Park,




2710-089 Sintra




Portugal






Nutrineal PD4


1,071 mg/ml Arginine; 0,714 mg/ml Histine; 0,955 mg/ml Lysine hydrochloride; 1,02 mg/ml Leucine; 0,85 mg/ml Isoleucine; 0,85 mg/ml Methionine; 1,393 mg/ml Valine; 0,951 mg/ml Alanine; 0,51 mg/ml Glycine; 0,595 mg/ml Proline; 0,51 mg/ml Serine; 0,646 mg/ml Threonine; 0,57 mg/ml Phenylalanine; 0,27 mg/ml Tryptophan; 0,3 mg/ml Tyrosine; 0,184 mg/ml Calcium Chloride Dihydrate; 0,051 mg/ml Magnesium Chloride Hexahydrate; 5,38 mg/ml Sodium Chloride; 4,48 mg/ml Sodium Lactate


solution for peritoneal dialysis


intraperitoneal use




Romania







BAXTER HEALTHCARE Ltd.,




Caxton Way,




Thetford,




Norfolk,




1P24 3SE, Thetford,




United Kingdom






EXTRANEAL


75 mg/ml


solution for peritoneal dialysis


intraperitoneal use




Romania







BAXTER HEALTHCARE S.A.




Moneen Road, Castelbar,




County Mayo




Ireland






DIANEAL PD4 GLUCOSE 1,36% m/v (13,6 mg/ml),


13,6 mg/ml


solution for peritoneal dialysis


intraperitoneal use




Romania







BAXTER HEALTHCARE S.A.




Moneen Road, Castelbar,




County Mayo




Ireland






DIANEAL PD4 GLUCOSE 2,27% m/v (22,7 mg/ml)


22,7 mg/ml


solution for peritoneal dialysis


Intraperitoneal use




Romania







BAXTER HEALTHCARE S.A.




Moneen Road, Castelbar,




County Mayo




Ireland






DIANEAL PD4 GLUCOSE 3,86% m/v (38,6 mg/ml)


38,6 mg/ml


solution for peritoneal dialysis


intraperitoneal use




Romania







BAXTER d.o.o.




Zelezna cesta 14,




SI-1000 Ljubljana




Slovenia






NUTRINEAL PD4 cu 1,1% aminoacizi


1,1%


solution for peritoneal dialysis


intraperitoneal use




Slovak Republic







Baxter Healthcare SA




Moneen Rd Castlebar,




Co. Mayo




Ireland






Dianeal® PD1 glucose 1,36% w/v /13,6 mg/ml


13,6 mg/1 ml


solution for peritoneal dialysis


intraperitoneal use




Slovak Republic







Baxter Healthcare SA




Moneen Rd Castlebar,




Co. Mayo




Ireland






Dianeal® PD1 glucose 2,27% w/v /22,7 mg/ml


22,7 mg/1 ml


solution for peritoneal dialysis


intraperitoneal use




Slovak Republic







Baxter Healthcare SA




Moneen Rd Castlebar,




Co. Mayo




Ireland






Dianeal® PD1 glucose 3,86% w/v /38,6 mg/ml


38,6 mg/1 ml


solution for peritoneal dialysis


intraperitoneal use




Slovak Republic







Baxter Healthcare SA




Moneen Rd Castlebar,




Co. Mayo




Ireland






DIANEAL PD4 glucose 1,36 % w/v/13,6 mg/ ml


13,6 mg/1 ml


solution for peritoneal dialysis


intraperitoneal use




Slovak Republic







Baxter Healthcare SA




Moneen Rd Castlebar,




Co. Mayo




Ireland






DIANEAL PD4 glucose 2,27 % w/v/22,7 mg/ ml


22,7 mg/1 ml


solution for peritoneal dialysis


intraperitoneal use




Slovak Republic







Baxter Healthcare SA




Moneen Rd Castlebar,




Co. Mayo




Ireland






DIANEAL PD4 glucose 3,86 % w/v/38,6 mg/ ml


38,6 mg/1 ml


solution for peritoneal dialysis


intraperitoneal use




Slovak Republic







Baxter Healthcare Ltd.




Caxton Way




Thetford




Norfolk




IP24 3SE




United Kingdom






EXTRANEAL


7,5%


solution for peritoneal dialysis


intraperitoneal use




Slovak Republic







Baxter Healthcare SA




Moneen Rd Castlebar,




Co. Mayo




Ireland






Nutrineal PD4 with 1,1 % Amino Acids


1,1%


solution for peritoneal dialysis


intraperitoneal use




Slovenia







Baxter d.o.o.,




Zelezna cesta 18,




SI-1000 Ljubljana,




Slovenia






Extraneal 75 mg/ml ikodekstrina raztopina za peritonealno dializo


75 mg/ml


solution for peritoneal dialysis


intraperitoneal use




Slovenia







Baxter d.o.o.,




Zelezna cesta 18,




SI-1000 Ljubljana,




Slovenia






Nutrineal PD4 11 mg/ml amino kislin raztopina za peritonealno dializo


11 mg/ml


solution for peritoneal dialysis


intraperitoneal use




Slovenia







Baxter d.o.o.,




Zelezna cesta 18,




SI-1000 Ljubljana,




Slovenia






Dianeal PD1 13,6 mg/ml glukoze raztopina za peritonelano dializo


13,6 mg/ml


solution for peritoneal dialysis


intraperitoneal use




Slovenia







Baxter d.o.o.,




Zelezna cesta 18,




SI-1000 Ljubljana,




Slovenia






Dianeal PD1 22,7 mg/ml glukoze raztopina za peritonelano dializo


22,7 mg/ml


solution for peritoneal dialysis


intraperitoneal use




Slovenia







Baxter d.o.o.,




Zelezna cesta 18,




SI-1000 Ljubljana,




Slovenia






Dianeal PD1 38,6 mg/ml glukoze raztopina za peritonelano dializo


38,6 mg/ml


solution for peritoneal dialysis


intraperitoneal use




Slovenia







Baxter d.o.o.,




Zelezna cesta 18,




SI-1000 Ljubljana,




Slovenia






Dianeal PD4 13,6 mg/ml glukoze raztopina za peritonelano dializo


13,6 mg/ml


solution for peritoneal dialysis


intraperitoneal use




Slovenia







Baxter d.o.o.,




Zelezna cesta 18,




SI-1000 Ljubljana,




Slovenia






Dianeal PD4 22,7 mg/ml glukoze raztopina za peritonelano dializo


22,7 mg/ml


solution for peritoneal dialysis


intraperitoneal use




Slovenia







Baxter d.o.o.,




Zelezna cesta 18,




SI-1000 Ljubljana,




Slovenia






Dianeal PD4 38,6 mg/ml glukoze raztopina za peritonelano dializo


38,6 mg/ml


solution for peritoneal dialysis


intraperitoneal use




Spain







BAXTER S.L.




Pouet de Camilo 2




Ribarroja del Turia Valencia)




46394




Spain






EXTRANEAL
Solución para diálisis peritoneal


75 g/l; 5,4 g/l; 4,5 g/l; 0,257 g/l; 0,051 g/l


solution for peritoneal dialysis


intraperitoneal use




Spain







BAXTER S.L.




Pouet de Camilo 2




Ribarroja del Turia (Valencia)




46394




Spain






Nutrineal PD4 con 1,1% de aminoácidos solución para diálisis peritoneal


951 mg/l; 1 071 mg/l; 510 mg/l; 714 mg/l; 850 mg/l; 1 020 mg/l; 955 mg/l; 850 mg/l; 570 mg/l; 595 mg/l; 510 mg/l; 646 mg/l; 270 mg/l; 300 mg/l; 393 mg/l; 5 380 mg/l; 184 mg/l; 51 mg/l; 4 480 mg/l


solution for peritoneal dialysis


intraperitoneal use




Spain







BAXTER S.L.




Pouet de Camilo 2




Ribarroja del Turia (Valencia)




46394




Spain






Nutrineal PD4 con 1,1% de aminoácidos con sistema de desconexión integrado solución para diálisis peritoneal


951 mg/l; 1 071 mg/l; 510 mg/l; 714 mg/l; 850 mg/l; 1 020 mg/l; 955 mg/l; 850 mg/l; 570 mg/l; 595 mg/l; 510 mg/l; 646 mg/l; 720 mg/l; 300 mg/l; 1 393 mg/l; 5 380 mg/l; 184 mg/l; 51 mg/l; 4 480 mg/l


solution for peritoneal dialysis


intraperitoneal use




Spain







BAXTER S.L.




Pouet de Camilo 2




Ribarroja del Turia (Valencia)




46394




Spain






Dianeal PD1 Glucosa 1,36% solución para diálisis peritoneal


15 g/l; 5,67 g/l; 3,92 g/l; 0,257 g/l; 0,152 g/l


solution for peritoneal dialysis


intraperitoneal use




Spain







BAXTER S.L.




Pouet de Camilo 2




Ribarroja del Turia (Valencia)




46394




Spain






Dianeal PD1 Glucosa 1,36% con sistema de desconexión integrado solución para diálisis peritoneal.


15 g/l; 5,67 g/l; 3,92 g/l; 0,257 g/l; 0,152 g/l


solution for peritoneal dialysis


intraperitoneal use




Spain







BAXTER S.L.




Pouet de Camilo 2




Ribarroja del Turia (Valencia)




46394




Spain






Dianeal PD1 Glucosa 2,27% solución para diálisis peritoneal


25,0 g/l; 5,67 g/l; 3,92 g/l; 0,257 g/l; 0,152 g/l


solution for peritoneal dialysis


intraperitoneal use




Spain







BAXTER S.L.




Pouet de Camilo 2




Ribarroja del Turia (Valencia)




46394




Spain






Dianeal PD1 Glucosa 2,27% con sistema de desconexión integrado solución para diálisis peritoneal


25,0 g/l; 5,67 g/l; 3,92 g/l; 0,257 g/l; 0,152 g/l


solution for peritoneal dialysis


intraperitoneal use




Spain







BAXTER S.L.




Pouet de Camilo 2




Ribarroja del Turia (Valencia)




46394




Spain






Dianeal PD1 Glucosa 3,86% solución para diálisis peritoneal


42,50 g/l; 5,67 g/l; 3,92 g/l; 0,257 g/l; 0,152 g/l


solution for peritoneal dialysis


intraperitoneal use




Spain







BAXTER S.L.




Pouet de Camilo 2




Ribarroja del Turia (Valencia)




46394




Spain






Dianeal PD1 Glucosa 3,86% con sistema de desconexión integrado solución para diálisis peritoneal


42,50 g/l; 5,67 g/l; 3,92 g/l; 0,257 g/l; 0,152 g/l


solution for peritoneal dialysis


intraperitoneal use




Spain







BAXTER S.L.




Pouet de Camilo 2




Ribarroja del Turia (Valencia)




46394




Spain






Dianeal PD4 Glucosa 1,36% solución para diálisis peritoneal


15,0 g/l; 5,38 g/l; 4,48 g/l; 0,184 g/l; 0,051 g/l


solution for peritoneal dialysis


intraperitoneal use




Spain







BAXTER S.L.




Pouet de Camilo 2




Ribarroja del Turia (Valencia)




46394




Spain






Dianeal PD4 Glucosa 1,36% con sistema de desconexión integrado solución para diálisis peritoneal.


15,0 g/l; 5,38 g/l; 4,48 g/l; 0,184 g/l; 0,051 g/l


solution for peritoneal dialysis


intraperitoneal use




Spain







BAXTER S.L.




Pouet de Camilo 2




Ribarroja del Turia (Valencia)




46394




Spain






Dianeal PD4 Glucosa 2,27% solución para diálisis peritoneal


25,0 g/l; 5,38 g/l; 4,48 g/l; 0,184 g/l; 0,051 g/l


solution for peritoneal dialysis


intraperitoneal use




Spain







BAXTER S.L.




Pouet de Camilo 2




Ribarroja del Turia (Valencia)




46394




Spain






Dianeal PD4 Glucosa 2,27% con sistema de desconexión integrado solución para diálisis peritoneal


25,0 g/l; 5,38 g/l; 4,48 g/l; 0,184 g/l; 0,051 g/l


solution for peritoneal dialysis


intraperitoneal use




Spain







BAXTER S.L.




Pouet de Camilo 2




Ribarroja del Turia (Valencia)




46394




Spain






Dianeal PD4 Glucosa 3,86% solución para diálisis peritoneal


42,50 g/l; 5,38 g/l; 4,48 g/l; 0,184 g/l; 0,051 g/l


solution for peritoneal dialysis


intraperitoneal use




Spain







BAXTER S.L.




Pouet de Camilo 2




Ribarroja del Turia (Valencia)




46394




Spain






Dianeal PD4 Glucosa 3,86% con sistema de desconexión integrado solución para diálisis peritoneal


42,50 g/l; 5,38 g/l; 4,48 g/l; 0,184 g/l; 0,051 g/l


solution for peritoneal dialysis


intraperitoneal use




Sweden







Baxter Medical AB




Box 63




164 94 Kista




Sweden






Natriumklorid Baxter 9 mg/ml


9 mg/ml


solution for infusion


intravenous use




Sweden







Baxter Healthare SA




Moneen Road Castlebar




County Mayo




Ireland






Dianeal PD4 med glucos 13,6 mg/ml


13,6 mg/ml


solution for peritoneal dialysis


intraperitoneal use




Sweden







Baxter Healthare SA




Moneen Road Castlebar




County Mayo




Ireland






Dianeal PD4 med glucos 22,7 mg/ml


22,7 mg/ml


solution for peritoneal dialysis


intraperitoneal use




Sweden







Baxter Healthare SA




Moneen Road Castlebar




County Mayo




Ireland






Dianeal PD4 med glucos 38,6 mg/ml


38,6 mg/ml


solution for peritoneal dialysis


intraperitoneal use




Sweden







Baxter Medical AB




Box 63




164 94 Kista




Sweden






Extraneal


7,5%


solution for peritoneal dialysis


intraperitoneal use




Sweden







Baxter Medical AB




Box 63




164 94 Kista




Sweden






Nutrineal PD4 1,1 % Aminosyror


1,10%


solution for peritoneal dialysis


intraperitoneal use




United Kingdom







Baxter Healthcare Limited,




Caxton Way,




Thetford,




Norfolk




IP24 3SE




United Kingdom






Monosol


Calcium Chloride: 0,026% w/v. glucose 0,110%w/v; sodium lactate 0,336%w/v; sodium chloride 0,643%w/v; magnesium chloride 0,015%w/v


solution for haemodialysis/haemofiltration


intraarterial use, intravenous use




United Kingdom







Baxter Healthcare Limited,




Caxton Way,




Thetford,




Norfolk




IP24 3SE




United Kingdom






Monosol-K with 2MEQ Potassium/L


sodium chloride 0,643%w/v; magnesium chloride 0,015%w/v; calcium chloride 0,026%w/v; glucoae 0,110%w/v; potassium chloride 0,015%w/v; sodium lactate 0,336%w/v


solution for haemodialysis/haemofiltration


intraarterial use, intravenous use




United Kingdom







Baxter Healthcare Limited,




Caxton Way,




Thetford,




Norfolk




IP24 3SE




United Kingdom






Monosol-K with 4MEQ Potassium/L


magnesium chloride 0,015%w/v; potassium chloride 0,029%w/v; calcium chloride 0,026%w/v; sodium lactate 0,336%w/v; sodium chloride 0,643%w/v; glucose 0,110%w/v


solution for haemodialysis/haemofiltration


intraarterial use, intravenous use




United Kingdom







Baxter Healthcare Limited,




Caxton Way,




Thetford,




Norfolk




IP24 3SE




United Kingdom






Dianeal PD1 Glucose 1,36% w/v /13,6mg/ml


magnesium chloride 0,015%w/v; calcium chloride 0,026%w/v; glucose 1,36%w/v; sodium lactate 0,39%w/v; sodium chloride 0,57%w/v


solution for peritoneal dialysis


intraperitoneal use




United Kingdom







Baxter Healthcare Limited,




Caxton Way,




Thetford,




Norfolk




IP24 3SE




United Kingdom






Dianeal PD1 Glucose 3.86% w/v /38,6mg/ml


magnesium chloride 0,015%w/v; calcium chloride 0,026%w/v; glucose 3,86%w/v; sodium lactate 0,39%w/v; sodium chloride 0,57%w/v


solution for peritoneal dialysis


intraperitoneal use




United Kingdom







Baxter Healthcare Limited,




Caxton Way,




Thetford,




Norfolk




IP24 3SE




United Kingdom






Dianeal PD1 Glucose 2,27% w/v /22,7mg/ml


sodium chloride 0,57%w/v; glucose 2,27%w/v; magnesium chloride 0,015%w/v; sodium lactate 0,39%w/v; calcium chloride 0,026%w/v


solution for peritoneal dialysis


intraperitoneal use




United Kingdom







Baxter Healthcare Limited,




Caxton Way,




Thetford,




Norfolk




IP24 3SE




United Kingdom






Dianeal PD4 Glucose 1,36% w/v /13,6mg/ml


magnesium chloride 0,005%w/v; glucose 1,36%w/v; sodium lactate 0,45%w/v; calcium chloride 0,018%w/v; sodium chloride 0,54%w/v


solution for peritoneal dialysis


intraperitoneal use




United Kingdom







Baxter Healthcare Limited,




Caxton Way,




Thetford,




Norfolk




IP24 3SE




United Kingdom






Dianeal PD4 Glucose 2,27% w/v /22,7mg/ml


magnesium chloride 0,005%w/v; glucose 2,27%w/v; sodium lactate 0,45%w/v; calcium chloride 0,018%w/v; sodium chloride 0,54%w/v


solution for peritoneal dialysis


intraperitoneal use




United Kingdom







Baxter Healthcare Limited,




Caxton Way,




Thetford,




Norfolk




IP24 3SE




United Kingdom






Dianeal PD4 Glucose 3,86% w/v /38,6mg/ml


magnesium chloride 0,005%w/v; glucose 3,86%w/v; sodium lactate 0,45%w/v; calcium chloride 0,018%w/v; sodium chloride 0,54%w/v


solution for peritoneal dialysis


intraperitoneal use




United Kingdom







Baxter Healthcare Limited,




Caxton Way,




Thetford,




Norfolk




IP24 3SE




United Kingdom






Extraneal (Icodextrin 7,5%) Solution for peritoneal dialysis


icodextrin 75g/l; sodium chloride 5,4g/l; calcium chloride 0,257g/l; magnesium chloride 0,051g/l; sodium s-lactate 4,5g/l


solution for peritoneal dialysis


intraperitoneal use




United Kingdom







Baxter Healthcare Limited,




Caxton Way,




Thetford,




Norfolk




IP24 3SE




United Kingdom






Nutrineal PD4 with 1,1% Amino Acids


tyrosine 0,03%w/v; tryptophan 0,027%w/v; phenylalanine 0,057%w/v; threonine 0,064%w/v; L-serine 0,051%w/v; L-proline 0,058%w/v; glycine 0,.051%w/v; L-alanine 0,095%w/v; valine 0,139%w/v; methionine 0,085%w/v; isoleucine 0,085%w/v; leucine 0,102%w/v; lysine 0,095%w/v; histidine 0/071%w/v; arginine 0,107%w/v; calcium chloride 0,018%w/v; magnesium chloride 0,005%w/v; sodium chloride 0,538%w/v; sodium s-lactate 0,448%w/v


solution for peritoneal dialysis


intraperitoneal use







ANNEX II

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCT, ANIMAL SPECIES AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES











Member State EU/EEA


Marketing authorisation holder


Invented name


Strength


Pharmaceutical form


Animal species




Austria







LABORATORIOS HIPRA, S.A.




Avda. la Selva, 135




17170- AMER (Girona)




SPAIN






HIPRABOVIS PNEUMOS -
Emulsion zur Injektion für Rinder



Mannheimia haemolytica Biotype A serotype A1, inactivated cell free suspension containing leukotoxoid Ph. Eur. Inactivated Histophilus somni Bailie strain


Emulsion for injection


Cattle from 2 months of age




Belgium







LABORATORIOS HIPRA, S.A.




Avda. la Selva, 135




17170- AMER (Girona)




SPAIN






HIPRABOVIS PNEUMOS



Mannheimia haemolytica Biotype A serotype A1, inactivated cell free suspension containing leukotoxoid Ph. Eur. Inactivated Histophilus somni Bailie strain


Emulsion for injection


Cattle from 2 months of age




Czech Republic







LABORATORIOS HIPRA, S.A.




Avda. la Selva, 135




17170- AMER (Girona)




SPAIN






HIPRABOVIS PNEUMOS
Injekční emulze pro skot



Mannheimia haemolytica Biotype A serotype A1, inactivated cell free suspension containing leukotoxoid Ph. Eur. Inactivated Histophilus somni Bailie strain


Emulsion for injection


Cattle from 2 months of age




Denmark







LABORATORIOS HIPRA, S.A.




Avda. la Selva, 135




17170- AMER (Girona)




SPAIN






HIPRABOVIS PNEUMOS



Mannheimia haemolytica Biotype A serotype A1, inactivated cell free suspension containing leukotoxoid Ph. Eur. Inactivated Histophilus somni Bailie strain


Emulsion for injection


Cattle from 2 months of age




France







LABORATORIOS HIPRA, S.A.




Avda. la Selva, 135




17170- AMER (Girona)




SPAIN






HIPRABOVIS PNEUMOS EMULSION INJECTABLE POUR BOVINS



Mannheimia haemolytica Biotype A serotype A1, inactivated cell free suspension containing leukotoxoid Ph. Eur. Inactivated Histophilus somni Bailie strain


Emulsion for injection


Cattle from 2 months of age




Germany







LABORATORIOS HIPRA, S.A.




Avda. la Selva, 135




17170- AMER (Girona)




SPAIN






HIPRABOVIS PNEUMOS



Mannheimia haemolytica Biotype A serotype A1, inactivated cell free suspension containing leukotoxoid Ph. Eur. Inactivated Histophilus somni Bailie strain


Emulsion for injection


Cattle from 2 months of age




Greece







LABORATORIOS HIPRA, S.A.




Avda. la Selva, 135




17170- AMER (Girona)




SPAIN






HIPRABOVIS PNEUMOS



Mannheimia haemolytica Biotype A serotype A1, inactivated cell free suspension containing leukotoxoid Ph. Eur. Inactivated Histophilus somni Bailie strain


Emulsion for injection


Cattle from 2 months of age




Hungary







LABORATORIOS HIPRA, S.A.




Avda. la Selva, 135




17170- AMER (Girona)




SPAIN






HIPRABOVIS PNEUMOS
vakcina A.U.V.



Mannheimia haemolytica Biotype A serotype A1, inactivated cell free suspension containing leukotoxoid Ph. Eur. Inactivated Histophilus somni Bailie strain


Emulsion for injection


Cattle from 2 months of age




Ireland







LABORATORIOS HIPRA, S.A.




Avda. la Selva, 135




17170- AMER (Girona)




SPAIN






HIPRABOVIS PNEUMOS
Emulsion for injection for cattle



Mannheimia haemolytica Biotype A serotype A1, inactivated cell free suspension containing leukotoxoid Ph. Eur. Inactivated Histophilus somni Bailie strain


Emulsion for injection


Cattle from 2 months of age




Italy







LABORATORIOS HIPRA, S.A.




Avda. la Selva, 135




17170- AMER (Girona)




SPAIN






HIPRABOVIS PNEUMOS
Emulsion for injection for cattle



Mannheimia haemolytica Biotype A serotype A1, inactivated cell free suspension containing leukotoxoid Ph. Eur. Inactivated Histophilus somni Bailie strain


Emulsion for injection


Cattle from 2 months of age




Poland







LABORATORIOS HIPRA, S.A.




Avda. la Selva, 135




17170- AMER (Girona)




SPAIN






HIPRABOVIS PNEUMOS
emulsja do wstrzykiwań dla bydła



Mannheimia haemolytica Biotype A serotype A1, inactivated cell free suspension containing leukotoxoid Ph. Eur. Inactivated Histophilus somni Bailie strain


Emulsion for injection


Cattle from 2 months of age




Portugal







LABORATORIOS HIPRA, S.A.




Avda. la Selva, 135




17170- AMER (Girona)




SPAIN






HIPRABOVIS PNEUMOS
Emulsão para injecção para bovinos



Mannheimia haemolytica Biotype A serotype A1, inactivated cell free suspension containing leukotoxoid Ph. Eur. Inactivated Histophilus somni Bailie strain


Emulsion for injection


Cattle from 2 months of age




Slovak Republic







LABORATORIOS HIPRA, S.A.




Avda. la Selva, 135




17170- AMER (Girona)




SPAIN






HIPRABOVIS PNEUMOS
injekčná emulzia pre dobytok



Mannheimia haemolytica Biotype A serotype A1, inactivated cell free suspension containing leukotoxoid Ph. Eur. Inactivated Histophilus somni Bailie strain


Emulsion for injection


Cattle from 2 months of age




Spain







LABORATORIOS HIPRA, S.A.




Avda. la Selva, 135




17170- AMER (Girona)




SPAIN






HIPRABOVIS PNEUMOS



Mannheimia haemolytica Biotype A serotype A1, inactivated cell free suspension containing leukotoxoid Ph. Eur. Inactivated Histophilus somni Bailie strain


Emulsion for injection


Cattle from 2 months of age




The Netherlands







LABORATORIOS HIPRA, S.A.




Avda. la Selva, 135




17170- AMER (Girona)




SPAIN






HIPRABOVIS PNEUMOS



Mannheimia haemolytica Biotype A serotype A1, inactivated cell free suspension containing leukotoxoid Ph. Eur. Inactivated Histophilus somni Bailie strain


Emulsion for injection


Cattle from 2 months of age




United Kingdom







LABORATORIOS HIPRA, S.A.




Avda. la Selva, 135




17170- AMER (Girona)




SPAIN






HIPRABOVIS PNEUMOS
Emulsion for Injection for Cattle



Mannheimia haemolytica Biotype A serotype A1, inactivated cell free suspension containing leukotoxoid Ph. Eur. Inactivated Histophilus somni Bailie strain


Emulsion for injection


Cattle from 2 months of age