| Methoxy polyethylene glycol-epoetin beta |
EU/1/07/400/008 |
Mircera, Solution for injection, 50 µg/0,3 ml, -, Pack: 1 pre-filled syringe |
Roche Registration GmbH, Германия |
Roche Pharma AG, Germany |
129.3 |
25.86 |
155.16 |
4% |
5.17 |
134.47 |
26.89 |
161.36 |
16% |
20.69 |
155.16 |
31.03 |
186.19 |
Промяна на обстоятелствата НСР-15749/25.05.2018. |
НСР-4286/05.08.2014; НСР-10453/29.09.2016; НСР-14667/20.12.2017; НСР-16584/24.08.2018; НСР-18673/20.05.2019 |
04.06.2019 |
02.07.2019 |
Активен |
3137 |
| Methoxy polyethylene glycol-epoetin beta |
EU/1/07/400/008 |
Mircera, Solution for injection, 50 µg/0,3 ml, -, Pack: 1 pre-filled syringe |
Roche Registration GmbH, Германия |
Roche Pharma AG, Germany |
129.3 |
25.86 |
155.16 |
4% |
5.17 |
134.47 |
26.89 |
161.36 |
16% |
20.69 |
155.16 |
31.03 |
186.19 |
Промяна на обстоятелствата НСР-15749/25.05.2018. |
НСР-4286/05.08.2014; НСР-10453/29.09.2016; НСР-14667/20.12.2017; НСР-16584/24.08.2018; НСР-18673/20.05.2019 |
04.06.2019 |
02.07.2019 |
Неактивен |
3137 |
| Methoxy polyethylene glycol-epoetin beta |
EU/1/07/400/010 |
Mircera, Solution for injection, 100 µg/0,3 ml, -, Pack: 1 pre-filled syringe |
Roche Registration GmbH, Германия |
Roche Pharma AG, Germany |
283.34 |
56.67 |
340.01 |
4% |
10 |
293.34 |
58.67 |
352.01 |
16% |
25 |
318.34 |
63.67 |
382.01 |
Промяна на обстоятелствата НСР-15750/25.05.2018. |
НСР-3304/24.04.2014; НСР-9707/07.07.2016; НСР-15199/09.03.2018; НСР-17062/26.10.2018 |
10.11.2018 |
02.12.2018 |
Активен |
2720 |
| Methoxy polyethylene glycol-epoetin beta |
EU/1/07/400/010 |
Mircera, Solution for injection, 100 µg/0,3 ml, -, Pack: 1 pre-filled syringe |
Roche Registration GmbH, Германия |
Roche Pharma AG, Germany |
283.34 |
56.67 |
340.01 |
4% |
10 |
293.34 |
58.67 |
352.01 |
16% |
25 |
318.34 |
63.67 |
382.01 |
Промяна на обстоятелствата НСР-15750/25.05.2018. |
НСР-3304/24.04.2014; НСР-9707/07.07.2016; НСР-15199/09.03.2018; НСР-17062/26.10.2018 |
10.11.2018 |
02.12.2018 |
Неактивен |
2720 |
| Methoxy polyethylene glycol-epoetin beta |
EU/1/07/400/011 |
Mircera, Solution for injection, 150 µg/0,3 ml, -, Pack: 1 pre-filled syringe |
Roche Registration GmbH, Германия |
Roche Pharma AG, Germany |
423.09 |
84.62 |
507.71 |
4% |
10 |
433.09 |
86.62 |
519.71 |
16% |
25 |
458.09 |
91.62 |
549.71 |
Промяна на обстоятелствата НСР-15748/25.05.2018. |
НСР-3302/24.04.2014; НСР-9709/07.07.2016; НСР-14020/02.10.2017; НСР-15826/08.06.2018; НСР-17870/07.02.2019 |
22.02.2019 |
02.03.2019 |
Активен |
2721 |
| Methoxy polyethylene glycol-epoetin beta |
EU/1/07/400/011 |
Mircera, Solution for injection, 150 µg/0,3 ml, -, Pack: 1 pre-filled syringe |
Roche Registration GmbH, Германия |
Roche Pharma AG, Germany |
423.09 |
84.62 |
507.71 |
4% |
10 |
433.09 |
86.62 |
519.71 |
16% |
25 |
458.09 |
91.62 |
549.71 |
Промяна на обстоятелствата НСР-15748/25.05.2018. |
НСР-3302/24.04.2014; НСР-9709/07.07.2016; НСР-14020/02.10.2017; НСР-15826/08.06.2018; НСР-17870/07.02.2019 |
22.02.2019 |
02.03.2019 |
Неактивен |
2721 |
| Methoxy polyethylene glycol-epoetin beta |
EU/1/07/400/009 |
Mircera, Solution for injection, 75 µg/0,3 ml, -, Pack: 1 pre-filled syringe |
Roche Registration GmbH, Германия |
Roche Pharma AG, Germany |
212.03 |
42.41 |
254.44 |
4% |
8.48 |
220.51 |
44.1 |
264.61 |
16% |
25 |
245.51 |
49.1 |
294.61 |
Промяна на обстоятелствата НСР-15751/25.05.2018. |
НСР-3305/24.04.2014; НСР-9708/07.07.2016; НСР-14021/02.10.2017; НСР-15825/08.06.2018; НСР-17869/07.02.2019 |
22.02.2019 |
02.03.2019 |
Активен |
2719 |
| Methoxy polyethylene glycol-epoetin beta |
EU/1/07/400/009 |
Mircera, Solution for injection, 75 µg/0,3 ml, -, Pack: 1 pre-filled syringe |
Roche Registration GmbH, Германия |
Roche Pharma AG, Germany |
212.03 |
42.41 |
254.44 |
4% |
8.48 |
220.51 |
44.1 |
264.61 |
16% |
25 |
245.51 |
49.1 |
294.61 |
Промяна на обстоятелствата НСР-15751/25.05.2018. |
НСР-3305/24.04.2014; НСР-9708/07.07.2016; НСР-14021/02.10.2017; НСР-15825/08.06.2018; НСР-17869/07.02.2019 |
22.02.2019 |
02.03.2019 |
Неактивен |
2719 |
| Methoxy polyethylene glycol-epoetin beta |
EU/1/07/400/008 |
Mircera, Solution for injection, 50 µg/0,3 ml, -, Pack: 1 pre-filled syringe |
Roche Registration GmbH, Германия |
Roche Pharma AG, Germany |
141.47 |
28.29 |
169.76 |
4% |
5.66 |
147.13 |
29.43 |
176.56 |
16% |
22.64 |
169.77 |
33.95 |
203.72 |
Промяна на обстоятелствата НСР-15749/25.05.2018. |
НСР-4286/05.08.2014; НСР-10453/29.09.2016; НСР-14667/20.12.2017; НСР-16584/24.08.2018 |
08.09.2018 |
02.10.2018 |
Неактивен |
3137 |
| Methoxy polyethylene glycol-epoetin beta |
EU/1/07/400/009 |
Mircera, Solution for injection, 75 µg/0,3 ml, -, Pack: 1 pre-filled syringe |
Roche Registration GmbH, Германия |
Roche Pharma AG, Germany |
212.72 |
42.54 |
255.26 |
4% |
8.51 |
221.23 |
44.25 |
265.48 |
16% |
25 |
246.23 |
49.25 |
295.48 |
Промяна на обстоятелствата НСР-15751/25.05.2018. |
НСР-3305/24.04.2014; НСР-9708/07.07.2016; НСР-14021/02.10.2017; НСР-15825/08.06.2018 |
23.06.2018 |
02.07.2018 |
Неактивен |
2719 |
| Methoxy polyethylene glycol-epoetin beta |
EU/1/07/400/011 |
Mircera, Solution for injection, 150 µg/0,3 ml, -, Pack: 1 pre-filled syringe |
Roche Registration GmbH, Германия |
Roche Pharma AG, Germany |
425.18 |
85.04 |
510.22 |
4% |
10 |
435.18 |
87.04 |
522.22 |
16% |
25 |
460.18 |
92.04 |
552.22 |
Промяна на обстоятелствата НСР-15748/25.05.2018. |
НСР-3302/24.04.2014; НСР-9709/07.07.2016; НСР-14020/02.10.2017; НСР-15826/08.06.2018 |
23.06.2018 |
02.07.2018 |
Неактивен |
2721 |
| Methoxy polyethylene glycol-epoetin beta |
EU/1/07/400/010 |
Mircera, Solution for injection, 100 µg/0,3 ml, -, Pack: 1 pre-filled syringe |
Roche Registration GmbH, Германия |
Roche Pharma AG, Germany |
283.61 |
56.72 |
340.33 |
4% |
10 |
293.61 |
58.72 |
352.33 |
16% |
25 |
318.61 |
63.72 |
382.33 |
Промяна на обстоятелствата НСР-15750/25.05.2018. |
НСР-3304/24.04.2014; НСР-9707/07.07.2016; НСР-15199/09.03.2018 |
24.03.2018 |
02.07.2018 |
Неактивен |
2720 |
| Methoxy polyethylene glycol-epoetin beta |
EU/1/07/400/008 |
Mircera, Solution for injection, 50 µg/0,3 ml, -, Pack: 1 pre-filled syringe |
Roche Registration GmbH, Германия |
Roche Pharma AG, Germany |
143.38 |
28.68 |
172.06 |
4% |
5.74 |
149.12 |
29.82 |
178.94 |
16% |
22.94 |
172.06 |
34.41 |
206.47 |
Промяна на обстоятелствата НСР-15749/25.05.2018. |
НСР-4286/05.08.2014; НСР-10453/29.09.2016; НСР-14667/20.12.2017 |
06.01.2018 |
02.07.2018 |
Неактивен |
3137 |
| Methoxy polyethylene glycol-epoetin beta |
EU/1/07/400/011 |
Mircera, Solution for injection, 150 µg/0,3 ml, -, Pack: 1 pre-filled syringe |
Roche Registration Limited, Обединено Кралство |
Roche Pharma AG, Germany |
428.35 |
85.67 |
514.02 |
4% |
10 |
438.35 |
87.67 |
526.02 |
16% |
25 |
463.35 |
92.67 |
556.02 |
|
НСР-3302/24.04.2014; НСР-9709/07.07.2016; НСР-14020/02.10.2017 |
17.10.2017 |
02.11.2017 |
Неактивен |
2721 |
| Methoxy polyethylene glycol-epoetin beta |
EU/1/07/400/008 |
Mircera, Solution for injection, 50 µg/0,3 ml, -, Pack: 1 pre-filled syringe |
Roche Registration Limited, Обединено Кралство |
Roche Pharma AG, Germany |
143.38 |
28.68 |
172.06 |
4% |
5.74 |
149.12 |
29.82 |
178.94 |
16% |
22.94 |
172.06 |
34.41 |
206.47 |
|
НСР-4286/05.08.2014; НСР-10453/29.09.2016; НСР-14667/20.12.2017 |
06.01.2018 |
02.02.2018 |
Неактивен |
3137 |
| Methoxy polyethylene glycol-epoetin beta |
EU/1/07/400/010 |
Mircera, Solution for injection, 100 µg/0,3 ml, -, Pack: 1 pre-filled syringe |
Roche Registration Limited, Обединено Кралство |
Roche Pharma AG, Germany |
283.61 |
56.72 |
340.33 |
4% |
10 |
293.61 |
58.72 |
352.33 |
16% |
25 |
318.61 |
63.72 |
382.33 |
|
НСР-3304/24.04.2014; НСР-9707/07.07.2016; НСР-15199/09.03.2018 |
24.03.2018 |
02.04.2018 |
Неактивен |
2720 |
| Methoxy polyethylene glycol-epoetin beta |
EU/1/07/400/009 |
Mircera, Solution for injection, 75 µg/0,3 ml, -, Pack: 1 pre-filled syringe |
Roche Registration Limited, Обединено Кралство |
Roche Pharma AG, Germany |
214.75 |
42.95 |
257.7 |
4% |
8.59 |
223.34 |
44.67 |
268.01 |
16% |
25 |
248.34 |
49.67 |
298.01 |
|
НСР-3305/24.04.2014; НСР-9708/07.07.2016; НСР-14021/02.10.2017 |
17.10.2017 |
02.11.2017 |
Неактивен |
2719 |
| Methoxy polyethylene glycol-epoetin beta |
EU/1/07/400/010 |
Mircera, Solution for injection, 100 µg/0,3 ml, -, Pack: 1 pre-filled syringe |
Roche Registration Limited, Обединено Кралство |
Roche Pharma AG, Germany |
287.29 |
57.46 |
344.75 |
4% |
10 |
297.29 |
59.46 |
356.75 |
16% |
25 |
322.29 |
64.46 |
386.75 |
|
НСР-3304/24.04.2014; НСР-9707/07.07.2016 |
22.07.2016 |
02.08.2016 |
Неактивен |
2720 |
| Methoxy polyethylene glycol-epoetin beta |
EU/1/07/400/008 |
Mircera, Solution for injection, 50 µg/0,3 ml, -, Pack: 1 pre-filled syringe |
Roche Registration Limited, Обединено Кралство |
Roche Pharma AG, Germany |
143.5 |
28.7 |
172.2 |
4% |
5.74 |
149.24 |
29.85 |
179.09 |
16% |
22.96 |
172.2 |
34.44 |
206.64 |
|
НСР-4286/05.08.2014; НСР-10453/29.09.2016 |
14.10.2016 |
02.11.2016 |
Неактивен |
3137 |
| Methoxy polyethylene glycol-epoetin beta |
EU/1/07/400/009 |
Mircera, Solution for injection, 75 µg/0,3 ml, -, Pack: 1 pre-filled syringe |
Roche Registration Limited, Обединено Кралство |
Roche Pharma AG, Germany |
215.47 |
43.09 |
258.56 |
4% |
8.62 |
224.09 |
44.82 |
268.91 |
16% |
25 |
249.09 |
49.82 |
298.91 |
|
НСР-3305/24.04.2014; НСР-9708/07.07.2016 |
02.08.2016 |
02.08.2016 |
Неактивен |
2719 |
| Methoxy polyethylene glycol-epoetin beta |
EU/1/07/400/011 |
Mircera, Solution for injection, 150 µg/0,3 ml, -, Pack: 1 pre-filled syringe |
Roche Registration Limited, Обединено Кралство |
Roche Pharma AG, Germany |
430.91 |
86.18 |
517.09 |
4% |
10 |
440.91 |
88.18 |
529.09 |
16% |
25 |
465.91 |
93.18 |
559.09 |
|
НСР-3302/24.04.2014; НСР-9709/07.07.2016 |
02.08.2016 |
02.08.2016 |
Неактивен |
2721 |
| Methoxy polyethylene glycol-epoetin beta |
EU/1/07/400/008 |
Mircera, Solution for injection, 50 µg/0,3 ml, -, Pack: 1 pre-filled syringe |
Roche Registration Limited, Обединено Кралство |
Roche Pharma AG, Germany |
143.66 |
28.73 |
172.39 |
4% |
5.75 |
149.41 |
29.88 |
179.29 |
16% |
22.99 |
172.4 |
34.48 |
206.88 |
|
НСР-4286/05.08.2014 |
20.08.2014 |
20.08.2014 |
Неактивен |
3137 |
| Methoxy polyethylene glycol-epoetin beta |
EU/1/07/400/010 |
Mircera, Solution for injection, 100 µg/0,3 ml, -, Pack: 1 pre-filled syringe |
Roche Registration Limited, Обединено Кралство |
Roche Pharma AG, Germany |
287.31 |
57.46 |
344.77 |
4% |
10 |
297.31 |
59.46 |
356.77 |
16% |
25 |
322.31 |
64.46 |
386.77 |
|
НСР-3304/24.04.2014 |
08.05.2014 |
08.05.2014 |
Неактивен |
2720 |
| Methoxy polyethylene glycol-epoetin beta |
EU/1/07/400/009 |
Mircera, Solution for injection, 75 µg/0,3 ml, -, Pack: 1 pre-filled syringe |
Roche Registration Limited, Обединено Кралство |
Roche Pharma AG, Germany |
215.49 |
43.1 |
258.59 |
4% |
8.62 |
224.11 |
44.82 |
268.93 |
16% |
25 |
249.11 |
49.82 |
298.93 |
|
НСР-3305/24.04.2014 |
08.05.2014 |
08.05.2014 |
Неактивен |
2719 |
| Methoxy polyethylene glycol-epoetin beta |
EU/1/07/400/011 |
Mircera, Solution for injection, 150 µg/0,3 ml, -, Pack: 1 pre-filled syringe |
Roche Registration Limited, Обединено Кралство |
Roche Pharma AG, Germany |
430.95 |
86.19 |
517.14 |
4% |
10 |
440.95 |
88.19 |
529.14 |
16% |
25 |
465.95 |
93.19 |
559.14 |
|
НСР-3302/24.04.2014 |
08.05.2014 |
08.05.2014 |
Неактивен |
2721 |