| Agomelatine |
20190222 |
Agomelatine G.L. Pharma, Film coated tablet, 25, mg, Pack: 30 |
G. L. Pharma GmbH, Австрия |
G.L. Pharma GmbH, Австрия; MEDIS International a.s., Чешка Република |
25.72 |
5.14 |
30.86 |
6% |
1.54 |
27.26 |
5.45 |
32.71 |
18% |
4.63 |
31.89 |
6.38 |
38.27 |
|
НСР-20979/12.03.2020; НСР-21124/30.03.2020 Предварително изпълнение** |
27.03.2020 |
02.04.2020 |
Неактивен |
16895 |
| Coagulation factor IX |
20040433 |
Aimafix, Powder and solvent for solution for infusion, 500, IU, Pack: 1 |
Kedrion S.p.A., Италия |
Kedrion S.p.A., Италия |
340.98 |
68.2 |
409.18 |
4% |
10 |
350.98 |
70.2 |
421.18 |
16% |
25 |
375.98 |
75.2 |
451.18 |
НСР-17764/17.01.2019 |
КЦ-358/19.12.2008; НСР-13031/23.06.2017 предварително изпълнение,КП-34/29.05.2017 и НСР-12077/21.03.2017; НСР-13258/18.07.2017 корекционно решение (допуска предварително изпълнение); НСР-17765/17.01.2019 |
01.02.2019 |
02.02.2019 |
Активен |
369 |
| Coagulation factor IX |
20040433 |
Aimafix, Powder and solvent for solution for infusion, 500, IU, Pack: 1 |
Kedrion S.p.A., Италия |
Kedrion S.p.A., Италия |
340.98 |
68.2 |
409.18 |
4% |
10 |
350.98 |
70.2 |
421.18 |
16% |
25 |
375.98 |
75.2 |
451.18 |
НСР-17764/17.01.2019 |
КЦ-358/19.12.2008; НСР-13031/23.06.2017 предварително изпълнение,КП-34/29.05.2017 и НСР-12077/21.03.2017; НСР-13258/18.07.2017 корекционно решение (допуска предварително изпълнение); НСР-17765/17.01.2019 |
01.02.2019 |
02.02.2019 |
Неактивен |
369 |
| Coagulation factor IX |
20040433 |
Aimafix, Powder and solvent for solution for infusion, 500, IU, Pack: 1 |
Kedrion S.p.A., Италия |
Kedrion S.p.A., Италия |
253.48 |
50.7 |
304.18 |
4% |
10 |
263.48 |
52.7 |
316.18 |
16% |
25 |
288.48 |
57.7 |
346.18 |
|
КЦ-358/19.12.2008; НСР-13031/23.06.2017 предварително изпълнение,КП-34/29.05.2017 и НСР-12077/21.03.2017; НСР-13258/18.07.2017 корекционно решение (допуска предварително изпълнение) |
19.07.2017 |
02.08.2017 |
Неактивен |
369 |
| Coagulation factor IX |
20040433 |
Aimafix DI, Powder and solvent for solution for infusion, 500, IU, Pack: 1 |
Kedrion S.p.A., Италия |
Kedrion S.p.A., Италия |
252.3 |
50.46 |
302.76 |
4% |
10 |
262.3 |
52.46 |
314.76 |
16% |
25 |
287.3 |
57.46 |
344.76 |
|
КЦ-358/19.12.2008; НСР-13031/23.06.2017 предварително изпълнение,КП-34/29.05.2017 и НСР-12077/21.03.2017 |
02.07.2017 |
02.07.2017 |
Неактивен |
369 |
| Coagulation factor IX |
II-9683/07,10,2004 |
Aimafix DI, Powder and solvent for solution for infusion, 500, IU, Pack: 1 |
Kedrion S.p.A., Италия |
Kedrion S.p.A., Italy |
253.48 |
50.7 |
304.18 |
4% |
10 |
263.48 |
52.7 |
316.18 |
16% |
25 |
288.48 |
57.7 |
346.18 |
|
КЦ-358/19.12.2008 |
05.01.2009 |
05.01.2009 |
Неактивен |
369 |
| Coagulation factor IX |
II-9683/07,10,2004 |
Aimafix DI, Powder and solvent for solution for infusion, 500, IU, Pack: 1 |
Kedrion S.p.A., Италия |
Kedrion S.p.A., Italy |
253.48 |
50.7 |
304.18 |
4% |
10 |
263.48 |
52.7 |
316.18 |
16% |
25 |
288.48 |
57.7 |
346.18 |
|
КЦ-358/19.12.2008 |
05.01.2009 |
05.01.2009 |
Неактивен |
369 |
| Budesonide, Formoterol |
20180167 |
AIRBUFO FORSPIRO, Inhalation powder, pre dispensed, 160 mcg + 4,5 mcg/dose 60 doses, UD, Pack: 2 |
Sandoz Pharmaceuticals d.d., Словения |
Aeropharm GmbH, Германия; LEK Farmacevtska druzba d.d., Словения; Salutas Pharma GmbH, Германия |
37.61 |
7.52 |
45.13 |
4% |
1.5 |
39.11 |
7.82 |
46.93 |
16% |
6.02 |
45.13 |
9.03 |
54.16 |
|
НСР-19247/18.07.2019; НСР-19373/26.07.2019-Предварително изпълнение |
18.07.2019 |
02.08.2019 |
Активен |
16618 |
| Salmeterol, Fluticasone |
20140018 |
AirFluSal Forspiro, Inhalation powder, pre dispensed, 50 mcg/500 mcg/ dose-60 doses, UD, Pack: 1 |
Sandoz Pharmaceuticals d.d., Словения |
Lek Pharmaceuticals d.d., Verovskova 57, 1526 Ljubljana, Словения; Aeropharm GmbH, Francois-Mitterrand-Allee 1, 07407 RudoIstadt, Германия; Lek Pharmaceuticals d.d.,Trimlini 2D, 9220 Lendava, Словения; Salutas Pharma GmbH., Otto-von-Guericke-Alle 1, 39179 Barleben, Германия |
51.71 |
10.34 |
62.05 |
4% |
2.07 |
53.78 |
10.76 |
64.54 |
16% |
8.27 |
62.05 |
12.41 |
74.46 |
Протокол № 202/15.12.2016 |
НСР-7270/21.10.2015.; КП-33/25.05.2017 и НСР-11769/17.02.2017; КП-11/21.01.2019 и НСР-16860/21.09.2018 предварително изпълнение; ВАС-1760/02.02.2020 |
02.03.2020 |
02.03.2020 |
Активен |
3051 |
| Salmeterol, Fluticasone |
20140018 |
AirFluSal Forspiro, Inhalation powder, pre dispensed, 50 mcg/500 mcg/ dose-60 doses, UD, Pack: 1 |
Sandoz Pharmaceuticals d.d., Словения |
Lek Pharmaceuticals d.d., Verovskova 57, 1526 Ljubljana, Словения; Aeropharm GmbH, Francois-Mitterrand-Allee 1, 07407 RudoIstadt, Германия; Lek Pharmaceuticals d.d.,Trimlini 2D, 9220 Lendava, Словения; Salutas Pharma GmbH., Otto-von-Guericke-Alle 1, 39179 Barleben, Германия |
34.09 |
6.82 |
40.91 |
4% |
1.36 |
35.45 |
7.09 |
42.54 |
16% |
5.45 |
40.9 |
8.18 |
49.08 |
Протокол № 202/15.12.2016 |
НСР-7270/21.10.2015.; КП-33/25.05.2017 и НСР-11769/17.02.2017; КП-11/21.01.2019 и НСР-16860/21.09.2018 предварително изпълнение |
21.09.2018 |
02.03.2019 |
Неактивен |
3051 |
| Salmeterol, Fluticasone |
20150137 |
AirFluSal Forspiro, Inhalation powder, pre dispensed, 50 mcg/250 mcg/dose - 60 doses, UD, Pack: 1 |
Sandoz d.d., Словения |
Aeropharm GmbH, Francois-Mitterrand-Allee 1, 07407 Rudolstadt, Германия; Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Германия |
26.19 |
5.24 |
31.43 |
6% |
1.57 |
27.76 |
5.55 |
33.31 |
18% |
4.71 |
32.47 |
6.49 |
38.96 |
|
НСР-6895/06.08.2015; НСР-9202/05.05.2016; НСР-13499/18.08.2017; КП-39/15.04.2019 и НСР-17268/14.11.2018 |
02.06.2019 |
02.06.2019 |
Активен |
4060 |
| Salmeterol, Fluticasone |
20150137 |
AirFluSal Forspiro, Inhalation powder, pre dispensed, 50 mcg/250 mcg/dose - 60 doses, UD, Pack: 1 |
Sandoz d.d., Словения |
Aeropharm GmbH, Francois-Mitterrand-Allee 1, 07407 Rudolstadt, Германия; Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Германия |
43.03 |
8.61 |
51.64 |
4% |
1.72 |
44.75 |
8.95 |
53.7 |
16% |
6.88 |
51.63 |
10.33 |
61.96 |
|
НСР-6895/06.08.2015; НСР-9202/05.05.2016; НСР-13499/18.08.2017 |
02.09.2017 |
02.10.2017 |
Неактивен |
4060 |
| Salmeterol, Fluticasone |
20140018 |
AirFluSal Forspiro, Inhalation powder, pre dispensed, 50 mcg/500 mcg/ dose-60 doses, UD, Pack: 1 |
Sandoz Pharmaceuticals d.d., Словения |
Lek Pharmaceuticals d.d., Verovskova 57, 1526 Ljubljana, Словения; Aeropharm GmbH, Francois-Mitterrand-Allee 1, 07407 RudoIstadt, Германия; Lek Pharmaceuticals d.d.,Trimlini 2D, 9220 Lendava, Словения; Salutas Pharma GmbH., Otto-von-Guericke-Alle 1, 39179 Barleben, Германия |
34.09 |
6.82 |
40.91 |
4% |
1.36 |
35.45 |
7.09 |
42.54 |
16% |
5.45 |
40.9 |
8.18 |
49.08 |
Протокол № 202/15.12.2016 |
НСР-7270/21.10.2015.; КП-33/25.05.2017 и НСР-11769/17.02.2017; НСР-16860/21.09.2018 предварително изпълнение* |
21.09.2018 |
02.10.2018 |
Неактивен |
3051 |
| Salmeterol, Fluticasone |
20140018 |
AirFluSal Forspiro, Inhalation powder, pre dispensed, 50 mcg/500 mcg/ dose-60 doses, UD, Pack: 1 |
Sandoz Pharmaceuticals d.d., Словения |
Lek Pharmaceuticals d.d., Verovskova 57, 1526 Ljubljana, Словения; Aeropharm GmbH, Francois-Mitterrand-Allee 1, 07407 RudoIstadt, Германия; Lek Pharmaceuticals d.d.,Trimlini 2D, 9220 Lendava, Словения; Salutas Pharma GmbH., Otto-von-Guericke-Alle 1, 39179 Barleben, Германия |
51.71 |
10.34 |
62.05 |
4% |
2.07 |
53.78 |
10.76 |
64.54 |
16% |
8.27 |
62.05 |
12.41 |
74.46 |
Протокол № 202/15.12.2016 |
НСР-7270/21.10.2015.; КП-33/25.05.2017 и НСР-11769/17.02.2017 |
02.07.2017 |
02.07.2017 |
Неактивен |
3051 |
| Salmeterol, Fluticasone |
20150137 |
AirFluSal Forspiro, Inhalation powder, pre dispensed, 50 mcg/250 mcg/dose - 60 doses, UD, Pack: 1 |
Sandoz d.d., Словения |
Aeropharm GmbH, Francois-Mitterrand-Allee 1, 07407 Rudolstadt, Германия; Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Германия |
55.08 |
11.02 |
66.1 |
4% |
2.2 |
57.28 |
11.46 |
68.74 |
16% |
8.81 |
66.09 |
13.22 |
79.31 |
|
НСР-6895/06.08.2015; НСР-9202/05.05.2016 |
02.06.2016 |
02.06.2016 |
Неактивен |
4060 |
| Salmeterol, Fluticasone |
20140018 |
AirFluSal Forspiro, Inhalation powder, pre dispensed, 50 mcg/500 mcg/ dose-60 doses, UD, Pack: 1 |
Sandoz Pharmaceuticals d.d., Словения |
Lek Pharmaceuticals d.d., Verovskova 57, 1526 Ljubljana, Словения; Aeropharm GmbH, Francois-Mitterrand-Allee 1, 07407 RudoIstadt, Германия; Lek Pharmaceuticals d.d.,Trimlini 2D, 9220 Lendava, Словения; Salutas Pharma GmbH., Otto-von-Guericke-Alle 1, 39179 Barleben, Германия |
69.53 |
13.91 |
83.44 |
4% |
2.78 |
72.31 |
14.46 |
86.77 |
16% |
11.12 |
83.43 |
16.69 |
100.12 |
Протокол № 202/15.12.2016 |
НСР-7270/21.10.2015. |
05.11.2015 |
02.01.2017 |
Неактивен |
3051 |
| Salmeterol, Fluticasone |
20140018 |
AirFluSal Forspiro, Inhalation powder, pre dispensed, 50 mcg/500 mcg/ dose-60 doses, UD, Pack: 1 |
Sandoz Pharmaceuticals GmbH, Германия |
Lek Pharmaceuticals d.d., Verovskova 57, 1526 Ljubljana, Словения; Aeropharm GmbH, Francois-Mitterrand-Allee 1, 07407 RudoIstadt, Германия; Lek Pharmaceuticals d.d.,Trimlini 2D, 9220 Lendava, Словения; Salutas Pharma GmbH., Otto-von-Guericke-Alle 1, 39179 Barleben, Германия |
69.53 |
13.91 |
83.44 |
4% |
2.78 |
72.31 |
14.46 |
86.77 |
16% |
11.12 |
83.43 |
16.69 |
100.12 |
|
НСР-7270/21.10.2015. |
05.11.2015 |
05.11.2015 |
Неактивен |
3051 |
| Salmeterol, Fluticasone |
20150137 |
AirFluSal Forspiro, Inhalation powder, pre dispensed, 50 mcg/250 mcg/dose - 60 doses, UD, Pack: 1 |
Sandoz d.d., Словения |
Aeropharm GmbH, Francois-Mitterrand-Allee 1, 07407 Rudolstadt, Германия; Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Германия |
57.17 |
11.43 |
68.6 |
4% |
2.29 |
59.46 |
11.89 |
71.35 |
16% |
9.15 |
68.61 |
13.72 |
82.33 |
|
НСР-6895/06.08.2015 |
21.08.2015 |
21.08.2015 |
Неактивен |
4060 |
| Salmeterol, Fluticasone |
20140018 |
AirFluSal Forspiro, Inhalation powder, pre dispensed, 50 mcg/500 mcg/ dose-60 doses, UD, Pack: 1 |
Sandoz Pharmaceuticals GmbH, Германия |
Lek Pharmaceuticals d.d., Verovskova 57, 1526 Ljubljana, Словения; Aeropharm GmbH, Francois-Mitterrand-Allee 1, 07407 RudoIstadt, Германия; Lek Pharmaceuticals d.d.,Trimlini 2D, 9220 Lendava, Словения; Salutas Pharma GmbH., Otto-von-Guericke-Alle 1, 39179 Barleben, Германия |
72.37 |
14.47 |
86.84 |
4% |
2.89 |
75.26 |
15.05 |
90.31 |
16% |
11.58 |
86.84 |
17.37 |
104.21 |
Протокол 135/09.09.2015 |
НСР-4246/30.07.2014 |
13.08.2014 |
13.08.2014 |
Неактивен |
3051 |
| Biperiden |
20050418 |
Akinestat, Tablet, 2, mg, Pack: 50 |
Чайкафарма Висококачествените лекарства АД, България |
Чайкафарма Висококачествените лекарства АД - София |
8.27 |
1.65 |
9.92 |
7% |
0.58 |
8.85 |
1.77 |
10.62 |
20% |
1.65 |
10.5 |
2.1 |
12.6 |
промяна на обстоятелства НСР-5815/12.03.2015 |
КЦ-278/14.11.2008; НСР-17928/18.02.2019 |
05.03.2019 |
02.04.2019 |
Активен |
253 |
| Biperiden |
20050418 |
Akinestat, Tablet, 2, mg, Pack: 50 |
Чайкафарма Висококачествените лекарства АД, България |
Чайкафарма Висококачествените лекарства АД - София |
7.16 |
1.43 |
8.59 |
7% |
0.5 |
7.66 |
1.53 |
9.19 |
20% |
1.43 |
9.09 |
1.82 |
10.91 |
промяна на обстоятелства НСР-5815/12.03.2015 |
КЦ-278/14.11.2008 |
09.12.2008 |
09.12.2008 |
Неактивен |
253 |
| Biperiden |
20020915 |
Akineton, Tablet, 2, mg, Pack: 50 |
Desma GmbH, Германия |
Laboratorio Farmaceutico S.I.T.stl., Италия |
2.95 |
0.59 |
3.54 |
7% |
0.21 |
3.16 |
0.63 |
3.79 |
20% |
0.59 |
3.75 |
0.75 |
4.5 |
|
НСР-6168/08.05.2015; НСР-13202/17.07.2017; НСР-18806/30.05.2019 |
14.06.2019 |
02.07.2019 |
Активен |
3921 |
| Biperiden |
20020915 |
Akineton, Tablet, 2, mg, Pack: 50 |
Desma GmbH, Германия |
Laboratorio Farmaceutico S.I.T.stl., Италия |
2.95 |
0.59 |
3.54 |
7% |
0.21 |
3.16 |
0.63 |
3.79 |
20% |
0.59 |
3.75 |
0.75 |
4.5 |
|
НСР-6168/08.05.2015; НСР-13202/17.07.2017; НСР-18806/30.05.2019 |
14.06.2019 |
02.07.2019 |
Неактивен |
3921 |
| Biperiden |
20020915 |
Akineton, Tablet, 2, mg, Pack: 50 |
Desma GmbH, Германия |
Laboratorio Farmaceutico S.I.T.stl., Италия |
2.95 |
0.59 |
3.54 |
7% |
0.21 |
3.16 |
0.63 |
3.79 |
20% |
0.59 |
3.75 |
0.75 |
4.5 |
|
НСР-6168/08.05.2015; НСР-13202/17.07.2017; НСР-18806/30.05.2019 |
14.06.2019 |
02.07.2019 |
Неактивен |
3921 |
| Biperiden |
20020915 |
Akineton, Tablet, 2, mg, Pack: 50 |
Desma GmbH, Германия |
Laboratorio Farmaceutico S.I.T.stl., Италия |
2.88 |
0.58 |
3.46 |
7% |
0.2 |
3.08 |
0.62 |
3.7 |
20% |
0.58 |
3.66 |
0.73 |
4.39 |
|
НСР-6168/08.05.2015; НСР-13202/17.07.2017 |
01.08.2017 |
02.09.2017 |
Неактивен |
3921 |