| Nonacog alfa |
EU/1/97/047/005 |
BeneFIX, Solution for injection, 500, IU, Pack: 1 |
Pfizer Limited, Обединено Кралство |
Wyeth Farma S.A. Аutovia del Norte. A-1, Km.23.Desvio Algete, Km. 1, 28700 S. Sebastian de los Reyes, Madrid Испания |
560.11 |
112.02 |
672.13 |
4% |
10.00 |
570.11 |
114.02 |
684.13 |
16% |
25.00 |
595.11 |
119.02 |
714.13 |
|
HCР-19/31.05.2013 |
02.06.2013 |
02.06.2013 |
Неактивен |
1849 |
| Nonacog alfa |
EU/1/97/047/005 |
BeneFIX, Solution for injection, 500, IU, Pack: 1 |
Pfizer Limited, Обединено Кралство |
Wyeth Farma S.A. Аutovia del Norte. A-1, Km.23.Desvio Algete, Km. 1, 28700 S. Sebastian de los Reyes, Madrid Испания |
560.11 |
112.02 |
672.13 |
4% |
10.00 |
570.11 |
114.02 |
684.13 |
16% |
25.00 |
595.11 |
119.02 |
714.13 |
|
HCР-19/31.05.2013 |
02.06.2013 |
02.06.2013 |
Неактивен |
1849 |
| Belimumab |
EU/1/11/700/001 |
Benlysta, Powder for concentrate for solution for infusion, 120, mg, Pack: 1 |
Glaxo Group Ltd., Обединено Кралство |
Human Genome Sciences, Inc. Belward Large Scale Manufacturing (LSM) Facility 9911 Belward Campus Drive Rockville, MD 20850 USA; GlaxoSmithKline Manufacturing S.P.A Strada Provinciale Asolana No. 90 I-43056 San Polo di Torrile, Parma, Italy |
249.90 |
49.98 |
299.88 |
4% |
10.00 |
259.90 |
51.98 |
311.88 |
16% |
25.00 |
284.90 |
56.98 |
341.88 |
|
НСР-6835/30.07.2015.; НСР-9123/27.04.2016; НСР-15081/23.02.2018; НСР-17250/14.11.2018 |
29.11.2018 |
02.12.2018 |
Активен |
3431 |
| Belimumab |
EU/1/11/700/001 |
Benlysta, Powder for concentrate for solution for infusion, 120, mg, Pack: 1 |
Glaxo Group Ltd., Обединено Кралство |
Human Genome Sciences, Inc. Belward Large Scale Manufacturing (LSM) Facility 9911 Belward Campus Drive Rockville, MD 20850 USA; GlaxoSmithKline Manufacturing S.P.A Strada Provinciale Asolana No. 90 I-43056 San Polo di Torrile, Parma, Italy |
252.52 |
50.50 |
303.02 |
4% |
10.00 |
262.52 |
52.50 |
315.02 |
16% |
25.00 |
287.52 |
57.50 |
345.02 |
|
НСР-6835/30.07.2015.; НСР-9123/27.04.2016; НСР-15081/23.02.2018 |
10.03.2018 |
02.04.2018 |
Неактивен |
3431 |
| Belimumab |
EU/1/11/700/002 |
Benlysta, Powder for concentrate for solution for infusion, 400, mg, Pack: 1 |
Glaxo Group Ltd., Обединено Кралство |
Human Genome Sciences, Inc. Belward Large Scale Manufacturing (LSM) Facility 9911 Belward Campus Drive Rockville, MD 20850 USA; GlaxoSmithKline Manufacturing S.P.A Strada Provinciale Asolana No. 90 I-43056 San Polo di Torrile, Parma, Italy |
837.23 |
167.45 |
1004.68 |
4% |
10.00 |
847.23 |
169.45 |
1016.68 |
16% |
25.00 |
872.23 |
174.45 |
1046.68 |
|
НСР-5210/04.12.2014; НСР-9909/29.07.2016; НСР-14469/17.11.2017; НСР-16689/30.08.2018 |
14.09.2018 |
02.10.2018 |
Активен |
3432 |
| Belimumab |
EU/1/11/700/002 |
Benlysta, Powder for concentrate for solution for infusion, 400, mg, Pack: 1 |
Glaxo Group Ltd., Обединено Кралство |
Human Genome Sciences, Inc. Belward Large Scale Manufacturing (LSM) Facility 9911 Belward Campus Drive Rockville, MD 20850 USA; GlaxoSmithKline Manufacturing S.P.A Strada Provinciale Asolana No. 90 I-43056 San Polo di Torrile, Parma, Italy |
841.79 |
168.36 |
1010.15 |
4% |
10.00 |
851.79 |
170.36 |
1022.15 |
16% |
25.00 |
876.79 |
175.36 |
1052.15 |
|
НСР-5210/04.12.2014; НСР-9909/29.07.2016; НСР-14469/17.11.2017 |
02.12.2017 |
02.01.2018 |
Неактивен |
3432 |
| Belimumab |
EU/1/11/700/001 |
Benlysta, Powder for concentrate for solution for infusion, 120, mg, Pack: 1 |
Glaxo Group Ltd., Обединено Кралство |
Human Genome Sciences, Inc. Belward Large Scale Manufacturing (LSM) Facility 9911 Belward Campus Drive Rockville, MD 20850 USA; GlaxoSmithKline Manufacturing S.P.A Strada Provinciale Asolana No. 90 I-43056 San Polo di Torrile, Parma, Italy |
254.22 |
50.84 |
305.06 |
4% |
10.00 |
264.22 |
52.84 |
317.06 |
16% |
25.00 |
289.22 |
57.84 |
347.06 |
|
НСР-6835/30.07.2015.; НСР-9123/27.04.2016 |
13.05.2016 |
02.06.2016 |
Неактивен |
3431 |
| Belimumab |
EU/1/11/700/002 |
Benlysta, Powder for concentrate for solution for infusion, 400, mg, Pack: 1 |
Glaxo Group Ltd., Обединено Кралство |
Human Genome Sciences, Inc. Belward Large Scale Manufacturing (LSM) Facility 9911 Belward Campus Drive Rockville, MD 20850 USA; GlaxoSmithKline Manufacturing S.P.A Strada Provinciale Asolana No. 90 I-43056 San Polo di Torrile, Parma, Italy |
847.48 |
169.50 |
1016.98 |
4% |
10.00 |
857.48 |
171.50 |
1028.98 |
16% |
25.00 |
882.48 |
176.50 |
1058.98 |
|
НСР-5210/04.12.2014; НСР-9909/29.07.2016 |
16.08.2016 |
02.09.2016 |
Неактивен |
3432 |
| Belimumab |
EU/1/11/700/002 |
Benlysta, Powder for concentrate for solution for infusion, 400, mg, Pack: 1 |
Glaxo Group Ltd., Обединено Кралство |
Human Genome Sciences, Inc. Belward Large Scale Manufacturing (LSM) Facility 9911 Belward Campus Drive Rockville, MD 20850 USA; GlaxoSmithKline Manufacturing S.P.A Strada Provinciale Asolana No. 90 I-43056 San Polo di Torrile, Parma, Italy |
848.83 |
169.77 |
1018.60 |
4% |
10.00 |
858.83 |
171.77 |
1030.60 |
16% |
25.00 |
883.83 |
176.77 |
1060.60 |
|
НСР-5210/04.12.2014 |
19.12.2014 |
19.12.2014 |
Неактивен |
3432 |
| Belimumab |
EU/1/11/700/001 |
Benlysta, Powder for concentrate for solution for infusion, 120, mg, Pack: 1 |
Glaxo Group Ltd., Обединено Кралство |
Human Genome Sciences, Inc. Belward Large Scale Manufacturing (LSM) Facility 9911 Belward Campus Drive Rockville, MD 20850 USA; GlaxoSmithKline Manufacturing S.P.A Strada Provinciale Asolana No. 90 I-43056 San Polo di Torrile, Parma, Italy |
254.63 |
50.93 |
305.56 |
4% |
10.00 |
264.63 |
52.93 |
317.56 |
16% |
25.00 |
289.63 |
57.93 |
347.56 |
|
НСР-6835/30.07.2015. |
14.08.2015 |
14.08.2015 |
Неактивен |
3431 |
| Belimumab |
EU/1/11/700/001 |
Benlysta, Powder for concentrate for solution for infusion, 120, mg, Pack: 1 |
Glaxo Group Ltd., Обединено Кралство |
Human Genome Sciences, Inc. Belward Large Scale Manufacturing (LSM) Facility 9911 Belward Campus Drive Rockville, MD 20850 USA; GlaxoSmithKline Manufacturing S.P.A Strada Provinciale Asolana No. 90 I-43056 San Polo di Torrile, Parma, Italy |
254.65 |
50.93 |
305.58 |
4% |
10.00 |
264.65 |
52.93 |
317.58 |
16% |
25.00 |
289.65 |
57.93 |
347.58 |
|
НСР-5211/04.12.2014 |
19.12.2014 |
19.12.2014 |
Неактивен |
3431 |
| Belimumab |
EU/1/11/700/001 |
Benlysta, Powder for concentrate for solution for infusion, 120, mg, Pack: 1 |
Glaxo Group Ltd., Обединено Кралство |
Human Genome Sciences, Inc. Belward Large Scale Manufacturing (LSM) Facility 9911 Belward Campus Drive Rockville, MD 20850 USA; GlaxoSmithKline Manufacturing S.P.A Strada Provinciale Asolana No. 90 I-43056 San Polo di Torrile, Parma, Italy |
276.77 |
55.35 |
332.12 |
4% |
10.00 |
286.77 |
57.35 |
344.12 |
16% |
25.00 |
311.77 |
62.35 |
374.12 |
|
НСР-3112/26.03.2014 |
10.04.2014 |
10.04.2014 |
Неактивен |
3431 |
| Belimumab |
EU/1/11/700/002 |
Benlysta, Powder for concentrate for solution for infusion, 400, mg, Pack: 1 |
Glaxo Group Ltd., Обединено Кралство |
Human Genome Sciences, Inc. Belward Large Scale Manufacturing (LSM) Facility 9911 Belward Campus Drive Rockville, MD 20850 USA; GlaxoSmithKline Manufacturing S.P.A Strada Provinciale Asolana No. 90 I-43056 San Polo di Torrile, Parma, Italy |
925.40 |
185.08 |
1110.48 |
4% |
10.00 |
935.40 |
187.08 |
1122.48 |
16% |
25.00 |
960.40 |
192.08 |
1152.48 |
|
НСР-3118/26.03.2014 |
10.04.2014 |
10.04.2014 |
Неактивен |
3432 |
| Belimumab |
EU/1/11/700/001 |
Benlysta, Powder for concentrate for solution for infusion, 120, mg, Pack: 1 |
Glaxo Group Ltd., Обединено Кралство |
Human Genome Sciences, Inc. Belward Large Scale Manufacturing (LSM) Facility 9911 Belward Campus Drive Rockville, MD 20850 USA; GlaxoSmithKline Manufacturing S.P.A Strada Provinciale Asolana No. 90 I-43056 San Polo di Torrile, Parma, Italy |
285.16 |
57.03 |
342.19 |
4% |
10.00 |
295.16 |
59.03 |
354.19 |
16% |
25.00 |
320.16 |
64.03 |
384.19 |
|
НСР-491/11.07.2013 |
31.07.2013 |
31.07.2013 |
Неактивен |
3431 |
| Belimumab |
EU/1/11/700/002 |
Benlysta, Powder for concentrate for solution for infusion, 400, mg, Pack: 1 |
Glaxo Group Ltd., Обединено Кралство |
Human Genome Sciences, Inc. Belward Large Scale Manufacturing (LSM) Facility 9911 Belward Campus Drive Rockville, MD 20850 USA; GlaxoSmithKline Manufacturing S.P.A Strada Provinciale Asolana No. 90 I-43056 San Polo di Torrile, Parma, Italy |
950.53 |
190.11 |
1140.64 |
4% |
10.00 |
960.53 |
192.11 |
1152.64 |
16% |
25.00 |
985.53 |
197.11 |
1182.64 |
|
НСР-491/11.07.2013 |
31.07.2013 |
31.07.2013 |
Неактивен |
3432 |
| Human coagulation factor VIII |
20150023 |
Beriate, Powder and solvent for solution for injection/infusion, 1000, IU, Pack: 1 |
CSL Behring GmbH, Германия |
CSL Behring GmbH, Германия |
744.45 |
148.89 |
893.34 |
4% |
10.00 |
754.45 |
150.89 |
905.34 |
16% |
25.00 |
779.45 |
155.89 |
935.34 |
Промяна на обстоятелствата НСР-16626/24.08.2018 |
НСР-6760/23.07.2015 |
08.08.2015 |
02.10.2018 |
Активен |
4047 |
| Human coagulation factor VIII |
II-28288/30.01.2015 |
Beriate, Powder and solvent for solution for injection/infusion, 1000, IU, Pack: 1 |
CSL Behring GmbH, Германия |
CSL Behring GmbH, Германия |
744.45 |
148.89 |
893.34 |
4% |
10.00 |
754.45 |
150.89 |
905.34 |
16% |
25.00 |
779.45 |
155.89 |
935.34 |
|
НСР-6760/23.07.2015 |
08.08.2015 |
08.08.2015 |
Неактивен |
4047 |
| Human coagulation factor VIII |
20150021 |
Beriate, Powder and solvent for solution for injection/infusion, 250, IU, Pack: 1 |
CSL Behring GmbH, Германия |
CSL Behring GmbH, Германия |
189.68 |
37.94 |
227.62 |
4% |
7.59 |
197.27 |
39.45 |
236.72 |
16% |
25.00 |
222.27 |
44.45 |
266.72 |
Промяна на обстоятелствата НСР-16624/24.08.2018 |
НСР-6760/23.07.2015 |
08.08.2015 |
02.10.2018 |
Активен |
4045 |
| Human coagulation factor VIII |
II-28286/30.01.2015 |
Beriate, Powder and solvent for solution for injection/infusion, 250, IU, Pack: 1 |
CSL Behring GmbH, Германия |
CSL Behring GmbH, Германия |
189.68 |
37.94 |
227.62 |
4% |
7.59 |
197.27 |
39.45 |
236.72 |
16% |
25.00 |
222.27 |
44.45 |
266.72 |
|
НСР-6760/23.07.2015 |
08.08.2015 |
08.08.2015 |
Неактивен |
4045 |
| Human coagulation factor VIII |
20150022 |
Beriate, Powder and solvent for solution for injection/infusion, 500, IU, Pack: 1 |
CSL Behring GmbH, Германия |
CSL Behring GmbH, Германия |
340.31 |
68.06 |
408.37 |
4% |
10.00 |
350.31 |
70.06 |
420.37 |
16% |
25.00 |
375.31 |
75.06 |
450.37 |
Промяна на обстоятелствата НСР-16625/24.08.2018 |
НСР-6760/23.07.2015 |
08.08.2015 |
02.10.2018 |
Активен |
4046 |
| Human coagulation factor VIII |
II-28287/30.01.2015 |
Beriate, Powder and solvent for solution for injection/infusion, 500, IU, Pack: 1 |
CSL Behring GmbH, Германия |
CSL Behring GmbH, Германия |
340.31 |
68.06 |
408.37 |
4% |
10.00 |
350.31 |
70.06 |
420.37 |
16% |
25.00 |
375.31 |
75.06 |
450.37 |
|
НСР-6760/23.07.2015 |
08.08.2015 |
08.08.2015 |
Неактивен |
4046 |
| Human coagulation factor VIII |
II-28288/30.01.2015 |
Beriate, Powder and solvent for solution for injection/infusion, 1000, IU, Pack: 1 |
CSL Behring GmbH, Германия |
CSL Behring GmbH, Германия |
744.45 |
148.89 |
893.34 |
4% |
10.00 |
754.45 |
150.89 |
905.34 |
16% |
25.00 |
779.45 |
155.89 |
935.34 |
|
НСР-6760/23.07.2015 |
08.08.2015 |
08.08.2015 |
Неактивен |
4047 |
| Human coagulation factor VIII |
II-28287/30.01.2015 |
Beriate, Powder and solvent for solution for injection/infusion, 500, IU, Pack: 1 |
CSL Behring GmbH, Германия |
CSL Behring GmbH, Германия |
340.31 |
68.06 |
408.37 |
4% |
10.00 |
350.31 |
70.06 |
420.37 |
16% |
25.00 |
375.31 |
75.06 |
450.37 |
|
НСР-6760/23.07.2015 |
08.08.2015 |
08.08.2015 |
Неактивен |
4046 |
| Human coagulation factor VIII |
II-28286/30.01.2015 |
Beriate, Powder and solvent for solution for injection/infusion, 250, IU, Pack: 1 |
CSL Behring GmbH, Германия |
CSL Behring GmbH, Германия |
189.68 |
37.94 |
227.62 |
4% |
7.59 |
197.27 |
39.45 |
236.72 |
16% |
25.00 |
222.27 |
44.45 |
266.72 |
|
НСР-6760/23.07.2015 |
08.08.2015 |
08.08.2015 |
Неактивен |
4045 |
| c1-inhibitor, plasma derived |
20080293 |
Berinert 500 IU, Powder and solvent for solution for injection/infusion, 500 IU, IU, Pack: 1 vial |
CSL Behring GmbH, Германия |
CSL Behring GmbH, E-mail-von-Behring-Str. 76,35041 Marburg, Германия |
885.40 |
177.08 |
1062.48 |
4% |
10.00 |
895.40 |
179.08 |
1074.48 |
16% |
25.00 |
920.40 |
184.08 |
1104.48 |
|
HCР-22/31.05.2013; НСР-15137/02.03.2018 |
17.03.2018 |
02.04.2018 |
Активен |
1848 |