| Hemophilus Influenzae B, Purified Antigen Conjugated |
II-16102/15.03.2007 |
ACT-HIB, Powder and solvent for suspension for injection, полизахарид на Haemophilus influenzae тип b..10 микрограма, ml, Pack: 1 |
Sanofi Pasteur S.A., Франция |
Sanofi Pasteur S.A., France |
13.61 |
2.72 |
16.33 |
6% |
0.82 |
14.43 |
2.89 |
17.32 |
18% |
2.45 |
16.88 |
3.38 |
20.26 |
|
КЦ-723/16.03.2009 |
03.04.2009 |
03.04.2009 |
Неактивен |
1387 |
| Alteplase |
9700107 |
Actilyse, Powder and solvent for solution for injection, 50, mg, Pack: x 1 |
Boehringer Ingelheim International GmbH, Германия |
Boehringer Ingelheim Pharma KG Manufakturing Site Biberach- Германия |
618.04 |
123.61 |
741.65 |
4% |
10 |
628.04 |
125.61 |
753.65 |
16% |
25 |
653.04 |
130.61 |
783.65 |
промяна на обстоятелства НСР-9682/30.06.2016 |
НСР-7194/09.10.2015.; НСР-14680/20.12.2017 |
06.01.2018 |
02.02.2018 |
Активен |
3530 |
| Alteplase |
9700107 |
Actilyse, Powder and solvent for solution for injection, 50, mg, Pack: x 1 |
Boehringer Ingelheim International GmbH, Германия |
Boehringer Ingelheim Pharma KG Manufakturing Site Biberach- Германия |
637.6 |
127.52 |
765.12 |
4% |
10 |
647.6 |
129.52 |
777.12 |
16% |
25 |
672.6 |
134.52 |
807.12 |
промяна на обстоятелства НСР-9682/30.06.2016 |
НСР-7194/09.10.2015. |
24.10.2015 |
02.08.2016 |
Неактивен |
3530 |
| Alteplase |
9700107 |
Actilyse, Powder and solvent for solution for injection, 50, mg, Pack: 1 |
Boehringer Ingelheim International GmbH, Германия |
Boehringer Ingelheim Pharma KG Manufakturing Site Biberach- Germany |
637.6 |
127.52 |
765.12 |
4% |
10 |
647.6 |
129.52 |
777.12 |
16% |
25 |
672.6 |
134.52 |
807.12 |
промяна на обстоятелства НСР-9682/30.06.2016 |
НСР-7194/09.10.2015. |
24.10.2015 |
24.10.2015 |
Неактивен |
3530 |
| Alteplase |
II-2317/ 18.06.2008 |
Actilyse, Powder and solvent for solution for injection, 50, mg, Pack: 1 |
Boehringer Ingelheim International GmbH, Германия |
Boehringer Ingelheim Pharma KG Manufakturing Site Biberach- Germany |
637.6 |
127.52 |
765.12 |
4% |
10 |
647.6 |
129.52 |
777.12 |
16% |
25 |
672.6 |
134.52 |
807.12 |
|
НСР-7194/09.10.2015. |
24.10.2015 |
24.10.2015 |
Неактивен |
3530 |
| Alteplase |
II-2317/ 18.06.2008 |
Actilyse, Powder and solvent for solution for injection, 50, mg, Pack: 1 |
Boehringer Ingelheim International GmbH, Германия |
Boehringer Ingelheim Pharma KG Manufakturing Site Biberach- Germany |
652.95 |
130.59 |
783.54 |
4% |
10 |
662.95 |
132.59 |
795.54 |
16% |
25 |
687.95 |
137.59 |
825.54 |
|
НСР-5514/29.01.2015 |
12.02.2015 |
12.02.2015 |
Неактивен |
3530 |
| Alteplase |
II-2317/ 18.06.2008 |
Actilyse, Powder and solvent for solution for injection, 50, mg, Pack: 1 |
Boehringer Ingelheim International GmbH, Германия |
Boehringer Ingelheim Pharma KG Manufakturing Site Biberach- Germany |
654.75 |
130.95 |
785.7 |
4% |
10 |
664.75 |
132.95 |
797.7 |
16% |
25 |
689.75 |
137.95 |
827.7 |
|
НСР-3741/06.06.2014 |
23.06.2014 |
23.06.2014 |
Неактивен |
3530 |
| Alteplase |
II-2317/ 18.06.2008 |
Actilyse, Powder and solvent for solution for injection, 50, mg, Pack: 1 |
Boehringer Ingelheim International GmbH, Германия |
Boehringer Ingelheim Pharma KG Manufakturing Site Biberach- Germany |
662.44 |
132.49 |
794.93 |
4% |
10 |
672.44 |
134.49 |
806.93 |
16% |
25 |
697.44 |
139.49 |
836.93 |
|
КЦРР-2435/27.02.2013 |
01.04.2013 |
01.04.2013 |
Неактивен |
3530 |
| Alteplase |
II-2317/ 18.06.2008 |
Actilyse, Powder and solvent for solution for injection, 50, mg, Pack: 1 |
Boehringer Ingelheim International GmbH, Германия |
Boehringer Ingelheim Pharma KG Manufakturing Site Biberach- Germany |
670.71 |
134.14 |
804.85 |
4% |
10 |
680.71 |
136.14 |
816.85 |
16% |
25 |
705.71 |
141.14 |
846.85 |
|
КЦРР-747/07.06.2012 |
25.06.2012 |
25.06.2012 |
Неактивен |
3530 |
| Alteplase |
II-2317/18,06,2008 |
Actilyse, Powder and solvent for solution for injection, 50, mg, Pack: 1 |
Boehringer Ingelheim International GmbH, Германия |
Boehringer Ingelheim Pharma KG Manufakturing Site Biberach- Germany |
719.41 |
143.88 |
863.29 |
6% |
15 |
734.41 |
146.88 |
881.29 |
18% |
30 |
764.41 |
152.88 |
917.29 |
|
КЦ-585/23.02.2009 |
18.03.2009 |
18.03.2009 |
Неактивен |
3530 |
| Insulin (human) |
EU/1/02/230/006 |
Actrapid Penfill, Solution for injection, 100 IU/ml - 3 ml, IU, Pack: 5 cartridges |
Novo Nordisk A/S, Дания |
Novo Nordisk A/S Novo Allé DK-2880 Bagsværd, Дания; Novo Nordisk Production SAS 45, Avenue d’Orléans F-28002 Chartres, Франция |
34.31 |
6.86 |
41.17 |
4% |
1.37 |
35.68 |
7.14 |
42.82 |
16% |
5.49 |
41.17 |
8.23 |
49.4 |
Протокол № 246/12.10.2017 |
НСР-4861/17.10.2014; НСР-11348/30.12.2016 |
14.01.2017 |
02.11.2017 |
Активен |
3290 |
| Insulin (human) |
EU/1/02/230/006 |
Actrapid Penfill, Solution for injection, 300, IU, Pack: 5 |
Novo Nordisk A/S, Дания |
Novo Nordisk A/S Novo Allé DK-2880 Bagsværd, Дания; Novo Nordisk Production SAS 45, Avenue d’Orléans F-28002 Chartres, Франция |
34.31 |
6.86 |
41.17 |
4% |
1.37 |
35.68 |
7.14 |
42.82 |
16% |
5.49 |
41.17 |
8.23 |
49.4 |
|
НСР-4861/17.10.2014; НСР-11348/30.12.2016 |
02.02.2017 |
02.02.2017 |
Неактивен |
3290 |
| Insulin (human) |
EU/1/02/230/006 |
Actrapid Penfill, Solution for injection, 300, IU, Pack: 5 |
Novo Nordisk A/S, Дания |
Novo Nordisk A/S Novo Allé DK-2880 Bagsværd, Дания; Novo Nordisk Production SAS 45, Avenue d’Orléans F-28002 Chartres, Франция |
34.91 |
6.98 |
41.89 |
4% |
1.4 |
36.31 |
7.26 |
43.57 |
16% |
5.59 |
41.9 |
8.38 |
50.28 |
|
НСР-4861/17.10.2014 |
03.11.2014 |
03.11.2014 |
Неактивен |
3290 |
| Insulin (human) |
EU/1/02/230/006 |
Actrapid Penfill, Solution for injection, 300, UI, Pack: 5 |
Novo Nordisk A/S, Дания |
Novo Nordisk A/S Novo Allé DK-2880 Bagsværd, Дания; Novo Nordisk Production SAS 45, Avenue d’Orléans F-28002 Chartres, Франция |
34.91 |
6.98 |
41.89 |
4% |
1.4 |
36.31 |
7.26 |
43.57 |
16% |
5.59 |
41.9 |
8.38 |
50.28 |
|
НСР-4861/17.10.2014 |
03.11.2014 |
03.11.2014 |
Неактивен |
3290 |
| Insulin (human) |
EU/1/02/230/006 |
Actrapid Penfill, Solution for injection, 300, UI, Pack: 5 |
Novo Nordisk A/S, Дания |
Novo Nordisk A/S Novo Allé DK-2880 Bagsværd, Дания; Novo Nordisk Production SAS 45, Avenue d’Orléans F-28002 Chartres, Франция |
38.12 |
7.62 |
45.74 |
4% |
1.52 |
39.64 |
7.93 |
47.57 |
16% |
6.1 |
45.74 |
9.15 |
54.89 |
|
НСР-825/07.08.2013 |
22.08.2013 |
22.08.2013 |
Неактивен |
3290 |
| Insulin (human) |
EU/1/02/230/006 |
Actrapid Penfill, Solution for injection, 300, UI, Pack: 5 |
Novo Nordisk A/S, Дания |
Novo Nordisk A/S Novo Allé DK-2880 Bagsværd, Дания; Novo Nordisk Production SAS 45, Avenue d’Orléans F-28002 Chartres, Франция |
39.64 |
7.93 |
47.57 |
4% |
1.59 |
41.23 |
8.25 |
49.48 |
16% |
6.34 |
47.57 |
9.51 |
57.08 |
|
КЦРР-1341/24.08.2012 |
27.11.2012 |
27.11.2012 |
Неактивен |
3290 |
| Insulin (human) |
EU/1/02/230/006 |
Actrapid Penfill, Solution for injection, 300, UI, Pack: 5 |
Novo Nordisk A/S, Дания |
1)Novo Nordisk A/S Novo Allé DK-2880 Bagsværd, Дания 2)Novo Nordisk Production SAS 45, Avenue d’Orléans F-28002 Chartres, Франция |
41.74 |
8.35 |
50.09 |
4% |
1.67 |
43.41 |
8.68 |
52.09 |
16% |
6.68 |
50.09 |
10.02 |
60.11 |
|
КЦ-730/18.03.2009 |
02.04.2009 |
02.04.2009 |
Неактивен |
3290 |
| Vancomycin |
20100271/ 26.04.2010 |
ACVISCIN, Powder for concentrate for solution for infusion, 1000, mg, Pack: 1 |
Actavis Group PTC ehf., Исландия |
Actavis Nordic, Denmark, Strides Arcolab Polska Sp. Zoo, Poland |
16.8 |
3.36 |
20.16 |
6% |
1.01 |
17.81 |
3.56 |
21.37 |
18% |
3.02 |
20.83 |
4.17 |
25 |
§ената е заличена с решение НСР-5864/19.03.2015 ( в сила от 16.04.2015 ) |
КЦРР-2455/27.02.2013 |
14.03.2013 |
14.03.2013 |
Заличен |
1689 |
| Vancomycin |
№ ІІ -10066/ 24.06.2010 |
ACVISCIN, Powder for concentrate for solution for infusion, 1000, mg, Pack: 1 |
Actavis Group PTC ehf., Исландия |
Actavis Nordic A/S, Denmark; Strides Arcolab Polska Sp. Zoo, Poland |
21.51 |
4.3 |
25.81 |
6% |
1.29 |
22.8 |
4.56 |
27.36 |
18% |
3.87 |
26.67 |
5.33 |
32 |
промяна на обстоятелства решение КЦPP-1151/02.08.2012 |
КЦ-1789/11.10.2010 |
25.10.2010 |
25.10.2010 |
Неактивен |
1689 |
| pertussis, purified antigen, combinations with toxoids |
20160287 |
Adacel, Suspension for injection, 0.5, ml, Pack: prefilled syringe with 2 separate needles x 10 |
Sanofi Pasteur S.A., Франция |
Sanofi Pasteur SA, Франция; Sanofi-Aventis Zrt., Унгария |
782.29 |
156.46 |
938.75 |
4% |
10 |
792.29 |
158.46 |
950.75 |
16% |
25 |
817.29 |
163.46 |
980.75 |
|
корекционно решение НСР-19717/30.08.2019 предварително изпълнение; НСР-19502/14.08.2019 |
02.09.2019 |
02.09.2019 |
Активен |
15515 |
| pertussis, purified antigen, combinations with toxoids |
20160287 |
Adacel, Suspension for injection, 0.5, ml, Pack: prefilled syringe with 1 separate needle x 10 |
Sanofi Pasteur S.A., Франция |
Sanofi Pasteur S.A., Франция; Sanofi-Аventis Zrt., Унгария |
782.29 |
156.46 |
938.75 |
4% |
10 |
792.29 |
158.46 |
950.75 |
16% |
25 |
817.29 |
163.46 |
980.75 |
корекционно решение НСР-19717/30.08.2019 предварително изпълнение |
НСР-19502/14.08.2019 |
02.09.2019 |
02.09.2019 |
Активен |
15505 |
| pertussis, purified antigen, combinations with toxoids |
20100342 |
ADACEL, Suspension for injection, 0.5, ml, Pack: 1 vial |
Sanofi Pasteur S.A., Франция |
Sanofi Pasteur SA., 2q avenue Pont Pasteur, 69007 Lyon, France Sanofi-Aventis Zrt., 1225 Budapest, Campona u. 1 (Harbor park), Hungary |
24.06 |
4.81 |
28.87 |
6% |
1.44 |
25.5 |
5.1 |
30.6 |
18% |
4.33 |
29.83 |
5.97 |
35.8 |
|
КЦРР-2314/20.02.2013; НСР-12527/28.04.2017 |
04.04.2013 |
02.06.2017 |
Заличен |
1753 |
| pertussis, purified antigen, combinations with toxoids |
20100342 |
ADACEL, Suspension for injection, 0.5, ml, Pack: 1 vial |
Sanofi Pasteur S.A., Франция |
Sanofi Pasteur SA., 2q avenue Pont Pasteur, 69007 Lyon, France Sanofi-Aventis Zrt., 1225 Budapest, Campona u. 1 (Harbor park), Hungary |
24.06 |
4.81 |
28.87 |
6% |
1.44 |
25.5 |
5.1 |
30.6 |
18% |
4.33 |
29.83 |
5.97 |
35.8 |
|
КЦРР-2314/20.02.2013 |
04.04.2013 |
02.01.2017 |
Неактивен |
1753 |
| pertussis, purified antigen, combinations with toxoids |
20100342 |
ADACEL susp. inj 0,5ml 1 vial x 1, Suspension for injection, 0.5, ml, Pack: 1 |
Sanofi Pasteur S.A., Франция |
Sanofi Pasteur SA., 2q avenue Pont Pasteur, 69007 Lyon, France Sanofi-Aventis Zrt., 1225 Budapest, Campona u. 1 (Harbor park), Hungary |
24.06 |
4.81 |
28.87 |
6% |
1.44 |
25.5 |
5.1 |
30.6 |
18% |
4.33 |
29.83 |
5.97 |
35.8 |
|
КЦРР-2314/20.02.2013 |
04.04.2013 |
04.04.2013 |
Неактивен |
1753 |
| pertussis, purified antigen, combinations with toxoids |
20100342 |
ADACEL susp. inj 0,5ml 1 vial x 1, Suspension for injection, 0.5, ml, Pack: 1 |
Sanofi Pasteur S.A., Франция |
Sanofi Pasteur SA., 2q avenue Pont Pasteur, 69007 Lyon, France Sanofi-Aventis Zrt., 1225 Budapest, Campona u. 1 (Harbor park), Hungary |
24.06 |
4.81 |
28.87 |
6% |
1.44 |
25.5 |
5.1 |
30.6 |
18% |
4.33 |
29.83 |
5.97 |
35.8 |
|
КЦРР-2314/20.02.2013 |
04.04.2013 |
04.04.2013 |
Неактивен |
1753 |