| Ustekinumab |
EU/1/08/ 494/003 |
STELARA, Solution for injection, 45, mg, Pack: 1 |
Janssen-Cilag International N.V., Белгия |
Janssen Biologics B.V.Einsteinweg 101NL-2333 CB Leiden,Холандия |
5407.79 |
1081.56 |
6489.35 |
4% |
10 |
5417.79 |
1083.56 |
6501.35 |
16% |
25 |
5442.79 |
1088.56 |
6531.35 |
|
НСР-3654/29.05.2014 |
13.06.2014 |
13.06.2014 |
Неактивен |
3636 |
| Ustekinumab |
EU/1/08/ 494/003 |
STELARA, Solution for injection, 45, mg, Pack: 1 |
Janssen-Cilag International N.V., Белгия |
Janssen Biologics B.V.Einsteinweg 101NL-2333 CB Leiden,Холандия |
5479.92 |
1095.98 |
6575.9 |
4% |
10 |
5489.92 |
1097.98 |
6587.9 |
16% |
25 |
5514.92 |
1102.98 |
6617.9 |
|
НСР-1117/10.09.2013 |
24.09.2013 |
24.09.2013 |
Неактивен |
3636 |
| Electrolytes |
20130250 |
Sterofundin ISO, Solution for infusion, 1000 ml 6.80 g/l /0.30 g/l / 0.20 g/l / 0.37 g/l / 3.27 g/l / 0.67 g/l, ml, Pack: 1 |
B. Braun Melsungen AG, Германия |
B. Braun Melsungen AG, Германия;B. Braun Medical S.A., Испания |
5.46 |
1.09 |
6.55 |
7% |
0.38 |
5.84 |
1.17 |
7.01 |
20% |
1.09 |
6.93 |
1.39 |
8.32 |
|
НСР-6207/21.05.2015 |
04.06.2015 |
04.06.2015 |
Активен |
3080 |
| Electrolytes |
20130250 |
Sterofundin ISO, Solution for infusion, 500 ml 6.80 g/l /0.30 g/l / 0.20 g/l / 0.37 g/l / 3.27 g/l / 0.67 g/l, ml, Pack: 1 |
B. Braun Melsungen AG, Германия |
B. Braun Melsungen AG, Германия;B. Braun Medical S.A., Испания |
4.65 |
0.93 |
5.58 |
7% |
0.33 |
4.98 |
1 |
5.98 |
20% |
0.93 |
5.91 |
1.18 |
7.09 |
|
НСР-6206/21.05.2015 |
04.06.2015 |
04.06.2015 |
Активен |
3079 |
| Electrolytes |
20130250 |
Sterofundin ISO, Solution for infusion, 1000 ml 6.80 g/l /0.30 g/l / 0.20 g/l / 0.37 g/l / 3.27 g/l / 0.67 g/l, ml, Pack: 1 |
B. Braun Melsungen AG, Германия |
B. Braun Melsungen AG, Германия;B. Braun Medical S.A., Испания |
5.57 |
1.11 |
6.68 |
7% |
0.39 |
5.96 |
1.19 |
7.15 |
20% |
1.11 |
7.07 |
1.41 |
8.48 |
|
НСР-4428/07.08.2014 |
25.08.2014 |
25.08.2014 |
Неактивен |
3080 |
| Electrolytes |
20130250 |
Sterofundin ISO, Solution for infusion, 500 ml 6.80 g/l /0.30 g/l / 0.20 g/l / 0.37 g/l / 3.27 g/l / 0.67 g/l, ml, Pack: 1 |
B. Braun Melsungen AG, Германия |
B. Braun Melsungen AG, Германия;B. Braun Medical S.A., Испания |
4.75 |
0.95 |
5.7 |
7% |
0.33 |
5.08 |
1.02 |
6.1 |
20% |
0.95 |
6.03 |
1.21 |
7.24 |
|
НСР-4427/07.08.2014 |
25.08.2014 |
25.08.2014 |
Неактивен |
3079 |
| Sertraline |
20040312 |
STIMULOTON, Film coated tablet, 50, mg, Pack: 30 |
EGIS Pharmaceuticals PLC, Унгария |
EGIS Pharmaceuticals PLC, УНГАРИЯ |
6.24 |
1.25 |
7.49 |
7% |
0.44 |
6.68 |
1.34 |
8.02 |
20% |
1.25 |
7.93 |
1.59 |
9.52 |
Отхвърлена жалба от Комисия по прозрачност с решение КП-105/06.04.2015; Промяна на обстоятелства НСР-11985/10.03.2017 |
НСР-3546/16.05.2014.; HCP-6025/09.04.2015. |
02.05.2015 |
02.04.2017 |
Активен |
3783 |
| Sertraline |
13679/27.06.2006 г. |
STIMULOTON, Film coated tablet, 50, mg, Pack: 30 |
EGIS Pharmaceuticals PLC, Унгария |
EGIS Pharmaceuticals PLC, УНГАРИЯ |
6.24 |
1.25 |
7.49 |
7% |
0.44 |
6.68 |
1.34 |
8.02 |
20% |
1.25 |
7.93 |
1.59 |
9.52 |
Отхвърлена жалба от Комисия по прозрачност с решение КП-105/06.04.2015 |
НСР-3546/16.05.2014.; HCP-6025/09.04.2015. |
02.05.2015 |
02.05.2015 |
Неактивен |
3783 |
| Sertraline |
13679/27.06.2006 г. |
STIMULOTON, Film coated tablet, 50, mg, Pack: 30 |
EGIS Pharmaceuticals PLC, Унгария |
EGIS Pharmaceuticals PLC, УНГАРИЯ |
9.27 |
1.85 |
11.12 |
7% |
0.65 |
9.92 |
1.98 |
11.9 |
20% |
1.85 |
11.77 |
2.35 |
14.12 |
|
КЦ-355/19.12.2008 |
20.01.2009 |
20.01.2009 |
Неактивен |
3783 |
| Regorafenib |
EU/1/13/858/002 |
Stivarga, Film coated tablet, 40, mg, Pack: 3 x 28 |
Bayer AG, Германия |
Bayer AG, Германия |
4213.66 |
842.73 |
5056.39 |
4% |
10 |
4223.66 |
844.73 |
5068.39 |
16% |
25 |
4248.66 |
849.73 |
5098.39 |
|
НСР-14781/28.12.2017 предварително изпълнение; НСР-16454/17.08.2018; НСР-19203/12.07.2019 |
27.07.2019 |
02.08.2019 |
Активен |
8906 |
| Regorafenib |
EU/1/13/858/002 |
Stivarga, Film coated tablet, 40, mg, Pack: 3 x 28 |
Bayer AG, Германия |
Bayer AG, Германия |
4251.78 |
850.36 |
5102.14 |
4% |
10 |
4261.78 |
852.36 |
5114.14 |
16% |
25 |
4286.78 |
857.36 |
5144.14 |
|
НСР-14781/28.12.2017 предварително изпълнение; НСР-16454/17.08.2018 |
01.09.2018 |
02.09.2018 |
Неактивен |
8906 |
| Regorafenib |
EU/1/13/858/002 |
Stivarga, Film coated tablet, 40, mg, Pack: 3 x 28 |
Bayer AG, Германия |
Bayer AG, Германия |
4251.78 |
850.36 |
5102.14 |
4% |
10 |
4261.78 |
852.36 |
5114.14 |
16% |
25 |
4286.78 |
857.36 |
5144.14 |
|
НСР-14781/28.12.2017 предварително изпълнение; НСР-16454/17.08.2018 |
01.09.2018 |
02.09.2018 |
Неактивен |
8906 |
| Regorafenib |
EU/1/13/858/002 |
Stivarga, Film coated tablet, 40, mg, Pack: 3 x 28 |
Bayer AG, Германия |
Bayer AG, Германия |
4300.62 |
860.12 |
5160.74 |
4% |
10 |
4310.62 |
862.12 |
5172.74 |
16% |
25 |
4335.62 |
867.12 |
5202.74 |
|
НСР-14781/28.12.2017 предварително изпълнение |
28.12.2017 |
02.01.2018 |
Неактивен |
8906 |
| Regorafenib |
EU/1/13/858/002 |
Stivarga, Film coated tablet, 40, mg, Pack: 3 x 28 |
Bayer AG, Германия |
Bayer AG, Германия |
4300.62 |
860.12 |
5160.74 |
4% |
10 |
4310.62 |
862.12 |
5172.74 |
16% |
25 |
4335.62 |
867.12 |
5202.74 |
|
НСР-14781/28.12.2017 предварително изпълнение |
28.12.2017 |
02.01.2018 |
Неактивен |
8906 |
| Regorafenib |
EU/1/13/858/002 |
Stivarga, Film coated tablet, 40, mg, Pack: 3 x 28 |
Bayer AG, Германия |
Bayer AG, Германия |
4300.62 |
860.12 |
5160.74 |
4% |
10 |
4310.62 |
862.12 |
5172.74 |
16% |
25 |
4335.62 |
867.12 |
5202.74 |
|
НСР-14781/28.12.2017 предварително изпълнение |
28.12.2017 |
02.01.2018 |
Неактивен |
8906 |
| Efavirenz |
EU/1/99/111/011 |
Stocrin, Film coated tablet, 200, tabl, Pack: 90 |
Merck Sharp & Dohme B.V., Нидерландия |
Merck Sharp & Dohme B.V.- The Netherlands |
106.2 |
21.24 |
127.44 |
4% |
4.25 |
110.45 |
22.09 |
132.54 |
16% |
16.99 |
127.44 |
25.49 |
152.93 |
Промяна на обстоятелствата НСР-16946/04.10.2018 |
КЦ-651/05.03.2009 |
18.03.2009 |
02.11.2018 |
Активен |
596 |
| Efavirenz |
EU/1/99/111/011 |
Stocrin, Film coated tablet, 200, tabl, Pack: 90 |
Merck Sharp & Dohme Ltd., Обединено Кралство |
Merck Sharp & Dohme B.V.- The Netherlands |
106.2 |
21.24 |
127.44 |
4% |
4.25 |
110.45 |
22.09 |
132.54 |
16% |
16.99 |
127.44 |
25.49 |
152.93 |
|
КЦ-651/05.03.2009 |
18.03.2009 |
18.03.2009 |
Неактивен |
596 |
| Perindopril |
20090314 |
Stopress, Tablet, 8, mg, Pack: 30 |
Pharmaceutical Works Polpharma S.A. (PL), Полша |
Pharmaceutical Works POLPHARMA S.A. Poland |
8.7 |
1.74 |
10.44 |
7% |
0.61 |
9.31 |
1.86 |
11.17 |
20% |
1.74 |
11.05 |
2.21 |
13.26 |
|
КЦРР-1513/18.10.2012 |
02.11.2012 |
02.11.2012 |
Активен |
1410 |
| Perindopril |
20090313 |
Stopress, Tablet, 4, mg, Pack: 30 |
Pharmaceutical Works Polpharma S.A. (PL), Полша |
Pharmaceutical Works POLPHARMA S.A. Poland |
4.6 |
0.92 |
5.52 |
7% |
0.32 |
4.92 |
0.98 |
5.9 |
20% |
0.92 |
5.84 |
1.17 |
7.01 |
|
КЦРР-1513/18.10.2012 |
02.11.2012 |
02.11.2012 |
Активен |
1409 |
| Perindopril |
20090314 |
Stopress, Tablet, 8, mg, Pack: 30 |
Pharmaceutical Works Polpharma S.A. (PL), Полша |
Pharmaceutical Works POLPHARMA S.A. Poland |
8.7 |
1.74 |
10.44 |
7% |
0.61 |
9.31 |
1.86 |
11.17 |
20% |
1.74 |
11.05 |
2.21 |
13.26 |
|
КЦРР-1513/18.10.2012 |
02.11.2012 |
02.11.2012 |
Неактивен |
1410 |
| Perindopril |
20090313 |
Stopress, Tablet, 4, mg, Pack: 30 |
Pharmaceutical Works Polpharma S.A. (PL), Полша |
Pharmaceutical Works POLPHARMA S.A. Poland |
4.6 |
0.92 |
5.52 |
7% |
0.32 |
4.92 |
0.98 |
5.9 |
20% |
0.92 |
5.84 |
1.17 |
7.01 |
|
КЦРР-1513/18.10.2012 |
02.11.2012 |
02.11.2012 |
Неактивен |
1409 |
| Iodine Ioflupane (123I) |
EU/1/19/1372/002 |
Striascan, Solution for injection, 74 MBq/ml - 5 ml, -, Pack: 1 vial, glass |
CIS Bio International, Франция |
CIS Bio International, Франция |
1054 |
210.8 |
1264.8 |
4% |
10 |
1064 |
212.8 |
1276.8 |
16% |
25 |
1089 |
217.8 |
1306.8 |
|
НСР-20567/09.01.2020 Предварително изпълнение |
09.01.2020 |
02.02.2020 |
Активен |
16842 |
| Olodaterol |
20130417 |
Striverdi Respimat, Inhalation solution, 2,5, mcg, Pack: 1 respimat inhaler and 1 cartridge (60 doses) |
Boehringer Ingelheim International GmbH, Германия |
Boehringer Ingelheim Pharma GmbH &Co.KG, Германия |
41.07 |
8.21 |
49.28 |
4% |
1.64 |
42.71 |
8.54 |
51.25 |
16% |
6.57 |
49.28 |
9.86 |
59.14 |
корекц. НСР-7731/17.12.2015 |
НСР-7563/24.11.2015 (допуска предварително изпълнение); НСР-14917/25.01.2018 |
02.12.2015 |
02.03.2018 |
Заличен |
4113 |
| Olodaterol |
20130417 |
Striverdi Respimat, Inhalation solution, 2,5, mcg, Pack: 1 respimat inhaler and 1 cartridge (60 doses) |
Boehringer Ingelheim International GmbH, Германия |
Boehringer Ingelheim Pharma GmbH &Co.KG, Германия |
41.07 |
8.21 |
49.28 |
4% |
1.64 |
42.71 |
8.54 |
51.25 |
16% |
6.57 |
49.28 |
9.86 |
59.14 |
корекц. НСР-7731/17.12.2015 |
НСР-7563/24.11.2015 (допуска предварително изпълнение) |
02.12.2015 |
02.12.2015 |
Неактивен |
4113 |
| Fat emulsions |
ІІ-6806/30.01.2003 г. |
Structolipid 20% emulsion for intravenous infusion, Emulsion for infusion, Purified structured triglyceride 20 g/100 ml - 250 ml, ml, Pack: 10 |
Fresenius Kabi AB, Швеция |
Fresenius Kabi AB, SE – 751 74 Uppsala, Sweden |
340.55 |
68.11 |
408.66 |
4% |
10 |
350.55 |
70.11 |
420.66 |
16% |
25 |
375.55 |
75.11 |
450.66 |
|
НСР-1443/10.10.2013; НСР-16908/28.09.2018 |
19.11.2013 |
02.11.2018 |
Заличен |
2218 |