# Official Journal C 447/29 D

| | ISSN 1977-091X |
| --- | --- |
| Official Journal
  of the European Union | C 447 |
| | |
| English edition | Information and Notices | Volume 6029 December 2017 |

ISSN 1977-091X

Official Journal

of the European Union

C 447

English edition

Information and Notices

Volume 6029 December 2017

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| Notice No | Contents | page |
| --- | --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2017/C 447/01 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2017 to 30 November 2017(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) | 1 |
| 2017/C 447/02 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2017 to 30 November 2017(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC) | 11 |

Notice No

Contents

page

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2017/C 447/01

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2017 to 30 November 2017(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

1

2017/C 447/02

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2017 to 30 November 2017(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)

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

11

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| | Corrigenda |
| --- | --- |
| 2017/C 447/03 | Corrigendum to the Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2016 to 31 August 2016 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) ( OJ C 362, 30.9.2016 ) | 110 |

Corrigenda

2017/C 447/03

Corrigendum to the Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2016 to 31 August 2016 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) ( OJ C 362, 30.9.2016 )

( OJ C 362, 30.9.2016 )

110

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| EN | |
| --- | --- |

EN

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IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 29.12.2017 | EN | Official Journal of the European Union | C 447/1 |
| --- | --- | --- | --- |

29.12.2017

EN

Official Journal of the European Union

C 447/1

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Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2017 to 30 November 2017

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))

(2017/C 447/01)

—   Issuing of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorisation | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 10.11.2017 | Cyltezo | adalimumab | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/17/1240 | Solution for injection | L04AB04 | 14.11.2017 |
| 10.11.2017 | Miglustat Gen.Orph | Miglustat | Gen.Orph
  100 rue Louis Blanc, TSA/Bâtiment Copenhague, 60160 Montataire, France | EU/1/17/1232 | Capsule, hard | A16AX06 | 14.11.2017 |
| 10.11.2017 | Nyxoid | naloxone | Mundipharma Corporation Limited
  Cambridge Science Park, Milton Road, Cambridge CB4 0AB, United Kingdom | EU/1/17/1238 | Nasal spray, solution | V03AB15 | 14.11.2017 |
| 10.11.2017 | Ritonavir Mylan | ritonavir | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/17/1242 | Film-coated tablet | J05AE03 | 14.11.2017 |
| 10.11.2017 | TOOKAD | padeliporfin | Steba Biotech S.A
  7 Place du Théâtre, 2613 Luxembourg, Luxembourg | EU/1/17/1228 | Powder for solution for injection | L01XD07 | 14.11.2017 |
| 10.11.2017 | Tremfya | Guselkumab | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/17/1234 | Solution for injection | L04AC | 14.11.2017 |
| 10.11.2017 | VeraSeal | human fibrinogen / human thrombin | Instituto Grifols, S.A.
  Can Guasch 2, Parets del Vallès, 08150 Barcelona, Espaňa | EU/1/17/1239 | Solutions for sealant | B02BC | 14.11.2017 |
| 10.11.2017 | Zubsolv | buprenorphine / naloxone | Mundipharma Corporation Limited
  Cambridge Science Park, Milton Road, Cambridge CB4 0AB, United Kingdom | EU/1/17/1233 | Sublingual tablet | N07BC51 | 14.11.2017 |
| 15.11.2017 | Elebrato Ellipta | fluticasone furoate/umeclidinium/vilanterol | GlaxoSmithKline Trading Services Limited
  Currabinny, Carrigaline, County Cork, Ireland | EU/1/17/1237 | Inhalation powder, pre-dispensed | Pending | 17.11.2017 |
| 15.11.2017 | Imatinib Teva B.V. | imatinib | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/17/1243 | Capsule, hard
  Film-coated tablet | L01XE01 | 17.11.2017 |
| 15.11.2017 | Ontruzant | trastuzumab | Samsung Bioepis UK Limited
  5th floor, Profile West, 950 Great West Road, Brentford, Middlesex TW8 9ES, United Kingdom | EU/1/17/1241 | Powder for concentrate for solution for infusion | L01XC03 | 17.11.2017 |
| 15.11.2017 | Trelegy Ellipta | fluticasone furoate/umeclidinium/vilanterol | GlaxoSmithKline Trading Services Limited
  Currabinny, Carrigaline, County Cork, Ireland | EU/1/17/1236 | Inhalation powder, pre-dispensed | Pending | 17.11.2017 |
| 16.11.2017 | Zejula | niraparib | TESARO UK LIMITED
  55 Baker Street, London W1U 7EU, United Kingdom | EU/1/17/1235 | Capsule, hard | L01XX54 | 20.11.2017 |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorisation

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

10.11.2017

Cyltezo

adalimumab

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/17/1240

Solution for injection

L04AB04

14.11.2017

10.11.2017

Miglustat Gen.Orph

Miglustat

Gen.Orph

100 rue Louis Blanc, TSA/Bâtiment Copenhague, 60160 Montataire, France

EU/1/17/1232

Capsule, hard

A16AX06

14.11.2017

10.11.2017

Nyxoid

naloxone

Mundipharma Corporation Limited

Cambridge Science Park, Milton Road, Cambridge CB4 0AB, United Kingdom

EU/1/17/1238

Nasal spray, solution

V03AB15

14.11.2017

10.11.2017

Ritonavir Mylan

ritonavir

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/17/1242

Film-coated tablet

J05AE03

14.11.2017

10.11.2017

TOOKAD

padeliporfin

Steba Biotech S.A

7 Place du Théâtre, 2613 Luxembourg, Luxembourg

EU/1/17/1228

Powder for solution for injection

L01XD07

14.11.2017

10.11.2017

Tremfya

Guselkumab

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/17/1234

Solution for injection

L04AC

14.11.2017

10.11.2017

VeraSeal

human fibrinogen / human thrombin

Instituto Grifols, S.A.

Can Guasch 2, Parets del Vallès, 08150 Barcelona, Espaňa

EU/1/17/1239

Solutions for sealant

B02BC

14.11.2017

10.11.2017

Zubsolv

buprenorphine / naloxone

Mundipharma Corporation Limited

Cambridge Science Park, Milton Road, Cambridge CB4 0AB, United Kingdom

EU/1/17/1233

Sublingual tablet

N07BC51

14.11.2017

15.11.2017

Elebrato Ellipta

fluticasone furoate/umeclidinium/vilanterol

GlaxoSmithKline Trading Services Limited

Currabinny, Carrigaline, County Cork, Ireland

EU/1/17/1237

Inhalation powder, pre-dispensed

Pending

17.11.2017

15.11.2017

Imatinib Teva B.V.

imatinib

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/17/1243

Capsule, hard

Film-coated tablet

L01XE01

17.11.2017

15.11.2017

Ontruzant

trastuzumab

Samsung Bioepis UK Limited

5th floor, Profile West, 950 Great West Road, Brentford, Middlesex TW8 9ES, United Kingdom

EU/1/17/1241

Powder for concentrate for solution for infusion

L01XC03

17.11.2017

15.11.2017

Trelegy Ellipta

fluticasone furoate/umeclidinium/vilanterol

GlaxoSmithKline Trading Services Limited

Currabinny, Carrigaline, County Cork, Ireland

EU/1/17/1236

Inhalation powder, pre-dispensed

Pending

17.11.2017

16.11.2017

Zejula

niraparib

TESARO UK LIMITED

55 Baker Street, London W1U 7EU, United Kingdom

EU/1/17/1235

Capsule, hard

L01XX54

20.11.2017

—   Issuing of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Rejected

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 16.11.2017 | Adlumiz | Helsinn Birex Pharmaceuticals Ltd
  Damastown, Mulhuddart, Dublin 15, Ireland | — | 20.11.2017 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

16.11.2017

Adlumiz

Helsinn Birex Pharmaceuticals Ltd

Damastown, Mulhuddart, Dublin 15, Ireland

—

20.11.2017

—   Modification of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 10.11.2017 | ADCETRIS | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/12/794 | 14.11.2017 |
| 10.11.2017 | APTIVUS | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/05/315 | 14.11.2017 |
| 10.11.2017 | Benlysta | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/11/700 | 16.11.2017 |
| 10.11.2017 | BYDUREON | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/11/696 | 14.11.2017 |
| 10.11.2017 | ellaOne | Laboratoire HRA Pharma
  15 rue Béranger, 75003 Paris, France | EU/1/09/522 | 14.11.2017 |
| 10.11.2017 | Emtricitabine /Tenofovir disoproxil Krka d.d. | Krka d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/17/1182 | 14.11.2017 |
| 10.11.2017 | Exjade | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/06/356 | 14.11.2017 |
| 10.11.2017 | Exviera | AbbVie Ltd
  Abbvie House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4UB, United Kingdom | EU/1/14/983 | 14.11.2017 |
| 10.11.2017 | Faslodex | AstraZeneca UK Limited
  Charter Way, Macclesfield, Cheshire, SK10 2NA, United Kingdom | EU/1/03/269 | 14.11.2017 |
| 10.11.2017 | Glubrava | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/07/421 | 14.11.2017 |
| 10.11.2017 | Humira | AbbVie Ltd
  Abbvie House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4UB, United Kingdom | EU/1/03/256 | 14.11.2017 |
| 10.11.2017 | Iblias | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/15/1077 | 14.11.2017 |
| 10.11.2017 | Kolbam | Retrophin Europe Limited
  Palmerstown House, Fenian Street, Dublin 2, Ireland | EU/1/13/895 | 14.11.2017 |
| 10.11.2017 | Kovaltry | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/15/1076 | 14.11.2017 |
| 10.11.2017 | Mepact | Takeda France SAS
  Immeuble Pacific, 11-13 cours Valmy, 92800 Puteaux, France | EU/1/08/502 | 14.11.2017 |
| 10.11.2017 | NexoBrid | MediWound Germany GmbH
  Eisenstraße 5, 65428 Ruesselsheim, Deutschland | EU/1/12/803 | 14.11.2017 |
| 10.11.2017 | Ovitrelle | Merck Serono Europe Limited
  56, Marsh Wall, London E14 9TP, United Kingdom | EU/1/00/165 | 15.11.2017 |
| 10.11.2017 | Pegasys | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/02/221 | 14.11.2017 |
| 10.11.2017 | Plegridy | Biogen Idec Limited
  Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | EU/1/14/934 | 14.11.2017 |
| 10.11.2017 | Revatio | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/05/318 | 14.11.2017 |
| 10.11.2017 | Selincro | H. Lundbeck A/S
  Ottiliavej 9, 2500 Valby, Danmark | EU/1/12/815 | 14.11.2017 |
| 10.11.2017 | Tandemact | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/06/366 | 14.11.2017 |
| 10.11.2017 | Teysuno | Nordic Group B.V.
  Siriusdreef 22, 2132 WT Hoofddorp, Nederland | EU/1/11/669 | 14.11.2017 |
| 10.11.2017 | Valdoxan | Les Laboratoires Servier
  50 rue Carnot, 92284 Suresnes CEDEX, France | EU/1/08/499 | 14.11.2017 |
| 15.11.2017 | Aripiprazole Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/15/1045 | 17.11.2017 |
| 15.11.2017 | Bortezomib SUN | Sun Pharmaceutical Industries Europe BV
  Polarisavenue 87, 2132 JH Hoofddorp, Nederland | EU/1/16/1102 | 17.11.2017 |
| 15.11.2017 | Emtricitabine/Tenofovir disoproxil Krka | Krka d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/16/1151 | 17.11.2017 |
| 15.11.2017 | Imvanex | Bavarian Nordic A/S
  Hejreskovvej 10a, 3490 Kvistgaard, Danmark | EU/1/13/855 | 17.11.2017 |
| 15.11.2017 | Kyprolis | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/15/1060 | 17.11.2017 |
| 15.11.2017 | Lemtrada | Genzyme Therapeutics Ltd
  4620 Kingsgate, Cascade Way, Oxford Business Park South, Oxford OX4 2SU, United Kingdom | EU/1/13/869 | 17.11.2017 |
| 15.11.2017 | NovoEight | Novo Nordisk A/S
  Novo Allé, 2880 Bagsvaerd, Danmark | EU/1/13/888 | 17.11.2017 |
| 15.11.2017 | Ozurdex | Allergan Pharmaceuticals Ireland
  Castlebar Road, Westport, County Mayo, Ireland | EU/1/10/638 | 20.11.2017 |
| 15.11.2017 | ReFacto AF | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/99/103 | 17.11.2017 |
| 15.11.2017 | Savene | Clinigen Healthcare Limited
  Pitcairn House, Crown Square, First Avenue, Burton-on-Trent, Staffordshire DE14 2WW, United Kingdom | EU/1/06/350 | 17.11.2017 |
| 15.11.2017 | Saxenda | Novo Nordisk A/S
  Novo Allé, 2880 Bagsvaerd, Danmark | EU/1/15/992 | 17.11.2017 |
| 15.11.2017 | Tasigna | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/07/422 | 17.11.2017 |
| 15.11.2017 | Viekirax | AbbVie Ltd
  Abbvie House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4UB, United Kingdom | EU/1/14/982 | 17.11.2017 |
| 15.11.2017 | Voncento | CSL Behring GmbH
  Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland | EU/1/13/857 | 17.11.2017 |
| 15.11.2017 | Zytiga | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/11/714 | 17.11.2017 |
| 16.11.2017 | ATryn | Laboratoire français du Fractionnement et des Biotechnologies
  3 Avenue des Tropiques, ZA de Courtaboeuf, 91940 Les Ulis, France | EU/1/06/355 | 20.11.2017 |
| 16.11.2017 | Cubicin | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/05/328 | 20.11.2017 |
| 16.11.2017 | Docetaxel Winthrop | Aventis Pharma S.A.
  20 avenue Raymond Aron, 92165 Antony CEDEX, France | EU/1/07/384 | 20.11.2017 |
| 16.11.2017 | Elocta | Swedish Orphan Biovitrum AB (publ)
  112 76 Stockholm, Sverige | EU/1/15/1046 | 20.11.2017 |
| 16.11.2017 | Helixate NexGen | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/00/144 | 20.11.2017 |
| 16.11.2017 | KOGENATE Bayer | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/00/143 | 20.11.2017 |
| 16.11.2017 | Levemir | Novo Nordisk A/S
  Novo Allé, 2880 Bagsvaerd, Danmark | EU/1/04/278 | 20.11.2017 |
| 16.11.2017 | Levetiracetam Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/11/712 | 20.11.2017 |
| 16.11.2017 | Taxotere | Aventis Pharma S.A.
  20 avenue Raymond Aron, 92165 Antony CEDEX, France | EU/1/95/002 | 20.11.2017 |
| 16.11.2017 | Zydelig | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/14/938 | 20.11.2017 |
| 24.11.2017 | Advate | Baxter AG
  Industriestraße 67, 1221 Wien, Österreich | EU/1/03/271 | 28.11.2017 |
| 24.11.2017 | Nuwiq | Octapharma AB
  Lars Forssells gata 23, 112 75 Stockholm, Sverige | EU/1/14/936 | 28.11.2017 |
| 28.11.2017 | Entacapone Orion | Orion Corporation
  Orionintie 1, 02200 Espoo, Suomi | EU/1/11/708 | 30.11.2017 |
| 28.11.2017 | Prepandrix | GlaxoSmithKline Biologicals S.A.
  rue de l'Institut 89, 1330 Rixensart, Belgique | EU/1/08/453 | 30.11.2017 |
| 28.11.2017 | Privigen | CSL Behring GmbH
  Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland | EU/1/08/446 | 30.11.2017 |
| 30.11.2017 | Zepatier | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/16/1119 | 4.12.2017 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

10.11.2017

ADCETRIS

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/12/794

14.11.2017

10.11.2017

APTIVUS

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/05/315

14.11.2017

10.11.2017

Benlysta

Glaxo Group Ltd

980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

EU/1/11/700

16.11.2017

10.11.2017

BYDUREON

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/11/696

14.11.2017

10.11.2017

ellaOne

Laboratoire HRA Pharma

15 rue Béranger, 75003 Paris, France

EU/1/09/522

14.11.2017

10.11.2017

Emtricitabine /Tenofovir disoproxil Krka d.d.

Krka d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/17/1182

14.11.2017

10.11.2017

Exjade

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/06/356

14.11.2017

10.11.2017

Exviera

AbbVie Ltd

Abbvie House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4UB, United Kingdom

EU/1/14/983

14.11.2017

10.11.2017

Faslodex

AstraZeneca UK Limited

Charter Way, Macclesfield, Cheshire, SK10 2NA, United Kingdom

EU/1/03/269

14.11.2017

10.11.2017

Glubrava

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/07/421

14.11.2017

10.11.2017

Humira

AbbVie Ltd

Abbvie House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4UB, United Kingdom

EU/1/03/256

14.11.2017

10.11.2017

Iblias

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/15/1077

14.11.2017

10.11.2017

Kolbam

Retrophin Europe Limited

Palmerstown House, Fenian Street, Dublin 2, Ireland

EU/1/13/895

14.11.2017

10.11.2017

Kovaltry

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/15/1076

14.11.2017

10.11.2017

Mepact

Takeda France SAS

Immeuble Pacific, 11-13 cours Valmy, 92800 Puteaux, France

EU/1/08/502

14.11.2017

10.11.2017

NexoBrid

MediWound Germany GmbH

Eisenstraße 5, 65428 Ruesselsheim, Deutschland

EU/1/12/803

14.11.2017

10.11.2017

Ovitrelle

Merck Serono Europe Limited

56, Marsh Wall, London E14 9TP, United Kingdom

EU/1/00/165

15.11.2017

10.11.2017

Pegasys

Roche Registration Limited

6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/02/221

14.11.2017

10.11.2017

Plegridy

Biogen Idec Limited

Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom

EU/1/14/934

14.11.2017

10.11.2017

Revatio

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

EU/1/05/318

14.11.2017

10.11.2017

Selincro

H. Lundbeck A/S

Ottiliavej 9, 2500 Valby, Danmark

EU/1/12/815

14.11.2017

10.11.2017

Tandemact

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/06/366

14.11.2017

10.11.2017

Teysuno

Nordic Group B.V.

Siriusdreef 22, 2132 WT Hoofddorp, Nederland

EU/1/11/669

14.11.2017

10.11.2017

Valdoxan

Les Laboratoires Servier

50 rue Carnot, 92284 Suresnes CEDEX, France

EU/1/08/499

14.11.2017

15.11.2017

Aripiprazole Accord

Accord Healthcare Limited

Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom

EU/1/15/1045

17.11.2017

15.11.2017

Bortezomib SUN

Sun Pharmaceutical Industries Europe BV

Polarisavenue 87, 2132 JH Hoofddorp, Nederland

EU/1/16/1102

17.11.2017

15.11.2017

Emtricitabine/Tenofovir disoproxil Krka

Krka d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/16/1151

17.11.2017

15.11.2017

Imvanex

Bavarian Nordic A/S

Hejreskovvej 10a, 3490 Kvistgaard, Danmark

EU/1/13/855

17.11.2017

15.11.2017

Kyprolis

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/15/1060

17.11.2017

15.11.2017

Lemtrada

Genzyme Therapeutics Ltd

4620 Kingsgate, Cascade Way, Oxford Business Park South, Oxford OX4 2SU, United Kingdom

EU/1/13/869

17.11.2017

15.11.2017

NovoEight

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/13/888

17.11.2017

15.11.2017

Ozurdex

Allergan Pharmaceuticals Ireland

Castlebar Road, Westport, County Mayo, Ireland

EU/1/10/638

20.11.2017

15.11.2017

ReFacto AF

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

EU/1/99/103

17.11.2017

15.11.2017

Savene

Clinigen Healthcare Limited

Pitcairn House, Crown Square, First Avenue, Burton-on-Trent, Staffordshire DE14 2WW, United Kingdom

EU/1/06/350

17.11.2017

15.11.2017

Saxenda

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/15/992

17.11.2017

15.11.2017

Tasigna

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/07/422

17.11.2017

15.11.2017

Viekirax

AbbVie Ltd

Abbvie House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4UB, United Kingdom

EU/1/14/982

17.11.2017

15.11.2017

Voncento

CSL Behring GmbH

Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland

EU/1/13/857

17.11.2017

15.11.2017

Zytiga

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/11/714

17.11.2017

16.11.2017

ATryn

Laboratoire français du Fractionnement et des Biotechnologies

3 Avenue des Tropiques, ZA de Courtaboeuf, 91940 Les Ulis, France

EU/1/06/355

20.11.2017

16.11.2017

Cubicin

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/05/328

20.11.2017

16.11.2017

Docetaxel Winthrop

Aventis Pharma S.A.

20 avenue Raymond Aron, 92165 Antony CEDEX, France

EU/1/07/384

20.11.2017

16.11.2017

Elocta

Swedish Orphan Biovitrum AB (publ)

112 76 Stockholm, Sverige

EU/1/15/1046

20.11.2017

16.11.2017

Helixate NexGen

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/00/144

20.11.2017

16.11.2017

KOGENATE Bayer

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/00/143

20.11.2017

16.11.2017

Levemir

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/04/278

20.11.2017

16.11.2017

Levetiracetam Accord

Accord Healthcare Limited

Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom

EU/1/11/712

20.11.2017

16.11.2017

Taxotere

Aventis Pharma S.A.

20 avenue Raymond Aron, 92165 Antony CEDEX, France

EU/1/95/002

20.11.2017

16.11.2017

Zydelig

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/14/938

20.11.2017

24.11.2017

Advate

Baxter AG

Industriestraße 67, 1221 Wien, Österreich

EU/1/03/271

28.11.2017

24.11.2017

Nuwiq

Octapharma AB

Lars Forssells gata 23, 112 75 Stockholm, Sverige

EU/1/14/936

28.11.2017

28.11.2017

Entacapone Orion

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/1/11/708

30.11.2017

28.11.2017

Prepandrix

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, 1330 Rixensart, Belgique

EU/1/08/453

30.11.2017

28.11.2017

Privigen

CSL Behring GmbH

Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland

EU/1/08/446

30.11.2017

30.11.2017

Zepatier

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/16/1119

4.12.2017

—   Withdrawal of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 10.11.2017 | Prevenar | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/00/167 | 14.11.2017 |
| 15.11.2017 | EVARREST | Omrix Biopharmaceuticals N.V.
  Leonardo Da Vincilaan 15, 1831 Diegem, België | EU/1/13/868 | 17.11.2017 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

10.11.2017

Prevenar

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

EU/1/00/167

14.11.2017

15.11.2017

EVARREST

Omrix Biopharmaceuticals N.V.

Leonardo Da Vincilaan 15, 1831 Diegem, België

EU/1/13/868

17.11.2017

—   Suspension of a marketing authorisation (Article 20 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 23.11.2017 | Optimark | Guerbet
  15 rue des Vanesses, 93420, Villepinte, France | EU/1/07/398 | 27.12.2017 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

23.11.2017

Optimark

Guerbet

15 rue des Vanesses, 93420, Villepinte, France

EU/1/07/398

27.12.2017

—   Issuing of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorisation | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 6.11.2017 | Nobivac LeuFel | Feline leukaemia vaccine (inactivated) | Virbac
  1ère Avenue — 2065 m — L.I.D., 06516 Carros CEDEX, France | EU/2/17/217 | Suspension for injection | QI06AA01 | 8.11.2017 |
| 21.11.2017 | Bovilis Blue-8 | Bluetongue virus vaccine (inactivated) serotype 8 | Intervet International B.V.
  Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/17/218 | Suspension for injection | QI02AA08
  QI04AA02 | 23.11.2017 |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorisation

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

6.11.2017

Nobivac LeuFel

Feline leukaemia vaccine (inactivated)

Virbac

1ère Avenue — 2065 m — L.I.D., 06516 Carros CEDEX, France

EU/2/17/217

Suspension for injection

QI06AA01

8.11.2017

21.11.2017

Bovilis Blue-8

Bluetongue virus vaccine (inactivated) serotype 8

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/17/218

Suspension for injection

QI02AA08

QI04AA02

23.11.2017

—   Modification of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 14.11.2017 | SevoFlo | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/02/035 | 16.11.2017 |
| 15.11.2017 | Contacera | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/12/144 | 16.11.2017 |
| 21.11.2017 | Circovac | Ceva-Phylaxia Zrt.
  Szállás u. 5, 1107 Budapest, Magyarország | EU/2/07/075 | 23.11.2017 |
| 21.11.2017 | Pexion | Boehringer Ingelheim Vetmedica GmbH
  D-55216 Ingelheim am Rhein, Deutschland | EU/2/12/147 | 23.11.2017 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

14.11.2017

SevoFlo

Zoetis Belgium S.A.

rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique

EU/2/02/035

16.11.2017

15.11.2017

Contacera

Zoetis Belgium S.A.

rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique

EU/2/12/144

16.11.2017

21.11.2017

Circovac

Ceva-Phylaxia Zrt.

Szállás u. 5, 1107 Budapest, Magyarország

EU/2/07/075

23.11.2017

21.11.2017

Pexion

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/12/147

23.11.2017

Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:

| European Medicines Agency |
| --- |
| 30 Churchill Place |
| Canary Wharf |
| London E14 5EU |
| United Kingdom |

European Medicines Agency

30 Churchill Place

Canary Wharf

London E14 5EU

United Kingdom

---

(1)  OJ L 136, 30.4.2004, p. 1.

---

| 29.12.2017 | EN | Official Journal of the European Union | C 447/11 |
| --- | --- | --- | --- |

29.12.2017

EN

Official Journal of the European Union

C 447/11

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2017 to 30 November 2017

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

(2017/C 447/02)

—   Issuing, maintenance or modification of a national marketing authorization

| Date of the decision | Name(s) of the medicinal product | INN (International Non-Proprietary Name) | Holder(s) of the marketing authorization | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- | --- |
| 10.11.2017 | Human coagulation factor VIII — Art 31 | Human coagulation factor VIII | See Annex I | See Annex I | 13.11.2017 |
| 23.11.2017 | Gadolinium — referral Art 31 | gadodiamide, gadopentetic acid, gadobenic acid, gadoxetic acid, gadoteridol, gadobutrol and gadoteric acid | See Annex II | See Annex II | 24.11.2017 |

Date of the decision

Name(s) of the medicinal product

INN (International Non-Proprietary Name)

Holder(s) of the marketing authorization

Member State concerned

Date of notification

10.11.2017

Human coagulation factor VIII — Art 31

Human coagulation factor VIII

See Annex I

See Annex I

13.11.2017

23.11.2017

Gadolinium — referral Art 31

gadodiamide, gadopentetic acid, gadobenic acid, gadoxetic acid, gadoteridol, gadobutrol and gadoteric acid

See Annex II

See Annex II

24.11.2017

—   Suspension of a national marketing authorization

| Date of the decision | Name(s) of the medicinal product | INN (International Non-Proprietary Name) | Holder(s) of the marketing authorization | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- | --- |
| 23.11.2017 | Gadolinium — referral Art 31 | gadodiamide, gadopentetic acid, gadobenic acid, gadoxetic acid, gadoteridol, gadobutrol and gadoteric acid | See Annex II | See Annex II | 24.11.2017 |

Date of the decision

Name(s) of the medicinal product

INN (International Non-Proprietary Name)

Holder(s) of the marketing authorization

Member State concerned

Date of notification

23.11.2017

Gadolinium — referral Art 31

gadodiamide, gadopentetic acid, gadobenic acid, gadoxetic acid, gadoteridol, gadobutrol and gadoteric acid

See Annex II

See Annex II

24.11.2017

---

(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 311, 28.11.2001, p. 1.

---

ANNEX I

List of medicinal products and presentations

| Member State in EEA | Product Name | Marketing authorisaton holder | INN | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- | --- |
| Austria | Immunate | Baxter Ag | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 100 I.U. / ml, Human Von Willebrand Factor 75 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Austria | Immunate | Baxter Ag | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 50 I.U. / ml, Human Von Willebrand Factor 38 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Austria | Optivate | Bio Products Laboratory | Human Coagulation Factor VIII | Human Coagulation Factor VIII 100 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Austria | Haemoctin Sdh | Biotest Austria Gmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 100 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Austria | Haemoctin Sdh | Biotest Austria Gmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 50 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Austria | Beriate | Csl Behring Gmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 100 I.U. / ml | Powder And Solvent For Solution For Injection/Infusion | Intravenous Use |
| Austria | Beriate | Csl Behring Gmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 200 I.U. / ml | Powder And Solvent For Solution For Injection/Infusion | Intravenous Use |
| Austria | Haemate P | Csl Behring Gmbh | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 50 I.U. / ml, Human Von Willebrand Factor 120 I.U. / ml | Powder And Solvent For Solution For Injection/Infusion | Intravenous Use |
| Austria | Haemate P | Csl Behring Gmbh | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 66.6 I.U. / ml, Human Von Willebrand Factor 160 I.U. / ml | Powder And Solvent For Solution For Injection/Infusion | Intravenous Use |
| Austria | Octanate | Octapharma Pharmazeutika Produktionsgesmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 1000 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Austria | Octanate | Octapharma Pharmazeutika Produktionsgesmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 250 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Austria | Octanate | Octapharma Pharmazeutika Produktionsgesmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 500 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Austria | Octanate Lv | Octapharma Pharmazeutika Produktionsgesmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 1000 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Austria | Octanate Lv | Octapharma Pharmazeutika Produktionsgesmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 500 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Austria | Wilate | Octapharma Pharmazeutika Produktionsgesmbh | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 1000 I.U. Vial, Human Von Willebrand Factor 1000 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Austria | Wilate | Octapharma Pharmazeutika Produktionsgesmbh | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 450 I.U. Vial, Human Von Willebrand Factor 400 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Austria | Wilate | Octapharma Pharmazeutika Produktionsgesmbh | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 500 I.U. Vial, Human Von Willebrand Factor 500 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Austria | Wilate | Octapharma Pharmazeutika Produktionsgesmbh | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 900 I.U. Vial, Human Von Willebrand Factor 800 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Belgium | Recombinate | Baxalta Innovations Gmbh | Human Coagulation Factor VIII (Rdna) | Human Coagulation Factor VIII (Rdna) 100 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Belgium | Recombinate | Baxalta Innovations Gmbh | Human Coagulation Factor VIII (Rdna) | Human Coagulation Factor VIII (Rdna) 200 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Belgium | Recombinate | Baxalta Innovations Gmbh | Human Coagulation Factor VIII (Rdna) | Human Coagulation Factor VIII (Rdna) 50 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Belgium | Optiwate | Bio Products Laboratory | Human Coagulation Factor VIII | Human Coagulation Factor VIII 100 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Belgium | Optiwate | Bio Products Laboratory | Human Coagulation Factor VIII | Human Coagulation Factor VIII 200 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Belgium | Optiwate | Bio Products Laboratory | Human Coagulation Factor VIII | Human Coagulation Factor VIII 400 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Belgium | Factane 500 IU — 5 ml | Cafdcf | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 100 I.U. / ml, Human Von Willebrand Factor 20 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Belgium | Factane 1000 IU/10 ml | Cafdcf | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 100 I.U. / ml, Human Von Willebrand Factor 20 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Belgium | Haemate P1200-500 | Csl Behring Gmbh | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 50 I.U. / ml, Human Von Willebrand Factor 120 I.U. / ml | Powder And Solvent For Solution For Injection/Infusion | Intravenous Use |
| Belgium | Haemate P2400-1000 | Csl Behring Gmbh | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 66.6 I.U. / ml, Human Von Willebrand Factor 160 I.U. / ml | Powder And Solvent For Solution For Injection/Infusion | Intravenous Use |
| Belgium | Haemate P600-250 | Csl Behring Gmbh | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 50 I.U. / ml, Human Von Willebrand Factor 120 I.U. / ml | Powder And Solvent For Solution For Injection/Infusion | Intravenous Use |
| Belgium | Octanate | Octapharma Benelux S.A./N.V. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 1000 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Belgium | Octanate | Octapharma Benelux S.A./N.V. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 250 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Belgium | Octanate | Octapharma Benelux S.A./N.V. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 500 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Belgium | Wilate | Octapharma Benelux S.A./N.V. | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 1000 I.U. Vial, Human Von Willebrand Factor 1000 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Belgium | Wilate | Octapharma Benelux S.A./N.V. | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 500 I.U. Vial, Human Von Willebrand Factor 500 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Bulgaria | Recombinate | Baxalta Innovations GmbH | Human Coagulation Factor VIII (Rdna) | Human Coagulation Factor VIII (Rdna) 250 I.U. / 5 ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Bulgaria | Recombinate | Baxalta Innovations GmbH | Human Coagulation Factor VIII (Rdna) | Human Coagulation Factor VIII (Rdna) 500 I.U. / 5 ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Bulgaria | Recombinate | Baxalta Innovations GmbH | Human Coagulation Factor VIII (Rdna) | Human Coagulation Factor VIII (Rdna) 1000 I.U. / 5ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Bulgaria | Immunate | Baxalta Innovations GmbH | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 250 I.U. Vial, Human Von Willebrand Factor 190 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Bulgaria | Immunate | Baxalta Innovations GmbH | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 500 I.U. Vial, Human Von Willebrand Factor 375 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Bulgaria | Immunate | Baxalta Innovations GmbH | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 1000 I.U. Vial, Human Von Willebrand Factor 750 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Bulgaria | Haemoctin | Biotest Pharma GmbH | Human Coagulation Factor VIII | Human Coagulation Factor VIII 250 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Bulgaria | Haemoctin | Biotest Pharma GmbH | Human Coagulation Factor VIII | Human Coagulation Factor VIII 500 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Bulgaria | Haemoctin | Biotest Pharma GmbH | Human Coagulation Factor VIII | Human Coagulation Factor VIII 1000 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Bulgaria | Beriate | CSL Behring Gmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 250 I.U. Vial | Powder And Solvent For Solution For Injection/Infusion | Intravenous Use |
| Bulgaria | Beriate | CSL Behring Gmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 500 I.U. Vial | Powder And Solvent For Solution For Injection/Infusion | Intravenous Use |
| Bulgaria | Beriate | CSL Behring Gmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 1000 I.U. Vial | Powder And Solvent For Solution For Injection/Infusion | Intravenous Use |
| Bulgaria | Beriate | CSL Behring Gmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 2000 I.U. Vial | Powder And Solvent For Solution For Injection/Infusion | Intravenous Use |
| Bulgaria | Fanhdi | Instituto Grifols, S.A. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 250 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Bulgaria | Fanhdi | Instituto Grifols, S.A. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 500 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Bulgaria | Fanhdi | Instituto Grifols, S.A. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 1000 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Bulgaria | Emoclot | Kedrion S.P.A. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 500 I.U. / 10 ml | Powder And Solvent For Solution For Infusion | Intravenous Use |
| Bulgaria | Octanate | Octapharma (Ip)-Ltd. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 1000 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Bulgaria | Octanate | Octapharma (Ip)-Ltd. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 500 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Bulgaria | Wilate | Octapharma (Ip)-Ltd. | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 1000 I.U. Vial, Human Von Willebrand Factor 1000 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Bulgaria | Wilate | Octapharma (Ip)-Ltd. | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 500 I.U. Vial, Human Von Willebrand Factor 500 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Croatia | Immunate | Agmar D.O.O. | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 500 I.U. Vial, Human Von Willebrand Factor 375 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Croatia | Immunate | Agmar D.O.O. | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 1000 I.U. Vial, Human Von Willebrand Factor 750 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Croatia | Recombinate | Agmar D.O.O. | Human Coagulation Factor VIII (Rdna) | Human Coagulation Factor VIII (Rdna) 250 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Croatia | Recombinate | Agmar D.O.O. | Human Coagulation Factor VIII (Rdna) | Human Coagulation Factor VIII (Rdna) 500 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Croatia | Recombinate | Agmar D.O.O. | Human Coagulation Factor VIII (Rdna) | Human Coagulation Factor VIII (Rdna) 1000 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Croatia | Fanhdi | Instituto Grifols, S.A. | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 100 I.U. / ml, Human Von Willebrand Factor 120 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Croatia | Fanhdi | Instituto Grifols, S.A. | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 25 I.U. / ml, Human Von Willebrand Factor 60 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Croatia | Fanhdi | Instituto Grifols, S.A. | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 50 I.U. / ml, Human Von Willebrand Factor 60 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Croatia | Beriate | Csl Behring Gmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 250 I.U. Vial | Powder And Solvent For Solution For Injection/Infusion | Intravenous Use |
| Croatia | Beriate | Csl Behring Gmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 500 I.U. Vial | Powder And Solvent For Solution For Injection/Infusion | Intravenous Use |
| Croatia | Beriate | Csl Behring Gmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 1000 I.U. Vial | Powder And Solvent For Solution For Injection/Infusion | Intravenous Use |
| Croatia | Beriate | Csl Behring Gmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 2000 I.U. Vial | Powder And Solvent For Solution For Injection/Infusion | Intravenous Use |
| Croatia | Haemate P | Csl Behring Gmbh | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 500 I.U. Vial, Human Von Willebrand Factor 1200 I.U. Vial | Powder And Solvent For Solution For Injection/Infusion | Intravenous Use |
| Croatia | Octanate | Jana Pharm D.O.O. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 1000 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Croatia | Octanate | Jana Pharm D.O.O. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 250 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Croatia | Octanate | Jana Pharm D.O.O. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 500 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Croatia | Wilate | Jana Pharm D.O.O. | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 1000 I.U. Vial, Human Von Willebrand Factor 1000 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Croatia | Wilate | Jana Pharm D.O.O. | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 500 I.U. Vial, Human Von Willebrand Factor 500 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Croatia | Emoclot | Jasika D.O.O. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 100 I.U. / ml | Powder And Solvent For Solution For Infusion | Intravenous Use |
| Croatia | Emoclot | Jasika D.O.O. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 50 I.U. / ml | Powder And Solvent For Solution For Infusion | Intravenous Use |
| Cyprus | Immunate | Baxalta Innovations Gmbh | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 100 I.U. / ml, Human Von Willebrand Factor 75 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Cyprus | Immunate | Baxalta Innovations Gmbh | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 50 I.U. / ml, Human Von Willebrand Factor 38 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Cyprus | Recombinate | Baxalta Innovations Gmbh | Human Coagulation Factor VIII (Rdna) | Human Coagulation Factor VIII (Rdna) 100 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Cyprus | Recombinate | Baxalta Innovations Gmbh | Human Coagulation Factor VIII (Rdna) | Human Coagulation Factor VIII (Rdna) 25 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Cyprus | Recombinate | Baxalta Innovations Gmbh | Human Coagulation Factor VIII (Rdna) | Human Coagulation Factor VIII (Rdna) 50 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Cyprus | Optivate | Bio Products Laboratory | Human Coagulation Factor VIII | Human Coagulation Factor VIII 100 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Cyprus | Dried Factor VIII Fraction, Type 8y Bio Products | Bio Products Laboratory | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 25 I.U. / ml, Human Von Willebrand Factor 26 I.U. / ml | Powder For Solution For Injection | Intravenous Use |
| Cyprus | Haemate P | Csl Behring Gmbh | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 66.6 I.U. / ml, Human Von Willebrand Factor 160 I.U. / ml | Powder And Solvent For Solution For Injection/Infusion | Intravenous Use |
| Cyprus | Octanate | Octapharma (Ip)-Ltd. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 1000 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Cyprus | Octanate | Octapharma (Ip)-Ltd. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 250 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Cyprus | Octanate | Octapharma (Ip)-Ltd. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 500 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Cyprus | Wilate | Octapharma (Ip)-Ltd. | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 1000 I.U. Vial, Human Von Willebrand Factor 1000 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Cyprus | Wilate | Octapharma (Ip)-Ltd. | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 450 I.U. Vial, Human Von Willebrand Factor 400 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Cyprus | Wilate | Octapharma (Ip)-Ltd. | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 500 I.U. Vial, Human Von Willebrand Factor 500 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Cyprus | Wilate | Octapharma (Ip)-Ltd. | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 900 I.U. Vial, Human Von Willebrand Factor 800 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Czech Republic | Immunate Stim Plus | Baxalta Innovations GmbH | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 100 I.U. / ml, Human Von Willebrand Factor 75 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Czech Republic | Immunate Stim Plus | Baxalta Innovations GmbH | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 50 I.U. / ml, Human Von Willebrand Factor 38 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Czech Republic | Recombinate | Baxalta Innovations GmbH | Human Coagulation Factor VIII (Rdna) | Human Coagulation Factor VIII (Rdna) 100 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Czech Republic | Recombinate | Baxalta Innovations GmbH | Human Coagulation Factor VIII (Rdna) | Human Coagulation Factor VIII (Rdna) 200 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Czech Republic | Optivate | Bio Products Laboratory | Human Coagulation Factor VIII | Human Coagulation Factor VIII 100 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Czech Republic | Haemoctin Sdh | Biotest Pharma Gmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 100 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Czech Republic | Haemoctin Sdh | Biotest Pharma Gmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 50 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Czech Republic | Beriate | Csl Behring Gmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 100 I.U. / ml | Powder And Solvent For Solution For Injection/Infusion | Intravenous Use |
| Czech Republic | Beriate | Csl Behring Gmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 200 I.U. / ml | Powder And Solvent For Solution For Injection/Infusion | Intravenous Use |
| Czech Republic | Haemate P | Csl Behring Gmbh | Human Coagulation Factor VIII (Rdna), Human Von Willebrand Factor | Human Coagulation Factor VIII (Rdna) 50 I.U. / ml, Human Von Willebrand Factor 120 I.U. / ml | Powder And Solvent For Solution For Injection/Infusion | Intravenous Use |
| Czech Republic | Haemate P | Csl Behring Gmbh | Human Coagulation Factor VIII (Rdna), Human Von Willebrand Factor | Human Coagulation Factor VIII (Rdna) 66.6 I.U. / ml, Human Von Willebrand Factor 160 I.U. / ml | Powder And Solvent For Solution For Injection/Infusion | Intravenous Use |
| Czech Republic | Fanhdi | Instituto Grifols, S.A. | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 100 I.U. / ml, Human Von Willebrand Factor 120 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Czech Republic | Fanhdi | Instituto Grifols, S.A. | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 25 I.U. / ml, Human Von Willebrand Factor 30 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Czech Republic | Fanhdi | Instituto Grifols, S.A. | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 50 I.U. / ml, Human Von Willebrand Factor 60 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Czech Republic | Octanate | Octapharma (Ip)-Ltd. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 1000 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Czech Republic | Octanate | Octapharma (Ip)-Ltd. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 250 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Czech Republic | Octanate | Octapharma (Ip)-Ltd. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 500 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Czech Republic | Wilate | Octapharma (Ip)-Ltd. | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 1000 I.U. Vial, Human Von Willebrand Factor 1000 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Czech Republic | Wilate | Octapharma (Ip)-Ltd. | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 500 I.U. Vial, Human Von Willebrand Factor 500 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Denmark | Haemate | Csl Behring Gmbh | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 50 I.U. / ml, Human Von Willebrand Factor 120 I.U. / ml | Powder And Solvent For Solution For Injection/Infusion | Intravenous Use |
| Denmark | Haemate | Csl Behring Gmbh | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 66.6 I.U. / ml, Human Von Willebrand Factor 160 I.U. / ml | Powder And Solvent For Solution For Injection/Infusion | Intravenous Use |
| Denmark | Octanate | Octapharma Ab | Human Coagulation Factor VIII | Human Coagulation Factor VIII 1000 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Denmark | Octanate | Octapharma Ab | Human Coagulation Factor VIII | Human Coagulation Factor VIII 250 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Denmark | Octanate | Octapharma Ab | Human Coagulation Factor VIII | Human Coagulation Factor VIII 500 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Denmark | Octanate Lv | Octapharma Ab | Human Coagulation Factor VIII | Human Coagulation Factor VIII 1000 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Denmark | Octanate Lv | Octapharma Ab | Human Coagulation Factor VIII | Human Coagulation Factor VIII 500 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Denmark | Wilnativ | Octapharma Ab | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 1000 I.U. Vial, Human Von Willebrand Factor 1000 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Denmark | Wilnativ | Octapharma Ab | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 500 I.U. Vial, Human Von Willebrand Factor 500 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Estonia | Immunate | Baxalta Innovations GmbH | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 250 I.U. / ml, Human Von Willebrand Factor 190 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Estonia | Immunate | Baxalta Innovations Gmbh | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 100 I.U. / ml, Human Von Willebrand Factor 75 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Estonia | Immunate | Baxalta Innovations Gmbh | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 50 I.U. / ml, Human Von Willebrand Factor 38 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Estonia | Recombinate | Baxalta Innovations Gmbh | Human Coagulation Factor VIII (Rdna) | Human Coagulation Factor VIII (Rdna) 100 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Estonia | Recombinate | Baxalta Innovations Gmbh | Human Coagulation Factor VIII (Rdna) | Human Coagulation Factor VIII (Rdna) 200 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Estonia | Recombinate | Baxalta Innovations Gmbh | Human Coagulation Factor VIII (Rdna) | Human Coagulation Factor VIII (Rdna) 50 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Estonia | Optivate | Bio Products Laboratory | Human Coagulation Factor VIII | Human Coagulation Factor VIII 100 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Estonia | Wilate | Octapharma (Ip)-Ltd. | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 100 I.U. / ml, Human Von Willebrand Factor 100 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Estonia | Wilate | Octapharma (Ip)-Ltd. | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 100 I.U. / ml, Human Von Willebrand Factor 1000 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Estonia | Octanate | Octapharma Ab | Human Coagulation Factor VIII | Human Coagulation Factor VIII 1000 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Estonia | Octanate | Octapharma Ab | Human Coagulation Factor VIII | Human Coagulation Factor VIII 500 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Finland | Immunate | Baxalta Innovations Gmbh | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 100 I.U. / ml, Human Von Willebrand Factor 75 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Finland | Immunate | Baxalta Innovations Gmbh | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 50 I.U. / ml, Human Von Willebrand Factor 38 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Finland | Haemate | Csl Behring Gmbh | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 50 I.U. / ml, Human Von Willebrand Factor 120 I.U. / ml | Powder And Solvent For Solution For Injection/Infusion | Intravenous Use |
| Finland | Haemate | Csl Behring Gmbh | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 66.6 I.U. / ml, Human Von Willebrand Factor 160 I.U. / ml | Powder And Solvent For Solution For Injection/Infusion | Intravenous Use |
| Finland | Octafil | Octapharma Ab | Human Coagulation Factor VIII | Human Coagulation Factor VIII 1000 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Finland | Octafil | Octapharma Ab | Human Coagulation Factor VIII | Human Coagulation Factor VIII 250 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Finland | Octafil | Octapharma Ab | Human Coagulation Factor VIII | Human Coagulation Factor VIII 500 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Finland | Octafil Lv | Octapharma Ab | Human Coagulation Factor VIII | Human Coagulation Factor VIII 1000 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Finland | Octafil Lv | Octapharma Ab | Human Coagulation Factor VIII | Human Coagulation Factor VIII 500 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Finland | Wilate | Octapharma Ab | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 1000 I.U. Vial, Human Von Willebrand Factor 1000 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Finland | Wilate | Octapharma Ab | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 500 I.U. Vial, Human Von Willebrand Factor 500 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Finland | Amofil | Sanquin Plasma Products B.V. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 100 I.U. / ml | Powder For Solution For Injection | Intravenous Use |
| Finland | Amofil | Sanquin Plasma Products B.V. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 500 I.U. / ml | Powder For Solution For Injection | Intravenous Use |
| France | Factane | Lfb Biomedicaments | Human Coagulation Factor VIII | Human Coagulation Factor VIII 100 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| France | Factane | Lfb Biomedicaments | Human Coagulation Factor VIII | Human Coagulation Factor VIII 200 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| France | Octanate | Octapharma France | Human Coagulation Factor VIII | Human Coagulation Factor VIII 100 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| France | Octanate | Octapharma France | Human Coagulation Factor VIII | Human Coagulation Factor VIII 50 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| France | Octanate LV | Octapharma France | Human Coagulation Factor VIII | Human Coagulation Factor VIII 100 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| France | Octanate | Octapharma France | Human Coagulation Factor VIII | Human Coagulation Factor VIII 200 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Germany | Immunate 250 I.E. | Baxalta Deutschland Gmbh | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 250 I.E. Human Von Willebrand Factor 150 I.E. | Powder And Solvent For Solution For Injection | Intravenous Use |
| Germany | Immunate 500 I.E. | Baxalta Deutschland Gmbh | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 500 I.E., Human Von Willebrand Factor 300 I.E. | Powder And Solvent For Solution For Injection | Intravenous Use |
| Germany | Immunate 1000 I.E. | Baxalta Deutschland Gmbh | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 1000 I.E./ Human Von Willebrand Factor 600 I.E. | Powder And Solvent For Solution For Injection | Intravenous Use |
| Germany | Recombinate Antihämophilie Faktor VIII (rek) 1000 | Baxalta Deutschland Gmbh | Human Coagulation Factor VIII (Rdna) | Human Coagulation Factor VIII (Rdna) 1000 I.U. / 10 ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Germany | Optivate 250 | Bio Products Laboratory | Human Coagulation Factor VIII | Human Coagulation Factor VIII 250 IUVIII | Powder And Solvent For Solution For Injection | Intravenous Use |
| Germany | Optivate 500 | Bio Products Laboratory | Human Coagulation Factor VIII | Human Coagulation Factor VIII 500 IU | Powder And Solvent For Solution For Injection | Intravenous Use |
| Germany | Optivate 1000 | Bio Products Laboratory | Human Coagulation Factor VIII | Human Coagulation Factor VIII 1000 IU | Powder And Solvent For Solution For Injection | Intravenous Use |
| Germany | Haemoctin Sdh 250 | Biotest Pharma Gmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 250 IU | Powder And Solvent For Solution For Injection | Intravenous Use |
| Germany | Haemoctin Sdh 500 | Biotest Pharma Gmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 500 IU | Powder And Solvent For Solution For Injection | Intravenous Use |
| Germany | Haemoctin Sdh 1000 | Biotest Pharma Gmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 1000 IU | Powder And Solvent For Solution For Injection | Intravenous Use |
| Germany | Beriate 250 | Csl Behring Gmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 250 IU | Powder And Solvent For Solution For Injection/Infusion | Intravenous Use |
| Germany | Beriate 500 | Csl Behring Gmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 500 IU | Powder And Solvent For Solution For Injection/Infusion | Intravenous Use |
| Germany | Beriate 1000 | Csl Behring Gmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 1000 IU | Powder And Solvent For Solution For Injection/Infusion | Intravenous Use |
| Germany | Beriate 2000 | Csl Behring Gmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 2000 IU | Powder And Solvent For Solution For Injection/Infusion | Intravenous Use |
| Germany | Haemate P 250 | Csl Behring Gmbh | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 250 I.E., Human Von Willebrand Factor 600 I.E. | Powder And Solvent For Solution For Injection/Infusion | Intravenous Use |
| Germany | Haemate P 500 | Csl Behring Gmbh | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 500 I.E., Human Von Willebrand Factor 1200 I.E. | Powder And Solvent For Solution For Injection/Infusion | Intravenous Use |
| Germany | Haemate P 1000 | Csl Behring Gmbh | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 1000 I.E. Human Von Willebrand Factor 2400 I.E. | Powder And Solvent For Solution For Injection/Infusion | Intravenous Use |
| Germany | Fanhdi 250 I.E. | Grifols Deutschland Gmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 250 I.E. | Powder And Solvent For Solution For Injection | Intravenous Use |
| Germany | Fanhdi 500 I.E. | Grifols Deutschland Gmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 500 I.E. | Powder And Solvent For Solution For Injection | Intravenous Use |
| Germany | Fanhdi 1000 I.E. | Grifols Deutschland Gmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 1000 I.E. | Powder And Solvent For Solution For Injection | Intravenous Use |
| Germany | Fanhdi 1500 I.E. | Grifols Deutschland Gmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 1500 I.E. | Powder And Solvent For Solution For Injection | Intravenous Use |
| Germany | Faktor VIII Sdh VIIIIntersero 250 | Intersero Gmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 250 I.E. | Powder And Solvent For Solution For Injection | Intravenous Use |
| Germany | Faktor VIII Sdh VIIIIntersero 500 | Intersero Gmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 500 I.E. | Powder And Solvent For Solution For Injection | Intravenous Use |
| Germany | Faktor VIII Sdh Intersero 1000 | Intersero Gmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 1000 I.E. | Powder And Solvent For Solution For Injection | Intravenous Use |
| Germany | Octanate 250 | Octapharma Gmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 250 I.E. | Powder And Solvent For Solution For Injection | Intravenous Use |
| Germany | Octanate 500 | Octapharma Gmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 500 I.E. | Powder And Solvent For Solution For Injection | Intravenous Use |
| Germany | Octanate 1000 | Octapharma Gmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 1000 I.E. | Powder And Solvent For Solution For Injection | Intravenous Use |
| Germany | Wilate 1000 | Octapharma Gmbh | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 1000 I.U. Vial, Human Von Willebrand Factor 1000 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Germany | Wilate 450 | Octapharma Gmbh | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 450 I.U. Vial, Human Von Willebrand Factor 400 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Germany | Wilate 500 | Octapharma Gmbh | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 500 I.U. Vial, Human Von Willebrand Factor 500 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Germany | Wilate 900 | Octapharma Gmbh | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 900 I.U. Vial, Human Von Willebrand Factor 800 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Greece | Immunate | Baxalta Innovations Gmbh | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 1000 I.U./Vial, Human Von Willebrand Factor 75 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Greece | Immunate | Baxalta Innovations Gmbh | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 500 I.U./Vial, Human Von Willebrand Factor 38 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Greece | Recombinate | Baxalta Innovations GmbH | Human Coagulation Factor VIII (Rdna) | Human Coagulation Factor VIII (Rdna) 1000 I.U./Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Greece | Recombinate | Baxalta Innovations GmbH | Human Coagulation Factor VIII (Rdna) | Human Coagulation Factor VIII (Rdna) 250 I.U./Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Greece | Recombinate | Baxalta Innovations GmbH | Human Coagulation Factor VIII (Rdna) | Human Coagulation Factor VIII (Rdna) 500 I.U./Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Greece | Haemate P | Csl Behring Mepe | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 500 I.U./Vial, Human Von Willebrand Factor 120 I.U. / ml | Powder And Solvent For Solution For Injection/Infusion | Intravenous Use |
| Greece | Haemate P | Csl Behring Mepe | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 66.6 I.U. / ml, Human Von Willebrand Factor 160 I.U. / ml | Powder And Solvent For Solution For Injection/Infusion | Intravenous Use |
| Greece | Fanhdi | Demo Abee | Human Coagulation Factor VIII | Human Coagulation Factor VIII 1000 I.U./Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Greece | Fanhdi | Demo Abee | Human Coagulation Factor VIII | Human Coagulation Factor VIII 250 I.U./Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Greece | Fanhdi | Demo Abee | Human Coagulation Factor VIII | Human Coagulation Factor VIII 500 I.U./Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Greece | Octanate | Octapharma Hellas A.E. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 1000 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Greece | Octanate | Octapharma Hellas A.E. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 250 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Greece | Octanate | Octapharma Hellas A.E. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 500 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Greece | Wilate | Octapharma Hellas A.E. | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 1000 I.U. Vial, Human Von Willebrand Factor 1000 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Greece | Wilate | Octapharma Hellas A.E. | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 500 I.U. Vial, Human Von Willebrand Factor 500 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Greece | Haemoctin | Vianex S.A. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 100 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Greece | Haemoctin | Vianex S.A. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 50 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Hungary | Immunate S/D | Baxalta Innovations Gmbh | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 100 I.U. / ml, Human Von Willebrand Factor 75 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Hungary | Immunate S/D | Baxalta Innovations Gmbh | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 50 I.U. / ml, Human Von Willebrand Factor 38 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Hungary | Recombinate | Baxalta Innovations Gmbh | Human Coagulation Factor VIII (Rdna) | Human Coagulation Factor VIII (Rdna) 100 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Hungary | Recombinate | Baxalta Innovations Gmbh | Human Coagulation Factor VIII (Rdna) | Human Coagulation Factor VIII (Rdna) 200 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Hungary | Recombinate | Baxalta Innovations Gmbh | Human Coagulation Factor VIII (Rdna) | Human Coagulation Factor VIII (Rdna) 50 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Hungary | Optivate | Bio Products Laboratory | Human Coagulation Factor VIII | Human Coagulation Factor VIII 100 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Hungary | Haemoctin | Biotest Hungaria Kft. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 100 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Hungary | Haemoctin | Biotest Hungaria Kft. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 50 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Hungary | Beriate | Csl Behring Gmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 100 I.U. / ml | Powder And Solvent For Solution For Injection/Infusion | Intravenous Use |
| Hungary | Beriate | Csl Behring Gmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 200 I.U. / ml | Powder And Solvent For Solution For Injection/Infusion | Intravenous Use |
| Hungary | Haemate | Csl Behring Gmbh | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 50 I.U. / ml, Human Von Willebrand Factor 120 I.U. / ml | Powder And Solvent For Solution For Injection/Infusion | Intravenous Use |
| Hungary | Haemate | Csl Behring Gmbh | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 66.6 I.U. / ml, Human Von Willebrand Factor 160 I.U. / ml | Powder And Solvent For Solution For Injection/Infusion | Intravenous Use |
| Hungary | Humaclot | Human Bioplazma Manufacturing And Trading Llc | Human Coagulation Factor VIII | Human Coagulation Factor VIII 100 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Hungary | Humaclot | Human Bioplazma Manufacturing And Trading Llc | Human Coagulation Factor VIII | Human Coagulation Factor VIII 50 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Hungary | Humafactor-8 | Human Bioplazma Manufacturing And Trading Llc | Human Coagulation Factor VIII | Human Coagulation Factor VIII 100 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Hungary | Fanhdi | Instituto Grifols, S.A. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 100 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Hungary | Fanhdi | Instituto Grifols, S.A. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 25 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Hungary | Fanhdi | Instituto Grifols, S.A. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 50 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Hungary | Octanate | Octapharma (Ip)-Ltd. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 1000 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Hungary | Octanate | Octapharma (Ip)-Ltd. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 250 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Hungary | Octanate | Octapharma (Ip)-Ltd. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 500 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Hungary | Wilate | Octapharma (Ip)-Ltd. | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 1000 I.U. Vial, Human Von Willebrand Factor 1000 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Hungary | Wilate | Octapharma (Ip)-Ltd. | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 500 I.U. Vial, Human Von Willebrand Factor 500 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Ireland | Recombinate | Baxalta Innovations Gmbh | Human Coagulation Factor VIII (Rdna) | Human Coagulation Factor VIII (Rdna) 1000 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Ireland | Recombinate | Baxalta Innovations Gmbh | Human Coagulation Factor VIII (Rdna) | Human Coagulation Factor VIII (Rdna) 250 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Ireland | Recombinate | Baxalta Innovations Gmbh | Human Coagulation Factor VIII (Rdna) | Human Coagulation Factor VIII (Rdna) 500 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Ireland | Optivate | Bio Products Laboratory | Human Coagulation Factor VIII | Human Coagulation Factor VIII 250 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Ireland | Optivate | Bio Products Laboratory | Human Coagulation Factor VIII | Human Coagulation Factor VIII 500 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Ireland | Optivate | Bio Products Laboratory | Human Coagulation Factor VIII | Human Coagulation Factor VIII 1000 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Ireland | Fanhdi | Instituto Grifols, S.A. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 1000 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Ireland | Fanhdi | Instituto Grifols, S.A. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 250 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Ireland | Fanhdi | Instituto Grifols, S.A. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 500 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Ireland | Octanate | Octapharma-Ltd | Human Coagulation Factor VIII | Human Coagulation Factor VIII 1000 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Ireland | Octanate | Octapharma-Ltd | Human Coagulation Factor VIII | Human Coagulation Factor VIII 250 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Ireland | Octanate | Octapharma-Ltd | Human Coagulation Factor VIII | Human Coagulation Factor VIII 500 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Ireland | Wilate | Octapharma-Ltd | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 1000 I.U. Vial, Human Von Willebrand Factor 1000 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Ireland | Wilate | Octapharma-Ltd | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 500 I.U. Vial, Human Von Willebrand Factor 500 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Italy | Recombinate | Baxalta Innovations Gmbh | Human Coagulation Factor VIII (Rdna) | Human Coagulation Factor VIII (Rdna) 100 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Italy | Recombinate | Baxalta Innovations Gmbh | Human Coagulation Factor VIII (Rdna) | Human Coagulation Factor VIII (Rdna) 200 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Italy | Recombinate | Baxalta Innovations Gmbh | Human Coagulation Factor VIII (Rdna) | Human Coagulation Factor VIII (Rdna) 25 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Italy | Recombinate | Baxalta Innovations Gmbh | Human Coagulation Factor VIII (Rdna) | Human Coagulation Factor VIII (Rdna) 250 I.U. / 5 ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Italy | Recombinate | Baxalta Innovations Gmbh | Human Coagulation Factor VIII (Rdna) | Human Coagulation Factor VIII (Rdna) 50 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Italy | Talate | Baxalta Innovations Gmbh | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 100 I.U. / ml, Human Von Willebrand Factor 75 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Italy | Talate | Baxalta Innovations Gmbh | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 50 I.U. / ml, Human Von Willebrand Factor 38 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Italy | Haemoctin | Biotest Pharma Gmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 100 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Italy | Haemoctin | Biotest Pharma Gmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 50 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Italy | Beriate | Csl Behring Gmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 100 I.U. / ml | Powder And Solvent For Solution For Injection/Infusion | Intravenous Use |
| Italy | Haemate P | Csl Behring Gmbh | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 50 I.U. / ml, Human Von Willebrand Factor 120 I.U. / ml | Powder And Solvent For Solution For Injection/Infusion | Intravenous Use |
| Italy | Haemate P | Csl Behring Gmbh | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 66.6 I.U. / ml, Human Von Willebrand Factor 160 I.U. / ml | Powder And Solvent For Solution For Injection/Infusion | Intravenous Use |
| Italy | Alphanate | Grifols Italia S.P.A | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 100 I.U. / ml, Human Von Willebrand Factor 120 I.U. / ml | Powder And Solvent For Solution For Infusion | Intravenous Use |
| Italy | Alphanate | Grifols Italia S.P.A | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 150 I.U. / ml, Human Von Willebrand Factor 180 I.U. / ml | Powder And Solvent For Solution For Infusion | Intravenous Use |
| Italy | Alphanate | Grifols Italia S.P.A | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 50 I.U. / ml, Human Von Willebrand Factor 60 I.U. / ml | Powder And Solvent For Solution For Infusion | Intravenous Use |
| Italy | Fanhdi | Instituto Grifols, S.A. | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 100 I.U. / ml, Human Von Willebrand Factor 120 I.U. / ml | Powder And Solvent For Solution For Infusion | Intravenous Use |
| Italy | Fanhdi | Instituto Grifols, S.A. | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 25 I.U. / ml, Human Von Willebrand Factor 30 I.U. / ml | Powder And Solvent For Solution For Infusion | Intravenous Use |
| Italy | Fanhdi | Instituto Grifols, S.A. | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 50 I.U. / ml, Human Von Willebrand Factor 60 I.U. / ml | Powder And Solvent For Solution For Infusion | Intravenous Use |
| Italy | Emoclot | Kedrion S.P.A. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 1000 I.U. / 10 ml | Powder And Solvent For Solution For Infusion | Intravenous Use |
| Italy | Emoclot | Kedrion S.P.A. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 500 I.U. / 10 ml | Powder And Solvent For Solution For Infusion | Intravenous Use |
| Italy | Emowil | Kedrion S.P.A. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 1000 I.U. / 10 ml | Powder And Solvent For Solution For Infusion | Intravenous Use |
| Italy | Emowil | Kedrion S.P.A. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 500 I.U. / 10 ml | Powder And Solvent For Solution For Infusion | Intravenous Use |
| Italy | Klott | Kedrion S.P.A. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 1000 I.U. / 10 ml | Powder And Solvent For Solution For Infusion | Intravenous Use |
| Italy | Klott | Kedrion S.P.A. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 500 I.U. / 10 ml | Powder And Solvent For Solution For Infusion | Intravenous Use |
| Italy | Octanate | Octapharma Italy S.P.A. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 1000 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Italy | Octanate | Octapharma Italy S.P.A. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 250 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Italy | Octanate | Octapharma Italy S.P.A. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 500 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Italy | Wilate | Octapharma Italy S.P.A. | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 1000 I.U. Vial, Human Von Willebrand Factor 1000 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Italy | Wilate | Octapharma Italy S.P.A. | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 450 I.U. Vial, Human Von Willebrand Factor 400 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Italy | Wilate | Octapharma Italy S.P.A. | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 500 I.U. Vial, Human Von Willebrand Factor 500 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Italy | Wilate | Octapharma Italy S.P.A. | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 900 I.U. Vial, Human Von Willebrand Factor 800 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Latvia | Immunate 1000 SV/750 SV pulveris un šķīdinātājs injekciju šķīduma pagatavošanai | Baxalta Innovations Gmbh | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 100 I.U. / ml, Human Von Willebrand Factor 75 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Latvia | Immunate 250 SV/190 SV pulveris un šķīdinātājs injekciju šķīduma pagatavošanai | Baxalta Innovations Gmbh | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 50 I.U. / ml, Human Von Willebrand Factor 38 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Latvia | Immunate 500 SV/375 SV pulveris un šķīdinātājs injekciju šķīduma pagatavošanai | Baxalta Innovations Gmbh | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 100 I.U. / ml, Human Von Willebrand Factor 75 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Latvia | Recombinate 500 SV/5 ml pulveris un šķīdinātājs injekciju šķīduma pagatavošanai | Baxalta Innovations Gmbh | Recombinant coagulation factor VIII (octocog alfa) | Human Coagulation Factor VIII (Rdna) 100 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Latvia | Recombinate
  1000 SV/5 ml pulveris un šķīdinātājs injekciju šķīduma pagatavošanai | Baxalta Innovations Gmbh | Recombinant coagulation factor VIII (octocog alfa) | Human Coagulation Factor VIII (Rdna) 200 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Latvia | Recombinate
  250 SV/5 ml pulveris un šķīdinātājs injekciju šķīduma pagatavošanai | Baxalta Innovations Gmbh | Recombinant coagulation factor VIII (octocog alfa) | Human Coagulation Factor VIII (Rdna) 50 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Latvia | Optivate 1000 SV pulveris un šķīdinātājs injekciju šķīduma pagatavošanai | Bio Products Laboratory Limited | Human Coagulation Factor VIII | Human Coagulation Factor VIII 100 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Latvia | Optivate 500 SV pulveris un šķīdinātājs injekciju šķīduma pagatavošanai | Bio Products Laboratory Limited | Human Coagulation Factor VIII | Human Coagulation Factor VIII 100 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Latvia | Optivate 250 SV pulveris un šķīdinātājs injekciju šķīduma pagatavošanai | Bio Products Laboratory Limited | Human Coagulation Factor VIII | Human Coagulation Factor VIII 100 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Latvia | Faktora VIII sausā frakcija tips 8Y, 25 SV/ml, pulveris injekciju šķīduma pagatavošanaiVIII | Bio Products Laboratory Limited | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 25 I.U. / ml, Human Von Willebrand Factor 26 I.U. / ml | Powder For Solution For Injection | Intravenous Use |
| Latvia | Octanate 1000 SV pulveris un šķīdinātājs injekciju šķīduma pagatavošanai | Octapharma (Ip)-Ltd. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 100 I.U./ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Latvia | Octanate 1000 SV/5 ml pulveris un šķīdinātājs injekciju šķīduma pagatavošanai | Octapharma (Ip) Limited | Human Coagulation Factor VIII | Human Coagulation Factor VIII 200 I.U./ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Latvia | Octanate 250 SV pulveris un šķīdinātājs injekciju šķīduma pagatavošanai | Octapharma (Ip)-Ltd. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 50 I.U./ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Latvia | Octanate 500 SV pulveris un šķīdinātājs injekciju šķīduma pagatavošanai | Octapharma (Ip)-Ltd. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 50 I.U./ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Latvia | Octanate 500 SV/5 ml pulveris un šķīdinātājs injekciju šķīduma pagatavošanai | Octapharma (Ip) Limited | Human Coagulation Factor VIII | Human Coagulation Factor VIII 100 I.U./ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Latvia | Wilate 1000 SV/1000 SV pulveris un šķīdinātājs injekciju šķīduma pagatavošanai | Octapharma (Ip)-Ltd. | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 100 I.U./ml, Human Von Willebrand Factor 100 I.U./ml VIII | Powder And Solvent For Solution For Injection | Intravenous Use |
| Latvia | Wilate 500 SV/500 SV pulveris un šķīdinātājs injekciju šķīduma pagatavošanai | Octapharma (Ip)-Ltd. | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 100 I.U./ml, Human Von Willebrand Factor 100 I.U./mlVIII | Powder And Solvent For Solution For Injection | Intravenous Use |
| Lithuania | Immunate | Baxalta Innovations GmbH | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 100 I.U. / ml, Human Von Willebrand Factor 75 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Lithuania | Immunate | Baxalta Innovations GmbH | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 50 I.U. / ml, Human Von Willebrand Factor 38 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Lithuania | Recombinate | Baxalta Innovations GmbH | Human Coagulation Factor VIII (Rdna) | Human Coagulation Factor VIII (Rdna) 100 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Lithuania | Recombinate | Baxalta Innovations GmbH | Human Coagulation Factor VIII (Rdna) | Human Coagulation Factor VIII (Rdna) 200 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Lithuania | Recombinate | Baxalta Innovations GmbH | Human Coagulation Factor VIII (Rdna) | Human Coagulation Factor VIII (Rdna) 50 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Lithuania | Optivate | Bio Products Laboratory | Human Coagulation Factor VIII | Human Coagulation Factor VIII 100 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Lithuania | Haemoctin SdH | Biotest Pharma GmbH | Human Coagulation Factor VIII | Human Coagulation Factor VIII 100 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Lithuania | Haemoctin SdH | Biotest Pharma GmbH | Human Coagulation Factor VIII | Human Coagulation Factor VIII 50 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Lithuania | Octanate | Octapharma (IP)-Ltd. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 1000 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Lithuania | Octanate | Octapharma (IP)-Ltd. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 250 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Lithuania | Octanate | Octapharma (IP)-Ltd. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 500 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Lithuania | Wilate | Octapharma (IP)-Ltd. | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 1000 I.U. Vial, Human Von Willebrand Factor 1000 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Lithuania | Wilate | Octapharma (IP)-Ltd. | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 500 I.U. Vial, Human Von Willebrand Factor 500 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Luxembourg | Recombinate | Baxalta Innovations Gmbh | Human Coagulation Factor VIII (Rdna) | Human Coagulation Factor VIII (Rdna) 100 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Luxembourg | Recombinate | Baxalta Innovations Gmbh | Human Coagulation Factor VIII (Rdna) | Human Coagulation Factor VIII (Rdna) 200 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Luxembourg | Recombinate | Baxalta Innovations Gmbh | Human Coagulation Factor VIII (Rdna) | Human Coagulation Factor VIII (Rdna) 25 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Luxembourg | Recombinate | Baxalta Innovations Gmbh | Human Coagulation Factor VIII (Rdna) | Human Coagulation Factor VIII (Rdna) 50 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Luxembourg | Haemate P | Csl Behring Gmbh | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 50 I.U. / ml, Human Von Willebrand Factor 120 I.U. / ml | Powder And Solvent For Solution For Injection/Infusion | Intravenous Use |
| Luxembourg | Haemate P | Csl Behring Gmbh | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 66.6 I.U. / ml, Human Von Willebrand Factor 160 I.U. / ml | Powder And Solvent For Solution For Injection/Infusion | Intravenous Use |
| Luxembourg | Factane | Lfb Biomedicaments | Human Coagulation Factor VIII | Human Coagulation Factor VIII 100 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Luxembourg | Octanate | Octapharma Benelux S.A./N.V. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 1000 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Luxembourg | Octanate | Octapharma Benelux S.A./N.V. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 250 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Luxembourg | Octanate | Octapharma Benelux S.A./N.V. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 500 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Luxembourg | Wilate | Octapharma Benelux S.A./N.V. | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 100 I.U. Vial, Human Von Willebrand Factor 100 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Malta | Recombinate | Baxalta Innovations Gmbh | Human Coagulation Factor VIII (Rdna) | Human Coagulation Factor VIII (Rdna) 1000 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Malta | Recombinate | Baxalta Innovations Gmbh | Human Coagulation Factor VIII (Rdna) | Human Coagulation Factor VIII (Rdna) 25 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Malta | Recombinate | Baxalta Innovations Gmbh | Human Coagulation Factor VIII (Rdna) | Human Coagulation Factor VIII (Rdna) 50 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Malta | Immunate | Baxter Ag | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 100 I.U. / ml, Human Von Willebrand Factor 75 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Malta | Immunate | Baxter Ag | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 50 I.U. / ml, Human Von Willebrand Factor 38 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Malta | Optivate | Bio Products Laboratory | Human Coagulation Factor VIII | Human Coagulation Factor VIII 100 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Malta | Dried Factor VIII Fraction, Type 8y Bio Products | Bio Products Laboratory | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 25 I.U. / ml, Human Von Willebrand Factor 26 I.U. / ml | Powder For Solution For Injection | Intravenous Use |
| Malta | Haemoctin Sdh | Biotest Pharma Gmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 100 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Malta | Haemoctin Sdh | Biotest Pharma Gmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 50 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Malta | Emoclot | Kedrion S.P.A. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 1000 I.U. / 10 ml | Powder And Solvent For Solution For Infusion | Intravenous Use |
| Malta | Octanate | Octapharma (Ip)-Ltd. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 1000 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Malta | Octanate | Octapharma (Ip)-Ltd. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 250 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Malta | Octanate | Octapharma (Ip)-Ltd. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 500 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Malta | Octanate Lv | Octapharma (Ip)-Ltd. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 1000 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Malta | Octanate Lv | Octapharma (Ip)-Ltd. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 500 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Malta | Wilate | Octapharma (Ip)-Ltd. | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 90 I.U. / ml, Human Von Willebrand Factor 80 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Netherlands | Immunate | Baxalta Innovations Gmbh | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 100 I.U. / ml, Human Von Willebrand Factor 75 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Netherlands | Immunate | Baxalta Innovations Gmbh | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 50 I.U. / ml, Human Von Willebrand Factor 38 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Netherlands | Recombinate | Baxalta Innovations Gmbh | Human Coagulation Factor VIII (Rdna) | Human Coagulation Factor VIII (Rdna) 1000 I.U. / 5 ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Netherlands | Recombinate | Baxalta Innovations Gmbh | Human Coagulation Factor VIII (Rdna) | Human Coagulation Factor VIII (Rdna) 250 I.U. / 5 ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Netherlands | Recombinate | Baxalta Innovations Gmbh | Human Coagulation Factor VIII (Rdna) | Human Coagulation Factor VIII (Rdna) 500 I.U. / 5 ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Netherlands | Recombinate | Baxalta Innovations Gmbh | Human Coagulation Factor VIII (Rdna) | Human Coagulation Factor VIII (Rdna) 1000 I.U. / 10 ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Netherlands | Recombinate | Baxalta Innovations Gmbh | Human Coagulation Factor VIII (Rdna) | Human Coagulation Factor VIII (Rdna) 250 I.U. / 10 ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Netherlands | Recombinate | Baxalta Innovations Gmbh | Human Coagulation Factor VIII (Rdna) | Human Coagulation Factor VIII (Rdna) 500 I.U. / 10 ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Netherlands | Optivate | Bio Products Laboratory | Human Coagulation Factor VIII | Human Coagulation Factor VIII 100 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Netherlands | Haemate P | Csl Behring Gmbh | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 50 I.U. / ml, Human Von Willebrand Factor 120 I.U. / ml | Powder And Solvent For Solution For Injection/Infusion | Intravenous Use |
| Netherlands | Haemate P | Csl Behring Gmbh | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 66.6 I.U. / ml, Human Von Willebrand Factor 160 I.U. / ml | Powder And Solvent For Solution For Injection/Infusion | Intravenous Use |
| Netherlands | Alphanate | Instituto Grifols, S.A. | Human Coagulation Factor VIII, Von Willebrand Factor | Human Coagulation Factor VIII 100 I.U. / ml, Von Willebrand Factor 25 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Netherlands | Alphanate | Instituto Grifols, S.A. | Human Coagulation Factor VIII, Von Willebrand Factor | Human Coagulation Factor VIII 50 I.U. / ml, Von Willebrand Factor 12.5 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Netherlands | Octanate | Octapharma Gmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 1000 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Netherlands | Octanate | Octapharma Gmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 250 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Netherlands | Octanate | Octapharma Gmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 500 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Netherlands | Octanate Lv | Octapharma Gmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 100 IU/ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Netherlands | Octanate Lv | Octapharma Gmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 200 IU/ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Netherlands | Wilate | Octapharma Gmbh | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 1000 I.U. Vial, Human Von Willebrand Factor 1000 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Netherlands | Wilate | Octapharma Gmbh | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 500 I.U. Vial, Human Von Willebrand Factor 500 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Netherlands | Aafact | Sanquin Plasma Products B.V. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 1000 I.U. Vial | Powder For Solution For Injection | Intravenous Use |
| Netherlands | Aafact | Sanquin Plasma Products B.V. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 500 I.U. Vial | Powder For Solution For Injection | Intravenous Use |
| Norway | Haemate | Csl Behring Gmbh | Human Coagulation Factor VIII (Rdna), Human Von Willebrand Factor | Human Coagulation Factor VIII (Rdna) 50 I.U. / ml, Human Von Willebrand Factor 120 I.U. / ml | Powder And Solvent For Solution For Injection/Infusion | Intravenous Use |
| Norway | Haemate | Csl Behring Gmbh | Human Coagulation Factor VIII (Rdna), Human Von Willebrand Factor | Human Coagulation Factor VIII (Rdna) 66.6 I.U. / ml, Human Von Willebrand Factor 160 I.U. / ml | Powder And Solvent For Solution For Injection/Infusion | Intravenous Use |
| Norway | Octanate | Octapharma | Human Coagulation Factor VIII | Human Coagulation Factor VIII 250 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Norway | Octanate | Octapharma | Human Coagulation Factor VIII | Human Coagulation Factor VIII 500 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Norway | Octanate | Octapharma | Human Coagulation Factor VIII | Human Coagulation Factor VIII 1000 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Norway | Wilate | Octapharma | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 1000 I.U. Vial, Human Von Willebrand Factor 1000 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Norway | Wilate | Octapharma | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 500 I.U. Vial, Human Von Willebrand Factor 500 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Poland | Immunate | Baxalta Poland Sp. z o.o. | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 100 I.U. / ml, Human Von Willebrand Factor 75 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Poland | Immunate | Baxalta Poland Sp. z o.o. | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 50 I.U. / ml, Human Von Willebrand Factor 38 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Poland | Recombinate | Baxalta Poland Sp. z o.o. | Human Coagulation Factor VIII (Rdna) | Human Coagulation Factor VIII (Rdna) 100 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Poland | Recombinate | Baxalta Poland Sp. z o.o. | Human Coagulation Factor VIII (Rdna) | Human Coagulation Factor VIII (Rdna) 200 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Poland | Recombinate | Baxalta Poland Sp. z o.o. | Human Coagulation Factor VIII (Rdna) | Human Coagulation Factor VIII (Rdna) 50 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Poland | Optivate | Bio Products Laboratory | Human Coagulation Factor VIII | Human Coagulation Factor VIII 100 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Poland | Innovate | Biomed-Lublin Wsisz S.A. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 1000 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Poland | Haemoctin | Biotest Pharma Gmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 100 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Poland | Haemoctin | Biotest Pharma Gmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 50 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Poland | Beriate | Csl Behring Gmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 100 I.U. / ml | Powder And Solvent For Solution For Injection/Infusion | Intravenous Use |
| Poland | Beriate | Csl Behring Gmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 200 I.U. / ml | Powder And Solvent For Solution For Injection/Infusion | Intravenous Use |
| Poland | Haemate P | Csl Behring Gmbh | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 50 I.U. / ml, Human Von Willebrand Factor 120 I.U. / ml | Powder And Solvent For Solution For Injection/Infusion | Intravenous Use |
| Poland | Haemate P | Csl Behring Gmbh | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 66.6 I.U. / ml, Human Von Willebrand Factor 160 I.U. / ml | Powder And Solvent For Solution For Injection/Infusion | Intravenous Use |
| Poland | Fanhdi | Instituto Grifols, S.A. | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 100 I.U. / ml, Human Von Willebrand Factor 120 I.U. / ml | Powder And Solvent For Solution For Injection/Infusion | Intravenous Use |
| Poland | Fanhdi | Instituto Grifols, S.A. | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 25 I.U. / ml, Human Von Willebrand Factor 30 I.U. / ml | Powder And Solvent For Solution For Injection/Infusion | Intravenous Use |
| Poland | Fanhdi | Instituto Grifols, S.A. | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 50 I.U. / ml, Human Von Willebrand Factor 60 I.U. / ml | Powder And Solvent For Solution For Injection/Infusion | Intravenous Use |
| Poland | Emoclot | Kedrion S.P.A. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 1000 I.U. / 10 ml | Powder And Solvent For Solution For Infusion | Intravenous Use |
| Poland | Emoclot | Kedrion S.P.A. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 500 I.U. / 10 ml | Powder And Solvent For Solution For Infusion | Intravenous Use |
| Poland | Octanate | Octapharma (Ip)-Ltd. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 1000 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Poland | Octanate | Octapharma (Ip)-Ltd. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 250 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Poland | Octanate | Octapharma (Ip)-Ltd. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 500 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Poland | Octanate Lv | Octapharma (Ip)-Ltd. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 1000 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Poland | Octanate Lv | Octapharma (Ip)-Ltd. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 500 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Poland | Wilate | Octapharma (Ip)-Ltd. | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 1000 I.U. Vial, Human Von Willebrand Factor 1000 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Poland | Wilate | Octapharma (Ip)-Ltd. | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 500 I.U. Vial, Human Von Willebrand Factor 500 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Portugal | Immunate | Baxalta Innovations Gmbh | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 1000 I.U. /10 ml, Human Von Willebrand Factor 750 I.U. / 10 ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Portugal | Immunate | Baxalta Innovations Gmbh | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 500 I.U. / 5 ml, Human Von Willebrand Factor 375 I.U. / 5 ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Portugal | Immunate | Baxalta Innovations Gmbh | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 250 I.U. / 5 ml, Human Von Willebrand Factor 190 I.U. / 5 ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Portugal | Optivate | Bio Products Laboratory Ltd. | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 1000 I.U. / 10 ml Human Von Willebrand Factor 2600 I.U. / 10 ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Portugal | Optivate | Bio Products Laboratory Ltd | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 500 I.U. / 5 ml Human Von Willebrand Factor 1300 I.U. / 5 ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Portugal | Optivate | Bio Products Laboratory Ltd | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 250 I.U. / 2,5 ml Human Von Willebrand Factor 650 I.U. / 2,5 ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Portugal | Haemoctin | Biotest Pharma Gmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 1000 I.U. / 10 ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Portugal | Haemoctin | Biotest Pharma Gmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 500 I.U. / 10 ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Portugal | Haemoctin | Biotest Pharma Gmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 250 I.U. /5 ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Portugal | Haemate P | CSL Behring Gmbh | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 500 I.U. / 10 ml, Human Von Willebrand Factor 1200 I.U. /10 ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Portugal | Haemate P | CSL Behring Gmbh | Human Coagulation Factor VIII Human Von Willebrand Factor | Human Coagulation Factor VIII 1000 I.U. / 15 ml, Human Von Willebrand Factor 2400 I.U. / 15 ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Portugal | Haemate P | CSL Behring Gmbh | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 250 I.U. / 5 ml, Human Von Willebrand Factor 600 I.U. / 5 ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Portugal | Beriate | CSL Behring Gmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 1000 I.U. / 10 ml | Powder And Solvent For Solution For Injection/Infusion | Intravenous Use |
| Portugal | Beriate | CSL Behring Gmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 250 I.U. / 2,5 ml | Powder And Solvent For Solution For Injection/Infusion | Intravenous Use |
| Portugal | Beriate | CSL Behring Gmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 500 I.U. / 5 ml | Powder And Solvent For Solution For Injection/Infusion | Intravenous Use |
| Portugal | Beriate | CSL Behring Gmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 2000 I.U. / 10 ml | Powder And Solvent For Solution For Injection/Infusion | Intravenous Use |
| Portugal | Fanhdi 100 U.I./ml Pó e solvente para solução injectável | Instituto Grifols, S.A. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 1000 I.U. / 10 ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Portugal | Fanhdi 25 U.I./ml Pó e solvente para solução injectável | Instituto Grifols, S.A. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 250 I.U. / 10 ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Portugal | Fanhdi 50 U.I./ml Pó e solvente para solução injectável | Instituto Grifols, S.A. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 500 I.U. / 10 ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Portugal | Fanhdi 100 U.I./ml Pó e solvente para solução injectável | Instituto Grifols, S.A. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 1500 I.U. / 15 ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Portugal | Emoclot D.I. 1000 | Kedrion S.P.A. | Human Coagulation Factor VIII | Human Coagulation Factor VIII1000 I.U. / 10 ml | Powder And Solvent For Solution For Infusion | Intravenous Use |
| Portugal | Emoclot D.I. 500 | Kedrion S.P.A. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 500 I.U. / 10 ml | Powder And Solvent For Solution For Infusion | Intravenous Use |
| Portugal | Factane | LFB Biomedicaments | Human Coagulation Factor VIII | Human Coagulation Factor VIII 1000 I.U. / 10 ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Portugal | Factane | LFB Biomedicaments | Human Coagulation Factor VIII | Human Coagulation Factor VIII 500 I.U. / 5 ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Portugal | Octanate | Octapharma Produtos Farmaceuticos, Lda. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 1000 I.U. / 5 ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Portugal | Octanate | Octapharma Produtos Farmaceuticos, Lda. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 250 I.U./ 5 ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Portugal | Octanate | Octapharma Produtos Farmaceuticos, Lda. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 500 I.U./ 10 ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Portugal | Octanate | Octapharma Produtos Farmaceuticos, Lda. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 1000 I.U./10 ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Portugal | Octanate | Octapharma Produtos Farmaceuticos, Lda. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 500 I.U./5 ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Portugal | Wilate 1000 | Octapharma Produtos Farmaceuticos, Lda. | Human Coagulation Factor VIII, Human Von Willebrand FactorVIII | Human Coagulation Factor VIII 1000 I.U. /10 ml, Human Von Willebrand Factor 1000 I.U./10 ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Portugal | Wilate 500 | Octapharma Produtos Farmaceuticos, Lda. | Human Coagulation Factor VIII, Human Von Willebrand FactorVIII | Human Coagulation Factor VIII 500 I.U./5 ml, Human Von Willebrand Factor 500 I.U./5 ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Romania | Immunate | Baxalta Innovations Gmbh | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 100 I.U. / ml, Human Von Willebrand Factor 75 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Romania | Immunate | Baxalta Innovations Gmbh | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 50 I.U. / ml, Human Von Willebrand Factor 38 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Romania | Recombinate | Baxalta Innovations Gmbh | Human Coagulation Factor VIII (Rdna) | Human Coagulation Factor VIII (Rdna) 100 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Romania | Recombinate | Baxalta Innovations Gmbh | Human Coagulation Factor VIII (Rdna) | Human Coagulation Factor VIII (Rdna) 200 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Romania | Recombinate | Baxalta Innovations Gmbh | Human Coagulation Factor VIII (Rdna) | Human Coagulation Factor VIII (Rdna) 25 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Romania | Recombinate | Baxalta Innovations Gmbh | Human Coagulation Factor VIII (Rdna) | Human Coagulation Factor VIII (Rdna) 50 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Romania | Optivate | Bio Products Laboratory | Human Coagulation Factor VIII | Human Coagulation Factor VIII 100 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Romania | Haemoctin Sdh | Biotest Pharma Gmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 100 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Romania | Haemoctin Sdh | Biotest Pharma Gmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 50 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Romania | Beriate | Csl Behring Gmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 100 I.U. / ml | Powder And Solvent For Solution For Injection/Infusion | Intravenous Use |
| Romania | Beriate | Csl Behring Gmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 200 I.U. / ml | Powder And Solvent For Solution For Injection/Infusion | Intravenous Use |
| Romania | Haemate P | Csl Behring Gmbh | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 50 I.U. / ml, Human Von Willebrand Factor 120 I.U. / ml | Powder And Solvent For Solution For Injection/Infusion | Intravenous Use |
| Romania | Haemate P | Csl Behring Gmbh | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 66.6 I.U. / ml, Human Von Willebrand Factor 160 I.U. / ml | Powder And Solvent For Solution For Injection/Infusion | Intravenous Use |
| Romania | Fanhdi | Instituto Grifols, S.A. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 100 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Romania | Fanhdi | Instituto Grifols, S.A. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 25 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Romania | Fanhdi | Instituto Grifols, S.A. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 50 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Romania | Emoclot | Kedrion S.P.A. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 500 I.U. / 10 ml | Powder And Solvent For Solution For Infusion | Intravenous Use |
| Romania | Octanate | Octapharma (Ip)-Ltd. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 1000 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Romania | Octanate | Octapharma (Ip)-Ltd. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 250 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Romania | Octanate | Octapharma (Ip)-Ltd. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 500 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Romania | Octanate Lv | Octapharma (Ip)-Ltd. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 1000 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Romania | Octanate Lv | Octapharma (Ip)-Ltd. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 500 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Romania | Wilate | Octapharma (Ip)-Ltd. | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 1000 I.U. Vial, Human Von Willebrand Factor 1000 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Romania | Wilate | Octapharma (Ip)-Ltd. | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 500 I.U. Vial, Human Von Willebrand Factor 500 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Slovakia | Immunate | Baxalta Innovations Gmbh | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 100 I.U. / ml, Human Von Willebrand Factor 75 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Slovakia | Immunate | Baxalta Innovations Gmbh | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 50 I.U. / ml, Human Von Willebrand Factor 38 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Slovakia | Immunate | Baxalta Innovations Gmbh | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 25 I.U. / ml, Human Von Willebrand Factor 19 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Slovakia | Recombinate | Baxalta Innovations Gmbh | Human Coagulation Factor VIII (Rdna) | Human Coagulation Factor VIII (Rdna) 100 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Slovakia | Recombinate | Baxalta Innovations Gmbh | Human Coagulation Factor VIII (Rdna) | Human Coagulation Factor VIII (Rdna) 25 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Slovakia | Recombinate | Baxalta Innovations Gmbh | Human Coagulation Factor VIII (Rdna) | Human Coagulation Factor VIII (Rdna) 50 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Slovakia | Optivate | Bio Products Laboratory | Human Coagulation Factor VIII | Human Coagulation Factor VIII 100 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Slovakia | Beriate | Csl Behring Gmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 100 I.U. / ml | Powder And Solvent For Solution For Injection/Infusion | Intravenous Use |
| Slovakia | Beriate | Csl Behring Gmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 200 I.U. / ml | Powder And Solvent For Solution For Injection/Infusion | Intravenous Use |
| Slovakia | Haemate P | Csl Behring Gmbh | Human Coagulation Factor VIII (Rdna), Human Von Willebrand Factor | Human Coagulation Factor VIII (Rdna) 50 I.U. / ml, Human Von Willebrand Factor 120 I.U. / ml | Powder And Solvent For Solution For Injection/Infusion | Intravenous Use |
| Slovakia | Haemate P | Csl Behring Gmbh | Human Coagulation Factor VIII (Rdna), Human Von Willebrand Factor | Human Coagulation Factor VIII (Rdna) 66.6 I.U. / ml, Human Von Willebrand Factor 160 I.U. / ml | Powder And Solvent For Solution For Injection/Infusion | Intravenous Use |
| Slovakia | Fanhdi | Instituto Grifols, S.A. | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 100 I.U. / ml, Human Von Willebrand Factor 120 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Slovakia | Fanhdi | Instituto Grifols, S.A. | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 25 I.U. / ml, Human Von Willebrand Factor 30 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Slovakia | Fanhdi | Instituto Grifols, S.A. | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 50 I.U. / ml, Human Von Willebrand Factor 60 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Slovakia | Wilate | Octapharma (Ip)-Ltd. | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 1000 I.U. Vial, Human Von Willebrand Factor 1000 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Slovakia | Wilate | Octapharma (Ip)-Ltd. | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 450 I.U. Vial, Human Von Willebrand Factor 400 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Slovakia | Wilate | Octapharma (Ip)-Ltd. | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 500 I.U. Vial, Human Von Willebrand Factor 500 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Slovakia | Wilate | Octapharma (Ip)-Ltd. | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 900 I.U. Vial, Human Von Willebrand Factor 800 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Slovakia | Octanate | Octapharma Pharmazeutika Produktionsgesmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 1000 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Slovakia | Octanate | Octapharma Pharmazeutika Produktionsgesmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 250 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Slovakia | Octanate | Octapharma Pharmazeutika Produktionsgesmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 500 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Slovenia | Beriate | Csl Behring Gmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 250 I.U. Vial | Powder And Solvent For Solution For Injection/Infusion | Intravenous Use |
| Slovenia | Beriate | Csl Behring Gmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 500 I.U. Vial | Powder And Solvent For Solution For Injection/Infusion | Intravenous Use |
| Slovenia | Beriate | Csl Behring Gmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 1000 I.U. Vial | Powder And Solvent For Solution For Injection/Infusion | Intravenous Use |
| Slovenia | Beriate | Csl Behring Gmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 2000 I.U. Vial | Powder And Solvent For Solution For Injection/Infusion | Intravenous Use |
| Slovenia | Haemate P | Csl Behring Gmbh | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 500 I.U. Vial, Human Von Willebrand Factor 1200 I.U. Vial VIII | Powder And Solvent For Solution For Injection/Infusion | Intravenous Use |
| Slovenia | Immunate | Baxalta Innovations Gmbh | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 250 I.U. Vial, Human Von Willebrand Factor 190 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Slovenia | Immunate | Baxalta Innovations Gmbh | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 500 I.U. Vial, Human Von Willebrand Factor 375 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Slovenia | Immunate | Baxalta Innovations Gmbh | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 1000 I.U. Vial, Human Von Willebrand Factor 750 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Slovenia | Octanate | Octapharma (Ip)-Ltd. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 1000 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Slovenia | Octanate | Octapharma (Ip)-Ltd. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 250 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Slovenia | Octanate | Octapharma (Ip)-Ltd. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 500 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Slovenia | Octanate Kons | Octapharma (Ip)-Ltd. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 1000 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Slovenia | Octanate Kons | Octapharma (Ip)-Ltd. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 500 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Slovenia | Wilate | Octapharma (Ip)-Ltd. | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 1000 I.U. Vial, Human Von Willebrand Factor 1000 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Slovenia | Wilate | Octapharma (Ip)-Ltd. | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 500 I.U. Vial, Human Von Willebrand Factor 500 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Spain | Haemoctin | Biotest Pharma Gmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 100 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Spain | Haemoctin | Biotest Pharma Gmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 50 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Spain | Beriate | Csl Behring Gmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 100 I.U. / ml | Powder And Solvent For Solution For Injection/Infusion | Intravenous Use |
| Spain | Beriate | Csl Behring Gmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 200 I.U. / ml | Powder And Solvent For Solution For Injection/Infusion | Intravenous Use |
| Spain | Haemate P | Csl Behring, S.A | Human Coagulation Factor VIII, Von Willebrand Factor | Human Coagulation Factor VIII 50 I.U. / ml, Von Willebrand Factor 120 I.U. / ml | Powder And Solvent For Solution For Injection/Infusion | Intravenous Use |
| Spain | Haemate P | Csl Behring, S.A | Human Coagulation Factor VIII, Von Willebrand Factor | Human Coagulation Factor VIII 66.6 I.U. / ml, Von Willebrand Factor 160 I.U. / ml | Powder And Solvent For Solution For Injection/Infusion | Intravenous Use |
| Spain | Fanhdi | Instituto Grifols, S.A. | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 100 I.U. / ml, Human Von Willebrand Factor 120 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Spain | Fanhdi | Instituto Grifols, S.A. | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 25 I.U. / ml, Human Von Willebrand Factor 30 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Spain | Fanhdi | Instituto Grifols, S.A. | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 50 I.U. / ml, Human Von Willebrand Factor 60 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Spain | Octanate | Octapharma S.A. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 1000 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Spain | Octanate | Octapharma S.A. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 250 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Spain | Octanate | Octapharma S.A. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 500 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Spain | Octanate Lv | Octapharma S.A. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 1000 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Spain | Octanate Lv | Octapharma S.A. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 500 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Spain | Wilate | Octapharma S.A. | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 100 I.U. / ml, Human Von Willebrand Factor 100 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Spain | Wilate | Octapharma S.A. | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 500 I.U. Vial, Human Von Willebrand Factor 500 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Sweden | Immunate | Baxalta Innovations Gmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 100 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Sweden | Immunate | Baxalta Innovations Gmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 50 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Sweden | Haemate | Csl Behring Gmbh | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 50 I.U. / ml, Human Von Willebrand Factor 120 I.U. / ml | Powder And Solvent For Solution For Injection/Infusion | Intravenous Use |
| Sweden | Haemate | Csl Behring Gmbh | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 67 I.U. / ml, Human Von Willebrand Factor 160 I.U. / ml | Powder And Solvent For Solution For Injection/Infusion | Intravenous Use |
| Sweden | Octanate | Octapharma Ab | Human Coagulation Factor VIII | Human Coagulation Factor VIII 1000 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Sweden | Octanate | Octapharma Ab | Human Coagulation Factor VIII | Human Coagulation Factor VIII 250 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Sweden | Octanate | Octapharma Ab | Human Coagulation Factor VIII | Human Coagulation Factor VIII 500 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Sweden | Octanate Lv | Octapharma Ab | Human Coagulation Factor VIII | Human Coagulation Factor VIII 1000 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Sweden | Octanate Lv | Octapharma Ab | Human Coagulation Factor VIII | Human Coagulation Factor VIII 500 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Sweden | Wilate | Octapharma Ab | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 1000 I.U. Vial, Human Von Willebrand Factor 1000 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Sweden | Wilate | Octapharma Ab | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 500 I.U. Vial, Human Von Willebrand Factor 500 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| United Kingdom | Optivate | Bio Products Laboratory | Human Coagulation Factor VIII | Human Coagulation Factor VIII 100 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| United Kingdom | Optivate | Bio Products Laboratory | Human Coagulation Factor VIII | Human Coagulation Factor VIII 80 — 130 I.U. / ml | Powder For Solution For Injection | Intravenous Use |
| United Kingdom | 8y | Bio Products Laboratory | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 25 I.U. / ml, Human Von Willebrand Factor 26 I.U. / ml | Powder For Solution For Injection | Intravenous Use |
| United Kingdom | Haemoctin | Biotest Pharma Gmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 100 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| United Kingdom | Haemoctin | Biotest Pharma Gmbh | Human Coagulation Factor VIII | Human Coagulation Factor VIII 50 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| United Kingdom | Haemate P | Csl Behring Gmbh | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 50 I.U. / ml, Human Von Willebrand Factor 120 I.U. / ml | Powder And Solvent For Solution For Injection/Infusion | Intravenous Use |
| United Kingdom | Haemate P | Csl Behring Gmbh | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 66.6 I.U. / ml, Human Von Willebrand Factor 160 I.U. / ml | Powder And Solvent For Solution For Injection/Infusion | Intravenous Use |
| United Kingdom | Fanhdi | Instituto Grifols, S.A. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 100 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| United Kingdom | Fanhdi | Instituto Grifols, S.A. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 25 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| United Kingdom | Fanhdi | Instituto Grifols, S.A. | Human Coagulation Factor VIII | Human Coagulation Factor VIII 50 I.U. / ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| United Kingdom | Alphanate | Instituto Grifols, S.A. | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 100 I.U. / ml, Human Von Willebrand Factor 120 I.U. / ml | Powder For Injection | Intravenous Use |
| United Kingdom | Alphanate | Instituto Grifols, S.A. | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 150 I.U. / ml, Human Von Willebrand Factor 180 I.U. / ml | Powder For Injection | Intravenous Use |
| United Kingdom | Alphanate | Instituto Grifols, S.A. | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 50 I.U. / ml, Human Von Willebrand Factor 60 I.U. / ml | Powder For Injection | Intravenous Use |
| United Kingdom | Octanate | Octapharma-Ltd | Human Coagulation Factor VIII | Human Coagulation Factor VIII 1000 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| United Kingdom | Octanate | Octapharma-Ltd | Human Coagulation Factor VIII | Human Coagulation Factor VIII 250 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| United Kingdom | Octanate | Octapharma-Ltd | Human Coagulation Factor VIII | Human Coagulation Factor VIII 500 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| United Kingdom | Octanate Lv | Octapharma-Ltd | Human Coagulation Factor VIII | Human Coagulation Factor VIII 1000 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| United Kingdom | Octanate Lv | Octapharma-Ltd | Human Coagulation Factor VIII | Human Coagulation Factor VIII 500 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| United Kingdom | Wilate | Octapharma-Ltd | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 1000 I.U. Vial, Human Von Willebrand Factor 1000 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| United Kingdom | Wilate | Octapharma-Ltd | Human Coagulation Factor VIII, Human Von Willebrand Factor | Human Coagulation Factor VIII 500 I.U. Vial, Human Von Willebrand Factor 500 I.U. Vial | Powder And Solvent For Solution For Injection | Intravenous Use |

Member State in EEA

Product Name

Marketing authorisaton holder

INN

Strength

Pharmaceutical form

Route of administration

Austria

Immunate

Baxter Ag

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 100 I.U. / ml, Human Von Willebrand Factor 75 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Austria

Immunate

Baxter Ag

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 50 I.U. / ml, Human Von Willebrand Factor 38 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Austria

Optivate

Bio Products Laboratory

Human Coagulation Factor VIII

Human Coagulation Factor VIII 100 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Austria

Haemoctin Sdh

Biotest Austria Gmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 100 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Austria

Haemoctin Sdh

Biotest Austria Gmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 50 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Austria

Beriate

Csl Behring Gmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 100 I.U. / ml

Powder And Solvent For Solution For Injection/Infusion

Intravenous Use

Austria

Beriate

Csl Behring Gmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 200 I.U. / ml

Powder And Solvent For Solution For Injection/Infusion

Intravenous Use

Austria

Haemate P

Csl Behring Gmbh

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 50 I.U. / ml, Human Von Willebrand Factor 120 I.U. / ml

Powder And Solvent For Solution For Injection/Infusion

Intravenous Use

Austria

Haemate P

Csl Behring Gmbh

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 66.6 I.U. / ml, Human Von Willebrand Factor 160 I.U. / ml

Powder And Solvent For Solution For Injection/Infusion

Intravenous Use

Austria

Octanate

Octapharma Pharmazeutika Produktionsgesmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 1000 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Austria

Octanate

Octapharma Pharmazeutika Produktionsgesmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 250 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Austria

Octanate

Octapharma Pharmazeutika Produktionsgesmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 500 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Austria

Octanate Lv

Octapharma Pharmazeutika Produktionsgesmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 1000 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Austria

Octanate Lv

Octapharma Pharmazeutika Produktionsgesmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 500 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Austria

Wilate

Octapharma Pharmazeutika Produktionsgesmbh

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 1000 I.U. Vial, Human Von Willebrand Factor 1000 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Austria

Wilate

Octapharma Pharmazeutika Produktionsgesmbh

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 450 I.U. Vial, Human Von Willebrand Factor 400 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Austria

Wilate

Octapharma Pharmazeutika Produktionsgesmbh

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 500 I.U. Vial, Human Von Willebrand Factor 500 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Austria

Wilate

Octapharma Pharmazeutika Produktionsgesmbh

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 900 I.U. Vial, Human Von Willebrand Factor 800 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Belgium

Recombinate

Baxalta Innovations Gmbh

Human Coagulation Factor VIII (Rdna)

Human Coagulation Factor VIII (Rdna) 100 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Belgium

Recombinate

Baxalta Innovations Gmbh

Human Coagulation Factor VIII (Rdna)

Human Coagulation Factor VIII (Rdna) 200 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Belgium

Recombinate

Baxalta Innovations Gmbh

Human Coagulation Factor VIII (Rdna)

Human Coagulation Factor VIII (Rdna) 50 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Belgium

Optiwate

Bio Products Laboratory

Human Coagulation Factor VIII

Human Coagulation Factor VIII 100 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Belgium

Optiwate

Bio Products Laboratory

Human Coagulation Factor VIII

Human Coagulation Factor VIII 200 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Belgium

Optiwate

Bio Products Laboratory

Human Coagulation Factor VIII

Human Coagulation Factor VIII 400 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Belgium

Factane 500 IU — 5 ml

Cafdcf

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 100 I.U. / ml, Human Von Willebrand Factor 20 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Belgium

Factane 1000 IU/10 ml

Cafdcf

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 100 I.U. / ml, Human Von Willebrand Factor 20 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Belgium

Haemate P1200-500

Csl Behring Gmbh

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 50 I.U. / ml, Human Von Willebrand Factor 120 I.U. / ml

Powder And Solvent For Solution For Injection/Infusion

Intravenous Use

Belgium

Haemate P2400-1000

Csl Behring Gmbh

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 66.6 I.U. / ml, Human Von Willebrand Factor 160 I.U. / ml

Powder And Solvent For Solution For Injection/Infusion

Intravenous Use

Belgium

Haemate P600-250

Csl Behring Gmbh

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 50 I.U. / ml, Human Von Willebrand Factor 120 I.U. / ml

Powder And Solvent For Solution For Injection/Infusion

Intravenous Use

Belgium

Octanate

Octapharma Benelux S.A./N.V.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 1000 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Belgium

Octanate

Octapharma Benelux S.A./N.V.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 250 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Belgium

Octanate

Octapharma Benelux S.A./N.V.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 500 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Belgium

Wilate

Octapharma Benelux S.A./N.V.

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 1000 I.U. Vial, Human Von Willebrand Factor 1000 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Belgium

Wilate

Octapharma Benelux S.A./N.V.

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 500 I.U. Vial, Human Von Willebrand Factor 500 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Bulgaria

Recombinate

Baxalta Innovations GmbH

Human Coagulation Factor VIII (Rdna)

Human Coagulation Factor VIII (Rdna) 250 I.U. / 5 ml

Powder And Solvent For Solution For Injection

Intravenous Use

Bulgaria

Recombinate

Baxalta Innovations GmbH

Human Coagulation Factor VIII (Rdna)

Human Coagulation Factor VIII (Rdna) 500 I.U. / 5 ml

Powder And Solvent For Solution For Injection

Intravenous Use

Bulgaria

Recombinate

Baxalta Innovations GmbH

Human Coagulation Factor VIII (Rdna)

Human Coagulation Factor VIII (Rdna) 1000 I.U. / 5ml

Powder And Solvent For Solution For Injection

Intravenous Use

Bulgaria

Immunate

Baxalta Innovations GmbH

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 250 I.U. Vial, Human Von Willebrand Factor 190 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Bulgaria

Immunate

Baxalta Innovations GmbH

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 500 I.U. Vial, Human Von Willebrand Factor 375 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Bulgaria

Immunate

Baxalta Innovations GmbH

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 1000 I.U. Vial, Human Von Willebrand Factor 750 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Bulgaria

Haemoctin

Biotest Pharma GmbH

Human Coagulation Factor VIII

Human Coagulation Factor VIII 250 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Bulgaria

Haemoctin

Biotest Pharma GmbH

Human Coagulation Factor VIII

Human Coagulation Factor VIII 500 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Bulgaria

Haemoctin

Biotest Pharma GmbH

Human Coagulation Factor VIII

Human Coagulation Factor VIII 1000 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Bulgaria

Beriate

CSL Behring Gmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 250 I.U. Vial

Powder And Solvent For Solution For Injection/Infusion

Intravenous Use

Bulgaria

Beriate

CSL Behring Gmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 500 I.U. Vial

Powder And Solvent For Solution For Injection/Infusion

Intravenous Use

Bulgaria

Beriate

CSL Behring Gmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 1000 I.U. Vial

Powder And Solvent For Solution For Injection/Infusion

Intravenous Use

Bulgaria

Beriate

CSL Behring Gmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 2000 I.U. Vial

Powder And Solvent For Solution For Injection/Infusion

Intravenous Use

Bulgaria

Fanhdi

Instituto Grifols, S.A.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 250 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Bulgaria

Fanhdi

Instituto Grifols, S.A.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 500 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Bulgaria

Fanhdi

Instituto Grifols, S.A.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 1000 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Bulgaria

Emoclot

Kedrion S.P.A.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 500 I.U. / 10 ml

Powder And Solvent For Solution For Infusion

Intravenous Use

Bulgaria

Octanate

Octapharma (Ip)-Ltd.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 1000 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Bulgaria

Octanate

Octapharma (Ip)-Ltd.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 500 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Bulgaria

Wilate

Octapharma (Ip)-Ltd.

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 1000 I.U. Vial, Human Von Willebrand Factor 1000 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Bulgaria

Wilate

Octapharma (Ip)-Ltd.

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 500 I.U. Vial, Human Von Willebrand Factor 500 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Croatia

Immunate

Agmar D.O.O.

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 500 I.U. Vial, Human Von Willebrand Factor 375 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Croatia

Immunate

Agmar D.O.O.

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 1000 I.U. Vial, Human Von Willebrand Factor 750 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Croatia

Recombinate

Agmar D.O.O.

Human Coagulation Factor VIII (Rdna)

Human Coagulation Factor VIII (Rdna) 250 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Croatia

Recombinate

Agmar D.O.O.

Human Coagulation Factor VIII (Rdna)

Human Coagulation Factor VIII (Rdna) 500 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Croatia

Recombinate

Agmar D.O.O.

Human Coagulation Factor VIII (Rdna)

Human Coagulation Factor VIII (Rdna) 1000 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Croatia

Fanhdi

Instituto Grifols, S.A.

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 100 I.U. / ml, Human Von Willebrand Factor 120 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Croatia

Fanhdi

Instituto Grifols, S.A.

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 25 I.U. / ml, Human Von Willebrand Factor 60 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Croatia

Fanhdi

Instituto Grifols, S.A.

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 50 I.U. / ml, Human Von Willebrand Factor 60 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Croatia

Beriate

Csl Behring Gmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 250 I.U. Vial

Powder And Solvent For Solution For Injection/Infusion

Intravenous Use

Croatia

Beriate

Csl Behring Gmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 500 I.U. Vial

Powder And Solvent For Solution For Injection/Infusion

Intravenous Use

Croatia

Beriate

Csl Behring Gmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 1000 I.U. Vial

Powder And Solvent For Solution For Injection/Infusion

Intravenous Use

Croatia

Beriate

Csl Behring Gmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 2000 I.U. Vial

Powder And Solvent For Solution For Injection/Infusion

Intravenous Use

Croatia

Haemate P

Csl Behring Gmbh

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 500 I.U. Vial, Human Von Willebrand Factor 1200 I.U. Vial

Powder And Solvent For Solution For Injection/Infusion

Intravenous Use

Croatia

Octanate

Jana Pharm D.O.O.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 1000 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Croatia

Octanate

Jana Pharm D.O.O.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 250 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Croatia

Octanate

Jana Pharm D.O.O.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 500 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Croatia

Wilate

Jana Pharm D.O.O.

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 1000 I.U. Vial, Human Von Willebrand Factor 1000 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Croatia

Wilate

Jana Pharm D.O.O.

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 500 I.U. Vial, Human Von Willebrand Factor 500 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Croatia

Emoclot

Jasika D.O.O.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 100 I.U. / ml

Powder And Solvent For Solution For Infusion

Intravenous Use

Croatia

Emoclot

Jasika D.O.O.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 50 I.U. / ml

Powder And Solvent For Solution For Infusion

Intravenous Use

Cyprus

Immunate

Baxalta Innovations Gmbh

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 100 I.U. / ml, Human Von Willebrand Factor 75 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Cyprus

Immunate

Baxalta Innovations Gmbh

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 50 I.U. / ml, Human Von Willebrand Factor 38 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Cyprus

Recombinate

Baxalta Innovations Gmbh

Human Coagulation Factor VIII (Rdna)

Human Coagulation Factor VIII (Rdna) 100 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Cyprus

Recombinate

Baxalta Innovations Gmbh

Human Coagulation Factor VIII (Rdna)

Human Coagulation Factor VIII (Rdna) 25 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Cyprus

Recombinate

Baxalta Innovations Gmbh

Human Coagulation Factor VIII (Rdna)

Human Coagulation Factor VIII (Rdna) 50 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Cyprus

Optivate

Bio Products Laboratory

Human Coagulation Factor VIII

Human Coagulation Factor VIII 100 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Cyprus

Dried Factor VIII Fraction, Type 8y Bio Products

Bio Products Laboratory

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 25 I.U. / ml, Human Von Willebrand Factor 26 I.U. / ml

Powder For Solution For Injection

Intravenous Use

Cyprus

Haemate P

Csl Behring Gmbh

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 66.6 I.U. / ml, Human Von Willebrand Factor 160 I.U. / ml

Powder And Solvent For Solution For Injection/Infusion

Intravenous Use

Cyprus

Octanate

Octapharma (Ip)-Ltd.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 1000 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Cyprus

Octanate

Octapharma (Ip)-Ltd.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 250 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Cyprus

Octanate

Octapharma (Ip)-Ltd.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 500 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Cyprus

Wilate

Octapharma (Ip)-Ltd.

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 1000 I.U. Vial, Human Von Willebrand Factor 1000 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Cyprus

Wilate

Octapharma (Ip)-Ltd.

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 450 I.U. Vial, Human Von Willebrand Factor 400 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Cyprus

Wilate

Octapharma (Ip)-Ltd.

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 500 I.U. Vial, Human Von Willebrand Factor 500 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Cyprus

Wilate

Octapharma (Ip)-Ltd.

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 900 I.U. Vial, Human Von Willebrand Factor 800 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Czech Republic

Immunate Stim Plus

Baxalta Innovations GmbH

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 100 I.U. / ml, Human Von Willebrand Factor 75 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Czech Republic

Immunate Stim Plus

Baxalta Innovations GmbH

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 50 I.U. / ml, Human Von Willebrand Factor 38 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Czech Republic

Recombinate

Baxalta Innovations GmbH

Human Coagulation Factor VIII (Rdna)

Human Coagulation Factor VIII (Rdna) 100 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Czech Republic

Recombinate

Baxalta Innovations GmbH

Human Coagulation Factor VIII (Rdna)

Human Coagulation Factor VIII (Rdna) 200 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Czech Republic

Optivate

Bio Products Laboratory

Human Coagulation Factor VIII

Human Coagulation Factor VIII 100 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Czech Republic

Haemoctin Sdh

Biotest Pharma Gmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 100 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Czech Republic

Haemoctin Sdh

Biotest Pharma Gmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 50 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Czech Republic

Beriate

Csl Behring Gmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 100 I.U. / ml

Powder And Solvent For Solution For Injection/Infusion

Intravenous Use

Czech Republic

Beriate

Csl Behring Gmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 200 I.U. / ml

Powder And Solvent For Solution For Injection/Infusion

Intravenous Use

Czech Republic

Haemate P

Csl Behring Gmbh

Human Coagulation Factor VIII (Rdna), Human Von Willebrand Factor

Human Coagulation Factor VIII (Rdna) 50 I.U. / ml, Human Von Willebrand Factor 120 I.U. / ml

Powder And Solvent For Solution For Injection/Infusion

Intravenous Use

Czech Republic

Haemate P

Csl Behring Gmbh

Human Coagulation Factor VIII (Rdna), Human Von Willebrand Factor

Human Coagulation Factor VIII (Rdna) 66.6 I.U. / ml, Human Von Willebrand Factor 160 I.U. / ml

Powder And Solvent For Solution For Injection/Infusion

Intravenous Use

Czech Republic

Fanhdi

Instituto Grifols, S.A.

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 100 I.U. / ml, Human Von Willebrand Factor 120 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Czech Republic

Fanhdi

Instituto Grifols, S.A.

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 25 I.U. / ml, Human Von Willebrand Factor 30 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Czech Republic

Fanhdi

Instituto Grifols, S.A.

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 50 I.U. / ml, Human Von Willebrand Factor 60 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Czech Republic

Octanate

Octapharma (Ip)-Ltd.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 1000 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Czech Republic

Octanate

Octapharma (Ip)-Ltd.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 250 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Czech Republic

Octanate

Octapharma (Ip)-Ltd.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 500 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Czech Republic

Wilate

Octapharma (Ip)-Ltd.

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 1000 I.U. Vial, Human Von Willebrand Factor 1000 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Czech Republic

Wilate

Octapharma (Ip)-Ltd.

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 500 I.U. Vial, Human Von Willebrand Factor 500 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Denmark

Haemate

Csl Behring Gmbh

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 50 I.U. / ml, Human Von Willebrand Factor 120 I.U. / ml

Powder And Solvent For Solution For Injection/Infusion

Intravenous Use

Denmark

Haemate

Csl Behring Gmbh

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 66.6 I.U. / ml, Human Von Willebrand Factor 160 I.U. / ml

Powder And Solvent For Solution For Injection/Infusion

Intravenous Use

Denmark

Octanate

Octapharma Ab

Human Coagulation Factor VIII

Human Coagulation Factor VIII 1000 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Denmark

Octanate

Octapharma Ab

Human Coagulation Factor VIII

Human Coagulation Factor VIII 250 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Denmark

Octanate

Octapharma Ab

Human Coagulation Factor VIII

Human Coagulation Factor VIII 500 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Denmark

Octanate Lv

Octapharma Ab

Human Coagulation Factor VIII

Human Coagulation Factor VIII 1000 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Denmark

Octanate Lv

Octapharma Ab

Human Coagulation Factor VIII

Human Coagulation Factor VIII 500 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Denmark

Wilnativ

Octapharma Ab

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 1000 I.U. Vial, Human Von Willebrand Factor 1000 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Denmark

Wilnativ

Octapharma Ab

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 500 I.U. Vial, Human Von Willebrand Factor 500 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Estonia

Immunate

Baxalta Innovations GmbH

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 250 I.U. / ml, Human Von Willebrand Factor 190 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Estonia

Immunate

Baxalta Innovations Gmbh

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 100 I.U. / ml, Human Von Willebrand Factor 75 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Estonia

Immunate

Baxalta Innovations Gmbh

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 50 I.U. / ml, Human Von Willebrand Factor 38 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Estonia

Recombinate

Baxalta Innovations Gmbh

Human Coagulation Factor VIII (Rdna)

Human Coagulation Factor VIII (Rdna) 100 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Estonia

Recombinate

Baxalta Innovations Gmbh

Human Coagulation Factor VIII (Rdna)

Human Coagulation Factor VIII (Rdna) 200 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Estonia

Recombinate

Baxalta Innovations Gmbh

Human Coagulation Factor VIII (Rdna)

Human Coagulation Factor VIII (Rdna) 50 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Estonia

Optivate

Bio Products Laboratory

Human Coagulation Factor VIII

Human Coagulation Factor VIII 100 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Estonia

Wilate

Octapharma (Ip)-Ltd.

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 100 I.U. / ml, Human Von Willebrand Factor 100 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Estonia

Wilate

Octapharma (Ip)-Ltd.

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 100 I.U. / ml, Human Von Willebrand Factor 1000 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Estonia

Octanate

Octapharma Ab

Human Coagulation Factor VIII

Human Coagulation Factor VIII 1000 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Estonia

Octanate

Octapharma Ab

Human Coagulation Factor VIII

Human Coagulation Factor VIII 500 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Finland

Immunate

Baxalta Innovations Gmbh

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 100 I.U. / ml, Human Von Willebrand Factor 75 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Finland

Immunate

Baxalta Innovations Gmbh

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 50 I.U. / ml, Human Von Willebrand Factor 38 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Finland

Haemate

Csl Behring Gmbh

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 50 I.U. / ml, Human Von Willebrand Factor 120 I.U. / ml

Powder And Solvent For Solution For Injection/Infusion

Intravenous Use

Finland

Haemate

Csl Behring Gmbh

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 66.6 I.U. / ml, Human Von Willebrand Factor 160 I.U. / ml

Powder And Solvent For Solution For Injection/Infusion

Intravenous Use

Finland

Octafil

Octapharma Ab

Human Coagulation Factor VIII

Human Coagulation Factor VIII 1000 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Finland

Octafil

Octapharma Ab

Human Coagulation Factor VIII

Human Coagulation Factor VIII 250 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Finland

Octafil

Octapharma Ab

Human Coagulation Factor VIII

Human Coagulation Factor VIII 500 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Finland

Octafil Lv

Octapharma Ab

Human Coagulation Factor VIII

Human Coagulation Factor VIII 1000 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Finland

Octafil Lv

Octapharma Ab

Human Coagulation Factor VIII

Human Coagulation Factor VIII 500 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Finland

Wilate

Octapharma Ab

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 1000 I.U. Vial, Human Von Willebrand Factor 1000 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Finland

Wilate

Octapharma Ab

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 500 I.U. Vial, Human Von Willebrand Factor 500 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Finland

Amofil

Sanquin Plasma Products B.V.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 100 I.U. / ml

Powder For Solution For Injection

Intravenous Use

Finland

Amofil

Sanquin Plasma Products B.V.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 500 I.U. / ml

Powder For Solution For Injection

Intravenous Use

France

Factane

Lfb Biomedicaments

Human Coagulation Factor VIII

Human Coagulation Factor VIII 100 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

France

Factane

Lfb Biomedicaments

Human Coagulation Factor VIII

Human Coagulation Factor VIII 200 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

France

Octanate

Octapharma France

Human Coagulation Factor VIII

Human Coagulation Factor VIII 100 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

France

Octanate

Octapharma France

Human Coagulation Factor VIII

Human Coagulation Factor VIII 50 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

France

Octanate LV

Octapharma France

Human Coagulation Factor VIII

Human Coagulation Factor VIII 100 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

France

Octanate

Octapharma France

Human Coagulation Factor VIII

Human Coagulation Factor VIII 200 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Germany

Immunate 250 I.E.

Baxalta Deutschland Gmbh

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 250 I.E. Human Von Willebrand Factor 150 I.E.

Powder And Solvent For Solution For Injection

Intravenous Use

Germany

Immunate 500 I.E.

Baxalta Deutschland Gmbh

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 500 I.E., Human Von Willebrand Factor 300 I.E.

Powder And Solvent For Solution For Injection

Intravenous Use

Germany

Immunate 1000 I.E.

Baxalta Deutschland Gmbh

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 1000 I.E./ Human Von Willebrand Factor 600 I.E.

Powder And Solvent For Solution For Injection

Intravenous Use

Germany

Recombinate Antihämophilie Faktor VIII (rek) 1000

Baxalta Deutschland Gmbh

Human Coagulation Factor VIII (Rdna)

Human Coagulation Factor VIII (Rdna) 1000 I.U. / 10 ml

Powder And Solvent For Solution For Injection

Intravenous Use

Germany

Optivate 250

Bio Products Laboratory

Human Coagulation Factor VIII

Human Coagulation Factor VIII 250 IUVIII

Powder And Solvent For Solution For Injection

Intravenous Use

Germany

Optivate 500

Bio Products Laboratory

Human Coagulation Factor VIII

Human Coagulation Factor VIII 500 IU

Powder And Solvent For Solution For Injection

Intravenous Use

Germany

Optivate 1000

Bio Products Laboratory

Human Coagulation Factor VIII

Human Coagulation Factor VIII 1000 IU

Powder And Solvent For Solution For Injection

Intravenous Use

Germany

Haemoctin Sdh 250

Biotest Pharma Gmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 250 IU

Powder And Solvent For Solution For Injection

Intravenous Use

Germany

Haemoctin Sdh 500

Biotest Pharma Gmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 500 IU

Powder And Solvent For Solution For Injection

Intravenous Use

Germany

Haemoctin Sdh 1000

Biotest Pharma Gmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 1000 IU

Powder And Solvent For Solution For Injection

Intravenous Use

Germany

Beriate 250

Csl Behring Gmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 250 IU

Powder And Solvent For Solution For Injection/Infusion

Intravenous Use

Germany

Beriate 500

Csl Behring Gmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 500 IU

Powder And Solvent For Solution For Injection/Infusion

Intravenous Use

Germany

Beriate 1000

Csl Behring Gmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 1000 IU

Powder And Solvent For Solution For Injection/Infusion

Intravenous Use

Germany

Beriate 2000

Csl Behring Gmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 2000 IU

Powder And Solvent For Solution For Injection/Infusion

Intravenous Use

Germany

Haemate P 250

Csl Behring Gmbh

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 250 I.E., Human Von Willebrand Factor 600 I.E.

Powder And Solvent For Solution For Injection/Infusion

Intravenous Use

Germany

Haemate P 500

Csl Behring Gmbh

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 500 I.E., Human Von Willebrand Factor 1200 I.E.

Powder And Solvent For Solution For Injection/Infusion

Intravenous Use

Germany

Haemate P 1000

Csl Behring Gmbh

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 1000 I.E. Human Von Willebrand Factor 2400 I.E.

Powder And Solvent For Solution For Injection/Infusion

Intravenous Use

Germany

Fanhdi 250 I.E.

Grifols Deutschland Gmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 250 I.E.

Powder And Solvent For Solution For Injection

Intravenous Use

Germany

Fanhdi 500 I.E.

Grifols Deutschland Gmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 500 I.E.

Powder And Solvent For Solution For Injection

Intravenous Use

Germany

Fanhdi 1000 I.E.

Grifols Deutschland Gmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 1000 I.E.

Powder And Solvent For Solution For Injection

Intravenous Use

Germany

Fanhdi 1500 I.E.

Grifols Deutschland Gmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 1500 I.E.

Powder And Solvent For Solution For Injection

Intravenous Use

Germany

Faktor VIII Sdh VIIIIntersero 250

Intersero Gmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 250 I.E.

Powder And Solvent For Solution For Injection

Intravenous Use

Germany

Faktor VIII Sdh VIIIIntersero 500

Intersero Gmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 500 I.E.

Powder And Solvent For Solution For Injection

Intravenous Use

Germany

Faktor VIII Sdh Intersero 1000

Intersero Gmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 1000 I.E.

Powder And Solvent For Solution For Injection

Intravenous Use

Germany

Octanate 250

Octapharma Gmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 250 I.E.

Powder And Solvent For Solution For Injection

Intravenous Use

Germany

Octanate 500

Octapharma Gmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 500 I.E.

Powder And Solvent For Solution For Injection

Intravenous Use

Germany

Octanate 1000

Octapharma Gmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 1000 I.E.

Powder And Solvent For Solution For Injection

Intravenous Use

Germany

Wilate 1000

Octapharma Gmbh

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 1000 I.U. Vial, Human Von Willebrand Factor 1000 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Germany

Wilate 450

Octapharma Gmbh

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 450 I.U. Vial, Human Von Willebrand Factor 400 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Germany

Wilate 500

Octapharma Gmbh

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 500 I.U. Vial, Human Von Willebrand Factor 500 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Germany

Wilate 900

Octapharma Gmbh

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 900 I.U. Vial, Human Von Willebrand Factor 800 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Greece

Immunate

Baxalta Innovations Gmbh

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 1000 I.U./Vial, Human Von Willebrand Factor 75 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Greece

Immunate

Baxalta Innovations Gmbh

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 500 I.U./Vial, Human Von Willebrand Factor 38 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Greece

Recombinate

Baxalta Innovations GmbH

Human Coagulation Factor VIII (Rdna)

Human Coagulation Factor VIII (Rdna) 1000 I.U./Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Greece

Recombinate

Baxalta Innovations GmbH

Human Coagulation Factor VIII (Rdna)

Human Coagulation Factor VIII (Rdna) 250 I.U./Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Greece

Recombinate

Baxalta Innovations GmbH

Human Coagulation Factor VIII (Rdna)

Human Coagulation Factor VIII (Rdna) 500 I.U./Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Greece

Haemate P

Csl Behring Mepe

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 500 I.U./Vial, Human Von Willebrand Factor 120 I.U. / ml

Powder And Solvent For Solution For Injection/Infusion

Intravenous Use

Greece

Haemate P

Csl Behring Mepe

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 66.6 I.U. / ml, Human Von Willebrand Factor 160 I.U. / ml

Powder And Solvent For Solution For Injection/Infusion

Intravenous Use

Greece

Fanhdi

Demo Abee

Human Coagulation Factor VIII

Human Coagulation Factor VIII 1000 I.U./Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Greece

Fanhdi

Demo Abee

Human Coagulation Factor VIII

Human Coagulation Factor VIII 250 I.U./Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Greece

Fanhdi

Demo Abee

Human Coagulation Factor VIII

Human Coagulation Factor VIII 500 I.U./Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Greece

Octanate

Octapharma Hellas A.E.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 1000 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Greece

Octanate

Octapharma Hellas A.E.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 250 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Greece

Octanate

Octapharma Hellas A.E.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 500 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Greece

Wilate

Octapharma Hellas A.E.

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 1000 I.U. Vial, Human Von Willebrand Factor 1000 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Greece

Wilate

Octapharma Hellas A.E.

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 500 I.U. Vial, Human Von Willebrand Factor 500 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Greece

Haemoctin

Vianex S.A.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 100 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Greece

Haemoctin

Vianex S.A.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 50 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Hungary

Immunate S/D

Baxalta Innovations Gmbh

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 100 I.U. / ml, Human Von Willebrand Factor 75 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Hungary

Immunate S/D

Baxalta Innovations Gmbh

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 50 I.U. / ml, Human Von Willebrand Factor 38 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Hungary

Recombinate

Baxalta Innovations Gmbh

Human Coagulation Factor VIII (Rdna)

Human Coagulation Factor VIII (Rdna) 100 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Hungary

Recombinate

Baxalta Innovations Gmbh

Human Coagulation Factor VIII (Rdna)

Human Coagulation Factor VIII (Rdna) 200 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Hungary

Recombinate

Baxalta Innovations Gmbh

Human Coagulation Factor VIII (Rdna)

Human Coagulation Factor VIII (Rdna) 50 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Hungary

Optivate

Bio Products Laboratory

Human Coagulation Factor VIII

Human Coagulation Factor VIII 100 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Hungary

Haemoctin

Biotest Hungaria Kft.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 100 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Hungary

Haemoctin

Biotest Hungaria Kft.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 50 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Hungary

Beriate

Csl Behring Gmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 100 I.U. / ml

Powder And Solvent For Solution For Injection/Infusion

Intravenous Use

Hungary

Beriate

Csl Behring Gmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 200 I.U. / ml

Powder And Solvent For Solution For Injection/Infusion

Intravenous Use

Hungary

Haemate

Csl Behring Gmbh

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 50 I.U. / ml, Human Von Willebrand Factor 120 I.U. / ml

Powder And Solvent For Solution For Injection/Infusion

Intravenous Use

Hungary

Haemate

Csl Behring Gmbh

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 66.6 I.U. / ml, Human Von Willebrand Factor 160 I.U. / ml

Powder And Solvent For Solution For Injection/Infusion

Intravenous Use

Hungary

Humaclot

Human Bioplazma Manufacturing And Trading Llc

Human Coagulation Factor VIII

Human Coagulation Factor VIII 100 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Hungary

Humaclot

Human Bioplazma Manufacturing And Trading Llc

Human Coagulation Factor VIII

Human Coagulation Factor VIII 50 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Hungary

Humafactor-8

Human Bioplazma Manufacturing And Trading Llc

Human Coagulation Factor VIII

Human Coagulation Factor VIII 100 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Hungary

Fanhdi

Instituto Grifols, S.A.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 100 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Hungary

Fanhdi

Instituto Grifols, S.A.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 25 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Hungary

Fanhdi

Instituto Grifols, S.A.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 50 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Hungary

Octanate

Octapharma (Ip)-Ltd.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 1000 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Hungary

Octanate

Octapharma (Ip)-Ltd.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 250 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Hungary

Octanate

Octapharma (Ip)-Ltd.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 500 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Hungary

Wilate

Octapharma (Ip)-Ltd.

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 1000 I.U. Vial, Human Von Willebrand Factor 1000 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Hungary

Wilate

Octapharma (Ip)-Ltd.

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 500 I.U. Vial, Human Von Willebrand Factor 500 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Ireland

Recombinate

Baxalta Innovations Gmbh

Human Coagulation Factor VIII (Rdna)

Human Coagulation Factor VIII (Rdna) 1000 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Ireland

Recombinate

Baxalta Innovations Gmbh

Human Coagulation Factor VIII (Rdna)

Human Coagulation Factor VIII (Rdna) 250 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Ireland

Recombinate

Baxalta Innovations Gmbh

Human Coagulation Factor VIII (Rdna)

Human Coagulation Factor VIII (Rdna) 500 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Ireland

Optivate

Bio Products Laboratory

Human Coagulation Factor VIII

Human Coagulation Factor VIII 250 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Ireland

Optivate

Bio Products Laboratory

Human Coagulation Factor VIII

Human Coagulation Factor VIII 500 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Ireland

Optivate

Bio Products Laboratory

Human Coagulation Factor VIII

Human Coagulation Factor VIII 1000 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Ireland

Fanhdi

Instituto Grifols, S.A.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 1000 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Ireland

Fanhdi

Instituto Grifols, S.A.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 250 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Ireland

Fanhdi

Instituto Grifols, S.A.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 500 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Ireland

Octanate

Octapharma-Ltd

Human Coagulation Factor VIII

Human Coagulation Factor VIII 1000 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Ireland

Octanate

Octapharma-Ltd

Human Coagulation Factor VIII

Human Coagulation Factor VIII 250 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Ireland

Octanate

Octapharma-Ltd

Human Coagulation Factor VIII

Human Coagulation Factor VIII 500 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Ireland

Wilate

Octapharma-Ltd

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 1000 I.U. Vial, Human Von Willebrand Factor 1000 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Ireland

Wilate

Octapharma-Ltd

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 500 I.U. Vial, Human Von Willebrand Factor 500 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Italy

Recombinate

Baxalta Innovations Gmbh

Human Coagulation Factor VIII (Rdna)

Human Coagulation Factor VIII (Rdna) 100 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Italy

Recombinate

Baxalta Innovations Gmbh

Human Coagulation Factor VIII (Rdna)

Human Coagulation Factor VIII (Rdna) 200 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Italy

Recombinate

Baxalta Innovations Gmbh

Human Coagulation Factor VIII (Rdna)

Human Coagulation Factor VIII (Rdna) 25 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Italy

Recombinate

Baxalta Innovations Gmbh

Human Coagulation Factor VIII (Rdna)

Human Coagulation Factor VIII (Rdna) 250 I.U. / 5 ml

Powder And Solvent For Solution For Injection

Intravenous Use

Italy

Recombinate

Baxalta Innovations Gmbh

Human Coagulation Factor VIII (Rdna)

Human Coagulation Factor VIII (Rdna) 50 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Italy

Talate

Baxalta Innovations Gmbh

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 100 I.U. / ml, Human Von Willebrand Factor 75 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Italy

Talate

Baxalta Innovations Gmbh

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 50 I.U. / ml, Human Von Willebrand Factor 38 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Italy

Haemoctin

Biotest Pharma Gmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 100 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Italy

Haemoctin

Biotest Pharma Gmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 50 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Italy

Beriate

Csl Behring Gmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 100 I.U. / ml

Powder And Solvent For Solution For Injection/Infusion

Intravenous Use

Italy

Haemate P

Csl Behring Gmbh

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 50 I.U. / ml, Human Von Willebrand Factor 120 I.U. / ml

Powder And Solvent For Solution For Injection/Infusion

Intravenous Use

Italy

Haemate P

Csl Behring Gmbh

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 66.6 I.U. / ml, Human Von Willebrand Factor 160 I.U. / ml

Powder And Solvent For Solution For Injection/Infusion

Intravenous Use

Italy

Alphanate

Grifols Italia S.P.A

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 100 I.U. / ml, Human Von Willebrand Factor 120 I.U. / ml

Powder And Solvent For Solution For Infusion

Intravenous Use

Italy

Alphanate

Grifols Italia S.P.A

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 150 I.U. / ml, Human Von Willebrand Factor 180 I.U. / ml

Powder And Solvent For Solution For Infusion

Intravenous Use

Italy

Alphanate

Grifols Italia S.P.A

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 50 I.U. / ml, Human Von Willebrand Factor 60 I.U. / ml

Powder And Solvent For Solution For Infusion

Intravenous Use

Italy

Fanhdi

Instituto Grifols, S.A.

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 100 I.U. / ml, Human Von Willebrand Factor 120 I.U. / ml

Powder And Solvent For Solution For Infusion

Intravenous Use

Italy

Fanhdi

Instituto Grifols, S.A.

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 25 I.U. / ml, Human Von Willebrand Factor 30 I.U. / ml

Powder And Solvent For Solution For Infusion

Intravenous Use

Italy

Fanhdi

Instituto Grifols, S.A.

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 50 I.U. / ml, Human Von Willebrand Factor 60 I.U. / ml

Powder And Solvent For Solution For Infusion

Intravenous Use

Italy

Emoclot

Kedrion S.P.A.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 1000 I.U. / 10 ml

Powder And Solvent For Solution For Infusion

Intravenous Use

Italy

Emoclot

Kedrion S.P.A.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 500 I.U. / 10 ml

Powder And Solvent For Solution For Infusion

Intravenous Use

Italy

Emowil

Kedrion S.P.A.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 1000 I.U. / 10 ml

Powder And Solvent For Solution For Infusion

Intravenous Use

Italy

Emowil

Kedrion S.P.A.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 500 I.U. / 10 ml

Powder And Solvent For Solution For Infusion

Intravenous Use

Italy

Klott

Kedrion S.P.A.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 1000 I.U. / 10 ml

Powder And Solvent For Solution For Infusion

Intravenous Use

Italy

Klott

Kedrion S.P.A.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 500 I.U. / 10 ml

Powder And Solvent For Solution For Infusion

Intravenous Use

Italy

Octanate

Octapharma Italy S.P.A.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 1000 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Italy

Octanate

Octapharma Italy S.P.A.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 250 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Italy

Octanate

Octapharma Italy S.P.A.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 500 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Italy

Wilate

Octapharma Italy S.P.A.

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 1000 I.U. Vial, Human Von Willebrand Factor 1000 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Italy

Wilate

Octapharma Italy S.P.A.

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 450 I.U. Vial, Human Von Willebrand Factor 400 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Italy

Wilate

Octapharma Italy S.P.A.

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 500 I.U. Vial, Human Von Willebrand Factor 500 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Italy

Wilate

Octapharma Italy S.P.A.

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 900 I.U. Vial, Human Von Willebrand Factor 800 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Latvia

Immunate 1000 SV/750 SV pulveris un šķīdinātājs injekciju šķīduma pagatavošanai

Baxalta Innovations Gmbh

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 100 I.U. / ml, Human Von Willebrand Factor 75 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Latvia

Immunate 250 SV/190 SV pulveris un šķīdinātājs injekciju šķīduma pagatavošanai

Baxalta Innovations Gmbh

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 50 I.U. / ml, Human Von Willebrand Factor 38 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Latvia

Immunate 500 SV/375 SV pulveris un šķīdinātājs injekciju šķīduma pagatavošanai

Baxalta Innovations Gmbh

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 100 I.U. / ml, Human Von Willebrand Factor 75 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Latvia

Recombinate 500 SV/5 ml pulveris un šķīdinātājs injekciju šķīduma pagatavošanai

Baxalta Innovations Gmbh

Recombinant coagulation factor VIII (octocog alfa)

Human Coagulation Factor VIII (Rdna) 100 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Latvia

Recombinate

1000 SV/5 ml pulveris un šķīdinātājs injekciju šķīduma pagatavošanai

Baxalta Innovations Gmbh

Recombinant coagulation factor VIII (octocog alfa)

Human Coagulation Factor VIII (Rdna) 200 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Latvia

Recombinate

250 SV/5 ml pulveris un šķīdinātājs injekciju šķīduma pagatavošanai

Baxalta Innovations Gmbh

Recombinant coagulation factor VIII (octocog alfa)

Human Coagulation Factor VIII (Rdna) 50 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Latvia

Optivate 1000 SV pulveris un šķīdinātājs injekciju šķīduma pagatavošanai

Bio Products Laboratory Limited

Human Coagulation Factor VIII

Human Coagulation Factor VIII 100 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Latvia

Optivate 500 SV pulveris un šķīdinātājs injekciju šķīduma pagatavošanai

Bio Products Laboratory Limited

Human Coagulation Factor VIII

Human Coagulation Factor VIII 100 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Latvia

Optivate 250 SV pulveris un šķīdinātājs injekciju šķīduma pagatavošanai

Bio Products Laboratory Limited

Human Coagulation Factor VIII

Human Coagulation Factor VIII 100 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Latvia

Faktora VIII sausā frakcija tips 8Y, 25 SV/ml, pulveris injekciju šķīduma pagatavošanaiVIII

Bio Products Laboratory Limited

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 25 I.U. / ml, Human Von Willebrand Factor 26 I.U. / ml

Powder For Solution For Injection

Intravenous Use

Latvia

Octanate 1000 SV pulveris un šķīdinātājs injekciju šķīduma pagatavošanai

Octapharma (Ip)-Ltd.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 100 I.U./ml

Powder And Solvent For Solution For Injection

Intravenous Use

Latvia

Octanate 1000 SV/5 ml pulveris un šķīdinātājs injekciju šķīduma pagatavošanai

Octapharma (Ip) Limited

Human Coagulation Factor VIII

Human Coagulation Factor VIII 200 I.U./ml

Powder And Solvent For Solution For Injection

Intravenous Use

Latvia

Octanate 250 SV pulveris un šķīdinātājs injekciju šķīduma pagatavošanai

Octapharma (Ip)-Ltd.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 50 I.U./ml

Powder And Solvent For Solution For Injection

Intravenous Use

Latvia

Octanate 500 SV pulveris un šķīdinātājs injekciju šķīduma pagatavošanai

Octapharma (Ip)-Ltd.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 50 I.U./ml

Powder And Solvent For Solution For Injection

Intravenous Use

Latvia

Octanate 500 SV/5 ml pulveris un šķīdinātājs injekciju šķīduma pagatavošanai

Octapharma (Ip) Limited

Human Coagulation Factor VIII

Human Coagulation Factor VIII 100 I.U./ml

Powder And Solvent For Solution For Injection

Intravenous Use

Latvia

Wilate 1000 SV/1000 SV pulveris un šķīdinātājs injekciju šķīduma pagatavošanai

Octapharma (Ip)-Ltd.

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 100 I.U./ml, Human Von Willebrand Factor 100 I.U./ml VIII

Powder And Solvent For Solution For Injection

Intravenous Use

Latvia

Wilate 500 SV/500 SV pulveris un šķīdinātājs injekciju šķīduma pagatavošanai

Octapharma (Ip)-Ltd.

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 100 I.U./ml, Human Von Willebrand Factor 100 I.U./mlVIII

Powder And Solvent For Solution For Injection

Intravenous Use

Lithuania

Immunate

Baxalta Innovations GmbH

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 100 I.U. / ml, Human Von Willebrand Factor 75 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Lithuania

Immunate

Baxalta Innovations GmbH

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 50 I.U. / ml, Human Von Willebrand Factor 38 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Lithuania

Recombinate

Baxalta Innovations GmbH

Human Coagulation Factor VIII (Rdna)

Human Coagulation Factor VIII (Rdna) 100 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Lithuania

Recombinate

Baxalta Innovations GmbH

Human Coagulation Factor VIII (Rdna)

Human Coagulation Factor VIII (Rdna) 200 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Lithuania

Recombinate

Baxalta Innovations GmbH

Human Coagulation Factor VIII (Rdna)

Human Coagulation Factor VIII (Rdna) 50 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Lithuania

Optivate

Bio Products Laboratory

Human Coagulation Factor VIII

Human Coagulation Factor VIII 100 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Lithuania

Haemoctin SdH

Biotest Pharma GmbH

Human Coagulation Factor VIII

Human Coagulation Factor VIII 100 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Lithuania

Haemoctin SdH

Biotest Pharma GmbH

Human Coagulation Factor VIII

Human Coagulation Factor VIII 50 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Lithuania

Octanate

Octapharma (IP)-Ltd.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 1000 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Lithuania

Octanate

Octapharma (IP)-Ltd.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 250 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Lithuania

Octanate

Octapharma (IP)-Ltd.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 500 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Lithuania

Wilate

Octapharma (IP)-Ltd.

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 1000 I.U. Vial, Human Von Willebrand Factor 1000 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Lithuania

Wilate

Octapharma (IP)-Ltd.

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 500 I.U. Vial, Human Von Willebrand Factor 500 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Luxembourg

Recombinate

Baxalta Innovations Gmbh

Human Coagulation Factor VIII (Rdna)

Human Coagulation Factor VIII (Rdna) 100 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Luxembourg

Recombinate

Baxalta Innovations Gmbh

Human Coagulation Factor VIII (Rdna)

Human Coagulation Factor VIII (Rdna) 200 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Luxembourg

Recombinate

Baxalta Innovations Gmbh

Human Coagulation Factor VIII (Rdna)

Human Coagulation Factor VIII (Rdna) 25 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Luxembourg

Recombinate

Baxalta Innovations Gmbh

Human Coagulation Factor VIII (Rdna)

Human Coagulation Factor VIII (Rdna) 50 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Luxembourg

Haemate P

Csl Behring Gmbh

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 50 I.U. / ml, Human Von Willebrand Factor 120 I.U. / ml

Powder And Solvent For Solution For Injection/Infusion

Intravenous Use

Luxembourg

Haemate P

Csl Behring Gmbh

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 66.6 I.U. / ml, Human Von Willebrand Factor 160 I.U. / ml

Powder And Solvent For Solution For Injection/Infusion

Intravenous Use

Luxembourg

Factane

Lfb Biomedicaments

Human Coagulation Factor VIII

Human Coagulation Factor VIII 100 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Luxembourg

Octanate

Octapharma Benelux S.A./N.V.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 1000 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Luxembourg

Octanate

Octapharma Benelux S.A./N.V.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 250 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Luxembourg

Octanate

Octapharma Benelux S.A./N.V.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 500 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Luxembourg

Wilate

Octapharma Benelux S.A./N.V.

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 100 I.U. Vial, Human Von Willebrand Factor 100 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Malta

Recombinate

Baxalta Innovations Gmbh

Human Coagulation Factor VIII (Rdna)

Human Coagulation Factor VIII (Rdna) 1000 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Malta

Recombinate

Baxalta Innovations Gmbh

Human Coagulation Factor VIII (Rdna)

Human Coagulation Factor VIII (Rdna) 25 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Malta

Recombinate

Baxalta Innovations Gmbh

Human Coagulation Factor VIII (Rdna)

Human Coagulation Factor VIII (Rdna) 50 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Malta

Immunate

Baxter Ag

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 100 I.U. / ml, Human Von Willebrand Factor 75 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Malta

Immunate

Baxter Ag

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 50 I.U. / ml, Human Von Willebrand Factor 38 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Malta

Optivate

Bio Products Laboratory

Human Coagulation Factor VIII

Human Coagulation Factor VIII 100 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Malta

Dried Factor VIII Fraction, Type 8y Bio Products

Bio Products Laboratory

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 25 I.U. / ml, Human Von Willebrand Factor 26 I.U. / ml

Powder For Solution For Injection

Intravenous Use

Malta

Haemoctin Sdh

Biotest Pharma Gmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 100 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Malta

Haemoctin Sdh

Biotest Pharma Gmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 50 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Malta

Emoclot

Kedrion S.P.A.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 1000 I.U. / 10 ml

Powder And Solvent For Solution For Infusion

Intravenous Use

Malta

Octanate

Octapharma (Ip)-Ltd.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 1000 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Malta

Octanate

Octapharma (Ip)-Ltd.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 250 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Malta

Octanate

Octapharma (Ip)-Ltd.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 500 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Malta

Octanate Lv

Octapharma (Ip)-Ltd.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 1000 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Malta

Octanate Lv

Octapharma (Ip)-Ltd.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 500 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Malta

Wilate

Octapharma (Ip)-Ltd.

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 90 I.U. / ml, Human Von Willebrand Factor 80 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Netherlands

Immunate

Baxalta Innovations Gmbh

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 100 I.U. / ml, Human Von Willebrand Factor 75 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Netherlands

Immunate

Baxalta Innovations Gmbh

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 50 I.U. / ml, Human Von Willebrand Factor 38 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Netherlands

Recombinate

Baxalta Innovations Gmbh

Human Coagulation Factor VIII (Rdna)

Human Coagulation Factor VIII (Rdna) 1000 I.U. / 5 ml

Powder And Solvent For Solution For Injection

Intravenous Use

Netherlands

Recombinate

Baxalta Innovations Gmbh

Human Coagulation Factor VIII (Rdna)

Human Coagulation Factor VIII (Rdna) 250 I.U. / 5 ml

Powder And Solvent For Solution For Injection

Intravenous Use

Netherlands

Recombinate

Baxalta Innovations Gmbh

Human Coagulation Factor VIII (Rdna)

Human Coagulation Factor VIII (Rdna) 500 I.U. / 5 ml

Powder And Solvent For Solution For Injection

Intravenous Use

Netherlands

Recombinate

Baxalta Innovations Gmbh

Human Coagulation Factor VIII (Rdna)

Human Coagulation Factor VIII (Rdna) 1000 I.U. / 10 ml

Powder And Solvent For Solution For Injection

Intravenous Use

Netherlands

Recombinate

Baxalta Innovations Gmbh

Human Coagulation Factor VIII (Rdna)

Human Coagulation Factor VIII (Rdna) 250 I.U. / 10 ml

Powder And Solvent For Solution For Injection

Intravenous Use

Netherlands

Recombinate

Baxalta Innovations Gmbh

Human Coagulation Factor VIII (Rdna)

Human Coagulation Factor VIII (Rdna) 500 I.U. / 10 ml

Powder And Solvent For Solution For Injection

Intravenous Use

Netherlands

Optivate

Bio Products Laboratory

Human Coagulation Factor VIII

Human Coagulation Factor VIII 100 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Netherlands

Haemate P

Csl Behring Gmbh

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 50 I.U. / ml, Human Von Willebrand Factor 120 I.U. / ml

Powder And Solvent For Solution For Injection/Infusion

Intravenous Use

Netherlands

Haemate P

Csl Behring Gmbh

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 66.6 I.U. / ml, Human Von Willebrand Factor 160 I.U. / ml

Powder And Solvent For Solution For Injection/Infusion

Intravenous Use

Netherlands

Alphanate

Instituto Grifols, S.A.

Human Coagulation Factor VIII, Von Willebrand Factor

Human Coagulation Factor VIII 100 I.U. / ml, Von Willebrand Factor 25 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Netherlands

Alphanate

Instituto Grifols, S.A.

Human Coagulation Factor VIII, Von Willebrand Factor

Human Coagulation Factor VIII 50 I.U. / ml, Von Willebrand Factor 12.5 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Netherlands

Octanate

Octapharma Gmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 1000 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Netherlands

Octanate

Octapharma Gmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 250 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Netherlands

Octanate

Octapharma Gmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 500 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Netherlands

Octanate Lv

Octapharma Gmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 100 IU/ml

Powder And Solvent For Solution For Injection

Intravenous Use

Netherlands

Octanate Lv

Octapharma Gmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 200 IU/ml

Powder And Solvent For Solution For Injection

Intravenous Use

Netherlands

Wilate

Octapharma Gmbh

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 1000 I.U. Vial, Human Von Willebrand Factor 1000 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Netherlands

Wilate

Octapharma Gmbh

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 500 I.U. Vial, Human Von Willebrand Factor 500 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Netherlands

Aafact

Sanquin Plasma Products B.V.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 1000 I.U. Vial

Powder For Solution For Injection

Intravenous Use

Netherlands

Aafact

Sanquin Plasma Products B.V.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 500 I.U. Vial

Powder For Solution For Injection

Intravenous Use

Norway

Haemate

Csl Behring Gmbh

Human Coagulation Factor VIII (Rdna), Human Von Willebrand Factor

Human Coagulation Factor VIII (Rdna) 50 I.U. / ml, Human Von Willebrand Factor 120 I.U. / ml

Powder And Solvent For Solution For Injection/Infusion

Intravenous Use

Norway

Haemate

Csl Behring Gmbh

Human Coagulation Factor VIII (Rdna), Human Von Willebrand Factor

Human Coagulation Factor VIII (Rdna) 66.6 I.U. / ml, Human Von Willebrand Factor 160 I.U. / ml

Powder And Solvent For Solution For Injection/Infusion

Intravenous Use

Norway

Octanate

Octapharma

Human Coagulation Factor VIII

Human Coagulation Factor VIII 250 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Norway

Octanate

Octapharma

Human Coagulation Factor VIII

Human Coagulation Factor VIII 500 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Norway

Octanate

Octapharma

Human Coagulation Factor VIII

Human Coagulation Factor VIII 1000 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Norway

Wilate

Octapharma

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 1000 I.U. Vial, Human Von Willebrand Factor 1000 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Norway

Wilate

Octapharma

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 500 I.U. Vial, Human Von Willebrand Factor 500 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Poland

Immunate

Baxalta Poland Sp. z o.o.

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 100 I.U. / ml, Human Von Willebrand Factor 75 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Poland

Immunate

Baxalta Poland Sp. z o.o.

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 50 I.U. / ml, Human Von Willebrand Factor 38 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Poland

Recombinate

Baxalta Poland Sp. z o.o.

Human Coagulation Factor VIII (Rdna)

Human Coagulation Factor VIII (Rdna) 100 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Poland

Recombinate

Baxalta Poland Sp. z o.o.

Human Coagulation Factor VIII (Rdna)

Human Coagulation Factor VIII (Rdna) 200 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Poland

Recombinate

Baxalta Poland Sp. z o.o.

Human Coagulation Factor VIII (Rdna)

Human Coagulation Factor VIII (Rdna) 50 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Poland

Optivate

Bio Products Laboratory

Human Coagulation Factor VIII

Human Coagulation Factor VIII 100 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Poland

Innovate

Biomed-Lublin Wsisz S.A.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 1000 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Poland

Haemoctin

Biotest Pharma Gmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 100 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Poland

Haemoctin

Biotest Pharma Gmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 50 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Poland

Beriate

Csl Behring Gmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 100 I.U. / ml

Powder And Solvent For Solution For Injection/Infusion

Intravenous Use

Poland

Beriate

Csl Behring Gmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 200 I.U. / ml

Powder And Solvent For Solution For Injection/Infusion

Intravenous Use

Poland

Haemate P

Csl Behring Gmbh

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 50 I.U. / ml, Human Von Willebrand Factor 120 I.U. / ml

Powder And Solvent For Solution For Injection/Infusion

Intravenous Use

Poland

Haemate P

Csl Behring Gmbh

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 66.6 I.U. / ml, Human Von Willebrand Factor 160 I.U. / ml

Powder And Solvent For Solution For Injection/Infusion

Intravenous Use

Poland

Fanhdi

Instituto Grifols, S.A.

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 100 I.U. / ml, Human Von Willebrand Factor 120 I.U. / ml

Powder And Solvent For Solution For Injection/Infusion

Intravenous Use

Poland

Fanhdi

Instituto Grifols, S.A.

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 25 I.U. / ml, Human Von Willebrand Factor 30 I.U. / ml

Powder And Solvent For Solution For Injection/Infusion

Intravenous Use

Poland

Fanhdi

Instituto Grifols, S.A.

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 50 I.U. / ml, Human Von Willebrand Factor 60 I.U. / ml

Powder And Solvent For Solution For Injection/Infusion

Intravenous Use

Poland

Emoclot

Kedrion S.P.A.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 1000 I.U. / 10 ml

Powder And Solvent For Solution For Infusion

Intravenous Use

Poland

Emoclot

Kedrion S.P.A.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 500 I.U. / 10 ml

Powder And Solvent For Solution For Infusion

Intravenous Use

Poland

Octanate

Octapharma (Ip)-Ltd.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 1000 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Poland

Octanate

Octapharma (Ip)-Ltd.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 250 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Poland

Octanate

Octapharma (Ip)-Ltd.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 500 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Poland

Octanate Lv

Octapharma (Ip)-Ltd.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 1000 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Poland

Octanate Lv

Octapharma (Ip)-Ltd.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 500 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Poland

Wilate

Octapharma (Ip)-Ltd.

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 1000 I.U. Vial, Human Von Willebrand Factor 1000 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Poland

Wilate

Octapharma (Ip)-Ltd.

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 500 I.U. Vial, Human Von Willebrand Factor 500 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Portugal

Immunate

Baxalta Innovations Gmbh

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 1000 I.U. /10 ml, Human Von Willebrand Factor 750 I.U. / 10 ml

Powder And Solvent For Solution For Injection

Intravenous Use

Portugal

Immunate

Baxalta Innovations Gmbh

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 500 I.U. / 5 ml, Human Von Willebrand Factor 375 I.U. / 5 ml

Powder And Solvent For Solution For Injection

Intravenous Use

Portugal

Immunate

Baxalta Innovations Gmbh

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 250 I.U. / 5 ml, Human Von Willebrand Factor 190 I.U. / 5 ml

Powder And Solvent For Solution For Injection

Intravenous Use

Portugal

Optivate

Bio Products Laboratory Ltd.

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 1000 I.U. / 10 ml Human Von Willebrand Factor 2600 I.U. / 10 ml

Powder And Solvent For Solution For Injection

Intravenous Use

Portugal

Optivate

Bio Products Laboratory Ltd

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 500 I.U. / 5 ml Human Von Willebrand Factor 1300 I.U. / 5 ml

Powder And Solvent For Solution For Injection

Intravenous Use

Portugal

Optivate

Bio Products Laboratory Ltd

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 250 I.U. / 2,5 ml Human Von Willebrand Factor 650 I.U. / 2,5 ml

Powder And Solvent For Solution For Injection

Intravenous Use

Portugal

Haemoctin

Biotest Pharma Gmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 1000 I.U. / 10 ml

Powder And Solvent For Solution For Injection

Intravenous Use

Portugal

Haemoctin

Biotest Pharma Gmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 500 I.U. / 10 ml

Powder And Solvent For Solution For Injection

Intravenous Use

Portugal

Haemoctin

Biotest Pharma Gmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 250 I.U. /5 ml

Powder And Solvent For Solution For Injection

Intravenous Use

Portugal

Haemate P

CSL Behring Gmbh

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 500 I.U. / 10 ml, Human Von Willebrand Factor 1200 I.U. /10 ml

Powder And Solvent For Solution For Injection

Intravenous Use

Portugal

Haemate P

CSL Behring Gmbh

Human Coagulation Factor VIII Human Von Willebrand Factor

Human Coagulation Factor VIII 1000 I.U. / 15 ml, Human Von Willebrand Factor 2400 I.U. / 15 ml

Powder And Solvent For Solution For Injection

Intravenous Use

Portugal

Haemate P

CSL Behring Gmbh

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 250 I.U. / 5 ml, Human Von Willebrand Factor 600 I.U. / 5 ml

Powder And Solvent For Solution For Injection

Intravenous Use

Portugal

Beriate

CSL Behring Gmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 1000 I.U. / 10 ml

Powder And Solvent For Solution For Injection/Infusion

Intravenous Use

Portugal

Beriate

CSL Behring Gmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 250 I.U. / 2,5 ml

Powder And Solvent For Solution For Injection/Infusion

Intravenous Use

Portugal

Beriate

CSL Behring Gmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 500 I.U. / 5 ml

Powder And Solvent For Solution For Injection/Infusion

Intravenous Use

Portugal

Beriate

CSL Behring Gmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 2000 I.U. / 10 ml

Powder And Solvent For Solution For Injection/Infusion

Intravenous Use

Portugal

Fanhdi 100 U.I./ml Pó e solvente para solução injectável

Instituto Grifols, S.A.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 1000 I.U. / 10 ml

Powder And Solvent For Solution For Injection

Intravenous Use

Portugal

Fanhdi 25 U.I./ml Pó e solvente para solução injectável

Instituto Grifols, S.A.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 250 I.U. / 10 ml

Powder And Solvent For Solution For Injection

Intravenous Use

Portugal

Fanhdi 50 U.I./ml Pó e solvente para solução injectável

Instituto Grifols, S.A.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 500 I.U. / 10 ml

Powder And Solvent For Solution For Injection

Intravenous Use

Portugal

Fanhdi 100 U.I./ml Pó e solvente para solução injectável

Instituto Grifols, S.A.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 1500 I.U. / 15 ml

Powder And Solvent For Solution For Injection

Intravenous Use

Portugal

Emoclot D.I. 1000

Kedrion S.P.A.

Human Coagulation Factor VIII

Human Coagulation Factor VIII1000 I.U. / 10 ml

Powder And Solvent For Solution For Infusion

Intravenous Use

Portugal

Emoclot D.I. 500

Kedrion S.P.A.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 500 I.U. / 10 ml

Powder And Solvent For Solution For Infusion

Intravenous Use

Portugal

Factane

LFB Biomedicaments

Human Coagulation Factor VIII

Human Coagulation Factor VIII 1000 I.U. / 10 ml

Powder And Solvent For Solution For Injection

Intravenous Use

Portugal

Factane

LFB Biomedicaments

Human Coagulation Factor VIII

Human Coagulation Factor VIII 500 I.U. / 5 ml

Powder And Solvent For Solution For Injection

Intravenous Use

Portugal

Octanate

Octapharma Produtos Farmaceuticos, Lda.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 1000 I.U. / 5 ml

Powder And Solvent For Solution For Injection

Intravenous Use

Portugal

Octanate

Octapharma Produtos Farmaceuticos, Lda.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 250 I.U./ 5 ml

Powder And Solvent For Solution For Injection

Intravenous Use

Portugal

Octanate

Octapharma Produtos Farmaceuticos, Lda.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 500 I.U./ 10 ml

Powder And Solvent For Solution For Injection

Intravenous Use

Portugal

Octanate

Octapharma Produtos Farmaceuticos, Lda.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 1000 I.U./10 ml

Powder And Solvent For Solution For Injection

Intravenous Use

Portugal

Octanate

Octapharma Produtos Farmaceuticos, Lda.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 500 I.U./5 ml

Powder And Solvent For Solution For Injection

Intravenous Use

Portugal

Wilate 1000

Octapharma Produtos Farmaceuticos, Lda.

Human Coagulation Factor VIII, Human Von Willebrand FactorVIII

Human Coagulation Factor VIII 1000 I.U. /10 ml, Human Von Willebrand Factor 1000 I.U./10 ml

Powder And Solvent For Solution For Injection

Intravenous Use

Portugal

Wilate 500

Octapharma Produtos Farmaceuticos, Lda.

Human Coagulation Factor VIII, Human Von Willebrand FactorVIII

Human Coagulation Factor VIII 500 I.U./5 ml, Human Von Willebrand Factor 500 I.U./5 ml

Powder And Solvent For Solution For Injection

Intravenous Use

Romania

Immunate

Baxalta Innovations Gmbh

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 100 I.U. / ml, Human Von Willebrand Factor 75 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Romania

Immunate

Baxalta Innovations Gmbh

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 50 I.U. / ml, Human Von Willebrand Factor 38 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Romania

Recombinate

Baxalta Innovations Gmbh

Human Coagulation Factor VIII (Rdna)

Human Coagulation Factor VIII (Rdna) 100 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Romania

Recombinate

Baxalta Innovations Gmbh

Human Coagulation Factor VIII (Rdna)

Human Coagulation Factor VIII (Rdna) 200 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Romania

Recombinate

Baxalta Innovations Gmbh

Human Coagulation Factor VIII (Rdna)

Human Coagulation Factor VIII (Rdna) 25 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Romania

Recombinate

Baxalta Innovations Gmbh

Human Coagulation Factor VIII (Rdna)

Human Coagulation Factor VIII (Rdna) 50 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Romania

Optivate

Bio Products Laboratory

Human Coagulation Factor VIII

Human Coagulation Factor VIII 100 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Romania

Haemoctin Sdh

Biotest Pharma Gmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 100 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Romania

Haemoctin Sdh

Biotest Pharma Gmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 50 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Romania

Beriate

Csl Behring Gmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 100 I.U. / ml

Powder And Solvent For Solution For Injection/Infusion

Intravenous Use

Romania

Beriate

Csl Behring Gmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 200 I.U. / ml

Powder And Solvent For Solution For Injection/Infusion

Intravenous Use

Romania

Haemate P

Csl Behring Gmbh

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 50 I.U. / ml, Human Von Willebrand Factor 120 I.U. / ml

Powder And Solvent For Solution For Injection/Infusion

Intravenous Use

Romania

Haemate P

Csl Behring Gmbh

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 66.6 I.U. / ml, Human Von Willebrand Factor 160 I.U. / ml

Powder And Solvent For Solution For Injection/Infusion

Intravenous Use

Romania

Fanhdi

Instituto Grifols, S.A.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 100 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Romania

Fanhdi

Instituto Grifols, S.A.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 25 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Romania

Fanhdi

Instituto Grifols, S.A.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 50 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Romania

Emoclot

Kedrion S.P.A.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 500 I.U. / 10 ml

Powder And Solvent For Solution For Infusion

Intravenous Use

Romania

Octanate

Octapharma (Ip)-Ltd.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 1000 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Romania

Octanate

Octapharma (Ip)-Ltd.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 250 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Romania

Octanate

Octapharma (Ip)-Ltd.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 500 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Romania

Octanate Lv

Octapharma (Ip)-Ltd.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 1000 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Romania

Octanate Lv

Octapharma (Ip)-Ltd.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 500 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Romania

Wilate

Octapharma (Ip)-Ltd.

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 1000 I.U. Vial, Human Von Willebrand Factor 1000 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Romania

Wilate

Octapharma (Ip)-Ltd.

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 500 I.U. Vial, Human Von Willebrand Factor 500 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Slovakia

Immunate

Baxalta Innovations Gmbh

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 100 I.U. / ml, Human Von Willebrand Factor 75 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Slovakia

Immunate

Baxalta Innovations Gmbh

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 50 I.U. / ml, Human Von Willebrand Factor 38 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Slovakia

Immunate

Baxalta Innovations Gmbh

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 25 I.U. / ml, Human Von Willebrand Factor 19 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Slovakia

Recombinate

Baxalta Innovations Gmbh

Human Coagulation Factor VIII (Rdna)

Human Coagulation Factor VIII (Rdna) 100 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Slovakia

Recombinate

Baxalta Innovations Gmbh

Human Coagulation Factor VIII (Rdna)

Human Coagulation Factor VIII (Rdna) 25 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Slovakia

Recombinate

Baxalta Innovations Gmbh

Human Coagulation Factor VIII (Rdna)

Human Coagulation Factor VIII (Rdna) 50 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Slovakia

Optivate

Bio Products Laboratory

Human Coagulation Factor VIII

Human Coagulation Factor VIII 100 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Slovakia

Beriate

Csl Behring Gmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 100 I.U. / ml

Powder And Solvent For Solution For Injection/Infusion

Intravenous Use

Slovakia

Beriate

Csl Behring Gmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 200 I.U. / ml

Powder And Solvent For Solution For Injection/Infusion

Intravenous Use

Slovakia

Haemate P

Csl Behring Gmbh

Human Coagulation Factor VIII (Rdna), Human Von Willebrand Factor

Human Coagulation Factor VIII (Rdna) 50 I.U. / ml, Human Von Willebrand Factor 120 I.U. / ml

Powder And Solvent For Solution For Injection/Infusion

Intravenous Use

Slovakia

Haemate P

Csl Behring Gmbh

Human Coagulation Factor VIII (Rdna), Human Von Willebrand Factor

Human Coagulation Factor VIII (Rdna) 66.6 I.U. / ml, Human Von Willebrand Factor 160 I.U. / ml

Powder And Solvent For Solution For Injection/Infusion

Intravenous Use

Slovakia

Fanhdi

Instituto Grifols, S.A.

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 100 I.U. / ml, Human Von Willebrand Factor 120 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Slovakia

Fanhdi

Instituto Grifols, S.A.

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 25 I.U. / ml, Human Von Willebrand Factor 30 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Slovakia

Fanhdi

Instituto Grifols, S.A.

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 50 I.U. / ml, Human Von Willebrand Factor 60 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Slovakia

Wilate

Octapharma (Ip)-Ltd.

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 1000 I.U. Vial, Human Von Willebrand Factor 1000 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Slovakia

Wilate

Octapharma (Ip)-Ltd.

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 450 I.U. Vial, Human Von Willebrand Factor 400 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Slovakia

Wilate

Octapharma (Ip)-Ltd.

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 500 I.U. Vial, Human Von Willebrand Factor 500 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Slovakia

Wilate

Octapharma (Ip)-Ltd.

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 900 I.U. Vial, Human Von Willebrand Factor 800 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Slovakia

Octanate

Octapharma Pharmazeutika Produktionsgesmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 1000 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Slovakia

Octanate

Octapharma Pharmazeutika Produktionsgesmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 250 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Slovakia

Octanate

Octapharma Pharmazeutika Produktionsgesmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 500 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Slovenia

Beriate

Csl Behring Gmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 250 I.U. Vial

Powder And Solvent For Solution For Injection/Infusion

Intravenous Use

Slovenia

Beriate

Csl Behring Gmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 500 I.U. Vial

Powder And Solvent For Solution For Injection/Infusion

Intravenous Use

Slovenia

Beriate

Csl Behring Gmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 1000 I.U. Vial

Powder And Solvent For Solution For Injection/Infusion

Intravenous Use

Slovenia

Beriate

Csl Behring Gmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 2000 I.U. Vial

Powder And Solvent For Solution For Injection/Infusion

Intravenous Use

Slovenia

Haemate P

Csl Behring Gmbh

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 500 I.U. Vial, Human Von Willebrand Factor 1200 I.U. Vial VIII

Powder And Solvent For Solution For Injection/Infusion

Intravenous Use

Slovenia

Immunate

Baxalta Innovations Gmbh

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 250 I.U. Vial, Human Von Willebrand Factor 190 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Slovenia

Immunate

Baxalta Innovations Gmbh

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 500 I.U. Vial, Human Von Willebrand Factor 375 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Slovenia

Immunate

Baxalta Innovations Gmbh

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 1000 I.U. Vial, Human Von Willebrand Factor 750 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Slovenia

Octanate

Octapharma (Ip)-Ltd.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 1000 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Slovenia

Octanate

Octapharma (Ip)-Ltd.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 250 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Slovenia

Octanate

Octapharma (Ip)-Ltd.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 500 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Slovenia

Octanate Kons

Octapharma (Ip)-Ltd.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 1000 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Slovenia

Octanate Kons

Octapharma (Ip)-Ltd.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 500 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Slovenia

Wilate

Octapharma (Ip)-Ltd.

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 1000 I.U. Vial, Human Von Willebrand Factor 1000 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Slovenia

Wilate

Octapharma (Ip)-Ltd.

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 500 I.U. Vial, Human Von Willebrand Factor 500 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Spain

Haemoctin

Biotest Pharma Gmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 100 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Spain

Haemoctin

Biotest Pharma Gmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 50 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Spain

Beriate

Csl Behring Gmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 100 I.U. / ml

Powder And Solvent For Solution For Injection/Infusion

Intravenous Use

Spain

Beriate

Csl Behring Gmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 200 I.U. / ml

Powder And Solvent For Solution For Injection/Infusion

Intravenous Use

Spain

Haemate P

Csl Behring, S.A

Human Coagulation Factor VIII, Von Willebrand Factor

Human Coagulation Factor VIII 50 I.U. / ml, Von Willebrand Factor 120 I.U. / ml

Powder And Solvent For Solution For Injection/Infusion

Intravenous Use

Spain

Haemate P

Csl Behring, S.A

Human Coagulation Factor VIII, Von Willebrand Factor

Human Coagulation Factor VIII 66.6 I.U. / ml, Von Willebrand Factor 160 I.U. / ml

Powder And Solvent For Solution For Injection/Infusion

Intravenous Use

Spain

Fanhdi

Instituto Grifols, S.A.

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 100 I.U. / ml, Human Von Willebrand Factor 120 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Spain

Fanhdi

Instituto Grifols, S.A.

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 25 I.U. / ml, Human Von Willebrand Factor 30 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Spain

Fanhdi

Instituto Grifols, S.A.

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 50 I.U. / ml, Human Von Willebrand Factor 60 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Spain

Octanate

Octapharma S.A.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 1000 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Spain

Octanate

Octapharma S.A.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 250 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Spain

Octanate

Octapharma S.A.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 500 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Spain

Octanate Lv

Octapharma S.A.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 1000 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Spain

Octanate Lv

Octapharma S.A.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 500 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Spain

Wilate

Octapharma S.A.

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 100 I.U. / ml, Human Von Willebrand Factor 100 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Spain

Wilate

Octapharma S.A.

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 500 I.U. Vial, Human Von Willebrand Factor 500 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Sweden

Immunate

Baxalta Innovations Gmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 100 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Sweden

Immunate

Baxalta Innovations Gmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 50 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

Sweden

Haemate

Csl Behring Gmbh

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 50 I.U. / ml, Human Von Willebrand Factor 120 I.U. / ml

Powder And Solvent For Solution For Injection/Infusion

Intravenous Use

Sweden

Haemate

Csl Behring Gmbh

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 67 I.U. / ml, Human Von Willebrand Factor 160 I.U. / ml

Powder And Solvent For Solution For Injection/Infusion

Intravenous Use

Sweden

Octanate

Octapharma Ab

Human Coagulation Factor VIII

Human Coagulation Factor VIII 1000 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Sweden

Octanate

Octapharma Ab

Human Coagulation Factor VIII

Human Coagulation Factor VIII 250 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Sweden

Octanate

Octapharma Ab

Human Coagulation Factor VIII

Human Coagulation Factor VIII 500 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Sweden

Octanate Lv

Octapharma Ab

Human Coagulation Factor VIII

Human Coagulation Factor VIII 1000 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Sweden

Octanate Lv

Octapharma Ab

Human Coagulation Factor VIII

Human Coagulation Factor VIII 500 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Sweden

Wilate

Octapharma Ab

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 1000 I.U. Vial, Human Von Willebrand Factor 1000 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Sweden

Wilate

Octapharma Ab

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 500 I.U. Vial, Human Von Willebrand Factor 500 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

United Kingdom

Optivate

Bio Products Laboratory

Human Coagulation Factor VIII

Human Coagulation Factor VIII 100 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

United Kingdom

Optivate

Bio Products Laboratory

Human Coagulation Factor VIII

Human Coagulation Factor VIII 80 — 130 I.U. / ml

Powder For Solution For Injection

Intravenous Use

United Kingdom

8y

Bio Products Laboratory

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 25 I.U. / ml, Human Von Willebrand Factor 26 I.U. / ml

Powder For Solution For Injection

Intravenous Use

United Kingdom

Haemoctin

Biotest Pharma Gmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 100 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

United Kingdom

Haemoctin

Biotest Pharma Gmbh

Human Coagulation Factor VIII

Human Coagulation Factor VIII 50 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

United Kingdom

Haemate P

Csl Behring Gmbh

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 50 I.U. / ml, Human Von Willebrand Factor 120 I.U. / ml

Powder And Solvent For Solution For Injection/Infusion

Intravenous Use

United Kingdom

Haemate P

Csl Behring Gmbh

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 66.6 I.U. / ml, Human Von Willebrand Factor 160 I.U. / ml

Powder And Solvent For Solution For Injection/Infusion

Intravenous Use

United Kingdom

Fanhdi

Instituto Grifols, S.A.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 100 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

United Kingdom

Fanhdi

Instituto Grifols, S.A.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 25 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

United Kingdom

Fanhdi

Instituto Grifols, S.A.

Human Coagulation Factor VIII

Human Coagulation Factor VIII 50 I.U. / ml

Powder And Solvent For Solution For Injection

Intravenous Use

United Kingdom

Alphanate

Instituto Grifols, S.A.

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 100 I.U. / ml, Human Von Willebrand Factor 120 I.U. / ml

Powder For Injection

Intravenous Use

United Kingdom

Alphanate

Instituto Grifols, S.A.

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 150 I.U. / ml, Human Von Willebrand Factor 180 I.U. / ml

Powder For Injection

Intravenous Use

United Kingdom

Alphanate

Instituto Grifols, S.A.

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 50 I.U. / ml, Human Von Willebrand Factor 60 I.U. / ml

Powder For Injection

Intravenous Use

United Kingdom

Octanate

Octapharma-Ltd

Human Coagulation Factor VIII

Human Coagulation Factor VIII 1000 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

United Kingdom

Octanate

Octapharma-Ltd

Human Coagulation Factor VIII

Human Coagulation Factor VIII 250 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

United Kingdom

Octanate

Octapharma-Ltd

Human Coagulation Factor VIII

Human Coagulation Factor VIII 500 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

United Kingdom

Octanate Lv

Octapharma-Ltd

Human Coagulation Factor VIII

Human Coagulation Factor VIII 1000 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

United Kingdom

Octanate Lv

Octapharma-Ltd

Human Coagulation Factor VIII

Human Coagulation Factor VIII 500 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

United Kingdom

Wilate

Octapharma-Ltd

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 1000 I.U. Vial, Human Von Willebrand Factor 1000 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

United Kingdom

Wilate

Octapharma-Ltd

Human Coagulation Factor VIII, Human Von Willebrand Factor

Human Coagulation Factor VIII 500 I.U. Vial, Human Von Willebrand Factor 500 I.U. Vial

Powder And Solvent For Solution For Injection

Intravenous Use

---

Annex II

List of nationally authorised medicinal products

Annex IIA — medicinal products containing intravenous gadobenic acid, gadobutrol, gadoteric acid, gadoteridol, gadoxetic acid and intra-articular gadopentetic acid and intra-articular gadoteric acid

| Member State EU/EEA | Marketing authorisation holder | Invented name | INN + Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | Bayer Austria GmbH | Magnevist | Gadopentetate Dimeglumine 1.876 mg/Ml | solution for injection | intra-articular use |
| Austria | Bayer Austria GmbH | Dotagraf | Gadoteric Acid 279.32 mg/Ml | solution for injection | intravenous use |
| Austria | Bayer Austria GmbH | Gadovist | Gadobutrol 604.72 mg/Ml | solution for injection | intravenous use |
| Austria | Bayer Austria GmbH | Primovist | Gadoxetic Acid, Disodium 181.43 mg/Ml | solution for injection | intravenous use |
| Austria | Bracco Imaging S.p.A. | Prohance | Gadoteridol 279.3 mg/Ml | solution for injection | intravenous use |
| Austria | Guerbet | Artirem | Gadoteric Acid 1.397 mg/Ml | solution for injection | intra-articular use |
| Austria | Guerbet | Dotarem | Gadoteric Acid 279.32 mg/Ml | solution for injection | intravenous use |
| Austria | Sanochemia Pharmazeutika AG | Cyclolux | Gadoteric Acid 0.5 mmol/Ml | solution for injection | intravenous use |
| Austria | Bracco Imaging S.p.A. | Multihance | Gadobenate Dimeglumine 529 mg/Ml | solution for injection | intravenous use |
| Belgium | Agfa Healthcare Imaging Agents GmbH | Dotagita | Gadoteric Acid 279.32 mg/Ml | solution for injection | intravenous use |
| Belgium | Bayer SA NV | Dotagraph | Gadoteric Acid 279.32 mg/Ml | solution for injection | intravenous use |
| Belgium | Bayer SA NV | Gadovist | Gadobutrol 604.72 mg/Ml | solution for injection | intravenous use |
| Belgium | Bayer SA NV | Primovist | Gadoxetic Acid, Disodium 181.43 mg/Ml | solution for injection | intravenous use |
| Belgium | Bracco Imaging Deutschland GmbH | Prohance | Gadoteridol 279.3 mg/Ml | solution for injection | intravenous use |
| Belgium | Guerbet | Artirem | Gadoteric Acid 1.397 mg/Ml | solution for injection | intra-articular use |
| Belgium | Guerbet | Dotarem | Meglumine Gadoterate 0.5 mmol/Ml | solution for injection | intravenous use |
| Belgium | Bracco Imaging Deutschland GmbH | Multihance | Gadobenate Dimeglumine 529 mg/Ml | solution for injection | intravenous use |
| Belgium | Bracco Imaging Deutschland GmbH | Multihance | Gadobenate Dimeglumine 10580 mg/20 Ml | solution for injection in pre-filled syringe | intravenous use |
| Belgium | Bracco Imaging Deutschland GmbH | Multihance | Gadobenate Dimeglumine 5290 mg/10 Ml | solution for injection in pre-filled syringe | intravenous use |
| Belgium | Bracco Imaging Deutschland GmbH | Multihance | Gadobenate Dimeglumine 7935 mg/15 Ml | solution for injection in pre-filled syringe | intravenous use |
| Bulgaria | Bayer Pharma AG | гадовист | Gadobutrol 604.72 mg/Ml | solution for injection | intravenous use |
| Bulgaria | Bayer Pharma AG | примовист | Gadoxetic Acid, Disodium 181.43 mg/Ml | solution for injection | intravenous use |
| Bulgaria | Guerbet | дотарем | Gadoteric Acid 279.32 mg/Ml | solution for injection | intravenous use |
| Bulgaria | Guerbet | дотарем | Gadoteric Acid 279.32 mg/Ml | solution for injection in pre-filled syringe | intravenous use |
| Croatia | Bayer d.o.o. | Gadovist | Gadobutrol 604.72 mg/Ml | solution for injection | intravenous use |
| Croatia | Bayer d.o.o. | Primovist | Gadoxetic Acid, Disodium 181.43 mg/Ml | solution for injection | intravenous use |
| Croatia | Pharmacol d.o.o. | Dotarem | Gadoteric Acid 27.932 g/100 Ml | solution for injection | intravenous use |
| Croatia | Pharmacol d.o.o. | Dotarem | Gadoteric Acid 279.32 mg/Ml | solution for injection | intravenous use |
| Croatia | Pharmacol d.o.o. | Dotarem | Gadoteric Acid 279.32 mg/Ml | solution for injection in pre-filled syringe | intravenous use |
| Croatia | Bracco Imaging S.p.A. | Multihance | Gadobenate Dimeglumine 529 mg/Ml | solution for injection | intravenous use |
| Cyprus | Bayer Hellas SA | Gadovist | Gadobutrol 604.72 mg/Ml | solution for injection | intravenous use |
| Cyprus | Bayer Hellas SA | Primovist | Gadoxetic Acid, Disodium 181.43 mg/Ml | solution for injection in pre-filled syringe | intravenous use |
| Cyprus | Guerbet | Dotarem | Gadoteric Acid 279.32 mg/Ml | solution for injection | intravenous use |
| Cyprus | Guerbet | Dotarem | Gadoteric Acid 279.32 mg/Ml | solution for injection in pre-filled syringe | intravenous use |
| Czech Republic | Bayer AG | Gadovist | Gadobutrol 604.72 mg/Ml | solution for injection | intravenous use |
| Czech Republic | Bayer AG | Primovist | Gadoxetic Acid, Disodium 181.43 mg/Ml | solution for injection | intravenous use |
| Czech Republic | Bracco Imaging Deutschland GmbH | Prohance | Gadoteridol 279.3 mg/Ml | solution for injection | intravenous use |
| Czech Republic | Bracco Imaging Deutschland GmbH | Prohance | Gadoteridol 279.3 mg/Ml | solution for injection in pre-filled syringe | intravenous use |
| Czech Republic | Guerbet | Dotarem | Gadoteric Acid 279.32 mg/Ml | solution for injection | intravenous use |
| Czech Republic | Guerbet | Dotarem | Gadoteric Acid 279.32 mg/Ml | solution for injection in pre-filled syringe | intravenous use |
| Czech Republic | Sanochemia Pharmazeutika AG | Cyclolux | Gadoteric Acid 0.5 Milli Molar / Ml | solution for injection | intravenous use |
| Czech Republic | Bracco Imaging Deutschland GmbH | Multihance | Gadobenate Dimeglumine 529 mg/Ml | solution for injection | intravenous use |
| Denmark | Bayer AB | Magnevist | Gadopentetate Dimeglumine 1.876 mg/Ml | solution for injection | intra-articular use |
| Denmark | Bayer AB | Gadovist | Gadobutrol 604.72 mg/Ml | solution for injection | intravenous use |
| Denmark | Bracco International BV | Prohance | Gadoteridol 279.3 mg/Ml | solution for injection | intravenous use |
| Denmark | Guerbet | Dotarem Arthro | Gadoteric Acid 1.397 mg/Ml | solution for injection in pre-filled syringe | intra-articular use |
| Denmark | Guerbet | Dotarem | Gadoteric Acid 279.3 mg/Ml | solution for injection | intravenous use |
| Denmark | Guerbet | Dotarem | Gadoteric Acid 279.3 mg/Ml | solution for injection in pre-filled syringe | intravenous use |
| Denmark | Bracco Imaging S.p.A. | Multihance | Gadobenate Dimeglumine 529 mg/Ml | solution for injection | intravenous use |
| Estonia | Agfa Healthcare Imaging Agents GmbH | Dotagita | Gadoteric Acid 279.32 mg/Ml | solution for injection | intravenous use |
| Estonia | Bayer AG | Gadovist | Gadobutrol 604.72 mg/Ml | solution for injection | intravenous use |
| Estonia | Bayer AG | Primovist | Gadoxetic Acid, Disodium 181.43 mg/Ml | solution for injection | intravenous use |
| Estonia | Guerbet | Dotarem | Gadoteric Acid 279.32 mg/Ml | solution for injection | intravenous use |
| Estonia | Guerbet | Dotarem | Gadoteric Acid 279.32 mg/Ml | solution for injection in pre-filled syringe | intravenous use |
| Finland | Bayer Oy | Gadovist | Gadobutrol 604.72 mg/Ml | solution for injection | intravenous use |
| Finland | Bayer Oy | Primovist | Gadoxetic Acid, Disodium 181.43 mg/Ml | solution for injection | intravenous use |
| Finland | Bracco International BV | Prohance | Gadoteridol 279.3 mg/Ml | solution for injection | intravenous use |
| Finland | Guerbet | Dotarem | Gadoteric Acid 279.32 mg/Ml | solution for injection | intravenous use |
| Finland | Bracco Imaging S.p.A. | Multihance | Gadobenate Dimeglumine 529 mg/Ml | solution for injection | intravenous use |
| France | Agfa Healthcare Imaging Agents GmbH | Dotagita | Gadoteric Acid 279.32 mg/Ml | solution for injection | intravenous use |
| France | Bayer SA NV | Magnevist | Gadopentetate Dimeglumine 1.876 mg/Ml | solution for injection in pre-filled syringe | intra-articular use |
| France | Bayer Healthcare | Gadovist | Gadobutrol 604.72 mg/Ml | solution for injection | intravenous use |
| France | Bracco Imaging France | Prohance | Gadoteridol 1396.5 mg/5 Ml | solution for injection | intravenous use |
| France | Bracco Imaging France | Prohance | Gadoteridol 2793 mg/10 Ml | solution for injection | intravenous use |
| France | Bracco Imaging France | Prohance | Gadoteridol 4189.5 mg/15 Ml | solution for injection | intravenous use |
| France | Bracco Imaging France | Prohance | Gadoteridol 5586 mg/20 Ml | solution for injection | intravenous use |
| France | Bracco Imaging France | Prohance | Gadoteridol 2793 mg/10 Ml | solution for injection in pre-filled syringe | intravenous use |
| France | Bracco Imaging France | Prohance | Gadoteridol 4189.5 mg/15 Ml | solution for injection in pre-filled syringe | intravenous use |
| France | Bracco Imaging France | Prohance | Gadoteridol 4748.1 mg/17 Ml | solution for injection in pre-filled syringe | intravenous use |
| France | Guerbet | Artirem | Gadoteric Acid 1.397 mg/Ml | solution for injection | intra-articular use |
| France | Guerbet | Dotarem | Gadoteric Acid 27.932 g/100 Ml | solution for injection | intravenous use |
| France | Guerbet | Dotarem | Gadoteric Acid 27.932 g/100 Ml | solution for injection in pre-filled syringe | intravenous use |
| France | Bracco Imaging France | Multihance | Gadobenate Dimeglumine 10580 mg/20 Ml | solution for injection | intravenous use |
| France | Bracco Imaging France | Multihance | Gadobenate Dimeglumine 2645 mg/5 Ml | solution for injection | intravenous use |
| France | Bracco Imaging France | Multihance | Gadobenate Dimeglumine 5290 mg/10 Ml | solution for injection | intravenous use |
| France | Bracco Imaging France | Multihance | Gadobenate Dimeglumine 7935 mg/15 Ml | solution for injection | intravenous use |
| France | Bracco Imaging France | Multihance | Gadobenate Dimeglumine 10580 mg/20 Ml | solution for injection in pre-filled syringe | intravenous use |
| Germany | Agfa Healthcare Imaging Agents GmbH | Dotagita | Gadoteric Acid 279.32 mg/Ml | solution for injection | intravenous use |
| Germany | Bayer Vital GmbH | Magnevist | Gadopentetate Dimeglumine 1.88 mg/Ml | solution for injection | intra-articular use |
| Germany | Bayer Vital GmbH | Gadovist | Gadobutrol 604.72 mg/Ml | solution for injection | intravenous use |
| Germany | Bayer Vital GmbH | Primovist | Gadoxetic Acid, Disodium 181.43 mg/Ml | solution for injection | intravenous use |
| Germany | Bracco Imaging Deutschland GmbH | Prohance | Gadoteridol 279.3 mg/Ml | solution for injection | intravenous use |
| Germany | Eurocontrast GmbH | Dotarem Dsf | Gadoteric Acid 0.5 mmol/Ml | solution for injection | intravenous use |
| Germany | Eurocontrast GmbH | Gadovist Dsf | Gadobutrol 1 mmol/Ml | solution for injection | intravenous use |
| Germany | Eurocontrast GmbH | Gadovist Fsp | Gadobutrol 1 mmol/Ml | solution for injection | intravenous use |
| Germany | Eurocontrast GmbH | Prohance | Gadoteridol 0.5 Molar / Ml | solution for injection | intravenous use |
| Germany | Eurocontrast GmbH | Dotarem Fsp | Gadoteric Acid 0.5 mmol/Ml | solution for injection in pre-filled syringe | intravenous use |
| Germany | Eurocontrast GmbH | Primovist 0,25 Mmol/Ml Injektionslösung | Gadoxetic Acid, Disodium 0.25mmol/Ml | solution for injection in pre-filled syringe | intravenous use |
| Germany | Guerbet | Artirem | Gadoteric Acid 1.397 mg/Ml | solution for injection | intra-articular use |
| Germany | Guerbet | Dotarem | Gadoteric Acid 279.32 mg/Ml | solution for injection | intravenous use |
| Germany | Guerbet | Dotaspin | Gadoteric Acid 279.32 mg/Ml | solution for injection | intravenous use |
| Germany | Guerbet | Dotarem | Gadoteric Acid 279.32 mg/Ml | solution for injection in pre-filled syringe | intravenous use |
| Germany | Guerbet | Dotaspin | Gadoteric Acid 279.32 mg/Ml | solution for injection in pre-filled syringe | intravenous use |
| Germany | Jenapharm GmbH & Co Kg | Dotagraf | Gadoteric Acid 279.32 mg/Ml | solution for injection | intravenous use |
| Germany | Sanochemia Pharmazeutika AG | Cyclolux | Gadoteric Acid 0.5 mmol/Ml | solution for injection | intravenous use |
| Germany | Sanochemia Pharmazeutika AG | Gadoteric Acid Gadotersäure Sanochemia 0,5  Mmol/Ml Injektionslösung | Gadoteric Acid 0.5 Milli Molar / Ml | solution for injection | intravenous use |
| Germany | Sanochemia Pharmazeutika AG | Gadotersäure Sanochemia | Gadoteric Acid 0.5 Milli Molar / Ml | solution for injection | intravenous use |
| Germany | Sanochemia Pharmazeutika AG | Gadotersäure Sanochemia | Gadoteric Acid 0.5 mmol/Ml | solution for injection | intravenous use |
| Germany | Bracco Imaging Deutschland GmbH | Multihance | Gadobenate Dimeglumine 529 mg/Ml | solution for injection | intravenous use |
| Germany | Eurocontrast GmbH | Multihance | Gadobenic Acid 0.5 Molar / Ml | solution for injection | intravenous use |
| Greece | Bayer Hellas SA | Gadovist | Gadobutrol 604.72 mg/Ml | solution for injection | intravenous use |
| Greece | Bayer Hellas SA | Gadovist Pfs | Gadobutrol 604.72 mg/Ml | solution for injection in cartridge / solution for injection in pre-filled syringe | intravenous use |
| Greece | Bayer Hellas SA | Primovist Pfs | Gadoxetic Acid, Disodium 181.43 mg/Ml | solution for injection in pre-filled syringe | intravenous use |
| Greece | Guerbet | Dotarem | Gadoteric Acid 279.32 mg/Ml | solution for injection | intravenous use |
| Greece | Bracco Imaging S.p.A. | Multihance | Gadobenate Dimeglumine 529 mg/Ml | solution for injection | intravenous use |
| Hungary | Bayer AG | Gadovist | Gadobutrol 604.72 mg/Ml | solution for injection | intravenous use |
| Hungary | Bayer AG | Primovist | Gadoxetic Acid, Disodium 181.43 mg/Ml | solution for injection | intravenous use |
| Hungary | Guerbet | Dotarem | Gadoteric Acid 27.932 g/100 Ml | solution for injection | intravenous use |
| Hungary | Guerbet | Dotarem | Gadoteric Acid 27.932 mg/100 Ml | solution for injection | intravenous use |
| Hungary | Sanochemia Pharmazeutika AG | Cyclolux | Gadoteric Acid 0.5 mmol/Ml | solution for injection | intravenous use |
| Hungary | Bracco Imaging S.p.A. | Multihance | Gadobenate Dimeglumine 10580 mg/20 Ml | solution for injection | intravenous use |
| Hungary | Bracco Imaging S.p.A. | Multihance | Gadobenate Dimeglumine 2645 mg/5 Ml | solution for injection | intravenous use |
| Hungary | Bracco Imaging S.p.A. | Multihance | Gadobenate Dimeglumine 5290 mg/10 Ml | solution for injection | intravenous use |
| Hungary | Bracco Imaging S.p.A. | Multihance | Gadobenate Dimeglumine 7935 mg/15 Ml | solution for injection | intravenous use |
| Hungary | Bracco Imaging S.p.A. | Multihance | Gadobenate Dimeglumine 10580 mg/20 Ml | solution for injection in pre-filled syringe | intravenous use |
| Hungary | Bracco Imaging S.p.A. | Multihance | Gadobenate Dimeglumine 5290 mg/10 Ml | solution for injection in pre-filled syringe | intravenous use |
| Hungary | Bracco Imaging S.p.A. | Multihance | Gadobenate Dimeglumine 7935 mg/15 Ml | solution for injection in pre-filled syringe | intravenous use |
| Iceland | Bayer Pharma AG | Magnevist | Gadopentetate Dimeglumine 1.876 mg/Ml | solution for injection | intra-articular use |
| Iceland | Bayer AB | Gadovist | Gadobutrol 604.72 mg/Ml | solution for injection | intravenous use |
| Ireland | Bayer Ltd | Gadovist | Gadobutrol 604.72 mg/Ml | solution for injection | intravenous use |
| Ireland | Bayer Ltd | Primovist | Gadoxetic Acid, Disodium 181.43 mg/Ml | solution for injection | intravenous use |
| Ireland | Bracco International BV | Prohance | Gadoteridol 2793 mg/10 Ml | solution for injection | intravenous use |
| Ireland | Bracco International BV | Prohance | Gadoteridol 4189.5 mg/15 Ml | solution for injection | intravenous use |
| Ireland | Bracco International BV | Prohance | Gadoteridol 5586 mg/20 Ml | solution for injection | intravenous use |
| Ireland | Guerbet | Dotarem | Gadoteric Acid 279.32 mg/Ml | solution for injection | intravenous use |
| Ireland | Bracco Imaging S.p.A. | Multihance | Gadobenate Dimeglumine 529 mg/Ml | solution for injection | intravenous use |
| Ireland | Bracco Imaging S.p.A. | Multihance | Gadobenate Dimeglumine 529 mg/Ml | solution for injection in pre-filled syringe | intravenous use |
| Italy | Agfa Healthcare Imaging Agents GmbH | Dotagita | Gadoteric Acid 279.32 mg/Ml | solution for injection | intravenous use |
| Italy | Agfa Healthcare Imaging Agents GmbH | Dotamulti | Gadoteric Acid 279.32 mg/Ml | solution for injection | intravenous use |
| Italy | Bayer Pharma AG | Magnevist | Gadopentetate Dimeglumine 1.88 mg/Ml | solution for injection | intra-articular use |
| Italy | Bayer S.p.A. | Gadovist | Gadobutrol 604.72 mg/Ml | solution for injection | intravenous use |
| Italy | Bayer S.p.A. | Primovist | Gadoxetic Acid, Disodium 181.43 mg/Ml | solution for injection | intravenous use |
| Italy | Bracco Imaging Italia SRL | Prohance | Gadoteridol 1396.5 mg/5 Ml | solution for injection | intravenous use |
| Italy | Bracco Imaging Italia SRL | Prohance | Gadoteridol 13965 mg/50 Ml | solution for injection | intravenous use |
| Italy | Bracco Imaging Italia SRL | Prohance | Gadoteridol 2793 mg/10 Ml | solution for injection | intravenous use |
| Italy | Bracco Imaging Italia SRL | Prohance | Gadoteridol 4189.5 mg/15 Ml | solution for injection | intravenous use |
| Italy | Bracco Imaging Italia SRL | Prohance | Gadoteridol 4748.1 mg/17 Ml | solution for injection | intravenous use |
| Italy | Bracco Imaging Italia SRL | Prohance | Gadoteridol 5586 mg/20 Ml | solution for injection | intravenous use |
| Italy | Guerbet | Dotarem | Gadoteric Acid 0.0025mmol/Ml | solution for injection | intra-articular use |
| Italy | Guerbet | Dotarem | Gadoteric Acid 27.932 g/100 Ml | solution for injection | intravenous use |
| Italy | Bracco Imaging S.p.A. | Multihance | Gadobenate Dimeglumine 10580 mg/20 Ml | solution for injection | intravenous use |
| Italy | Bracco Imaging S.p.A. | Multihance | Gadobenate Dimeglumine 2645 mg/5 Ml | solution for injection | intravenous use |
| Italy | Bracco Imaging S.p.A. | Multihance | Gadobenate Dimeglumine 5290 mg/10 Ml | solution for injection | intravenous use |
| Italy | Bracco Imaging S.p.A. | Multihance | Gadobenate Dimeglumine 7935 mg/15 Ml | solution for injection | intravenous use |
| Latvia | Bayer Pharma AG | Gadovist | Gadobutrol 604.72 mg/Ml | solution for injection | intravenous use |
| Latvia | Bayer Pharma AG | Primovist | Gadoxetic Acid, Disodium 181.43 mg/Ml | solution for injection | intravenous use |
| Latvia | Guerbet | Dotarem | Gadoteric Acid 279.32 mg/Ml | solution for injection | intravenous use |
| Latvia | Guerbet | Dotarem | Gadoteric Acid 279.32 mg/Ml | solution for injection in pre-filled syringe | intravenous use |
| Lithuania | Agfa Healthcare Imaging Agents GmbH | Dotagita | Gadoteric Acid 279.32 mg/Ml | solution for injection | intravenous use |
| Lithuania | Bayer Pharma AG | Gadovist | Gadobutrol 604.72 mg/Ml | solution for injection | intravenous use |
| Lithuania | Bayer Pharma AG | Primovist | Gadoxetic Acid, Disodium 181.43 mg/Ml | solution for injection | intravenous use |
| Lithuania | Guerbet | Dotarem | Gadoteric Acid 279.32 mg/Ml | solution for injection | intravenous use |
| Lithuania | Guerbet | Dotarem | Gadoteric Acid 279.32 mg/Ml | solution for injection in pre-filled syringe | intravenous use |
| Luxembourg | Bayer SA NV | Gadovist | Gadobutrol 604.72 mg/Ml | solution for injection | intravenous use |
| Luxembourg | Bayer SA NV | Primovist | Gadoxetic Acid, Disodium 181.43 mg/Ml | solution for injection | intravenous use |
| Luxembourg | Bracco Imaging Deutschland GmbH | Prohance | Gadoteridol 279.3 mg/Ml | solution for injection | intravenous use |
| Luxembourg | Guerbet | Artirem | Gadoteric Acid 1.397 mg/Ml | solution for injection | intra-articular use |
| Luxembourg | Guerbet | Dotarem | Meglumine Gadoterate 0.5 mmol/Ml | solution for injection | intravenous use |
| Luxembourg | Bracco Imaging Deutschland GmbH | Multihance | Gadobenate Dimeglumine 529 mg/Ml | solution for injection | intravenous use |
| Malta | Bayer PLC | Gadovist | Gadobutrol 604.72 mg/Ml | solution for injection | intravenous use |
| Malta | Bayer PLC | Primovist | Gadoxetic Acid, Disodium 181.43 mg/Ml | solution for injection | intravenous use |
| Netherlands | Bayer BV | Gadovist | Gadobutrol 604.72 mg/Ml | solution for injection | intravenous use |
| Netherlands | Bayer BV | Primovist | Gadoxetic Acid, Disodium 181.43 mg/Ml | solution for injection | intravenous use |
| Netherlands | Bayer BV | Gadovist | Gadobutrol 604.72 mg/Ml | solution for injection in cartridge / solution for injection in pre-filled syringe | intravenous use |
| Netherlands | Bracco Imaging Deutschland GmbH | Prohance | Gadoteridol 279.3 mg/Ml | solution for injection | intravenous use |
| Netherlands | Guerbet | Gadoteerzuur Guerbet | Gadoteric Acid 279.32 mg/Ml | solution for injection | intravenous use |
| Netherlands | Guerbet | Gadoteerzuur Guerbet | Gadoteric Acid 279.32 mg/Ml | solution for injection in pre-filled syringe | intravenous use |
| Netherlands | Guerbet Nederland BV | Artirem | Gadoteric Acid 1.397 mg/Ml | solution for injection in pre-filled syringe | intra-articular use |
| Netherlands | Guerbet Nederland BV | Dotarem | Gadoteric Acid 279.32 mg/Ml | solution for injection | intravenous use |
| Netherlands | Guerbet Nederland BV | Dotarem | Gadoteric Acid 279.32 mg/Ml | solution for injection in pre-filled syringe | intravenous use |
| Netherlands | Bracco Imaging Deutschland GmbH | Multihance | Gadobenate Dimeglumine 529 mg/Ml | solution for injection | intravenous use |
| Norway | Bayer AB | Magnevist | Gadopentetate Dimeglumine 1.876 mg/Ml | solution for injection | intra-articular use |
| Norway | Bayer AB | Gadovist | Gadobutrol 604.72 mg/Ml | solution for injection | intravenous use |
| Norway | Bayer AB | Primovist | Gadoxetic Acid, Disodium 181.43 mg/Ml | solution for injection | intravenous use |
| Norway | Bracco International BV | Prohance | Gadoteridol 279.3 mg/Ml | solution for injection | intravenous use |
| Norway | Guerbet | Dotarem | Gadoteric Acid 279.3 mg/Ml | solution for injection | intravenous use |
| Norway | Bracco Imaging S.p.A. | Multihance | Gadobenate Dimeglumine 529 mg/Ml | solution for injection | intravenous use |
| Poland | Bayer AG | Gadovist | Gadobutrol 604.72 mg/Ml | solution for injection | intravenous use |
| Poland | Bayer Pharma AG | Primovist | Gadoxetic Acid, Disodium 181.43 mg/Ml | solution for injection | intravenous use |
| Poland | Bracco Imaging Deutschland GmbH | Prohance | Gadoteridol 279.3 mg/Ml | solution for injection | intravenous use |
| Poland | Guerbet | Dotarem | Gadoteric Acid 279.32 mg/Ml | solution for injection | intravenous use |
| Poland | Guerbet | Dotarem | Gadoteric Acid 279.32 mg/Ml | solution for injection in pre-filled syringe | intravenous use |
| Poland | Sanochemia Pharmazeutika AG | Cyclolux | Gadoteric Acid 0.5 Milli Molar / Ml | solution for injection | intravenous use |
| Poland | Sanochemia Pharmazeutika AG | Cyclolux Multidose | Gadoteric Acid 0.5 mmol/Ml | solution for injection | intravenous use |
| Poland | Bracco Imaging Deutschland GmbH | Multihance | Gadobenate Dimeglumine 529 mg/Ml | solution for injection | intravenous use |
| Portugal | A. Martins & Fernandes, S.A. | Dotarem | Meglumine Gadoterate 377 mg/Ml | solution for injection | intravenous use |
| Portugal | Bayer Portugal SA | Primovist | Gadoxetic Acid, Disodium 181.43 mg/Ml | solution for injection | intravenous use |
| Portugal | Lusal Lda | Gadovist | Gadobutrol 604.72 mg/Ml | solution for injection | intravenous use |
| Portugal | Lusal Lda | Gadovist | Gadobutrol 604.72 mg/Ml | solution for injection in cartridge | intravenous use |
| Portugal | Lusal Lda | Gadovist | Gadobutrol 604.72 mg/Ml | solution for injection in pre-filled syringe | intravenous use |
| Portugal | Bracco Imaging S.p.A. | Multihance | Gadobenate Dimeglumine 10580 mg/20 Ml | solution for injection | intravenous use |
| Portugal | Bracco Imaging S.p.A. | Multihance | Gadobenate Dimeglumine 2645 mg/5 Ml | solution for injection | intravenous use |
| Portugal | Bracco Imaging S.p.A. | Multihance | Gadobenate Dimeglumine 5290 mg/10 Ml | solution for injection | intravenous use |
| Portugal | Bracco Imaging S.p.A. | Multihance | Gadobenate Dimeglumine 7935 mg/15 Ml | solution for injection | intravenous use |
| Romania | Agfa Healthcare Imaging Agents GmbH | Dotagita | Gadoteric Acid 279.32 mg/Ml | solution for injection | intravenous use |
| Romania | Bayer Pharma AG | Gadovist | Gadobutrol 604.72 mg/Ml | solution for injection | intravenous use |
| Romania | Bayer Pharma AG | Primovist | Gadoxetic Acid, Disodium 181.43 mg/Ml | solution for injection | intravenous use |
| Romania | Guerbet | Dotarem | Gadoteric Acid 279.32 mg/Ml | solution for injection | intravenous use |
| Romania | Guerbet | Dotarem | Gadoteric Acid 279.32 mg/Ml | solution for injection in pre-filled syringe | intravenous use |
| Romania | Bracco Imaging S.p.A. | Multihance | Gadobenate Dimeglumine 10580 mg/20 Ml | solution for injection | intravenous use |
| Romania | Bracco Imaging S.p.A. | Multihance | Gadobenate Dimeglumine 2645 mg/5 Ml | solution for injection | intravenous use |
| Romania | Bracco Imaging S.p.A. | Multihance | Gadobenate Dimeglumine 5290 mg/10 Ml | solution for injection | intravenous use |
| Romania | Bracco Imaging S.p.A. | Multihance | Gadobenate Dimeglumine 7935 mg/15 Ml | solution for injection | intravenous use |
| Slovakia | Bayer Pharma AG | Gadovist | Gadobutrol 604.72 mg/Ml | solution for injection | intravenous use |
| Slovakia | Bayer AG | Primovist | Gadoxetic Acid, Disodium 181.43 mg/Ml | solution for injection | intravenous use |
| Slovakia | Bracco Imaging Deutschland GmbH | Prohance | Gadoteridol 1396.5 mg/5 Ml | solution for injection | intravenous use |
| Slovakia | Bracco Imaging Deutschland GmbH | Prohance | Gadoteridol 2793 mg/10 Ml | solution for injection | intravenous use |
| Slovakia | Bracco Imaging Deutschland GmbH | Prohance | Gadoteridol 4189.5 mg/15 Ml | solution for injection | intravenous use |
| Slovakia | Bracco Imaging Deutschland GmbH | Prohance | Gadoteridol 4748.1 mg/17 Ml | solution for injection | intravenous use |
| Slovakia | Bracco Imaging Deutschland GmbH | Prohance | Gadoteridol 5586 mg/20 Ml | solution for injection | intravenous use |
| Slovakia | Guerbet | Dotarem | Gadoteric Acid 279.32 mg/Ml | solution for injection | intravenous use |
| Slovakia | Guerbet | Dotarem | Gadoteric Acid 279.32 mg/Ml | solution for injection in pre-filled syringe | intravenous use |
| Slovakia | Sanochemia Pharmazeutika AG | Cyclolux | Gadoteric Acid 0.5 mmol/Ml | solution for injection | intravenous use |
| Slovakia | Sanochemia Pharmazeutika AG | Cyclolux Multi | Gadoteric Acid 0.5 Milli Molar / Ml | solution for injection | intravenous use |
| Slovenia | Bayer Pharma AG | Gadovist | Gadobutrol 604.72 mg/Ml | solution for injection | intravenous use |
| Slovenia | Bayer Pharma AG | Primovist | Gadoxetic Acid, Disodium 181.43 mg/Ml | solution for injection | intravenous use |
| Slovenia | Emporio Medical d.o.o. | Dotarem | Gadoteric Acid 279.32 mg/Ml | solution for injection | intravenous use |
| Slovenia | Bracco Imaging S.p.A. | Multihance | Gadobenate Dimeglumine 10580 mg/20 Ml | solution for injection | intravenous use |
| Slovenia | Bracco Imaging S.p.A. | Multihance | Gadobenate Dimeglumine 2645 mg/5 Ml | solution for injection | intravenous use |
| Slovenia | Bracco Imaging S.p.A. | Multihance | Gadobenate Dimeglumine 5290 mg/10 Ml | solution for injection | intravenous use |
| Slovenia | Bracco Imaging S.p.A. | Multihance | Gadobenate Dimeglumine 7935 mg/15 Ml | solution for injection | intravenous use |
| Spain | Agfa Healthcare Imaging Agents GmbH | Dotagita | Gadoteric Acid 279.32 mg/Ml | solution for injection | intravenous use |
| Spain | Bayer Hispania SL | Dotagraf | Gadoteric Acid 279.32 mg/Ml | solution for injection | intravenous use |
| Spain | Bayer Hispania SL | Gadovist | Gadobutrol 604.72 mg/Ml | solution for injection | intravenous use |
| Spain | Bayer Hispania SL | Primovist | Gadoxetic Acid, Disodium 181.43 mg/Ml | solution for injection | intravenous use |
| Spain | Bracco International BV | Prohance | Gadoteridol 279.3 mg/Ml | solution for injection | intravenous use |
| Spain | Guerbet | Dotarem | Meglumine Gadoterate 376.4 mg/Ml | solution for injection | intravenous use |
| Spain | Guerbet | Dotarem | Meglumine Gadoterate 376.4 mg/Ml | solution for injection in pre-filled syringe | intravenous use |
| Spain | Sanochemia Pharmazeutika AG | Cyclolux | Gadoteric Acid 0.5 Milli Molar / Ml | solution for injection | intravenous use |
| Spain | Sanochemia Pharmazeutika AG | Cyclolux Rep | Gadoteric Acid 0.5 Milli Molar / Ml | solution for injection | intravenous use |
| Spain | Bracco Imaging S.p.A. | Multihance | Gadobenate Dimeglumine 529 mg/Ml | solution for injection | intravenous use |
| Spain | Bracco Imaging S.p.A. | Multihance | Gadobenate Dimeglumine 529 mg/Ml | Solution For Injection In Pre-Filled Syringe | intravenous use |
| Sweden | Bayer Pharma AG | Magnevist | Gadopentetate Dimeglumine 1.88 mg/Ml | solution for injection | intra-articular use |
| Sweden | Bayer AB | Gadovist | Gadobutrol 604.72 mg/Ml | solution for injection | intravenous use |
| Sweden | Bayer AB | Primovist | Gadoxetic Acid, Disodium 181.43 mg/Ml | solution for injection | intravenous use |
| Sweden | Bracco International BV | Prohance | Gadoteridol 279.3 mg/Ml | solution for injection | intravenous use |
| Sweden | Guerbet | Dotarem | Gadoteric Acid 279.3 mg/Ml | solution for injection | intravenous use |
| Sweden | Bracco Imaging S.p.A. | Multihance | Gadobenate Dimeglumine 529 mg/Ml | solution for injection | intravenous use |
| United Kingdom | Agfa Healthcare Imaging Agents GmbH | Dotagita | Gadoteric Acid 279.32 mg/Ml | solution for injection | intravenous use |
| United Kingdom | Bayer PLC | Magnevist | Gadopentetate Dimeglumine 1.876 mg/Ml | solution for injection | intra-articular use |
| United Kingdom | Bayer PLC | Gadovist | Gadobutrol 604.72 mg/Ml | solution for injection | intravenous use |
| United Kingdom | Bayer PLC | Primovist | Gadoxetic Acid, Disodium 181.43 mg/Ml | solution for injection | intravenous use |
| United Kingdom | Bracco International BV | Prohance | Gadoteridol 279.3 mg/Ml | solution for injection | intravenous use |
| United Kingdom | Guerbet | Dotarem | Gadoteric Acid 279.32 mg/Ml | solution for injection | intravenous use |
| United Kingdom | Guerbet | Dotarem | Gadoteric Acid 279.32 mg/Ml | solution for injection in pre-filled syringe | intravenous use |
| United Kingdom | Sanochemia Pharmazeutika AG | Cyclolux | Gadoteric Acid 0.5 mmol/Ml | solution for injection | intravenous use |
| United Kingdom | Bracco Imaging S.p.A. | Multihance | Gadobenate Dimeglumine 529 mg/Ml | solution for injection | intravenous use |
| United Kingdom | Bracco Imaging S.p.A. | Multihance | Gadobenate Dimeglumine 529 mg/Ml | solution for injection in pre-filled syringe | intravenous use |

Member State EU/EEA

Marketing authorisation holder

Invented name

INN + Strength

Pharmaceutical form

Route of administration

Austria

Bayer Austria GmbH

Magnevist

Gadopentetate Dimeglumine 1.876 mg/Ml

solution for injection

intra-articular use

Austria

Bayer Austria GmbH

Dotagraf

Gadoteric Acid 279.32 mg/Ml

solution for injection

intravenous use

Austria

Bayer Austria GmbH

Gadovist

Gadobutrol 604.72 mg/Ml

solution for injection

intravenous use

Austria

Bayer Austria GmbH

Primovist

Gadoxetic Acid, Disodium 181.43 mg/Ml

solution for injection

intravenous use

Austria

Bracco Imaging S.p.A.

Prohance

Gadoteridol 279.3 mg/Ml

solution for injection

intravenous use

Austria

Guerbet

Artirem

Gadoteric Acid 1.397 mg/Ml

solution for injection

intra-articular use

Austria

Guerbet

Dotarem

Gadoteric Acid 279.32 mg/Ml

solution for injection

intravenous use

Austria

Sanochemia Pharmazeutika AG

Cyclolux

Gadoteric Acid 0.5 mmol/Ml

solution for injection

intravenous use

Austria

Bracco Imaging S.p.A.

Multihance

Gadobenate Dimeglumine 529 mg/Ml

solution for injection

intravenous use

Belgium

Agfa Healthcare Imaging Agents GmbH

Dotagita

Gadoteric Acid 279.32 mg/Ml

solution for injection

intravenous use

Belgium

Bayer SA NV

Dotagraph

Gadoteric Acid 279.32 mg/Ml

solution for injection

intravenous use

Belgium

Bayer SA NV

Gadovist

Gadobutrol 604.72 mg/Ml

solution for injection

intravenous use

Belgium

Bayer SA NV

Primovist

Gadoxetic Acid, Disodium 181.43 mg/Ml

solution for injection

intravenous use

Belgium

Bracco Imaging Deutschland GmbH

Prohance

Gadoteridol 279.3 mg/Ml

solution for injection

intravenous use

Belgium

Guerbet

Artirem

Gadoteric Acid 1.397 mg/Ml

solution for injection

intra-articular use

Belgium

Guerbet

Dotarem

Meglumine Gadoterate 0.5 mmol/Ml

solution for injection

intravenous use

Belgium

Bracco Imaging Deutschland GmbH

Multihance

Gadobenate Dimeglumine 529 mg/Ml

solution for injection

intravenous use

Belgium

Bracco Imaging Deutschland GmbH

Multihance

Gadobenate Dimeglumine 10580 mg/20 Ml

solution for injection in pre-filled syringe

intravenous use

Belgium

Bracco Imaging Deutschland GmbH

Multihance

Gadobenate Dimeglumine 5290 mg/10 Ml

solution for injection in pre-filled syringe

intravenous use

Belgium

Bracco Imaging Deutschland GmbH

Multihance

Gadobenate Dimeglumine 7935 mg/15 Ml

solution for injection in pre-filled syringe

intravenous use

Bulgaria

Bayer Pharma AG

гадовист

Gadobutrol 604.72 mg/Ml

solution for injection

intravenous use

Bulgaria

Bayer Pharma AG

примовист

Gadoxetic Acid, Disodium 181.43 mg/Ml

solution for injection

intravenous use

Bulgaria

Guerbet

дотарем

Gadoteric Acid 279.32 mg/Ml

solution for injection

intravenous use

Bulgaria

Guerbet

дотарем

Gadoteric Acid 279.32 mg/Ml

solution for injection in pre-filled syringe

intravenous use

Croatia

Bayer d.o.o.

Gadovist

Gadobutrol 604.72 mg/Ml

solution for injection

intravenous use

Croatia

Bayer d.o.o.

Primovist

Gadoxetic Acid, Disodium 181.43 mg/Ml

solution for injection

intravenous use

Croatia

Pharmacol d.o.o.

Dotarem

Gadoteric Acid 27.932 g/100 Ml

solution for injection

intravenous use

Croatia

Pharmacol d.o.o.

Dotarem

Gadoteric Acid 279.32 mg/Ml

solution for injection

intravenous use

Croatia

Pharmacol d.o.o.

Dotarem

Gadoteric Acid 279.32 mg/Ml

solution for injection in pre-filled syringe

intravenous use

Croatia

Bracco Imaging S.p.A.

Multihance

Gadobenate Dimeglumine 529 mg/Ml

solution for injection

intravenous use

Cyprus

Bayer Hellas SA

Gadovist

Gadobutrol 604.72 mg/Ml

solution for injection

intravenous use

Cyprus

Bayer Hellas SA

Primovist

Gadoxetic Acid, Disodium 181.43 mg/Ml

solution for injection in pre-filled syringe

intravenous use

Cyprus

Guerbet

Dotarem

Gadoteric Acid 279.32 mg/Ml

solution for injection

intravenous use

Cyprus

Guerbet

Dotarem

Gadoteric Acid 279.32 mg/Ml

solution for injection in pre-filled syringe

intravenous use

Czech Republic

Bayer AG

Gadovist

Gadobutrol 604.72 mg/Ml

solution for injection

intravenous use

Czech Republic

Bayer AG

Primovist

Gadoxetic Acid, Disodium 181.43 mg/Ml

solution for injection

intravenous use

Czech Republic

Bracco Imaging Deutschland GmbH

Prohance

Gadoteridol 279.3 mg/Ml

solution for injection

intravenous use

Czech Republic

Bracco Imaging Deutschland GmbH

Prohance

Gadoteridol 279.3 mg/Ml

solution for injection in pre-filled syringe

intravenous use

Czech Republic

Guerbet

Dotarem

Gadoteric Acid 279.32 mg/Ml

solution for injection

intravenous use

Czech Republic

Guerbet

Dotarem

Gadoteric Acid 279.32 mg/Ml

solution for injection in pre-filled syringe

intravenous use

Czech Republic

Sanochemia Pharmazeutika AG

Cyclolux

Gadoteric Acid 0.5 Milli Molar / Ml

solution for injection

intravenous use

Czech Republic

Bracco Imaging Deutschland GmbH

Multihance

Gadobenate Dimeglumine 529 mg/Ml

solution for injection

intravenous use

Denmark

Bayer AB

Magnevist

Gadopentetate Dimeglumine 1.876 mg/Ml

solution for injection

intra-articular use

Denmark

Bayer AB

Gadovist

Gadobutrol 604.72 mg/Ml

solution for injection

intravenous use

Denmark

Bracco International BV

Prohance

Gadoteridol 279.3 mg/Ml

solution for injection

intravenous use

Denmark

Guerbet

Dotarem Arthro

Gadoteric Acid 1.397 mg/Ml

solution for injection in pre-filled syringe

intra-articular use

Denmark

Guerbet

Dotarem

Gadoteric Acid 279.3 mg/Ml

solution for injection

intravenous use

Denmark

Guerbet

Dotarem

Gadoteric Acid 279.3 mg/Ml

solution for injection in pre-filled syringe

intravenous use

Denmark

Bracco Imaging S.p.A.

Multihance

Gadobenate Dimeglumine 529 mg/Ml

solution for injection

intravenous use

Estonia

Agfa Healthcare Imaging Agents GmbH

Dotagita

Gadoteric Acid 279.32 mg/Ml

solution for injection

intravenous use

Estonia

Bayer AG

Gadovist

Gadobutrol 604.72 mg/Ml

solution for injection

intravenous use

Estonia

Bayer AG

Primovist

Gadoxetic Acid, Disodium 181.43 mg/Ml

solution for injection

intravenous use

Estonia

Guerbet

Dotarem

Gadoteric Acid 279.32 mg/Ml

solution for injection

intravenous use

Estonia

Guerbet

Dotarem

Gadoteric Acid 279.32 mg/Ml

solution for injection in pre-filled syringe

intravenous use

Finland

Bayer Oy

Gadovist

Gadobutrol 604.72 mg/Ml

solution for injection

intravenous use

Finland

Bayer Oy

Primovist

Gadoxetic Acid, Disodium 181.43 mg/Ml

solution for injection

intravenous use

Finland

Bracco International BV

Prohance

Gadoteridol 279.3 mg/Ml

solution for injection

intravenous use

Finland

Guerbet

Dotarem

Gadoteric Acid 279.32 mg/Ml

solution for injection

intravenous use

Finland

Bracco Imaging S.p.A.

Multihance

Gadobenate Dimeglumine 529 mg/Ml

solution for injection

intravenous use

France

Agfa Healthcare Imaging Agents GmbH

Dotagita

Gadoteric Acid 279.32 mg/Ml

solution for injection

intravenous use

France

Bayer SA NV

Magnevist

Gadopentetate Dimeglumine 1.876 mg/Ml

solution for injection in pre-filled syringe

intra-articular use

France

Bayer Healthcare

Gadovist

Gadobutrol 604.72 mg/Ml

solution for injection

intravenous use

France

Bracco Imaging France

Prohance

Gadoteridol 1396.5 mg/5 Ml

solution for injection

intravenous use

France

Bracco Imaging France

Prohance

Gadoteridol 2793 mg/10 Ml

solution for injection

intravenous use

France

Bracco Imaging France

Prohance

Gadoteridol 4189.5 mg/15 Ml

solution for injection

intravenous use

France

Bracco Imaging France

Prohance

Gadoteridol 5586 mg/20 Ml

solution for injection

intravenous use

France

Bracco Imaging France

Prohance

Gadoteridol 2793 mg/10 Ml

solution for injection in pre-filled syringe

intravenous use

France

Bracco Imaging France

Prohance

Gadoteridol 4189.5 mg/15 Ml

solution for injection in pre-filled syringe

intravenous use

France

Bracco Imaging France

Prohance

Gadoteridol 4748.1 mg/17 Ml

solution for injection in pre-filled syringe

intravenous use

France

Guerbet

Artirem

Gadoteric Acid 1.397 mg/Ml

solution for injection

intra-articular use

France

Guerbet

Dotarem

Gadoteric Acid 27.932 g/100 Ml

solution for injection

intravenous use

France

Guerbet

Dotarem

Gadoteric Acid 27.932 g/100 Ml

solution for injection in pre-filled syringe

intravenous use

France

Bracco Imaging France

Multihance

Gadobenate Dimeglumine 10580 mg/20 Ml

solution for injection

intravenous use

France

Bracco Imaging France

Multihance

Gadobenate Dimeglumine 2645 mg/5 Ml

solution for injection

intravenous use

France

Bracco Imaging France

Multihance

Gadobenate Dimeglumine 5290 mg/10 Ml

solution for injection

intravenous use

France

Bracco Imaging France

Multihance

Gadobenate Dimeglumine 7935 mg/15 Ml

solution for injection

intravenous use

France

Bracco Imaging France

Multihance

Gadobenate Dimeglumine 10580 mg/20 Ml

solution for injection in pre-filled syringe

intravenous use

Germany

Agfa Healthcare Imaging Agents GmbH

Dotagita

Gadoteric Acid 279.32 mg/Ml

solution for injection

intravenous use

Germany

Bayer Vital GmbH

Magnevist

Gadopentetate Dimeglumine 1.88 mg/Ml

solution for injection

intra-articular use

Germany

Bayer Vital GmbH

Gadovist

Gadobutrol 604.72 mg/Ml

solution for injection

intravenous use

Germany

Bayer Vital GmbH

Primovist

Gadoxetic Acid, Disodium 181.43 mg/Ml

solution for injection

intravenous use

Germany

Bracco Imaging Deutschland GmbH

Prohance

Gadoteridol 279.3 mg/Ml

solution for injection

intravenous use

Germany

Eurocontrast GmbH

Dotarem Dsf

Gadoteric Acid 0.5 mmol/Ml

solution for injection

intravenous use

Germany

Eurocontrast GmbH

Gadovist Dsf

Gadobutrol 1 mmol/Ml

solution for injection

intravenous use

Germany

Eurocontrast GmbH

Gadovist Fsp

Gadobutrol 1 mmol/Ml

solution for injection

intravenous use

Germany

Eurocontrast GmbH

Prohance

Gadoteridol 0.5 Molar / Ml

solution for injection

intravenous use

Germany

Eurocontrast GmbH

Dotarem Fsp

Gadoteric Acid 0.5 mmol/Ml

solution for injection in pre-filled syringe

intravenous use

Germany

Eurocontrast GmbH

Primovist 0,25 Mmol/Ml Injektionslösung

Gadoxetic Acid, Disodium 0.25mmol/Ml

solution for injection in pre-filled syringe

intravenous use

Germany

Guerbet

Artirem

Gadoteric Acid 1.397 mg/Ml

solution for injection

intra-articular use

Germany

Guerbet

Dotarem

Gadoteric Acid 279.32 mg/Ml

solution for injection

intravenous use

Germany

Guerbet

Dotaspin

Gadoteric Acid 279.32 mg/Ml

solution for injection

intravenous use

Germany

Guerbet

Dotarem

Gadoteric Acid 279.32 mg/Ml

solution for injection in pre-filled syringe

intravenous use

Germany

Guerbet

Dotaspin

Gadoteric Acid 279.32 mg/Ml

solution for injection in pre-filled syringe

intravenous use

Germany

Jenapharm GmbH & Co Kg

Dotagraf

Gadoteric Acid 279.32 mg/Ml

solution for injection

intravenous use

Germany

Sanochemia Pharmazeutika AG

Cyclolux

Gadoteric Acid 0.5 mmol/Ml

solution for injection

intravenous use

Germany

Sanochemia Pharmazeutika AG

Gadoteric Acid Gadotersäure Sanochemia 0,5  Mmol/Ml Injektionslösung

Gadoteric Acid 0.5 Milli Molar / Ml

solution for injection

intravenous use

Germany

Sanochemia Pharmazeutika AG

Gadotersäure Sanochemia

Gadoteric Acid 0.5 Milli Molar / Ml

solution for injection

intravenous use

Germany

Sanochemia Pharmazeutika AG

Gadotersäure Sanochemia

Gadoteric Acid 0.5 mmol/Ml

solution for injection

intravenous use

Germany

Bracco Imaging Deutschland GmbH

Multihance

Gadobenate Dimeglumine 529 mg/Ml

solution for injection

intravenous use

Germany

Eurocontrast GmbH

Multihance

Gadobenic Acid 0.5 Molar / Ml

solution for injection

intravenous use

Greece

Bayer Hellas SA

Gadovist

Gadobutrol 604.72 mg/Ml

solution for injection

intravenous use

Greece

Bayer Hellas SA

Gadovist Pfs

Gadobutrol 604.72 mg/Ml

solution for injection in cartridge / solution for injection in pre-filled syringe

intravenous use

Greece

Bayer Hellas SA

Primovist Pfs

Gadoxetic Acid, Disodium 181.43 mg/Ml

solution for injection in pre-filled syringe

intravenous use

Greece

Guerbet

Dotarem

Gadoteric Acid 279.32 mg/Ml

solution for injection

intravenous use

Greece

Bracco Imaging S.p.A.

Multihance

Gadobenate Dimeglumine 529 mg/Ml

solution for injection

intravenous use

Hungary

Bayer AG

Gadovist

Gadobutrol 604.72 mg/Ml

solution for injection

intravenous use

Hungary

Bayer AG

Primovist

Gadoxetic Acid, Disodium 181.43 mg/Ml

solution for injection

intravenous use

Hungary

Guerbet

Dotarem

Gadoteric Acid 27.932 g/100 Ml

solution for injection

intravenous use

Hungary

Guerbet

Dotarem

Gadoteric Acid 27.932 mg/100 Ml

solution for injection

intravenous use

Hungary

Sanochemia Pharmazeutika AG

Cyclolux

Gadoteric Acid 0.5 mmol/Ml

solution for injection

intravenous use

Hungary

Bracco Imaging S.p.A.

Multihance

Gadobenate Dimeglumine 10580 mg/20 Ml

solution for injection

intravenous use

Hungary

Bracco Imaging S.p.A.

Multihance

Gadobenate Dimeglumine 2645 mg/5 Ml

solution for injection

intravenous use

Hungary

Bracco Imaging S.p.A.

Multihance

Gadobenate Dimeglumine 5290 mg/10 Ml

solution for injection

intravenous use

Hungary

Bracco Imaging S.p.A.

Multihance

Gadobenate Dimeglumine 7935 mg/15 Ml

solution for injection

intravenous use

Hungary

Bracco Imaging S.p.A.

Multihance

Gadobenate Dimeglumine 10580 mg/20 Ml

solution for injection in pre-filled syringe

intravenous use

Hungary

Bracco Imaging S.p.A.

Multihance

Gadobenate Dimeglumine 5290 mg/10 Ml

solution for injection in pre-filled syringe

intravenous use

Hungary

Bracco Imaging S.p.A.

Multihance

Gadobenate Dimeglumine 7935 mg/15 Ml

solution for injection in pre-filled syringe

intravenous use

Iceland

Bayer Pharma AG

Magnevist

Gadopentetate Dimeglumine 1.876 mg/Ml

solution for injection

intra-articular use

Iceland

Bayer AB

Gadovist

Gadobutrol 604.72 mg/Ml

solution for injection

intravenous use

Ireland

Bayer Ltd

Gadovist

Gadobutrol 604.72 mg/Ml

solution for injection

intravenous use

Ireland

Bayer Ltd

Primovist

Gadoxetic Acid, Disodium 181.43 mg/Ml

solution for injection

intravenous use

Ireland

Bracco International BV

Prohance

Gadoteridol 2793 mg/10 Ml

solution for injection

intravenous use

Ireland

Bracco International BV

Prohance

Gadoteridol 4189.5 mg/15 Ml

solution for injection

intravenous use

Ireland

Bracco International BV

Prohance

Gadoteridol 5586 mg/20 Ml

solution for injection

intravenous use

Ireland

Guerbet

Dotarem

Gadoteric Acid 279.32 mg/Ml

solution for injection

intravenous use

Ireland

Bracco Imaging S.p.A.

Multihance

Gadobenate Dimeglumine 529 mg/Ml

solution for injection

intravenous use

Ireland

Bracco Imaging S.p.A.

Multihance

Gadobenate Dimeglumine 529 mg/Ml

solution for injection in pre-filled syringe

intravenous use

Italy

Agfa Healthcare Imaging Agents GmbH

Dotagita

Gadoteric Acid 279.32 mg/Ml

solution for injection

intravenous use

Italy

Agfa Healthcare Imaging Agents GmbH

Dotamulti

Gadoteric Acid 279.32 mg/Ml

solution for injection

intravenous use

Italy

Bayer Pharma AG

Magnevist

Gadopentetate Dimeglumine 1.88 mg/Ml

solution for injection

intra-articular use

Italy

Bayer S.p.A.

Gadovist

Gadobutrol 604.72 mg/Ml

solution for injection

intravenous use

Italy

Bayer S.p.A.

Primovist

Gadoxetic Acid, Disodium 181.43 mg/Ml

solution for injection

intravenous use

Italy

Bracco Imaging Italia SRL

Prohance

Gadoteridol 1396.5 mg/5 Ml

solution for injection

intravenous use

Italy

Bracco Imaging Italia SRL

Prohance

Gadoteridol 13965 mg/50 Ml

solution for injection

intravenous use

Italy

Bracco Imaging Italia SRL

Prohance

Gadoteridol 2793 mg/10 Ml

solution for injection

intravenous use

Italy

Bracco Imaging Italia SRL

Prohance

Gadoteridol 4189.5 mg/15 Ml

solution for injection

intravenous use

Italy

Bracco Imaging Italia SRL

Prohance

Gadoteridol 4748.1 mg/17 Ml

solution for injection

intravenous use

Italy

Bracco Imaging Italia SRL

Prohance

Gadoteridol 5586 mg/20 Ml

solution for injection

intravenous use

Italy

Guerbet

Dotarem

Gadoteric Acid 0.0025mmol/Ml

solution for injection

intra-articular use

Italy

Guerbet

Dotarem

Gadoteric Acid 27.932 g/100 Ml

solution for injection

intravenous use

Italy

Bracco Imaging S.p.A.

Multihance

Gadobenate Dimeglumine 10580 mg/20 Ml

solution for injection

intravenous use

Italy

Bracco Imaging S.p.A.

Multihance

Gadobenate Dimeglumine 2645 mg/5 Ml

solution for injection

intravenous use

Italy

Bracco Imaging S.p.A.

Multihance

Gadobenate Dimeglumine 5290 mg/10 Ml

solution for injection

intravenous use

Italy

Bracco Imaging S.p.A.

Multihance

Gadobenate Dimeglumine 7935 mg/15 Ml

solution for injection

intravenous use

Latvia

Bayer Pharma AG

Gadovist

Gadobutrol 604.72 mg/Ml

solution for injection

intravenous use

Latvia

Bayer Pharma AG

Primovist

Gadoxetic Acid, Disodium 181.43 mg/Ml

solution for injection

intravenous use

Latvia

Guerbet

Dotarem

Gadoteric Acid 279.32 mg/Ml

solution for injection

intravenous use

Latvia

Guerbet

Dotarem

Gadoteric Acid 279.32 mg/Ml

solution for injection in pre-filled syringe

intravenous use

Lithuania

Agfa Healthcare Imaging Agents GmbH

Dotagita

Gadoteric Acid 279.32 mg/Ml

solution for injection

intravenous use

Lithuania

Bayer Pharma AG

Gadovist

Gadobutrol 604.72 mg/Ml

solution for injection

intravenous use

Lithuania

Bayer Pharma AG

Primovist

Gadoxetic Acid, Disodium 181.43 mg/Ml

solution for injection

intravenous use

Lithuania

Guerbet

Dotarem

Gadoteric Acid 279.32 mg/Ml

solution for injection

intravenous use

Lithuania

Guerbet

Dotarem

Gadoteric Acid 279.32 mg/Ml

solution for injection in pre-filled syringe

intravenous use

Luxembourg

Bayer SA NV

Gadovist

Gadobutrol 604.72 mg/Ml

solution for injection

intravenous use

Luxembourg

Bayer SA NV

Primovist

Gadoxetic Acid, Disodium 181.43 mg/Ml

solution for injection

intravenous use

Luxembourg

Bracco Imaging Deutschland GmbH

Prohance

Gadoteridol 279.3 mg/Ml

solution for injection

intravenous use

Luxembourg

Guerbet

Artirem

Gadoteric Acid 1.397 mg/Ml

solution for injection

intra-articular use

Luxembourg

Guerbet

Dotarem

Meglumine Gadoterate 0.5 mmol/Ml

solution for injection

intravenous use

Luxembourg

Bracco Imaging Deutschland GmbH

Multihance

Gadobenate Dimeglumine 529 mg/Ml

solution for injection

intravenous use

Malta

Bayer PLC

Gadovist

Gadobutrol 604.72 mg/Ml

solution for injection

intravenous use

Malta

Bayer PLC

Primovist

Gadoxetic Acid, Disodium 181.43 mg/Ml

solution for injection

intravenous use

Netherlands

Bayer BV

Gadovist

Gadobutrol 604.72 mg/Ml

solution for injection

intravenous use

Netherlands

Bayer BV

Primovist

Gadoxetic Acid, Disodium 181.43 mg/Ml

solution for injection

intravenous use

Netherlands

Bayer BV

Gadovist

Gadobutrol 604.72 mg/Ml

solution for injection in cartridge / solution for injection in pre-filled syringe

intravenous use

Netherlands

Bracco Imaging Deutschland GmbH

Prohance

Gadoteridol 279.3 mg/Ml

solution for injection

intravenous use

Netherlands

Guerbet

Gadoteerzuur Guerbet

Gadoteric Acid 279.32 mg/Ml

solution for injection

intravenous use

Netherlands

Guerbet

Gadoteerzuur Guerbet

Gadoteric Acid 279.32 mg/Ml

solution for injection in pre-filled syringe

intravenous use

Netherlands

Guerbet Nederland BV

Artirem

Gadoteric Acid 1.397 mg/Ml

solution for injection in pre-filled syringe

intra-articular use

Netherlands

Guerbet Nederland BV

Dotarem

Gadoteric Acid 279.32 mg/Ml

solution for injection

intravenous use

Netherlands

Guerbet Nederland BV

Dotarem

Gadoteric Acid 279.32 mg/Ml

solution for injection in pre-filled syringe

intravenous use

Netherlands

Bracco Imaging Deutschland GmbH

Multihance

Gadobenate Dimeglumine 529 mg/Ml

solution for injection

intravenous use

Norway

Bayer AB

Magnevist

Gadopentetate Dimeglumine 1.876 mg/Ml

solution for injection

intra-articular use

Norway

Bayer AB

Gadovist

Gadobutrol 604.72 mg/Ml

solution for injection

intravenous use

Norway

Bayer AB

Primovist

Gadoxetic Acid, Disodium 181.43 mg/Ml

solution for injection

intravenous use

Norway

Bracco International BV

Prohance

Gadoteridol 279.3 mg/Ml

solution for injection

intravenous use

Norway

Guerbet

Dotarem

Gadoteric Acid 279.3 mg/Ml

solution for injection

intravenous use

Norway

Bracco Imaging S.p.A.

Multihance

Gadobenate Dimeglumine 529 mg/Ml

solution for injection

intravenous use

Poland

Bayer AG

Gadovist

Gadobutrol 604.72 mg/Ml

solution for injection

intravenous use

Poland

Bayer Pharma AG

Primovist

Gadoxetic Acid, Disodium 181.43 mg/Ml

solution for injection

intravenous use

Poland

Bracco Imaging Deutschland GmbH

Prohance

Gadoteridol 279.3 mg/Ml

solution for injection

intravenous use

Poland

Guerbet

Dotarem

Gadoteric Acid 279.32 mg/Ml

solution for injection

intravenous use

Poland

Guerbet

Dotarem

Gadoteric Acid 279.32 mg/Ml

solution for injection in pre-filled syringe

intravenous use

Poland

Sanochemia Pharmazeutika AG

Cyclolux

Gadoteric Acid 0.5 Milli Molar / Ml

solution for injection

intravenous use

Poland

Sanochemia Pharmazeutika AG

Cyclolux Multidose

Gadoteric Acid 0.5 mmol/Ml

solution for injection

intravenous use

Poland

Bracco Imaging Deutschland GmbH

Multihance

Gadobenate Dimeglumine 529 mg/Ml

solution for injection

intravenous use

Portugal

A. Martins & Fernandes, S.A.

Dotarem

Meglumine Gadoterate 377 mg/Ml

solution for injection

intravenous use

Portugal

Bayer Portugal SA

Primovist

Gadoxetic Acid, Disodium 181.43 mg/Ml

solution for injection

intravenous use

Portugal

Lusal Lda

Gadovist

Gadobutrol 604.72 mg/Ml

solution for injection

intravenous use

Portugal

Lusal Lda

Gadovist

Gadobutrol 604.72 mg/Ml

solution for injection in cartridge

intravenous use

Portugal

Lusal Lda

Gadovist

Gadobutrol 604.72 mg/Ml

solution for injection in pre-filled syringe

intravenous use

Portugal

Bracco Imaging S.p.A.

Multihance

Gadobenate Dimeglumine 10580 mg/20 Ml

solution for injection

intravenous use

Portugal

Bracco Imaging S.p.A.

Multihance

Gadobenate Dimeglumine 2645 mg/5 Ml

solution for injection

intravenous use

Portugal

Bracco Imaging S.p.A.

Multihance

Gadobenate Dimeglumine 5290 mg/10 Ml

solution for injection

intravenous use

Portugal

Bracco Imaging S.p.A.

Multihance

Gadobenate Dimeglumine 7935 mg/15 Ml

solution for injection

intravenous use

Romania

Agfa Healthcare Imaging Agents GmbH

Dotagita

Gadoteric Acid 279.32 mg/Ml

solution for injection

intravenous use

Romania

Bayer Pharma AG

Gadovist

Gadobutrol 604.72 mg/Ml

solution for injection

intravenous use

Romania

Bayer Pharma AG

Primovist

Gadoxetic Acid, Disodium 181.43 mg/Ml

solution for injection

intravenous use

Romania

Guerbet

Dotarem

Gadoteric Acid 279.32 mg/Ml

solution for injection

intravenous use

Romania

Guerbet

Dotarem

Gadoteric Acid 279.32 mg/Ml

solution for injection in pre-filled syringe

intravenous use

Romania

Bracco Imaging S.p.A.

Multihance

Gadobenate Dimeglumine 10580 mg/20 Ml

solution for injection

intravenous use

Romania

Bracco Imaging S.p.A.

Multihance

Gadobenate Dimeglumine 2645 mg/5 Ml

solution for injection

intravenous use

Romania

Bracco Imaging S.p.A.

Multihance

Gadobenate Dimeglumine 5290 mg/10 Ml

solution for injection

intravenous use

Romania

Bracco Imaging S.p.A.

Multihance

Gadobenate Dimeglumine 7935 mg/15 Ml

solution for injection

intravenous use

Slovakia

Bayer Pharma AG

Gadovist

Gadobutrol 604.72 mg/Ml

solution for injection

intravenous use

Slovakia

Bayer AG

Primovist

Gadoxetic Acid, Disodium 181.43 mg/Ml

solution for injection

intravenous use

Slovakia

Bracco Imaging Deutschland GmbH

Prohance

Gadoteridol 1396.5 mg/5 Ml

solution for injection

intravenous use

Slovakia

Bracco Imaging Deutschland GmbH

Prohance

Gadoteridol 2793 mg/10 Ml

solution for injection

intravenous use

Slovakia

Bracco Imaging Deutschland GmbH

Prohance

Gadoteridol 4189.5 mg/15 Ml

solution for injection

intravenous use

Slovakia

Bracco Imaging Deutschland GmbH

Prohance

Gadoteridol 4748.1 mg/17 Ml

solution for injection

intravenous use

Slovakia

Bracco Imaging Deutschland GmbH

Prohance

Gadoteridol 5586 mg/20 Ml

solution for injection

intravenous use

Slovakia

Guerbet

Dotarem

Gadoteric Acid 279.32 mg/Ml

solution for injection

intravenous use

Slovakia

Guerbet

Dotarem

Gadoteric Acid 279.32 mg/Ml

solution for injection in pre-filled syringe

intravenous use

Slovakia

Sanochemia Pharmazeutika AG

Cyclolux

Gadoteric Acid 0.5 mmol/Ml

solution for injection

intravenous use

Slovakia

Sanochemia Pharmazeutika AG

Cyclolux Multi

Gadoteric Acid 0.5 Milli Molar / Ml

solution for injection

intravenous use

Slovenia

Bayer Pharma AG

Gadovist

Gadobutrol 604.72 mg/Ml

solution for injection

intravenous use

Slovenia

Bayer Pharma AG

Primovist

Gadoxetic Acid, Disodium 181.43 mg/Ml

solution for injection

intravenous use

Slovenia

Emporio Medical d.o.o.

Dotarem

Gadoteric Acid 279.32 mg/Ml

solution for injection

intravenous use

Slovenia

Bracco Imaging S.p.A.

Multihance

Gadobenate Dimeglumine 10580 mg/20 Ml

solution for injection

intravenous use

Slovenia

Bracco Imaging S.p.A.

Multihance

Gadobenate Dimeglumine 2645 mg/5 Ml

solution for injection

intravenous use

Slovenia

Bracco Imaging S.p.A.

Multihance

Gadobenate Dimeglumine 5290 mg/10 Ml

solution for injection

intravenous use

Slovenia

Bracco Imaging S.p.A.

Multihance

Gadobenate Dimeglumine 7935 mg/15 Ml

solution for injection

intravenous use

Spain

Agfa Healthcare Imaging Agents GmbH

Dotagita

Gadoteric Acid 279.32 mg/Ml

solution for injection

intravenous use

Spain

Bayer Hispania SL

Dotagraf

Gadoteric Acid 279.32 mg/Ml

solution for injection

intravenous use

Spain

Bayer Hispania SL

Gadovist

Gadobutrol 604.72 mg/Ml

solution for injection

intravenous use

Spain

Bayer Hispania SL

Primovist

Gadoxetic Acid, Disodium 181.43 mg/Ml

solution for injection

intravenous use

Spain

Bracco International BV

Prohance

Gadoteridol 279.3 mg/Ml

solution for injection

intravenous use

Spain

Guerbet

Dotarem

Meglumine Gadoterate 376.4 mg/Ml

solution for injection

intravenous use

Spain

Guerbet

Dotarem

Meglumine Gadoterate 376.4 mg/Ml

solution for injection in pre-filled syringe

intravenous use

Spain

Sanochemia Pharmazeutika AG

Cyclolux

Gadoteric Acid 0.5 Milli Molar / Ml

solution for injection

intravenous use

Spain

Sanochemia Pharmazeutika AG

Cyclolux Rep

Gadoteric Acid 0.5 Milli Molar / Ml

solution for injection

intravenous use

Spain

Bracco Imaging S.p.A.

Multihance

Gadobenate Dimeglumine 529 mg/Ml

solution for injection

intravenous use

Spain

Bracco Imaging S.p.A.

Multihance

Gadobenate Dimeglumine 529 mg/Ml

Solution For Injection In Pre-Filled Syringe

intravenous use

Sweden

Bayer Pharma AG

Magnevist

Gadopentetate Dimeglumine 1.88 mg/Ml

solution for injection

intra-articular use

Sweden

Bayer AB

Gadovist

Gadobutrol 604.72 mg/Ml

solution for injection

intravenous use

Sweden

Bayer AB

Primovist

Gadoxetic Acid, Disodium 181.43 mg/Ml

solution for injection

intravenous use

Sweden

Bracco International BV

Prohance

Gadoteridol 279.3 mg/Ml

solution for injection

intravenous use

Sweden

Guerbet

Dotarem

Gadoteric Acid 279.3 mg/Ml

solution for injection

intravenous use

Sweden

Bracco Imaging S.p.A.

Multihance

Gadobenate Dimeglumine 529 mg/Ml

solution for injection

intravenous use

United Kingdom

Agfa Healthcare Imaging Agents GmbH

Dotagita

Gadoteric Acid 279.32 mg/Ml

solution for injection

intravenous use

United Kingdom

Bayer PLC

Magnevist

Gadopentetate Dimeglumine 1.876 mg/Ml

solution for injection

intra-articular use

United Kingdom

Bayer PLC

Gadovist

Gadobutrol 604.72 mg/Ml

solution for injection

intravenous use

United Kingdom

Bayer PLC

Primovist

Gadoxetic Acid, Disodium 181.43 mg/Ml

solution for injection

intravenous use

United Kingdom

Bracco International BV

Prohance

Gadoteridol 279.3 mg/Ml

solution for injection

intravenous use

United Kingdom

Guerbet

Dotarem

Gadoteric Acid 279.32 mg/Ml

solution for injection

intravenous use

United Kingdom

Guerbet

Dotarem

Gadoteric Acid 279.32 mg/Ml

solution for injection in pre-filled syringe

intravenous use

United Kingdom

Sanochemia Pharmazeutika AG

Cyclolux

Gadoteric Acid 0.5 mmol/Ml

solution for injection

intravenous use

United Kingdom

Bracco Imaging S.p.A.

Multihance

Gadobenate Dimeglumine 529 mg/Ml

solution for injection

intravenous use

United Kingdom

Bracco Imaging S.p.A.

Multihance

Gadobenate Dimeglumine 529 mg/Ml

solution for injection in pre-filled syringe

intravenous use

Annex IIB — medicinal products containing gadodiamide, gadopentetic acid and gadoversetamide for intravenous use

| Member State EU/EEA | Marketing authorisation holder | Invented name | INN + Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | Bayer Austria GmbH | Magnevist | Gadopentetate Dimeglumine 469 mg/Ml | solution for injection | intravenous use |
| Austria | GE Healthcare Handels GmbH | Omniscan | Gadodiamide 287 mg/Ml | solution for injection | intravenous use |
| Austria | Sanochemia Pharmazeutika AG | Magnetolux | Gadopentetate Dimeglumine 469 mg/Ml | solution for injection | intravenous use |
| Belgium | Bayer SA NV | Magnevist | Gadopentetate Dimeglumine 469.01 mg/Ml | solution for injection | intravenous use |
| Belgium | GE Healthcare Bvba | Omniscan | Gadodiamide 287 mg/Ml | solution for injection | intravenous use |
| Bulgaria | Bayer Pharma AG | магневист | Gadopentetate Dimeglumine 469.01 mg/Ml | solution for injection | intravenous use |
| Bulgaria | GE Healthcare AS | омнискен | Gadodiamide 287 mg/Ml | solution for injection | intravenous use |
| Bulgaria | Sanochemia Pharmazeutika AG | Magnetolux | Gadopentetate Dimeglumine 469 mg/Ml | solution for injection | intravenous use |
| Croatia | Agfa Healthcare Imaging Agents GmbH | Magnegita | Gadopentetate Dimeglumine 469.01 mg/Ml | solution for injection | intravenous use |
| Croatia | Bayer d.o.o. | Magnevist | Gadopentetate Dimeglumine 469.01 mg/Ml | solution for injection | intravenous use |
| Croatia | GE Healthcare d.o.o. | Omniscan | Gadodiamide 287 mg/Ml | solution for injection | intravenous use |
| Cyprus | Bayer Hellas SA | Magnevist | Gadopentetate Dimeglumine 469.01 mg/Ml | solution for injection | intravenous use |
| Cyprus | Phadisco Ltd | Omniscan | Gadodiamide 287 mg/Ml | solution for injection | intravenous use |
| Czech Republic | Bayer AG | Magnevist | Gadopentetate Dimeglumine 469.01 mg/Ml | solution for injection | intravenous use |
| Czech Republic | GE Healthcare AS | Omniscan | Gadodiamide 287 mg/Ml | solution for injection | intravenous use |
| Denmark | Bayer Pharma AG | Magnevist | Gadopentetate Dimeglumine 469.01 mg/Ml | solution for injection | intravenous use |
| Denmark | GE Healthcare AS | Omniscan | Gadodiamide 0.5 mmol/Ml | solution for injection | intravenous use |
| Estonia | Agfa Healthcare Imaging Agents GmbH | Magnegita | Gadopentetate Dimeglumine 469.01 mg/Ml | solution for injection | intravenous use |
| Estonia | Bayer AG | Magnevist | Gadopentetate Dimeglumine 469.01 mg/Ml | solution for injection | intravenous use |
| Estonia | GE Healthcare AS | Omniscan | Gadodiamide 287 mg/Ml | solution for injection | intravenous use |
| Finland | Bayer Oy | Magnevist | Gadopentetate Dimeglumine 469.01 mg/Ml | solution for injection | intravenous use |
| France | Bayer Healthcare | Magnevist | Gadopentetate Dimeglumine 469.01 mg/Ml | solution for injection | intravenous use |
| France | GE Healthcare Sas | Omniscan | Gadodiamide 287 mg/Ml | solution for injection | intravenous use |
| France | GE Healthcare Sas | Omniscan | Gadodiamide 287 mg/Ml | solution for injection in pre-filled syringe | intravenous use |
| Germany | Agfa Healthcare Imaging Agents GmbH | Magnegita | Gadopentetate Dimeglumine 469.01 mg/Ml | solution for injection | intravenous use |
| Germany | B.E.Imaging.GmbH | Magnevision | Gadopentetate Dimeglumine 469 mg/Ml | solution for injection | intravenous use |
| Germany | B.E.Imaging.GmbH | Magnevision B.E. | Gadopentetate Dimeglumine 469 mg/Ml | solution for injection | intravenous use |
| Germany | Bayer Vital GmbH | Magnevist | Gadopentetate Dimeglumine 469.01 mg/Ml | solution for injection | intravenous use |
| Germany | Eurocontrast GmbH | Magnegita | Gadopentetate Dimeglumine 500 μmol/Ml | solution for injection | intravenous use |
| Germany | Eurocontrast GmbH | Magnevist | Gadopentetate Dimeglumine 0.5 mmol/Ml | solution for injection | intravenous use |
| Germany | Eurocontrast GmbH | Omniscan 0,5 Mmol/Ml | Gadodiamide 0.5 mmol/Ml | solution for injection | intravenous use |
| Germany | Eurocontrast GmbH | Omniscan 0,5 Mmol/Ml | Gadodiamide 0.5 mmol/Ml | solution for injection in pre-filled syringe | intravenous use |
| Germany | GE Healthcare Buchler GmbH & Co. Kg | Omniscan | Gadodiamide 287 mg/Ml | solution for injection | intravenous use |
| Germany | GE Healthcare Buchler GmbH & Co. Kg | Omniscan | Gadodiamide 287 mg/Ml | solution for injection in pre-filled syringe | intravenous use |
| Germany | Jenapharm GmbH & Co Kg | Magnograf | Gadopentetate Dimeglumine 469.01 mg/Ml | solution for injection | intravenous use |
| Germany | M.C.S. Conpharm GmbH | Gadopentat | Gadopentetate Dimeglumine 469 mg/Ml | solution for injection | intravenous use |
| Germany | Medithek GmbH | Gadocon | Gadopentetate Dimeglumine 469 mg/Ml | solution for injection | intravenous use |
| Germany | Medithek GmbH | Gadopent | Gadopentetate Dimeglumine 469 mg/Ml | solution for injection | intravenous use |
| Germany | Medithek GmbH | Gadothek | Gadopentetate Dimeglumine 500 μmol/Ml | solution for injection | intravenous use |
| Germany | Radco-Imaging GmbH | Gadolan | Gadopentetate Dimeglumine 469 mg/Ml | solution for injection | intravenous use |
| Germany | Radiomed Service Für Radiologische Großpraxen GmbH | Gadopur | Gadopentetate Dimeglumine 469 mg/Ml | solution for injection | intravenous use |
| Germany | Sanochemia Diagnostics Deutschland GmbH | Mr-Lux | Gadopentetate Dimeglumine 469 mg/Ml | solution for injection | intravenous use |
| Germany | Sanochemia Pharmazeutika AG | Magnetolux | Gadopentetate Dimeglumine 469 mg/Ml | solution for injection | intravenous use |
| Greece | Bayer Hellas SA | Magnevist | Gadopentetate Dimeglumine 469.01 mg/Ml | solution for injection | intravenous use |
| Greece | GE Healthcare Ae | Omniscan | Gadodiamide 287 mg/Ml | solution for injection | intravenous use |
| Greece | Vianex S.A. | Magnetolux | Gadopentetate Dimeglumine 500 μmol/Ml | solution for injection | intravenous use |
| Hungary | Bayer AG | Magnevist | Gadopentetate Dimeglumine 469.01 mg/Ml | solution for injection | intravenous use |
| Hungary | GE Healthcare AS | Omniscan | Gadodiamide 14.35 g/50 Ml | solution for injection | intravenous use |
| Hungary | GE Healthcare AS | Omniscan | Gadodiamide 2.87 g/10 Ml | solution for injection | intravenous use |
| Hungary | GE Healthcare AS | Omniscan | Gadodiamide 4.31 g/15 Ml | solution for injection | intravenous use |
| Hungary | GE Healthcare AS | Omniscan | Gadodiamide 5.74 g/20 Ml | solution for injection | intravenous use |
| Hungary | GE Healthcare AS | Omniscan | Gadodiamide 5.74 mol/15 Ml | solution for injection | intravenous use |
| Hungary | Sanochemia Pharmazeutika AG | Magnetolux | Gadopentetate Dimeglumine 469 mg/Ml | solution for injection | intravenous use |
| Iceland | Bayer AB | Magnevist | Gadopentetate Dimeglumine 469.01 mg/Ml | solution for injection | intravenous use |
| Iceland | GE Healthcare AS | Omniscan | Gadodiamide 287 mg/Ml | solution for injection | intravenous use |
| Iceland | GE Healthcare AS | Omniscan | Gadodiamide 287 mg/Ml | solution for injection in pre-filled syringe | intravenous use |
| Iceland | Mallinckrodt Deutschland GmbH | Optimark | Gadoversetamide 330.9 mg/Ml | solution for injection | intravenous use |
| Iceland | Mallinckrodt Deutschland GmbH | Optimark | Gadoversetamide 330.9 mg/Ml | solution for injection in pre-filled syringe | intravenous use |
| Ireland | Bayer Ltd | Magnevist | Gadopentetate Dimeglumine 469.01 mg/Ml | solution for injection | intravenous use |
| Ireland | GE Healthcare AS | Omniscan | Gadodiamide 287 mg/Ml | solution for injection | intravenous use |
| Ireland | GE Healthcare AS | Omniscan | Gadodiamide 287 mg/Ml | solution for injection in pre-filled syringe | intravenous use |
| Italy | Agfa Healthcare Imaging Agents GmbH | Magnegita | Gadopentetate Dimeglumine 469.01 mg/Ml | solution for injection | intravenous use |
| Italy | Bayer Pharma AG | Magnevist | Gadopentetate Dimeglumine 469 mg/Ml | solution for injection/infusion | intravenous use |
| Italy | Bayer S.p.A. | Magnograf | Gadopentetate Dimeglumine 469.01 mg/Ml | solution for injection | intravenous use |
| Italy | Bayer S.p.A. | Magnograf | Gadopentetate Dimeglumine 469 mg/Ml | solution for injection/infusion | intravenous use |
| Italy | GE Healthcare S.R.L. | Omniscan | Gadodiamide 0.5 mmol/Ml | solution for injection | intravenous use |
| Italy | Sanochemia Pharmazeutika AG | Magnetolux | Gadopentetate Dimeglumine 469 mg/Ml | solution for injection | intravenous use |
| Latvia | Agfa Healthcare Imaging Agents GmbH | Magnegita | Gadopentetate Dimeglumine 469.01 mg/Ml | solution for injection | intravenous use |
| Latvia | Bayer Pharma AG | Magnevist | Gadopentetate Dimeglumine 469.01 mg/Ml | solution for injection | intravenous use |
| Latvia | GE Healthcare AS | Omniscan | Gadodiamide 287 mg/Ml | solution for injection | intravenous use |
| Lithuania | Agfa Healthcare Imaging Agents GmbH | Magnegita | Gadopentetate Dimeglumine 469.01 mg/Ml | solution for injection | intravenous use |
| Lithuania | Agfa Healthcare Imaging Agents GmbH | Magnegita | Gadopentetate Dimeglumine 469 mg/Ml | solution for injection | intravenous use |
| Lithuania | Agfa Healthcare Imaging Agents GmbH | Magnegita | Gadopentetate Dimeglumine 469.01 mg/Ml | solution for injection/infusion | intravenous use |
| Lithuania | Bayer Pharma AG | Magnevist | Gadopentetate Dimeglumine 469.01 mg/Ml | solution for injection | intravenous use |
| Lithuania | GE Healthcare AS | Omniscan | Gadodiamide 287 mg/Ml | solution for injection | intravenous use |
| Luxembourg | Bayer SA NV | Magnevist | Gadopentetate Dimeglumine 469.01 mg/Ml | solution for injection | intravenous use |
| Luxembourg | GE Healthcare Bvba | Omniscan | Gadodiamide 287 mg/Ml | solution for injection | intravenous use |
| Luxembourg | Medithek GmbH | Gadocon | Gadopentetate Dimeglumine 469 mg/Ml | solution for injection | intravenous use |
| Luxembourg | Medithek GmbH | Gadopent | Gadopentetate Dimeglumine 469 mg/Ml | solution for injection | intravenous use |
| Luxembourg | Medithek GmbH | Gadothek | Gadopentetate Dimeglumine 469 mg/Ml | solution for injection | intravenous use |
| Malta | Bayer PLC | Magnevist | Gadopentetate Dimeglumine 469.01 mg/Ml | solution for injection | intravenous use |
| Malta | GE Healthcare AS | Omniscan | Gadodiamide 287 mg/Ml | solution for injection | intravenous use |
| Netherlands | GE Healthcare B.V. | Omniscan | Gadodiamide 2.87 g/10 Ml | solution for injection | intravenous use |
| Netherlands | GE Healthcare B.V. | Omniscan | Gadodiamide 287 mg/Ml | solution for injection | intravenous use |
| Netherlands | GE Healthcare B.V. | Omniscan | Gadodiamide 4.305 g/15 Ml | solution for injection | intravenous use |
| Netherlands | GE Healthcare B.V. | Omniscan | Gadodiamide 5.74 g/20 Ml | solution for injection | intravenous use |
| Norway | Bayer Pharma AG | Magnevist | Gadopentetate Dimeglumine 469.01 mg/Ml | solution for injection | intravenous use |
| Norway | GE Healthcare AS | Omniscan | Gadodiamide 287 mg/Ml | solution for injection | intravenous use |
| Norway | Mallinckrodt Deutschland GmbH | Optimark | Gadoversetamide 330.9 mg/Ml | solution for injection | intravenous use |
| Norway | Mallinckrodt Deutschland GmbH | Optimark | Gadoversetamide 330.9 mg/Ml | solution for injection in pre-filled syringe | intravenous use |
| Poland | Bayer AG | Magnevist | Gadopentetate Dimeglumine 469.01 mg/Ml | solution for injection | intravenous use |
| Poland | GE Healthcare AS | Omniscan | Gadodiamide 287 mg/Ml | solution for injection | intravenous use |
| Portugal | Bayer Portugal SA | Magnevist | Gadopentetate Dimeglumine 469 mg/Ml | solution for injection | intravenous use |
| Portugal | Satis-Radioisótopos E Protecções Contra Sobretensões Eléctricas Unipessoal, Lda | Omniscan | Gadodiamide 287 mg/Ml | solution for injection | intravenous use |
| Romania | Agfa Healthcare Imaging Agents GmbH | Magnegita | Gadopentetate Dimeglumine 469.01 mg/Ml | solution for injection/infusion | intravenous use |
| Romania | Bayer Pharma AG | Magnevist | Gadopentetate Dimeglumine 469.01 mg/Ml | solution for injection | intravenous use |
| Romania | GE Healthcare AS | Omniscan | Gadodiamide 287 mg/Ml | solution for injection | intravenous use |
| Romania | Sanochemia Pharmazeutika AG | Magnetolux | Gadopentetate Dimeglumine 469 mg/Ml | solution for injection | intravenous use |
| Slovakia | Agfa Healthcare Imaging Agents GmbH | Magnegita | Gadopentetate Dimeglumine 469.01 mg/Ml | solution for injection/infusion | intravenous use |
| Slovakia | GE Healthcare AS | Omniscan | Gadodiamide 287 mg/Ml | solution for injection | intravenous use |
| Slovakia | Sanochemia Pharmazeutika AG | Magnetolux | Gadopentetate Dimeglumine 469 mg/Ml | solution for injection | intravenous use |
| Slovenia | Agfa Healthcare Imaging Agents GmbH | Magnegita | Gadopentetate Dimeglumine 469.01 mg/Ml | solution for injection/infusion | intravenous use |
| Slovenia | Bayer Pharma AG | Magnevist | Gadopentetate Dimeglumine 469 mg/Ml | solution for injection | intravenous use |
| Slovenia | GE Healthcare AS | Omniscan | Gadodiamide 1.44 g/5 Ml | solution for injection | intravenous use |
| Slovenia | GE Healthcare AS | Omniscan | Gadodiamide 2.87 g/10 Ml | solution for injection | intravenous use |
| Slovenia | GE Healthcare AS | Omniscan | Gadodiamide 4.31 g/15 Ml | solution for injection | intravenous use |
| Slovenia | GE Healthcare AS | Omniscan | Gadodiamide 5.74 g/20 Ml | solution for injection | intravenous use |
| Spain | Bayer Hispania SL | Magnevist | Gadopentetate Dimeglumine 469.01 mg/Ml | solution for injection | intravenous use |
| Spain | GE Healthcare Bio-Sciences, S.A.U. | Omniscan | Gadodiamide 287 mg/Ml | solution for injection in pre-filled syringe | intravenous use |
| Spain | Sanochemia Pharmazeutika AG | Magnetolux | Gadopentetate Dimeglumine 469 mg/Ml | solution for injection | intravenous use |
| Sweden | Bayer AB | Magnevist | Gadopentetate Dimeglumine 469.01 mg/Ml | solution for injection | intravenous use |
| Sweden | GE Healthcare AS | Omniscan | Gadodiamide 287 mg/Ml | solution for injection | intravenous use |
| Sweden | GE Healthcare AS | Omniscan | Gadodiamide 287 mg/Ml | solution for injection in pre-filled syringe | intravenous use |
| United Kingdom | Agfa Healthcare Imaging Agents GmbH | Magnegita | Gadopentetate Dimeglumine 469.01 mg/Ml | solution for injection | intravenous use |
| United Kingdom | Bayer PLC | Magnevist | Gadopentetate Dimeglumine 469.01 mg/Ml | solution for injection | intravenous use |
| United Kingdom | GE Healthcare AS | Omniscan | Gadodiamide 287 mg/Ml | injection | intravenous use |
| United Kingdom | GE Healthcare AS | Omniscan | Gadodiamide 287 mg/Ml | solution for injection | intravenous use |
| United Kingdom | Sanochemia Pharmazeutika AG | Magnetolux | Gadopentetate Dimeglumine 469 mg/Ml | solution for injection | intravenous use |

Member State EU/EEA

Marketing authorisation holder

Invented name

INN + Strength

Pharmaceutical form

Route of administration

Austria

Bayer Austria GmbH

Magnevist

Gadopentetate Dimeglumine 469 mg/Ml

solution for injection

intravenous use

Austria

GE Healthcare Handels GmbH

Omniscan

Gadodiamide 287 mg/Ml

solution for injection

intravenous use

Austria

Sanochemia Pharmazeutika AG

Magnetolux

Gadopentetate Dimeglumine 469 mg/Ml

solution for injection

intravenous use

Belgium

Bayer SA NV

Magnevist

Gadopentetate Dimeglumine 469.01 mg/Ml

solution for injection

intravenous use

Belgium

GE Healthcare Bvba

Omniscan

Gadodiamide 287 mg/Ml

solution for injection

intravenous use

Bulgaria

Bayer Pharma AG

магневист

Gadopentetate Dimeglumine 469.01 mg/Ml

solution for injection

intravenous use

Bulgaria

GE Healthcare AS

омнискен

Gadodiamide 287 mg/Ml

solution for injection

intravenous use

Bulgaria

Sanochemia Pharmazeutika AG

Magnetolux

Gadopentetate Dimeglumine 469 mg/Ml

solution for injection

intravenous use

Croatia

Agfa Healthcare Imaging Agents GmbH

Magnegita

Gadopentetate Dimeglumine 469.01 mg/Ml

solution for injection

intravenous use

Croatia

Bayer d.o.o.

Magnevist

Gadopentetate Dimeglumine 469.01 mg/Ml

solution for injection

intravenous use

Croatia

GE Healthcare d.o.o.

Omniscan

Gadodiamide 287 mg/Ml

solution for injection

intravenous use

Cyprus

Bayer Hellas SA

Magnevist

Gadopentetate Dimeglumine 469.01 mg/Ml

solution for injection

intravenous use

Cyprus

Phadisco Ltd

Omniscan

Gadodiamide 287 mg/Ml

solution for injection

intravenous use

Czech Republic

Bayer AG

Magnevist

Gadopentetate Dimeglumine 469.01 mg/Ml

solution for injection

intravenous use

Czech Republic

GE Healthcare AS

Omniscan

Gadodiamide 287 mg/Ml

solution for injection

intravenous use

Denmark

Bayer Pharma AG

Magnevist

Gadopentetate Dimeglumine 469.01 mg/Ml

solution for injection

intravenous use

Denmark

GE Healthcare AS

Omniscan

Gadodiamide 0.5 mmol/Ml

solution for injection

intravenous use

Estonia

Agfa Healthcare Imaging Agents GmbH

Magnegita

Gadopentetate Dimeglumine 469.01 mg/Ml

solution for injection

intravenous use

Estonia

Bayer AG

Magnevist

Gadopentetate Dimeglumine 469.01 mg/Ml

solution for injection

intravenous use

Estonia

GE Healthcare AS

Omniscan

Gadodiamide 287 mg/Ml

solution for injection

intravenous use

Finland

Bayer Oy

Magnevist

Gadopentetate Dimeglumine 469.01 mg/Ml

solution for injection

intravenous use

France

Bayer Healthcare

Magnevist

Gadopentetate Dimeglumine 469.01 mg/Ml

solution for injection

intravenous use

France

GE Healthcare Sas

Omniscan

Gadodiamide 287 mg/Ml

solution for injection

intravenous use

France

GE Healthcare Sas

Omniscan

Gadodiamide 287 mg/Ml

solution for injection in pre-filled syringe

intravenous use

Germany

Agfa Healthcare Imaging Agents GmbH

Magnegita

Gadopentetate Dimeglumine 469.01 mg/Ml

solution for injection

intravenous use

Germany

B.E.Imaging.GmbH

Magnevision

Gadopentetate Dimeglumine 469 mg/Ml

solution for injection

intravenous use

Germany

B.E.Imaging.GmbH

Magnevision B.E.

Gadopentetate Dimeglumine 469 mg/Ml

solution for injection

intravenous use

Germany

Bayer Vital GmbH

Magnevist

Gadopentetate Dimeglumine 469.01 mg/Ml

solution for injection

intravenous use

Germany

Eurocontrast GmbH

Magnegita

Gadopentetate Dimeglumine 500 μmol/Ml

solution for injection

intravenous use

Germany

Eurocontrast GmbH

Magnevist

Gadopentetate Dimeglumine 0.5 mmol/Ml

solution for injection

intravenous use

Germany

Eurocontrast GmbH

Omniscan 0,5 Mmol/Ml

Gadodiamide 0.5 mmol/Ml

solution for injection

intravenous use

Germany

Eurocontrast GmbH

Omniscan 0,5 Mmol/Ml

Gadodiamide 0.5 mmol/Ml

solution for injection in pre-filled syringe

intravenous use

Germany

GE Healthcare Buchler GmbH & Co. Kg

Omniscan

Gadodiamide 287 mg/Ml

solution for injection

intravenous use

Germany

GE Healthcare Buchler GmbH & Co. Kg

Omniscan

Gadodiamide 287 mg/Ml

solution for injection in pre-filled syringe

intravenous use

Germany

Jenapharm GmbH & Co Kg

Magnograf

Gadopentetate Dimeglumine 469.01 mg/Ml

solution for injection

intravenous use

Germany

M.C.S. Conpharm GmbH

Gadopentat

Gadopentetate Dimeglumine 469 mg/Ml

solution for injection

intravenous use

Germany

Medithek GmbH

Gadocon

Gadopentetate Dimeglumine 469 mg/Ml

solution for injection

intravenous use

Germany

Medithek GmbH

Gadopent

Gadopentetate Dimeglumine 469 mg/Ml

solution for injection

intravenous use

Germany

Medithek GmbH

Gadothek

Gadopentetate Dimeglumine 500 μmol/Ml

solution for injection

intravenous use

Germany

Radco-Imaging GmbH

Gadolan

Gadopentetate Dimeglumine 469 mg/Ml

solution for injection

intravenous use

Germany

Radiomed Service Für Radiologische Großpraxen GmbH

Gadopur

Gadopentetate Dimeglumine 469 mg/Ml

solution for injection

intravenous use

Germany

Sanochemia Diagnostics Deutschland GmbH

Mr-Lux

Gadopentetate Dimeglumine 469 mg/Ml

solution for injection

intravenous use

Germany

Sanochemia Pharmazeutika AG

Magnetolux

Gadopentetate Dimeglumine 469 mg/Ml

solution for injection

intravenous use

Greece

Bayer Hellas SA

Magnevist

Gadopentetate Dimeglumine 469.01 mg/Ml

solution for injection

intravenous use

Greece

GE Healthcare Ae

Omniscan

Gadodiamide 287 mg/Ml

solution for injection

intravenous use

Greece

Vianex S.A.

Magnetolux

Gadopentetate Dimeglumine 500 μmol/Ml

solution for injection

intravenous use

Hungary

Bayer AG

Magnevist

Gadopentetate Dimeglumine 469.01 mg/Ml

solution for injection

intravenous use

Hungary

GE Healthcare AS

Omniscan

Gadodiamide 14.35 g/50 Ml

solution for injection

intravenous use

Hungary

GE Healthcare AS

Omniscan

Gadodiamide 2.87 g/10 Ml

solution for injection

intravenous use

Hungary

GE Healthcare AS

Omniscan

Gadodiamide 4.31 g/15 Ml

solution for injection

intravenous use

Hungary

GE Healthcare AS

Omniscan

Gadodiamide 5.74 g/20 Ml

solution for injection

intravenous use

Hungary

GE Healthcare AS

Omniscan

Gadodiamide 5.74 mol/15 Ml

solution for injection

intravenous use

Hungary

Sanochemia Pharmazeutika AG

Magnetolux

Gadopentetate Dimeglumine 469 mg/Ml

solution for injection

intravenous use

Iceland

Bayer AB

Magnevist

Gadopentetate Dimeglumine 469.01 mg/Ml

solution for injection

intravenous use

Iceland

GE Healthcare AS

Omniscan

Gadodiamide 287 mg/Ml

solution for injection

intravenous use

Iceland

GE Healthcare AS

Omniscan

Gadodiamide 287 mg/Ml

solution for injection in pre-filled syringe

intravenous use

Iceland

Mallinckrodt Deutschland GmbH

Optimark

Gadoversetamide 330.9 mg/Ml

solution for injection

intravenous use

Iceland

Mallinckrodt Deutschland GmbH

Optimark

Gadoversetamide 330.9 mg/Ml

solution for injection in pre-filled syringe

intravenous use

Ireland

Bayer Ltd

Magnevist

Gadopentetate Dimeglumine 469.01 mg/Ml

solution for injection

intravenous use

Ireland

GE Healthcare AS

Omniscan

Gadodiamide 287 mg/Ml

solution for injection

intravenous use

Ireland

GE Healthcare AS

Omniscan

Gadodiamide 287 mg/Ml

solution for injection in pre-filled syringe

intravenous use

Italy

Agfa Healthcare Imaging Agents GmbH

Magnegita

Gadopentetate Dimeglumine 469.01 mg/Ml

solution for injection

intravenous use

Italy

Bayer Pharma AG

Magnevist

Gadopentetate Dimeglumine 469 mg/Ml

solution for injection/infusion

intravenous use

Italy

Bayer S.p.A.

Magnograf

Gadopentetate Dimeglumine 469.01 mg/Ml

solution for injection

intravenous use

Italy

Bayer S.p.A.

Magnograf

Gadopentetate Dimeglumine 469 mg/Ml

solution for injection/infusion

intravenous use

Italy

GE Healthcare S.R.L.

Omniscan

Gadodiamide 0.5 mmol/Ml

solution for injection

intravenous use

Italy

Sanochemia Pharmazeutika AG

Magnetolux

Gadopentetate Dimeglumine 469 mg/Ml

solution for injection

intravenous use

Latvia

Agfa Healthcare Imaging Agents GmbH

Magnegita

Gadopentetate Dimeglumine 469.01 mg/Ml

solution for injection

intravenous use

Latvia

Bayer Pharma AG

Magnevist

Gadopentetate Dimeglumine 469.01 mg/Ml

solution for injection

intravenous use

Latvia

GE Healthcare AS

Omniscan

Gadodiamide 287 mg/Ml

solution for injection

intravenous use

Lithuania

Agfa Healthcare Imaging Agents GmbH

Magnegita

Gadopentetate Dimeglumine 469.01 mg/Ml

solution for injection

intravenous use

Lithuania

Agfa Healthcare Imaging Agents GmbH

Magnegita

Gadopentetate Dimeglumine 469 mg/Ml

solution for injection

intravenous use

Lithuania

Agfa Healthcare Imaging Agents GmbH

Magnegita

Gadopentetate Dimeglumine 469.01 mg/Ml

solution for injection/infusion

intravenous use

Lithuania

Bayer Pharma AG

Magnevist

Gadopentetate Dimeglumine 469.01 mg/Ml

solution for injection

intravenous use

Lithuania

GE Healthcare AS

Omniscan

Gadodiamide 287 mg/Ml

solution for injection

intravenous use

Luxembourg

Bayer SA NV

Magnevist

Gadopentetate Dimeglumine 469.01 mg/Ml

solution for injection

intravenous use

Luxembourg

GE Healthcare Bvba

Omniscan

Gadodiamide 287 mg/Ml

solution for injection

intravenous use

Luxembourg

Medithek GmbH

Gadocon

Gadopentetate Dimeglumine 469 mg/Ml

solution for injection

intravenous use

Luxembourg

Medithek GmbH

Gadopent

Gadopentetate Dimeglumine 469 mg/Ml

solution for injection

intravenous use

Luxembourg

Medithek GmbH

Gadothek

Gadopentetate Dimeglumine 469 mg/Ml

solution for injection

intravenous use

Malta

Bayer PLC

Magnevist

Gadopentetate Dimeglumine 469.01 mg/Ml

solution for injection

intravenous use

Malta

GE Healthcare AS

Omniscan

Gadodiamide 287 mg/Ml

solution for injection

intravenous use

Netherlands

GE Healthcare B.V.

Omniscan

Gadodiamide 2.87 g/10 Ml

solution for injection

intravenous use

Netherlands

GE Healthcare B.V.

Omniscan

Gadodiamide 287 mg/Ml

solution for injection

intravenous use

Netherlands

GE Healthcare B.V.

Omniscan

Gadodiamide 4.305 g/15 Ml

solution for injection

intravenous use

Netherlands

GE Healthcare B.V.

Omniscan

Gadodiamide 5.74 g/20 Ml

solution for injection

intravenous use

Norway

Bayer Pharma AG

Magnevist

Gadopentetate Dimeglumine 469.01 mg/Ml

solution for injection

intravenous use

Norway

GE Healthcare AS

Omniscan

Gadodiamide 287 mg/Ml

solution for injection

intravenous use

Norway

Mallinckrodt Deutschland GmbH

Optimark

Gadoversetamide 330.9 mg/Ml

solution for injection

intravenous use

Norway

Mallinckrodt Deutschland GmbH

Optimark

Gadoversetamide 330.9 mg/Ml

solution for injection in pre-filled syringe

intravenous use

Poland

Bayer AG

Magnevist

Gadopentetate Dimeglumine 469.01 mg/Ml

solution for injection

intravenous use

Poland

GE Healthcare AS

Omniscan

Gadodiamide 287 mg/Ml

solution for injection

intravenous use

Portugal

Bayer Portugal SA

Magnevist

Gadopentetate Dimeglumine 469 mg/Ml

solution for injection

intravenous use

Portugal

Satis-Radioisótopos E Protecções Contra Sobretensões Eléctricas Unipessoal, Lda

Omniscan

Gadodiamide 287 mg/Ml

solution for injection

intravenous use

Romania

Agfa Healthcare Imaging Agents GmbH

Magnegita

Gadopentetate Dimeglumine 469.01 mg/Ml

solution for injection/infusion

intravenous use

Romania

Bayer Pharma AG

Magnevist

Gadopentetate Dimeglumine 469.01 mg/Ml

solution for injection

intravenous use

Romania

GE Healthcare AS

Omniscan

Gadodiamide 287 mg/Ml

solution for injection

intravenous use

Romania

Sanochemia Pharmazeutika AG

Magnetolux

Gadopentetate Dimeglumine 469 mg/Ml

solution for injection

intravenous use

Slovakia

Agfa Healthcare Imaging Agents GmbH

Magnegita

Gadopentetate Dimeglumine 469.01 mg/Ml

solution for injection/infusion

intravenous use

Slovakia

GE Healthcare AS

Omniscan

Gadodiamide 287 mg/Ml

solution for injection

intravenous use

Slovakia

Sanochemia Pharmazeutika AG

Magnetolux

Gadopentetate Dimeglumine 469 mg/Ml

solution for injection

intravenous use

Slovenia

Agfa Healthcare Imaging Agents GmbH

Magnegita

Gadopentetate Dimeglumine 469.01 mg/Ml

solution for injection/infusion

intravenous use

Slovenia

Bayer Pharma AG

Magnevist

Gadopentetate Dimeglumine 469 mg/Ml

solution for injection

intravenous use

Slovenia

GE Healthcare AS

Omniscan

Gadodiamide 1.44 g/5 Ml

solution for injection

intravenous use

Slovenia

GE Healthcare AS

Omniscan

Gadodiamide 2.87 g/10 Ml

solution for injection

intravenous use

Slovenia

GE Healthcare AS

Omniscan

Gadodiamide 4.31 g/15 Ml

solution for injection

intravenous use

Slovenia

GE Healthcare AS

Omniscan

Gadodiamide 5.74 g/20 Ml

solution for injection

intravenous use

Spain

Bayer Hispania SL

Magnevist

Gadopentetate Dimeglumine 469.01 mg/Ml

solution for injection

intravenous use

Spain

GE Healthcare Bio-Sciences, S.A.U.

Omniscan

Gadodiamide 287 mg/Ml

solution for injection in pre-filled syringe

intravenous use

Spain

Sanochemia Pharmazeutika AG

Magnetolux

Gadopentetate Dimeglumine 469 mg/Ml

solution for injection

intravenous use

Sweden

Bayer AB

Magnevist

Gadopentetate Dimeglumine 469.01 mg/Ml

solution for injection

intravenous use

Sweden

GE Healthcare AS

Omniscan

Gadodiamide 287 mg/Ml

solution for injection

intravenous use

Sweden

GE Healthcare AS

Omniscan

Gadodiamide 287 mg/Ml

solution for injection in pre-filled syringe

intravenous use

United Kingdom

Agfa Healthcare Imaging Agents GmbH

Magnegita

Gadopentetate Dimeglumine 469.01 mg/Ml

solution for injection

intravenous use

United Kingdom

Bayer PLC

Magnevist

Gadopentetate Dimeglumine 469.01 mg/Ml

solution for injection

intravenous use

United Kingdom

GE Healthcare AS

Omniscan

Gadodiamide 287 mg/Ml

injection

intravenous use

United Kingdom

GE Healthcare AS

Omniscan

Gadodiamide 287 mg/Ml

solution for injection

intravenous use

United Kingdom

Sanochemia Pharmazeutika AG

Magnetolux

Gadopentetate Dimeglumine 469 mg/Ml

solution for injection

intravenous use

---

Corrigenda

| 29.12.2017 | EN | Official Journal of the European Union | C 447/110 |
| --- | --- | --- | --- |

29.12.2017

EN

Official Journal of the European Union

C 447/110

---

Corrigendum to the Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2016 to 31 August 2016 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

(
  Official Journal of the European Union C 362 of 30 September 2016
  )

(2017/C 447/03)

On page 9:

| for: | ‘Withdrawal of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)’, |
| --- | --- |

for:

‘Withdrawal of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)’,

| read: | ‘Suspension of a marketing authorization (Article 45 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)’. |
| --- | --- |

read:

‘Suspension of a marketing authorization (Article 45 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)’.

---