8 July 2016 EMA/472578/20166 Procedure Management and Committees Support Division List of the names, pharmaceutical s, strengths of the medicinal products, routes of, marketing authorisation s in the member states for human and recombinant coagulation factor VIII containing medicinal products Article 31 of Directive 2001/83/EC Procedure number: EMEA/H/A-31/1448 Advate EMEA/H/C/0520/A31/0078 Elocta EMEA/H/C/3964/A31/0006 Helixate Nexgen EMEA/H/C/0276/A31/0178 Iblias EMEA/H/C/4147/A31/0002 Kogenate EMEA/H/C/0275/A31/0185 Kovaltry EMEA/H/C/3825/A31/0004 Novoeight EMEA/H/C/2719/A31/0014 Nuwiq EMEA/H/C/2813/A31/0015 Obizur EMEA/H/C/2792/A31/0003 Refacto AF EMEA/H/C/0232/A31/0134 Voncento EMEA/H/C/2493/A31/0022 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact An agency of the European Union European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged.
Nationally authorised products Member State in Austria Immunate Baxter Ag, Von Factor 100 I.U. /, Von Factor 75 I.U. / Austria Immunate Baxter Ag, Von Factor 50 I.U. /, Von Factor 38 I.U. / Austria Optivate Bio Products Laboratory 100 I.U. / Austria Haemoctin Sdh Biotest Austria 100 I.U. / Austria Haemoctin Sdh Biotest Austria EMA/472578/2016 Page 2/124
50 I.U. / Austria Beriate Csl Behring 100 I.U. / /Infusion Austria Beriate Csl Behring 200 I.U. / /Infusion Austria Haemate P Csl Behring, Von Factor 50 I.U. /, Von Factor 120 I.U. / /Infusion Austria Haemate P Csl Behring, Von Factor 66.6 I.U. /, Von Factor 160 I.U. / /Infusion Austria Octanate Octapharma Pharmazeutika EMA/472578/2016 Page 3/124
Produktionsgesmbh 1000 Austria Octanate Octapharma Pharmazeutika Produktionsgesmbh 250 Austria Octanate Octapharma Pharmazeutika Produktionsgesmbh 500 Austria Octanate Lv Octapharma Pharmazeutika Produktionsgesmbh 1000 Austria Octanate Lv Octapharma Pharmazeutika Produktionsgesmbh 500 Austria Wilate Octapharma Pharmazeutika, Von Produktionsgesmbh Factor 1000, Von Factor 1000 Austria Wilate Octapharma Pharmazeutika, Von EMA/472578/2016 Page 4/124
Produktionsgesmbh Factor 450, Von Factor 400 I.U. Vial Austria Wilate Octapharma Pharmazeutika Produktionsgesmbh, Von Factor 500, Von Factor 500 I.U. Vial Austria Wilate Octapharma Pharmazeutika Produktionsgesmbh, Von Factor 900, Von Factor 800 I.U. Vial Belgium Recombinate Baxalta Innovations (Rdna) (Rdna) 100 I.U. / Belgium Recombinate Baxalta Innovations EMA/472578/2016 Page 5/124
(Rdna) (Rdna) 200 I.U. / Belgium Recombinate Baxalta Innovations (Rdna) (Rdna) 50 I.U. / Belgium Optivate Bio Products Laboratory 100 I.U. / Belgium Factane Cafdcf, Von Factor 100 I.U. /, Von Factor 20 I.U. / Belgium Haemate P Csl Behring, Von Factor 50 I.U. /, Von Factor 120 I.U. /Infusion EMA/472578/2016 Page 6/124
/ Belgium Haemate P Csl Behring, Von Factor 66.6 I.U. /, Von Factor 160 I.U. / /Infusion Belgium Octanate Octapharma Benelux S.A./N.V. 1000 Belgium Octanate Octapharma Benelux S.A./N.V. 250 Belgium Octanate Octapharma Benelux S.A./N.V. 500 Belgium Wilate Octapharma Benelux S.A./N.V., Von Factor 1000, Von Factor 1000 EMA/472578/2016 Page 7/124
Belgium Wilate Octapharma Benelux S.A./N.V., Von Factor 500, Von Factor 500 I.U. Vial Bulgaria рекомбинейт Baxter Ag (Rdna) (Rdna) 100 I.U. / Bulgaria рекомбинейт Baxter Ag (Rdna) (Rdna) 200 I.U. / Bulgaria рекомбинейт Baxter Ag (Rdna) (Rdna) 50 I.U. / Bulgaria хемоктин Biotest Pharma 100 I.U. / EMA/472578/2016 Page 8/124
Bulgaria хемоктин Biotest Pharma 50 I.U. / Bulgaria бериате Csl Behring 100 I.U. / /Infusion Bulgaria бериате Csl Behring 200 I.U. / /Infusion Bulgaria фанди Instituto Grifols, S.A., Von Factor 100 I.U. /, Von Factor 120 I.U. / Bulgaria фанди Instituto Grifols, S.A., Von Factor 25 I.U. /, Von Factor 30 I.U. / EMA/472578/2016 Page 9/124
Bulgaria фанди Instituto Grifols, S.A., Von Factor 50 I.U. /, Von Factor 60 I.U. / Bulgaria Emoclot Kedrion S.P.A. 500 I.U. / 10 Infusion Bulgaria Octanate Octapharma (Ip)- 1000 Bulgaria Octanate Octapharma (Ip)- 500 Bulgaria Wilate Octapharma (Ip)-, Von Factor 1000, Von Factor 1000 EMA/472578/2016 Page 10/124
Bulgaria Wilate Octapharma (Ip)-, Von Factor 500, Von Factor 500 I.U. Vial Croatia Immunate Agmar D.O.O., Von Factor 100 I.U. /, Von Factor 75 I.U. / Croatia Recombinate Agmar D.O.O. (Rdna) (Rdna) 100 I.U. / Croatia Recombinate Agmar D.O.O. (Rdna) (Rdna) 25 I.U. / Croatia Recombinate Agmar D.O.O. (Rdna) EMA/472578/2016 Page 11/124
(Rdna) 50 I.U. / Croatia Fanhdi Biognost D.O.O. 100 I.U. / Croatia Fanhdi Biognost D.O.O. 25 I.U. / Croatia Fanhdi Biognost D.O.O. 50 I.U. / Croatia Fanhdi Biognost D.O.O., Von Factor 100 I.U. /, Von Factor 120 I.U. / Croatia Fanhdi Biognost D.O.O., Von Factor 25 I.U. /, Von EMA/472578/2016 Page 12/124
Factor 60 I.U. / Croatia Fanhdi Biognost D.O.O., Von Factor 50 I.U. /, Von Factor 60 I.U. / Croatia Beriate Csl Behring 100 I.U. / /Infusion Croatia Beriate Csl Behring 200 I.U. / /Infusion Croatia Haemate P Csl Behring, Von Factor 50 I.U. /, Von Factor 120 I.U. / /Infusion Croatia Octanate Jana Pharm D.O.O. EMA/472578/2016 Page 13/124
1000 Croatia Octanate Jana Pharm D.O.O. 250 Croatia Octanate Jana Pharm D.O.O. 500 Croatia Wilate Jana Pharm D.O.O., Von Factor 1000, Von Factor 1000 Croatia Wilate Jana Pharm D.O.O., Von Factor 500, Von Factor 500 I.U. Vial Croatia Emoclot Jasika D.O.O. EMA/472578/2016 Page 14/124
1000 I.U. / 10 Infusion Croatia Emoclot Jasika D.O.O. 500 I.U. / 10 Infusion Cyprus Immunate Baxter Hellas, Von Factor 100 I.U. /, Von Factor 75 I.U. / Cyprus Immunate Baxter Hellas, Von Factor 50 I.U. /, Von Factor 38 I.U. / Cyprus Recombinate Baxter Hellas (Rdna) (Rdna) 100 I.U. / EMA/472578/2016 Page 15/124
Cyprus Recombinate Baxter Hellas (Rdna) (Rdna) 25 I.U. / Cyprus Recombinate Baxter Hellas (Rdna) (Rdna) 50 I.U. / Cyprus Optivate Bio Products Laboratory 100 I.U. / Cyprus Dried Fraction, Type 8y Bio Products Bio Products Laboratory, Von Factor 25 I.U. /, Von Factor 26 I.U. / Powder For Solution For Cyprus Haemate P Csl Behring, Von Factor 66.6 I.U. /, Von /Infusion EMA/472578/2016 Page 16/124
Factor 160 I.U. / Cyprus Octanate Octapharma (Ip)- 1000 Cyprus Octanate Octapharma (Ip)- 250 Cyprus Octanate Octapharma (Ip)- 500 Cyprus Wilate Octapharma (Ip)-, Von Factor 1000, Von Factor 1000 Cyprus Wilate Octapharma (Ip)-, Von Factor 450, Von EMA/472578/2016 Page 17/124
Factor 400 I.U. Vial Cyprus Wilate Octapharma (Ip)-, Von Factor 500, Von Factor 500 I.U. Vial Cyprus Wilate Octapharma (Ip)-, Von Factor 900, Von Factor 800 I.U. Vial Czech Republic Immunate Stim Plus Baxter Ag, Von Factor 100 I.U. /, Von Factor 75 I.U. / Czech Republic Immunate Stim Plus Baxter Ag, Von EMA/472578/2016 Page 18/124
Factor 50 I.U. /, Von Factor 38 I.U. / Czech Republic Recombinate Baxter Ag (Rdna) (Rdna) 100 I.U. / Czech Republic Recombinate Baxter Ag (Rdna) (Rdna) 200 I.U. / Czech Republic Recombinate Baxter Ag (Rdna) (Rdna) 50 I.U. / Czech Republic Recombinate Baxter Czech Spol. S R.O. (Rdna) (Rdna) 100 I.U. / Czech Republic Recombinate Baxter Czech Spol. S R.O. (Rdna) EMA/472578/2016 Page 19/124
(Rdna) 200 I.U. / Czech Republic Recombinate Baxter Czech Spol. S R.O. (Rdna) (Rdna) 50 I.U. / Czech Republic Optivate Bio Products Laboratory 100 I.U. / Czech Republic Haemoctin Sdh Biotest Pharma 100 I.U. / Czech Republic Haemoctin Sdh Biotest Pharma 50 I.U. / Czech Republic Beriate Csl Behring 100 I.U. / /Infusion Czech Republic Beriate Csl Behring 200 I.U. / /Infusion EMA/472578/2016 Page 20/124
Czech Republic Haemate P Csl Behring (Rdna), Von Factor (Rdna) 50 I.U. /, Von Factor 120 I.U. / /Infusion Czech Republic Haemate P Csl Behring (Rdna), Von Factor (Rdna) 66.6 I.U. /, Von Factor 160 I.U. / /Infusion Czech Republic Fanhdi Instituto Grifols, S.A., Von Factor 100 I.U. /, Von Factor 120 I.U. / Czech Republic Fanhdi Instituto Grifols, S.A., Von Factor 25 EMA/472578/2016 Page 21/124
I.U. /, Von Factor 30 I.U. / Czech Republic Fanhdi Instituto Grifols, S.A., Von Factor 50 I.U. /, Von Factor 60 I.U. / Czech Republic Octanate Octapharma (Ip)- 1000 Czech Republic Octanate Octapharma (Ip)- 250 Czech Republic Octanate Octapharma (Ip)- 500 Czech Republic Wilate Octapharma (Ip)-, Von Factor 1000 EMA/472578/2016 Page 22/124
, Von Factor 1000 Czech Republic Wilate Octapharma (Ip)-, Von Factor 500, Von Factor 500 I.U. Vial Denmark Haemate Csl Behring, Von Factor 50 I.U. /, Von Factor 120 I.U. / /Infusion Denmark Haemate Csl Behring, Von Factor 66.6 I.U. /, Von Factor 160 I.U. /Infusion EMA/472578/2016 Page 23/124
/ Denmark Octanate Octapharma Ab 1000 Denmark Octanate Octapharma Ab 250 Denmark Octanate Octapharma Ab 500 Denmark Octanate Lv Octapharma Ab 1000 Denmark Octanate Lv Octapharma Ab 500 Denmark Wilnativ Octapharma Ab, Von Factor 1000, Von Factor 1000 EMA/472578/2016 Page 24/124
Denmark Wilnativ Octapharma Ab, Von Factor 500, Von Factor 500 I.U. Vial Estonia Immunate Baxalta Innovations, Von Factor 100 I.U. /, Von Factor 75 I.U. / Estonia Immunate Baxalta Innovations, Von Factor 50 I.U. /, Von Factor 38 I.U. / Estonia Recombinate Baxalta Innovations (Rdna) EMA/472578/2016 Page 25/124
(Rdna) 100 I.U. / Estonia Recombinate Baxalta Innovations (Rdna) (Rdna) 200 I.U. / Estonia Recombinate Baxalta Innovations (Rdna) (Rdna) 25 I.U. / Estonia Recombinate Baxalta Innovations (Rdna) (Rdna) 50 I.U. / Estonia Optivate Bio Products Laboratory 100 I.U. / Estonia Wilate Octapharma (Ip)-, Von Factor 100 I.U. /, Von Factor 100 I.U. EMA/472578/2016 Page 26/124
/ Estonia Wilate Octapharma (Ip)-, Von Factor 100 I.U. /, Von Factor 1000 I.U. / Estonia Octanate Octapharma Ab 1000 Estonia Octanate Octapharma Ab 500 Finland Immunate Baxalta Innovations, Von Factor 100 I.U. /, Von Factor 75 I.U. / Finland Immunate Baxalta Innovations, Von Factor 50 EMA/472578/2016 Page 27/124
I.U. /, Von Factor 38 I.U. / Finland Haemate Csl Behring, Von Factor 50 I.U. /, Von Factor 120 I.U. / /Infusion Finland Haemate Csl Behring, Von Factor 66.6 I.U. /, Von Factor 160 I.U. / /Infusion Finland Octafil Octapharma Ab 1000 Finland Octafil Octapharma Ab 250 EMA/472578/2016 Page 28/124
Finland Octafil Octapharma Ab 500 Finland Octafil Lv Octapharma Ab 1000 Finland Octafil Lv Octapharma Ab 500 Finland Wilate Octapharma Ab, Von Factor 1000, Von Factor 1000 Finland Wilate Octapharma Ab, Von Factor 500, Von Factor 500 I.U. EMA/472578/2016 Page 29/124
Vial Finland Amofil Sanquin Plasma Products B.V. 100 I.U. / Powder For Solution For Finland Amofil Sanquin Plasma Products B.V. 500 I.U. / Powder For Solution For France Factane Lfb Biomedicaments 100 I.U. / France Factane Lfb Biomedicaments 200 I.U. / France Octanate Octapharma France 100 I.U. / France Octanate Octapharma France 1000 France Octanate Octapharma France EMA/472578/2016 Page 30/124
200 I.U. / France Octanate Octapharma France 250 France Octanate Octapharma France 500 Germany Immunate Baxalta Deutschland, Von Factor 100 I.U. /, Von Factor 60 I.U. / Germany Immunate Baxalta Deutschland, Von Factor 50 I.U. /, Von Factor 30 I.U. / Germany Recombinate Baxalta Deutschland (Rdna) EMA/472578/2016 Page 31/124
(Rdna) 1000 I.U. / 10 Germany Optivate Bio Products Laboratory 100 I.U. / Germany Haemoctin Sdh Biotest Pharma 100 I.U. / Germany Haemoctin Sdh Biotest Pharma 50 I.U. / Germany Beriate Csl Behring 100 I.U. / Germany Haemate P Csl Behring, Von Factor 50 I.U. /, Von Factor 120 I.U. / /Infusion /Infusion Germany Haemate P Csl Behring EMA/472578/2016 Page 32/124
, Von Factor 66.6 I.U. /, Von Factor 160 I.U. / /Infusion Germany Fanhdi Grifols Deutschland 100 I.U. / Germany Fanhdi Grifols Deutschland 25 I.U. / Germany Fanhdi Grifols Deutschland 50 I.U. / Germany Faktor Viii Sdh Aus Plasma Vom Menschen Gewonnener Blutgerinnungsfaktor Viii Intersero Intersero 100 I.U. / Germany Faktor Viii Sdh Aus Plasma Vom Menschen Intersero 50 EMA/472578/2016 Page 33/124
Gewonnener Blutgerinnungsfaktor Viii Intersero I.U. / Germany Octanate Octapharma 1000 Germany Octanate Octapharma 250 Germany Octanate Octapharma 500 Germany Wilate Octapharma, Von Factor 1000, Von Factor 1000 Germany Wilate Octapharma, Von Factor 450, Von EMA/472578/2016 Page 34/124
Factor 400 I.U. Vial Germany Wilate Octapharma, Von Factor 500, Von Factor 500 I.U. Vial Germany Wilate Octapharma, Von Factor 900, Von Factor 800 I.U. Vial Greece Immunate Baxter Hellas, Von Factor 100 I.U. /, Von Factor 75 I.U. / Greece Immunate Baxter Hellas EMA/472578/2016 Page 35/124
, Von Factor 50 I.U. /, Von Factor 38 I.U. / Greece Recombinate Baxter Hellas (Rdna) (Rdna) 100 I.U. / Greece Recombinate Baxter Hellas (Rdna) (Rdna) 25 I.U. / Greece Recombinate Baxter Hellas (Rdna) (Rdna) 50 I.U. / Greece Haemate P Csl Behring Mepe, Von Factor 50 I.U. /, Von /Infusion EMA/472578/2016 Page 36/124
Factor 120 I.U. / Greece Haemate P Csl Behring Mepe, Von Factor 66.6 I.U. /, Von Factor 160 I.U. / /Infusion Greece Fanhdi Demo Abee 100 I.U. / Greece Fanhdi Demo Abee 25 I.U. / Greece Fanhdi Demo Abee 50 I.U. / Greece Octanate Octapharma Hellas A.E. 1000 Greece Octanate Octapharma Hellas A.E. EMA/472578/2016 Page 37/124
250 Greece Octanate Octapharma Hellas A.E. 500 Greece Wilate Octapharma Hellas A.E., Von Factor 1000, Von Factor 1000 Greece Wilate Octapharma Hellas A.E., Von Factor 500, Von Factor 500 I.U. Vial Greece Haemoctin Vianex S.A. 100 I.U. / Greece Haemoctin Vianex S.A. EMA/472578/2016 Page 38/124
50 I.U. / Hungary Immunate S/D Baxalta Innovations, Von Factor 100 I.U. /, Von Factor 75 I.U. / Hungary Immunate S/D Baxalta Innovations, Von Factor 50 I.U. /, Von Factor 38 I.U. / Hungary Recombinate Baxalta Innovations (Rdna) (Rdna) 100 I.U. / Hungary Recombinate Baxalta Innovations (Rdna) (Rdna) 200 I.U. / EMA/472578/2016 Page 39/124
Hungary Recombinate Baxalta Innovations (Rdna) (Rdna) 50 I.U. / Hungary Optivate Bio Products Laboratory 100 I.U. / Hungary Haemoctin Biotest Hungaria Kft. 100 I.U. / Hungary Haemoctin Biotest Hungaria Kft. 50 I.U. / Hungary Beriate Csl Behring 100 I.U. / /Infusion Hungary Beriate Csl Behring 200 I.U. / /Infusion Hungary Haemate Csl Behring, Von Factor 50 /Infusion EMA/472578/2016 Page 40/124
I.U. /, Von Factor 120 I.U. / Hungary Haemate Csl Behring, Von Factor 66.6 I.U. /, Von Factor 160 I.U. / /Infusion Hungary Humaclot Bioplazma Manufacturing And Trading Llc 100 I.U. / Hungary Humaclot Bioplazma Manufacturing And Trading Llc 50 I.U. / Hungary Humafactor-8 Bioplazma Manufacturing And Trading Llc 100 I.U. / Hungary Fanhdi Instituto Grifols, S.A. 100 EMA/472578/2016 Page 41/124
I.U. / Hungary Fanhdi Instituto Grifols, S.A. 25 I.U. / Hungary Fanhdi Instituto Grifols, S.A. 50 I.U. / Hungary Octanate Octapharma (Ip)- 1000 Hungary Octanate Octapharma (Ip)- 250 Hungary Octanate Octapharma (Ip)- 500 Hungary Wilate Octapharma (Ip)-, Von Factor 1000, Von Factor 1000 EMA/472578/2016 Page 42/124
Hungary Wilate Octapharma (Ip)-, Von Factor 500, Von Factor 500 I.U. Vial Iceland Obizur Baxalta Innovations 500 Units Vial Iceland Advate Baxter Ag Octocog Alfa Octocog Alfa 100 I.U. / Iceland Advate Baxter Ag Octocog Alfa Octocog Alfa 125 I.U. / Iceland Advate Baxter Ag Octocog Alfa Octocog Alfa 200 I.U. / Iceland Advate Baxter Ag Octocog Alfa Octocog Alfa 250 I.U. / Iceland Advate Baxter Ag Octocog Alfa Octocog Alfa 300 I.U. / EMA/472578/2016 Page 43/124
Iceland Advate Baxter Ag Octocog Alfa Octocog Alfa 400 I.U. / Iceland Advate Baxter Ag Octocog Alfa Octocog Alfa 50 I.U. / Iceland Advate Baxter Ag Octocog Alfa Octocog Alfa 500 I.U. / Iceland Advate Baxter Ag Octocog Alfa Octocog Alfa 600 I.U. / Iceland Advate Baxter Ag Octocog Alfa Octocog Alfa 750 I.U. / Iceland Helixate Nexgen Bayer Pharma Ag Octocog Alfa Octocog Alfa 1000 I.U. / 2.5 Iceland Helixate Nexgen Bayer Pharma Ag Octocog Alfa Octocog Alfa 2000 I.U. / 5 Iceland Helixate Nexgen Bayer Pharma Ag Octocog Alfa Octocog Alfa 250 I.U. / 2.5 Iceland Helixate Nexgen Bayer Pharma Ag Octocog Alfa Octocog Alfa 3000 I.U. / 5 EMA/472578/2016 Page 44/124
Iceland Helixate Nexgen Bayer Pharma Ag Octocog Alfa Octocog Alfa 500 I.U. / 2.5 Iceland Iblias Bayer Pharma Ag Octocog Alfa Octocog Alfa 1000 I.U. / 2.5 Iceland Iblias Bayer Pharma Ag Octocog Alfa Octocog Alfa 2000 I.U. / 5 Iceland Iblias Bayer Pharma Ag Octocog Alfa Octocog Alfa 250 I.U. / 2.5 Iceland Iblias Bayer Pharma Ag Octocog Alfa Octocog Alfa 3000 I.U. / 5 Iceland Iblias Bayer Pharma Ag Octocog Alfa Octocog Alfa 500 I.U. / 2.5 Iceland Kogenate Bayer Pharma Ag Octocog Alfa Octocog Alfa 1000 I.U. / 2.5 Iceland Kogenate Bayer Pharma Ag Octocog Alfa Octocog Alfa 2000 I.U. / 5 Iceland Kogenate Bayer Pharma Ag Octocog Alfa Octocog Alfa 250 I.U. / 2.5 EMA/472578/2016 Page 45/124
Iceland Kogenate Bayer Pharma Ag Octocog Alfa Octocog Alfa 3000 I.U. / 5 Iceland Kogenate Bayer Pharma Ag Octocog Alfa Octocog Alfa 500 I.U. / 2.5 Iceland Kovaltry Bayer Pharma Ag Octocog Alfa Octocog Alfa 1000 I.U. / 2.5 Iceland Kovaltry Bayer Pharma Ag Octocog Alfa Octocog Alfa 2000 I.U. / 5 Iceland Kovaltry Bayer Pharma Ag Octocog Alfa Octocog Alfa 250 I.U. / 2.5 Iceland Kovaltry Bayer Pharma Ag Octocog Alfa Octocog Alfa 3000 I.U. / 5 Iceland Kovaltry Bayer Pharma Ag Octocog Alfa Octocog Alfa 500 I.U. / 2.5 Iceland Novoeight Novo Nordisk A/S Turoctocog Alfa Turoctocog Alfa 125 I.U. / Iceland Novoeight Novo Nordisk A/S Turoctocog Alfa Turoctocog Alfa 250 I.U. / EMA/472578/2016 Page 46/124
Iceland Novoeight Novo Nordisk A/S Turoctocog Alfa Turoctocog Alfa 375 I.U. / Iceland Novoeight Novo Nordisk A/S Turoctocog Alfa Turoctocog Alfa 500 I.U. / Iceland Novoeight Novo Nordisk A/S Turoctocog Alfa Turoctocog Alfa 62.5 I.U. / Iceland Novoeight Novo Nordisk A/S Turoctocog Alfa Turoctocog Alfa 750 I.U. / Iceland Nuwiq Octapharma Ab (Rdna) (Rdna) 250 I.U. Vial Iceland Nuwiq Octapharma Ab (Rdna) (Rdna) 400 I.U. / Iceland Nuwiq Octapharma Ab (Rdna) (Rdna) 500 I.U. Vial EMA/472578/2016 Page 47/124
Iceland Nuwiq Octapharma Ab (Rdna) (Rdna) 800 I.U. / Iceland Refacto Af Pfizer Limited Moroctocog Alfa Moroctocog Alfa 125 I.U. / Iceland Refacto Af Pfizer Limited Moroctocog Alfa Moroctocog Alfa 250 I.U. / Iceland Refacto Af Pfizer Limited Moroctocog Alfa Moroctocog Alfa 500 I.U. / Iceland Refacto Af Pfizer Limited Moroctocog Alfa Moroctocog Alfa 62.5 I.U. / Iceland Refacto Af Pfizer Limited Moroctocog Alfa Moroctocog Alfa 125 I.U. / Iceland Refacto Af Pfizer Limited Moroctocog Alfa Moroctocog Alfa 250 I.U. / Iceland Refacto Af Pfizer Limited Moroctocog Alfa Moroctocog Alfa 500 I.U. / In Pre- Filled Syringe In Pre- Filled Syringe EMA/472578/2016 Page 48/124
Iceland Refacto Af Pfizer Limited Moroctocog Alfa Moroctocog Alfa 62.5 I.U. / Iceland Refacto Af Pfizer Limited Moroctocog Alfa Moroctocog Alfa 750 I.U. / Ireland Recombinate Baxalta Innovations (Rdna) (Rdna) 100 I.U. / Ireland Recombinate Baxalta Innovations (Rdna) (Rdna) 25 I.U. / Ireland Recombinate Baxalta Innovations (Rdna) (Rdna) 50 I.U. / Ireland Optivate Bio Products Laboratory 100 In Pre- Filled Syringe In Pre- Filled Syringe In Pre- Filled Syringe EMA/472578/2016 Page 49/124
I.U. / Ireland Fanhdi Instituto Grifols, S.A. 100 I.U. / Ireland Fanhdi Instituto Grifols, S.A. 25 I.U. / Ireland Fanhdi Instituto Grifols, S.A. 50 I.U. / Ireland Octanate Octapharma-Ltd 1000 Ireland Octanate Octapharma-Ltd 250 Ireland Octanate Octapharma-Ltd 500 Ireland Wilate Octapharma-Ltd, Von EMA/472578/2016 Page 50/124
Factor 1000, Von Factor 1000 Ireland Wilate Octapharma-Ltd, Von Factor 500, Von Factor 500 I.U. Vial Italy Recombinate Baxalta Innovations (Rdna) (Rdna) 100 I.U. / Italy Recombinate Baxalta Innovations (Rdna) (Rdna) 200 I.U. / Italy Recombinate Baxalta Innovations (Rdna) (Rdna) 25 I.U. EMA/472578/2016 Page 51/124
/ Italy Recombinate Baxalta Innovations (Rdna) (Rdna) 250 I.U. / 5 Italy Recombinate Baxalta Innovations (Rdna) (Rdna) 50 I.U. / Italy Talate Baxalta Innovations, Von Factor 100 I.U. /, Von Factor 75 I.U. / Italy Talate Baxalta Innovations, Von Factor 50 I.U. /, Von Factor 38 I.U. / Italy Haemoctin Biotest Pharma EMA/472578/2016 Page 52/124
100 I.U. / Italy Haemoctin Biotest Pharma 50 I.U. / Italy Beriate Csl Behring 100 I.U. / /Infusion Italy Haemate P Csl Behring, Von Factor 50 I.U. /, Von Factor 120 I.U. / /Infusion Italy Haemate P Csl Behring, Von Factor 66.6 I.U. /, Von Factor 160 I.U. / /Infusion Italy Alphanate Grifols Italia S.P.A EMA/472578/2016 Page 53/124
, Von Factor 100 I.U. /, Von Factor 120 I.U. / Infusion Italy Alphanate Grifols Italia S.P.A, Von Factor 150 I.U. /, Von Factor 180 I.U. / Infusion Italy Alphanate Grifols Italia S.P.A, Von Factor 50 I.U. /, Von Factor 60 I.U. / Infusion Italy Fanhdi Instituto Grifols, S.A., Von Factor 100 I.U. /, Von Infusion EMA/472578/2016 Page 54/124
Factor 120 I.U. / Italy Fanhdi Instituto Grifols, S.A., Von Factor 25 I.U. /, Von Factor 30 I.U. / Infusion Italy Fanhdi Instituto Grifols, S.A., Von Factor 50 I.U. /, Von Factor 60 I.U. / Infusion Italy Emoclot Kedrion S.P.A. 1000 I.U. / 10 Infusion Italy Emoclot Kedrion S.P.A. 500 I.U. / 10 Infusion Italy Emowil Kedrion S.P.A. EMA/472578/2016 Page 55/124
1000 I.U. / 10 Infusion Italy Emowil Kedrion S.P.A. 500 I.U. / 10 Infusion Italy Klott Kedrion S.P.A. 1000 I.U. / 10 Infusion Italy Klott Kedrion S.P.A. 500 I.U. / 10 Infusion Italy Octanate Octapharma Italy S.P.A. 1000 Italy Octanate Octapharma Italy S.P.A. 250 Italy Octanate Octapharma Italy S.P.A. 500 EMA/472578/2016 Page 56/124
Italy Wilate Octapharma Italy S.P.A., Von Factor 1000, Von Factor 1000 Italy Wilate Octapharma Italy S.P.A., Von Factor 450, Von Factor 400 I.U. Vial Italy Wilate Octapharma Italy S.P.A., Von Factor 500, Von Factor 500 I.U. Vial Italy Wilate Octapharma Italy S.P.A., Von Factor 900, EMA/472578/2016 Page 57/124
Von Factor 800 I.U. Vial Latvia Immunate Baxalta Innovations, Von Factor 100 I.U. /, Von Factor 75 I.U. / Latvia Immunate Baxalta Innovations, Von Factor 50 I.U. /, Von Factor 38 I.U. / Latvia Recombinate Baxalta Innovations (Rdna) (Rdna) 100 I.U. / Latvia Recombinate Baxalta Innovations (Rdna) EMA/472578/2016 Page 58/124
(Rdna) 200 I.U. / Latvia Recombinate Baxalta Innovations (Rdna) (Rdna) 50 I.U. / Latvia Optivate Bio Products Laboratory 100 I.U. / Latvia Dried Bio Products Powder For Solution Fraction, Type 8y Bio Products Laboratory, Von Factor 25 I.U. /, Von Factor 26 I.U. / For Latvia Octanate Octapharma (Ip)- 1000 Latvia Octanate Octapharma (Ip)- 250 Latvia Octanate Octapharma (Ip)- EMA/472578/2016 Page 59/124
500 Latvia Wilate Octapharma (Ip)-, Von Factor 1000, Von Factor 1000 Latvia Wilate Octapharma (Ip)-, Von Factor 500, Von Factor 500 I.U. Vial Liechtenstein Obizur Baxalta Innovations 500 Units Vial Liechtenstein Advate Baxter Ag Octocog Alfa Octocog Alfa 100 I.U. / Liechtenstein Advate Baxter Ag Octocog Alfa Octocog Alfa 125 I.U. / EMA/472578/2016 Page 60/124
Liechtenstein Advate Baxter Ag Octocog Alfa Octocog Alfa 200 I.U. / Liechtenstein Advate Baxter Ag Octocog Alfa Octocog Alfa 250 I.U. / Liechtenstein Advate Baxter Ag Octocog Alfa Octocog Alfa 300 I.U. / Liechtenstein Advate Baxter Ag Octocog Alfa Octocog Alfa 400 I.U. / Liechtenstein Advate Baxter Ag Octocog Alfa Octocog Alfa 50 I.U. / Liechtenstein Advate Baxter Ag Octocog Alfa Octocog Alfa 500 I.U. / Liechtenstein Advate Baxter Ag Octocog Alfa Octocog Alfa 600 I.U. / Liechtenstein Advate Baxter Ag Octocog Alfa Octocog Alfa 750 I.U. / Liechtenstein Helixate Nexgen Bayer Pharma Ag Octocog Alfa Octocog Alfa 1000 I.U. / 2.5 EMA/472578/2016 Page 61/124
Liechtenstein Helixate Nexgen Bayer Pharma Ag Octocog Alfa Octocog Alfa 2000 I.U. / 5 Liechtenstein Helixate Nexgen Bayer Pharma Ag Octocog Alfa Octocog Alfa 250 I.U. / 2.5 Liechtenstein Helixate Nexgen Bayer Pharma Ag Octocog Alfa Octocog Alfa 3000 I.U. / 5 Liechtenstein Helixate Nexgen Bayer Pharma Ag Octocog Alfa Octocog Alfa 500 I.U. / 2.5 Liechtenstein Iblias Bayer Pharma Ag Octocog Alfa Octocog Alfa 1000 I.U. / 2.5 Liechtenstein Iblias Bayer Pharma Ag Octocog Alfa Octocog Alfa 2000 I.U. / 5 Liechtenstein Iblias Bayer Pharma Ag Octocog Alfa Octocog Alfa 250 I.U. / 2.5 Liechtenstein Iblias Bayer Pharma Ag Octocog Alfa Octocog Alfa 3000 I.U. / 5 Liechtenstein Iblias Bayer Pharma Ag Octocog Alfa Octocog Alfa 500 I.U. / 2.5 EMA/472578/2016 Page 62/124
Liechtenstein Kogenate Bayer Pharma Ag Octocog Alfa Octocog Alfa 1000 I.U. / 2.5 Liechtenstein Kogenate Bayer Pharma Ag Octocog Alfa Octocog Alfa 2000 I.U. / 5 Liechtenstein Kogenate Bayer Pharma Ag Octocog Alfa Octocog Alfa 250 I.U. / 2.5 Liechtenstein Kogenate Bayer Pharma Ag Octocog Alfa Octocog Alfa 3000 I.U. / 5 Liechtenstein Kogenate Bayer Pharma Ag Octocog Alfa Octocog Alfa 500 I.U. / 2.5 Liechtenstein Kovaltry Bayer Pharma Ag Octocog Alfa Octocog Alfa 1000 I.U. / 2.5 Liechtenstein Kovaltry Bayer Pharma Ag Octocog Alfa Octocog Alfa 2000 I.U. / 5 Liechtenstein Kovaltry Bayer Pharma Ag Octocog Alfa Octocog Alfa 250 I.U. / 2.5 Liechtenstein Kovaltry Bayer Pharma Ag Octocog Alfa Octocog Alfa 3000 I.U. / 5 EMA/472578/2016 Page 63/124
Liechtenstein Kovaltry Bayer Pharma Ag Octocog Alfa Octocog Alfa 500 I.U. / 2.5 Liechtenstein Novoeight Novo Nordisk Turoctocog Alfa Turoctocog Alfa Pharma Ag 125 I.U. / Liechtenstein Novoeight Novo Nordisk Turoctocog Alfa Turoctocog Alfa Pharma Ag 250 I.U. / Liechtenstein Novoeight Novo Nordisk Turoctocog Alfa Turoctocog Alfa Pharma Ag 375 I.U. / Liechtenstein Novoeight Novo Nordisk Turoctocog Alfa Turoctocog Alfa Pharma Ag 500 I.U. / Liechtenstein Novoeight Novo Nordisk Turoctocog Alfa Turoctocog Alfa Pharma Ag 62.5 I.U. / Liechtenstein Novoeight Novo Nordisk Turoctocog Alfa Turoctocog Alfa Pharma Ag 750 I.U. / Liechtenstein Nuwiq Octapharma Ab (Rdna) (Rdna) 250 I.U. Vial Liechtenstein Nuwiq Octapharma Ab EMA/472578/2016 Page 64/124
(Rdna) (Rdna) 400 I.U. / Liechtenstein Nuwiq Octapharma Ab (Rdna) (Rdna) 500 I.U. Vial Liechtenstein Nuwiq Octapharma Ab (Rdna) (Rdna) 800 I.U. / Liechtenstein Refacto Af Pfizer Limited Moroctocog Alfa Moroctocog Alfa 125 I.U. / Liechtenstein Refacto Af Pfizer Limited Moroctocog Alfa Moroctocog Alfa 250 I.U. / Liechtenstein Refacto Af Pfizer Limited Moroctocog Alfa Moroctocog Alfa 500 I.U. / Liechtenstein Refacto Af Pfizer Limited Moroctocog Alfa Moroctocog Alfa 62.5 I.U. / Liechtenstein Refacto Af Pfizer Limited Moroctocog Alfa Moroctocog EMA/472578/2016 Page 65/124
Alfa 125 I.U. / In Pre- Filled Syringe Liechtenstein Refacto Af Pfizer Limited Moroctocog Alfa Moroctocog Alfa 250 I.U. / In Pre- Filled Syringe Liechtenstein Refacto Af Pfizer Limited Moroctocog Alfa Moroctocog Alfa 500 I.U. / In Pre- Filled Syringe Liechtenstein Refacto Af Pfizer Limited Moroctocog Alfa Moroctocog Alfa 62.5 I.U. / In Pre- Filled Syringe Liechtenstein Refacto Af Pfizer Limited Moroctocog Alfa Moroctocog Alfa 750 I.U. / In Pre- Filled Syringe Lithuania Immunate Baxter Ag, Von Factor 100 I.U. /, Von Factor 75 I.U. / Lithuania Immunate Baxter Ag EMA/472578/2016 Page 66/124
, Von Factor 50 I.U. /, Von Factor 38 I.U. / Lithuania Recombinate Baxter Ag (Rdna) (Rdna) 100 I.U. / Lithuania Recombinate Baxter Ag (Rdna) (Rdna) 200 I.U. / Lithuania Recombinate Baxter Ag (Rdna) (Rdna) 50 I.U. / Lithuania Optivate Bio Products Laboratory 100 I.U. / Lithuania Haemoctin Sdh Biotest Pharma EMA/472578/2016 Page 67/124
100 I.U. / Lithuania Haemoctin Sdh Biotest Pharma 50 I.U. / Lithuania Octanate Octapharma (Ip)- 1000 Lithuania Octanate Octapharma (Ip)- 250 Lithuania Octanate Octapharma (Ip)- 500 Lithuania Wilate Octapharma (Ip)-, Von Factor 1000, Von Factor 1000 Lithuania Wilate Octapharma (Ip)-, Von EMA/472578/2016 Page 68/124
Factor 500, Von Factor 500 I.U. Vial Luxembourg Recombinate Baxalta Innovations (Rdna) (Rdna) 100 I.U. / Luxembourg Recombinate Baxalta Innovations (Rdna) (Rdna) 200 I.U. / Luxembourg Recombinate Baxalta Innovations (Rdna) (Rdna) 25 I.U. / Luxembourg Recombinate Baxalta Innovations (Rdna) (Rdna) 50 I.U. / Luxembourg Haemate P Csl Behring, Von EMA/472578/2016 Page 69/124
Factor 50 I.U. /, Von Factor 120 I.U. / Luxembourg Haemate P Csl Behring, Von Factor 66.6 I.U. /, Von Factor 160 I.U. / Luxembourg Factane Lfb Biomedicaments 100 I.U. / Luxembourg Octanate Octapharma Benelux S.A./N.V. 1000 Luxembourg Octanate Octapharma Benelux S.A./N.V. 250 Luxembourg Octanate Octapharma Benelux S.A./N.V. /Infusion /Infusion EMA/472578/2016 Page 70/124
500 Luxembourg Wilate Octapharma Benelux S.A./N.V., Von Factor 100, Von Factor 100 I.U. Vial Malta Recombinate Baxalta Innovations (Rdna) (Rdna) 1000 Malta Recombinate Baxalta Innovations (Rdna) (Rdna) 25 I.U. / Malta Recombinate Baxalta Innovations (Rdna) (Rdna) 50 I.U. / Malta Immunate Baxter Ag, Von Factor 100 EMA/472578/2016 Page 71/124
I.U. /, Von Factor 75 I.U. / Malta Immunate Baxter Ag, Von Factor 50 I.U. /, Von Factor 38 I.U. / Malta Optivate Bio Products Laboratory 100 I.U. / Malta Dried Fraction, Type 8y Bio Products Bio Products Laboratory, Von Factor 25 I.U. /, Von Factor 26 I.U. / Powder For Solution For Malta Haemoctin Sdh Biotest Pharma 100 EMA/472578/2016 Page 72/124
I.U. / Malta Haemoctin Sdh Biotest Pharma 50 I.U. / Malta Emoclot Kedrion S.P.A. 1000 I.U. / 10 Infusion Malta Octanate Octapharma (Ip)- 1000 Malta Octanate Octapharma (Ip)- 250 Malta Octanate Octapharma (Ip)- 500 Malta Octanate Lv Octapharma (Ip)- 1000 Malta Octanate Lv Octapharma (Ip)- EMA/472578/2016 Page 73/124
500 Malta Wilate Octapharma (Ip)-, Von Factor 90 I.U. /, Von Factor 80 I.U. / Netherlands Immunate Baxalta Innovations, Von Factor 100 I.U. /, Von Factor 75 I.U. / Netherlands Immunate Baxalta Innovations, Von Factor 50 I.U. /, Von Factor 38 I.U. / Netherlands Recombinate Baxalta Innovations (Rdna) EMA/472578/2016 Page 74/124
(Rdna) 100 I.U. / Netherlands Recombinate Baxalta Innovations (Rdna) (Rdna) 200 I.U. / Netherlands Recombinate Baxalta Innovations (Rdna) (Rdna) 25 I.U. / Netherlands Recombinate Baxalta Innovations (Rdna) (Rdna) 50 I.U. / Netherlands Optivate Bio Products Laboratory 100 I.U. / Netherlands Haemate P Csl Behring, Von Factor 50 I.U. /, Von /Infusion EMA/472578/2016 Page 75/124
Factor 120 I.U. / Netherlands Haemate P Csl Behring, Von Factor 66.6 I.U. /, Von Factor 160 I.U. / /Infusion Netherlands Alphanate Instituto Grifols, S.A., Von Factor 100 I.U. /, Von Factor 25 I.U. / Netherlands Alphanate Instituto Grifols, S.A., Von Factor 50 I.U. /, Von Factor 12.5 I.U. / Netherlands Octanate Octapharma 1000 EMA/472578/2016 Page 76/124
Netherlands Octanate Octapharma 250 Netherlands Octanate Octapharma 500 Netherlands Octanate Lv Octapharma 1000 Netherlands Octanate Lv Octapharma 500 Netherlands Wilate Octapharma, Von Factor 1000, Von Factor 1000 Netherlands Wilate Octapharma, Von Factor 500, EMA/472578/2016 Page 77/124
Von Factor 500 I.U. Vial Netherlands Aafact Sanquin Plasma Products B.V. 1000 Netherlands Aafact Sanquin Plasma Products B.V. 500 Norway Obizur Baxalta Innovations 500 Units Vial Norway Advate Baxter Ag Octocog Alfa Octocog Alfa 100 I.U. / Norway Advate Baxter Ag Octocog Alfa Octocog Alfa 125 I.U. / Norway Advate Baxter Ag Octocog Alfa Octocog Alfa 200 I.U. / Norway Advate Baxter Ag Octocog Alfa Octocog Alfa 250 I.U. / Powder For Solution For Powder For Solution For EMA/472578/2016 Page 78/124
Norway Advate Baxter Ag Octocog Alfa Octocog Alfa 300 I.U. / Norway Advate Baxter Ag Octocog Alfa Octocog Alfa 400 I.U. / Norway Advate Baxter Ag Octocog Alfa Octocog Alfa 50 I.U. / Norway Advate Baxter Ag Octocog Alfa Octocog Alfa 500 I.U. / Norway Advate Baxter Ag Octocog Alfa Octocog Alfa 600 I.U. / Norway Advate Baxter Ag Octocog Alfa Octocog Alfa 750 I.U. / Norway Helixate Nexgen Bayer Pharma Ag Octocog Alfa Octocog Alfa 1000 I.U. / 2.5 Norway Helixate Nexgen Bayer Pharma Ag Octocog Alfa Octocog Alfa 2000 I.U. / 5 Norway Helixate Nexgen Bayer Pharma Ag Octocog Alfa Octocog Alfa 250 I.U. / 2.5 EMA/472578/2016 Page 79/124
Norway Helixate Nexgen Bayer Pharma Ag Octocog Alfa Octocog Alfa 3000 I.U. / 5 Norway Helixate Nexgen Bayer Pharma Ag Octocog Alfa Octocog Alfa 500 I.U. / 2.5 Norway Iblias Bayer Pharma Ag Octocog Alfa Octocog Alfa 1000 I.U. / 2.5 Norway Iblias Bayer Pharma Ag Octocog Alfa Octocog Alfa 2000 I.U. / 5 Norway Iblias Bayer Pharma Ag Octocog Alfa Octocog Alfa 250 I.U. / 2.5 Norway Iblias Bayer Pharma Ag Octocog Alfa Octocog Alfa 3000 I.U. / 5 Norway Iblias Bayer Pharma Ag Octocog Alfa Octocog Alfa 500 I.U. / 2.5 Norway Kogenate Bayer Pharma Ag Octocog Alfa Octocog Alfa 1000 I.U. / 2.5 Norway Kogenate Bayer Pharma Ag Octocog Alfa Octocog Alfa 2000 I.U. / 5 EMA/472578/2016 Page 80/124
Norway Kogenate Bayer Pharma Ag Octocog Alfa Octocog Alfa 250 I.U. / 2.5 Norway Kogenate Bayer Pharma Ag Octocog Alfa Octocog Alfa 3000 I.U. / 5 Norway Kogenate Bayer Pharma Ag Octocog Alfa Octocog Alfa 500 I.U. / 2.5 Norway Kovaltry Bayer Pharma Ag Octocog Alfa Octocog Alfa 1000 I.U. / 2.5 Norway Kovaltry Bayer Pharma Ag Octocog Alfa Octocog Alfa 2000 I.U. / 5 Norway Kovaltry Bayer Pharma Ag Octocog Alfa Octocog Alfa 250 I.U. / 2.5 Norway Kovaltry Bayer Pharma Ag Octocog Alfa Octocog Alfa 3000 I.U. / 5 Norway Kovaltry Bayer Pharma Ag Octocog Alfa Octocog Alfa 500 I.U. / 2.5 Norway Haemate Csl Behring (Rdna), Von /Infusion EMA/472578/2016 Page 81/124
Factor (Rdna) 50 I.U. /, Von Factor 120 I.U. / Norway Haemate Csl Behring (Rdna), Von Factor (Rdna) 66.6 I.U. /, Von Factor 160 I.U. / Norway Novoeight Novo Nordisk A/S Turoctocog Alfa Turoctocog Alfa 125 I.U. / Norway Novoeight Novo Nordisk A/S Turoctocog Alfa Turoctocog Alfa 250 I.U. / Norway Novoeight Novo Nordisk A/S Turoctocog Alfa Turoctocog Alfa 375 I.U. / Norway Novoeight Novo Nordisk A/S Turoctocog Alfa Turoctocog Alfa 500 I.U. / Norway Novoeight Novo Nordisk A/S Turoctocog Alfa Turoctocog Alfa 62.5 I.U. / /Infusion EMA/472578/2016 Page 82/124
Norway Novoeight Novo Nordisk A/S Turoctocog Alfa Turoctocog Alfa 750 I.U. / Norway Nuwiq Octapharma Ab (Rdna) (Rdna) 250 I.U. Vial Norway Nuwiq Octapharma Ab (Rdna) (Rdna) 400 I.U. / Norway Nuwiq Octapharma Ab (Rdna) (Rdna) 500 I.U. Vial Norway Nuwiq Octapharma Ab (Rdna) (Rdna) 800 I.U. / Norway Octanate Octapharma Ag 250 EMA/472578/2016 Page 83/124
Norway Wilate Octapharma Ag, Von Factor 1000, Von Factor 1000 Norway Wilate Octapharma Ag, Von Factor 500, Von Factor 500 I.U. Vial Norway Refacto Af Pfizer Limited Moroctocog Alfa Moroctocog Alfa 125 I.U. / Norway Refacto Af Pfizer Limited Moroctocog Alfa Moroctocog Alfa 250 I.U. / Norway Refacto Af Pfizer Limited Moroctocog Alfa Moroctocog Alfa 500 I.U. / Norway Refacto Af Pfizer Limited Moroctocog Alfa Moroctocog Alfa 62.5 I.U. / EMA/472578/2016 Page 84/124
Norway Refacto Af Pfizer Limited Moroctocog Alfa Moroctocog Alfa 125 I.U. / Norway Refacto Af Pfizer Limited Moroctocog Alfa Moroctocog Alfa 250 I.U. / Norway Refacto Af Pfizer Limited Moroctocog Alfa Moroctocog Alfa 500 I.U. / Norway Refacto Af Pfizer Limited Moroctocog Alfa Moroctocog Alfa 62.5 I.U. / Norway Refacto Af Pfizer Limited Moroctocog Alfa Moroctocog Alfa 750 I.U. / Poland Immunate Baxter Polska Sp Z O.O., Von Factor 100 I.U. /, Von Factor 75 I.U. / In Pre- Filled Syringe In Pre- Filled Syringe In Pre- Filled Syringe In Pre- Filled Syringe In Pre- Filled Syringe EMA/472578/2016 Page 85/124
Poland Immunate Baxter Polska Sp Z O.O., Von Factor 50 I.U. /, Von Factor 38 I.U. / Poland Recombinate Baxter Polska Sp Z O.O. (Rdna) (Rdna) 100 I.U. / Poland Recombinate Baxter Polska Sp Z O.O. (Rdna) (Rdna) 200 I.U. / Poland Recombinate Baxter Polska Sp Z O.O. (Rdna) (Rdna) 50 I.U. / Poland Optivate Bio Products Laboratory 100 I.U. / Poland Innovate Biomed-Lublin EMA/472578/2016 Page 86/124
Wsisz S.A. 1000 I.U. / Poland Haemoctin Biotest Pharma 100 I.U. / Poland Haemoctin Biotest Pharma 50 I.U. / Poland Beriate Csl Behring 100 I.U. / Poland Beriate Csl Behring 200 I.U. / Poland Haemate P Csl Behring, Von Factor 50 I.U. /, Von Factor 120 I.U. / /Infusion /Infusion /Infusion Poland Haemate P Csl Behring EMA/472578/2016 Page 87/124
, Von Factor 66.6 I.U. /, Von Factor 160 I.U. / /Infusion Poland Fanhdi Instituto Grifols, S.A., Von Factor 100 I.U. /, Von Factor 120 I.U. / /Infusion Poland Fanhdi Instituto Grifols, S.A., Von Factor 25 I.U. /, Von Factor 30 I.U. / /Infusion Poland Fanhdi Instituto Grifols, S.A., Von Factor 50 I.U. /, Von /Infusion EMA/472578/2016 Page 88/124
Factor 60 I.U. / Poland Emoclot Kedrion S.P.A. 1000 I.U. / 10 Infusion Poland Emoclot Kedrion S.P.A. 500 I.U. / 10 Infusion Poland Octanate Octapharma (Ip)- 1000 Poland Octanate Octapharma (Ip)- 250 Poland Octanate Octapharma (Ip)- 500 Poland Octanate Lv Octapharma (Ip)- 1000 EMA/472578/2016 Page 89/124
Poland Octanate Lv Octapharma (Ip)- 500 Poland Wilate Octapharma (Ip)-, Von Factor 1000, Von Factor 1000 Poland Wilate Octapharma (Ip)-, Von Factor 500, Von Factor 500 I.U. Vial Portugal Immunate Baxalta Innovations, Von Factor 100 I.U. /, Von Factor 75 I.U. / EMA/472578/2016 Page 90/124
Portugal Immunate Baxalta Innovations, Von Factor 50 I.U. /, Von Factor 38 I.U. / Portugal Optivate Bio Products Laboratory 100 I.U. / Portugal Haemoctin Biotest Pharma 100 I.U. / Portugal Haemoctin Biotest Pharma 50 I.U. / Portugal Haemate P Csl Behring, Von Factor 50 I.U. /, Von Factor 120 I.U. / EMA/472578/2016 Page 91/124
Portugal Haemate P Csl Behring, Von Factor 66.6 I.U. /, Von Factor 160 I.U. / Portugal Beriate Csl Behring 100 I.U. / /Infusion Portugal Fanhdi Instituto Grifols, S.A. 100 I.U. / Portugal Fanhdi Instituto Grifols, S.A. 25 I.U. / Portugal Fanhdi Instituto Grifols, S.A. 50 I.U. / Portugal Emoclot D.I. Kedrion S.P.A. 1000 I.U. / 10 Infusion EMA/472578/2016 Page 92/124
Portugal Emoclot D.I. Kedrion S.P.A. 500 I.U. / 10 Infusion Portugal Factane Lfb Biomedicaments 100 I.U. / Portugal Octanate Octapharma Produtos Farmaceuticos, Lda. 1000 Portugal Octanate Octapharma Produtos Farmaceuticos, Lda. 250 Portugal Octanate Octapharma Produtos Farmaceuticos, Lda. 500 Portugal Octanate Lv Octapharma Produtos Farmaceuticos, Lda. 1000 Portugal Octanate Lv Octapharma Produtos Farmaceuticos, Lda. 500 EMA/472578/2016 Page 93/124
Portugal Wilate Octapharma Produtos Farmaceuticos, Lda., Von Factor 1000, Von Factor 1000 Portugal Wilate Octapharma Produtos Farmaceuticos, Lda., Von Factor 500, Von Factor 500 I.U. Vial Romania Immunate Baxalta Innovations, Von Factor 100 I.U. /, Von Factor 75 I.U. / Romania Immunate Baxalta Innovations, Von Factor 50 I.U. /, EMA/472578/2016 Page 94/124
Von Factor 38 I.U. / Romania Recombinate Baxalta Innovations (Rdna) (Rdna) 100 I.U. / Romania Recombinate Baxalta Innovations (Rdna) (Rdna) 200 I.U. / Romania Recombinate Baxalta Innovations (Rdna) (Rdna) 25 I.U. / Romania Recombinate Baxalta Innovations (Rdna) (Rdna) 50 I.U. / Romania Optivate Bio Products Laboratory 100 I.U. / EMA/472578/2016 Page 95/124
Romania Haemoctin Sdh Biotest Pharma 100 I.U. / Romania Haemoctin Sdh Biotest Pharma 50 I.U. / Romania Beriate Csl Behring 100 I.U. / /Infusion Romania Beriate Csl Behring 200 I.U. / /Infusion Romania Haemate P Csl Behring, Von Factor 50 I.U. /, Von Factor 120 I.U. / /Infusion Romania Haemate P Csl Behring, Von Factor 66.6 I.U. /, /Infusion EMA/472578/2016 Page 96/124
Von Factor 160 I.U. / Romania Fanhdi Instituto Grifols, S.A. 100 I.U. / Romania Fanhdi Instituto Grifols, S.A. 25 I.U. / Romania Fanhdi Instituto Grifols, S.A. 50 I.U. / Romania Emoclot Kedrion S.P.A. 500 I.U. / 10 Infusion Romania Octanate Octapharma (Ip)- 1000 Romania Octanate Octapharma (Ip)- 250 EMA/472578/2016 Page 97/124
Romania Octanate Octapharma (Ip)- 500 Romania Octanate Lv Octapharma (Ip)- 1000 Romania Octanate Lv Octapharma (Ip)- 500 Romania Wilate Octapharma (Ip)-, Von Factor 1000, Von Factor 1000 Romania Wilate Octapharma (Ip)-, Von Factor 500, Von Factor 500 I.U. Vial EMA/472578/2016 Page 98/124
Slovakia Immunate Baxalta Innovations, Von Factor 100 I.U. /, Von Factor 75 I.U. / Slovakia Immunate Baxalta Innovations, Von Factor 50 I.U. /, Von Factor 38 I.U. / Slovakia Recombinate Baxter Ag (Rdna) (Rdna) 100 I.U. / Slovakia Recombinate Baxter Ag (Rdna) (Rdna) 25 I.U. / Slovakia Recombinate Baxter Ag (Rdna) EMA/472578/2016 Page 99/124
(Rdna) 50 I.U. / Slovakia Optivate Bio Products Laboratory 100 I.U. / Slovakia Beriate Csl Behring 100 I.U. / /Infusion Slovakia Beriate Csl Behring 200 I.U. / /Infusion Slovakia Haemate P Csl Behring (Rdna), Von Factor (Rdna) 50 I.U. /, Von Factor 120 I.U. / /Infusion Slovakia Haemate P Csl Behring (Rdna), Von Factor (Rdna) 66.6 I.U. /, /Infusion EMA/472578/2016 Page 100/124
Von Factor 160 I.U. / Slovakia Fanhdi Instituto Grifols, S.A., Von Factor 100 I.U. /, Von Factor 120 I.U. / Slovakia Fanhdi Instituto Grifols, S.A., Von Factor 25 I.U. /, Von Factor 30 I.U. / Slovakia Fanhdi Instituto Grifols, S.A., Von Factor 50 I.U. /, Von Factor 60 I.U. / EMA/472578/2016 Page 101/124
Slovakia Wilate Octapharma (Ip)-, Von Factor 1000, Von Factor 1000 Slovakia Wilate Octapharma (Ip)-, Von Factor 450, Von Factor 400 I.U. Vial Slovakia Wilate Octapharma (Ip)-, Von Factor 500, Von Factor 500 I.U. Vial Slovakia Wilate Octapharma (Ip)-, Von Factor 900, EMA/472578/2016 Page 102/124
Von Factor 800 I.U. Vial Slovakia Octanate Octapharma Pharmazeutika Produktionsgesmbh 1000 Slovakia Octanate Octapharma Pharmazeutika Produktionsgesmbh 250 Slovakia Octanate Octapharma Pharmazeutika Produktionsgesmbh 500 Slovenia Beriate Csl Behring 100 I.U. / /Infusion Slovenia Haemate P Csl Behring (Rdna), Von Factor (Rdna) 50 I.U. /, Von Factor 120 I.U. / /Infusion EMA/472578/2016 Page 103/124
Slovenia Octanate Octapharma (Ip)- 1000 Slovenia Octanate Octapharma (Ip)- 250 Slovenia Octanate Octapharma (Ip)- 500 Slovenia Octanate Kons Octapharma (Ip)- 1000 Slovenia Octanate Kons Octapharma (Ip)- 500 Slovenia Wilate Octapharma (Ip)-, Von Factor 1000, Von Factor 1000 EMA/472578/2016 Page 104/124
Slovenia Wilate Octapharma (Ip)-, Von Factor 500, Von Factor 500 I.U. Vial Spain Haemoctin Biotest Pharma 100 I.U. / Spain Haemoctin Biotest Pharma 50 I.U. / Spain Beriate Csl Behring 100 I.U. / /Infusion Spain Beriate Csl Behring 200 I.U. / /Infusion Spain Haemate P Csl Behring, S.A, Von Factor 50 I.U. /, Von /Infusion EMA/472578/2016 Page 105/124
Factor 120 I.U. / Spain Haemate P Csl Behring, S.A, Von Factor 66.6 I.U. /, Von Factor 160 I.U. / /Infusion Spain Fanhdi Instituto Grifols, S.A., Von Factor 100 I.U. /, Von Factor 120 I.U. / Spain Fanhdi Instituto Grifols, S.A., Von Factor 25 I.U. /, Von Factor 30 I.U. / Spain Fanhdi Instituto Grifols, S.A., Von EMA/472578/2016 Page 106/124
Factor 50 I.U. /, Von Factor 60 I.U. / Spain Octanate Octapharma S.A. 1000 Spain Octanate Octapharma S.A. 250 Spain Octanate Octapharma S.A. 500 Spain Octanate Lv Octapharma S.A. 1000 Spain Octanate Lv Octapharma S.A. 500 Spain Wilate Octapharma S.A., Von EMA/472578/2016 Page 107/124
Factor 100 I.U. /, Von Factor 100 I.U. / Spain Wilate Octapharma S.A., Von Factor 500, Von Factor 500 I.U. Vial Sweden Immunate Baxalta Innovations 100 I.U. / Sweden Immunate Baxalta Innovations 50 I.U. / Sweden Haemate Csl Behring, Von Factor 50 I.U. /, Von /Infusion EMA/472578/2016 Page 108/124
Factor 120 I.U. / Sweden Haemate Csl Behring, Von Factor 67 I.U. /, Von Factor 160 I.U. / /Infusion Sweden Octanate Octapharma Ab 1000 Sweden Octanate Octapharma Ab 250 Sweden Octanate Octapharma Ab 500 Sweden Octanate Lv Octapharma Ab 1000 Sweden Octanate Lv Octapharma Ab EMA/472578/2016 Page 109/124
500 Sweden Wilate Octapharma Ab, Von Factor 1000, Von Factor 1000 Sweden Wilate Octapharma Ab, Von Factor 500, Von Factor 500 I.U. Vial United Kingdom Optivate Bio Products Laboratory 100 I.U. / United Kingdom Optivate Bio Products Laboratory 80-130 I.U. / Powder For Solution United Kingdom 8y Bio Products Laboratory, Von Powder For Solution For EMA/472578/2016 Page 110/124
Factor 25 I.U. /, Von Factor 26 I.U. / United Kingdom Haemoctin Biotest Pharma 100 I.U. / United Kingdom Haemoctin Biotest Pharma 50 I.U. / United Kingdom Haemate P Csl Behring, Von Factor 50 I.U. /, Von Factor 120 I.U. / United Kingdom Haemate P Csl Behring, Von Factor 66.6 I.U. /, Von /Infusion /Infusion EMA/472578/2016 Page 111/124
Factor 160 I.U. / United Kingdom Fanhdi Instituto Grifols, S.A. 100 I.U. / United Kingdom Fanhdi Instituto Grifols, S.A. 25 I.U. / United Kingdom Fanhdi Instituto Grifols, S.A. 50 I.U. / United Kingdom Alphanate Instituto Grifols, S.A., Von Factor 100 I.U. /, Von Factor 120 I.U. / Powder For United Kingdom Alphanate Instituto Grifols, S.A., Von Factor 150 I.U. /, Von Powder For EMA/472578/2016 Page 112/124
Factor 180 I.U. / United Kingdom Alphanate Instituto Grifols, S.A., Von Factor 50 I.U. /, Von Factor 60 I.U. / Powder For United Kingdom Octanate Octapharma-Ltd 1000 United Kingdom Octanate Octapharma-Ltd 250 United Kingdom Octanate Octapharma-Ltd 500 United Kingdom Octanate Lv Octapharma-Ltd 1000 United Kingdom Octanate Lv Octapharma-Ltd EMA/472578/2016 Page 113/124
500 United Kingdom Wilate Octapharma-Ltd, Von Factor 1000, Von Factor 1000 United Kingdom Wilate Octapharma-Ltd, Von Factor 500, Von Factor 500 I.U. Vial Centrally authorised products MA (EU) number (Invented) name Strength Pharmaceutical Form Administration Immediate Packaging Pack size EU/1/03/271/001 Advate 250 IU Powder and powder: vial (glass); solvent: vial (glass) 1 vial + 1 vial + reconstitution device EMA/472578/2016 Page 114/124
MA (EU) number (Invented) name Strength Pharmaceutical Form Administration Immediate Packaging Pack size EU/1/03/271/002 Advate 500 IU Powder and EU/1/03/271/003 Advate 1000 IU Powder and EU/1/03/271/004 Advate 1500 IU Powder and EU/1/03/271/005 Advate 2000 IU Powder and EU/1/03/271/006 Advate 3000 IU Powder and EU/1/03/271/007 Advate 250 IU Powder and EU/1/03/271/008 Advate 500 IU Powder and EU/1/03/271/009 Advate 1000 IU Powder and EU/1/03/271/010 Advate 1500 IU Powder and EU/1/03/271/011 Advate 250 IU Powder and EU/1/03/271/012 Advate 500 IU Powder and EU/1/03/271/013 Advate 1000 IU Powder and powder: vial (glass); solvent: vial (glass) powder: vial (glass); solvent: vial (glass) powder: vial (glass); solvent: vial (glass) powder: vial (glass); solvent: vial (glass) powder: vial (glass); solvent: vial (glass) powder: vial (glass); solvent: vial (glass) powder: vial (glass); solvent: vial (glass) powder: vial (glass); solvent: vial (glass) powder: vial (glass); solvent: vial (glass) powder: vial (glass); solvent: vial (glass) powder: vial (glass); solvent: vial (glass) powder: vial (glass); solvent: vial (glass) 1 vial + 1 vial + reconstitution device 1 vial + 1 vial + reconstitution device 1 vial + 1 vial + reconstitution device 1 vial + 1 vial + reconstitution device 1 vial + 1 vial + reconstitution device 1 vial + 1 vial + reconstitution device 1 vial + 1 vial + reconstitution device 1 vial + 1 vial + reconstitution device 1 vial + 1 vial + reconstitution device 1 vial + 1 vial preassembled with reconstitution device 1 vial + 1 vial preassembled with reconstitution device 1 vial + 1 vial preassembled with reconstitution device EMA/472578/2016 Page 115/124
MA (EU) number (Invented) name Strength Pharmaceutical Form Administration Immediate Packaging Pack size EU/1/03/271/014 Advate 1500 IU Powder and EU/1/03/271/015 Advate 2000 IU Powder and EU/1/03/271/016 Advate 3000 IU Powder and EU/1/03/271/017 Advate 250 IU Powder and EU/1/03/271/018 Advate 500 IU Powder and EU/1/03/271/019 Advate 1000 IU Powder and EU/1/03/271/020 Advate 1500 IU Powder and powder: vial (glass); solvent: vial (glass) powder: vial (glass); solvent: vial (glass) powder: vial (glass); solvent: vial (glass) powder: vial (glass); solvent: vial (glass) powder: vial (glass); solvent: vial (glass) powder: vial (glass); solvent: vial (glass) powder: vial (glass); solvent: vial (glass) 1 vial + 1 vial preassembled with reconstitution device 1 vial + 1 vial preassembled with reconstitution device 1 vial + 1 vial preassembled with reconstitution device 1 vial + 1 vial preassembled with reconstitution device 1 vial + 1 vial preassembled with reconstitution device 1 vial + 1 vial preassembled with reconstitution device 1 vial + 1 vial preassembled with reconstitution device MA (EU) number (Invented) name Strength Pharmaceutical Form Administration Immediate Packaging Pack size EU/1/15/1046/001 ELOCTA 250 IU Powder and EU/1/15/1046/002 ELOCTA 500 IU Powder and Powder: vial (glass); Solvent: pre-filled syringe (glass) Powder: vial (glass); Solvent: pre-filled syringe (glass) 1 vial (powder) + 1 pre-filled syringe (solvent) 1 vial (powder) + 1 pre-filled syringe (solvent) EMA/472578/2016 Page 116/124
MA (EU) number (Invented) name Strength Pharmaceutical Form Administration Immediate Packaging Pack size EU/1/15/1046/003 ELOCTA 750 IU Powder and EU/1/15/1046/004 ELOCTA 1000 IU Powder and EU/1/15/1046/005 ELOCTA 1500 IU Powder and EU/1/15/1046/006 ELOCTA 2000 IU Powder and EU/1/15/1046/007 ELOCTA 3000 IU Powder and Powder: vial (glass); Solvent: pre-filled syringe (glass) Powder: vial (glass); Solvent: pre-filled syringe (glass) Powder: vial (glass); Solvent: pre-filled syringe (glass) Powder: vial (glass); Solvent: pre-filled syringe (glass) Powder: vial (glass); Solvent: pre-filled syringe (glass) 1 vial (powder) + 1 pre-filled syringe (solvent) 1 vial (powder) + 1 pre-filled syringe (solvent) 1 vial (powder) + 1 pre-filled syringe (solvent) 1 vial (powder) + 1 pre-filled syringe (solvent) 1 vial (powder) + 1 pre-filled syringe (solvent) EMA/472578/2016 Page 117/124
MA (EU) number (Invented) name Strength Pharmaceutical Form Administration Immediate Packaging Pack size EU/1/00/144/001 Helixate NexGen 250 IU Powder and EU/1/00/144/002 Helixate NexGen 500 IU Powder and EU/1/00/144/003 Helixate NexGen 1000 IU Powder and EU/1/00/144/004 Helixate NexGen 2000 IU Powder and EU/1/00/144/005 Helixate NexGen 3000 IU Powder and powder: vial (glass); solvent: vial (glass) powder: vial (glass); solvent: vial (glass) powder: vial (glass); solvent: vial (glass) powder: vial (glass); solvent: vial (glass) powder: vial (glass); solvent: vial (glass) 1 vial + 1 vial + 1 filter transfer + 1 venipuncture set + 1 syringe + 2 swabs 1 vial + 1 vial + 1 filter transfer + 1 venipuncture set + 1 syringe + 2 swabs 1 vial + 1 vial + 1 filter transfer + 1 venipuncture set + 1 syringe + 2 swabs 1 vial + 1 vial + 1 filter transfer + 1 venipuncture set + 1 syringe + 2 swabs 1 vial + 1 vial + 1 filter transfer + 1 venipuncture set + 1 syringe + 2 swabs MA (EU) number (Invented) name Strength Pharmaceutical Form Administration Immediate Packaging Pack size EU/1/15/1077/001 Iblias 250 IU Powder and EU/1/15/1077/002 Iblias 500 IU Powder and EU/1/15/1077/003 Iblias 1000 IU Powder and EU/1/15/1077/004 Iblias 2000 IU Powder and EU/1/15/1077/005 Iblias 3000 IU Powder and powder: vial (glass); solvent: vial (glass) powder: vial (glass); solvent: vial (glass) powder: vial (glass); solvent: vial (glass) powder: vial (glass); solvent: vial (glass) powder: vial (glass); solvent: vial (glass) 1 vial + 1 vial + 1 filter transfer device + 1 venipuncture set + 1 syringe + 2 swabs 1 vial + 1 vial + 1 filter transfer device + 1 venipuncture set + 1 syringe + 2 swabs 1 vial + 1 vial + 1 filter transfer device + 1 venipuncture set + 1 syringe + 2 swabs 1 vial + 1 vial + 1 filter transfer device + 1 venipuncture set + 1 syringe + 2 swabs 1 vial + 1 vial + 1 filter transfer device + 1 venipuncture set + 1 syringe + 2 swabs EMA/472578/2016 Page 118/124
MA (EU) number (Invented) name Strength Pharmaceutical Form Administration Immediate Packaging Pack size EU/1/00/143/004 KOGENATE Bayer 250 IU Powder and EU/1/00/143/005 KOGENATE Bayer 500 IU Powder and EU/1/00/143/006 KOGENATE Bayer 1000 IU Powder and EU/1/00/143/007 KOGENATE Bayer 250 IU Powder and EU/1/00/143/008 KOGENATE Bayer 500 IU Powder and EU/1/00/143/009 KOGENATE Bayer 1000 IU Powder and EU/1/00/143/010 KOGENATE Bayer 2000 IU Powder and EU/1/00/143/011 KOGENATE Bayer 2000 IU Powder and powder: vial (glass); solvent: pre-filled syringe (glass) powder: vial (glass); solvent: pre-filled syringe (glass) powder: vial (glass); solvent: pre-filled syringe (glass) powder: vial (glass); solvent: pre-filled syringe (glass) powder: vial (glass); solvent: pre-filled syringe (glass) powder: vial (glass); solvent: pre-filled syringe (glass) powder: vial (glass); solvent: pre-filled syringe (glass) powder: vial (glass); solvent: pre-filled syringe (glass) 1 vial + 1 Bio-Set device + 1 prefilled syringe + 1 syringe plunger rod + 1 venipuncture set + 4 swabs + 2 plasters 1 vial + 1 Bio-Set device + 1 prefilled syringe + 1 syringe plunger rod + 1 venipuncture set + 4 swabs + 2 plasters 1 vial + 1 Bio-Set device + 1 prefilled syringe + 1 syringe plunger rod + 1 venipuncture set + 4 swabs + 2 plasters 1 vial + 1 pre-filled syringe + 1 syringe plunger rod + 1 vial adapter + 1 venipuncture set + 4 swabs + 2 plasters 1 vial + 1 pre-filled syringe + 1 syringe plunger rod + 1 vial adapter + 1 venipuncture set + 4 swabs + 2 plasters 1 vial + 1 pre-filled syringe + 1 syringe plunger rod + 1 vial adapter + 1 venipuncture set + 4 swabs + 2 plasters 1 vial + 1 Bio-Set device + 1 prefilled syringe + 1 syringe plunger rod + 1 venipuncture set + 4 swabs + 2 plasters 1 vial + 1 pre-filled syringe + 1 syringe plunger rod + 1 vial adapter + 1 venipuncture set + 4 swabs + 2 plasters EMA/472578/2016 Page 119/124
MA (EU) number (Invented) name Strength Pharmaceutical Form Administration Immediate Packaging Pack size EU/1/00/143/012 KOGENATE Bayer 3000 IU Powder and EU/1/00/143/013 KOGENATE Bayer 3000 IU Powder and powder: vial (glass); solvent: pre-filled syringe (glass) powder: vial (glass); solvent: pre-filled syringe (glass) 1 vial + 1 Bio-Set device + 1 prefilled syringe + 1 syringe plunger rod + 1 venipuncture set + 4 swabs + 2 plasters 1 vial + 1 pre-filled syringe + 1 syringe plunger rod + 1 vial adapter + 1 venipuncture set + 4 swabs + 2 plasters MA (EU) number (Invented) name Strength Pharmaceutical Form Administration Immediate Packaging Pack size EU/1/15/1076/001 Kovaltry 250 IU Powder and EU/1/15/1076/002 Kovaltry 250 IU Powder and EU/1/15/1076/003 Kovaltry 500 IU Powder and EU/1/15/1076/004 Kovaltry 500 IU Powder and EU/1/15/1076/005 Kovaltry 1000 IU Powder and EU/1/15/1076/006 Kovaltry 1000 IU Powder and powder: vial (glass); solvent: pre-filled syringe (glass) powder: vial (glass); solvent: pre-filled syringe (glass) powder: vial (glass); solvent: pre-filled syringe (glass) powder: vial (glass); solvent: pre-filled syringe (glass) powder: vial (glass); solvent: pre-filled syringe (glass) powder: vial (glass); solvent: pre-filled syringe (glass) 1 vial with reconstitution cap + 1 pre-filled syringe (3 ml) + 1 venipuncture set 1 vial + 1 pre-filled syringe (3 ml) + 1 vial adapter + 1 venipuncture set 1 vial with reconstitution cap + 1 pre-filled syringe (3 ml) + 1 venipuncture set 1 vial + 1 pre-filled syringe (3 ml) + 1 vial adapter + 1 venipuncture set 1 vial with reconstitution cap + 1 pre-filled syringe (3 ml) + 1 venipuncture set 1 vial + 1 pre-filled syringe (3 ml) + 1 vial adapter + 1 venipuncture set EMA/472578/2016 Page 120/124
MA (EU) number (Invented) name Strength Pharmaceutical Form Administration Immediate Packaging Pack size EU/1/15/1076/007 Kovaltry 2000 IU Powder and EU/1/15/1076/008 Kovaltry 2000 IU Powder and EU/1/15/1076/009 Kovaltry 3000 IU Powder and EU/1/15/1076/010 Kovaltry 3000 IU Powder and powder: vial (glass); solvent: pre-filled syringe (glass) powder: vial (glass); solvent: pre-filled syringe (glass) powder: vial (glass); solvent: pre-filled syringe (glass) powder: vial (glass); solvent: pre-filled syringe (glass) 1 vial with reconstitution cap + 1 pre-filled syringe (5 ml) + 1 venipuncture set 1 vial + 1 pre-filled syringe (5 ml) + 1 vial adapter + 1 venipuncture set 1 vial with reconstitution cap + 1 pre-filled syringe (5 ml) + 1 venipuncture set 1 vial + 1 pre-filled syringe (5 ml) + 1 vial adapter + 1 venipuncture set MA (EU) number (Invented) name Strength Pharmaceutical Form Administration Immediate Packaging Pack size EU/1/13/888/001 NovoEight 250 IU Powder and EU/1/13/888/002 NovoEight 500 IU Powder and EU/1/13/888/003 NovoEight 1000 IU Powder and EU/1/13/888/004 NovoEight 1500 IU Powder and EU/1/13/888/005 NovoEight 2000 IU Powder and vial (glass) 1 vial + 1 pre-filled syringe + 1 vial adapter vial (glass) 1 vial + 1 pre-filled syringe + 1 vial adapter vial (glass) 1 vial + 1 pre-filled syringe + 1 vial adapter vial (glass) 1 vial + 1 pre-filled syringe + 1 vial adapter vial (glass) 1 vial + 1 pre-filled syringe + 1 vial adapter EMA/472578/2016 Page 121/124
MA (EU) number (Invented) name Strength Pharmaceutical Form Administration Immediate Packaging Pack size EU/1/13/888/006 NovoEight 3000 IU Powder and vial (glass) 1 vial + 1 pre-filled syringe + 1 vial adapter MA (EU) number (Invented) name Strength Pharmaceutical Form Administration Immediate Packaging Pack size EU/1/14/936/001 Nuwiq 250 IU Powder and EU/1/14/936/002 Nuwiq 500 IU Powder and EU/1/14/936/003 Nuwiq 1000 IU Powder and EU/1/14/936/004 Nuwiq 2000 IU Powder and Powder: vial (glass); Solvent: pre-filled syringe (glass) Powder: vial (glass); Solvent: pre-filled syringe (glass) Powder: vial (glass); Solvent: pre-filled syringe (glass) Powder: vial (glass); Solvent: pre-filled syringe (glass) 1 vial (powder) + 1 pre-filled syringe (solvent) + 1 vial adapter 1 vial (powder) + 1 pre-filled syringe (solvent) + 1 vial adapter 1 vial (powder) + 1 pre-filled syringe (solvent) + 1 vial adapter 1 vial (powder) + 1 pre-filled syringe (solvent) + 1 vial adapter MA (EU) number (Invented) name Strength Pharmaceutical Form Administration Immediate Packaging Pack size EU/1/15/1035/001 Obizur 500 U Powder and solution for solution for injection vial (glass) 1 vial EMA/472578/2016 Page 122/124
MA (EU) number (Invented) name Strength Pharmaceutical Form Administration Immediate Packaging Pack size EU/1/15/1035/002 Obizur 500 U Powder and solution for solution for injection EU/1/15/1035/003 Obizur 500 U Powder and solution for solution for injection vial (glass) 5 vials vial (glass) 10 vials MA (EU) number (Invented) name Strength Pharmaceutical Form Administration Immediate Packaging Pack size EU/1/99/103/001 ReFacto AF 250 IU Powder and EU/1/99/103/002 ReFacto AF 500 IU Powder and EU/1/99/103/003 ReFacto AF 1000 IU Powder and EU/1/99/103/004 ReFacto AF 2000 IU Powder and EU/1/99/103/005 ReFacto AF 3000 IU Powder and EU/1/99/103/006 ReFacto AF 500 IU Powder and EU/1/99/103/007 ReFacto AF 1000 IU Powder and powder: vial (glass); solvent: vial (glass) powder: vial (glass); solvent: vial (glass) powder: vial (glass); solvent: vial (glass) powder: vial (glass); solvent: vial (glass) powder and solvent: prefilled syringe (glass) powder and solvent: prefilled syringe (glass) powder and solvent: prefilled syringe (glass) 1 vial +1 pre-filled syringe + 1 injection kit 1 vial +1 pre-filled syringe + 1 injection kit 1 vial +1 pre-filled syringe + 1 injection kit 1 vial +1 pre-filled syringe + 1 injection kit 1 pre-filled syringe + 1 injection kit 1 pre-filled syringe + 1 injection kit 1 pre-filled syringe + 1 injection kit EMA/472578/2016 Page 123/124
MA (EU) number (Invented) name Strength Pharmaceutical Form Administration Immediate Packaging Pack size EU/1/99/103/008 ReFacto AF 2000 IU Powder and EU/1/99/103/009 ReFacto AF 250 IU Powder and powder and solvent: prefilled syringe (glass) powder and solvent: prefilled syringe (glass) 1 pre-filled syringe + 1 injection kit 1 pre-filled syringe + 1 injection kit MA (EU) number (Invented) name Strength Pharmaceutical Form Administration Immediate Packaging Pack size EU/1/13/857/001 Voncento 250 IU / 600 IU EU/1/13/857/002 Voncento 500 IU / 1200 IU EU/1/13/857/003 Voncento 500 IU / 1200 IU EU/1/13/857/004 Voncento 1000 IU / 2400 IU Powder and for injection/infusion Powder and for injection/infusion Powder and for injection/infusion Powder and for injection/infusion powder: vial (glass) + solvent: vial (glass) powder: vial (glass) + solvent: vial (glass) powder: vial (glass) + solvent: vial (glass) powder: vial (glass) + solvent: vial (glass) 1 vial + 1 vial 1 vial + 1 vial 1 vial + 1 vial 1 vial + 1 vial EMA/472578/2016 Page 124/124