Набор от данни:  Актуализация на регистрите на НСЦРЛП към 02.11.2020

одобрен

Приложение 4 на ПЛС от 02.11.2020 г.

Уникален идентификатор:  683bfadb-6a82-4a8e-8e6a-e976e4021fe3

НСЦРЛП РМС 214/2016 РМС 435/2020

Текуща версия: 1

Показвана версия: 1

Формат: CSV

  • Създаден на: 2021-02-18 12:57:01
  • Създаден от: georgi_sivchev
  • Последна промяна: 2021-07-16 13:46:05
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Подреди по:
Възходящ ред Низходящ ред

Международно непатентно наименование /INN/

Регистрационен №, вписан в разрешението за употреба

Наименование на лекарствения продукт/лекарствена форма и количество активно вещество в окончателна опаковка

Притежател на разрешението за употреба

Производител

Заявена цена производител, въз основа на която се образува цената

Утвърдена цена по елементи

Забележка

№/дата на решението

Дата на вписване след изтичане на 14-дневен срок за обжалване от деня на съобщаването

Дата на актуализация

Статус

Идентификатор на ЛП
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 837.23 167.45 1004.68 4% 10 847.23 169.45 1016.68 16% 25 872.23 174.45 1046.68 НСР-5210/04.12.2014; НСР-9909/29.07.2016; НСР-14469/17.11.2017; НСР-16689/30.08.2018 14.09.2018 02.10.2018 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 252.52 50.5 303.02 4% 10 262.52 52.5 315.02 16% 25 287.52 57.5 345.02 НСР-6835/30.07.2015.; НСР-9123/27.04.2016; НСР-15081/23.02.2018 10.03.2018 02.04.2018 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 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 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 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 Неактивен 4046
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 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 Неактивен 4045
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 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 Неактивен 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 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 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 866.71 173.34 1040.05 4% 10 876.71 175.34 1052.05 16% 25 901.71 180.34 1082.05 HCР-22/31.05.2013; НСР-15137/02.03.2018; НСР-18824/30.05.2019 14.06.2019 02.07.2019 Активен 1848
Показва 1725 до 1749 от общо 18069 записа
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