| B02BD02 |
coagulation factor VIII (efmoroctocog alfa) |
Elocta |
Powder and solvent for solution for injection |
1000 |
IU |
1 vial (powder)+1 pre-filled syringe (solvent) |
Swedish Orphan Biovitrum AB, Швеция |
500 |
IU |
1481.74 |
736.87167 |
1473.74 |
100% |
|
Съгласно РУ |
НСР-12362/18.04.2017; НСР-15073/23.02.2018; КП-54/19.06.2019 и НСР-17247/14.11.2018 |
02.08.2019 |
|
Активен |
15668 |
| B02BD02 |
coagulation factor VIII (efmoroctocog alfa) |
Elocta |
Powder and solvent for solution for injection |
500 |
IU |
1 vial (powder)+ 1 pre-filled syringe (solvent) |
Swedish Orphan Biovitrum AB, Швеция |
500 |
IU |
746.87 |
736.87167 |
736.87 |
100% |
|
Съгласно РУ |
НСР-12362/18.04.2017; НСР-13653/01.09.2017; КП-55/19.06.2019 и НСР-17248/14.11.2018 |
02.08.2019 |
|
Активен |
15667 |
| B02BD02 |
coagulation factor VIII (efmoroctocog alfa) |
Elocta |
Powder and solvent for solution for injection |
1500 |
IU |
1 vial (powder) +1 pre-filled syringe (solvent) |
Swedish Orphan Biovitrum AB, Швеция |
500 |
IU |
2216.6 |
736.87167 |
2210.62 |
100% |
|
Съгласно РУ |
НСР-15271/16.03.2018 Предварително изпълнение; КП-53/19.06.2019 и НСР-17246/14.11.2018 |
02.08.2019 |
|
Активен |
16049 |
| B02BD02 |
coagulation factor VIII (efmoroctocog alfa) |
Elocta |
Powder and solvent for solution for injection |
2000 |
IU |
1 vial (powder) +1 pre-filled syringe (solvent) |
Swedish Orphan Biovitrum AB, Швеция |
500 |
IU |
2951.47 |
736.87167 |
2947.49 |
100% |
|
Съгласно РУ |
НСР-15271/16.03.2018 Предварително изпълнение; КП-52/19.06.2019 и НСР-17245/14.11.2018 |
02.08.2019 |
|
Активен |
16050 |
| B02BD02 |
coagulation factor VIII (efmoroctocog alfa) |
Elocta |
Powder and solvent for solution for injection |
3000 |
IU |
1 vial (powder) +1 pre-filled syringe (solvent) |
Swedish Orphan Biovitrum AB, Швеция |
500 |
IU |
4421.23 |
736.87167 |
4421.23 |
100% |
|
Съгласно РУ |
НСР-15271/16.03.2018 Предварително изпълнение |
02.08.2019 |
|
Активен |
16051 |
| B02BD02 |
Coagulation factor VIII (Damoctocog alfa pegol) |
Jivi |
Powder and solvent for solution for injection |
500 |
IU |
1 vial with powder + 1 pre-filled syringe with 2.5 ml solvent + 1 syringe plunger rod + 1 vial adapter + 1 venipuncture set |
Bayer AG, Германия |
500 |
IU |
927.32 |
736.87167 |
736.87 |
100% |
|
Съгласно РУ |
НСР-19863/27.09.2019 |
02.11.2019 |
|
Активен |
16728 |
| B02BD02 |
Coagulation factor VIII (Damoctocog alfa pegol) |
Jivi |
Powder and solvent for solution for injection |
1000 |
IU |
1 vial with powder + 1 pre-filled syringe with 2.5 ml solvent + 1 syringe plunger rod + 1 vial adapter + 1 venipuncture set |
Bayer AG, Германия |
500 |
IU |
1842.66 |
736.87167 |
1473.74 |
100% |
|
Съгласно РУ |
НСР-19863/27.09.2019 |
02.11.2019 |
|
Активен |
16729 |
| B02BD03 |
coagulation factor, Factor VIII inhibitor bypassing activity |
B02BD03 coagulation factor, Factor VIII inhibitor bypassing activity |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| 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 |
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 |
6753.52 |
2.25117 |
6753.52 |
100% |
|
Съгласно РУ |
НСР-14169/13.10.2017; КП-31/06.03.2019 и НСР-17528/13.12.2018; НСР-20369/12.12.2019 |
02.01.2020 |
|
Активен |
15908 |
| 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 |
4506.34 |
2.25117 |
4502.34 |
100% |
|
Съгласно РУ |
НСР-14169/13.10.2017; КП-31/06.03.2019 и НСР-17526/13.12.2018; НСР-20370/12.12.2019 |
02.01.2020 |
|
Активен |
15907 |
| 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 |
2259.18 |
2.25117 |
2251.17 |
100% |
|
Съгласно РУ |
НСР-14169/13.10.2017; КП-31/06.03.2019 и НСР-17525/13.12.2018; НСР-20371/12.12.2019 |
02.01.2020 |
|
Активен |
15906 |
| 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 |
1135.57 |
2.25117 |
1125.59 |
100% |
|
Съгласно РУ |
НСР-14169/13.10.2017; КП-31/06.03.2019 и НСР-17515/13.12.2018; НСР-20372/12.12.2019 |
02.01.2020 |
|
Активен |
15905 |
| 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 |
573.8 |
2.25117 |
562.79 |
100% |
|
Съгласно РУ |
НСР-14169/13.10.2017; КП-31/06.03.2019 и НСР-17527/13.12.2018; НСР-20373/12.12.2019 |
02.01.2020 |
|
Активен |
15904 |
| 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 |
560.38 |
504.84685 |
560.38 |
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 |
02.07.2019 |
|
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 |