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)
Date: 2017-12-29
Institutions: European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, medicinal product








C_2017447EN.01001101.xml










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




—   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






(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







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





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