| Coagulation factor VIII (Octocog alfa) |
EU/1/03/271/002 |
Advate 500 IU, Powder and solvent for solution for injection, 500, IU, Pack: 1 vial powder + 1 vial solvent (5 ml) + reconstitution device |
Baxter AG, Австрия |
Baxter SA., Belgium; Baxalta Belgium Manufacturing SA, Белгия |
560.48 |
112.1 |
672.58 |
4% |
10 |
570.48 |
114.1 |
684.58 |
16% |
25 |
595.48 |
119.1 |
714.58 |
Протокол №224/18.05.2017; промяна на обстоятелства НСР-15263/15.03.2018 |
НСР-2214/20.12.2013; НСР-15430/19.04.2018 |
04.05.2018 |
02.06.2018 |
Активен |
2443 |
| Coagulation factor VIII (Octocog alfa) |
EU/1/03/271/002 |
Advate 500 IU, Powder and solvent for solution for injection, 500, IU, Pack: 1 vial powder + 1 vial solvent (5 ml) + reconstitution device |
Baxter AG, Австрия |
Baxter SA., Belgium; Baxalta Belgium Manufacturing SA, Белгия |
560.48 |
112.1 |
672.58 |
4% |
10 |
570.48 |
114.1 |
684.58 |
16% |
25 |
595.48 |
119.1 |
714.58 |
Протокол №224/18.05.2017; промяна на обстоятелства НСР-15263/15.03.2018 |
НСР-2214/20.12.2013; НСР-15430/19.04.2018 |
04.05.2018 |
02.06.2018 |
Неактивен |
2443 |
| Coagulation factor VIII (Octocog alfa) |
EU/1/03/271/002 |
Advate 500 IU, Powder and solvent for solution for injection, 500, IU, Pack: 1 vial powder + 1 vial solvent (5 ml) + reconstitution device |
Baxter AG, Австрия |
Baxter SA., Belgium; Baxalta Belgium Manufacturing SA, Белгия |
568.19 |
113.64 |
681.83 |
4% |
10 |
578.19 |
115.64 |
693.83 |
16% |
25 |
603.19 |
120.64 |
723.83 |
Протокол №224/18.05.2017; промяна на обстоятелства НСР-15263/15.03.2018 |
НСР-2214/20.12.2013 |
06.02.2014 |
02.04.2018 |
Неактивен |
2443 |
| Coagulation factor VIII (Octocog alfa) |
EU/1/03/271/002 |
Advate 500 IU, Powder and solvent for solution for injection, 500, IU, Pack: 1 vial powder + 1 vial solvent (5 ml) + reconstitution device |
Baxter AG, Австрия |
Baxter SA., Belgium |
568.19 |
113.64 |
681.83 |
4% |
10 |
578.19 |
115.64 |
693.83 |
16% |
25 |
603.19 |
120.64 |
723.83 |
Протокол №224/18.05.2017 |
НСР-2214/20.12.2013 |
06.02.2014 |
02.06.2017 |
Неактивен |
2443 |
| Coagulation factor VIII (Octocog alfa) |
EU/1/03/271/002 |
Advate 500 IU, Powder and solvent for solution for injection, 500, IU, Pack: 1 |
Baxter AG, Австрия |
Baxter SA., Belgium |
568.19 |
113.64 |
681.83 |
4% |
10 |
578.19 |
115.64 |
693.83 |
16% |
25 |
603.19 |
120.64 |
723.83 |
|
НСР-2214/20.12.2013 |
06.02.2014 |
06.02.2014 |
Неактивен |
2443 |
| Coagulation factor VIII (Octocog alfa) |
EU/1/03/271/002 |
Advate 500 IU, Powder and solvent for solution for injection, 500, IU, Pack: 1 |
Baxter AG, Австрия |
Baxter SA., Belgium |
568.19 |
113.64 |
681.83 |
4% |
10 |
578.19 |
115.64 |
693.83 |
16% |
25 |
603.19 |
120.64 |
723.83 |
|
НСР-2214/20.12.2013 |
06.02.2014 |
06.02.2014 |
Неактивен |
2443 |
| Coagulation factor VIII (Octocog alfa) |
EU/1/03/271/002 |
Advate 500 IU, Powder and solvent for solution for injection, 500, IU, Pack: 1 |
Baxter AG, Австрия |
Baxter SA., Belgium |
733.44 |
146.69 |
880.13 |
4% |
10 |
743.44 |
148.69 |
892.13 |
16% |
25 |
768.44 |
153.69 |
922.13 |
|
КЦРР-259/06.03.2012 |
21.03.2012 |
21.03.2012 |
Неактивен |
2443 |
| Coagulation factor VIII (Octocog alfa) |
EU/1/03/271/002 |
Advate 500 IU, Powder and solvent for solution for injection, 500, IU, Pack: 1 |
Baxter AG, Австрия |
Baxter SA., Belgium |
758.67 |
151.73 |
910.4 |
6% |
15 |
773.67 |
154.73 |
928.4 |
18% |
30 |
803.67 |
160.73 |
964.4 |
|
КЦ-950/10.06.2009 |
30.06.2009 |
30.06.2009 |
Неактивен |
2443 |
| Coagulation factor VIII (rurioctocog alfa pegol) |
EU/1/17/1247/010 |
Adynovi, Powder and solvent for injection, 1000, IU, Pack: 1 vial + 1 vial (solvent 2 ml), preassembled whit reconstitution device |
Baxalta Innovations GmbH, Австрия |
Baxalta Belgium Manufacturing, Belgium |
1609.3 |
321.86 |
1931.16 |
4% |
10 |
1619.3 |
323.86 |
1943.16 |
16% |
25 |
1644.3 |
328.86 |
1973.16 |
|
НСР-17647/21.12.2018 предварително изпълнение |
21.12.2018 |
02.01.2019 |
Активен |
16388 |
| Coagulation factor VIII (rurioctocog alfa pegol) |
EU/1/17/1247/010 |
Adynovi, Powder and solvent for injection, 1000, IU, Pack: 1 vial + 1 vial (solvent 2 ml), preassembled whit reconstitution device |
Baxalta Innovations GmbH, Австрия |
Baxalta Belgium Manufacturing, Belgium |
1609.3 |
321.86 |
1931.16 |
4% |
10 |
1619.3 |
323.86 |
1943.16 |
16% |
25 |
1644.3 |
328.86 |
1973.16 |
|
НСР-17647/21.12.2018 предварително изпълнение |
21.12.2018 |
02.01.2019 |
Неактивен |
16388 |
| Coagulation factor VIII (rurioctocog alfa pegol) |
EU/1/17/1247/006 |
Adynovi, Powder and solvent for injection, 500, IU, Pack: 1 vial + 1 vial (solvent 2 ml), preassembled whit reconstitution device |
Baxalta Innovations GmbH, Австрия |
Baxalta Belgium Manufacturing, Belgium |
804.65 |
160.93 |
965.58 |
4% |
10 |
814.65 |
162.93 |
977.58 |
16% |
25 |
839.65 |
167.93 |
1007.58 |
|
НСР-17647/21.12.2018 предварително изпълнение |
21.12.2018 |
02.01.2019 |
Активен |
16387 |
| Coagulation factor VIII (rurioctocog alfa pegol) |
EU/1/17/1247/006 |
Adynovi, Powder and solvent for injection, 500, IU, Pack: 1 vial + 1 vial (solvent 2 ml), preassembled whit reconstitution device |
Baxalta Innovations GmbH, Австрия |
Baxalta Belgium Manufacturing, Belgium |
804.65 |
160.93 |
965.58 |
4% |
10 |
814.65 |
162.93 |
977.58 |
16% |
25 |
839.65 |
167.93 |
1007.58 |
|
НСР-17647/21.12.2018 предварително изпълнение |
21.12.2018 |
02.01.2019 |
Неактивен |
16387 |
| Olanzapine |
20100375 |
AEDON, Orodispersible tablet, 10, mg, Pack: 30 |
G. L. Pharma GmbH, Австрия |
Pharmathen S.A.Гърция |
18.05 |
3.61 |
21.66 |
6% |
1.08 |
19.13 |
3.83 |
22.96 |
18% |
3.25 |
22.38 |
4.48 |
26.86 |
|
НСР-3987/30.06.2014; НСР-9586/23.06.2016 |
15.07.2014 |
02.08.2016 |
Заличен |
3019 |
| Olanzapine |
20100375 |
AEDON, Orodispersible tablet, 10, mg, Pack: 30 |
G. L. Pharma GmbH, Австрия |
Pharmathen S.A.Гърция |
18.05 |
3.61 |
21.66 |
6% |
1.08 |
19.13 |
3.83 |
22.96 |
18% |
3.25 |
22.38 |
4.48 |
26.86 |
|
НСР-3987/30.06.2014 |
15.07.2014 |
15.07.2014 |
Неактивен |
3019 |
| Olanzapine |
20100373 |
AEDON, Orodispersible tablet, 5, mg, Pack: 30 |
G. L. Pharma GmbH, Австрия |
Pharmathen S.A.Гърция |
5.52 |
1.1 |
6.62 |
7% |
0.39 |
5.91 |
1.18 |
7.09 |
20% |
1.1 |
7.01 |
1.4 |
8.41 |
|
НСР-3986/30.06.2014; НСР-9586/23.06.2016 |
15.07.2014 |
02.08.2016 |
Заличен |
3020 |
| Olanzapine |
20100373 |
AEDON, Orodispersible tablet, 5, mg, Pack: 30 |
G. L. Pharma GmbH, Австрия |
Pharmathen S.A.Гърция |
5.52 |
1.1 |
6.62 |
7% |
0.39 |
5.91 |
1.18 |
7.09 |
20% |
1.1 |
7.01 |
1.4 |
8.41 |
|
НСР-3986/30.06.2014 |
15.07.2014 |
15.07.2014 |
Неактивен |
3020 |
| Olanzapine |
№ - 12525/21.03.2011 |
AEDON, Orodispersible tablet, 10, mg, Pack: 30 |
G. L. Pharma GmbH, Австрия |
Pharmathen S.A.Гърция |
18.68 |
3.74 |
22.42 |
6% |
1.12 |
19.8 |
3.96 |
23.76 |
18% |
3.36 |
23.16 |
4.63 |
27.79 |
|
НСР-1524/25.10.2013 |
11.11.2013 |
11.11.2013 |
Неактивен |
3019 |
| Olanzapine |
№ - 12524/21.03.2011 |
AEDON, Orodispersible tablet, 5, mg, Pack: 30 |
G. L. Pharma GmbH, Австрия |
Pharmathen S.A.Гърция |
5.71 |
1.14 |
6.85 |
7% |
0.4 |
6.11 |
1.22 |
7.33 |
20% |
1.14 |
7.25 |
1.45 |
8.7 |
|
НСР-1511/25.10.2013 |
11.11.2013 |
11.11.2013 |
Неактивен |
3020 |
| Olanzapine |
№ - 12525/21.03.2011 |
AEDON, Orodispersible tablet, 10, mg, Pack: 30 |
G. L. Pharma GmbH, Австрия |
Pharmathen S.A.Гърция |
74.32 |
14.86 |
89.18 |
4% |
2.97 |
77.29 |
15.46 |
92.75 |
16% |
11.89 |
89.18 |
17.84 |
107.02 |
|
КЦ-2424/06.07.2011 |
20.07.2011 |
20.07.2011 |
Неактивен |
3019 |
| Olanzapine |
№ - 12524/21.03.2011 |
AEDON, Orodispersible tablet, 5, mg, Pack: 30 |
G. L. Pharma GmbH, Австрия |
Pharmathen S.A.Гърция |
37.16 |
7.43 |
44.59 |
4% |
1.49 |
38.65 |
7.73 |
46.38 |
16% |
5.95 |
44.6 |
8.92 |
53.52 |
|
КЦ-2424/06.07.2011 |
20.07.2011 |
20.07.2011 |
Неактивен |
3020 |
| Salmeterol, Fluticasone |
EU/1/16/1122/001 |
Aerivio Spiromax, Inhalation powder, 50 mcg/500 mcg, -, Pack: 1 inhaler (60 doses) |
Teva B.V., Нидерландия |
Norton (Waterford) Limited T/A Teva Pharmaceuticals Ireland, Ирландия; Teva Pharmaceuticals Europe B.V., Нидерландия |
51.71 |
10.34 |
62.05 |
4% |
2.07 |
53.78 |
10.76 |
64.54 |
16% |
8.27 |
62.05 |
12.41 |
74.46 |
|
НСР-12270/07.04.2017; НСР-15920/15.06.2018; НСР-18913/06.06.2019 |
30.06.2018 |
02.07.2019 |
Заличен |
15649 |
| Salmeterol, Fluticasone |
EU/1/16/1122/001 |
Aerivio Spiromax, Inhalation powder, 50 mcg/500 mcg, -, Pack: 1 inhaler (60 doses) |
Teva B.V., Нидерландия |
Norton (Waterford) Limited T/A Teva Pharmaceuticals Ireland, Ирландия; Teva Pharmaceuticals Europe B.V., Нидерландия |
51.71 |
10.34 |
62.05 |
4% |
2.07 |
53.78 |
10.76 |
64.54 |
16% |
8.27 |
62.05 |
12.41 |
74.46 |
|
НСР-12270/07.04.2017; НСР-15920/15.06.2018 |
30.06.2018 |
02.07.2018 |
Неактивен |
15649 |
| Salmeterol, Fluticasone |
EU/1/16/1122/001 |
Aerivio Spiromax, Inhalation powder, 50 mcg/500 mcg, -, Pack: 1 inhaler (60 doses) |
Teva B.V., Нидерландия |
Norton (Waterford) Limited T/A Teva Pharmaceuticals Ireland, Ирландия;
Teva Pharmaceuticals Europe B.V., Нидерландия |
60.63 |
12.13 |
72.76 |
4% |
2.43 |
63.06 |
12.61 |
75.67 |
16% |
9.7 |
72.76 |
14.55 |
87.31 |
|
НСР-12270/07.04.2017 |
22.04.2017 |
02.05.2017 |
Неактивен |
15649 |
| Isoflurane |
20020030 |
Aerrane, Inhalation vapour, liquid, 250, ml, Pack: 1 |
Бакстер България ЕООД, България |
Baxter SA, Boulevard Rene Branquart 80, 7860 Lessines, Белгия; Baxter Manufacturing Sp z.o.o., Полша |
114.34 |
22.87 |
137.21 |
4% |
4.57 |
118.91 |
23.78 |
142.69 |
16% |
18.29 |
137.2 |
27.44 |
164.64 |
промяна на обстоятелства НСР-4890/22.10.2014; НСР-7100/15.09.2015; промяна на обстоятелства НСР-12882/02.06.2017 |
НСР-822/07.08.2013 |
29.08.2013 |
02.07.2017 |
Активен |
2037 |
| Isoflurane |
II-0410/ 08.08.2007 |
Aerrane, Inhalation vapour, liquid, 250, ml, Pack: 1 |
Бакстер България ЕООД, България |
Baxter SA, Boulevard Rene Branquart 80, 7860 Lessines, Белгия; Baxter Manufacturing Sp z.o.o., Полша |
114.34 |
22.87 |
137.21 |
4% |
4.57 |
118.91 |
23.78 |
142.69 |
16% |
18.29 |
137.2 |
27.44 |
164.64 |
промяна на обстоятелства НСР-4890/22.10.2014; НСР-7100/15.09.2015 |
НСР-822/07.08.2013 |
29.08.2013 |
29.08.2013 |
Неактивен |
2037 |