| Olanzapine |
EU/1/08/479/002; EMA/PD/2014/21815/N |
Zypadhera, Powder and solvent for prolonged release suspension for injection, 300, mg, Pack: 1 vial + 1 vial + 1 syringe with pre-attached safety needle+2 safety needles |
Рацио Лек ЕООД, (притежател на разрешение за паралелен внос), България |
Lilly Pharma Fertigung und Distribution GmbH & Co.KG, Germany; Софарма АД, България |
365.97 |
73.19 |
439.16 |
4% |
10 |
375.97 |
75.19 |
451.16 |
16% |
25 |
400.97 |
80.19 |
481.16 |
|
НСР-4783/ 13.10.2014 паралелен внос |
27.10.2014 |
27.10.2014 |
Неактивен |
3244 |
| Olanzapine |
EU/1/08/479/003 |
Zypadhera, Powder and solvent for prolonged release suspension for injection, 405, mg, Pack: 1 |
Eli Lilly Nederland B.V, Нидерландия |
Lilly S.A., Madrid, Испания |
368.2 |
73.64 |
441.84 |
4% |
10 |
378.2 |
75.64 |
453.84 |
16% |
25 |
403.2 |
80.64 |
483.84 |
промяна на обстоятелства НСР-9601/23.06.2016 |
НСР-8440/07.03.2016; НСР-10689/21.10.2016; НСР-13350/28.07.2017; НСР-15427/19.04.2018; НСР-17713/10.01.2019; НСР-19910/ 03.10.2019 |
18.10.2019 |
02.11.2019 |
Активен |
3942 |
| Olanzapine |
EU/1/08/479/003 |
Zypadhera, Powder and solvent for prolonged release suspension for injection, 405, mg, Pack: 1 |
Eli Lilly Nederland B.V, Нидерландия |
Lilly S.A., Madrid, Испания |
450.23 |
90.05 |
540.28 |
4% |
10 |
460.23 |
92.05 |
552.28 |
16% |
25 |
485.23 |
97.05 |
582.28 |
промяна на обстоятелства НСР-9601/23.06.2016 |
НСР-8440/07.03.2016; НСР-10689/21.10.2016; НСР-13350/28.07.2017; НСР-15427/19.04.2018; НСР-17713/10.01.2019 |
25.01.2019 |
02.02.2019 |
Неактивен |
3942 |
| Olanzapine |
EU/1/08/479/002 |
Zypadhera, Powder and solvent for prolonged release suspension for injection, 300, mg, Pack: 1 |
Eli Lilly Nederland B.V, Нидерландия |
Lilly S.A., Madrid, Испания |
268.85 |
53.77 |
322.62 |
4% |
10 |
278.85 |
55.77 |
334.62 |
16% |
25 |
303.85 |
60.77 |
364.62 |
промяна обстоятелства НСР-9598/23.06.2016 |
НСР-9213/ 05.05.2016; НСР-9213/ 05.05.2016; НСР-11690/10.02.2017; НСР-14321/03.11.2017; НСР-16074/05.07.2018; НСР-19908/03.10.2019 |
18.10.2019 |
02.11.2019 |
Активен |
2860 |
| Olanzapine |
EU/1/08/479/002 |
Zypadhera, Powder and solvent for prolonged release suspension for injection, 300, mg, Pack: 1 |
Eli Lilly Nederland B.V, Нидерландия |
Lilly S.A., Madrid, Испания |
332.39 |
66.48 |
398.87 |
4% |
10 |
342.39 |
68.48 |
410.87 |
16% |
25 |
367.39 |
73.48 |
440.87 |
промяна обстоятелства НСР-9598/23.06.2016 |
НСР-9213/ 05.05.2016; НСР-9213/ 05.05.2016; НСР-11690/10.02.2017; НСР-14321/03.11.2017; НСР-16074/05.07.2018 |
20.07.2018 |
02.08.2018 |
Неактивен |
2860 |
| Olanzapine |
EU/1/08/479/003 |
Zypadhera, Powder and solvent for prolonged release suspension for injection, 405, mg, Pack: 1 |
Eli Lilly Nederland B.V, Нидерландия |
Lilly S.A., Madrid, Испания |
451.72 |
90.34 |
542.06 |
4% |
10 |
461.72 |
92.34 |
554.06 |
16% |
25 |
486.72 |
97.34 |
584.06 |
промяна на обстоятелства НСР-9601/23.06.2016 |
НСР-8440/07.03.2016; НСР-10689/21.10.2016; НСР-13350/28.07.2017; НСР-15427/19.04.2018 |
04.05.2018 |
02.06.2018 |
Неактивен |
3942 |
| Olanzapine |
EU/1/08/479/002 |
Zypadhera, Powder and solvent for prolonged release suspension for injection, 300, mg, Pack: 1 |
Eli Lilly Nederland B.V, Нидерландия |
Lilly S.A., Madrid, Испания |
333.49 |
66.7 |
400.19 |
4% |
10 |
343.49 |
68.7 |
412.19 |
16% |
25 |
368.49 |
73.7 |
442.19 |
промяна обстоятелства НСР-9598/23.06.2016 |
НСР-9213/ 05.05.2016; НСР-9213/ 05.05.2016; НСР-11690/10.02.2017; НСР-14321/03.11.2017 |
18.11.2017 |
02.12.2017 |
Неактивен |
2860 |
| Olanzapine |
EU/1/08/479/003 |
Zypadhera, Powder and solvent for prolonged release suspension for injection, 405, mg, Pack: 1 |
Eli Lilly Nederland B.V, Нидерландия |
Lilly S.A., Madrid, Испания |
456.2 |
91.24 |
547.44 |
4% |
10 |
466.2 |
93.24 |
559.44 |
16% |
25 |
491.2 |
98.24 |
589.44 |
промяна на обстоятелства НСР-9601/23.06.2016 |
НСР-8440/07.03.2016; НСР-10689/21.10.2016; НСР-13350/28.07.2017 |
12.08.2017 |
02.09.2017 |
Неактивен |
3942 |
| Olanzapine |
EU/1/08/479/002 |
Zypadhera, Powder and solvent for prolonged release suspension for injection, 300, mg, Pack: 1 |
Eli Lilly Nederland B.V, Нидерландия |
Lilly S.A., Madrid, Испания |
339.77 |
67.95 |
407.72 |
4% |
10 |
349.77 |
69.95 |
419.72 |
16% |
25 |
374.77 |
74.95 |
449.72 |
промяна обстоятелства НСР-9598/23.06.2016 |
НСР-9213/ 05.05.2016; НСР-9213/ 05.05.2016; НСР-11690/10.02.2017 |
02.03.2017 |
02.03.2017 |
Неактивен |
2860 |
| Olanzapine |
EU/1/08/479/003 |
Zypadhera, Powder and solvent for prolonged release suspension for injection, 405, mg, Pack: 1 |
Eli Lilly Nederland B.V, Нидерландия |
Lilly S.A., Madrid, Испания |
458.68 |
91.74 |
550.42 |
4% |
10 |
468.68 |
93.74 |
562.42 |
16% |
25 |
493.68 |
98.74 |
592.42 |
промяна на обстоятелства НСР-9601/23.06.2016 |
НСР-8440/07.03.2016; НСР-10689/21.10.2016 |
02.12.2016 |
02.12.2016 |
Неактивен |
3942 |
| Olanzapine |
EU/1/08/479/002 |
Zypadhera, Powder and solvent for prolonged release suspension for injection, 300, mg, Pack: 1 |
Eli Lilly Nederland B.V, Нидерландия |
Lilly S.A., Madrid, Испания |
346.57 |
69.31 |
415.88 |
4% |
10 |
356.57 |
71.31 |
427.88 |
16% |
25 |
381.57 |
76.31 |
457.88 |
промяна обстоятелства НСР-9598/23.06.2016 |
; НСР-9213/ 05.05.2016; НСР-9213/ 05.05.2016 |
02.06.2016 |
02.08.2016 |
Неактивен |
2860 |
| Olanzapine |
EU/1/08/479/003 |
Zypadhera, Powder and solvent for prolonged release suspension for injection, 405, mg, Pack: 1 |
Eli Lilly Nederland B.V, Нидерландия |
Lilly S.A., Madrid, Испания |
466.29 |
93.26 |
559.55 |
4% |
10 |
476.29 |
95.26 |
571.55 |
16% |
25 |
501.29 |
100.26 |
601.55 |
промяна на обстоятелства НСР-9601/23.06.2016 |
НСР-8440/07.03.2016 |
22.03.2016 |
02.08.2016 |
Неактивен |
3942 |
| Olanzapine |
EU/1/08/479/003 |
Zypadhera, Powder and solvent for prolonged release suspension for injection, 405, mg, Pack: 1 |
Eli Lilly Nederland B.V, Нидерландия |
Lilly S.A., Madrid, Испания |
466.29 |
93.26 |
559.55 |
4% |
10 |
476.29 |
95.26 |
571.55 |
16% |
25 |
501.29 |
100.26 |
601.55 |
промяна на обстоятелства НСР-9601/23.06.2016 |
НСР-8440/07.03.2016 |
22.03.2016 |
22.03.2016 |
Неактивен |
3942 |
| Olanzapine |
EU/1/08/479/002 |
Zypadhera, Powder and solvent for prolonged release suspension for injection, 300, mg, Pack: 1 |
Eli Lilly Nederland B.V, Нидерландия |
Lilly S.A., Madrid, Испания |
346.57 |
69.31 |
415.88 |
4% |
10 |
356.57 |
71.31 |
427.88 |
16% |
25 |
381.57 |
76.31 |
457.88 |
промяна на обстоятелства НСР-9598/23.06.2016 |
НСР-9213/ 05.05.2016 |
02.06.2016 |
02.06.2016 |
Неактивен |
2860 |
| Olanzapine |
EU/1/08/479/002 |
Zypadhera, Powder and solvent for prolonged release suspension for injection, 300, mg, Pack: 1 |
Eli Lilly Nederland B.V, Нидерландия |
Lilly S.A., Madrid, Испания |
346.57 |
69.31 |
415.88 |
4% |
10 |
356.57 |
71.31 |
427.88 |
16% |
25 |
381.57 |
76.31 |
457.88 |
|
НСР-7000/24.08.2015.; НСР-9213/ 05.05.2016 |
02.06.2016 |
02.06.2016 |
Неактивен |
2860 |
| Olanzapine |
EU/1/08/479/003 |
Zypadhera, Powder and solvent for prolonged release suspension for injection, 405, mg, Pack: 1 |
Eli Lilly Nederland B.V, Нидерландия |
Lilly Pharma Fertigung und Distribution GmbH & Co. KG, Germany |
466.29 |
93.26 |
559.55 |
4% |
10 |
476.29 |
95.26 |
571.55 |
16% |
25 |
501.29 |
100.26 |
601.55 |
|
НСР-8440/07.03.2016 |
22.03.2016 |
22.03.2016 |
Неактивен |
3942 |
| Olanzapine |
EU/1/08/479/002 |
Zypadhera, Powder and solvent for prolonged release suspension for injection, 300, mg, Pack: 1 |
Eli Lilly Nederland B.V, Нидерландия |
Lilly Pharma Fertigung und Distribution GmbH & Co. KG, Germany |
348.78 |
69.76 |
418.54 |
4% |
10 |
358.78 |
71.76 |
430.54 |
16% |
25 |
383.78 |
76.76 |
460.54 |
|
НСР-7000/24.08.2015. |
08.09.2015 |
08.09.2015 |
Неактивен |
2860 |
| Olanzapine |
EU/1/08/479/002 |
Zypadhera, Powder and solvent for prolonged release suspension for injection, 300, mg, Pack: 1 |
Eli Lilly Nederland B.V, Нидерландия |
Lilly Pharma Fertigung und Distribution GmbH & Co. KG, Germany |
350.82 |
70.16 |
420.98 |
4% |
10 |
360.82 |
72.16 |
432.98 |
16% |
25 |
385.82 |
77.16 |
462.98 |
Отхвърлена жалба от Комисия по прозрачност с решение КП-326/22.06.2015 |
НСР-5749/26.02.2015 |
16.08.2015 |
16.08.2015 |
Неактивен |
2860 |
| Olanzapine |
EU/1/08/479/003 |
Zypadhera, Powder and solvent for prolonged release suspension for injection, 405, mg, Pack: 1 |
Eli Lilly Nederland B.V, Нидерландия |
Lilly Pharma Fertigung und Distribution GmbH & Co. KG, Germany |
471.43 |
94.29 |
565.72 |
4% |
10 |
481.43 |
96.29 |
577.72 |
16% |
25 |
506.43 |
101.29 |
607.72 |
Oтхвърлена жалба от Комисия по прозрачност КП-304/17.06.2015 |
НСР-5960/01.04.2015 |
16.07.2015 |
16.07.2015 |
Неактивен |
3942 |
| Olanzapine |
EU/1/08/479/003 |
Zypadhera, Powder and solvent for prolonged release suspension for injection, 405, mg, Pack: 1 |
Eli Lilly Nederland B.V, Нидерландия |
Lilly Pharma Fertigung und Distribution GmbH & Co. KG, Germany |
491.5 |
98.3 |
589.8 |
4% |
10 |
501.5 |
100.3 |
601.8 |
16% |
25 |
526.5 |
105.3 |
631.8 |
Oтхвърлена жалба от Комисия по прозрачност КП-277/15.05.2015 |
НСР-3420/30.04.2014 |
02.06.2015 |
02.06.2015 |
Неактивен |
3942 |
| Olanzapine |
EU/1/08/479/003 |
Zypadhera, Powder and solvent for prolonged release suspension for injection, 405, mg, Pack: 1 |
Eli Lilly Nederland B.V, Нидерландия |
Lilly Pharma Fertigung und Distribution GmbH & Co. KG, Germany |
493.93 |
98.79 |
592.72 |
4% |
10 |
503.93 |
100.79 |
604.72 |
16% |
25 |
528.93 |
105.79 |
634.72 |
Oтхвърлена жалба от Комисия по прозрачност КП-6/15.01.2014 |
НСР-810/07.08.2013 |
02.07.2014 |
02.07.2014 |
Неактивен |
3942 |
| Olanzapine |
EU/1/08/479/002 |
Zypadhera, Powder and solvent for prolonged release suspension for injection, 300, mg, Pack: 1 |
Eli Lilly Nederland B.V, Нидерландия |
Lilly Pharma Fertigung und Distribution GmbH & Co. KG, Germany |
365.97 |
73.19 |
439.16 |
4% |
10 |
375.97 |
75.19 |
451.16 |
16% |
25 |
400.97 |
80.19 |
481.16 |
Отхвърлена жалба от Комисия по прозрачност с решение КП-11/19.02.2014 |
НСР-809/07.08.2013 |
16.06.2014 |
16.06.2014 |
Неактивен |
2860 |
| Olanzapine |
EU/1/08/479/003 |
Zypadhera, Powder and solvent for prolonged release suspension for injection, 405, mg, Pack: 1 |
Eli Lilly Nederland B.V, Нидерландия |
Lilly Pharma Fertigung und Distribution GmbH & Co. KG, Germany |
792.13 |
158.43 |
950.56 |
4% |
10 |
802.13 |
160.43 |
962.56 |
16% |
25 |
827.13 |
165.43 |
992.56 |
|
КЦ-607/23.02.2009 |
18.03.2009 |
18.03.2009 |
Неактивен |
3942 |
| Olanzapine |
EU/1/08/479/002 |
Zypadhera, Powder and solvent for prolonged release suspension for injection, 300, mg, Pack: 1 |
Eli Lilly Nederland B.V, Нидерландия |
Lilly Pharma Fertigung und Distribution GmbH & Co. KG, Germany |
653.25 |
130.65 |
783.9 |
4% |
10 |
663.25 |
132.65 |
795.9 |
16% |
25 |
688.25 |
137.65 |
825.9 |
|
КЦ-607/23.02.2009 |
18.03.2009 |
18.03.2009 |
Неактивен |
2860 |
| Olanzapine |
EU/1/96/022/010 |
ZYPREXA, Tablet, 10, mg, Pack: 56 |
Eli Lilly Nederland B.V, Нидерландия |
Lilly S.A., Spain |
132.53 |
26.51 |
159.04 |
4% |
5.3 |
137.83 |
27.57 |
165.4 |
16% |
21.2 |
159.03 |
31.81 |
190.84 |
|
НСР-8549/24.03.2016.; НСР-13958/25.09.2017 |
08.04.2016 |
02.11.2017 |
Заличен |
3485 |