| coagulation factor VIII (efmoroctocog alfa) |
EU/1/15/1046/004 |
Elocta, Powder and solvent for solution for injection, 1000, IU, Pack: 1 vial (powder)+1 pre-filled syringe (solvent) |
Swedish Orphan Biovitrum AB, Швеция |
Swedish Orphan Biovitrum AB (publ), Швеция |
1408.2 |
281.64 |
1689.84 |
4% |
10 |
1418.2 |
283.64 |
1701.84 |
16% |
25 |
1443.2 |
288.64 |
1731.84 |
|
НСР-12362/18.04.2017 |
03.05.2017 |
02.06.2017 |
Неактивен |
15668 |
| coagulation factor VIII (efmoroctocog alfa) |
EU/1/15/1046/002 |
Elocta, Powder and solvent for solution for injection, 500, IU, Pack: 1 vial (powder)+ 1 pre-filled syringe (solvent) |
Swedish Orphan Biovitrum AB, Швеция |
Swedish Orphan Biovitrum AB (publ), Швеция |
612.39 |
122.48 |
734.87 |
4% |
10 |
622.39 |
124.48 |
746.87 |
16% |
25 |
647.39 |
129.48 |
776.87 |
НСР-18707/20.05.2019 и КП-86/14.11.2019 |
НСР-12362/18.04.2017; НСР-13653/01.09.2017; КП-55/19.06.2019 и НСР-17248/14.11.2018 |
02.08.2019 |
02.01.2020 |
Активен |
15667 |
| coagulation factor VIII (efmoroctocog alfa) |
EU/1/15/1046/002 |
Elocta, Powder and solvent for solution for injection, 500, IU, Pack: 1 vial (powder)+ 1 pre-filled syringe (solvent) |
Swedish Orphan Biovitrum AB, Швеция |
Swedish Orphan Biovitrum AB (publ), Швеция |
612.39 |
122.48 |
734.87 |
4% |
10 |
622.39 |
124.48 |
746.87 |
16% |
25 |
647.39 |
129.48 |
776.87 |
|
НСР-12362/18.04.2017; НСР-13653/01.09.2017; КП-55/19.06.2019 и НСР-17248/14.11.2018 |
02.08.2019 |
02.08.2019 |
Неактивен |
15667 |
| coagulation factor VIII (efmoroctocog alfa) |
EU/1/15/1046/002 |
Elocta, Powder and solvent for solution for injection, 500, IU, Pack: 1 vial (powder)+ 1 pre-filled syringe (solvent) |
Swedish Orphan Biovitrum AB, Швеция |
Swedish Orphan Biovitrum AB (publ), Швеция |
612.39 |
122.48 |
734.87 |
4% |
10 |
622.39 |
124.48 |
746.87 |
16% |
25 |
647.39 |
129.48 |
776.87 |
|
НСР-12362/18.04.2017; НСР-13653/01.09.2017; КП-55/19.06.2019 и НСР-17248/14.11.2018 |
02.08.2019 |
02.08.2019 |
Неактивен |
15667 |
| coagulation factor VIII (efmoroctocog alfa) |
EU/1/15/1046/002 |
Elocta, Powder and solvent for solution for injection, 500, IU, Pack: 1 vial (powder)+ 1 pre-filled syringe (solvent) |
Swedish Orphan Biovitrum AB, Швеция |
Swedish Orphan Biovitrum AB (publ), Швеция |
633.69 |
126.74 |
760.43 |
4% |
10 |
643.69 |
128.74 |
772.43 |
16% |
25 |
668.69 |
133.74 |
802.43 |
|
НСР-12362/18.04.2017; НСР-13653/01.09.2017 |
16.09.2017 |
02.10.2017 |
Неактивен |
15667 |
| coagulation factor VIII (efmoroctocog alfa) |
EU/1/15/1046/002 |
Elocta, Powder and solvent for solution for injection, 500, IU, Pack: 1 vial (powder)+ 1 pre-filled syringe (solvent) |
Swedish Orphan Biovitrum AB, Швеция |
Swedish Orphan Biovitrum AB (publ), Швеция |
704.1 |
140.82 |
844.92 |
4% |
10 |
714.1 |
142.82 |
856.92 |
16% |
25 |
739.1 |
147.82 |
886.92 |
|
НСР-12362/18.04.2017 |
02.06.2017 |
02.06.2017 |
Неактивен |
15667 |
| coagulation factor VIII (efmoroctocog alfa) |
EU/1/15/1046/005 |
Elocta, Powder and solvent for solution for injection, 1500, IU, Pack: 1 vial (powder) +1 pre-filled syringe (solvent) |
Swedish Orphan Biovitrum AB, Швеция |
Swedish Orphan Biovitrum AB (publ), Швеция |
1837.17 |
367.43 |
2204.6 |
4% |
10 |
1847.17 |
369.43 |
2216.6 |
16% |
25 |
1872.17 |
374.43 |
2246.6 |
НСР-18711/20.05.2019 и КП-86/14.11.2019 |
НСР-15271/16.03.2018 Предварително изпълнение; КП-53/19.06.2019 и НСР-17246/14.11.2018 |
02.08.2019 |
02.01.2020 |
Активен |
16049 |
| coagulation factor VIII (efmoroctocog alfa) |
EU/1/15/1046/005 |
Elocta, Powder and solvent for solution for injection, 1500, IU, Pack: 1 vial (powder) +1 pre-filled syringe (solvent) |
Swedish Orphan Biovitrum AB, Швеция |
Swedish Orphan Biovitrum AB (publ), Швеция |
1837.17 |
367.43 |
2204.6 |
4% |
10 |
1847.17 |
369.43 |
2216.6 |
16% |
25 |
1872.17 |
374.43 |
2246.6 |
|
НСР-15271/16.03.2018 Предварително изпълнение; КП-53/19.06.2019 и НСР-17246/14.11.2018 |
02.08.2019 |
02.08.2019 |
Неактивен |
16049 |
| coagulation factor VIII (efmoroctocog alfa) |
EU/1/15/1046/006 |
Elocta, Powder and solvent for solution for injection, 2000, IU, Pack: 1 vial (powder) +1 pre-filled syringe (solvent) |
Swedish Orphan Biovitrum AB, Швеция |
Swedish Orphan Biovitrum AB (publ), Швеция |
2449.56 |
489.91 |
2939.47 |
4% |
10 |
2459.56 |
491.91 |
2951.47 |
16% |
25 |
2484.56 |
496.91 |
2981.47 |
НСР-18713/20.05.2019 и КП-86/14.11.2019 |
НСР-15271/16.03.2018 Предварително изпълнение; КП-52/19.06.2019 и НСР-17245/14.11.2018 |
02.08.2019 |
02.01.2020 |
Активен |
16050 |
| coagulation factor VIII (efmoroctocog alfa) |
EU/1/15/1046/006 |
Elocta, Powder and solvent for solution for injection, 2000, IU, Pack: 1 vial (powder) +1 pre-filled syringe (solvent) |
Swedish Orphan Biovitrum AB, Швеция |
Swedish Orphan Biovitrum AB (publ), Швеция |
2449.56 |
489.91 |
2939.47 |
4% |
10 |
2459.56 |
491.91 |
2951.47 |
16% |
25 |
2484.56 |
496.91 |
2981.47 |
|
НСР-15271/16.03.2018 Предварително изпълнение; КП-52/19.06.2019 и НСР-17245/14.11.2018 |
02.08.2019 |
02.08.2019 |
Неактивен |
16050 |
| coagulation factor VIII (efmoroctocog alfa) |
EU/1/15/1046/007 |
Elocta, Powder and solvent for solution for injection, 3000, IU, Pack: 1 vial (powder) +1 pre-filled syringe (solvent) |
Swedish Orphan Biovitrum AB, Швеция |
Swedish Orphan Biovitrum AB (publ), Швеция |
3674.36 |
734.87 |
4409.23 |
4% |
10 |
3684.36 |
736.87 |
4421.23 |
16% |
25 |
3709.36 |
741.87 |
4451.23 |
НСР-18714/20.05.2019 и КП-86/14.11.2019 |
НСР-15271/16.03.2018 Предварително изпълнение; КП-51/19.06.2019 и НСР-17244/14.11.2018 |
02.08.2019 |
02.01.2020 |
Активен |
16051 |
| coagulation factor VIII (efmoroctocog alfa) |
EU/1/15/1046/007 |
Elocta, Powder and solvent for solution for injection, 3000, IU, Pack: 1 vial (powder) +1 pre-filled syringe (solvent) |
Swedish Orphan Biovitrum AB, Швеция |
Swedish Orphan Biovitrum AB (publ), Швеция |
3674.36 |
734.87 |
4409.23 |
4% |
10 |
3684.36 |
736.87 |
4421.23 |
16% |
25 |
3709.36 |
741.87 |
4451.23 |
|
НСР-15271/16.03.2018 Предварително изпълнение; КП-51/19.06.2019 и НСР-17244/14.11.2018 |
02.08.2019 |
02.08.2019 |
Неактивен |
16051 |
| coagulation factor VIII (efmoroctocog alfa) |
EU/1/15/1046/007 |
Elocta, Powder and solvent for solution for injection, 3000, IU, Pack: 1 vial (powder) +1 pre-filled syringe (solvent) |
Swedish Orphan Biovitrum AB, Швеция |
Swedish Orphan Biovitrum AB (publ), Швеция |
3674.36 |
734.87 |
4409.23 |
4% |
10 |
3684.36 |
736.87 |
4421.23 |
16% |
25 |
3709.36 |
741.87 |
4451.23 |
|
НСР-15271/16.03.2018 Предварително изпълнение; КП-51/19.06.2019 и НСР-17244/14.11.2018 |
02.08.2019 |
02.08.2019 |
Неактивен |
16051 |
| coagulation factor VIII (efmoroctocog alfa) |
EU/1/15/1046/006 |
Elocta, Powder and solvent for solution for injection, 2000, IU, Pack: 1 vial (powder) +1 pre-filled syringe (solvent) |
Swedish Orphan Biovitrum AB, Швеция |
Swedish Orphan Biovitrum AB (publ), Швеция |
2449.56 |
489.91 |
2939.47 |
4% |
10 |
2459.56 |
491.91 |
2951.47 |
16% |
25 |
2484.56 |
496.91 |
2981.47 |
|
НСР-15271/16.03.2018 Предварително изпълнение; КП-52/19.06.2019 и НСР-17245/14.11.2018 |
02.08.2019 |
02.08.2019 |
Неактивен |
16050 |
| coagulation factor VIII (efmoroctocog alfa) |
EU/1/15/1046/005 |
Elocta, Powder and solvent for solution for injection, 1500, IU, Pack: 1 vial (powder) +1 pre-filled syringe (solvent) |
Swedish Orphan Biovitrum AB, Швеция |
Swedish Orphan Biovitrum AB (publ), Швеция |
1837.17 |
367.43 |
2204.6 |
4% |
10 |
1847.17 |
369.43 |
2216.6 |
16% |
25 |
1872.17 |
374.43 |
2246.6 |
|
НСР-15271/16.03.2018 Предварително изпълнение; КП-53/19.06.2019 и НСР-17246/14.11.2018 |
02.08.2019 |
02.08.2019 |
Неактивен |
16049 |
| coagulation factor VIII (efmoroctocog alfa) |
EU/1/15/1046/005 |
Elocta, Powder and solvent for solution for injection, 1500, IU, Pack: 1 vial (powder) +1 pre-filled syringe (solvent) |
Swedish Orphan Biovitrum AB, Швеция |
Swedish Orphan Biovitrum AB (publ), Швеция |
1901.07 |
380.21 |
2281.28 |
4% |
10 |
1911.07 |
382.21 |
2293.28 |
16% |
25 |
1936.07 |
387.21 |
2323.28 |
|
НСР-15271/16.03.2018 Предварително изпълнение |
16.03.2018 |
02.04.2018 |
Неактивен |
16049 |
| coagulation factor VIII (efmoroctocog alfa) |
EU/1/15/1046/007 |
Elocta, Powder and solvent for solution for injection, 3000, IU, Pack: 1 vial (powder) +1 pre-filled syringe (solvent) |
Swedish Orphan Biovitrum AB, Швеция |
Swedish Orphan Biovitrum AB (publ), Швеция |
3802.13 |
760.43 |
4562.56 |
4% |
10 |
3812.13 |
762.43 |
4574.56 |
16% |
25 |
3837.13 |
767.43 |
4604.56 |
|
НСР-15271/16.03.2018 Предварително изпълнение |
16.03.2018 |
02.04.2018 |
Неактивен |
16051 |
| coagulation factor VIII (efmoroctocog alfa) |
EU/1/15/1046/006 |
Elocta, Powder and solvent for solution for injection, 2000, IU, Pack: 1 vial (powder) +1 pre-filled syringe (solvent) |
Swedish Orphan Biovitrum AB, Швеция |
Swedish Orphan Biovitrum AB (publ), Швеция |
2534.76 |
506.95 |
3041.71 |
4% |
10 |
2544.76 |
508.95 |
3053.71 |
16% |
25 |
2569.76 |
513.95 |
3083.71 |
|
НСР-15271/16.03.2018 Предварително изпълнение |
16.03.2018 |
02.04.2018 |
Неактивен |
16050 |
| Corifollitropin alfa |
EU/1/09/609/001 |
Elonva, Solution for injection, 100 µg/0.5ml, -, Pack: 1 pre-filled syringe + 1 needle |
Merck Sharp & Dohme B.V., Нидерландия |
N.V. Organon Kloosterstraat 6 5349 AB Oss The Netherlands; Organon (Ireland) Ltd. Drynam Road, Swords, Co. Dublin Ireland |
750.26 |
150.05 |
900.31 |
4% |
10 |
760.26 |
152.05 |
912.31 |
16% |
25 |
785.26 |
157.05 |
942.31 |
Промяна на обстоятелствата НСР-16938/04.10.2018 |
НСР-7655/01.12.2015. |
16.12.2015 |
02.11.2018 |
Активен |
3731 |
| Corifollitropin alfa |
EU/1/09/609/001 |
Elonva, Solution for injection, 100 µg/0.5ml, -, Pack: 1 pre-filled syringe + 1 needle |
Merck Sharp & Dohme Ltd., Обединено Кралство |
N.V. Organon Kloosterstraat 6 5349 AB Oss The Netherlands; Organon (Ireland) Ltd. Drynam Road, Swords, Co. Dublin Ireland |
750.26 |
150.05 |
900.31 |
4% |
10 |
760.26 |
152.05 |
912.31 |
16% |
25 |
785.26 |
157.05 |
942.31 |
|
НСР-7655/01.12.2015. |
16.12.2015 |
16.12.2015 |
Неактивен |
3731 |
| Corifollitropin alfa |
EU/1/09/609/001 |
Elonva, Solution for injection, 0.1, mg/ 0.5ml, Pack: 1 |
Merck Sharp & Dohme Ltd., Обединено Кралство |
N.V. Organon Kloosterstraat 6 5349 AB Oss The Netherlands; Organon (Ireland) Ltd. Drynam Road, Swords, Co. Dublin Ireland |
753.68 |
150.74 |
904.42 |
4% |
10 |
763.68 |
152.74 |
916.42 |
16% |
25 |
788.68 |
157.74 |
946.42 |
|
НСР-5956/01.04.2015. |
16.04.2015 |
16.04.2015 |
Неактивен |
3731 |
| Corifollitropin alfa |
EU/1/09/609/001 |
Elonva, Solution for injection, 0.1, mg/ 0.5ml, Pack: 1 |
Merck Sharp & Dohme Ltd., Обединено Кралство |
N.V. Organon Kloosterstraat 6 5349 AB Oss The Netherlands; Organon (Ireland) Ltd. Drynam Road, Swords, Co. Dublin Ireland |
769.87 |
153.97 |
923.84 |
4% |
10 |
779.87 |
155.97 |
935.84 |
16% |
25 |
804.87 |
160.97 |
965.84 |
корекц.НСР-4088/03.07.2014; промяна на обстоятелства НСР-4420/07.08.2014( в сила от 25.08.2014) |
НСР-3733/06.06.2014 |
04.07.2014 |
04.07.2014 |
Неактивен |
3731 |
| Corifollitropin alfa |
EU/1/09/609/001 |
Elonva, Solution for injection, 0.1, mg/ 0.5ml, Pack: 1 |
N.V. Organon, Нидерландия |
N.V. Organon Kloosterstraat 6 5349 AB Oss The Netherlands; Organon (Ireland) Ltd. Drynam Road, Swords, Co. Dublin Ireland |
777.54 |
155.51 |
933.05 |
4% |
10 |
787.54 |
157.51 |
945.05 |
16% |
25 |
812.54 |
162.51 |
975.05 |
|
КЦРР-2589/14.03.2013 |
02.04.2013 |
02.04.2013 |
Неактивен |
3731 |
| Corifollitropin alfa |
EU/1/09/609/002/ 25.01.2010 |
Elonva, Solution for injection, 0.15, mg/ 0.5ml, Pack: 1 |
Merck Sharp & Dohme Ltd., Обединено Кралство |
N.V. Organon Netherlands Organon (Ireland) Ltd. Ireland |
970.62 |
194.12 |
1164.74 |
4% |
10 |
980.62 |
196.12 |
1176.74 |
16% |
25 |
1005.62 |
201.12 |
1206.74 |
промяна на обстоятелства НСР-4419/07.08.2014 ( в сила от 25.08.2014) |
КЦРР-2059/24.01.2013 г |
25.02.2013 |
25.02.2013 |
Неактивен |
3715 |
| Corifollitropin alfa |
EU/1/09/609/002/ 25.01.2010 |
Elonva, Solution for injection, 0.15, mg/ 0.5ml, Pack: 1 |
N.V. Organon, Нидерландия |
N.V. Organon Netherlands Organon (Ireland) Ltd. Ireland |
1034.63 |
206.93 |
1241.56 |
4% |
10 |
1044.63 |
208.93 |
1253.56 |
16% |
25 |
1069.63 |
213.93 |
1283.56 |
|
КЦ-2768/28.09.2011 |
13.10.2011 |
13.10.2011 |
Неактивен |
3715 |