Набор от данни:  Актуализация на регистрите на НСЦРЛП към 02.06.2020

одобрен

Приложение 4 на ПЛС от 02.06.2020 г.

Уникален идентификатор:  4ae0eb5e-4f0c-4e5f-b918-75e603e96e47

Текуща версия: 1

Показвана версия: 1

Формат: CSV

  • Създаден на: 2020-06-11 15:08:08
  • Създаден от: georgi_sivchev
  • Последна промяна: 2020-06-11 15:08:08
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ПОЗИТИВЕН ЛЕКАРСТВЕН СПИСЪК

Bendamustine 20190061 Bendamustine Sandoz, Powder for concentrate for solution for infusion, 2,5 mg/ml (100 mg), -, Pack: 1 Sandoz d.d., Словения Synthon Hispania S.L., Испания; Synthon s.r.o., Чешка република; Sandoz GmbH, Австрия; Salutas Pharma GmbH, Германия 224.92 44.98 269.9 4% 9 233.92 46.78 280.7 16% 25 258.92 51.78 310.7 НСР-20122/08.11.2019 23.11.2019 02.12.2019 Активен 16773
Coagulation factor IX (nonacog alfa) EU/1/97/047/005 BeneFIX, Powder and solvent for solution for injection, 500, IU, Pack: 1 vial powder + 1 pre-filled syringe solvent 5 ml + 1 injection set Pfizer Europe MA EEIG, Белгия Wyeth Farma S.A. Аutovia del Norte. A-1, Km.23.Desvio Algete, Km. 1, 28700 S. Sebastian de los Reyes, Madrid Испания 454.28 90.86 545.14 4% 10 464.28 92.86 557.14 16% 25 489.28 97.86 587.14 Протокол № 270/15.03.2018; Промяна на обстоятелствата НСР-17316/22.11.2018 HCР-19/31.05.2013; НСР-16545/17.08.2018 (предварително изпъленение); НСР-18670/20.05.2019; НСР-20840/20.02.2020 06.03.2020 02.04.2020 Активен 1849
Coagulation factor IX (nonacog alfa) EU/1/97/047/005 BeneFIX, Powder and solvent for solution for injection, 500, IU, Pack: 1 vial powder + 1 pre-filled syringe solvent 5 ml + 1 injection set Pfizer Europe MA EEIG, Белгия Wyeth Farma S.A. Аutovia del Norte. A-1, Km.23.Desvio Algete, Km. 1, 28700 S. Sebastian de los Reyes, Madrid Испания 456.98 91.4 548.38 4% 10 466.98 93.4 560.38 16% 25 491.98 98.4 590.38 Протокол № 270/15.03.2018; Промяна на обстоятелствата НСР-17316/22.11.2018 HCР-19/31.05.2013; НСР-16545/17.08.2018 (предварително изпъленение); НСР-18670/20.05.2019 04.06.2019 02.07.2019 Неактивен 1849
Coagulation factor IX (nonacog alfa) EU/1/97/047/005 BeneFIX, Powder and solvent for solution for injection, 500, IU, Pack: 1 vial powder + 1 pre-filled syringe solvent 5 ml + 1 injection set Pfizer Europe MA EEIG, Белгия Wyeth Farma S.A. Аutovia del Norte. A-1, Km.23.Desvio Algete, Km. 1, 28700 S. Sebastian de los Reyes, Madrid Испания 456.98 91.4 548.38 4% 10 466.98 93.4 560.38 16% 25 491.98 98.4 590.38 Протокол № 270/15.03.2018; Промяна на обстоятелствата НСР-17316/22.11.2018 HCР-19/31.05.2013; НСР-16545/17.08.2018 (предварително изпъленение); НСР-18670/20.05.2019 04.06.2019 02.07.2019 Неактивен 1849
Coagulation factor IX (nonacog alfa) EU/1/97/047/005 BeneFIX, Powder and solvent for solution for injection, 500, IU, Pack: 1 vial powder + 1 pre-filled syringe solvent 5 ml + 1 injection set Pfizer Europe MA EEIG, Белгия Wyeth Farma S.A. Аutovia del Norte. A-1, Km.23.Desvio Algete, Km. 1, 28700 S. Sebastian de los Reyes, Madrid Испания 495.31 99.06 594.37 4% 10 505.31 101.06 606.37 16% 25 530.31 106.06 636.37 Протокол № 270/15.03.2018; Промяна на обстоятелствата НСР-17316/22.11.2018 HCР-19/31.05.2013; НСР-16545/17.08.2018 (предварително изпъленение) 17.08.2018 02.01.2019 Неактивен 1849
Coagulation factor IX (nonacog alfa) EU/1/97/047/005 BeneFIX, Powder and solvent for solution for injection, 500, IU, Pack: 1 vial powder + 1 pre-filled syringe solvent 5 ml + 1 injection set Pfizer Limited, Обединено Кралство Wyeth Farma S.A. Аutovia del Norte. A-1, Km.23.Desvio Algete, Km. 1, 28700 S. Sebastian de los Reyes, Madrid Испания 495.31 99.06 594.37 4% 10 505.31 101.06 606.37 16% 25 530.31 106.06 636.37 Протокол № 270/15.03.2018 HCР-19/31.05.2013; НСР-16545/17.08.2018 (предварително изпъленение) 17.08.2018 02.09.2018 Неактивен 1849
Coagulation factor IX (nonacog alfa) EU/1/97/047/005 BeneFIX, Powder and solvent for solution for injection, 500, IU, Pack: 1 vial powder + 1 pre-filled syringe solvent 5 ml + 1 injection set Pfizer Limited, Обединено Кралство Wyeth Farma S.A. Аutovia del Norte. A-1, Km.23.Desvio Algete, Km. 1, 28700 S. Sebastian de los Reyes, Madrid Испания 560.11 112.02 672.13 4% 10 570.11 114.02 684.13 16% 25 595.11 119.02 714.13 Протокол № 270/15.03.2018 HCР-19/31.05.2013 02.06.2013 02.04.2018 Неактивен 1849
Coagulation factor IX (nonacog alfa) EU/1/97/047/005 BeneFIX, Solution for injection, 500, IU, Pack: 1 Pfizer Limited, Обединено Кралство Wyeth Farma S.A. Аutovia del Norte. A-1, Km.23.Desvio Algete, Km. 1, 28700 S. Sebastian de los Reyes, Madrid Испания 560.11 112.02 672.13 4% 10 570.11 114.02 684.13 16% 25 595.11 119.02 714.13 HCР-19/31.05.2013 02.06.2013 02.06.2013 Неактивен 1849
Nonacog alfa EU/1/97/047/005 BeneFIX, Solution for injection, 500, IU, Pack: 1 Pfizer Limited, Обединено Кралство Wyeth Farma S.A. Аutovia del Norte. A-1, Km.23.Desvio Algete, Km. 1, 28700 S. Sebastian de los Reyes, Madrid Испания 560.11 112.02 672.13 4% 10 570.11 114.02 684.13 16% 25 595.11 119.02 714.13 HCР-19/31.05.2013 02.06.2013 02.06.2013 Неактивен 1849
Nonacog alfa EU/1/97/047/005 BeneFIX, Solution for injection, 500, IU, Pack: 1 Pfizer Limited, Обединено Кралство Wyeth Farma S.A. Аutovia del Norte. A-1, Km.23.Desvio Algete, Km. 1, 28700 S. Sebastian de los Reyes, Madrid Испания 560.11 112.02 672.13 4% 10 570.11 114.02 684.13 16% 25 595.11 119.02 714.13 HCР-19/31.05.2013 02.06.2013 02.06.2013 Неактивен 1849
Belimumab EU/1/11/700/001 Benlysta, Powder for concentrate for solution for infusion, 120, mg, Pack: 1 GlaxoSmithKline (Ireland) Limited, Ирландия 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 249.9 49.98 299.88 4% 10 259.9 51.98 311.88 16% 25 284.9 56.98 341.88 Промяна на обстоятелства НСР-18155/07.03.2019 НСР-6835/30.07.2015.; НСР-9123/27.04.2016; НСР-15081/23.02.2018; НСР-17250/14.11.2018 29.11.2018 02.04.2019 Активен 3431
Belimumab EU/1/11/700/001 Benlysta, Powder for concentrate for solution for infusion, 120, mg, Pack: 1 GlaxoSmithKline (Ireland) Limited, Ирландия 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 249.9 49.98 299.88 4% 10 259.9 51.98 311.88 16% 25 284.9 56.98 341.88 Промяна на обстоятелства НСР-18155/07.03.2019 НСР-6835/30.07.2015.; НСР-9123/27.04.2016; НСР-15081/23.02.2018; НСР-17250/14.11.2018 29.11.2018 02.04.2019 Неактивен 3431
Belimumab EU/1/11/700/002 Benlysta, Powder for concentrate for solution for infusion, 400, mg, Pack: 1 GlaxoSmithKline (Ireland) Limited, Ирландия 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 831.15 166.23 997.38 4% 10 841.15 168.23 1009.38 16% 25 866.15 173.23 1039.38 Промяна на обстоятелства НСР-18155/07.03.2019 НСР-5210/04.12.2014; НСР-9909/29.07.2016; НСР-14469/17.11.2017; НСР-16689/30.08.2018; НСР-18821/30.05.2019 14.06.2019 02.07.2019 Активен 3432
Belimumab EU/1/11/700/002 Benlysta, Powder for concentrate for solution for infusion, 400, mg, Pack: 1 GlaxoSmithKline (Ireland) Limited, Ирландия 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 831.15 166.23 997.38 4% 10 841.15 168.23 1009.38 16% 25 866.15 173.23 1039.38 Промяна на обстоятелства НСР-18155/07.03.2019 НСР-5210/04.12.2014; НСР-9909/29.07.2016; НСР-14469/17.11.2017; НСР-16689/30.08.2018; НСР-18821/30.05.2019 14.06.2019 02.07.2019 Неактивен 3432
Belimumab EU/1/11/700/002 Benlysta, Powder for concentrate for solution for infusion, 400, mg, Pack: 1 GlaxoSmithKline (Ireland) Limited, Ирландия 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 Промяна на обстоятелства НСР-18155/07.03.2019 НСР-5210/04.12.2014; НСР-9909/29.07.2016; НСР-14469/17.11.2017; НСР-16689/30.08.2018 14.09.2018 02.04.2019 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 249.9 49.98 299.88 4% 10 259.9 51.98 311.88 16% 25 284.9 56.98 341.88 НСР-6835/30.07.2015.; НСР-9123/27.04.2016; НСР-15081/23.02.2018; НСР-17250/14.11.2018 29.11.2018 02.12.2018 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 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
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