Набор от данни:  Актуализация на регистрите на НСЦРЛП към 02.06.2019 г.

одобрен

Приложение 4 на ПЛС от 02.06.2019 г.

Уникален идентификатор:  f09a5d85-659a-4b8f-bb62-2e369d2147cb

Текуща версия: 1

Показвана версия: 1

Формат: CSV

  • Създаден на: 2019-06-04 09:40:33
  • Създаден от: georgi_sivchev
  • Последна промяна: 2019-06-04 09:40:33
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ПОЗИТИВЕН ЛЕКАРСТВЕН СПИСЪК

Belimumab EU/1/11/700/002 Benlysta, Powder for concentrate for solution for infusion, 400, mg, Pack: 1 Glaxo Group Ltd., Обединено Кралство Human Genome Sciences, Inc. Belward Large Scale Manufacturing (LSM) Facility 9911 Belward Campus Drive Rockville, MD 20850 USA; GlaxoSmithKline Manufacturing S.P.A Strada Provinciale Asolana No. 90 I-43056 San Polo di Torrile, Parma, Italy 841.79 168.36 1010.15 4% 10 851.79 170.36 1022.15 16% 25 876.79 175.36 1052.15 НСР-5210/04.12.2014; НСР-9909/29.07.2016; НСР-14469/17.11.2017 02.12.2017 02.01.2018 Неактивен 3432
Belimumab EU/1/11/700/001 Benlysta, Powder for concentrate for solution for infusion, 120, mg, Pack: 1 Glaxo Group Ltd., Обединено Кралство Human Genome Sciences, Inc. Belward Large Scale Manufacturing (LSM) Facility 9911 Belward Campus Drive Rockville, MD 20850 USA; GlaxoSmithKline Manufacturing S.P.A Strada Provinciale Asolana No. 90 I-43056 San Polo di Torrile, Parma, Italy 254.22 50.84 305.06 4% 10 264.22 52.84 317.06 16% 25 289.22 57.84 347.06 НСР-6835/30.07.2015.; НСР-9123/27.04.2016 13.05.2016 02.06.2016 Неактивен 3431
Belimumab EU/1/11/700/002 Benlysta, Powder for concentrate for solution for infusion, 400, mg, Pack: 1 Glaxo Group Ltd., Обединено Кралство Human Genome Sciences, Inc. Belward Large Scale Manufacturing (LSM) Facility 9911 Belward Campus Drive Rockville, MD 20850 USA; GlaxoSmithKline Manufacturing S.P.A Strada Provinciale Asolana No. 90 I-43056 San Polo di Torrile, Parma, Italy 847.48 169.5 1016.98 4% 10 857.48 171.5 1028.98 16% 25 882.48 176.5 1058.98 НСР-5210/04.12.2014; НСР-9909/29.07.2016 16.08.2016 02.09.2016 Неактивен 3432
Belimumab EU/1/11/700/002 Benlysta, Powder for concentrate for solution for infusion, 400, mg, Pack: 1 Glaxo Group Ltd., Обединено Кралство Human Genome Sciences, Inc. Belward Large Scale Manufacturing (LSM) Facility 9911 Belward Campus Drive Rockville, MD 20850 USA; GlaxoSmithKline Manufacturing S.P.A Strada Provinciale Asolana No. 90 I-43056 San Polo di Torrile, Parma, Italy 848.83 169.77 1018.6 4% 10 858.83 171.77 1030.6 16% 25 883.83 176.77 1060.6 НСР-5210/04.12.2014 19.12.2014 19.12.2014 Неактивен 3432
Belimumab EU/1/11/700/001 Benlysta, Powder for concentrate for solution for infusion, 120, mg, Pack: 1 Glaxo Group Ltd., Обединено Кралство Human Genome Sciences, Inc. Belward Large Scale Manufacturing (LSM) Facility 9911 Belward Campus Drive Rockville, MD 20850 USA; GlaxoSmithKline Manufacturing S.P.A Strada Provinciale Asolana No. 90 I-43056 San Polo di Torrile, Parma, Italy 254.63 50.93 305.56 4% 10 264.63 52.93 317.56 16% 25 289.63 57.93 347.56 НСР-6835/30.07.2015. 14.08.2015 14.08.2015 Неактивен 3431
Belimumab EU/1/11/700/001 Benlysta, Powder for concentrate for solution for infusion, 120, mg, Pack: 1 Glaxo Group Ltd., Обединено Кралство Human Genome Sciences, Inc. Belward Large Scale Manufacturing (LSM) Facility 9911 Belward Campus Drive Rockville, MD 20850 USA; GlaxoSmithKline Manufacturing S.P.A Strada Provinciale Asolana No. 90 I-43056 San Polo di Torrile, Parma, Italy 254.65 50.93 305.58 4% 10 264.65 52.93 317.58 16% 25 289.65 57.93 347.58 НСР-5211/04.12.2014 19.12.2014 19.12.2014 Неактивен 3431
Belimumab EU/1/11/700/001 Benlysta, Powder for concentrate for solution for infusion, 120, mg, Pack: 1 Glaxo Group Ltd., Обединено Кралство Human Genome Sciences, Inc. Belward Large Scale Manufacturing (LSM) Facility 9911 Belward Campus Drive Rockville, MD 20850 USA; GlaxoSmithKline Manufacturing S.P.A Strada Provinciale Asolana No. 90 I-43056 San Polo di Torrile, Parma, Italy 276.77 55.35 332.12 4% 10 286.77 57.35 344.12 16% 25 311.77 62.35 374.12 НСР-3112/26.03.2014 10.04.2014 10.04.2014 Неактивен 3431
Belimumab EU/1/11/700/002 Benlysta, Powder for concentrate for solution for infusion, 400, mg, Pack: 1 Glaxo Group Ltd., Обединено Кралство Human Genome Sciences, Inc. Belward Large Scale Manufacturing (LSM) Facility 9911 Belward Campus Drive Rockville, MD 20850 USA; GlaxoSmithKline Manufacturing S.P.A Strada Provinciale Asolana No. 90 I-43056 San Polo di Torrile, Parma, Italy 925.4 185.08 1110.48 4% 10 935.4 187.08 1122.48 16% 25 960.4 192.08 1152.48 НСР-3118/26.03.2014 10.04.2014 10.04.2014 Неактивен 3432
Belimumab EU/1/11/700/001 Benlysta, Powder for concentrate for solution for infusion, 120, mg, Pack: 1 Glaxo Group Ltd., Обединено Кралство Human Genome Sciences, Inc. Belward Large Scale Manufacturing (LSM) Facility 9911 Belward Campus Drive Rockville, MD 20850 USA; GlaxoSmithKline Manufacturing S.P.A Strada Provinciale Asolana No. 90 I-43056 San Polo di Torrile, Parma, Italy 285.16 57.03 342.19 4% 10 295.16 59.03 354.19 16% 25 320.16 64.03 384.19 НСР-491/11.07.2013 31.07.2013 31.07.2013 Неактивен 3431
Belimumab EU/1/11/700/002 Benlysta, Powder for concentrate for solution for infusion, 400, mg, Pack: 1 Glaxo Group Ltd., Обединено Кралство Human Genome Sciences, Inc. Belward Large Scale Manufacturing (LSM) Facility 9911 Belward Campus Drive Rockville, MD 20850 USA; GlaxoSmithKline Manufacturing S.P.A Strada Provinciale Asolana No. 90 I-43056 San Polo di Torrile, Parma, Italy 950.53 190.11 1140.64 4% 10 960.53 192.11 1152.64 16% 25 985.53 197.11 1182.64 НСР-491/11.07.2013 31.07.2013 31.07.2013 Неактивен 3432
Human coagulation factor VIII 20150023 Beriate, Powder and solvent for solution for injection/infusion, 1000, IU, Pack: 1 CSL Behring GmbH, Германия CSL Behring GmbH, Германия 744.45 148.89 893.34 4% 10 754.45 150.89 905.34 16% 25 779.45 155.89 935.34 Промяна на обстоятелствата НСР-16626/24.08.2018 НСР-6760/23.07.2015 08.08.2015 02.10.2018 Активен 4047
Human coagulation factor VIII II-28288/30.01.2015 Beriate, Powder and solvent for solution for injection/infusion, 1000, IU, Pack: 1 CSL Behring GmbH, Германия CSL Behring GmbH, Германия 744.45 148.89 893.34 4% 10 754.45 150.89 905.34 16% 25 779.45 155.89 935.34 НСР-6760/23.07.2015 08.08.2015 08.08.2015 Неактивен 4047
Human coagulation factor VIII 20150021 Beriate, Powder and solvent for solution for injection/infusion, 250, IU, Pack: 1 CSL Behring GmbH, Германия CSL Behring GmbH, Германия 189.68 37.94 227.62 4% 7.59 197.27 39.45 236.72 16% 25 222.27 44.45 266.72 Промяна на обстоятелствата НСР-16624/24.08.2018 НСР-6760/23.07.2015 08.08.2015 02.10.2018 Активен 4045
Human coagulation factor VIII II-28286/30.01.2015 Beriate, Powder and solvent for solution for injection/infusion, 250, IU, Pack: 1 CSL Behring GmbH, Германия CSL Behring GmbH, Германия 189.68 37.94 227.62 4% 7.59 197.27 39.45 236.72 16% 25 222.27 44.45 266.72 НСР-6760/23.07.2015 08.08.2015 08.08.2015 Неактивен 4045
Human coagulation factor VIII 20150022 Beriate, Powder and solvent for solution for injection/infusion, 500, IU, Pack: 1 CSL Behring GmbH, Германия CSL Behring GmbH, Германия 340.31 68.06 408.37 4% 10 350.31 70.06 420.37 16% 25 375.31 75.06 450.37 Промяна на обстоятелствата НСР-16625/24.08.2018 НСР-6760/23.07.2015 08.08.2015 02.10.2018 Активен 4046
Human coagulation factor VIII II-28287/30.01.2015 Beriate, Powder and solvent for solution for injection/infusion, 500, IU, Pack: 1 CSL Behring GmbH, Германия CSL Behring GmbH, Германия 340.31 68.06 408.37 4% 10 350.31 70.06 420.37 16% 25 375.31 75.06 450.37 НСР-6760/23.07.2015 08.08.2015 08.08.2015 Неактивен 4046
Human coagulation factor VIII II-28288/30.01.2015 Beriate, Powder and solvent for solution for injection/infusion, 1000, IU, Pack: 1 CSL Behring GmbH, Германия CSL Behring GmbH, Германия 744.45 148.89 893.34 4% 10 754.45 150.89 905.34 16% 25 779.45 155.89 935.34 НСР-6760/23.07.2015 08.08.2015 08.08.2015 Неактивен 4047
Human coagulation factor VIII II-28287/30.01.2015 Beriate, Powder and solvent for solution for injection/infusion, 500, IU, Pack: 1 CSL Behring GmbH, Германия CSL Behring GmbH, Германия 340.31 68.06 408.37 4% 10 350.31 70.06 420.37 16% 25 375.31 75.06 450.37 НСР-6760/23.07.2015 08.08.2015 08.08.2015 Неактивен 4046
Human coagulation factor VIII II-28286/30.01.2015 Beriate, Powder and solvent for solution for injection/infusion, 250, IU, Pack: 1 CSL Behring GmbH, Германия CSL Behring GmbH, Германия 189.68 37.94 227.62 4% 7.59 197.27 39.45 236.72 16% 25 222.27 44.45 266.72 НСР-6760/23.07.2015 08.08.2015 08.08.2015 Неактивен 4045
c1-inhibitor, plasma derived 20080293 Berinert 500 IU, Powder and solvent for solution for injection/infusion, 500 IU, IU, Pack: 1 vial CSL Behring GmbH, Германия CSL Behring GmbH, E-mail-von-Behring-Str. 76,35041 Marburg, Германия 885.4 177.08 1062.48 4% 10 895.4 179.08 1074.48 16% 25 920.4 184.08 1104.48 HCР-22/31.05.2013; НСР-15137/02.03.2018 17.03.2018 02.04.2018 Активен 1848
c1-inhibitor, plasma derived 20080293 Berinert 500 IU, Powder and solvent for solution for injection/infusion, 500 IU, IU, Pack: 1 vial CSL Behring GmbH, Германия CSL Behring GmbH, E-mail-von-Behring-Str. 76,35041 Marburg, Германия 898.2 179.64 1077.84 4% 10 908.2 181.64 1089.84 16% 25 933.2 186.64 1119.84 HCР-22/31.05.2013 02.06.2013 02.06.2013 Неактивен 1848
Enalapril 20020461 Berlipril, Tablet, 20, mg, Pack: 30 Berlin-Chemie AG (Menarini Group), Германия Berlin-Chemie AG (Menarini Group), Glienicker Weg 125, 12489 Berlin, Germany 4.79 0.96 5.75 7% 0.34 5.13 1.03 6.16 20% 0.96 6.09 1.22 7.31 промяна на обстоятелства НСР-4529/22.08.2014( в сила от 08.09.2014), промяна обстоятелства НСР-9893/29.07.2016; НСР-17104/26.10.2018 КЦ-48/21.04.2008; НСР-13083/29.06.2017 14.07.2017 02.12.2018 Активен 29
Enalapril 20020461 Berlipril, Tablet, 20, mg, Pack: 30 Berlin-Chemie AG (Menarini Group), Германия Berlin-Chemie AG (Menarini Group), Glienicker Weg 125, 12489 Berlin, Germany; Menarini - Von Heyden GmbH, Germany 4.79 0.96 5.75 7% 0.34 5.13 1.03 6.16 20% 0.96 6.09 1.22 7.31 промяна на обстоятелства НСР-4529/22.08.2014( в сила от 08.09.2014), промяна обстоятелства НСР-9893/29.07.2016 КЦ-48/21.04.2008; НСР-13083/29.06.2017 14.07.2017 02.08.2017 Неактивен 29
Enalapril 20020461 Berlipril, Tablet, 20, mg, Pack: 30 Berlin-Chemie AG (Menarini Group), Германия Berlin-Chemie AG (Menarini Group), Glienicker Weg 125, 12489 Berlin, Germany; Menarini - Von Heyden GmbH, Germany 5.2 1.04 6.24 7% 0.36 5.56 1.11 6.67 20% 1.04 6.6 1.32 7.92 промяна на обстоятелства НСР-4529/22.08.2014( в сила от 08.09.2014), промяна обстоятелства НСР-9893/29.07.2016 КЦ-48/21.04.2008 23.05.2008 02.09.2016 Неактивен 29
Enalapril 9600019 Berlipril, Tablet, 5, mg, Pack: 30 Berlin-Chemie AG (Menarini Group), Германия Berlin-Chemie AG (Menarini Group), Glienicker Weg 125, 12489 Berlin, Germany; Menarini - Von Heyden GmbH, Germany 2.72 0.54 3.26 7% 0.19 2.91 0.58 3.49 20% 0.54 3.45 0.69 4.14 промяна на обстоятелства НСР-4465/15.08.2014( в сила от 01.09.2014), НСР-9895/29.07.2016 КЦ-48/21.04.2008 23.05.2008 02.09.2016 Активен 27
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