| B02BD02 |
Coagulation factor VIII (Moroctocog alfa) |
ReFacto AF |
Powder and solvent for solution for injection |
250 |
IU |
1 |
Pfizer Limited, Обединено Кралство |
500 |
IU |
348.11 |
- |
674.82501 |
337.41 |
100% |
337.41 |
За експертиза по чл.78 т.2 от ЗЗО |
D66 |
№ 180/ 27.07.2011.; КЦРР-1462/02.10.2012; НСР-3155/26.03.2014 |
16.04.2014 |
08.09.2012 |
|
Заличен |
1013 |
| B02BD02 |
-3 |
B02BD02 Coagulation factor VIII (efmoroctocog alfa, rurioctocog alfa pegol) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| B02BD02 |
Coagulation factor VIII (rurioctocog alfa pegol) |
Adynovi |
Powder and solvent for injection |
500 |
IU |
1 vial + 1 vial (solvent 2 ml), preassembled whit reconstitution device |
Baxalta Innovations GmbH, Австрия |
500 |
IU |
977.58 |
- |
762.42667 |
762.43 |
100% |
762.43 |
за експертиза по чл.78 т.2 от ЗЗО |
D66 |
НСР-17647/21.12.2018 предварително изпълнение |
02.01.2019 |
|
|
Активен |
16387 |
| B02BD02 |
Coagulation factor VIII (rurioctocog alfa pegol) |
Adynovi |
Powder and solvent for injection |
1000 |
IU |
1 vial + 1 vial (solvent 2 ml), preassembled whit reconstitution device |
Baxalta Innovations GmbH, Австрия |
500 |
IU |
1943.16 |
- |
762.42667 |
1524.85 |
100% |
1524.85 |
за експертиза по чл.78 т.2 от ЗЗО |
D66 |
НСР-17647/21.12.2018 предварително изпълнение |
02.01.2019 |
|
|
Активен |
16388 |
| 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 |
1532.86 |
- |
762.42667 |
1524.85 |
100% |
1524.85 |
За експертиза по чл.78, т.2 от ЗЗО |
D66 |
НСР-12362/18.04.2017; НСР-15073/23.02.2018 |
02.04.2018 |
|
|
Активен |
15668 |
| B02BD02 |
coagulation factor VIII (efmoroctocog alfa) |
Elocta |
Powder and solvent for solution for injection |
250 |
IU |
1 vial (powder)+1 pre-filled syringe (solvent) |
Swedish Orphan Biovitrum AB, Швеция |
500 |
IU |
392.21 |
- |
762.42667 |
381.21 |
100% |
381.21 |
За експертиза по чл.78, т.2 от ЗЗО |
D66 |
НСР-12362/18.04.2017; НСР-15072/23.02.2018 |
02.04.2018 |
|
|
Активен |
15666 |
| 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 |
772.43 |
- |
762.42667 |
762.43 |
100% |
762.43 |
За експертиза по чл.78, т.2 от ЗЗО |
D66 |
НСР-12362/18.04.2017; НСР-13653/01.09.2017 |
02.04.2018 |
|
|
Активен |
15667 |
| 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 |
4574.56 |
- |
762.42667 |
4574.56 |
100% |
4574.56 |
за експертиза по чл.78, т.2 от ЗЗО |
D66 |
НСР-15271/16.03.2018 Предварително изпълнение |
02.04.2018 |
|
|
Активен |
16051 |
| 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 |
3053.71 |
- |
762.42667 |
3049.71 |
100% |
3049.71 |
за експертиза по чл.78, т.2 от ЗЗО |
D66 |
НСР-15271/16.03.2018 Предварително изпълнение |
02.04.2018 |
|
|
Активен |
16050 |
| 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 |
2293.28 |
- |
762.42667 |
2287.28 |
100% |
2287.28 |
за експертиза по чл.78, т.2 от ЗЗО |
D66 |
НСР-15271/16.03.2018 Предварително изпълнение |
02.04.2018 |
|
|
Активен |
16049 |
| 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 |
762.31 |
- |
15246.2 |
762.31 |
100% |
762.31 |
За експертиза по чл.78 т.2 от ЗЗО |
D66 |
НСР-13563/25.08.2017; НСР-15794/04.06.2018 (предварително изпълнение) |
02.07.2018 |
|
|
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% |
762.31 |
За експертиза по чл.78 т.2 от ЗЗО |
D66 |
№ 43/ 07.01.2010; № 140/ 24.01.2011; 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% |
405.7 |
За експертиза по чл.78 т.2 от ЗЗО |
D67 |
№ 140/ 24.01.2011; 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% |
486.84 |
За експертиза по чл.78 т.2 от ЗЗО |
D67 |
№ 43/ 07.01.2010; № 140/ 24.01.2011КЦРР-211/27.02.2012; 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 |
IMMUNINE |
Powder and solvent for solution for injection/infusion |
1200 |
IU |
1 |
Baxter AG, Австрия |
350 |
IU |
879.9 |
- |
221.1049 |
758.39 |
100% |
758.39 |
За експертиза по чл.78 т.2 от ЗЗО |
D67 |
№ 43/ 07.01.2010; № 140/ 24.01.2011; КЦРР-211/27.02.2012; НСР-2007/11.12.2013 |
16.01.2014 |
08.09.2012 |
16.11.2013 |
Заличен |
1148 |
| 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% |
632.36 |
За експертиза по чл.78 т.2 от ЗЗО |
D67 |
№ 43/ 07.01.2010; № 140/ 24.01.2011; 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% |
405.7 |
За експертиза по чл.78 т.2 от ЗЗО |
D67 |
№ 43/07.01.2010; № 140/ 24.01.2011; 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 |
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 |
1138.56 |
- |
2.25712 |
1128.56 |
100% |
1128.56 |
За експертиза по чл.78 т.2 от ЗЗО |
D67 |
НСР-14169/13.10.2017; КП-31/06.03.2019 и НСР-17515/13.12.2018 |
02.04.2019 |
|
|
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 |
575.28 |
- |
2.25712 |
564.28 |
100% |
564.28 |
За експертиза по чл.78 т.2 от ЗЗО |
D67 |
НСР-14169/13.10.2017; КП-31/06.03.2019 и НСР-17527/13.12.2018 |
02.04.2019 |
|
|
Активен |
15904 |
| 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 |
4518.23 |
- |
2.25712 |
4514.24 |
100% |
4514.24 |
За експертиза по чл.78 т.2 от ЗЗО |
D67 |
НСР-14169/13.10.2017; КП-31/06.03.2019 и НСР-17526/13.12.2018 |
02.04.2019 |
|
|
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 |
2265.12 |
- |
2.25712 |
2257.12 |
100% |
2257.12 |
За експертиза по чл.78 т.2 от ЗЗО |
D67 |
НСР-14169/13.10.2017; КП-31/06.03.2019 и НСР-17525/13.12.2018 |
02.04.2019 |
|
|
Активен |
15906 |
| 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 |
6771.35 |
- |
2.25712 |
6771.35 |
100% |
6771.35 |
За експертиза по чл.78 т.2 от ЗЗО |
D67 |
НСР-14169/13.10.2017; КП-31/06.03.2019 и НСР-17528/13.12.2018 |
02.04.2019 |
|
|
Активен |
15908 |