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