| Ofatumumab |
EU/1/10/625/001 |
Arzerra, Concentrate for solution for infusion, 100 mg (20 mg/ml), 5 ml, mg, Pack: 3 vials with 2 extension sets |
Novartis Europharm Limited, Обединено Кралство |
Glaxo Operations UK Ltd.,Harmire Road, Barnard Castle Durham, DL12 8DT, United Kingdom |
1196.34 |
239.27 |
1435.61 |
4% |
10 |
1206.34 |
241.27 |
1447.61 |
16% |
25 |
1231.34 |
246.27 |
1477.61 |
промяна в обстоятелствата НСР-6998/24.08.2015 |
НСР-4324/05.08.2014 |
20.08.2014 |
20.08.2014 |
Неактивен |
3106 |
| Ofatumumab |
EU/1/10/625/001 |
Arzerra, Concentrate for solution for infusion, 100 mg (20 mg/ml), 5 ml, mg, Pack: 3 vials with 2 extension sets |
Glaxo Group Ltd., Обединено Кралство |
Glaxo Operations UK Ltd.,Harmire Road, Barnard Castle Durham, DL12 8DT, United Kingdom |
1208.7 |
241.74 |
1450.44 |
4% |
10 |
1218.7 |
243.74 |
1462.44 |
16% |
25 |
1243.7 |
248.74 |
1492.44 |
|
НСР-2265/27.12.2013 |
30.12.2013 |
30.12.2013 |
Неактивен |
3106 |
| Ofatumumab |
EU/1/10/625/003 |
Arzerra, Concentrate for solution for infusion, 1000 mg (20 mg/ml), 50 ml, mg, Pack: 1 vials with 2 extension sets |
Novartis Europharm Limited, Обединено Кралство |
Glaxo Operations UK Ltd.,Harmire Road, Barnard Castle Durham, DL12 8DT, United Kingdom |
3806.67 |
761.33 |
4568 |
4% |
10 |
3816.67 |
763.33 |
4580 |
16% |
25 |
3841.67 |
768.33 |
4610 |
|
НСР-8220/22.02.2016; НСР-10753/27.10.2016; НСР-14823/18.01.2018; НСР-16931/04.10.2018 |
19.10.2018 |
02.11.2018 |
Активен |
3107 |
| Ofatumumab |
EU/1/10/625/003 |
Arzerra, Concentrate for solution for infusion, 1000 mg (20 mg/ml), 50 ml, mg, Pack: 1 vials with 2 extension sets |
Novartis Europharm Limited, Обединено Кралство |
Glaxo Operations UK Ltd.,Harmire Road, Barnard Castle Durham, DL12 8DT, United Kingdom |
3867.32 |
773.46 |
4640.78 |
4% |
10 |
3877.32 |
775.46 |
4652.78 |
16% |
25 |
3902.32 |
780.46 |
4682.78 |
|
НСР-8220/22.02.2016; НСР-10753/27.10.2016; НСР-14823/18.01.2018 |
02.02.2018 |
02.03.2018 |
Неактивен |
3107 |
| Ofatumumab |
EU/1/10/625/003 |
Arzerra, Concentrate for solution for infusion, 1000 mg (20 mg/ml), 50 ml, mg, Pack: 1 vials with 2 extension sets |
Novartis Europharm Limited, Обединено Кралство |
Glaxo Operations UK Ltd.,Harmire Road, Barnard Castle Durham, DL12 8DT, United Kingdom |
3883.16 |
776.63 |
4659.79 |
4% |
10 |
3893.16 |
778.63 |
4671.79 |
16% |
25 |
3918.16 |
783.63 |
4701.79 |
|
НСР-8220/22.02.2016; НСР-10753/27.10.2016 |
11.11.2016 |
02.12.2016 |
Неактивен |
3107 |
| Ofatumumab |
EU/1/10/625/003 |
Arzerra, Concentrate for solution for infusion, 1000 mg (20 mg/ml), 50 ml, mg, Pack: 1 vials with 2 extension sets |
Novartis Europharm Limited, Обединено Кралство |
Glaxo Operations UK Ltd.,Harmire Road, Barnard Castle Durham, DL12 8DT, United Kingdom |
3936.4 |
787.28 |
4723.68 |
4% |
10 |
3946.4 |
789.28 |
4735.68 |
16% |
25 |
3971.4 |
794.28 |
4765.68 |
|
НСР-8220/22.02.2016 |
09.03.2016 |
09.03.2016 |
Неактивен |
3107 |
| Ofatumumab |
EU/1/10/625/003 |
Arzerra, Concentrate for solution for infusion, 1000 mg (20 mg/ml), 50 ml, mg, Pack: 1 vials with 2 extension sets |
Novartis Europharm Limited, Обединено Кралство |
Glaxo Operations UK Ltd.,Harmire Road, Barnard Castle Durham, DL12 8DT, United Kingdom |
3972.04 |
794.41 |
4766.45 |
4% |
10 |
3982.04 |
796.41 |
4778.45 |
16% |
25 |
4007.04 |
801.41 |
4808.45 |
промяна в обстоятелствата НСР-6997/24.08.2015 |
НСР-6548/24.06.2015 |
10.07.2015 |
10.07.2015 |
Неактивен |
3107 |
| Ofatumumab |
EU/1/10/625/003 |
Arzerra, Concentrate for solution for infusion, 1000 mg (20 mg/ml), 50 ml, mg, Pack: 1 vials with 2 extension sets |
Glaxo Group Ltd., Обединено Кралство |
Glaxo Operations UK Ltd.,Harmire Road, Barnard Castle Durham, DL12 8DT, United Kingdom |
3979.02 |
795.8 |
4774.82 |
4% |
10 |
3989.02 |
797.8 |
4786.82 |
16% |
25 |
4014.02 |
802.8 |
4816.82 |
|
НСР-4323/05.08.2014 |
20.08.2014 |
20.08.2014 |
Неактивен |
3107 |
| Ofatumumab |
EU/1/10/625/003 |
Arzerra, Concentrate for solution for infusion, 1000 mg (20 mg/ml), 50 ml, mg, Pack: 1 vials with 2 extension sets |
Glaxo Group Ltd., Обединено Кралство |
Glaxo Operations UK Ltd.,Harmire Road, Barnard Castle Durham, DL12 8DT, United Kingdom |
4029.01 |
805.8 |
4834.81 |
4% |
10 |
4039.01 |
807.8 |
4846.81 |
16% |
25 |
4064.01 |
812.8 |
4876.81 |
|
НСР-2265/27.12.2013 |
30.12.2013 |
30.12.2013 |
Неактивен |
3107 |
| Amlodipine, Valsartan |
20160078 |
Asbima, Film coated tablet, 5 mg/160 mg, -, Pack: 30 |
Zentiva k.s., Чешка република |
Zentiva k.s., Чешка република |
21.51 |
4.3 |
25.81 |
6% |
1.29 |
22.8 |
4.56 |
27.36 |
18% |
3.87 |
26.67 |
5.33 |
32 |
|
НСР-15403/04.04.2018 |
19.04.2018 |
02.05.2018 |
Активен |
16085 |
| Amlodipine, Valsartan |
20160080 |
Asbima, Film coated tablet, 10 mg/160 mg, -, Pack: 30 |
Zentiva k.s., Чешка република |
Zentiva k.s., Чешка република |
23.45 |
4.69 |
28.14 |
6% |
1.41 |
24.86 |
4.97 |
29.83 |
18% |
4.22 |
29.08 |
5.82 |
34.9 |
|
НСР-15403/04.04.2018 |
19.04.2018 |
02.05.2018 |
Активен |
16086 |
| Sertraline |
20050296 |
ASENTRA, Film coated tablet, 50, mg, Pack: 28 |
KRKA, d.d., Словения |
KRKA, d.d. Novo Mesto, Slovenia |
3.52 |
0.7 |
4.22 |
7% |
0.25 |
3.77 |
0.75 |
4.52 |
20% |
0.7 |
4.47 |
0.89 |
5.36 |
промяна на обстоятелства НСР-10633/12.10.2016 |
НСР-8437/07.03.2016 |
22.03.2016 |
02.11.2016 |
Активен |
2404 |
| Sertraline |
II-10841/ 16.05.2005 |
ASENTRA, Film coated tablet, 50, mg, Pack: 28 |
KRKA, d.d., Словения |
KRKA, d.d. Novo Mesto, Slovenia |
3.52 |
0.7 |
4.22 |
7% |
0.25 |
3.77 |
0.75 |
4.52 |
20% |
0.7 |
4.47 |
0.89 |
5.36 |
|
НСР-8437/07.03.2016 |
22.03.2016 |
22.03.2016 |
Неактивен |
2404 |
| Sertraline |
20050297 |
ASENTRA, Film coated tablet, 100, mg, Pack: 28 |
KRKA, d.d., Словения |
KRKA, d.d. Novo Mesto, Slovenia |
8.66 |
1.73 |
10.39 |
7% |
0.61 |
9.27 |
1.85 |
11.12 |
20% |
1.73 |
11 |
2.2 |
13.2 |
промяна на обстоятелства НСР-10634/12.10.2016 |
НСР-8438/07.03.2016 |
22.03.2016 |
02.11.2016 |
Активен |
2403 |
| Sertraline |
II-10842/ 16.05.2005 |
ASENTRA, Film coated tablet, 100, mg, Pack: 28 |
KRKA, d.d., Словения |
KRKA, d.d. Novo Mesto, Slovenia |
8.66 |
1.73 |
10.39 |
7% |
0.61 |
9.27 |
1.85 |
11.12 |
20% |
1.73 |
11 |
2.2 |
13.2 |
|
НСР-8438/07.03.2016 |
22.03.2016 |
22.03.2016 |
Неактивен |
2403 |
| Sertraline |
II-10841/ 16.05.2005 |
ASENTRA, Film coated tablet, 50, mg, Pack: 28 |
KRKA, d.d., Словения |
KRKA, d.d. Novo Mesto, Slovenia |
5.36 |
1.07 |
6.43 |
7% |
0.38 |
5.74 |
1.15 |
6.89 |
20% |
1.07 |
6.81 |
1.36 |
8.17 |
|
НСР-2189/20.12.2013 |
28.01.2014 |
28.01.2014 |
Неактивен |
2404 |
| Sertraline |
II-10842/ 16.05.2005 |
ASENTRA, Film coated tablet, 100, mg, Pack: 28 |
KRKA, d.d., Словения |
KRKA, d.d. Novo Mesto, Slovenia |
9.04 |
1.81 |
10.85 |
7% |
0.63 |
9.67 |
1.93 |
11.6 |
20% |
1.81 |
11.48 |
2.3 |
13.78 |
|
НСР-2188/20.12.2013 |
28.01.2014 |
28.01.2014 |
Неактивен |
2403 |
| Sertraline |
II-10842/ 16.05.2005 |
ASENTRA, Film coated tablet, 100, mg, Pack: 28 |
KRKA, d.d., Словения |
KRKA, d.d. Novo Mesto, Slovenia |
12.58 |
2.52 |
15.1 |
6% |
0.75 |
13.33 |
2.67 |
16 |
18% |
2.26 |
15.59 |
3.12 |
18.71 |
|
КЦРР-2294/20.02.2013 |
01.04.2013 |
01.04.2013 |
Неактивен |
2403 |
| Sertraline |
II-10841/ 16.05.2005 |
ASENTRA, Film coated tablet, 50, mg, Pack: 28 |
KRKA, d.d., Словения |
KRKA, d.d. Novo Mesto, Slovenia |
6.81 |
1.36 |
8.17 |
7% |
0.48 |
7.29 |
1.46 |
8.75 |
20% |
1.36 |
8.65 |
1.73 |
10.38 |
|
КЦРР-2293/20.02.2013 |
01.04.2013 |
01.04.2013 |
Неактивен |
2404 |
| Sertraline |
II-10842/16.05.2005 |
ASENTRA, Film coated tablet, 100, mg, Pack: 28 |
KRKA, d.d., Словения |
KRKA, d.d. Novo Mesto, Slovenia |
13.77 |
2.75 |
16.52 |
6% |
0.83 |
14.6 |
2.92 |
17.52 |
18% |
2.48 |
17.08 |
3.42 |
20.5 |
|
КЦ-326/28.11.2008 |
30.12.2008 |
30.12.2008 |
Неактивен |
2403 |
| Sertraline |
II-10841/16.05.2005 |
ASENTRA, Film coated tablet, 50, mg, Pack: 28 |
KRKA, d.d., Словения |
KRKA, d.d. Novo Mesto, Slovenia |
7.16 |
1.43 |
8.59 |
7% |
0.5 |
7.66 |
1.53 |
9.19 |
20% |
1.43 |
9.09 |
1.82 |
10.91 |
|
КЦ-326/28.11.2008 |
30.12.2008 |
30.12.2008 |
Неактивен |
2404 |
| Candesartan |
20060845 |
ATACAND, Tablet, 8, mg, Pack: 28 |
Astra Zeneca AB, Швеция |
AstraZeneca AB, Швеция; Corden Pharma Gmbh, Германия; AstraZeneca GmbH, Германия; AndersonBrecon UK Ltd, Обединено кралство; Astra Zeneka UK Ltd, Обединено кралство; Astra Zeneca Франция |
12.73 |
2.55 |
15.28 |
6% |
0.76 |
13.49 |
2.7 |
16.19 |
18% |
2.29 |
15.78 |
3.16 |
18.94 |
|
НСР-80/07.06.2013; НСР-9905/29.07.2016. |
02.09.2016 |
02.09.2016 |
Заличен |
1874 |
| Candesartan |
II-15681/ 29.12.2006 |
ATACAND, Tablet, 8, mg, Pack: 28 |
Astra Zeneca AB, Швеция |
AstraZeneca AB, Sweden; AstraZeneca GmbH, Germany |
12.73 |
2.55 |
15.28 |
6% |
0.76 |
13.49 |
2.7 |
16.19 |
18% |
2.29 |
15.78 |
3.16 |
18.94 |
|
НСР-80/07.06.2013 |
02.07.2013 |
02.07.2013 |
Неактивен |
1874 |
| Candesartan |
20060845 |
ATACAND, Tablet, 16, mg, Pack: 28 |
Astra Zeneca AB, Швеция |
AstraZeneca AB, Швеция; Corden Pharma Gmbh, Германия; AstraZeneca GmbH, Германия; AndersonBrecon UK Ltd, Обединено кралство; Astra Zeneka UK Ltd, Обединено кралство; Astra Zeneca Франция |
14.16 |
2.83 |
16.99 |
6% |
0.85 |
15.01 |
3 |
18.01 |
18% |
2.55 |
17.56 |
3.51 |
21.07 |
|
НСР-79/07.06.2013; НСР-9904/29.07.2016 |
02.09.2016 |
02.09.2016 |
Заличен |
1873 |
| Candesartan |
II-15681/ 29.12.2006 |
ATACAND, Tablet, 16, mg, Pack: 28 |
Astra Zeneca AB, Швеция |
AstraZeneca AB, Sweden; AstraZeneca GmbH, Germany |
14.16 |
2.83 |
16.99 |
6% |
0.85 |
15.01 |
3 |
18.01 |
18% |
2.55 |
17.56 |
3.51 |
21.07 |
|
НСР-79/07.06.2013 |
02.07.2013 |
02.07.2013 |
Неактивен |
1873 |