| Atorvastatin |
20110515 |
Torvalipin, Film coated tablet, 10, mg, Pack: 30 |
Actavis Group PTC ehf., Исландия |
Actavis hf. Iceland, Actavis Ltd. - Malta |
2.41 |
0.48 |
2.89 |
7% |
0.17 |
2.58 |
0.52 |
3.1 |
20% |
0.48 |
3.06 |
0.61 |
3.67 |
корекц. КЦPP-2521/06.03.2013 |
КЦРР-2372/21.02.2013 |
08.03.2013 |
08.03.2013 |
Неактивен |
3871 |
| Atorvastatin |
20110514 |
Torvalipin, Film coated tablet, 20, mg, Pack: 30 |
Actavis Group PTC ehf., Исландия |
Actavis hf. Iceland, Actavis Ltd. - Malta |
2.78 |
0.56 |
3.34 |
7% |
0.19 |
2.97 |
0.59 |
3.56 |
20% |
0.56 |
3.53 |
0.71 |
4.24 |
корекц. КЦPP-2521/06.03.2013 |
КЦРР-2372/21.02.2013 |
08.03.2013 |
08.03.2013 |
Неактивен |
3872 |
| Atorvastatin |
20110516/ 31.08.2011 |
Torvalipin, Film coated tablet, 40, mg, Pack: 30 |
Actavis Group PTC ehf., Исландия |
Actavis hf, Iceland; Actavis Ltd. , Malta |
17.8 |
3.56 |
21.36 |
6% |
1.07 |
18.87 |
3.77 |
22.64 |
18% |
3.2 |
22.07 |
4.41 |
26.48 |
|
КЦРР-662/30.05.2012 |
13.06.2012 |
13.06.2012 |
Неактивен |
3873 |
| Atorvastatin |
20110515/ 31.08.2011 |
Torvalipin, Film coated tablet, 10, mg, Pack: 30 |
Actavis Group PTC ehf., Исландия |
Actavis hf, Iceland; Actavis Ltd. , Malta |
3.74 |
0.75 |
4.49 |
7% |
0.26 |
4 |
0.8 |
4.8 |
20% |
0.75 |
4.75 |
0.95 |
5.7 |
|
КЦРР-662/30.05.2012 |
13.06.2012 |
13.06.2012 |
Неактивен |
3871 |
| Atorvastatin |
20110514/ 31.08.2011 |
Torvalipin, Film coated tablet, 20, mg, Pack: 30 |
Actavis Group PTC ehf., Исландия |
Actavis hf, Iceland; Actavis Ltd. , Malta |
7.31 |
1.46 |
8.77 |
7% |
0.51 |
7.82 |
1.56 |
9.38 |
20% |
1.46 |
9.28 |
1.86 |
11.14 |
|
КЦРР-662/30.05.2012 |
13.06.2012 |
13.06.2012 |
Неактивен |
3872 |
| Insulin glargine |
EU/1/00/133/035 |
Toujeo, Solution for injection, 300 IU/ml-1.5 ml, mg, Pack: 5 pre-filled pen (Solostar) |
Sanofi-Aventis Deutschland GmbH, Германия |
Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Германия |
102.52 |
20.5 |
123.02 |
4% |
4.1 |
106.62 |
21.32 |
127.94 |
16% |
16.4 |
123.02 |
24.6 |
147.62 |
|
НСР-6923/12.08.2015.; НСР-10679/21.10.2016; НСР-17590/20.12.2018 |
04.01.2019 |
02.02.2019 |
Активен |
4061 |
| Insulin glargine |
EU/1/00/133/035 |
Toujeo, Solution for injection, 300 IU/ml-1.5 ml, mg, Pack: 5 pre-filled pen (Solostar) |
Sanofi-Aventis Deutschland GmbH, Германия |
Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Германия |
115.69 |
23.14 |
138.83 |
4% |
4.63 |
120.32 |
24.06 |
144.38 |
16% |
18.51 |
138.83 |
27.77 |
166.6 |
|
НСР-6923/12.08.2015.; НСР-10679/21.10.2016 |
08.11.2016 |
02.12.2016 |
Неактивен |
4061 |
| Insulin glargine |
EU/1/00/133/035 |
Toujeo, Solution for injection, 300 IU/ml-1.5 ml, mg, Pack: 5 pre-filled pen (Solostar) |
Sanofi-Aventis Deutschland GmbH, Германия |
Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Германия |
121.69 |
24.34 |
146.03 |
4% |
4.87 |
126.56 |
25.31 |
151.87 |
16% |
19.47 |
146.03 |
29.21 |
175.24 |
|
НСР-6923/12.08.2015. |
28.08.2015 |
28.08.2015 |
Неактивен |
4061 |
| Bosentan |
EU/1/02/220/002 |
Tracleer, Film coated tablet, 125, mg, Pack: 56 |
Actelion Registration Ltd., Обединено Кралство |
Actelion Pharmaceuticals Deutschland GmbH, Germany |
3556.97 |
711.39 |
4268.36 |
4% |
10 |
3566.97 |
713.39 |
4280.36 |
16% |
25 |
3591.97 |
718.39 |
4310.36 |
Отхвърля като нередовна жалбата Комисия по прозрачност КП-233/11.05.2015 |
НСР-2442/21.01.2014; НСР-9943/29.07.2016; НСР-12417/18.04.2017 |
02.09.2016 |
02.06.2017 |
Заличен |
3902 |
| Bosentan |
EU/1/02/220/002 |
Tracleer, Film coated tablet, 125, mg, Pack: 56 |
Actelion Registration Ltd., Обединено Кралство |
Actelion Pharmaceuticals Deutschland GmbH, Germany |
3556.97 |
711.39 |
4268.36 |
4% |
10 |
3566.97 |
713.39 |
4280.36 |
16% |
25 |
3591.97 |
718.39 |
4310.36 |
Отхвърля като нередовна жалбата Комисия по прозрачност КП-233/11.05.2015 |
НСР-2442/21.01.2014; НСР-9943/29.07.2016 |
02.09.2016 |
02.09.2016 |
Неактивен |
3902 |
| Bosentan |
EU/1/02/220/002 |
Tracleer, Film coated tablet, 125, mg, Pack: 56 |
Actelion Registration Ltd., Обединено Кралство |
Actelion Pharmaceuticals Deutschland GmbH, Germany |
3736.44 |
747.29 |
4483.73 |
4% |
10 |
3746.44 |
749.29 |
4495.73 |
16% |
25 |
3771.44 |
754.29 |
4525.73 |
Отхвърля като нередовна жалбата Комисия по прозрачност КП-233/11.05.2015 |
НСР-2442/21.01.2014 |
02.06.2015 |
02.06.2015 |
Неактивен |
3902 |
| Bosentan |
EU/1/02/220/002 |
Tracleer, Film coated tablet, 125, mg, Pack: 56 |
Actelion Registration Ltd., Обединено Кралство |
Actelion Pharmaceuticals Deutschland GmbH, Germany |
4361.01 |
872.2 |
5233.21 |
4% |
10 |
4371.01 |
874.2 |
5245.21 |
16% |
25 |
4396.01 |
879.2 |
5275.21 |
|
КЦ-851/12.05.2009 |
29.05.2009 |
29.05.2009 |
Неактивен |
3902 |
| Atracurium |
20000494 |
Tracrium, Solution for injection, 10 mg/ ml - 2.5 ml, -, Pack: 5 |
Aspen Pharma Trading Limited, Ирландия |
GlaxoSmithKline Manufacturing S.p.A., Strada Provinciale Asolana, 90 43056 San Polo di Torrile Parma, Italy |
6.4 |
1.28 |
7.68 |
7% |
0.45 |
6.85 |
1.37 |
8.22 |
20% |
1.28 |
8.13 |
1.63 |
9.76 |
Промяна на обстоятелствата НСР-17107/26.10.2018 |
КЦРР-811/15.06.2012 |
02.07.2012 |
02.12.2018 |
Активен |
1257 |
| Atracurium |
II-11710 / 24.10.2005 г. |
Tracrium, Solution for injection, 10 mg/ ml - 2.5 ml, -, Pack: 5 |
Glaxo Group Ltd., Обединено Кралство |
Glaxo Wellcome Operations, Temle Hill, Dartford, Kent, United Kingdom; GlaxoSmithKline Manufacturing S.p.A., Strada Provinciale Asolana, 90 43056 San Polo di Torrile Parma, Italy |
6.4 |
1.28 |
7.68 |
7% |
0.45 |
6.85 |
1.37 |
8.22 |
20% |
1.28 |
8.13 |
1.63 |
9.76 |
|
КЦРР-811/15.06.2012 |
02.07.2012 |
02.07.2012 |
Неактивен |
1257 |
| Atracurium |
20000494 |
Tracrium, Solution for injection, 10 mg/ml - 5 ml, -, Pack: 5 |
Aspen Pharma Trading Limited, Ирландия |
GlaxoSmithKline Manufacturing S.p.A., Strada Provinciale Asolana, 90 43056 San Polo di Torrile Parma, Italy |
12.63 |
2.53 |
15.16 |
6% |
0.76 |
13.39 |
2.68 |
16.07 |
18% |
2.27 |
15.66 |
3.13 |
18.79 |
Промяна на обстоятелствата НСР-17109/26.10.2018 |
НСР-4714/26.09.2014; НСР-14514/23.11.2017; НСР-16688/30.08.2018 |
14.09.2018 |
02.12.2018 |
Активен |
3185 |
| Atracurium |
II-11710/24.10.2005 г. |
Tracrium, Solution for injection, 10 mg/ ml - 5 ml, -, Pack: 5 |
Glaxo Group Ltd., Обединено Кралство |
Glaxo Wellcome Operations, Temle Hill, Dartford, Kent, United Kingdom; GlaxoSmithKline Manufacturing S.p.A., Strada Provinciale Asolana, 90 43056 San Polo di Torrile Parma, Italy |
12.63 |
2.53 |
15.16 |
6% |
0.76 |
13.39 |
2.68 |
16.07 |
18% |
2.27 |
15.66 |
3.13 |
18.79 |
|
НСР-4714/26.09.2014; НСР-14514/23.11.2017; НСР-16688/30.08.2018 |
14.09.2018 |
02.10.2018 |
Неактивен |
3185 |
| Atracurium |
II-11710/24.10.2005 г. |
Tracrium, Solution for injection, 10 mg/ ml - 5 ml, -, Pack: 5 |
Glaxo Group Ltd., Обединено Кралство |
Glaxo Wellcome Operations, Temle Hill, Dartford, Kent, United Kingdom; GlaxoSmithKline Manufacturing S.p.A., Strada Provinciale Asolana, 90 43056 San Polo di Torrile Parma, Italy |
12.69 |
2.54 |
15.23 |
6% |
0.76 |
13.45 |
2.69 |
16.14 |
18% |
2.28 |
15.73 |
3.15 |
18.88 |
|
НСР-4714/26.09.2014; НСР-14514/23.11.2017 |
08.12.2017 |
02.01.2018 |
Неактивен |
3185 |
| Atracurium |
II-11710 / 24.10.2005 г. |
Tracrium, Solution for injection, 10 mg/ ml - 5 ml, -, Pack: 5 |
Glaxo Group Ltd., Обединено Кралство |
Glaxo Wellcome Operations, Temle Hill, Dartford, Kent, United Kingdom; GlaxoSmithKline Manufacturing S.p.A., Strada Provinciale Asolana, 90 43056 San Polo di Torrile Parma, Italy |
12.79 |
2.56 |
15.35 |
6% |
0.77 |
13.56 |
2.71 |
16.27 |
18% |
2.3 |
15.86 |
3.17 |
19.03 |
|
НСР-4714/26.09.2014 |
10.10.2014 |
10.10.2014 |
Неактивен |
3185 |
| Atracurium |
II-11710 / 24.10.2005 г. |
Tracrium sol. Inj. 10 mg/ ml, 2.5 ml x 5, Solution for injection, 25, mg, Pack: 5 |
Glaxo Group Ltd., Обединено Кралство |
Glaxo Wellcome Operations, Temle Hill, Dartford, Kent, United Kingdom
GlaxoSmithKline Manufacturing S.p.A., Strada Provinciale Asolana, 90 43056 San Polo di Torrile Parma, Italy |
11.34 |
2.27 |
13.61 |
8% |
0.91 |
12.25 |
2.45 |
14.7 |
20% |
2.27 |
14.52 |
2.9 |
17.42 |
|
КЦ-704/09.03.2009 |
24.03.2009 |
24.03.2009 |
Неактивен |
1257 |
| Atracurium |
II-11710 / 24.10.2005 г. |
Tracrium sol. Inj. 10 mg/ ml, 5 ml x 5, Solution for injection, 50, mg, Pack: 5 |
Glaxo Group Ltd., Обединено Кралство |
Glaxo Wellcome Operations, Temle Hill, Dartford, Kent, United Kingdom; GlaxoSmithKline Manufacturing S.p.A., Strada Provinciale Asolana, 90 43056 San Polo di Torrile Parma, Italy |
12.81 |
2.56 |
15.37 |
6% |
0.77 |
13.58 |
2.72 |
16.3 |
18% |
2.31 |
15.89 |
3.18 |
19.07 |
|
КЦРР-811/15.06.2012 |
02.07.2012 |
02.07.2012 |
Неактивен |
3185 |
| Atracurium |
II-11710 / 24.10.2005 г. |
Tracrium sol. Inj. 10 mg/ ml, 5 ml x 5, Solution for injection, 50, mg, Pack: 5 |
Glaxo Group Ltd., Обединено Кралство |
Glaxo Wellcome Operations, Temle Hill, Dartford, Kent, United Kingdom
GlaxoSmithKline Manufacturing S.p.A., Strada Provinciale Asolana, 90 43056 San Polo di Torrile Parma, Italy |
21.81 |
4.36 |
26.17 |
8% |
1.74 |
23.55 |
4.71 |
28.26 |
20% |
4.36 |
27.91 |
5.58 |
33.49 |
|
КЦ-704/09.03.2009 |
24.03.2009 |
24.03.2009 |
Неактивен |
3185 |
| Combinations (trace elements) |
20010028 |
Tracutil, Concentrate for solution for infusion, 10, ml, Pack: 5 |
B. Braun Melsungen AG, Германия |
B.Braun Melsungen AG, 34212 Carl Braun Str.1, Melsungen Germany |
11.05 |
2.21 |
13.26 |
6% |
0.66 |
11.71 |
2.34 |
14.05 |
18% |
1.99 |
13.7 |
2.74 |
16.44 |
промяна на обстоятелства НСР-11502/19.01.2017 г. |
КЦ-1003/25.06.2009 |
16.07.2009 |
02.03.2017 |
Активен |
778 |
| Combinations (trace elements) |
ІІ-14207/28.08.2006 г. |
Tracutil, Concentrate for solution for infusion, 10, ml, Pack: 5 |
B. Braun Melsungen AG, Германия |
B.Braun Melsungen AG, 34212 Carl Braun Str.1, Melsungen Germany |
11.05 |
2.21 |
13.26 |
6% |
0.66 |
11.71 |
2.34 |
14.05 |
18% |
1.99 |
13.7 |
2.74 |
16.44 |
|
КЦ-1003/25.06.2009 |
16.07.2009 |
16.07.2009 |
Неактивен |
778 |
| Linagliptin |
EU/1/11/707/004 |
Trajenta, Film coated tablet, 5, mg, Pack: 30 |
Boehringer Ingelheim International GmbH, Германия |
Boehringer Ingelheim Pharma GmbH & Co. KG, Binger Strasse 173 D-55216 Ingelheim am Rhein Германия |
63.56 |
12.71 |
76.27 |
4% |
2.54 |
66.1 |
13.22 |
79.32 |
16% |
10.17 |
76.27 |
15.25 |
91.52 |
корекционно решение НСР-7674/10.12.2015 |
НСР-7593/26.11.2015.; НСР-9833/21.07.2016; НСР-12729/19.05.2017; НСР-15171/02.03.2018; НСР-17242/14.11.2018 |
29.11.2018 |
02.12.2018 |
Активен |
2034 |
| Linagliptin |
EU/1/11/707/004 |
Trajenta, Film coated tablet, 5, mg, Pack: 30 |
Boehringer Ingelheim International GmbH, Германия |
Boehringer Ingelheim Pharma GmbH & Co. KG, Binger Strasse 173 D-55216 Ingelheim am Rhein Германия |
63.99 |
12.8 |
76.79 |
4% |
2.56 |
66.55 |
13.31 |
79.86 |
16% |
10.24 |
76.79 |
15.36 |
92.15 |
корекционно решение НСР-7674/10.12.2015 |
НСР-7593/26.11.2015.; НСР-9833/21.07.2016; НСР-12729/19.05.2017; НСР-15171/02.03.2018 |
17.03.2018 |
02.04.2018 |
Неактивен |
2034 |