| Paliperidone |
EU/1/11/672/005 |
XEPLION, Prolonged release suspension for injection, 150, mg, Pack: 1 |
Janssen-Cilag International N.V., Белгия |
Janssen Pharmaceutica N.V., Белгия |
763.16 |
152.63 |
915.79 |
4% |
10 |
773.16 |
154.63 |
927.79 |
16% |
25 |
798.16 |
159.63 |
957.79 |
|
НСР-6837/30.07.2015. |
14.08.2015 |
14.08.2015 |
Неактивен |
3365 |
| Paliperidone |
EU/1/11/672/005 |
XEPLION, Prolonged release suspension for injection, 150, mg, Pack: 1 |
Janssen-Cilag International N.V., Белгия |
Janssen Pharmaceutica N.V., Белгия |
805.88 |
161.18 |
967.06 |
4% |
10 |
815.88 |
163.18 |
979.06 |
16% |
25 |
840.88 |
168.18 |
1009.06 |
|
НСР-5119/21.11.2014 |
08.12.2014 |
08.12.2014 |
Неактивен |
3365 |
| Paliperidone |
EU/1/11/672/003 |
XEPLION, Prolonged release suspension for injection, 75, mg, Pack: 1 |
Janssen-Cilag International N.V., Белгия |
Janssen Pharmaceutica N.V., Белгия |
459.25 |
91.85 |
551.1 |
4% |
10 |
469.25 |
93.85 |
563.1 |
16% |
25 |
494.25 |
98.85 |
593.1 |
|
НСР-5120/24.11.2014 |
08.12.2014 |
08.12.2014 |
Неактивен |
3363 |
| Paliperidone |
EU/1/11/672/004 |
XEPLION, Prolonged release suspension for injection, 100, mg, Pack: 1 |
Janssen-Cilag International N.V., Белгия |
Janssen Pharmaceutica N.V., Белгия |
565.29 |
113.06 |
678.35 |
4% |
10 |
575.29 |
115.06 |
690.35 |
16% |
25 |
600.29 |
120.06 |
720.35 |
|
НСР-5121/24.11.2014 |
08.12.2014 |
08.12.2014 |
Неактивен |
3364 |
| Paliperidone |
EU/1/11/672/004 |
XEPLION, Prolonged release suspension for injection, 100, mg, Pack: 1 |
Janssen-Cilag International N.V., Белгия |
Janssen Pharmaceutica N.V., Белгия |
565.31 |
113.06 |
678.37 |
4% |
10 |
575.31 |
115.06 |
690.37 |
16% |
25 |
600.31 |
120.06 |
720.37 |
|
НСР-2326/13.01.2014 |
20.03.2014 |
20.03.2014 |
Неактивен |
3364 |
| Paliperidone |
EU/1/11/672/005 |
XEPLION, Prolonged release suspension for injection, 150, mg, Pack: 1 |
Janssen-Cilag International N.V., Белгия |
Janssen Pharmaceutica N.V., Белгия |
844.04 |
168.81 |
1012.85 |
4% |
10 |
854.04 |
170.81 |
1024.85 |
16% |
25 |
879.04 |
175.81 |
1054.85 |
|
НСР-2326/13.01.2014 |
20.03.2014 |
20.03.2014 |
Неактивен |
3365 |
| Paliperidone |
EU/1/11/672/003 |
XEPLION, Prolonged release suspension for injection, 75, mg, Pack: 1 |
Janssen-Cilag International N.V., Белгия |
Janssen Pharmaceutica N.V., Белгия |
459.27 |
91.85 |
551.12 |
4% |
10 |
469.27 |
93.85 |
563.12 |
16% |
25 |
494.27 |
98.85 |
593.12 |
|
НСР-640/29.07.2013 |
24.09.2013 |
24.09.2013 |
Неактивен |
3363 |
| Paliperidone |
EU/1/11/672/005 |
XEPLION, Prolonged release suspension for injection, 150, mg, Pack: 1 |
Janssen-Cilag International N.V., Белгия |
Janssen Pharmaceutica N.V., Белгия |
878.29 |
175.66 |
1053.95 |
4% |
10 |
888.29 |
177.66 |
1065.95 |
16% |
25 |
913.29 |
182.66 |
1095.95 |
|
КЦРР-2382/21.02.2013 |
19.04.2013 |
19.04.2013 |
Неактивен |
3365 |
| Paliperidone |
EU/1/11/672/004 |
XEPLION, Prolonged release suspension for injection, 100, mg, Pack: 1 |
Janssen-Cilag International N.V., Белгия |
Janssen Pharmaceutica N.V., Белгия |
675.58 |
135.12 |
810.7 |
4% |
10 |
685.58 |
137.12 |
822.7 |
16% |
25 |
710.58 |
142.12 |
852.7 |
|
КЦРР-2382/21.02.2013 |
19.04.2013 |
19.04.2013 |
Неактивен |
3364 |
| Paliperidone |
EU/1/11/672/005 |
XEPLION, Prolonged release suspension for injection, 150, mg, Pack: 1 |
Janssen-Cilag International N.V., Белгия |
Janssen Pharmaceutica N.V., Белгия |
1047.03 |
209.41 |
1256.44 |
4% |
10 |
1057.03 |
211.41 |
1268.44 |
16% |
25 |
1082.03 |
216.41 |
1298.44 |
|
КЦ-2736/28.09.2011 |
13.10.2011 |
13.10.2011 |
Неактивен |
3365 |
| Paliperidone |
EU/1/11/672/003 |
XEPLION, Prolonged release suspension for injection, 75, mg, Pack: 1 |
Janssen-Cilag International N.V., Белгия |
Janssen Pharmaceutica N.V., Белгия |
516.03 |
103.21 |
619.24 |
4% |
10 |
526.03 |
105.21 |
631.24 |
16% |
25 |
551.03 |
110.21 |
661.24 |
|
КЦ-2740/28.09.2011 |
14.10.2011 |
14.10.2011 |
Неактивен |
3363 |
| Paliperidone |
EU/1/11/672/004 |
XEPLION, Prolonged release suspension for injection, 100, mg, Pack: 1 |
Janssen-Cilag International N.V., Белгия |
Janssen Pharmaceutica N.V., Белгия |
693.03 |
138.61 |
831.64 |
4% |
10 |
703.03 |
140.61 |
843.64 |
16% |
25 |
728.03 |
145.61 |
873.64 |
|
КЦ-2738/28.09.2011 |
13.10.2011 |
13.10.2011 |
Неактивен |
3364 |
| Paroxetine |
20040160 |
XETANOR, Film coated tablet, 20, mg, Pack: 30 |
Актавис EАД, България |
Actavis hf, Iceland; Actavis Ltd, Malta; Балканфарма Дупница АД |
6.16 |
1.23 |
7.39 |
7% |
0.43 |
6.59 |
1.32 |
7.91 |
20% |
1.23 |
7.82 |
1.56 |
9.38 |
|
НСР-1209/23.09.2013; НСР-20530/30.12.2019 |
14.01.2020 |
02.02.2020 |
Активен |
2111 |
| Paroxetine |
20040160 |
XETANOR, Film coated tablet, 20, mg, Pack: 30 |
Актавис EАД, България |
Actavis hf, Iceland; Actavis Ltd, Malta; Балканфарма Дупница АД |
4.48 |
0.9 |
5.38 |
7% |
0.31 |
4.79 |
0.96 |
5.75 |
20% |
0.9 |
5.69 |
1.14 |
6.83 |
|
НСР-1209/23.09.2013 |
11.10.2013 |
11.10.2013 |
Неактивен |
2111 |
| Paroxetine |
II-8821/ 09.04.2004 |
XETANOR, Film coated tablet, 20, mg, Pack: 30 |
Актавис EАД, България |
Actavis hf, Iceland; Actavis Ltd, Malta; Балканфарма Дупница АД |
6.86 |
1.37 |
8.23 |
7% |
0.48 |
7.34 |
1.47 |
8.81 |
20% |
1.37 |
8.71 |
1.74 |
10.45 |
|
КЦРР-634/18.05.2012 |
03.06.2012 |
03.06.2012 |
Неактивен |
2111 |
| Paroxetine |
II-8821/09.04.2004 |
XETANOR, Film coated tablet, 20, mg, Pack: 30 |
Актавис EАД, България |
Actavis hf, Iceland; Actavis Ltd, Malta; Балканфарма Дупница АД |
8.5 |
1.7 |
10.2 |
9% |
0.77 |
9.27 |
1.85 |
11.12 |
22% |
1.87 |
11.14 |
2.23 |
13.37 |
|
КЦ-507/06.02.2009 |
19.02.2009 |
19.02.2009 |
Неактивен |
2111 |
| Denosumab |
EU/1/11/703/001 |
Xgeva, Solution for injection, 120 mg/1.7 ml, mg, Pack: 1 |
Amgen Eurоpe B.V., Нидерландия |
Amgen Europe BV., The Netherlands |
464 |
92.8 |
556.8 |
4% |
10 |
474 |
94.8 |
568.8 |
16% |
25 |
499 |
99.8 |
598.8 |
|
НСР-8623/31.03.2016.; НСР-10993/24.11.2016; НСР-13514/18.08.2017 |
02.09.2017 |
02.10.2017 |
Активен |
1470 |
| Denosumab |
EU/1/11/703/001 |
Xgeva, Solution for injection, 120 mg/1.7ml, mg, Pack: 1 |
Amgen Eurоpe B.V., Нидерландия |
Amgen Europe BV., The Netherlands |
464 |
92.8 |
556.8 |
4% |
10 |
474 |
94.8 |
568.8 |
16% |
25 |
499 |
99.8 |
598.8 |
|
НСР-8623/31.03.2016.; НСР-10993/24.11.2016; НСР-13514/18.08.2017 |
02.09.2017 |
02.10.2017 |
Неактивен |
1470 |
| Denosumab |
EU/1/11/703/001 |
Xgeva, Solution for injection, 120 mg/1.7ml, mg, Pack: 1 |
Amgen Eurоpe B.V., Нидерландия |
Amgen Europe BV., The Netherlands |
464 |
92.8 |
556.8 |
4% |
10 |
474 |
94.8 |
568.8 |
16% |
25 |
499 |
99.8 |
598.8 |
|
НСР-8623/31.03.2016.; НСР-10993/24.11.2016; НСР-13514/18.08.2017 |
02.09.2017 |
02.10.2017 |
Неактивен |
1470 |
| Denosumab |
EU/1/11/703/001 |
Xgeva, Solution for injection, 120 mg/1.7ml, mg, Pack: 1 |
Amgen Eurоpe B.V., Нидерландия |
Amgen Europe BV., The Netherlands |
464.02 |
92.8 |
556.82 |
4% |
10 |
474.02 |
94.8 |
568.82 |
16% |
25 |
499.02 |
99.8 |
598.82 |
|
НСР-8623/31.03.2016.; НСР-10993/24.11.2016 |
02.01.2017 |
02.01.2017 |
Неактивен |
1470 |
| Denosumab |
EU/1/11/703/001 |
Xgeva, Solution for injection, 120 mg/1.7ml, mg, Pack: 1 |
Amgen Eurоpe B.V., Нидерландия |
Amgen Europe BV., The Netherlands |
522.01 |
104.4 |
626.41 |
4% |
10 |
532.01 |
106.4 |
638.41 |
16% |
25 |
557.01 |
111.4 |
668.41 |
|
НСР-8623/31.03.2016. |
15.04.2016 |
15.04.2016 |
Неактивен |
1470 |
| Denosumab |
EU/1/11/703/001 |
Xgeva, Solution for injection, 120 mg/1.7ml, mg, Pack: 1 |
Amgen Eurоpe B.V., Нидерландия |
Amgen Europe BV., The Netherlands |
549.57 |
109.91 |
659.48 |
4% |
10 |
559.57 |
111.91 |
671.48 |
16% |
25 |
584.57 |
116.91 |
701.48 |
|
НСР-6832/30.07.2015 |
14.08.2015 |
14.08.2015 |
Неактивен |
1470 |
| Denosumab |
EU/1/11/703/001 |
Xgeva, Solution for injection, 120 mg/1.7ml, mg, Pack: 1 |
Amgen Eurоpe B.V., Нидерландия |
Amgen Europe BV., The Netherlands |
573.06 |
114.61 |
687.67 |
4% |
10 |
583.06 |
116.61 |
699.67 |
16% |
25 |
608.06 |
121.61 |
729.67 |
|
КЦРР-1863/15.12.2012 |
19.12.2012 |
19.12.2012 |
Неактивен |
1470 |
| Dapagliflozin, metformin |
EU/1/13/900/009 |
Xigduo, Film coated tablet, 5 mg/1000, mg, Pack: 56 |
AstraZeneca AB, Швеция |
AstraZeneca GmbH, Tinsdaler Weg 183 22880 Wedel Германия; Bristol Myers Squibb S.r.l., Loc. Fontana del Ceraso Anagni, 03012, Италия |
64.09 |
12.82 |
76.91 |
4% |
2.56 |
66.65 |
13.33 |
79.98 |
16% |
10.25 |
76.9 |
15.38 |
92.28 |
отхвърлана жалба с Решение КП-83/15.06.2016 |
НСР-8556/24.03.2016; ВАС №8405/30.06.2017 и НСР-6687/09.07.2015; НСР-16433/09.08.2018 |
24.08.2018 |
02.09.2018 |
Активен |
4030 |
| Dapagliflozin, metformin |
EU/1/13/900/009 |
Xigduo, Film coated tablet, 5 mg/1000, mg, Pack: 56 |
AstraZeneca AB, Швеция |
AstraZeneca GmbH, Tinsdaler Weg 183 22880 Wedel Германия; Bristol Myers Squibb S.r.l., Loc. Fontana del Ceraso Anagni, 03012, Италия |
64.09 |
12.82 |
76.91 |
4% |
2.56 |
66.65 |
13.33 |
79.98 |
16% |
10.25 |
76.9 |
15.38 |
92.28 |
отхвърлана жалба с Решение КП-83/15.06.2016 |
НСР-8556/24.03.2016; ВАС №8405/30.06.2017 и НСР-6687/09.07.2015; НСР-16433/09.08.2018 |
24.08.2018 |
02.09.2018 |
Неактивен |
4030 |