| B02BD03 |
factor VIII inhibitor bypassyng activity |
Feiba |
Powder and solvent for solution for infusion |
25 U/ml (500 U) |
|
1 vial 500 U powder for solution for infusion+1 vial 20 ml water for injection+1 administration set |
Baxalta Innovations GmbH, Австрия |
10000 |
IU |
752.57 |
15051.4 |
752.57 |
100% |
|
Съгласно РУ |
НСР-13563/25.08.2017; НСР-15794/04.06.2018 (предварително изпълнение); НСР-19667/29.08.2019 |
02.10.2019 |
|
Активен |
15828 |
| B02BD03 |
factor VIII inhibitor bypassyng activity |
Feiba NF |
Powder and solvent for solution for injection |
500 U |
|
1 pre-filled syringe + powd.vial + solv.vial 20 ml + adm.set |
Baxter AG, Австрия |
10000 |
IU |
762.31 |
15246.2 |
762.31 |
100% |
|
Съгласно РУ |
№ 190/ 22.08.2011; НСР-2195/20.12.2013; НСР-14088/06.10.2017; НСР-15691/17.05.2018; НСР-18079/01.03.2019 |
02.04.2019 |
08.09.2012 |
Заличен |
2439 |
| B02BD04 |
Coagulation factor IX |
B02BD04 Coagulation factor IX |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| B02BD04 |
Coagulation factor IX |
Aimafix |
Powder and solvent for solution for infusion |
500 |
IU |
1 |
Kedrion S.p.A., Италия |
1 |
IU |
421.18 |
0.8114 |
405.7 |
100% |
|
Съгласно РУ |
№ 164/ 20.04.2011; НСР-13031/23.06.2017 предварително изпълнение,КП-34/29.05.2017 и НСР-12077/21.03.2017,Протокол № 230/22.06.2017; НСР-13258/18.07.2017 предварително изпълнение; НСР-17764/17.01.2019; НСР-17765/17.01.2019 |
02.02.2019 |
08.09.2012 |
Активен |
369 |
| B02BD04 |
Coagulation factor IX |
IMMUNINE |
Powder and solvent for solution for injection/infusion |
600 |
IU |
1 |
Baxalta Innovations GmbH, Австрия |
1 |
IU |
486.84 |
0.8114 |
486.84 |
100% |
|
Съгласно РУ |
№ 190/ 22.08.2011; НСР-2198/20.12.2013; НСР-3381/29.04.2014; Протокол № 230/22.06.2017 |
02.02.2019 |
08.09.2012 |
Активен |
2442 |
| B02BD04 |
Coagulation factor IX |
OCTANINE F 1000 |
Powder and solvent for solution for injection |
1000 |
IU |
1 |
Octapharma (IP) Ltd., Обединено Кралство |
350 |
IU |
799.54 |
221.1049 |
632.36 |
100% |
|
Съгласно РУ |
№ 162/ 20.04.2011; НСР-7583/26.11.2015. и КП-10/28.01.2016.; КП-37/29.05.2017 и НСР-12093/21.03.2017 |
02.07.2017 |
08.09.2012 |
Заличен |
766 |
| B02BD04 |
Coagulation factor IX |
OCTANINE F 500 |
Powder and solvent for solution for injection |
500 |
IU |
1 |
Octapharma (IP) SPRL, Белгия |
1 |
IU |
417.84 |
0.8114 |
405.7 |
100% |
|
Съгласно РУ |
№ 162/ 20.04.2011; КП-26/15.02.2016 и НСР-7510/19.11.2015; НСР-13069/29.06.2017,НСР-13089/29.06.2017 предварително изпълнение,КП-39/02.06.2017 и НСР-12093/31.03.2017, Протокол № 230/22.06.2017; НСР-16885/28.09.2018; НСР-17620/20.12.2018 |
02.02.2019 |
08.09.2012 |
Активен |
765 |
| B02BD04 |
Coagulation factor IX |
B02BD04 Coagulation factor IX |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| B02BD04 |
Coagulation factor IX |
Alprolix |
Powder and solvent for solution for injection |
250 |
IU |
1 vial + 1 pre-filled syringe + 1 plunger rod + 1 vial adapter + 1 infusion set + 2 swabs + 2 plasters + 1 gauze |
Swedish Orphan Biovitrum AB, Швеция |
1 |
IU |
560.63 |
2.19854 |
549.64 |
100% |
|
Съгласно РУ |
НСР-14169/13.10.2017; КП-31/06.03.2019 и НСР-17527/13.12.2018; НСР-20373/12.12.2019; НСР-22163/13.08.2020 |
02.09.2020 |
|
Активен |
15904 |
| B02BD04 |
Coagulation factor IX |
Alprolix |
Powder and solvent for solution for injection |
500 |
IU |
1 vial + 1 pre-filled syringe + 1 plunger rod + 1 vial adapter + 1 infusion set + 2 swabs + 2 plasters + 1 gauze |
Swedish Orphan Biovitrum AB, Швеция |
1 |
IU |
1109.27 |
2.19854 |
1099.27 |
100% |
|
Съгласно РУ |
НСР-14169/13.10.2017; КП-31/06.03.2019 и НСР-17515/13.12.2018; НСР-20372/12.12.2019; НСР-22160/13.08.2020 |
02.09.2020 |
|
Активен |
15905 |
| B02BD04 |
Coagulation factor IX |
Alprolix |
Powder and solvent for solution for injection |
1000 |
IU |
1 vial + 1 pre-filled syringe + 1 plunger rod + 1 vial adapter + 1 infusion set + 2 swabs + 2 plasters + 1 gauze |
Swedish Orphan Biovitrum AB, Швеция |
1 |
IU |
2206.54 |
2.19854 |
2198.54 |
100% |
|
Съгласно РУ |
НСР-14169/13.10.2017; КП-31/06.03.2019 и НСР-17525/13.12.2018; НСР-20371/12.12.2019; НСР-22159/13.08.2020 |
02.09.2020 |
|
Активен |
15906 |
| B02BD04 |
Coagulation factor IX |
Alprolix |
Powder and solvent for solution for injection |
2000 |
IU |
1 vial + 1 pre-filled syringe + 1 plunger rod + 1 vial adapter + 1 infusion set + 2 swabs + 2 plasters + 1 gauze |
Swedish Orphan Biovitrum AB, Швеция |
1 |
IU |
4401.07 |
2.19854 |
4397.08 |
100% |
|
Съгласно РУ |
НСР-14169/13.10.2017; КП-31/06.03.2019 и НСР-17526/13.12.2018; НСР-20370/12.12.2019; НСР-22158/13.08.2020 |
02.09.2020 |
|
Активен |
15907 |
| B02BD04 |
Coagulation factor IX |
Alprolix |
Powder and solvent for solution for injection |
3000 |
IU |
1 vial + 1 pre-filled syringe + 1 plunger rod + 1 vial adapter + 1 infusion set + 2 swabs + 2 plasters + 1 gauze |
Swedish Orphan Biovitrum AB, Швеция |
1 |
IU |
6595.61 |
2.19854 |
6595.61 |
100% |
|
Съгласно РУ |
НСР-14169/13.10.2017; КП-31/06.03.2019 и НСР-17528/13.12.2018; НСР-20369/12.12.2019; НСР-22157/13.08.2020 |
02.09.2020 |
|
Активен |
15908 |
| B02BD04 |
Coagulation factor IX (nonacog alfa) |
B02BD04 Coagulation factor IX (nonacog alfa) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| B02BD04 |
Coagulation factor IX (nonacog alfa) |
BeneFIX |
Powder and solvent for solution for injection |
500 |
IU |
1 vial powder + 1 pre-filled syringe solvent 5 ml + 1 injection set |
Pfizer Europe MA EEIG, Белгия |
450 |
IU |
557.14 |
501.92793 |
557.14 |
100% |
|
Съгласно РУ |
HCР-19/31.05.2013 г.; НСР-14847/18.01.2018; НСР-16545/17.08.2018 (предварително изпъленение); НСР-17316/22.11.2018; НСР-18670/20.05.2019; НСР-20840/20.02.2020 |
02.04.2020 |
|
Активен |
1849 |
| B02BD06 |
Coagulation factor VIII, Factor von Willebrand |
B02BD06 Coagulation factor VIII, Factor von Willebrand |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| B02BD06 |
Coagulation factor VIII, Factor von Willebrand |
Wilate 1000 |
Powder and solvent for solution for injection |
1000 |
IU |
1 |
Octapharma (IP) Ltd., Обединено Кралство |
7200 |
IU |
938.96 |
6760.51221 |
938.96 |
100% |
|
Съгласно РУ |
НСР-1794/25.11.2013; НСР-5155/27.11.2014; НСР-6059/16.04.2015. |
16.05.2015 |
|
Заличен |
3419 |
| B02BD06 |
Coagulation factor VIII, Factor von Willebrand |
WILATE 450 powder for solution for injection 450 IU x 1 |
Powder and solvent for solution for injection |
450 |
IU |
1 |
Octapharma (IP) Ltd., Обединено Кралство |
7200 |
IU |
962.53 |
6845.75977 |
427.86 |
100% |
|
Съгласно РУ |
№ 162/ 20.04.2011; НСР-3931/30.06.2014 |
02.08.2014 |
08.09.2012 |
Заличен |
723 |
| B02BD06 |
Coagulation factor VIII, Factor von Willebrand |
Wilate 500 |
Powder and solvent for solution for injection |
500 |
IU |
1 |
Octapharma (IP) SPRL, Белгия |
7200 |
IU |
471.14 |
6730.57143 |
471.14 |
100% |
|
Съгласно РУ |
НСР-1794/25.11.2013; НСР-5154/27.11.2014; КП-394/06.11.2015 и НСР-7055/03.09.2015; НСР-10295/15.09.2016; КП-142/08.11.2017 и НСР-13402/04.08.2017; АССГ № 481/19.01.2018 и НСР-10295/15.09.2016; НСР-17635/20.12.2018 |
02.02.2019 |
|
Активен |
3418 |
| B02BD06 |
Coagulation factor VIII, Factor von Willebrand |
WILATE 900 powder for solution for injection 900 IU x 1 |
Powder and solvent for solution for injection |
900 |
IU |
1 |
Octapharma (IP) Ltd., Обединено Кралство |
7200 |
IU |
856.92 |
6845.75977 |
855.72 |
100% |
|
Съгласно РУ |
№ 162/ 20.04.2011; КЦРР-2256/11.02.2013 и КП-4/05.02.2014; НСР-3931/30.06.2014 |
02.08.2014 |
08.09.2012 |
Заличен |
2556 |
| B02BD08 |
Eptacog alfa (activated) |
B02BD08 Eptacog alfa (activated) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| B02BD08 |
Eptacog alfa (activated) |
NovoSeven |
Powder and solvent for solution for injection |
2 mg (100KIU) |
|
1 vial + 1 vial |
Novo Nordisk A/S, Дания |
2500 |
KIU |
2590.99 |
64774.75 |
2590.99 |
100% |
|
Съгласно РУ |
№ 179/ 22.06.2011; КЦРР-1385/05.09.2012 г.; НСР-515/11.07.2013; НСР-3328/24.04.20124.; НСР-7854/15.01.2016.; НСР-15693/17.05.2018 |
02.06.2018 |
08.09.2012 |
Заличен |
2734 |
| B02BD08 |
Eptacog alfa (activated) |
NovoSeven |
Powder and solvent for solution for injection |
2 mg (100 KIU) |
|
1 vial + 1 syringe + 1 vial adapter |
Novo Nordisk A/S, Дания |
2500 |
KIU |
2369.39 |
59055 |
2362.2 |
100% |
|
Съгласно РУ |
НСР-11317/30.12.2016; НСР-18043/28.02.2019 предварително изпълнение; НСР-19909/03.10.2019 |
02.11.2019 |
|
Активен |
15557 |
| B02BD08 |
Eptacog alfa (activated) |
NovoSeven |
Powder and solvent for solution for injection |
5 mg (250 KIU) |
|
1 vial + 1 syringe + 1 vial adapter |
Novo Nordisk A/S, Дания |
2500 |
KIU |
5905.5 |
59055 |
5905.5 |
100% |
|
Съгласно РУ |
НСР-11317/30.12.2016 г.; НСР-18140/07.03.2019; НСР-19907/03.10.2019 |
02.11.2019 |
|
Активен |
15558 |
| B02BD08 |
Eptacog alfa (activated) |
NovoSeven 2.4 mg |
Powder and solvent for solution for injection |
120 |
KIU |
1 |
Novo Nordisk A/S, Дания |
2500 |
TIU |
3007 |
62645.83203 |
3007 |
100% |
|
Съгласно РУ |
КЦРР-982/16.07.2012 |
14.08.2012 |
08.09.2012 |
Заличен |
676 |