| Daratumumab |
EU/1/16/1101/ 001 |
DARZALEX, Concentrate for solution for infusion, 20 mg/ml-5 ml, -, Pack: 1 |
Janssen-Cilag International N.V., Белгия |
Janssen Biologics B.V., Холандия |
823.4 |
164.68 |
988.08 |
4% |
10 |
833.4 |
166.68 |
1000.08 |
16% |
25 |
858.4 |
171.68 |
1030.08 |
|
НСР-17642/20.12.2018 предварително изпълнение |
20.12.2018 |
02.01.2019 |
Активен |
16382 |
| Daratumumab |
EU/1/16/1101/002 |
DARZALEX, Concentrate for solution for infusion, 20 mg/ml-20 ml, -, Pack: 1 |
Janssen-Cilag International N.V., Белгия |
Janssen Biologics B.V., Холандия |
3293.62 |
658.72 |
3952.34 |
4% |
10 |
3303.62 |
660.72 |
3964.34 |
16% |
25 |
3328.62 |
665.72 |
3994.34 |
|
НСР-17642/20.12.2018 предварително изпълнение |
20.12.2018 |
02.01.2019 |
Активен |
16383 |
| Iodine Ioflupane (123I) |
EU/1/00/135/002 |
DaTSCAN, Solution for injection, 74 MBq/ml-5 ml, -, Pack: 1 vial, glass |
GE Healthcare Ltd, Обединено Кралство |
GE Healthcare Limited |
1505.99 |
301.2 |
1807.19 |
4% |
10 |
1515.99 |
303.2 |
1819.19 |
16% |
25 |
1540.99 |
308.2 |
1849.19 |
Протокол 231/29.06.2017 |
КЦ-823/15.04.2009 |
30.04.2009 |
02.08.2017 |
Активен |
710 |
| Iodine Ioflupane (123I) |
EU/1/00/135/002 |
DATSCAN, Solution for injection, 74 MBq/ml-2.5 ml, -, Pack: 1 vial, glass x 10 ml |
GE Healthcare Ltd, Обединено Кралство |
GE Healthcare Limited |
1505.99 |
301.2 |
1807.19 |
4% |
10 |
1515.99 |
303.2 |
1819.19 |
16% |
25 |
1540.99 |
308.2 |
1849.19 |
|
КЦ-823/15.04.2009 |
30.04.2009 |
30.04.2009 |
Неактивен |
710 |
| Iodine Ioflupane (123I) |
EU/1/00/135/002 |
DATSCAN, Solution for injection, 74 MBq/ml-5 ml, -, Pack: 1 vial, glass |
GE Healthcare Ltd, Обединено Кралство |
GE Healthcare Limited |
1505.99 |
301.2 |
1807.19 |
4% |
10 |
1515.99 |
303.2 |
1819.19 |
16% |
25 |
1540.99 |
308.2 |
1849.19 |
|
КЦ-823/15.04.2009 |
30.04.2009 |
30.04.2009 |
Неактивен |
710 |
| Roflumilast |
EU/1/10/636/002 |
Daxas, Film coated tablet, 0.5, mg, Pack: 30 |
Astra Zeneca AB, Швеция |
Takeda GmbH, Германия |
68.86 |
13.77 |
82.63 |
4% |
2.75 |
71.61 |
14.32 |
85.93 |
16% |
11.02 |
82.63 |
16.53 |
99.16 |
Промяна на обстоятелства НСР-14564/30.11.2017 |
НСР-7806/28.12.2015; HCP-10170/31.08.2016 |
16.09.2016 |
02.01.2018 |
Активен |
3775 |
| Roflumilast |
EU/1/10/636/002 |
Daxas, Film coated tablet, 0.5, mg, Pack: 30 |
Takeda GmbH, Германия |
Takeda GmbH, Германия |
68.86 |
13.77 |
82.63 |
4% |
2.75 |
71.61 |
14.32 |
85.93 |
16% |
11.02 |
82.63 |
16.53 |
99.16 |
|
НСР-7806/28.12.2015; HCP-10170/31.08.2016 |
16.09.2016 |
02.10.2016 |
Неактивен |
3775 |
| Roflumilast |
EU/1/10/636/002 |
Daxas, Film coated tablet, 0.5, mg, Pack: 30 |
Takeda GmbH, Германия |
Takeda GmbH, Германия |
70.41 |
14.08 |
84.49 |
4% |
2.82 |
73.23 |
14.65 |
87.88 |
16% |
11.27 |
84.5 |
16.9 |
101.4 |
|
НСР-7806/28.12.2015 |
13.01.2016 |
13.01.2016 |
Неактивен |
3775 |
| Roflumilast |
EU/1/10/636 |
Daxas, Film coated tablet, 0.5, mg, Pack: 30 |
Takeda GmbH, Германия |
Takeda GmbH, Германия |
70.61 |
14.12 |
84.73 |
4% |
2.82 |
73.43 |
14.69 |
88.12 |
16% |
11.3 |
84.73 |
16.95 |
101.68 |
Отхвърлена жалба от Комисия по прозрачност с решение КП-119/06.04.2015 |
НСР-5402/07.01.2015. |
02.05.2015 |
02.05.2015 |
Неактивен |
3775 |
| Roflumilast |
EU/1/10/636 |
Daxas, Film coated tablet, 0.5, mg, Pack: 30 |
Takeda GmbH, Германия |
Takeda GmbH, Германия |
72.46 |
14.49 |
86.95 |
4% |
2.9 |
75.36 |
15.07 |
90.43 |
16% |
11.59 |
86.95 |
17.39 |
104.34 |
промяна на обстоятелства НСР-2923/07.03.2014 |
КЦРР-1608/05.11.2012 |
19.11.2012 |
19.11.2012 |
Неактивен |
3775 |
| Indapamide |
№ ІІ-6733/22.01.2010 |
DAXPAMIL, Prolonged release tablet, 1.5, mg, Pack: 30 |
Sandoz d.d., Словения |
Salutas Pharma GmbH Lek S.A Lek Pharmaceuticals d.d. |
3.76 |
0.75 |
4.51 |
7% |
0.26 |
4.02 |
0.8 |
4.82 |
20% |
0.75 |
4.77 |
0.95 |
5.72 |
цената се заличава HCP-6035/09.04.2015 (в сила от 02.05.2015) |
КЦРР-2210/06.02.2013 г |
21.02.2013 |
21.02.2013 |
Заличен |
1617 |
| Indapamide |
№ ІІ-6733/22.01.2010 |
DAXPAMIL, Prolonged release tablet, 1.5, mg, Pack: 30 |
Sandoz d.d., Словения |
Salutas Pharma GmbH Lek S.A Lek Pharmaceuticals d.d. |
4.89 |
0.98 |
5.87 |
7% |
0.34 |
5.23 |
1.05 |
6.28 |
20% |
0.98 |
6.21 |
1.24 |
7.45 |
|
КЦ-1890/02.11.2010 |
17.11.2010 |
17.11.2010 |
Неактивен |
1617 |
| Perindopril, Indapamide |
20120498 |
Daxpamil Duo, Tablet, 4mg/1,25mg, mg, Pack: 30 |
Sandoz d.d., Словения |
Lek Pharmaceuticals d.d., Словения; Lek S.A., Полша; Salutas Pharma GmbH Barleben, Германия; Salutas Pharma GmbH Gerlingen, Германия |
6.28 |
1.26 |
7.54 |
7% |
0.44 |
6.72 |
1.34 |
8.06 |
20% |
1.26 |
7.98 |
1.6 |
9.58 |
|
НСР-5139/27.11.2014 |
11.12.2014 |
11.12.2014 |
Активен |
3412 |
| Perindopril, Indapamide |
20120498 |
Daxpamil Duo, Tablet, 4mg/1,25mg, mg, Pack: 30 |
Sandoz d.d., Словения |
Lek Pharmaceuticals d.d., Словения; Lek S.A., Полша; Salutas Pharma GmbH Barleben, Германия; Salutas Pharma GmbH Gerlingen, Германия |
7.22 |
1.44 |
8.66 |
7% |
0.51 |
7.73 |
1.55 |
9.28 |
20% |
1.44 |
9.17 |
1.83 |
11 |
|
НСР-1298/03.10.2013 |
18.10.2013 |
18.10.2013 |
Неактивен |
3412 |
| Triptorelin |
6164/11.11.2009. |
Decapeptyl, Solution for injection, 0.1 mg/ml - 1 ml, -, Pack: 7 pre-filled syringe |
Ferring GmbH, Германия |
Ferring GmbH, Германия |
57.54 |
11.51 |
69.05 |
4% |
2.3 |
59.84 |
11.97 |
71.81 |
16% |
9.21 |
69.05 |
13.81 |
82.86 |
Отхвърлена жалба от Комисия по прозрачност с решение КП-264/11.12.2013 |
НСР-50/07.06.2013 |
16.06.2014 |
16.06.2014 |
Активен |
2861 |
| Triptorelin |
6164/11.11.2009. |
Decapeptyl 0.1 mg, Solution for injection, 0.1, mg, Pack: 7 |
Ferring GmbH, Германия |
Ferring GmbH, Германия |
80.15 |
16.03 |
96.18 |
4% |
3.21 |
83.36 |
16.67 |
100.03 |
16% |
12.82 |
96.18 |
19.24 |
115.42 |
КЦ-1439/05.03.2010 за промяна на обстоятелства |
КЦ-473/29.01.2009 |
12.02.2009 |
12.02.2009 |
Неактивен |
2861 |
| Triptorelin |
6165/11.11.2009 |
Decapeptyl Depot, Powder and solvent for suspension for injection, 3.75, mg, Pack: 1 |
Ferring GmbH, Германия |
Ferring GmbH, Германия |
123.86 |
24.77 |
148.63 |
4% |
4.95 |
128.81 |
25.76 |
154.57 |
16% |
19.82 |
148.63 |
29.73 |
178.36 |
|
НСР-7108/15.09.2015; НСР-11216/15.12.2016; НСР-14173/13.10.2017; НСР-15831/08.06.2018 |
23.06.2018 |
02.07.2018 |
Активен |
3557 |
| Triptorelin |
6165/11.11.2009 |
Decapeptyl Depot, Powder and solvent for suspension for injection, 3.75, mg, Pack: 1 |
Ferring GmbH, Германия |
Ferring GmbH, Германия |
125.94 |
25.19 |
151.13 |
4% |
5.04 |
130.98 |
26.2 |
157.18 |
16% |
20.15 |
151.13 |
30.23 |
181.36 |
|
НСР-7108/15.09.2015; НСР-11216/15.12.2016; НСР-14173/13.10.2017 |
28.10.2017 |
02.11.2017 |
Неактивен |
3557 |
| Triptorelin |
6165/11.11.2009 |
Decapeptyl Depot, Powder and solvent for suspension for injection, 3.75, mg, Pack: 1 |
Ferring GmbH, Германия |
Ferring GmbH, Германия |
126.58 |
25.32 |
151.9 |
4% |
5.06 |
131.64 |
26.33 |
157.97 |
16% |
20.25 |
151.89 |
30.38 |
182.27 |
|
НСР-7108/15.09.2015; НСР-11216/15.12.2016 |
02.02.2017 |
02.02.2017 |
Неактивен |
3557 |
| Triptorelin |
6165/11.11.2009 |
Decapeptyl Depot, Powder and solvent for suspension for injection, 3.75, mg, Pack: 1 |
Ferring GmbH, Германия |
Ferring GmbH, Германия |
132.45 |
26.49 |
158.94 |
4% |
5.3 |
137.75 |
27.55 |
165.3 |
16% |
21.19 |
158.94 |
31.79 |
190.73 |
|
НСР-7108/15.09.2015 |
01.10.2015 |
01.10.2015 |
Неактивен |
3557 |
| Triptorelin |
6165/11.11.2009 |
Decapeptyl Depot, Powder and solvent for suspension for injection, 3.75, mg, Pack: 1 |
Ferring GmbH, Германия |
Ferring GmbH, Германия |
136.42 |
27.28 |
163.7 |
4% |
5.46 |
141.88 |
28.38 |
170.26 |
16% |
21.83 |
163.71 |
32.74 |
196.45 |
|
НСР-5538/29.01.2015 |
12.02.2015 |
12.02.2015 |
Неактивен |
3557 |
| Triptorelin |
6165/11.11.2009 |
Decapeptyl Depot, Powder and solvent for suspension for injection, 3.75, mg, Pack: 1 |
Ferring GmbH, Германия |
Ferring GmbH, Германия |
150.05 |
30.01 |
180.06 |
4% |
6 |
156.05 |
31.21 |
187.26 |
16% |
24.01 |
180.06 |
36.01 |
216.07 |
|
НСР-3687/06.06.2014 |
23.06.2014 |
23.06.2014 |
Неактивен |
3557 |
| Triptorelin |
6165/11.11.2009 |
Decapeptyl Depot, Powder and solvent for suspension for injection, 3.75, mg, Pack: 1 |
Ferring GmbH, Германия |
Ferring GmbH, Германия |
151.05 |
30.21 |
181.26 |
4% |
6.04 |
157.09 |
31.42 |
188.51 |
16% |
24.17 |
181.26 |
36.25 |
217.51 |
|
НСР-1383/07.10.2013 |
28.10.2013 |
28.10.2013 |
Неактивен |
3557 |
| Triptorelin |
6165/11.11.2009 |
Decapeptyl Depot, Powder and solvent for suspension for injection, 3.75, mg, Pack: 1 |
Ferring GmbH, Германия |
Ferring GmbH, Германия |
177.61 |
35.52 |
213.13 |
4% |
7.1 |
184.71 |
36.94 |
221.65 |
16% |
25 |
209.71 |
41.94 |
251.65 |
|
КЦРР-881/28.06.2012 |
24.07.2012 |
24.07.2012 |
Неактивен |
3557 |
| Triptorelin |
6165/11.11.2009 |
Decapeptyl Depot, Powder and solvent for suspension for injection, 3.75, mg, Pack: 1 |
Ferring GmbH, Германия |
Ferring GmbH, Германия |
191.12 |
38.22 |
229.34 |
6% |
11.47 |
202.59 |
40.52 |
243.11 |
18% |
30 |
232.59 |
46.52 |
279.11 |
КЦ-1662/25.06.2010 за промяна на обстоятелства |
КЦ-473/29.01.2009 |
12.02.2009 |
12.02.2009 |
Неактивен |
3557 |