Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2011 to 30 June 2011 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)
Date: 2011-08-26
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2011250EN.01001801.xml










26.8.2011   


EN


Official Journal of the European Union


C 250/18





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2011 to 30 June 2011

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

2011/C 250/02
—   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




18.5.2011


Arimidex and associated names - Referral Art 30 (amend)


See Annex I


See Annex I


20.5.2011




12.5.2011


Dianeal, Extraneal and Nutrineal and associated names - Art. 31 (amend)


See Annex II


See Annex II


13.5.2011




15.6.2011


Cinryze


ViroPharma SPRL-BVBA, rue Montoyer 47, 1000 Bruxelles, Belgique / Montoyerstraat 47, 1000 Brussel, België


These Decisions are addressed to the Member States.


20.6.2011




29.6.2011


Instanyl


Nycomed Danmark ApS, Langebjerg 1, DK-4000 Roskilde, Danmark


These Decisions are addressed to the Member States.


4.7.2011




6.5.2011


ReFacto AF


Wyeth Europa Ltd., Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom


These Decisions are addressed to the Member States.


10.5.2011




6.5.2011


Tygacil


Wyeth Europa Ltd., Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom


These Decisions are addressed to the Member States.


12.5.2011




27.5.2011


Lucentis


Novartis Europharm Ltd, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom


These Decisions are addressed to the Member States.


31.5.2011




16.6.2011


Tysabri


Elan Pharma International Ltd., Monksland, Athlone, County Westmeath, Ireland


These Decisions are addressed to the Member States.


20.6.2011




2.5.2011


Revolade


GlaxoSmithKline Trading Services Limited, 6900 Cork Airport Business Park, Kinsale Road, Cork, Ireland


These Decisions are addressed to the Member States.


3.5.2011




16.6.2011


Ozurdex


Allergan Pharmaceuticals (Ireland) Ltd, Castlebar Road, Westport, Co. Mayo, Ireland


These Decisions are addressed to the Member States.


20.6.2011




6.5.2011


Rotarix


GlaxoSmithKline Biologicals S.A., rue de l’Institut 89, Rixensart, B-1330 Belgique


These Decisions are addressed to the Member States.


11.5.2011







—   Refusal 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




18.5.2011


Isotretinoin


See Annex III


See Annex III


19.5.2011







—   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




18.5.2011


Isotretinoin


See Annex III


See Annex III


19.5.2011




23.5.2011


Octagam Article 107 Final measures


See Annex IV


See Annex IV


25.5.2011







—   Lift of 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




30.5.2011


Octagam Art 31 Lift of suspension


See Annex V


See Annex V


31.5.2011






(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







AstraZeneca Österreich GmbH,




Schwarzenbergplatz 7,




A-1037 Wien,




Austria






Arimidex


1 mg


Film-coated Tablets


Oral use




Belgium







NV AstraZeneca SA




Egide Van Ophemstraat 110




B-1180 Brussels,




Belgium






Arimidex


1 mg


Film-coated Tablets


Oral use




Bulgaria







AstraZeneca Pharmaceuticals AB,




S-15185 Södertälje,




Sweden






Arimidex


1 mg


Film-coated Tablets


Oral use




Cyprus







AstraZeneca UK Ltd




Silk Road Business Park




Macclesfield




Cheshire




SK10 2NA




United Kingdom






Arimidex


1 mg


Film-coated Tablets


Oral use




Czech Republic







AstraZeneca UK Ltd




Silk Road Business Park




Macclesfield




Cheshire




SK10 2NA




United Kingdom






Arimidex


1 mg


Film-coated Tablets


Oral use




Denmark







AstraZeneca A/S




Roskildevej 22




2620 Albertslund,




Denmark






Arimidex


1 mg


Film-coated Tablets


Oral use




Estonia







AstraZeneca UK Ltd.




2 Kingdom Street,




London




W2 6BD,




United Kingdom






Arimidex


1 mg


Film-coated Tablets


Oral use




Finland







AstraZeneca Oy




Luomanportti 3




02200 Espoo




Finland






Arimidex


1 mg


Film-coated Tablets


Oral use




France







AstraZeneca




1, Place Renault




92844 RUEIL-MALMAISON CEDEX




France






Arimidex


1 mg


Film-coated Tablets


Oral use




Germany







AstraZeneca GmbH




Tinsdaler Weg 183




22880 Wedel




Postanschrift 22876 Wedel




Germany






Arimidex


1 mg


Film-coated Tablets


Oral use




Greece







AstraZeneca S.A.




4 Theotokopoulou & Astronafton str




151 25 Maroussi




Athens,




Greece






Arimidex


1 mg


Film-coated Tablets


Oral use




Hungary







AstraZeneca Kft.




1113 Budapest, Bocskai ut 134-146




Hungary






Arimidex


1 mg


Film-coated Tablets


Oral use




Iceland







AstraZeneca AB




151 85 Södertälje




Sweden






Arimidex


1 mg


Film-coated Tablets


Oral use




Ireland







AstraZeneca UK Limited




600 Capability Green




Luton LU1 3LU




United Kingdom






Arimidex


1 mg


Film-coated Tablets


Oral use




Italy







AstraZeneca UK Limited




600 Capability Green




Luton LU1 3LU




United Kingdom






Arimidex


1 mg


Film-coated Tablets


Oral use




Latvia







AstraZeneca UK Limited




Silk Road Business Park Macclesfield,




Cheshire




SK 10 2NA




United Kingdom






Arimidex


1 mg


Film-coated Tablets


Oral use




Lithuania







AstraZeneca UK Ltd.




Silk Road Business Park




Macclesfield,




Cheshire




SK10 2NA




United Kingdom






Arimidex


1 mg


Film-coated Tablets


Oral use




Luxembourg







NV AstraZeneca SA




Egide Van Ophemstraat 110




B-1180 Brussels,




Belgium






Arimidex


1 mg


Film-coated Tablets


Oral use




Malta







AstraZeneca UK Ltd.




Silk Road Business Park




Macclesfield,




Cheshire




SK10 2NA




United Kingdom






Arimidex


1 mg


Film-coated Tablets


Oral use




Netherlands







AstraZeneca BV




Louis Pasteurlaan 5




2719 EE Zoetermeer




The Netherlands






Arimidex


1 mg


Film-coated Tablets


Oral use




Norway







AstraZeneca AS




Innspurten 15, 0663 OSLO, Postboks 6050




Etterstad 0601,




OSLO




Norway






Arimidex


1 mg


Film-coated Tablets


Oral use




Poland







AstraZeneca UK Ltd.




Silk Road Business Park




Macclesfield,




Cheshire,




SK10 2NA




United Kingdom






Arimidex


1 mg


Film-coated Tablets


Oral use




Portugal







AstraZeneca Produtos Farmacêuticos, Lda.




Rua Humberto Madeira, n.o 7, Queluz de Baixo,




2730-097 Barcarena,




Portugal






Arimidex


1 mg


Film-coated Tablets


Oral use




Romania







AstraZeneca UK Limited




600 Capability Green




Luton,




LU1 3LU




United Kingdom






Arimidex


1 mg


Film-coated Tablets


Oral use




Slovak Republic







AstraZeneca UK Ltd.




Silk Road Business Park




Macclesfield,




Cheshire,




SK10 2NA




United Kingdom






Arimidex


1 mg


Film-coated Tablets


Oral use




Slovenia







AstraZeneca UK Limited




2 Kingdom Street,




London




W2 6BD,




United Kingdom






Arimidex 1 mg filmsko obložene tablete


1 mg


Film-coated Tablets


Oral use




Spain







AstraZeneca Farmacéutica Spain, S.A.




C/ Serrano Galvache, 56 Edificio Roble




28033 Madrid,




Spain






Arimidex


1 mg


Film-coated Tablets


Oral use




Sweden







AstraZeneca AB




151 85 Södertälje




Sweden






Arimidex


1 mg


Film-coated Tablets


Oral use




United Kingdom







AstraZeneca UK Limited




600 Capability Green




Luton




LU1 3LU




United Kingdom






Arimidex


1 mg


Film-coated Tablets


Oral use







ANNEX II

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES











Member State


Marketing authorisation holder


Product name


Strength


Pharmaceutical form


Route of administration




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


EXTRANEAL - Peritonealdialyselösung


75 g/L


Solution for peritoneal dialysis


Intraperitoneal use




Belgium







Baxter SA




Bld R Branquart 80




7860 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




Bld R Branquart 80




7860 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




Bld R Branquart 80




7860 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




Bld R Branquart 80




7860 Lessines




Belgium






EXTRANEAL 7,5 %, solution pour dialyse péritonéale


75,00 g/l Icodextrine


Solution for peritoneal dialysis


Intraperitoneal use




Bulgaria


BAXTER d.o.o., Zelezna cesta 18, 1000 Ljubljana, Slovenia


Dianeal PD4 Glucose


2,27 % w/v/ 22,7 mg/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/ 38,6 mg/ml


Solution for peritoneal dialysis


Intraperitoneal use




Bulgaria


BAXTER d.o.o., Zelezna cesta 18, 1000 Ljubljana, Slovenia


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


1,36 % w/v/ 13,6 mg/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




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


Intraperitoneal 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/22,6 mg/ml


Solution for peritoneal dialysis


Intraperitoneal 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


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


Intraperitoneal 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




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


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




Finland


Baxter Oy Valimotie 15 A 00380 Helsinki Finland


Extraneal


7,5 %


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






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 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






EXTRANEAL, solution pour dialyse péritonéale


7,50 %


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 PDG4 1,36 %


13,6 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






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






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




Greece







DIOPHAR S.A.




Kifissias Avenue 368,




Halandri, 152 33




Greece






DIANEAL PD4


1,36 %


Solution for peritoneal dialysis


Intraperitoneal use




Greece







DIOPHAR S.A.




Kifissias Avenue 368,




Halandri, 152 33




Greece






EXTRANEAL


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


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




Hungary







Baxter Hungary Kft.




Népfürdő u. 22.




1138, Budapest




Hungary






EXTRANEAL peritoneális dializáló oldat


7,5 % (icodextrin)


Solution for peritoneal dialysis


Intraperitoneal use




Iceland


Baxter Healthare SA Moneen Road Castlebar County Mayo Irland


Dianeal PD4 Glucose


13,6 mg/ml


Solution for peritoneal dialysis


Intraperitoneal use




Iceland


Baxter Healthare SA Moneen Road Castlebar County Mayo Irland


Dianeal PD4 Glucose


22,7 mg/ml


Solution for peritoneal dialysis


Intraperitoneal use




Iceland


Baxter Healthare SA Moneen Road Castlebar County Mayo Irland


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


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


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






SOLUZIONI PER DIALISI PERITONEALE BAXTER


4,95 g/l - 49,54 g/l;


Solution for dialysis peritoneal


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




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 Oy Valimotie 15 A 00380 Helsinki Finland




FINLAND






Extraneal solution for peritoneal dialysis


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




Lithuania


Baxter Healthcare S.A., Moneen Road, Castlebar County Mayo, Ireland


Dianeal PD4 Glucose


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


Solution for peritoneal dialysis


Intraperitoneal use




Lithuania


Baxter Healthcare S.A., Moneen Road, Castlebar County Mayo, Ireland


Dianeal PD4 Glucose


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


Solution for peritoneal dialysis


Intraperitoneal use




Lithuania


Baxter Healthcare S.A., Moneen Road, Castlebar County Mayo, Ireland


Dianeal PD4 Glucose


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


Solution for peritoneal dialysis


Intraperitoneal use




Lithuania


Baxter Oy, P.O. Box 270 Valimotie 15A 00381 Helsinki, Finland


EXTRANEAL


75 g + 5,4 g + 4,5 g + 0,257 g + 0,051 g/1 000 ml


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






Dianeal PD4 Glucose 1,36 % w/v 13,6 mg/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 22,7 mg/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 38,6 mg/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 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




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 Warsawa, Poland






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


 


Solution for peritoneal dialysis


Intraperitoneal use




Poland







Baxter Polska SP. z o.o.




Kruczkowskiego 8 st.,




00-380 Warsawa, Poland






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


 


Solution for peritoneal dialysis


Intraperitoneal use




Poland







Baxter Polska SP. z o.o.




Kruczkowskiego 8 st.,




00-380 Warsawa, Poland






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


 


Solution for peritoneal dialysis


Intraperitoneal use




Poland







Baxter Polska SP. z o.o.




Kruczkowskiego 8 st.,




00-380 Warsawa, Poland






Extraneal Zestaw do dializy otrzewnowej


 


Solution for peritoneal dialysis


Intraperitoneal use




Poland







Baxter Polska SP. z o.o.




Kruczkowskiego 8 st.,




00-380 Warsawa, Poland






Extraneal Zestaw do dializy otrzewnowej


 


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


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




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 HEALTHCARE Ltd.,




Caxton Way, Thetford, Norfolk, 1P24 3SE, Thetford,




United Kingdom






EXTRANEAL


75 mg/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




Slovenia


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


Solution for peritoneal dialysis


Intraperitoneal use




Slovenia


Baxter d.o.o., Zelezna cesta 18, Ljubljana, SI-1000, 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, Ljubljana, SI-1000, Slovenia


Dianeal PD4 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, Ljubljana, SI-1000, Slovenia


Extraneal 75 mg/ml ikodekstrina raztopina za peritonealno dializo


75 mg/ml


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 %


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


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 %


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


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 %


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


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




46394 Ribarroja del Turia (Valencia)




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




Sweden


Baxter Healthare SA Moneen Road Castlebar County Mayo Irland


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 Irland


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 Irland


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 Sverige Sweden


Extraneal


7,5 %


Solution for peritoneal dialysis


Intraperitoneal use




The 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




The 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




The 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




The 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




United Kingdom


Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk IP24 3SE, United Kingdom


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


magnseium 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 /22,7 mg/ml


magnseium 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 /38,6 mg/ml


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


Solution for peritoneal dialysis


Intraperitoneal use







ANNEX III

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, APPLICANTS/MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES












Member State EU/EEA


Marketing authorisation holder


Applicant


(Invented) Name


Strength


Pharmaceutical form


Route of administration




France


 







Ranbaxy (UK) Ltd.




Building 4, Chiswick Park,




566 Chiswick High Road,




London W4 5YE,




United Kingdom






ISOTRETINOINE RANBAXY 10 mg, capsule molle


10 mg


Capsules, soft


Oral




France


 







Ranbaxy (UK) Ltd.




Building 4, Chiswick Park,




566 Chiswick High Road,




London W4 5YE,




United Kingdom






ISOTRETINOINE RANBAXY 20 mg, capsule molle


20 mg


Capsules, soft


Oral




Spain


 







Ranbaxy (UK) Ltd.




Building 4, Chiswick Park,




566 Chiswick High Road,




London W4 5YE,




United Kingdom






ISOTRETINOINA RANBAXY 10 mg CAPSULAS BLANDAS EFG


10 mg


Capsules, soft


Oral




Spain


 







Ranbaxy (UK) Ltd.




Building 4, Chiswick Park,




566 Chiswick High Road,




London W4 5YE,




United Kingdom






ISOTRETINOINA RANBAXY 20 mg CAPSULAS BLANDAS EFG


20 mg


Capsules, soft


Oral




United Kingdom







Ranbaxy (UK) Ltd.




Building 4, Chiswick Park,




566 Chiswick High Road,




London W4 5YE,




United Kingdom






 


Isotretinoin 10 mg Capsules


10 mg


Capsules, soft


Oral




United Kingdom







Ranbaxy (UK) Ltd.




Building 4, Chiswick Park,




566 Chiswick High Road,




London W4 5YE,




United Kingdom






 


Isotretinoin 20 mg Capsules


20 mg


Capsules, soft


Oral







ANNEX IV

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES











Member State EU/EEA


Marketing Authorisation Holder


Invented name


Strength


Pharmaceutical Form


Route of administration




AT - Austria







Octapharma Pharmazeutika




Produktionsgesellschaft m.b.H.




Oberlaaerstraße 235




A-1100 Wien




Austria






Octagam 100 mg/ml Infusionslösung


100 mg/ml


Solution for infusion


Intravenous Use




AT - Austria







Octapharma Pharmazeutika




Produktionsgesellschaft m.b.H.




Oberlaaerstraße 235




A-1100 Wien




Austria






Octagam 50 mg/ml Infusionslösung


50 mg/ml


Solution for infusion


Intravenous Use




BE - Belgium







OCTAPHARMA BENELUX SA




Rue de Stalle 63




1180 Bruxelles (Brussels)




Belgium






Octagam 10 %, solution pour perfusion


10 % (100 mg/ml)


Solution for infusion


Intravenous Use




BE - Belgium







OCTAPHARMA BENELUX SA




Rue de Stalle 63




1180 Bruxelles (Brussels)




Belgium






Octagam 50 mg/ml solution pour perfusion


50 mg/ml


Solution for infusion


Intravenous Use




BG - Bulgaria







Octapharma (IP) Limited




The Zenith Building




26 Spring Gardens




Manchester M2 1AB




United Kingdom






Octagam 10 %


100 mg/ml


Solution for infusion


Intravenous Use




CY - Cyprus







Octapharma (IP) Limited




The Zenith Building




26 Spring Gardens




Manchester M2 1AB




United Kingdom






OCTAGAM INFUSION 10 %


10 %


Solution for infusion


Intravenous use




CY - Cyprus







Hospitec Co Ltd




5 Thessalonikis, Block B




2085 Lefkosia




Cyprus






OCTAGAM INFUSION 5 %


5 %


Solution for infusion


Intravenous use




CZ - Czech Republic







Octapharma (IP) Limited




The Zenith Building




26 Spring Gardens




Manchester M2 1AB




United Kingdom






OCTAGAM


50 mg/ml


Solution for infusion


Intravenous Use




CZ - Czech Republic







Octapharma (IP) Limited




The Zenith Building




26 Spring Gardens




Manchester M2 1AB




United Kingdom






OCTAGAM 10 %


100 mg/ml


Solution for infusion


Intravenous Use




DE - Germany







OCTAPHARMA GmbH




Elisabeth-Selbert-Str. 11




40764 Langenfeld




Germany






Octagam 50 mg/ml


50 mg/ml


Solution for infusion


Intravenous Use




DE - Germany







OCTAPHARMA GmbH




Elisabeth-Selbert-Str. 11




40764 Langenfeld




Germany






Octagam 5 %


50 mg/ml


Solution for infusion


Intravenous Use




DE - Germany







OCTAPHARMA GmbH




Elisabeth-Selbert-Str. 11




40764 Langenfeld




Germany






Octagam 10 %


100 mg/ml


Solution for infusion


Intravenous Use




DK - Denmark







Octapharma AB




Elersvägen 40




SE-11275 Stockholm




Sweden






Octagam


50 mg/ml


Solution for infusion


Intravenous Use




DK - Denmark







Octapharma AB




Elersvägen 40




SE-11275 Stockholm




Sweden






Octagam


100 mg/ml


Solution for infusion


Intravenous Use




EL - Greece







Octapharma Hellas SA




George Kalbitzer




60, posidonos Ave.




166 75 Glyfada Attiki




Greece






OCTAGAM


5 % (W/V)


Solution for infusion


Intravenous Use




EL - Greece







Octapharma Hellas SA




George Kalbitzer




60, posidonos Ave.




166 75 Glyfada Attiki




Greece






OCTAGAM


10 % (100 MG/ML)


Solution for infusion


Intravenous Use




ES - Spain







OCTAPHARMA, S.A.




C/ Velázquez, 150




28002 Madrid




ESPAÑA






Octagamocta 100 mg/ml solución para perfusión


100 mg/ml


Solution for infusion


Intravenous use




ES - Spain







OCTAPHARMA, S.A.




C/ Velázquez, 150




28002 Madrid




ESPAÑA






Octagamocta 50 mg/ml solución para perfusión


50 mg/ml


Solution for infusion


Intravenous use




ET - Estonia







Octapharma AB




Elersvägen 40




SE-11275 Stockholm




Sweden






OCTAGAM


50 mg/ml


Solution for infusion


Intravenous Use




ET - Estonia







Octapharma (IP) Limited




The Zenith Building




26 Spring Gardens




Manchester M2 1AB




United Kingdom






OCTAGAM 10 %


100 mg/1 ml


Solution for infusion


Intravenous Use




FI - Finland







OCTAPHARMA




Rajatorpantie 41 C




01640 Vantaa




FINLAND






OCTAGAM


50 mg/ml
100 mg/ml


Solution for infusion


Intravenous Use




FR - France







Octapharma France SAS




Laurent de Narbonne




62Bis Avenue André Morizet




F- 92100 Boulogne




Billancourt




France






OCTAGAM 100 mg/ml, solution pour perfusion


100 mg/ml


Solution for infusion


Intravenous Use




FR - France







Octapharma France SAS




Laurent de Narbonne




62Bis Avenue André Morizet




F- 92100 Boulogne




Billancourt




France






OCTAGAM 50 mg/ml, solution pour perfusion


50 mg/ml


Solution for infusion


Intravenous Use




HU - Hungary







Octapharma (IP) Limited




The Zenith Building




26 Spring Gardens




Manchester M2 1AB




United Kingdom






OCTAGAM 50 mg/ml oldatos infúzió


50 mg/ml


Solution for infusion


Intravenous Use




HU - Hungary







Octapharma (IP) Limited




The Zenith Building




26 Spring Gardens




Manchester M2 1AB




United Kingdom






OCTAGAM 100 mg/ml oldatos infúzió


100 mg/ml


Solution for infusion


Intravenous Use




IS - Iceland







Octapharma AB




Nordenflychtsvägen 55




SE-112 75 Stockholm




Sweden






Octagam 5 %


50 mg/ml


Solution for infusion


Intravenous Use




IS - Iceland







Octapharma AB




Nordenflychtsvägen 55




SE-112 75 Stockholm




Sweden






Octagam 10 %


100 mg/ml


Solution for infusion


Intravenous Use




IT - Italy







Octapharma Ltd




The Zenith Building




26 Spring Gardens




Manchester M2 1AB




United Kingdom






OCTAGAM


5 %


Solution for infusion


Intravenous Use




LT - Lithuania







Octapharma (IP) Limited




The Zenith Building




26 Spring Gardens




Manchester M2 1AB




United Kingdom






octagam


100 mg/ml


Solution for infusion


Intravenous Use




LU - Luxembourg







OCTAPHARMA BENELUX SA




Rue de Stalle 63




1180 Bruxelles (Brussels)




Belgium






Octagam


5 %


Solution for infusion


Intravenous use




LU - Luxembourg







OCTAPHARMA BENELUX SA




Rue de Stalle 63




1180 Bruxelles (Brussels)




Belgium






Octagam-10


10 %


Solution for infusion


Intravenous use




LV - Latvia







Octapharma AB




Elesvagen 40




Stockholm, S-112 75




Sweden






Octagam 50 mg/ml solution for infusion


1 g/20 ml


Solution for infusion


Intravenous Use




LV - Latvia







Octapharma AB




Elesvagen 40




Stockholm, S-112 75




Sweden






Octagam 50 mg/ml solution for infusion


2,5 g/50 ml


Solution for infusion


Intravenous Use




LV - Latvia







Octapharma AB




Elesvagen 40




Stockholm, S-112 75




Sweden






Octagam 50 mg/ml solution for infusion


5 g/100 ml


Solution for infusion


Intravenous Use




LV - Latvia







Octapharma AB




Elesvagen 40




Stockholm, S-112 75




Sweden






Octagam 50 mg/ml solution for infusion


10 g/200 ml


Solution for infusion


Intravenous Use




LV - Latvia







Octapharma (IP) Limited




The Zenith Building




26 Spring Gardens




Manchester M2 1AB




United Kingdom






Octagam 100 mg/ml šķīdums infūzijām, 2 g/20 ml


2 g/20 ml


Solution for infusion


Intravenous Use




LV - Latvia







Octapharma (IP) Limited




The Zenith Building




26 Spring Gardens




Manchester M2 1AB




United Kingdom






Octagam 100 mg/ml šķīdums infūzijām, 5 g/50 ml


5 g/50 ml


Solution for infusion


Intravenous Use




LV - Latvia







Octapharma (IP) Limited




The Zenith Building




26 Spring Gardens




Manchester M2 1AB




United Kingdom






Octagam 100 mg/ml šķīdums infūzijām, 10 g/100 ml


10 g/100 ml


Solution for infusion


Intravenous Use




LV - Latvia







Octapharma (IP) Limited




The Zenith Building




26 Spring Gardens




Manchester M2 1AB




United Kingdom






Octagam 100 mg/ml šķīdums infūzijām, 20 g/200 ml


20 g/200 ml


Solution for infusion


Intravenous Use




MT - Malta







Octapharma (IP) Limited,




The Zenith Building,




26 Spring Gardens, Manchester M2 1AB,




United Kingdom






OCTAGAM 10 %


1 ml contains: protein 100 mg (of which ≥ 95 % is human Immunoglobulin G), IgA ≤ 0,4 mg, IgM ≤ 0,3 mg


Solution for infusion


Intravenous use




NL - Netherlands







Octapharma GmbH




Reinhard Rettinghaus




Elisabeth-Selbert-Str. 11




40764 Langenfeld




Germany






Octagam 10 %


100 mg/ml


Solution for infusion


Intravenous Use




NL - Netherlands







Octapharma GmbH




Reinhard Rettinghaus




Elisabeth-Selbert-Str. 11




40764 Langenfeld




Germany






Octagam 5 %


50 mg/ml


Solution for infusion


Intravenous Use




NO - Norway







Octapharma AG




Kim Björnstrup




Seidenstraße 2




CH-8853 Lachen




Switzerland






Octagam


50 mg/ml


Solution for infusion


Intravenous Use




NO - Norway







Octapharma AG




Kim Björnstrup




Seidenstraße 2




CH-8853 Lachen




Switzerland






Octagam


100 mg/ml


Solution for infusion


Intravenous Use




PL - Poland







Octapharma (IP) Limited




The Zenith Building




26 Spring Gardens




Manchester M2 1AB




United Kingdom






Octagam


2,5 g/50 ml


Solution for infusion


Intravenous Use




PL - Poland







Octapharma (IP) Limited




The Zenith Building




26 Spring Gardens




Manchester M2 1AB




United Kingdom






Octagam


5 g/100 ml


Solution for infusion


Intravenous Use




PL - Poland







Octapharma (IP) Limited




The Zenith Building




26 Spring Gardens




Manchester M2 1AB




United Kingdom






Octagam 10 %


20 g/200 ml


Solution for infusion


Intravenous Use




PL - Poland







Octapharma (IP) Limited




The Zenith Building




26 Spring Gardens




Manchester M2 1AB




United Kingdom






Octagam 10 %


100 mg/ml


Solution for infusion


Intravenous Use




PT - Portugal







Octapharma




Produtos Farmaceuticos, Lda.




Paulo Castro




Rua da Graca, 14




P-1170-169 Lisboa




Portugal






Octagam


50 mg/ml


Solution for infusion


Intravenous use




PT - Portugal







Octapharma




Produtos Farmaceuticos, Lda.




Paulo Castro




Rua da Graca, 14




P-1170-169 Lisboa




Portugal






Octagam


100 mg/ml


Solution for infusion


Intravenous use




RO - Romania







OCTAPHARMA (IP) Ltd.




The Zenith Building 26 Spring Gardens




Manchester, M2 1AB




United Kingdom






OCTAGAM


50 mg/ml


Solution for infusion


Intravenous use




RO - Romania







OCTAPHARMA (IP) Ltd.




The Zenith Building 26 Spring Gardens




Manchester, M2 1AB




United Kingdom






OCTAGAM 10 %


100 mg/ml


Solution for infusion


Intravenous use




SE - Sweden







Octapharma AB




Olivier Clairotte




Elersvägen 40




SE-11275 Stockholm




Sweden






Octagem


50 mg/ml


Solution for infusion


Intravenous use




SE - Sweden







Octapharma AB




Olivier Clairotte




Elersvägen 40




SE-11275 Stockholm




Sweden






Octagem


100 mg/ml


Solution for infusion


Intravenous use




SI - Slovenia







Zavod Republike Slovenije za transfuzijsko medicino




Šlajmerjeva 6




1000 Ljubljana




Slovenija






Octagam 50 mg/ml raztopina za infundiranje


50 mg/ ml


Solution for infusion


Intravenous use




SI - Slovenia







Zavod Republike Slovenije za transfuzijsko medicino




Šlajmerjeva 6




1000 Ljubljana




Slovenija






Octagam 100 mg/ml raztopina za infundiranje


100 mg/ ml


Solution for infusion


Intravenous use




SK - Slovakia







Octapharma (IP) Limited




The Zenith Building




26 Spring Gardens




Manchester M2 1AB




United Kingdom






Octagam


20 ml 50 mg/ml


Solution for infusion


Intravenous use




SK - Slovakia







Octapharma (IP) Limited




The Zenith Building




26 Spring Gardens




Manchester M2 1AB




United Kingdom






Octagam


50 ml 50 mg/ml


Solution for infusion


Intravenous use




SK - Slovakia







Octapharma (IP) Limited




The Zenith Building




26 Spring Gardens




Manchester M2 1AB




United Kingdom






Octagam


100 ml 50 mg/ml


Solution for infusion


Intravenous use




SK - Slovakia







Octapharma (IP) Limited




The Zenith Building




26 Spring Gardens




Manchester M2 1AB




United Kingdom






Octagam


200 ml 50 mg/ml


Solution for infusion


Intravenous use




SK - Slovakia







Octapharma (IP) Limited




The Zenith Building




26 Spring Gardens




Manchester M2 1AB




United Kingdom






Octagam 10 %


20 ml 100 mg/ml


Solution for infusion


Intravenous use




SK - Slovakia







Octapharma (IP) Limited




The Zenith Building




26 Spring Gardens




Manchester M2 1AB




United Kingdom






Octagam 10 %


50 ml 100 mg/ml


Solution for infusion


Intravenous use




SK - Slovakia







Octapharma (IP) Limited




The Zenith Building




26 Spring Gardens




Manchester M2 1AB




United Kingdom






Octagam 10 %


100 ml 100 mg/ml


Solution for infusion


Intravenous use




SK - Slovakia







Octapharma (IP) Limited




The Zenith Building




26 Spring Gardens




Manchester M2 1AB




United Kingdom






Octagam 10 %


200 ml 100 mg/ml


Solution for infusion


Intravenous use




UK - United Kingdom







Octapharma Limited




The Zenith Building




26 Spring Gardens




Manchester M2 1AB




United Kingdom






Octagam Infusion


5 % w/v


Solution for infusion


Intravenous use




UK - United Kingdom







Octapharma Limited




The Zenith Building




26 Spring Gardens




Manchester M2 1AB




United Kingdom






Octagam 10 % solution for Infusion


10 % w/v


Solution for infusion


Intravenous use







ANNEX V

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES











Member State EU/EEA


Marketing Authorisation Holder


Invented name


Strength


Pharmaceutical Form


Route of administration




AT - Austria







Octapharma Pharmazeutika




Produktionsgesellschaft m.b.H.




Oberlaaerstraße 235




A-1100 Wien




Austria






Octagam 100 mg/ml Infusionslösung


100 mg/ml


Solution for infusion


Intravenous Use




AT - Austria







Octapharma Pharmazeutika




Produktionsgesellschaft m.b.H.




Oberlaaerstraße 235




A-1100 Wien




Austria






Octagam 50 mg/ml Infusionslösung


50 mg/ml


Solution for infusion


Intravenous Use




BE - Belgium







OCTAPHARMA BENELUX SA




Rue de Stalle 63




1180 Bruxelles (Brussels)




Belgium






Octagam 10 %, solution pour perfusion


10 % (100 mg/ml)


Solution for infusion


Intravenous Use




BE - Belgium







OCTAPHARMA BENELUX SA




Rue de Stalle 63




1180 Bruxelles (Brussels)




Belgium






Octagam 50 mg/ml solution pour perfusion


50 mg/ml


Solution for infusion


Intravenous Use




BG - Bulgaria







Octapharma (IP) Limited




The Zenith Building




26 Spring Gardens




Manchester M2 1AB




United Kingdom






Octagam 10 %


100 mg/ml


Solution for infusion


Intravenous Use




CY - Cyprus







Octapharma (IP) Limited




The Zenith Building




26 Spring Gardens




Manchester M2 1AB




United Kingdom






Octagam Infusion 10 %


10 %


Solution for infusion


Intravenous use




CY - Cyprus







Hospitec Co Ltd




5 Thessalonikis, Block B




2085 Nicosia




Cyprus






Octagam Infusion 5 %


5 %


Solution for infusion


Intravenous use




CZ - Czech Republic







Octapharma (IP) Limited




The Zenith Building




26 Spring Gardens




Manchester M2 1AB




United Kingdom






Octagam


50 mg/ml


Solution for infusion


Intravenous Use




CZ - Czech Republic







Octapharma (IP) Limited




The Zenith Building




26 Spring Gardens




Manchester M2 1AB




United Kingdom






Octagam 10 %


100 mg/ml


Solution for infusion


Intravenous Use




DE - Germany







OCTAPHARMA GmbH




Elisabeth-Selbert-Str. 11




40764 Langenfeld




Germany






Octagam 50 mg/ml


50 mg/ml


Solution for infusion


Intravenous Use




DE - Germany







OCTAPHARMA GmbH




Elisabeth-Selbert-Str. 11




40764 Langenfeld




Germany






Octagam 5 %


50 mg/ml


Solution for infusion


Intravenous Use




DE - Germany







OCTAPHARMA GmbH




Elisabeth-Selbert-Str. 11




40764 Langenfeld




Germany






Octagam 10 %


100 mg/ml


Solution for infusion


Intravenous Use




DK - Denmark







Octapharma AB




Elersvägen 40




SE-11275 Stockholm




Sweden






Octagam


50 mg/ml


Solution for infusion


Intravenous Use




DK - Denmark







Octapharma AB




Elersvägen 40




SE-11275 Stockholm




Sweden






Octagam


100 mg/ml


Solution for infusion


Intravenous Use




EL - Greece







Octapharma Hellas SA




60, posidonos Ave.




166 75 Glyfada Attiki




Greece






Octagam


5 % (W/V)


Solution for infusion


Intravenous Use




EL - Greece







Octapharma Hellas SA




60, posidonos Ave.




166 75 Glyfada Attiki




Greece






Octagam


10 % (100 MG/ML)


Solution for infusion


Intravenous Use




ES - Spain







OCTAPHARMA, S.A.




C/ Velázquez, 150




28002 Madrid




ESPAÑA






Octagamocta 100 mg/ml solución para perfusión


100 mg/ml


Solution for infusion


Intravenous use




ES - Spain







OCTAPHARMA, S.A.




C/ Velázquez, 150




28002 Madrid




ESPAÑA






Octagamocta 50 mg/ml solución para perfusión


50 mg/ml


Solution for infusion


Intravenous use




ET - Estonia







Octapharma AB




Elersvägen 40




SE-11275 Stockholm




Sweden






Octagam


50 mg/ml


Solution for infusion


Intravenous Use




ET - Estonia







Octapharma (IP) Limited




The Zenith Building




26 Spring Gardens




Manchester M2 1AB




United Kingdom






Octagam 10 %


100 mg/1 ml


Solution for infusion


Intravenous Use




FI - Finland







Octapharma AB




Elersvägen 40




SE-11275 Stockholm




Sweden






Octagam


50 mg/ml
100 mg/ml


Solution for infusion


Intravenous Use




FR - France







Octapharma France SAS




62Bis Avenue André Morizet




F- 92100 Boulogne




Billancourt




France






Octagam 100 mg/ml, solution pour perfusion


100 mg/ml


Solution for infusion


Intravenous Use




FR - France







Octapharma France SAS




62Bis Avenue André Morizet




F- 92100 Boulogne




Billancourt




France






Octagam 50 mg/ml, solution pour perfusion


50 mg/ml


Solution for infusion


Intravenous Use




HU - Hungary







Octapharma (IP) Limited




The Zenith Building




26 Spring Gardens




Manchester M2 1AB




United Kingdom






Octagam 50 mg/ml oldatos infúzió


50 mg/ml


Solution for infusion


Intravenous Use




HU - Hungary







Octapharma (IP) Limited




The Zenith Building




26 Spring Gardens




Manchester M2 1AB




United Kingdom






Octagam 100 mg/ml oldatos infúzió


100 mg/ml


Solution for infusion


Intravenous Use




IS - Iceland







Octapharma AB




Nordenflychtsvägen 55




SE-112 75 Stockholm




Sweden






Octagam 5 %


50 mg/ml


Solution for infusion


Intravenous Use




IS - Iceland







Octapharma AB




Nordenflychtsvägen 55




SE-112 75 Stockholm




Sweden






Octagam 10 %


100 mg/ml


Solution for infusion


Intravenous Use




IT - Italy







Octapharma Ltd




The Zenith Building




26 Spring Gardens




Manchester M2 1AB




United Kingdom






Octagam


5 %


Solution for infusion


Intravenous Use




IT – Italy







Octapharma Italy S.p.A




Via Cisanello 145




56100 Pisa




Italy






Gamten


10 %


Solution for infusion


Intravenous Use




LT - Lithuania







Octapharma (IP) Limited




The Zenith Building




26 Spring Gardens




Manchester M2 1AB




United Kingdom






Octagam


100 mg/ml


Solution for infusion


Intravenous Use




LU - Luxembourg







OCTAPHARMA BENELUX SA




Rue de Stalle 63




1180 Bruxelles (Brussels)




Belgium






Octagam


5 %


Solution for infusion


Intravenous use




LU - Luxembourg







OCTAPHARMA BENELUX SA




Rue de Stalle 63




1180 Bruxelles (Brussels)




Belgium






Octagam-10


10 %


Solution for infusion


Intravenous use




LV - Latvia







Octapharma AB




Elesvagen 40




Stockholm, S-112 75




Sweden






Octagam 50 mg/ml solution for infusion


1 g/20 ml


Solution for infusion


Intravenous Use




LV - Latvia







Octapharma AB




Elesvagen 40




Stockholm, S-112 75




Sweden






Octagam 50 mg/ml solution for infusion


2,5 g/50 ml


Solution for infusion


Intravenous Use




LV - Latvia







Octapharma AB




Elesvagen 40




Stockholm, S-112 75




Sweden






Octagam 50 mg/ml solution for infusion


5 g/100 ml


Solution for infusion


Intravenous Use




LV - Latvia







Octapharma AB




Elesvagen 40




Stockholm, S-112 75




Sweden






Octagam 50 mg/ml solution for infusion


10 g/200 ml


Solution for infusion


Intravenous Use




LV - Latvia







Octapharma (IP) Limited




The Zenith Building




26 Spring Gardens




Manchester M2 1AB




United Kingdom






Octagam 100 mg/ml solution for infusion, 2 g/20 ml


2 g/20 ml


Solution for infusion


Intravenous Use




LV - Latvia







Octapharma (IP) Limited




The Zenith Building




26 Spring Gardens




Manchester M2 1AB




United Kingdom






Octagam 100 mg/ml solution for infusion, 5 g/50 ml


5 g/50 ml


Solution for infusion


Intravenous Use




LV - Latvia







Octapharma (IP) Limited




The Zenith Building




26 Spring Gardens




Manchester M2 1AB




United Kingdom






Octagam 100 mg/ml solution for infusion, 10 g/100 ml


10 g/100 ml


Solution for infusion


Intravenous Use




LV - Latvia







Octapharma (IP) Limited




The Zenith Building




26 Spring Gardens




Manchester M2 1AB




United Kingdom






Octagam 100 mg/ml solution for infusion, 20 g/200 ml


20 g/200 ml


Solution for infusion


Intravenous Use




MT - Malta







Octapharma (IP) Limited,




The Zenith Building,




26 Spring Gardens, Manchester M2 1AB,




United Kingdom






Octagam 10 %, solution for infusion


1 ml contains: protein 100 mg (of which ≥ 95 % is human Immunoglobulin G), IgA ≤ 0,4 mg, IgM ≤ 0,3 mg


Solution for infusion


Intravenous use




NL - Netherlands







Octapharma GmbH




Elisabeth-Selbert-Str. 11




40764 Langenfeld




Germany






Octagam 10 %


100 mg/ml


Solution for infusion


Intravenous Use




NL - Netherlands







Octapharma GmbH




Elisabeth-Selbert-Str. 11




40764 Langenfeld




Germany






Octagam 5 %


50 mg/ml


Solution for infusion


Intravenous Use




NO - Norway







Octapharma AG




Seidenstraße 2




CH-8853 Lachen




Switzerland






Octagam


50 mg/ml


Solution for infusion


Intravenous Use




NO - Norway







Octapharma AG




Seidenstraße 2




CH-8853 Lachen




Switzerland






Octagam


100 mg/ml


Solution for infusion


Intravenous Use




PL - Poland







Octapharma (IP) Limited




The Zenith Building




26 Spring Gardens




Manchester M2 1AB




United Kingdom






Octagam


2,5 g/50 ml


Solution for infusion


Intravenous Use




PL - Poland







Octapharma (IP) Limited




The Zenith Building




26 Spring Gardens




Manchester M2 1AB




United Kingdom






Octagam


5 g/100 ml


Solution for infusion


Intravenous Use




PL - Poland







Octapharma (IP) Limited




The Zenith Building




26 Spring Gardens




Manchester M2 1AB




United Kingdom






Octagam


10 g/200 ml


Solution for infusion


Intravenous Use




PL - Poland







Octapharma (IP) Limited




The Zenith Building




26 Spring Gardens




Manchester M2 1AB




United Kingdom






Octagam 10 %


100 mg/ml


Solution for infusion


Intravenous Use




PT - Portugal







Octapharma




Produtos Farmaceuticos, Lda.




Rua dos Lagares D'el Rei, 21C r/c Dto.




P-1170-268 Lisboa




Portugal






Octagam


50 mg/ml


Solution for infusion


Intravenous use




PT - Portugal







Octapharma




Produtos Farmaceuticos, Lda.




Rua dos Lagares D'el Rei, 21C r/c Dto.




P-1170-268 Lisboa




Portugal






Octagam


100 mg/ml


Solution for infusion


Intravenous use




RO - Romania







OCTAPHARMA (IP) Ltd.




The Zenith Building 26 Spring Gardens




Manchester, M2 1AB




United Kingdom






Octagam


50 mg/ml


Solution for infusion


Intravenous use




RO - Romania







OCTAPHARMA (IP) Ltd.




The Zenith Building 26 Spring Gardens




Manchester, M2 1AB




United Kingdom






Octagam 10 %


100 mg/ml


Solution for infusion


Intravenous use




SE - Sweden







Octapharma AB




Elersvägen 40




112 75 Stockholm




Sweden






Octagam


50 mg/ml


Solution for infusion


Intravenous use




SE - Sweden







Octapharma AB




Elersvägen 40




112 75 Stockholm




Sweden






Octagam


100 mg/ml


Solution for infusion


Intravenous use




SI - Slovenia







Zavod Republike Slovenije za transfuzijsko medicino




Šlajmerjeva 6




1000 Ljubljana




Slovenija






Octagam 50 mg/ml raztopina za infundiranje


50 mg/ ml


Solution for infusion


Intravenous use




SI - Slovenia







Zavod Republike Slovenije za transfuzijsko medicino




Šlajmerjeva 6




1000 Ljubljana




Slovenija






Octagam 100 mg/ml raztopina za infundiranje


100 mg/ ml


Solution for infusion


Intravenous use




SK - Slovakia







Octapharma (IP) Limited




The Zenith Building




26 Spring Gardens




Manchester M2 1AB




United Kingdom






Octagam


50 mg/ml


Solution for infusion


Intravenous use




SK - Slovakia







Octapharma (IP) Limited




The Zenith Building




26 Spring Gardens




Manchester M2 1AB




United Kingdom






Octagam 10 %


100 mg/ml


Solution for infusion


Intravenous use




UK - United Kingdom







Octapharma Limited




The Zenith Building




26 Spring Gardens




Manchester M2 1AB




United Kingdom






Octagam Infusion


5 % w/v


Solution for infusion


Intravenous use




UK - United Kingdom







Octapharma Limited




The Zenith Building




26 Spring Gardens




Manchester M2 1AB




United Kingdom






Octagam 10 % solution for Infusion


10 % w/v


Solution for infusion


Intravenous use