| Crizotinib |
EU/1/12/793/001 |
Xalkori, Capsule, hard, 200 mg, -, Pack: 60 |
Pfizer Europe MA EEIG, Белгия |
Pfizer Manufacturing Deutschland GmbH, Германия |
9892.2 |
1978.44 |
11870.64 |
4% |
10 |
9902.2 |
1980.44 |
11882.64 |
16% |
25 |
9927.2 |
1985.44 |
11912.64 |
НСР-4356/05.08.2014 |
02.09.2014 |
02.01.2019 |
Промяна на обстоятелства НСР-17457/13.12.2018 |
|
Активен |
2410 |
| Crizotinib |
EU/1/12/793/001 |
Xalkori, Capsule, hard, 200 mg, -, Pack: 60 |
Pfizer Limited, Обединено Кралство |
Pfizer Manufacturing Deutschland GmbH, Германия |
9892.2 |
1978.44 |
11870.64 |
4% |
10 |
9902.2 |
1980.44 |
11882.64 |
16% |
25 |
9927.2 |
1985.44 |
11912.64 |
НСР-4356/05.08.2014 |
02.09.2014 |
02.09.2014 |
|
|
Неактивен |
2410 |
| Mercaptopurine |
EU/1/11/727/001 |
Xaluprine, Oral suspension, 20 mg/ml - 100 ml, -, Pack: 1 bottle adaptor + 2 oral syringes |
Nova Laboratories Limited, Обединено Кралство |
Nova Laboratories Limited (Обединено Кралство) |
418.55 |
83.71 |
502.26 |
4% |
10 |
428.55 |
85.71 |
514.26 |
16% |
25 |
453.55 |
90.71 |
544.26 |
НСР-9727/07.07.2016 г.; НСР-11883/06.03.017 г. |
02.08.2016 |
02.04.2017 |
|
|
Заличен |
15117 |
| Mercaptopurine |
EU/1/11/727/001 |
Xaluprine, Oral suspension, 20 mg/ml - 100 ml, -, Pack: 1 bottle adaptor + 2 oral syringes |
Nova Laboratories Limited, Обединено Кралство |
Nova Laboratories Limited (Обединено Кралство) |
418.55 |
83.71 |
502.26 |
4% |
10 |
428.55 |
85.71 |
514.26 |
16% |
25 |
453.55 |
90.71 |
544.26 |
НСР-9727/07.07.2016 г. |
02.08.2016 |
02.08.2016 |
|
|
Неактивен |
15117 |
| Alprazolam |
20020165 |
XANAX, Tablet, 0,5, mg, Pack: 100 |
Pfizer Europe MA EEIG, Белгия |
Pfizer Italia S.r.l., Localita Marino del Tronto, Ascoli, 63100 Piceno (AP), Italy |
4.21 |
0.84 |
5.05 |
7% |
0.29 |
4.5 |
0.9 |
5.4 |
20% |
0.84 |
5.34 |
1.07 |
6.41 |
НСР-3791/16.06.2014 |
16.07.2014 |
02.02.2019 |
Промяна на обстоятелства НСР-11027/24.11.2016; НСР-17753/17.01.2019 |
|
Активен |
2891 |
| Alprazolam |
20020165 |
XANAX, Tablet, 0,5, mg, Pack: 100 |
Pfizer Europe MA EEIG, Обединено Кралство |
Pfizer Italia S.r.l., Localita Marino del Tronto, Ascoli, 63100 Piceno (AP), Italy |
4.21 |
0.84 |
5.05 |
7% |
0.29 |
4.5 |
0.9 |
5.4 |
20% |
0.84 |
5.34 |
1.07 |
6.41 |
НСР-3791/16.06.2014 |
16.07.2014 |
02.01.2017 |
Промяна на обстоятелства НСР-11027/24.11.2016 |
|
Неактивен |
2891 |
| Alprazolam |
20020166 |
XANAX, Tablet, 0.25, mg, Pack: 100 |
Pfizer Europe MA EEIG, Белгия |
Pfizer Italia S.r.l., Localita Marino del Tronto, 63100 Ascoli Piceno (AP), Italy |
5.1 |
1.02 |
6.12 |
7% |
0.36 |
5.46 |
1.09 |
6.55 |
20% |
1.02 |
6.48 |
1.3 |
7.78 |
НСР-15255/15.03.2018 |
02.04.2018 |
02.02.2019 |
Промяна на обстоятелства НСР-17753/17.01.2019 |
|
Активен |
1641 |
| Alprazolam |
20020166 |
XANAX, Tablet, 0.25, mg, Pack: 100 |
Pfizer Europe MA EEIG, Обединено Кралство |
Pfizer Italia S.r.l., Localita Marino del Tronto, 63100 Ascoli Piceno (AP), Italy |
5.1 |
1.02 |
6.12 |
7% |
0.36 |
5.46 |
1.09 |
6.55 |
20% |
1.02 |
6.48 |
1.3 |
7.78 |
НСР-15255/15.03.2018 |
02.04.2018 |
02.04.2018 |
|
|
Неактивен |
1641 |
| Alprazolam |
20020165 |
XANAX, Tablet, 0.5, mg, Pack: 30 |
Pfizer Europe MA EEIG, Белгия |
Pfizer Italia S.r.l., Localita Marino del Tronto, 63100 Ascoli Piceno (AP), Italy |
2.64 |
0.53 |
3.17 |
7% |
0.18 |
2.82 |
0.56 |
3.38 |
20% |
0.53 |
3.35 |
0.67 |
4.02 |
НСР-15227/09.03.2018 |
02.04.2018 |
02.02.2019 |
Промяна на обстоятелства НСР-17753/17.01.2019 |
|
Активен |
2890 |
| Alprazolam |
20020165 |
XANAX, Tablet, 0.5, mg, Pack: 30 |
Pfizer Europe MA EEIG, Обединено Кралство |
Pfizer Italia S.r.l., Localita Marino del Tronto, 63100 Ascoli Piceno (AP), Italy |
2.64 |
0.53 |
3.17 |
7% |
0.18 |
2.82 |
0.56 |
3.38 |
20% |
0.53 |
3.35 |
0.67 |
4.02 |
НСР-15227/09.03.2018 |
02.04.2018 |
02.04.2018 |
|
|
Неактивен |
2890 |
| Alprazolam |
20020166 |
XANAX, Tablet, 0.25, mg, Pack: 30 |
Pfizer Europe MA EEIG, Обединено Кралство |
Pfizer Italia S.r.l., Localita Marino del Tronto, 63100 Ascoli Piceno (AP), Italy |
1.66 |
0.33 |
1.99 |
7% |
0.12 |
1.78 |
0.36 |
2.14 |
20% |
0.33 |
2.11 |
0.42 |
2.53 |
НСР-15228/09.03.2018 |
02.04.2018 |
02.04.2018 |
|
|
Активен |
3353 |
| Alprazolam |
II-1337/27.12.2007 |
XANAX, Tablet, 0,5 mg, -, Pack: 100 |
Pfizer Europe MA EEIG, Обединено Кралство |
Pfizer manufacturing Belgium N.V./S.A., Rijksweg 12 B-2870 Puurs, Belgium
Pharmacia Italia S.p.A., Via del Commercio, 63046 Localita Marino del Tronto, Ascoli Piceno (AP), Italy |
4.21 |
0.84 |
5.05 |
7% |
0.29 |
4.5 |
0.9 |
5.4 |
20% |
0.84 |
5.34 |
1.07 |
6.41 |
НСР-3791/16.06.2014 |
16.07.2014 |
16.07.2014 |
|
|
Неактивен |
2891 |
| Rivaroxaban |
EU/1/08/472/027 |
Xarelto, Film coated tablet, 2.5, mg, Pack: 56 |
Bayer AG, Германия |
Bayer AG, Germany; Bayer HealthCare Manufacturing Srl, Italy; Bayer Bitterfeld GmbH, Germany |
113.52 |
22.7 |
136.22 |
4% |
4.54 |
118.06 |
23.61 |
141.67 |
16% |
18.16 |
136.22 |
27.24 |
163.46 |
НСР-16129/13.07.2018 |
28.07.2018 |
02.08.2018 |
|
|
Активен |
16186 |
| Rivaroxaban |
EU/1/08/472/018 |
Xarelto, Film coated tablet, 20mg, -, Pack: 28 |
Bayer Pharma AG, Германия |
Bayer Pharma AG Leverkusen, Deutschland |
131.43 |
26.29 |
157.72 |
4% |
5.26 |
136.69 |
27.34 |
164.03 |
16% |
21.03 |
157.72 |
31.54 |
189.26 |
КЦPP-928/04.07.2012 г. |
24.07.2012 |
24.07.2012 |
корекц. решение КЦРР-1152/02.08.2012. |
|
Заличен |
3578 |
| Rivaroxaban |
EU/1/08/472/013 |
Xarelto, Film coated tablet, 15mg, -, Pack: 42 |
Bayer Pharma AG, Германия |
Bayer Pharma AG Leverkusen, Deutschland |
197.15 |
39.43 |
236.58 |
4% |
7.89 |
205.04 |
41.01 |
246.05 |
16% |
25 |
230.04 |
46.01 |
276.05 |
КЦPP-928/04.07.2012 г. |
24.07.2012 |
24.07.2012 |
корекц. решение КЦРР-1152/02.08.2012. |
|
Заличен |
2506 |
| Rivaroxaban |
EU/1/08/472/012 |
Xarelto, Film coated tablet, 15mg, -, Pack: 28 |
Bayer Pharma AG, Германия |
Bayer Pharma AG Leverkusen, Deutschland |
131.43 |
26.29 |
157.72 |
4% |
5.26 |
136.69 |
27.34 |
164.03 |
16% |
21.03 |
157.72 |
31.54 |
189.26 |
КЦPP-928/04.07.2012 г. |
24.07.2012 |
24.07.2012 |
корекц. решение КЦРР-1152/02.08.2012. |
|
Заличен |
3537 |
| Rivaroxaban |
EU/1/08/472/001 |
Xarelto, Film coated tablet, 10 mg, -, Pack: 5 |
Bayer Schering Pharma AG,, Германия |
Bayer Schering Pharma AG, Германия |
50.85 |
10.17 |
61.02 |
4% |
2.03 |
52.88 |
10.58 |
63.46 |
16% |
8.14 |
61.02 |
12.2 |
73.22 |
КЦ-1424/
05,03,2010 г. |
30.03.2010 |
30.03.2010 |
Прот. № 154/14.01.2016 |
|
Заличен |
1521 |
| Lornoxicam |
II-10657/07.09.2010 |
Xefo, Powder and solvent for solution for injection, 8, mg, Pack: 1 |
Takeda Austria GmbH, Австрия |
Takeda Austria GmbH, Австрия |
3.68 |
0.74 |
4.42 |
7% |
0.26 |
3.94 |
0.79 |
4.73 |
20% |
0.74 |
4.68 |
0.94 |
5.62 |
КЦ-1862/27.10.2010 |
02.07.2016 |
02.11.2016 |
промяна на обстоятелства НСР-10289/15.09.2016; Протокол 188/08.09.2016г. |
|
Активен |
15276 |
| Lornoxicam |
II-10657/07.09.2010 |
Xefo, Powder for solution for injection, 8, mg, Pack: 1 |
Nycomed Austria GmbH, Австрия |
Nycomed Austria GmbH,Austria |
3.68 |
0.74 |
4.42 |
7% |
0.26 |
3.94 |
0.79 |
4.73 |
20% |
0.74 |
4.68 |
0.94 |
5.62 |
КЦ-1862/27.10.2010 |
02.07.2016 |
02.07.2016 |
|
|
Неактивен |
15276 |
| Lornoxicam |
№ ІІ - 5026/28.05.2009 |
Xefo Rapid, Film coated tablet, 8 mg, -, Pack: 10 |
Takeda Austria GmbH, Австрия |
Takeda Austria GmbH, Austria |
4.95 |
0.99 |
5.94 |
7% |
0.35 |
5.3 |
1.06 |
6.36 |
20% |
0.99 |
6.29 |
1.26 |
7.55 |
КЦ-1866/27.10.2010 |
|
|
промяна на обстоятелства НСР-2918/07.03.2014 |
|
Активен |
983 |
| Capecitabine |
20120245 |
Xeloda, Film coated tablet, 500 mg, -, Pack: 120 |
Roche Registration GmbH, Германия |
Roche Pharma AG, Germany |
288.5 |
57.7 |
346.2 |
4% |
10 |
298.5 |
59.7 |
358.2 |
16% |
25 |
323.5 |
64.7 |
388.2 |
НСР-8581/24.03.2016 |
02.05.2016 |
02.09.2019 |
Промяна на обстоятелствата НСР-15844/08.06.2018;НСР-19225/12.07.2019;Корекционно решение НСР-19368/26.07.2019 |
|
Активен |
3127 |
| Capecitabine |
EU/1/00/163/001 |
Xeloda, Film coated tablet, 150 mg, -, Pack: 60 |
Roche Registration GmbH, Германия |
Roche Pharma AG, Germany |
42.44 |
8.49 |
50.93 |
4% |
1.7 |
44.14 |
8.83 |
52.97 |
16% |
6.79 |
50.93 |
10.19 |
61.12 |
НСР-8580/24.03.2016.; НСР-19225/12.07.2019; Корекционно решение НСР-19368/26.07.2019 |
02.05.2016 |
02.09.2019 |
Промяна на обстоятелствата НСР-15843/08.06.2018; |
|
Заличен |
2541 |
| Capecitabine |
EU/1/00/163/001 |
Xeloda, Film coated tablet, 150 mg, -, Pack: 60 |
Roche Registration GmbH, Германия |
Roche Pharma AG, Germany |
42.44 |
8.49 |
50.93 |
4% |
1.7 |
44.14 |
8.83 |
52.97 |
16% |
6.79 |
50.93 |
10.19 |
61.12 |
НСР-8580/24.03.2016. |
02.05.2016 |
02.07.2018 |
Промяна на обстоятелствата НСР-15843/08.06.2018 |
|
Неактивен |
2541 |
| Capecitabine |
EU/1/00/163/002 |
Xeloda, Film coated tablet, 500 mg, -, Pack: 120 |
Roche Registration GmbH, Германия |
Roche Pharma AG, Germany |
288.5 |
57.7 |
346.2 |
4% |
10 |
298.5 |
59.7 |
358.2 |
16% |
25 |
323.5 |
64.7 |
388.2 |
НСР-8581/24.03.2016.; НСР-19225/12.07.2019 |
02.05.2016 |
02.08.2019 |
Промяна на обстоятелствата НСР-15844/08.06.2018 |
|
Заличен |
3127 |
| Capecitabine |
EU/1/00/163/002 |
Xeloda, Film coated tablet, 500 mg, -, Pack: 120 |
Roche Registration GmbH, Германия |
Roche Pharma AG, Germany |
288.5 |
57.7 |
346.2 |
4% |
10 |
298.5 |
59.7 |
358.2 |
16% |
25 |
323.5 |
64.7 |
388.2 |
НСР-8581/24.03.2016. |
02.05.2016 |
02.07.2018 |
Промяна на обстоятелствата НСР-15844/08.06.2018 |
|
Неактивен |
3127 |