| Coagulation factor IX (nonacog alfa) |
EU/1/97/047/005 |
BeneFIX, Powder and solvent for solution for injection, 500, IU, Pack: 1 vial powder + 1 pre-filled syringe solvent 5 ml + 1 injection set |
Pfizer Europe MA EEIG, Белгия |
Wyeth Farma S.A. Аutovia del Norte. A-1, Km.23.Desvio Algete, Km. 1, 28700 S. Sebastian de los Reyes, Madrid Испания |
456.98 |
91.4 |
548.38 |
4% |
10 |
466.98 |
93.4 |
560.38 |
16% |
25 |
491.98 |
98.4 |
590.38 |
Протокол № 270/15.03.2018; Промяна на обстоятелствата НСР-17316/22.11.2018 |
HCР-19/31.05.2013; НСР-16545/17.08.2018 (предварително изпъленение); НСР-18670/20.05.2019 |
04.06.2019 |
02.07.2019 |
Активен |
1849 |
| Coagulation factor IX (nonacog alfa) |
EU/1/97/047/005 |
BeneFIX, Powder and solvent for solution for injection, 500, IU, Pack: 1 vial powder + 1 pre-filled syringe solvent 5 ml + 1 injection set |
Pfizer Europe MA EEIG, Белгия |
Wyeth Farma S.A. Аutovia del Norte. A-1, Km.23.Desvio Algete, Km. 1, 28700 S. Sebastian de los Reyes, Madrid Испания |
495.31 |
99.06 |
594.37 |
4% |
10 |
505.31 |
101.06 |
606.37 |
16% |
25 |
530.31 |
106.06 |
636.37 |
Протокол № 270/15.03.2018; Промяна на обстоятелствата НСР-17316/22.11.2018 |
HCР-19/31.05.2013; НСР-16545/17.08.2018 (предварително изпъленение) |
17.08.2018 |
02.01.2019 |
Неактивен |
1849 |
| Coagulation factor IX (nonacog alfa) |
EU/1/97/047/005 |
BeneFIX, Powder and solvent for solution for injection, 500, IU, Pack: 1 vial powder + 1 pre-filled syringe solvent 5 ml + 1 injection set |
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 |
495.31 |
99.06 |
594.37 |
4% |
10 |
505.31 |
101.06 |
606.37 |
16% |
25 |
530.31 |
106.06 |
636.37 |
Протокол № 270/15.03.2018 |
HCР-19/31.05.2013; НСР-16545/17.08.2018 (предварително изпъленение) |
17.08.2018 |
02.09.2018 |
Неактивен |
1849 |
| Coagulation factor IX (nonacog alfa) |
EU/1/97/047/005 |
BeneFIX, Powder and solvent for solution for injection, 500, IU, Pack: 1 vial powder + 1 pre-filled syringe solvent 5 ml + 1 injection set |
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 |
570.11 |
114.02 |
684.13 |
16% |
25 |
595.11 |
119.02 |
714.13 |
Протокол № 270/15.03.2018 |
HCР-19/31.05.2013 |
02.06.2013 |
02.04.2018 |
Неактивен |
1849 |
| Coagulation factor IX (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 |
570.11 |
114.02 |
684.13 |
16% |
25 |
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 |
570.11 |
114.02 |
684.13 |
16% |
25 |
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 |
570.11 |
114.02 |
684.13 |
16% |
25 |
595.11 |
119.02 |
714.13 |
|
HCР-19/31.05.2013 |
02.06.2013 |
02.06.2013 |
Неактивен |
1849 |
| Belimumab |
EU/1/11/700/002 |
Benlysta, Powder for concentrate for solution for infusion, 400, mg, Pack: 1 |
GlaxoSmithKline (Ireland) Limited, Ирландия |
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 |
831.15 |
166.23 |
997.38 |
4% |
10 |
841.15 |
168.23 |
1009.38 |
16% |
25 |
866.15 |
173.23 |
1039.38 |
Промяна на обстоятелства НСР-18155/07.03.2019 |
НСР-5210/04.12.2014; НСР-9909/29.07.2016; НСР-14469/17.11.2017; НСР-16689/30.08.2018; НСР-18821/30.05.2019 |
14.06.2019 |
02.07.2019 |
Активен |
3432 |
| Belimumab |
EU/1/11/700/002 |
Benlysta, Powder for concentrate for solution for infusion, 400, mg, Pack: 1 |
GlaxoSmithKline (Ireland) Limited, Ирландия |
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 |
847.23 |
169.45 |
1016.68 |
16% |
25 |
872.23 |
174.45 |
1046.68 |
Промяна на обстоятелства НСР-18155/07.03.2019 |
НСР-5210/04.12.2014; НСР-9909/29.07.2016; НСР-14469/17.11.2017; НСР-16689/30.08.2018 |
14.09.2018 |
02.04.2019 |
Неактивен |
3432 |
| Belimumab |
EU/1/11/700/001 |
Benlysta, Powder for concentrate for solution for infusion, 120, mg, Pack: 1 |
GlaxoSmithKline (Ireland) Limited, Ирландия |
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 |
249.9 |
49.98 |
299.88 |
4% |
10 |
259.9 |
51.98 |
311.88 |
16% |
25 |
284.9 |
56.98 |
341.88 |
Промяна на обстоятелства НСР-18155/07.03.2019 |
НСР-6835/30.07.2015.; НСР-9123/27.04.2016; НСР-15081/23.02.2018; НСР-17250/14.11.2018 |
29.11.2018 |
02.04.2019 |
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 |
249.9 |
49.98 |
299.88 |
4% |
10 |
259.9 |
51.98 |
311.88 |
16% |
25 |
284.9 |
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 |
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 |
847.23 |
169.45 |
1016.68 |
16% |
25 |
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 |
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 |
252.52 |
50.5 |
303.02 |
4% |
10 |
262.52 |
52.5 |
315.02 |
16% |
25 |
287.52 |
57.5 |
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 |
841.79 |
168.36 |
1010.15 |
4% |
10 |
851.79 |
170.36 |
1022.15 |
16% |
25 |
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 |
264.22 |
52.84 |
317.06 |
16% |
25 |
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 |
169.5 |
1016.98 |
4% |
10 |
857.48 |
171.5 |
1028.98 |
16% |
25 |
882.48 |
176.5 |
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 |
1018.6 |
4% |
10 |
858.83 |
171.77 |
1030.6 |
16% |
25 |
883.83 |
176.77 |
1060.6 |
|
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 |
264.63 |
52.93 |
317.56 |
16% |
25 |
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 |
264.65 |
52.93 |
317.58 |
16% |
25 |
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 |
286.77 |
57.35 |
344.12 |
16% |
25 |
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 |
925.4 |
185.08 |
1110.48 |
4% |
10 |
935.4 |
187.08 |
1122.48 |
16% |
25 |
960.4 |
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 |
295.16 |
59.03 |
354.19 |
16% |
25 |
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 |
960.53 |
192.11 |
1152.64 |
16% |
25 |
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 |
754.45 |
150.89 |
905.34 |
16% |
25 |
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 |
754.45 |
150.89 |
905.34 |
16% |
25 |
779.45 |
155.89 |
935.34 |
|
НСР-6760/23.07.2015 |
08.08.2015 |
08.08.2015 |
Неактивен |
4047 |
