| 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 |
02.09.2016 |
02.09.2016 |
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 |
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 |
254.22 |
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 |
02.06.2016 |
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 |
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 |
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 |
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 |
| 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 |
08.08.2015 |
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 |
350.31 |
70.06 |
420.37 |
16% |
25 |
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 |
222.27 |
44.45 |
266.72 |
|
НСР-6760/23.07.2015 |
08.08.2015 |
08.08.2015 |
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 |
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 |
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 |
02.06.2013 |
Активен |
1848 |
| Enalapril |
9600019 |
Berlipril, Tablet, 5, 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 |
2.72 |
0.54 |
3.26 |
7% |
0.19 |
2.91 |
0.58 |
3.49 |
20% |
0.54 |
3.45 |
0.69 |
4.14 |
промяна на обстоятелства НСР-4465/15.08.2014( в сила от 01.09.2014), НСР-9895/29.07.2016 |
КЦ-48/21.04.2008 |
23.05.2008 |
02.09.2016 |
Активен |
27 |
| Enalapril |
II-0177/06.07.2007 |
Berlipril, Tablet, 5, 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 |
2.72 |
0.54 |
3.26 |
7% |
0.19 |
2.91 |
0.58 |
3.49 |
20% |
0.54 |
3.45 |
0.69 |
4.14 |
промяна на обстоятелства НСР-4465/15.08.2014( в сила от 01.09.2014) |
КЦ-48/21.04.2008 |
23.05.2008 |
23.05.2008 |
Неактивен |
27 |
| 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 обстоятелства НСР-9894/29.07.2016 |
НСР-6499/18.06.2015 |
04.07.2015 |
02.09.2016 |
Активен |
28 |
| Enalapril |
II-0178/06.07.2007 |
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 |
НСР-6499/18.06.2015 |
04.07.2015 |
04.07.2015 |
Неактивен |
28 |
| Enalapril |
20020461 |
Berlipril, Tablet, 20, 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 |
5.2 |
1.04 |
6.24 |
7% |
0.36 |
5.56 |
1.11 |
6.67 |
20% |
1.04 |
6.6 |
1.32 |
7.92 |
промяна на обстоятелства НСР-4529/22.08.2014( в сила от 08.09.2014), промяна обстоятелства НСР-9893/29.07.2016 |
КЦ-48/21.04.2008 |
23.05.2008 |
02.09.2016 |
Активен |
29 |
| Enalapril |
II-0179/06.07.2007 |
Berlipril, Tablet, 20, 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 |
5.2 |
1.04 |
6.24 |
7% |
0.36 |
5.56 |
1.11 |
6.67 |
20% |
1.04 |
6.6 |
1.32 |
7.92 |
промяна на обстоятелства НСР-4529/22.08.2014( в сила от 08.09.2014) |
КЦ-48/21.04.2008 |
23.05.2008 |
23.05.2008 |
Неактивен |
29 |
| Enalapril |
II-0178/06.07.2007 |
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 |
3.09 |
0.62 |
3.71 |
7% |
0.22 |
3.31 |
0.66 |
3.97 |
20% |
0.62 |
3.93 |
0.79 |
4.72 |
промяна на обстоятелства НСР-4466/15.08.2014( в сила от 01.09.2014) |
КЦ-48/21.04.2008 |
23.05.2008 |
23.05.2008 |
Неактивен |
28 |
| Metoprolol |
20100090 |
BETABLOCKADE, Prolonged release tablet, 50, mg, Pack: 30 |
Чайкафарма Висококачествените лекарства АД, България |
"Чайкафарма Висококачествените Лекарства" АД гр. Пловдив, България |
4.69 |
0.94 |
5.63 |
7% |
0.33 |
5.02 |
1 |
6.02 |
20% |
0.94 |
5.96 |
1.19 |
7.15 |
|
НСР-3869/20.06.2014 |
04.07.2014 |
04.07.2014 |
Активен |
2953 |
| Metoprolol |
20100091 |
BETABLOCKADE, Prolonged release tablet, 100, mg, Pack: 30 |
Чайкафарма Висококачествените лекарства АД, България |
"Чайкафарма Висококачествените Лекарства" АД гр. Пловдив, България |
6.57 |
1.31 |
7.88 |
7% |
0.46 |
7.03 |
1.41 |
8.44 |
20% |
1.31 |
8.34 |
1.67 |
10.01 |
|
НСР-3869/20.06.2014 |
04.07.2014 |
04.07.2014 |
Активен |
2952 |