| Risperidone |
ІІ-0417/08.08.2007 г. |
SPERIDAN, Film coated tablet, 1, mg, Pack: 30 |
Актавис EАД, България |
Actavis h.f., Iceland
Actavis Ltd., Malta |
3.44 |
0.69 |
4.13 |
7% |
0.24 |
3.68 |
0.74 |
4.42 |
20% |
0.69 |
4.37 |
0.87 |
5.24 |
|
КЦ-1621/11.06.2010 |
01.07.2010 |
01.07.2010 |
Неактивен |
938 |
| Risperidone |
20070071 |
SPERIDAN, Film coated tablet, 2, mg, Pack: 30 |
Актавис EАД, България |
Actavis h.f., Iceland
Actavis Ltd., Malta; Балканфарма-Дупница АД, България |
6.9 |
1.38 |
8.28 |
7% |
0.48 |
7.38 |
1.48 |
8.86 |
20% |
1.38 |
8.76 |
1.75 |
10.51 |
промяна на обстоятелства НСР-11853/24.02.2017 г. |
КЦ-1621/11.06.2010 |
01.07.2010 |
02.04.2017 |
Активен |
939 |
| Risperidone |
ІІ-0418/08.08.2007 г. |
SPERIDAN, Film coated tablet, 2, mg, Pack: 30 |
Актавис EАД, България |
Actavis h.f., Iceland
Actavis Ltd., Malta |
6.9 |
1.38 |
8.28 |
7% |
0.48 |
7.38 |
1.48 |
8.86 |
20% |
1.38 |
8.76 |
1.75 |
10.51 |
|
КЦ-1621/11.06.2010 |
01.07.2010 |
01.07.2010 |
Неактивен |
939 |
| Risperidone |
20070072 |
SPERIDAN, Film coated tablet, 3, mg, Pack: 30 |
Актавис EАД, България |
Actavis h.f., Iceland; Actavis Ltd., Malta; Балканфарма-Дупница АД, България |
10.44 |
2.09 |
12.53 |
6% |
0.63 |
11.07 |
2.21 |
13.28 |
18% |
1.88 |
12.95 |
2.59 |
15.54 |
Промяна на обстоятелства НСР-11852/24.02.2017 |
КЦ-1621/11.06.2010 |
01.07.2010 |
02.04.2017 |
Активен |
940 |
| Risperidone |
ІІ-0419/08.08.2007 г. |
SPERIDAN, Film coated tablet, 3, mg, Pack: 30 |
Актавис EАД, България |
Actavis h.f., Iceland
Actavis Ltd., Malta |
10.44 |
2.09 |
12.53 |
6% |
0.63 |
11.07 |
2.21 |
13.28 |
18% |
1.88 |
12.95 |
2.59 |
15.54 |
|
КЦ-1621/11.06.2010 |
01.07.2010 |
01.07.2010 |
Неактивен |
940 |
| Risperidone |
20070073 |
SPERIDAN, Film coated tablet, 4, mg, Pack: 30 |
Актавис EАД, България |
Actavis h.f., Iceland; Actavis Ltd., Malta; Балканфарма-Дупница АД, България |
13.93 |
2.79 |
16.72 |
6% |
0.84 |
14.77 |
2.95 |
17.72 |
18% |
2.51 |
17.28 |
3.46 |
20.74 |
Промяна на обстоятелства НСР-11851/24.02.2017 |
КЦ-1621/11.06.2010 |
01.07.2010 |
02.04.2017 |
Активен |
941 |
| Risperidone |
ІІ-0420/08.08.2007 г. |
SPERIDAN, Film coated tablet, 4, mg, Pack: 30 |
Актавис EАД, България |
Actavis h.f., Iceland
Actavis Ltd., Malta |
13.93 |
2.79 |
16.72 |
6% |
0.84 |
14.77 |
2.95 |
17.72 |
18% |
2.51 |
17.28 |
3.46 |
20.74 |
|
КЦ-1621/11.06.2010 |
01.07.2010 |
01.07.2010 |
Неактивен |
941 |
| Tiotropium bromide, Olodaterol |
20150259 |
Spiolto Respimat, Inhalation solution, 2,5 mcg/2,5 mcg, -, Pack: Single pack: 1 Respimat inhaler and 1 cartridge, providing 60 puffs (30 medicinal doses) |
Boehringer Ingelheim International GmbH, Германия |
Boehringer Ingelheim Pharma GmbH & Co. KG, Binger Strasse 173, D-55216 Ingelheim Rhein, Германия |
66.3 |
13.26 |
79.56 |
4% |
2.65 |
68.95 |
13.79 |
82.74 |
16% |
10.61 |
79.56 |
15.91 |
95.47 |
|
НСР-11252/16.12.2016 г. (предварително изпълнение); НСР-13795/12.09.2017; НСР-15684/17.05.2018; НСР-17850/31.01.2019 предварително изпъленение |
31.01.2019 |
02.08.2019 |
Активен |
15523 |
| Tiotropium bromide, Olodaterol |
20150259 |
Spiolto Respimat, Inhalation solution, 2,5 mcg/2,5 mcg, -, Pack: Single pack: 1 Respimat inhaler and 1 cartridge, providing 60 puffs (30 medicinal doses) |
Boehringer Ingelheim International GmbH, Германия |
Boehringer Ingelheim Pharma GmbH & Co. KG, Binger Strasse 173, D-55216 Ingelheim Rhein, Германия |
66.3 |
13.26 |
79.56 |
4% |
2.65 |
68.95 |
13.79 |
82.74 |
16% |
10.61 |
79.56 |
15.91 |
95.47 |
|
НСР-11252/16.12.2016 г. (предварително изпълнение); НСР-13795/12.09.2017; НСР-15684/17.05.2018; НСР-17850/31.01.2019 предварително изпъленение* |
31.01.2019 |
02.02.2019 |
Неактивен |
15523 |
| Tiotropium bromide, Olodaterol |
20150259 |
Spiolto Respimat, Inhalation solution, 2,5 mcg/2,5 mcg, -, Pack: Single pack: 1 Respimat inhaler and 1 cartridge, providing 60 puffs (30 medicinal doses) |
Boehringer Ingelheim International GmbH, Германия |
Boehringer Ingelheim Pharma GmbH & Co. KG, Binger Strasse 173, D-55216 Ingelheim Rhein, Германия |
69.43 |
13.89 |
83.32 |
4% |
2.78 |
72.21 |
14.44 |
86.65 |
16% |
11.11 |
83.32 |
16.66 |
99.98 |
|
НСР-11252/16.12.2016 г. (предварително изпълнение); НСР-13795/12.09.2017; НСР-15684/17.05.2018 |
01.06.2018 |
02.06.2018 |
Неактивен |
15523 |
| Tiotropium bromide, Olodaterol |
20150259 |
Spiolto Respimat, Inhalation solution, 2,5 mcg/2,5 mcg, -, Pack: Single pack: 1 Respimat inhaler and 1 cartridge, providing 60 puffs (30 medicinal doses) |
Boehringer Ingelheim International GmbH, Германия |
Boehringer Ingelheim Pharma GmbH & Co. KG, Binger Strasse 173, D-55216 Ingelheim Rhein, Германия |
71.76 |
14.35 |
86.11 |
4% |
2.87 |
74.63 |
14.93 |
89.56 |
16% |
11.48 |
86.11 |
17.22 |
103.33 |
|
НСР-11252/16.12.2016 г. (предварително изпълнение); НСР-13795/12.09.2017 |
27.09.2017 |
02.10.2017 |
Неактивен |
15523 |
| Tiotropium bromide, Olodaterol |
20150259 |
Spiolto Respimat, Inhalation solution, 2,5 mcg/2,5 mcg, -, Pack: Single pack: 1 Respimat inhaler and 1 cartridge, providing 60 puffs (30 medicinal doses) |
Boehringer Ingelheim International GmbH, Германия |
Boehringer Ingelheim Pharma GmbH & Co. KG, Binger Strasse 173, D-55216 Ingelheim Rhein, Германия |
82.14 |
16.43 |
98.57 |
4% |
3.29 |
85.43 |
17.09 |
102.52 |
16% |
13.14 |
98.57 |
19.71 |
118.28 |
|
НСР-11252/16.12.2016 г. (предварително изпълнение) |
02.01.2017 |
02.01.2017 |
Неактивен |
15523 |
| Tiotropium bromide |
20020374 |
SPIRIVA, Inhalation powder, hard capsule, 18, mcg, Pack: 30 (without HandiHaler) |
Boehringer Ingelheim International GmbH, Германия |
Boehringer Ingelheim Pharma GmbH & Co. KG,Germany |
43.2 |
8.64 |
51.84 |
4% |
1.73 |
44.93 |
8.99 |
53.92 |
16% |
6.91 |
51.84 |
10.37 |
62.21 |
|
НСР-57124/24.09.2015; НСР-12819/26.05.2017 г.; НСР-16349/02.08.2018 |
17.08.2018 |
02.09.2018 |
Активен |
3558 |
| Tiotropium bromide |
20020374 |
SPIRIVA, Inhalation powder, hard capsule, 18, mcg, Pack: 30 (without HandiHaler) |
Boehringer Ingelheim International GmbH, Германия |
Boehringer Ingelheim Pharma GmbH & Co. KG,Germany |
47.53 |
9.51 |
57.04 |
4% |
1.9 |
49.43 |
9.89 |
59.32 |
16% |
7.6 |
57.03 |
11.41 |
68.44 |
|
НСР-57124/24.09.2015; НСР-12819/26.05.2017 г. |
10.06.2017 |
02.07.2017 |
Неактивен |
3558 |
| Tiotropium bromide |
20020374 |
SPIRIVA, Inhalation powder, hard capsule, 18, mcg, Pack: 30 (without HandiHaler) |
Boehringer Ingelheim International GmbH, Германия |
Boehringer Ingelheim Pharma GmbH & Co. KG,Germany |
52.81 |
10.56 |
63.37 |
4% |
2.11 |
54.92 |
10.98 |
65.9 |
16% |
8.45 |
63.37 |
12.67 |
76.04 |
|
НСР-57124/24.09.2015 |
10.10.2015 |
10.10.2015 |
Неактивен |
3558 |
| Tiotropium bromide |
20020374 |
SPIRIVA, Inhalation powder, hard capsule, 18, mcg, Pack: 30 |
Boehringer Ingelheim International GmbH, Германия |
Boehringer Ingelheim Pharma GmbH & Co. KG,Germany |
53.16 |
10.63 |
63.79 |
4% |
2.13 |
55.29 |
11.06 |
66.35 |
16% |
8.51 |
63.8 |
12.76 |
76.56 |
|
НСР-5546/29.01.2015 |
12.02.2015 |
12.02.2015 |
Неактивен |
3558 |
| Tiotropium bromide |
20020374 |
SPIRIVA, Inhalation powder, hard capsule, 18, mcg, Pack: 30 |
Boehringer Ingelheim International GmbH, Германия |
Boehringer Ingelheim Pharma GmbH & Co. KG,Germany |
53.88 |
10.78 |
64.66 |
4% |
2.16 |
56.04 |
11.21 |
67.25 |
16% |
8.62 |
64.66 |
12.93 |
77.59 |
|
НСР-2124/14.12.2013 |
30.12.2013 |
30.12.2013 |
Неактивен |
3558 |
| Tiotropium bromide |
II-0691/27.09.2007 |
SPIRIVA, Inhalation powder, hard capsule, 18, mcg, Pack: 30 |
Boehringer Ingelheim International GmbH, Германия |
Boehringer Ingelheim Pharma GmbH & Co. KG,Germany |
60.36 |
12.07 |
72.43 |
4% |
2.41 |
62.77 |
12.55 |
75.32 |
16% |
9.66 |
72.43 |
14.49 |
86.92 |
|
КЦРР-2599/14.03.2013 |
01.04.2013 |
01.04.2013 |
Неактивен |
3558 |
| Tiotropium bromide |
II-0691/27.09.2007 |
SPIRIVA, Inhalation powder, hard capsule, 18, mcg, Pack: 30 |
Boehringer Ingelheim International GmbH, Германия |
Boehringer Ingelheim Pharma GmbH & Co. KG,Germany |
66.54 |
13.31 |
79.85 |
4% |
2.66 |
69.2 |
13.84 |
83.04 |
16% |
10.65 |
79.85 |
15.97 |
95.82 |
|
КЦ-415/07.01.2009 |
20.01.2009 |
20.01.2009 |
Неактивен |
3558 |
| Tiotropium bromide |
20110382 |
Spiriva Respimat, Inhalation solution, 2.5, mcg, Pack: 1 respimat inhaler and 1 cartridge (60 впръсквания/30 doses x 5 mcg) |
Boehringer Ingelheim International GmbH, Германия |
Boehringer Ingelheim International GmbH, Binger Strasse 173, D-55216 Ingelheim am Rhein, Германия |
43.2 |
8.64 |
51.84 |
4% |
1.73 |
44.93 |
8.99 |
53.92 |
16% |
6.91 |
51.84 |
10.37 |
62.21 |
Протокол №336/20.06.2019 |
НСР-7057/09.09.2015; НСР-10757/27.10.2016; НСР-13277/20.07.2017; НСР-15278/22.03.2018 (предварително изпълнение) |
22.03.2018 |
02.07.2019 |
Активен |
3493 |
| Tiotropium bromide |
20110382 |
Spiriva Respimat, Inhalation solution, 2.5, mcg, Pack: 1 respimat inhaler and 1 cartridge (60 doses) |
Boehringer Ingelheim International GmbH, Германия |
Boehringer Ingelheim International GmbH, Binger Strasse 173, D-55216 Ingelheim am Rhein, Германия |
43.2 |
8.64 |
51.84 |
4% |
1.73 |
44.93 |
8.99 |
53.92 |
16% |
6.91 |
51.84 |
10.37 |
62.21 |
|
НСР-7057/09.09.2015; НСР-10757/27.10.2016; НСР-13277/20.07.2017; НСР-15278/22.03.2018 (предварително изпълнение) |
22.03.2018 |
02.04.2018 |
Неактивен |
3493 |
| Tiotropium bromide |
20110382 |
Spiriva Respimat, Inhalation solution, 2.5, mcg, Pack: 1 respimat inhaler and 1 cartridge (60 doses) |
Boehringer Ingelheim International GmbH, Германия |
Boehringer Ingelheim International GmbH, Binger Strasse 173, D-55216 Ingelheim am Rhein, Германия |
47.53 |
9.51 |
57.04 |
4% |
1.9 |
49.43 |
9.89 |
59.32 |
16% |
7.6 |
57.03 |
11.41 |
68.44 |
|
НСР-7057/09.09.2015; НСР-10757/27.10.2016; НСР-13277/20.07.2017 |
04.08.2017 |
02.09.2017 |
Неактивен |
3493 |
| Tiotropium bromide |
20110382 |
Spiriva Respimat, Inhalation solution, 2,5, mcg, Pack: 1 respimat inhaler and 1 cartridge (60 doses) |
Boehringer Ingelheim International GmbH, Германия |
Boehringer Ingelheim International GmbH, Binger Strasse 173, D-55216 Ingelheim am Rhein, Германия |
51.79 |
10.36 |
62.15 |
4% |
2.07 |
53.86 |
10.77 |
64.63 |
16% |
8.29 |
62.15 |
12.43 |
74.58 |
|
НСР-7057/09.09.2015; НСР-10757/27.10.2016 |
02.12.2016 |
02.12.2016 |
Неактивен |
3493 |
| Tiotropium bromide |
20110382 |
Spiriva Respimat, Inhalation solution, 2,5, mcg, Pack: 1 respimat inhaler and 1 cartridge (60 doses) |
Boehringer Ingelheim International GmbH, Германия |
Boehringer Ingelheim International GmbH, Binger Strasse 173, D-55216 Ingelheim am Rhein, Германия |
52.08 |
10.42 |
62.5 |
4% |
2.08 |
54.16 |
10.83 |
64.99 |
16% |
8.33 |
62.49 |
12.5 |
74.99 |
|
НСР-7057/09.09.2015 |
25.09.2015 |
25.09.2015 |
Неактивен |
3493 |
| Tiotropium bromide |
20110382 |
Spiriva Respimat, Inhalation solution, 2,5 (60 doses), mcg, Pack: 1 |
Boehringer Ingelheim International GmbH, Германия |
Boehringer Ingelheim International GmbH, Binger Strasse 173, D-55216 Ingelheim am Rhein, Германия |
52.69 |
10.54 |
63.23 |
4% |
2.11 |
54.8 |
10.96 |
65.76 |
16% |
8.43 |
63.23 |
12.65 |
75.88 |
|
НСР-5394/07.01.2015 |
21.01.2015 |
21.01.2015 |
Неактивен |
3493 |