| Entecavir |
EU/1/06/343/003 |
BARACLUDE, Film‐coated tablet, 0.5, mg, Pack: 30 |
Bristol-Myers Squibb Pharma EEIG, Обединено Кралство |
Bristol-Myers Squibb, Champ “Lachaud”, La Goualle, 19250 Meymac, France; Bristol-Myers Squibb, Rue du Docteur André Gilles, 28230 Epernon, France |
702.44 |
140.49 |
842.93 |
4% |
10 |
712.44 |
142.49 |
854.93 |
16% |
25 |
737.44 |
147.49 |
884.93 |
|
КЦРР-990/23.07.2012 |
06.08.2012 |
Неактивен |
3455 |
| Entecavir |
EU/1/06/343/003 |
BARACLUDE, Film‐coated tablet, 0.5, mg, Pack: 30 |
Bristol-Myers Squibb Pharma EEIG, Обединено Кралство |
Bristol-Myers Squibb, Champ “Lachaud”, La Goualle, 19250 Meymac, France; Bristol-Myers Squibb, Rue du Docteur André Gilles, 28230 Epernon, France |
762.77 |
152.55 |
915.32 |
6% |
15 |
777.77 |
155.55 |
933.32 |
18% |
30 |
807.77 |
161.55 |
969.32 |
|
КЦ-682/06.03.2009 |
23.03.2009 |
Неактивен |
3455 |
| Mycobacterium bovis BCG |
ІІ-13285/08.06.2006 г. |
BCG VACCINE, FREEZE-DRIED, Powder and solvent for suspension for injection, 10 doses amp. + solv. 1 ml amp (200 doses), -, Pack: 20 |
БУЛ БИО-НЦЗПБ ЕООД, България |
БУЛ БИО-НЦЗПБ ЕООД |
26 |
5.2 |
31.2 |
6% |
1.56 |
27.56 |
5.51 |
33.07 |
18% |
4.68 |
32.24 |
6.45 |
38.69 |
|
КЦ-25/25.02.2008 |
23.03.2008 |
Активен |
17 |
| Follitropin alfa |
EU/1/13/909/004 |
Bemfola, Solution for injection, 300 IU/0,5 ml, -, Pack: 1 pre-filled pen and 1 injection needle |
Finox Biotech AG, Лихтенщайн |
Finox Biotech AG Gewerbestrasse 7 FL-9496 Balzers, Лихтенщайн |
145.89 |
29.18 |
175.07 |
4% |
5.84 |
151.73 |
30.35 |
182.08 |
16% |
23.34 |
175.07 |
35.01 |
210.08 |
|
НСР-6184/08.05.2015 |
25.05.2015 |
Неактивен |
3927 |
| Follitropin alfa |
EU/1/13/909/002 |
Bemfola, Solution for injection, 150 IU/0,25 ml, -, Pack: 1 pre-filled pen and 1 injection needle |
Finox Biotech AG, Лихтенщайн |
Finox Biotech AG Gewerbestrasse 7 FL-9496 Balzers, Лихтенщайн |
72.95 |
14.59 |
87.54 |
4% |
2.92 |
75.87 |
15.17 |
91.04 |
16% |
11.67 |
87.54 |
17.51 |
105.05 |
|
НСР-6162/08.05.2015 |
25.05.2015 |
Неактивен |
3925 |
| Follitropin alfa |
EU/1/13/909/003 |
Bemfola, Solution for injection, 225 IU/0,375 ml, -, Pack: 1 pre-filled pen and 1 injection needle |
Finox Biotech AG, Лихтенщайн |
Finox Biotech AG Gewerbestrasse 7 FL-9496 Balzers, Лихтенщайн |
109.42 |
21.88 |
131.3 |
4% |
4.38 |
113.8 |
22.76 |
136.56 |
16% |
17.51 |
131.31 |
26.26 |
157.57 |
|
НСР-6163/08.05.2015 |
25.05.2015 |
Неактивен |
3926 |
| Follitropin alfa |
EU/1/13/909/001 |
Bemfola, Solution for injection, 75 IU/0,125 ml, -, Pack: 1 pre-filled pen and 1 injection needle |
Finox Biotech AG, Лихтенщайн |
Finox Biotech AG Gewerbestrasse 7 FL-9496 Balzers, Лихтенщайн |
36.47 |
7.29 |
43.76 |
4% |
1.46 |
37.93 |
7.59 |
45.52 |
16% |
5.84 |
43.77 |
8.75 |
52.52 |
|
НСР-6161/08.05.2015 |
25.05.2015 |
Неактивен |
3924 |
| Calcium folinate |
20130337 |
Bendafolin, Solution for injection, 10 mg/ml - 100 ml, mg, Pack: 1 |
Lyomark Pharma GmbH, Германия |
Bendalis GmbH, Германия |
509.94 |
101.99 |
611.93 |
4% |
10 |
519.94 |
103.99 |
623.93 |
16% |
25 |
544.94 |
108.99 |
653.93 |
|
НСР-2982/12.03.2014 |
28.03.2014 |
Активен |
2573 |
| Calcium folinate |
20130337 |
Bendafolin, Solution for injection, 10 mg/ml - 50 ml, mg, Pack: 1 |
Lyomark Pharma GmbH, Германия |
Bendalis GmbH, Германия |
254.98 |
51 |
305.98 |
4% |
10 |
264.98 |
53 |
317.98 |
16% |
25 |
289.98 |
58 |
347.98 |
|
НСР-2982/12.03.2014 |
28.03.2014 |
Активен |
2574 |
| Bendamustine |
20150116 |
Bendamustine Actavis, Powder for concentrate for solution for infusion, 2.5 mg/ ml, mg, Pack: 60 ml (100 mg) x 1 |
Actavis Group PTC ehf., Исландия |
S.C.Sindan-Pharma S.R.L., 11th Ion Mihalache Boulevard, 011171 Bucharest 1, Румъния |
418.74 |
83.75 |
502.49 |
4% |
10 |
428.74 |
85.75 |
514.49 |
16% |
25 |
453.74 |
90.75 |
544.49 |
|
НСР-6438/12.06.2015. |
26.06.2015 |
Активен |
4013 |
| Bendamustine |
20140098 |
Bendamustine Sandoz, Powder for concentrate for solution for infusion, 2.5 mg/ ml, mg, Pack: 100 mg x 5 |
Sandoz d.d., Словения |
Helm AG Nordkanalstr. 28 20097 Hamburg Германия; S.C. POLIPHARMA INDUSTRIES S.R.L. Sos. Alba Iulia nr. 156, Sibiu, Jud. Sibiu, cod 550052, Румъния |
1758.06 |
351.61 |
2109.67 |
4% |
10 |
1768.06 |
353.61 |
2121.67 |
16% |
25 |
1793.06 |
358.61 |
2151.67 |
|
НСР-7722/17.12.2015 |
02.01.2016 |
Активен |
4163 |
| 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 |
Активен |
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 |
254.22 |
50.84 |
305.06 |
4% |
10 |
264.22 |
52.84 |
317.06 |
16% |
25 |
289.22 |
57.84 |
347.06 |
|
; НСР-9123/27.04.2016 |
02.06.2016 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
Неактивен |
3432 |
| 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 |
350.31 |
70.06 |
420.37 |
16% |
25 |
375.31 |
75.06 |
450.37 |
|
НСР-6760/23.07.2015 |
08.08.2015 |
Активен |
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 |
754.45 |
150.89 |
905.34 |
16% |
25 |
779.45 |
155.89 |
935.34 |
|
НСР-6760/23.07.2015 |
08.08.2015 |
Активен |
4047 |
| 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 |
222.27 |
44.45 |
266.72 |
|
НСР-6760/23.07.2015 |
08.08.2015 |
Активен |
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 |
898.2 |
179.64 |
1077.84 |
4% |
10 |
908.2 |
181.64 |
1089.84 |
16% |
25 |
933.2 |
186.64 |
1119.84 |
|
HCР-22/31.05.2013 |
02.06.2013 |
Активен |
1848 |
| Enalapril |
20020460 |
Berlipril, Tablet, 10, mg, Pack: 30 |
Berlin-Chemie AG (Menarini Group), Германия |
Berlin-Chemie AG (Menarini Group), Glienicker Weg 125, 12489 Berlin, Germany; Menarini - Von Heyden GmbH, Germany |
3.03 |
0.61 |
3.64 |
7% |
0.21 |
3.24 |
0.65 |
3.89 |
20% |
0.61 |
3.85 |
0.77 |
4.62 |
корекционно решение НСР-6578/01.07.2015; промяна на обстоятелства НСР-9894/29.07.2016. |
НСР-6499/18.06.2015 |
04.07.2015 |
Активен |
28 |