| Sevoflurane |
II-14475/ 16.10.2006 |
Sevorane, Inhalation vapour, liquid, 250, ml, Pack: 1 |
AbbVie Ltd, Обединено Кралство |
Aesica Queenborough Limited, Kent ME11 5EL, Великобритания |
176.22 |
35.24 |
211.46 |
4% |
7.05 |
183.27 |
36.65 |
219.92 |
16% |
25 |
208.27 |
41.65 |
249.92 |
промяна на обстоятелства НСР-1693/11.11.2013; промяна на обстоятелства НСР-2000/06.12.2013 |
КЦРР-562/04.05.2012 |
23.05.2012 |
23.05.2012 |
Неактивен |
1210 |
| Sevoflurane |
II-14475/16.10.2006 |
Sevorane, Inhalation vapour, liquid, 250, ml, Pack: 1 |
Abbott Laboratories Limited, Обединено Кралство |
Aesica Queenborough Limited, Kent ME11 5EL, Великобритания |
178.63 |
35.73 |
214.36 |
6% |
10.72 |
189.35 |
37.87 |
227.22 |
18% |
30 |
219.35 |
43.87 |
263.22 |
|
КЦ-453/21.01.2009 |
12.02.2009 |
12.02.2009 |
Неактивен |
1210 |
| Pasireotide |
EU/1/12/753/004 |
Signifor, Solution for injection, 0.3, mg, Pack: 60 ampoules |
Novartis Europharm Limited, Обединено Кралство |
Novartis Pharma GmbH, Германия |
5378.04 |
1075.61 |
6453.65 |
4% |
10 |
5388.04 |
1077.61 |
6465.65 |
16% |
25 |
5413.04 |
1082.61 |
6495.65 |
|
НСР-4944/22.10.2014 |
06.11.2014 |
06.11.2014 |
Активен |
3303 |
| Papillomavirus (human types 6, 11, 16, 18) |
EU/1/06/358/007 |
Silgard, suspention injection pre-filled syringe - 1 доза (0, 5 мл), HPV Тип 6 L1 20 mcg; HPV Type 11 L1 40 mcg; HPV Type 16 L1 40 mcg; HPV Type 18 L1 20 mcg, -, Pack: |
Merck Sharp & Dohme Ltd., Обединено Кралство |
Merck Sharp & Dohme B.V.- The Netherlands |
181.36 |
36.27 |
217.63 |
4% |
7.25 |
188.61 |
37.72 |
226.33 |
16% |
25 |
213.61 |
42.72 |
256.33 |
|
КЦРР-742/07.06.2012 |
27.06.2012 |
27.06.2012 |
Неактивен |
1501 |
| Papillomavirus (human types 6, 11, 16, 18) |
EU/1/06/358/007 |
Silgard, suspention injection pre-filled syringe - 1 доза (0, 5 мл), HPV Тип 6 L1 20 mcg; HPV Type 11 L1 40 mcg; HPV Type 16 L1 40 mcg; HPV Type 18 L1 20 mcg, -, Pack: |
Merck Sharp & Dohme Ltd., Обединено Кралство |
Merck Sharp & Dohme B.V.- The Netherlands |
185.8 |
37.16 |
222.96 |
6% |
11.15 |
196.95 |
39.39 |
236.34 |
18% |
30 |
226.95 |
45.39 |
272.34 |
|
КЦ-651/05.03.2009 |
18.03.2009 |
18.03.2009 |
Неактивен |
1501 |
| Papillomavirus (human types 6, 11, 16, 18) |
EU/1/06/358/007 |
SILGARD, Suspension for injection, 0,5 ml, -, Pack: 1 pre-filled syringe + 2 needles |
Merck Sharp & Dohme Ltd., Обединено Кралство |
Merck Sharp & Dohme B.V.- The Netherlands |
169.57 |
33.91 |
203.48 |
4% |
6.78 |
176.35 |
35.27 |
211.62 |
16% |
25 |
201.35 |
40.27 |
241.62 |
|
КЦРР-1735/04.12.2012 г |
21.12.2012 |
21.12.2012 |
Активен |
1501 |
| Papillomavirus (human types 6, 11, 16, 18) |
EU/1/06/358/007 |
SILGARD, Suspension for injection, 0,5 ml, -, Pack: 1 pre-filled syringe + 2 needles |
Merck Sharp & Dohme Ltd., Обединено Кралство |
Merck Sharp & Dohme B.V.- The Netherlands |
169.57 |
33.91 |
203.48 |
4% |
6.78 |
176.35 |
35.27 |
211.62 |
16% |
25 |
201.35 |
40.27 |
241.62 |
|
КЦРР-1735/04.12.2012 г |
21.12.2012 |
21.12.2012 |
Неактивен |
1501 |
| Brinzolamide, Brimonidine |
EU/1/14/933/001 |
Simbrinza, Eye drops, emulsion, 10 mg/ml + 2 mg/ml, mg, Pack: 5 ml x 1 |
Alcon Laboratories (UK) Ltd., Обединено Кралство |
Alcon-Couvreur N.V., Белгия; Alcon Cusi, S.A., Испания |
20.99 |
4.2 |
25.19 |
6% |
1.26 |
22.25 |
4.45 |
26.7 |
18% |
3.78 |
26.03 |
5.21 |
31.24 |
|
НСР-7562/24.11.2015 (допуска предварително изпълнение) |
02.12.2015 |
02.12.2015 |
Активен |
8974 |
| Simvastatin |
20050470 |
SIMGAL 20 MG, Film coated tablet, 20, mg, Pack: 28 |
Teva Czech Industries s.r.o., Чешка република |
Teva Czech Industries s.r.o., Czech Republic |
1.9 |
0.38 |
2.28 |
7% |
0.13 |
2.03 |
0.41 |
2.44 |
20% |
0.38 |
2.41 |
0.48 |
2.89 |
промяна на обстоятелства НСР-8267/26.02.2016 |
НСР-7922/28.01.2016. |
12.02.2016 |
12.02.2016 |
Активен |
2292 |
| Simvastatin |
II-12106/ 17.02.2011 |
SIMGAL 20 MG, Film coated tablet, 20, mg, Pack: 28 |
Teva Czech Industries s.r.o., Чешка република |
Teva Czech Industries s.r.o., Czech Republic |
1.98 |
0.4 |
2.38 |
7% |
0.14 |
2.12 |
0.42 |
2.54 |
20% |
0.4 |
2.52 |
0.5 |
3.02 |
|
НСР-1745/21.11.2013 |
11.12.2013 |
11.12.2013 |
Неактивен |
2292 |
| Simvastatin |
II-12106/ 17.02.2011 |
SIMGAL 20 MG, Film coated tablet, 20, mg, Pack: 28 |
Teva Czech Industries s.r.o., Чешка република |
Teva Czech Industries s.r.o., Czech Republic |
4.75 |
0.95 |
5.7 |
7% |
0.33 |
5.08 |
1.02 |
6.1 |
20% |
0.95 |
6.03 |
1.21 |
7.24 |
|
КЦРР-1204/13.08.2012 |
28.08.2012 |
28.08.2012 |
Неактивен |
2292 |
| Simvastatin |
II-12106/17,02,2011 |
SIMGAL 20 MG, Film coated tablet, 20, mg, Pack: 28 |
Teva Czech Industries s.r.o., Чешка република |
Teva Czech Industries s.r.o., Czech Republic |
7.28 |
1.46 |
8.74 |
9% |
0.66 |
7.94 |
1.59 |
9.53 |
22% |
1.6 |
9.54 |
1.91 |
11.45 |
КЦ-3039/28.10.2011 промяна на обстоятелства |
КЦ-700/09.03.2009 |
24.03.2009 |
24.03.2009 |
Неактивен |
2292 |
| Golimumab |
EU/1/09/546/003 |
Simponi, Solution for injection, 50 mg/0,5 ml, -, Pack: 1 pre-filled syringe |
Janssen Biologics B.V., Нидерландия |
Janssen Biologics B.V., Холандия |
1602.41 |
320.48 |
1922.89 |
4% |
10 |
1612.41 |
322.48 |
1934.89 |
16% |
25 |
1637.41 |
327.48 |
1964.89 |
корекционно решение НСР-9728/07.07.2016 |
НСР-5957/01.04.2015.; НСР-9616/23.06.2016 |
02.08.2016 |
02.08.2016 |
Активен |
3739 |
| Golimumab |
EU/1/09/546/003 |
Simponi, Solution for injection, 50 mg/0,5 ml, -, Pack: 1 pre-filled syringe |
Janssen Biologics B.V., Нидерландия |
Janssen Biologics B.V., Холандия |
1610.43 |
322.09 |
1932.52 |
4% |
10 |
1620.43 |
324.09 |
1944.52 |
16% |
25 |
1645.43 |
329.09 |
1974.52 |
|
НСР-5957/01.04.2015. |
16.04.2015 |
16.04.2015 |
Неактивен |
3739 |
| Golimumab |
EU/1/09/546/001 |
Simponi, Solution for injection, 50 mg/0,5 ml, -, Pack: 1 pre-filled pen |
Janssen Biologics B.V., Нидерландия |
Janssen Biologics B.V., Холандия |
1610.43 |
322.09 |
1932.52 |
4% |
10 |
1620.43 |
324.09 |
1944.52 |
16% |
25 |
1645.43 |
329.09 |
1974.52 |
|
НСР-5958/01.04.2015. |
16.04.2015 |
16.04.2015 |
Неактивен |
3740 |
| Golimumab |
EU/1/09/546/001 |
SIMPONI, Solution for injection, 50, mg, Pack: pre - filled pen x 1 |
Janssen Biologics B.V., Нидерландия |
Janssen Biologics B.V., Холандия |
1602.41 |
320.48 |
1922.89 |
4% |
10 |
1612.41 |
322.48 |
1934.89 |
16% |
25 |
1637.41 |
327.48 |
1964.89 |
корекционно решение НСР-9729/07.07.2016 |
НСР-5958/01.04.2015.; НСР-9615/23.06.2016 |
02.08.2016 |
02.08.2016 |
Активен |
3740 |
| Golimumab |
EU/1/09/546/001 |
SIMPONI, Solution for injection, 50, mg, Pack: 1 |
Janssen Biologics B.V., Нидерландия |
Jenssen Biologics B.V., Холандия |
1619.41 |
323.88 |
1943.29 |
4% |
10 |
1629.41 |
325.88 |
1955.29 |
16% |
25 |
1654.41 |
330.88 |
1985.29 |
Оставена без разглеждане жалба от Комисия по прозрачност КП-50/28.05.2014 |
НСР-1565/25.10.2013 |
02.07.2014 |
02.07.2014 |
Неактивен |
3740 |
| Golimumab |
EU/1/09/546/003 |
SIMPONI, Solution for injection, 50, mg, Pack: 1 |
Janssen Biologics B.V., Нидерландия |
Janssen Biologics B.V., Холандия |
1619.41 |
323.88 |
1943.29 |
4% |
10 |
1629.41 |
325.88 |
1955.29 |
16% |
25 |
1654.41 |
330.88 |
1985.29 |
Оставена без разглеждане жалба от Комисия по прозрачност КП-49/28.05.2014 |
НСР-1824/25.11.2013 |
02.07.2014 |
02.07.2014 |
Неактивен |
3739 |
| Golimumab |
EU/1/09/546/001 |
SIMPONI, Solution for injection, 50, mg, Pack: 1 |
Janssen Biologics B.V., Нидерландия |
Jenssen Biologics B.V., Холандия |
1619.43 |
323.89 |
1943.32 |
4% |
10 |
1629.43 |
325.89 |
1955.32 |
16% |
25 |
1654.43 |
330.89 |
1985.32 |
Отхвърлена жалба от Комисия по прозрачност с решение КП-5/05.02.2014 |
НСР-140/07.06.2013 |
02.04.2014 |
02.04.2014 |
Неактивен |
3740 |
| Golimumab |
EU/1/09/546/003 |
SIMPONI, Solution for injection, 50, mg, Pack: 1 |
Janssen Biologics B.V., Нидерландия |
Janssen Biologics B.V., Холандия |
2044.98 |
409 |
2453.98 |
4% |
10 |
2054.98 |
411 |
2465.98 |
16% |
25 |
2079.98 |
416 |
2495.98 |
|
КЦ-2680/07.09.2011 |
28.09.2011 |
28.09.2011 |
Неактивен |
3739 |
| Golimumab |
EU/1/09/546/001 |
SIMPONI, Solution for injection, 50, mg, Pack: 1 |
Janssen Biologics B.V., Нидерландия |
Jenssen Biologics B.V., Холандия |
2044.98 |
409 |
2453.98 |
4% |
10 |
2054.98 |
411 |
2465.98 |
16% |
25 |
2079.98 |
416 |
2495.98 |
|
КЦ-2500/29.07.2011 |
12.08.2011 |
12.08.2011 |
Неактивен |
3740 |
| Basiliximab |
EU/1/98/084/001 |
Simulect, powder and solvent for solution for injection/ infusion, 20, mg, Pack: 1 |
Novartis Europharm Limited, Обединено Кралство |
Novartis Pharma S.A.S., France |
1773.45 |
354.69 |
2128.14 |
4% |
10 |
1783.45 |
356.69 |
2140.14 |
16% |
25 |
1808.45 |
361.69 |
2170.14 |
|
НСР-8234/22.02.2016 |
09.03.2016 |
09.03.2016 |
Активен |
3403 |
| Basiliximab |
EU/1/98/084/001 |
Simulect, powder and solvent for solution for injection/ infusion, 20, mg, Pack: 1 |
Novartis Europharm Limited, Обединено Кралство |
Novartis Pharma S.A.S., France |
1773.94 |
354.79 |
2128.73 |
4% |
10 |
1783.94 |
356.79 |
2140.73 |
16% |
25 |
1808.94 |
361.79 |
2170.73 |
|
НСР-5153/27.11.2014 |
11.12.2014 |
11.12.2014 |
Неактивен |
3403 |
| Basiliximab |
EU/1/98/084/001 |
Simulect, powder and solvent for solution for injection/ infusion, 20, mg, Pack: 1 |
Novartis Europharm Limited, Обединено Кралство |
Novartis Pharma S.A.S., France |
1795.88 |
359.18 |
2155.06 |
4% |
10 |
1805.88 |
361.18 |
2167.06 |
16% |
25 |
1830.88 |
366.18 |
2197.06 |
|
НСР-1400/10.10.2013 |
25.10.2013 |
25.10.2013 |
Неактивен |
3403 |
| Basiliximab |
EU/1/98/084/001 |
Simulect, powder and solvent for solution for injection/ infusion, 20, mg, Pack: 1 |
Novartis Europharm Limited, Обединено Кралство |
Novartis Pharma S.A.S., France |
1945.48 |
389.1 |
2334.58 |
4% |
10 |
1955.48 |
391.1 |
2346.58 |
16% |
25 |
1980.48 |
396.1 |
2376.58 |
|
КЦ-377/05.01.2009 |
28.01.2009 |
28.01.2009 |
Неактивен |
3403 |