| Mycophenolic acid |
0387/02.08.2007 г. |
Myfortic, Gastro resistant tablet, 180, mg, Pack: 120 |
Novartis Pharma GmbH, Германия |
Novartis Pharma S.A.S., Франция |
242.25 |
48.45 |
290.7 |
6% |
14.54 |
256.79 |
51.36 |
308.15 |
18% |
30 |
286.79 |
57.36 |
344.15 |
|
КЦ-480/29.01.2009 |
16.02.2009 |
16.02.2009 |
Неактивен |
2647 |
| Gemtuzumab ozogamicin |
EU/1/18/1277/001 |
Mylotarg, Powder for concentrate for solution for infusion, 5, mg, Pack: 1 vial |
Pfizer Europe MA EEIG, Белгия |
Pfizer Ireland Pharmaceuticals, Ирландия |
14019.25 |
2803.85 |
16823.1 |
4% |
10 |
14029.25 |
2805.85 |
16835.1 |
16% |
25 |
14054.25 |
2810.85 |
16865.1 |
|
НСР-19859/20.09.2019-предварително изпълнение |
20.09.2019 |
02.10.2019 |
Активен |
16703 |
| Doxorubicin |
EU/1/00/141/001 |
Myocet, Powder, dispersion and solvent for concentrate for dispersion for infusion, 50, mg, Pack: 2 |
Teva B.V., Нидерландия |
GP-Pharma Poligon Industrial Els Vinyets – Els Fogars, Sector 2, Carretera Comarcal C244, km22 08777 Sant Quinti de Mediona (Barcelona) Spain |
1156.01 |
231.2 |
1387.21 |
4% |
10 |
1166.01 |
233.2 |
1399.21 |
16% |
25 |
1191.01 |
238.2 |
1429.21 |
промяна на обстоятелства НСР-6874/30.07.2015; НСР-17899/07.02.2019; НСР-19860/20.09.2019 предварително изпълнение;НСР-20021/21.10.2019 |
НСР-5292/18.12.2014.; НСР-20216/22.11.2019 Предварително изпълнение; КП-12/18.03.2020 |
22.11.2019 |
02.05.2020 |
Активен |
3463 |
| Doxorubicin |
EU/1/00/141/001 |
Myocet, Powder, dispersion and solvent for concentrate for dispersion for infusion, 50, mg, Pack: 2 |
Teva B.V., Нидерландия |
GP-Pharma Poligon Industrial Els Vinyets – Els Fogars, Sector 2, Carretera Comarcal C244, km22 08777 Sant Quinti de Mediona (Barcelona) Spain |
1156.01 |
231.2 |
1387.21 |
4% |
10 |
1166.01 |
233.2 |
1399.21 |
16% |
25 |
1191.01 |
238.2 |
1429.21 |
промяна на обстоятелства НСР-6874/30.07.2015; НСР-17899/07.02.2019; НСР-19860/20.09.2019 предварително изпълнение;НСР-20021/21.10.2019 |
НСР-5292/18.12.2014.; НСР-20216/22.11.2019 Предварително изпълнение* |
22.11.2019 |
02.12.2019 |
Неактивен |
3463 |
| Doxorubicin |
EU/1/00/141/001 |
Myocet, Powder, dispersion and solvent for concentrate for dispersion for infusion, 50, mg, Pack: 2 |
Teva B.V., Нидерландия |
GP-Pharma Poligon Industrial Els Vinyets – Els Fogars, Sector 2, Carretera Comarcal C244, km22 08777 Sant Quinti de Mediona (Barcelona) Spain |
1708.34 |
341.67 |
2050.01 |
4% |
10 |
1718.34 |
343.67 |
2062.01 |
16% |
25 |
1743.34 |
348.67 |
2092.01 |
промяна на обстоятелства НСР-6874/30.07.2015; НСР-17899/07.02.2019; НСР-19860/20.09.2019 предварително изпълнение;НСР-20021/21.10.2019 |
НСР-5292/18.12.2014. |
01.01.2015 |
02.11.2019 |
Неактивен |
3463 |
| Doxorubicin |
EU/1/00/141/001 |
Myocet, Powder, dispersion and solvent for concentrate for dispersion for infusion, 50, mg, Pack: 2 |
Teva B.V., Нидерландия |
GP-Pharma Poligon Industrial Els Vinyets – Els Fogars, Sector 2, Carretera Comarcal C244, km22 08777 Sant Quinti de Mediona (Barcelona) Spain |
1156.01 |
231.2 |
1387.21 |
4% |
10 |
1166.01 |
233.2 |
1399.21 |
16% |
25 |
1191.01 |
238.2 |
1429.21 |
промяна на обстоятелства НСР-6874/30.07.2015; НСР-17899/07.02.2019 |
НСР-5292/ 18.12.2014.; НСР-19860/20.09.2019 предварително изпълнение* |
20.09.2019 |
02.10.2019 |
Неактивен |
3463 |
| Doxorubicin |
EU/1/00/141/001 |
Myocet, Powder, dispersion and solvent for concentrate for dispersion for infusion, 50, mg, Pack: 2 |
Teva B.V., Нидерландия |
GP-Pharma Poligon Industrial Els Vinyets – Els Fogars, Sector 2, Carretera Comarcal C244, km22 08777 Sant Quinti de Mediona (Barcelona) Spain |
1708.34 |
341.67 |
2050.01 |
4% |
10 |
1718.34 |
343.67 |
2062.01 |
16% |
25 |
1743.34 |
348.67 |
2092.01 |
промяна на обстоятелства НСР-6874/30.07.2015; НСР-17899/07.02.2019 |
НСР-5292/ 18.12.2014. |
01.01.2015 |
02.03.2019 |
Неактивен |
3463 |
| Doxorubicin |
EU/1/00/141/001 |
Myocet, Powder, dispersion and solvent for concentrate for dispersion for infusion, 50, mg, Pack: 2 |
Teva B.V., Нидерландия |
GP-Pharma Poligon Industrial Els Vinyets – Els Fogars, Sector 2, Carretera Comarcal C244, km22 08777 Sant Quinti de Mediona (Barcelona) Spain; Teva Operations Poland Sp. z o.o., ul. Mogilska 80, 31-546 |
1708.34 |
341.67 |
2050.01 |
4% |
10 |
1718.34 |
343.67 |
2062.01 |
16% |
25 |
1743.34 |
348.67 |
2092.01 |
промяна на обстоятелства НСР-6874/30.07.2015 |
НСР-5292/ 18.12.2014. |
01.01.2015 |
01.01.2015 |
Неактивен |
3463 |
| Doxorubicin |
EU/1/00/141/001 |
Myocet, Powder, dispersion and solvent for concentrate for dispersion for infusion, 50, mg, Pack: 2 |
Teva Pharma B.V., Нидерландия |
GP-Pharma Poligon Industrial Els Vinyets – Els Fogars, Sector 2, Carretera Comarcal C244, km22 08777 Sant Quinti de Mediona (Barcelona) Spain; Teva Operations Poland Sp. z o.o., ul. Mogilska 80, 31-546 |
1735.72 |
347.14 |
2082.86 |
4% |
10 |
1745.72 |
349.14 |
2094.86 |
16% |
25 |
1770.72 |
354.14 |
2124.86 |
|
НСР-3355/29.04.2014 |
13.05.2014 |
13.05.2014 |
Неактивен |
3463 |
| Doxorubicin |
EU/1/12/769/001EU/1/00/141/001 |
Myocet, Powder, dispersion and solvent for concentrate for dispersion for infusion, 50, mg, Pack: 2 |
Teva Pharma B.V., Нидерландия |
GP-Pharma Poligon Industrial Els Vinyets – Els Fogars, Sector 2, Carretera Comarcal C244, km22 08777 Sant Quinti de Mediona (Barcelona) Spain; Teva Operations Poland Sp. z o.o., ul. Mogilska 80, 31-546 |
1774.88 |
354.98 |
2129.86 |
4% |
10 |
1784.88 |
356.98 |
2141.86 |
16% |
25 |
1809.88 |
361.98 |
2171.86 |
промяна на осбстоятелства НСР-1009/16.08.2013 |
НСР-990/16.08.2013 |
04.09.2013 |
04.09.2013 |
Неактивен |
3463 |
| Doxorubicin |
EU/1/12/769/001EU/1/00/141/001 |
Myocet, Powder, dispersion and solvent for concentrate for dispersion for infusion, 50, mg, Pack: 2 |
Cephalon Europe, Франция |
GP-Pharma Poligon Industrial Els Vinyets – Els Fogars, Sector 2, Carretera Comarcal C244, km22 08777 Sant Quinti de Mediona (Barcelona) Spain; Teva Operations Poland Sp. z o.o., ul. Mogilska 80, 31-546 |
1865.16 |
373.03 |
2238.19 |
4% |
10 |
1875.16 |
375.03 |
2250.19 |
16% |
25 |
1900.16 |
380.03 |
2280.19 |
|
КЦРР-1702/27.11.2012 |
12.12.2012 |
12.12.2012 |
Неактивен |
3463 |
| Technetium [99mTc] tetrofosmin |
II-15004/24.11.2006 |
Myoview, Powder for solution for injection, 230, mcg, Pack: 5 vial (kit for radiopharmaceutical preparation) |
GE Healthcare AS, Норвегия |
GE Healthcare AS, Норвегия |
1093.31 |
218.66 |
1311.97 |
4% |
10 |
1103.31 |
220.66 |
1323.97 |
16% |
25 |
1128.31 |
225.66 |
1353.97 |
НСР-20918/27.02.2020 промяна на обстоятелства |
КЦ-823/15.04.2009 |
30.04.2009 |
02.04.2020 |
Активен |
711 |
| Technetium [99mTc] tetrofosmin |
II-15004/24.11.2006 |
Myoview, Powder for solution for injection, 230, mcg, Pack: 5 vial (kit for radiopharmaceutical preparation) |
GE Healthcare Ltd, Обединено Кралство |
GE Healthcare Limited |
1093.31 |
218.66 |
1311.97 |
4% |
10 |
1103.31 |
220.66 |
1323.97 |
16% |
25 |
1128.31 |
225.66 |
1353.97 |
|
КЦ-823/15.04.2009 |
30.04.2009 |
30.04.2009 |
Неактивен |
711 |
| Technetium [99mTc] tetrofosmin |
II-15004/24.11.2006 |
Myoview, Powder for solution for injection, 230, mcg, Pack: 5 vial (kit for radiopharmaceutical preparation) |
GE Healthcare Ltd, Обединено Кралство |
GE Healthcare Limited |
1093.31 |
218.66 |
1311.97 |
4% |
10 |
1103.31 |
220.66 |
1323.97 |
16% |
25 |
1128.31 |
225.66 |
1353.97 |
|
КЦ-823/15.04.2009 |
30.04.2009 |
30.04.2009 |
Неактивен |
711 |
| Alglucosidase alfa |
EU/1/06/333/001 |
Myozyme, Powder for concentrate for solution for infusion, 50, mg, Pack: 1 |
Genzyme Europe B.V., Нидерландия |
Genzyme Ltd., UK; Genzyme Ireland Ltd., Ирландия |
790.68 |
158.14 |
948.82 |
4% |
10 |
800.68 |
160.14 |
960.82 |
16% |
25 |
825.68 |
165.14 |
990.82 |
Промяна на обстоятелства НСР-19627/21.08.2019 |
НСР-8521/16.03.2016; НСР-10987/24.11.2016; НСР-14190/13.10.2017; НСР-15921/15.06.2018 |
30.06.2018 |
02.10.2019 |
Активен |
3264 |
| Alglucosidase alfa |
EU/1/06/333/001 |
Myozyme, Powder for concentrate for solution for infusion, 50, mg, Pack: 1 |
Genzyme Europe B.V., Нидерландия |
Genzyme Ltd., UK; Genzyme Ireland Ltd., Ирландия |
790.68 |
158.14 |
948.82 |
4% |
10 |
800.68 |
160.14 |
960.82 |
16% |
25 |
825.68 |
165.14 |
990.82 |
Промяна на обстоятелства НСР-19627/21.08.2019 |
НСР-8521/16.03.2016; НСР-10987/24.11.2016; НСР-14190/13.10.2017; НСР-15921/15.06.2018 |
30.06.2018 |
02.10.2019 |
Неактивен |
3264 |
| Alglucosidase alfa |
EU/1/06/333/001 |
Myozyme, Powder for concentrate for solution for infusion, 50, mg, Pack: 1 |
Genzyme Europe B.V., Нидерландия |
Genzyme Ltd., UK |
790.68 |
158.14 |
948.82 |
4% |
10 |
800.68 |
160.14 |
960.82 |
16% |
25 |
825.68 |
165.14 |
990.82 |
|
НСР-8521/16.03.2016; НСР-10987/24.11.2016; НСР-14190/13.10.2017; НСР-15921/15.06.2018 |
30.06.2018 |
02.07.2018 |
Неактивен |
3264 |
| Alglucosidase alfa |
EU/1/06/333/001 |
Myozyme, Powder for concentrate for solution for infusion, 50, mg, Pack: 1 |
Genzyme Europe B.V., Нидерландия |
Genzyme Ltd., UK |
807.91 |
161.58 |
969.49 |
4% |
10 |
817.91 |
163.58 |
981.49 |
16% |
25 |
842.91 |
168.58 |
1011.49 |
|
НСР-8521/16.03.2016; НСР-10987/24.11.2016; НСР-14190/13.10.2017 |
28.10.2017 |
02.11.2017 |
Неактивен |
3264 |
| Alglucosidase alfa |
EU/1/06/333/001 |
Myozyme, Powder for concentrate for solution for infusion, 50, mg, Pack: 1 |
Genzyme Europe B.V., Нидерландия |
Genzyme Ltd., UK |
828.06 |
165.61 |
993.67 |
4% |
10 |
838.06 |
167.61 |
1005.67 |
16% |
25 |
863.06 |
172.61 |
1035.67 |
|
НСР-8521/16.03.2016; НСР-10987/24.11.2016 |
02.01.2017 |
02.01.2017 |
Неактивен |
3264 |
| Alglucosidase alfa |
EU/1/06/333/001 |
Myozyme, Powder for concentrate for solution for infusion, 50, mg, Pack: 1 |
Genzyme Europe B.V., Нидерландия |
Genzyme Ltd., UK |
832.99 |
166.6 |
999.59 |
4% |
10 |
842.99 |
168.6 |
1011.59 |
16% |
25 |
867.99 |
173.6 |
1041.59 |
|
НСР-8521/16.03.2016 |
31.03.2016 |
31.03.2016 |
Неактивен |
3264 |
| Alglucosidase alfa |
EU/1/06/333/001 |
Myozyme, Powder for concentrate for solution for infusion, 50, mg, Pack: 1 |
Genzyme Europe B.V., Нидерландия |
Genzyme Ltd., UK |
832.99 |
166.6 |
999.59 |
4% |
10 |
842.99 |
168.6 |
1011.59 |
16% |
25 |
867.99 |
173.6 |
1041.59 |
|
НСР-8521/16.03.2016 |
31.03.2016 |
31.03.2016 |
Неактивен |
3264 |
| Alglucosidase alfa |
EU/1/06/333/001 |
Myozyme, Powder for concentrate for solution for infusion, 50, mg, Pack: 1 |
Genzyme Europe B.V., Нидерландия |
Genzyme Ltd., UK |
838.58 |
167.72 |
1006.3 |
4% |
10 |
848.58 |
169.72 |
1018.3 |
16% |
25 |
873.58 |
174.72 |
1048.3 |
|
НСР-6598/01.07.2015 |
17.07.2015 |
17.07.2015 |
Неактивен |
3264 |
| Alglucosidase alfa |
EU/1/06/333/001 |
Myozyme, Powder for concentrate for solution for infusion, 50, mg, Pack: 1 |
Genzyme Europe B.V., Нидерландия |
Genzyme Ltd., UK |
844.06 |
168.81 |
1012.87 |
4% |
10 |
854.06 |
170.81 |
1024.87 |
16% |
25 |
879.06 |
175.81 |
1054.87 |
|
НСР-4936/22.10.2014 |
06.11.2014 |
06.11.2014 |
Неактивен |
3264 |
| Alglucosidase alfa |
EU/1/06/333/001 |
Myozyme, Powder for concentrate for solution for infusion, 50, mg, Pack: 1 |
Genzyme Europe B.V., Нидерландия |
Genzyme Ltd. UK |
862.15 |
172.43 |
1034.58 |
4% |
10 |
872.15 |
174.43 |
1046.58 |
16% |
25 |
897.15 |
179.43 |
1076.58 |
корекц. Решение НСР-3158/26.03.2014 |
НСР-2771/17.02.2014 |
06.03.2014 |
06.03.2014 |
Неактивен |
3264 |
| Alglucosidase alfa |
EU/1/06/333/001-003 |
Myozyme, Powder for concentrate for solution for infusion, 50, mg, Pack: 1 |
Genzyme Europe B.V., Нидерландия |
Genzyme Ltd. UK |
916.27 |
183.25 |
1099.52 |
4% |
10 |
926.27 |
185.25 |
1111.52 |
16% |
25 |
951.27 |
190.25 |
1141.52 |
|
HCР-18/31.05.2013 |
02.06.2013 |
02.06.2013 |
Неактивен |
3264 |