| influenza, inactivated, split virus or surface antigen |
II-1583/14.02.2008 |
Vaxigrip pediatric use, Suspension for injection, за доза от 0,25 ml - произведен в кокоши ембриони от групи здрави кокошки, хемаглутинин, ml, Pack: 1 |
Sanofi Pasteur S.A., Франция |
Sanofi Pasteur S.A., France |
7.43 |
1.49 |
8.92 |
7% |
0.52 |
7.95 |
1.59 |
9.54 |
20% |
1.49 |
9.44 |
1.89 |
11.33 |
|
КЦ-723/16.03.2009 |
03.04.2009 |
03.04.2009 |
Неактивен |
669 |
| influenza, inactivated, split virus or surface antigen |
20160310 |
VaxigripTetra, Suspension for injection, 15 mcg /0.5 ml, -, Pack: 10 pre-filled syringe with attached needle |
Sanofi Pasteur S.A., Франция |
Sanofi Pasteur, 69280 Marcyl Etoile, Франция; Sanofi Pasteur, 27100 Val dereuil, Франция; Sanofi Aventis Zrt., Унгария |
178.16 |
35.63 |
213.79 |
4% |
7.13 |
185.29 |
37.06 |
222.35 |
16% |
25 |
210.29 |
42.06 |
252.35 |
|
НСР-18933/13.06.2019г.; НСР-20733/30.01.2020 |
14.02.2020 |
02.03.2020 |
Активен |
16568 |
| influenza, inactivated, split virus or surface antigen |
20160310 |
VaxigripTetra, Suspension for injection, 15 mcg /0.5 ml, -, Pack: 10 pre-filled syringe with attached needle |
Sanofi Pasteur S.A., Франция |
Sanofi Pasteur, 69280 Marcyl Etoile, Франция; Sanofi Pasteur, 27100 Val de
reuil, Франция; Sanofi Aventis Zrt., Унгария |
185.8 |
37.16 |
222.96 |
4% |
7.43 |
193.23 |
38.65 |
231.88 |
16% |
25 |
218.23 |
43.65 |
261.88 |
|
НСР-18933/13.06.2019г. |
28.06.2019 |
02.07.2019 |
Неактивен |
16568 |
| Panitumumab |
EU/1/07/423/001 |
Vectibix, Concentrate for solution for infusion, 20mg/ml - 5ml, -, Pack: 1 vial |
Amgen Eurоpe B.V., Нидерландия |
Amgen Europe B.V., The Netherlands |
615.34 |
123.07 |
738.41 |
4% |
10 |
625.34 |
125.07 |
750.41 |
16% |
25 |
650.34 |
130.07 |
780.41 |
|
НСР-4862/17.10.2014; НСР-9798/14.07.2016г.; НСР-12148/27.03.2017; НСР-14665/20.12.2017; НСР-16635/24.08.2018 предварително изпълнение |
24.08.2018 |
02.10.2018 |
Активен |
3297 |
| Panitumumab |
EU/1/07/423/001 |
Vectibix, Concentrate for solution for infusion, 20mg/ml - 5ml, -, Pack: 1 vial |
Amgen Eurоpe B.V., Нидерландия |
Amgen Europe B.V., The Netherlands |
615.34 |
123.07 |
738.41 |
4% |
10 |
625.34 |
125.07 |
750.41 |
16% |
25 |
650.34 |
130.07 |
780.41 |
|
НСР-4862/17.10.2014; НСР-9798/14.07.2016г.; НСР-12148/27.03.2017; НСР-14665/20.12.2017; НСР-16635/24.08.2018 предварително изпълнение |
24.08.2018 |
02.10.2018 |
Неактивен |
3297 |
| Panitumumab |
EU/1/07/423/001 |
Vectibix, Concentrate for solution for infusion, 20mg/ml - 5ml, -, Pack: 1 vial |
Amgen Eurоpe B.V., Нидерландия |
Amgen Europe B.V., The Netherlands |
615.34 |
123.07 |
738.41 |
4% |
10 |
625.34 |
125.07 |
750.41 |
16% |
25 |
650.34 |
130.07 |
780.41 |
|
НСР-4862/17.10.2014; НСР-9798/14.07.2016г.; НСР-12148/27.03.2017; НСР-14665/20.12.2017; НСР-16635/24.08.2018 предварително изпълнение* |
24.08.2018 |
02.09.2018 |
Неактивен |
3297 |
| Panitumumab |
EU/1/07/423/001 |
Vectibix, Concentrate for solution for infusion, 20mg/ml - 5ml, -, Pack: 1 vial |
Amgen Eurоpe B.V., Нидерландия |
Amgen Europe B.V., The Netherlands |
658.7 |
131.74 |
790.44 |
4% |
10 |
668.7 |
133.74 |
802.44 |
16% |
25 |
693.7 |
138.74 |
832.44 |
|
НСР-4862/17.10.2014; НСР-9798/14.07.2016г.; НСР-12148/27.03.2017; НСР-14665/20.12.2017 |
06.01.2018 |
02.02.2018 |
Неактивен |
3297 |
| Panitumumab |
EU/1/07/423/001 |
Vectibix, Concentrate for solution for infusion, 20mg/ml - 5ml, -, Pack: 1 vial |
Amgen Eurоpe B.V., Нидерландия |
Amgen Europe B.V., The Netherlands |
661.21 |
132.24 |
793.45 |
4% |
10 |
671.21 |
134.24 |
805.45 |
16% |
25 |
696.21 |
139.24 |
835.45 |
|
НСР-4862/17.10.2014; НСР-9798/14.07.2016г.; НСР-12148/27.03.2017 |
11.04.2017 |
02.05.2017 |
Неактивен |
3297 |
| Panitumumab |
EU/1/07/423/001 |
Vectibix, Concentrate for solution for infusion, 20mg/ml - 5ml, -, Pack: 1 vial |
Amgen Eurоpe B.V., Нидерландия |
Amgen Europe B.V., The Netherlands |
663.07 |
132.61 |
795.68 |
4% |
10 |
673.07 |
134.61 |
807.68 |
16% |
25 |
698.07 |
139.61 |
837.68 |
|
НСР-4862/17.10.2014; НСР-9798/14.07.2016г. |
02.08.2016 |
02.08.2016 |
Неактивен |
3297 |
| Panitumumab |
EU/1/07/423/001 |
Vectibix, Concentrate for solution for infusion, 20mg/ml - 5ml, -, Pack: 1 vial |
Amgen Eurоpe B.V., Нидерландия |
Amgen Europe B.V., The Netherlands |
685.71 |
137.14 |
822.85 |
4% |
10 |
695.71 |
139.14 |
834.85 |
16% |
25 |
720.71 |
144.14 |
864.85 |
|
НСР-4862/17.10.2014 |
03.11.2014 |
03.11.2014 |
Неактивен |
3297 |
| Panitumumab |
EU/1/07/423/001 |
Vectibix, Concentrate for solution for infusion, 100, mg, Pack: 1 |
Amgen Eurоpe B.V., Нидерландия |
Amgen Europe B.V., The Netherlands |
705.78 |
141.16 |
846.94 |
4% |
10 |
715.78 |
143.16 |
858.94 |
16% |
25 |
740.78 |
148.16 |
888.94 |
|
НСР-2700/06.02.2014 |
24.02.2014 |
24.02.2014 |
Неактивен |
3297 |
| Panitumumab |
EU/1/07/423/001 |
Vectibix, Concentrate for solution for infusion, 100, mg, Pack: 1 |
Amgen Eurоpe B.V., Нидерландия |
Amgen Europe B.V., The Netherlands |
705.78 |
141.16 |
846.94 |
4% |
10 |
715.78 |
143.16 |
858.94 |
16% |
25 |
740.78 |
148.16 |
888.94 |
|
НСР-2211/20.12.2013 |
11.02.2014 |
11.02.2014 |
Неактивен |
3297 |
| Panitumumab |
EU/1/07/423/001 |
Vectibix, Concentrate for solution for infusion, 100, mg, Pack: 1 |
Amgen Eurоpe B.V., Нидерландия |
Amgen Europe B.V., The Netherlands |
708.32 |
141.66 |
849.98 |
4% |
10 |
718.32 |
143.66 |
861.98 |
16% |
25 |
743.32 |
148.66 |
891.98 |
отхвърлена жалба от Комисия по прозрачност с решение КП-228/06.06.2013 |
КЦРР-1893/15.12.2012 |
16.10.2013 |
16.10.2013 |
Неактивен |
3297 |
| Panitumumab |
EU/1/07/423/001 |
Vectibix, Concentrate for solution for infusion, 100, mg, Pack: 1 |
Amgen Eurоpe B.V., Нидерландия |
Amgen Europe B.V., The Netherlands |
749.98 |
150 |
899.98 |
4% |
10 |
759.98 |
152 |
911.98 |
16% |
25 |
784.98 |
157 |
941.98 |
|
КЦ-2726/14.09.2011 |
12.10.2011 |
12.10.2011 |
Неактивен |
3297 |
| Venlafaxine |
20070055 |
VELAXIN, Prolonged release capsule, hard, 75, mg, Pack: 28 |
EGIS Pharmaceuticals PLC, Унгария |
EGIS Pharmaceuticals PLC, УНГАРИЯ |
7.12 |
1.42 |
8.54 |
7% |
0.5 |
7.62 |
1.52 |
9.14 |
20% |
1.42 |
9.04 |
1.81 |
10.85 |
Отхвърлена жалба от Комисия по прозрачност КП-30/05.03.2015
Промяна на обстоятелства НСР-11986/10.03.2017 |
НСР-1566/25.10.2013; HCP-6026/09.04.2015. |
02.04.2015 |
02.04.2017 |
Активен |
3647 |
| Venlafaxine |
II-0219/13.07.2007 г. |
VELAXIN, Prolonged release capsule, hard, 75, mg, Pack: 28 |
EGIS Pharmaceuticals PLC, Унгария |
EGIS Pharmaceuticals PLC, УНГАРИЯ |
7.12 |
1.42 |
8.54 |
7% |
0.5 |
7.62 |
1.52 |
9.14 |
20% |
1.42 |
9.04 |
1.81 |
10.85 |
Отхвърлена жалба от Комисия по прозрачност КП-30/05.03.2015 |
НСР-1566/25.10.2013; HCP-6026/09.04.2015. |
02.04.2015 |
02.04.2015 |
Неактивен |
3647 |
| Venlafaxine |
20070056 |
VELAXIN, Prolonged release capsule, hard, 150, mg, Pack: 28 |
EGIS Pharmaceuticals PLC, Унгария |
EGIS Pharmaceuticals PLC, УНГАРИЯ |
11.73 |
2.35 |
14.08 |
6% |
0.7 |
12.43 |
2.49 |
14.92 |
18% |
2.11 |
14.54 |
2.91 |
17.45 |
Отхвърлена жалба от Комисия по прозрачност КП-30/05.03.2015
Промяна на обстоятелства НСР-11987/10.03.2017 |
НСР-1566/25.10.2013; HCP-6027/09.04.2015. |
02.04.2015 |
02.04.2017 |
Активен |
3648 |
| Venlafaxine |
II-0220/13.07.2007 г. |
VELAXIN, Prolonged release capsule, hard, 150, mg, Pack: 28 |
EGIS Pharmaceuticals PLC, Унгария |
EGIS Pharmaceuticals PLC, УНГАРИЯ |
11.73 |
2.35 |
14.08 |
6% |
0.7 |
12.43 |
2.49 |
14.92 |
18% |
2.11 |
14.54 |
2.91 |
17.45 |
Отхвърлена жалба от Комисия по прозрачност КП-30/05.03.2015 |
НСР-1566/25.10.2013; HCP-6027/09.04.2015. |
02.04.2015 |
02.04.2015 |
Неактивен |
3648 |
| Venlafaxine |
II-0219/13.07.2007 г. |
VELAXIN, Prolonged release capsule, hard, 75, mg, Pack: 28 |
EGIS Pharmaceuticals PLC, Унгария |
EGIS Pharmaceuticals PLC, УНГАРИЯ |
16.64 |
3.33 |
19.97 |
6% |
1 |
17.64 |
3.53 |
21.17 |
18% |
3 |
20.64 |
4.13 |
24.77 |
|
КЦ-355/19.12.2008 |
20.01.2009 |
20.01.2009 |
Неактивен |
3647 |
| Venlafaxine |
II-0220/13.07.2007 г. |
VELAXIN, Prolonged release capsule, hard, 150, mg, Pack: 28 |
EGIS Pharmaceuticals PLC, Унгария |
EGIS Pharmaceuticals PLC, УНГАРИЯ |
33.74 |
6.75 |
40.49 |
4% |
1.35 |
35.09 |
7.02 |
42.11 |
16% |
5.4 |
40.49 |
8.1 |
48.59 |
|
КЦ-355/19.12.2008 |
20.01.2009 |
20.01.2009 |
Неактивен |
3648 |
| Bortezomib |
EU/1/04/274/001 |
Velcade, Powder for solution for injection, 3.5, mg, Pack: 1 |
Janssen-Cilag International N.V., Белгия |
Janssen Pharmaceutica N.V., Belgium |
1726.27 |
345.25 |
2071.52 |
4% |
10 |
1736.27 |
347.25 |
2083.52 |
16% |
25 |
1761.27 |
352.25 |
2113.52 |
|
НСР-5750/26.02.2015.; НСР-9216/ 05.05.2016; НСР-13349/28.07.2017 г; НСР-15385/30.03.2018 |
12.08.2017 |
02.05.2018 |
Заличен |
3627 |
| Bortezomib |
EU/1/04/274/001 |
Velcade, Powder for solution for injection, 3.5, mg, Pack: 1 |
Janssen-Cilag International N.V., Белгия |
Janssen Pharmaceutica N.V., Belgium |
1726.27 |
345.25 |
2071.52 |
4% |
10 |
1736.27 |
347.25 |
2083.52 |
16% |
25 |
1761.27 |
352.25 |
2113.52 |
|
НСР-5750/26.02.2015.; НСР-9216/ 05.05.2016; НСР-13349/28.07.2017 г |
12.08.2017 |
02.09.2017 |
Неактивен |
3627 |
| Bortezomib |
EU/1/04/274/001 |
Velcade, Powder for solution for injection, 3.5, mg, Pack: 1 |
Janssen-Cilag International N.V., Белгия |
Janssen Pharmaceutica N.V., Belgium |
1731.26 |
346.25 |
2077.51 |
4% |
10 |
1741.26 |
348.25 |
2089.51 |
16% |
25 |
1766.26 |
353.25 |
2119.51 |
|
НСР-5750/26.02.2015.; НСР-9216/ 05.05.2016 |
02.06.2016 |
02.06.2016 |
Неактивен |
3627 |
| Bortezomib |
EU/1/04/274/001 |
Velcade, Powder for solution for injection, 3.5, mg, Pack: 1 |
Janssen-Cilag International N.V., Белгия |
Janssen Pharmaceutica N.V., Belgium |
1731.3 |
346.26 |
2077.56 |
4% |
10 |
1741.3 |
348.26 |
2089.56 |
16% |
25 |
1766.3 |
353.26 |
2119.56 |
|
НСР-5750/26.02.2015. |
12.03.2015 |
12.03.2015 |
Неактивен |
3627 |
| Bortezomib |
EU/1/04/274/001 |
Velcade, Powder for solution for injection, 3.5, mg, Pack: 1 |
Janssen-Cilag International N.V., Белгия |
Janssen Pharmaceutica N.V., Belgium |
1763.85 |
352.77 |
2116.62 |
4% |
10 |
1773.85 |
354.77 |
2128.62 |
16% |
25 |
1798.85 |
359.77 |
2158.62 |
|
НСР-3990/30.06.2014 |
15.07.2014 |
15.07.2014 |
Неактивен |
3627 |