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

Follitropin alfa EU/1/13/909/001 Bemfola, Solution for injection, 75 IU/0,125 ml, -, Pack: 1 pre-filled pen and 1 injection needle Finox Biotech AG, Лихтенщайн Finox Biotech AG Gewerbestrasse 7 FL-9496 Balzers, Лихтенщайн 36.47 7.29 43.76 4% 1.46 37.93 7.59 45.52 16% 5.84 43.77 8.75 52.52 НСР-6161/08.05.2015 25.05.2015 25.05.2015 Неактивен 3924
Follitropin alfa EU/1/13/909/002 Bemfola, Solution for injection, 150 IU/0,25 ml, -, Pack: 1 pre-filled pen and 1 injection needle Finox Biotech AG, Лихтенщайн Finox Biotech AG Gewerbestrasse 7 FL-9496 Balzers, Лихтенщайн 72.95 14.59 87.54 4% 2.92 75.87 15.17 91.04 16% 11.67 87.54 17.51 105.05 НСР-6162/08.05.2015 25.05.2015 25.05.2015 Неактивен 3925
Follitropin alfa EU/1/13/909/003 Bemfola, Solution for injection, 225 IU/0,375 ml, -, Pack: 1 pre-filled pen and 1 injection needle Finox Biotech AG, Лихтенщайн Finox Biotech AG Gewerbestrasse 7 FL-9496 Balzers, Лихтенщайн 109.42 21.88 131.3 4% 4.38 113.8 22.76 136.56 16% 17.51 131.31 26.26 157.57 НСР-6163/08.05.2015 25.05.2015 25.05.2015 Неактивен 3926
Follitropin alfa EU/1/13/909/004 Bemfola, Solution for injection, 300 IU/0,5 ml, -, Pack: 1 pre-filled pen and 1 injection needle Finox Biotech AG, Лихтенщайн Finox Biotech AG Gewerbestrasse 7 FL-9496 Balzers, Лихтенщайн 145.89 29.18 175.07 4% 5.84 151.73 30.35 182.08 16% 23.34 175.07 35.01 210.08 НСР-6184/08.05.2015 25.05.2015 25.05.2015 Неактивен 3927
Calcium folinate 20130337 Bendafolin, Solution for injection, 10 mg/ml - 100 ml, mg, Pack: 1 Lyomark Pharma GmbH, Германия Bendalis GmbH, Германия 118.7 23.74 142.44 4% 4.75 123.45 24.69 148.14 16% 18.99 142.44 28.49 170.93 НСР-2982/12.03.2014; НСР-15715/25.05.2018 09.06.2018 02.07.2018 Активен 2573
Calcium folinate 20130337 Bendafolin, Solution for injection, 10 mg/ml - 100 ml, mg, Pack: 1 Lyomark Pharma GmbH, Германия Bendalis GmbH, Германия 509.94 101.99 611.93 4% 10 519.94 103.99 623.93 16% 25 544.94 108.99 653.93 НСР-2982/12.03.2014 28.03.2014 28.03.2014 Неактивен 2573
Calcium folinate 20130337 Bendafolin, Solution for injection, 10 mg/ml - 50 ml, mg, Pack: 1 Lyomark Pharma GmbH, Германия Bendalis GmbH, Германия 59.36 11.87 71.23 4% 2.37 61.73 12.35 74.08 16% 9.5 71.23 14.25 85.48 НСР-2982/12.03.2014; НСР-15713/25.05.2018 09.06.2018 02.07.2018 Активен 2574
Calcium folinate 20130337 Bendafolin, Solution for injection, 10 mg/ml - 50 ml, mg, Pack: 1 Lyomark Pharma GmbH, Германия Bendalis GmbH, Германия 254.98 51 305.98 4% 10 264.98 53 317.98 16% 25 289.98 58 347.98 НСР-2982/12.03.2014 28.03.2014 28.03.2014 Неактивен 2574
Bendamustine 20160007 Bendamustine Accord, Powder for concentrate for solution for infusion, 2.5 mg/ ml - 50 ml (100 mg), mg, Pack: 5 Accord Healthcare Limited, Обединено Кралство Accord Healthcare Limited, Обединено кралство; Wessling Hungary Kft., Унгария 1261.39 252.28 1513.67 4% 10 1271.39 254.28 1525.67 16% 25 1296.39 259.28 1555.67 НСР-14628/14.12.2017 ( допуска предварително изпълнение ) 14.12.2017 02.01.2018 Активен 15948
Bendamustine 20150116 Bendamustine Actavis, Powder for concentrate for solution for infusion, 2.5 mg/ml, mg, Pack: 60 ml (100 mg) x 1 Actavis Group PTC ehf., Исландия S.C.Sindan-Pharma S.R.L., 11th Ion Mihalache Boulevard, 011171 Bucharest 1, Румъния 292.98 58.6 351.58 4% 10 302.98 60.6 363.58 16% 25 327.98 65.6 393.58 НСР-6438/12.06.2015.; НСР-16240/27.07.2018 11.08.2018 02.09.2018 Активен 4013
Bendamustine 20150116 Bendamustine Actavis, Powder for concentrate for solution for infusion, 2.5 mg/ ml, mg, Pack: 60 ml (100 mg) x 1 Actavis Group PTC ehf., Исландия S.C.Sindan-Pharma S.R.L., 11th Ion Mihalache Boulevard, 011171 Bucharest 1, Румъния 418.74 83.75 502.49 4% 10 428.74 85.75 514.49 16% 25 453.74 90.75 544.49 НСР-6438/12.06.2015. 26.06.2015 26.06.2015 Неактивен 4013
Bendamustine 20160265 Bendamustine Mylan, Powder for concentrate for solution for infusion, 2.5 mg/ml - 50 ml (100 mg), -, Pack: 5 Mylan S.A.S., Франция Agila Specialites Polska Sp.z.o.o, Полша; Mylan S.A.S., Франция; Wessling Hungary Kft., Унгария 1261.39 252.28 1513.67 4% 10 1271.39 254.28 1525.67 16% 25 1296.39 259.28 1555.67 НСР-13492/11.08.2017 26.08.2017 02.09.2017 Активен 15822
Bendamustine 20140098 Bendamustine Sandoz, Powder for concentrate for solution for infusion, 2.5 mg/ ml, mg, Pack: 100 mg x 5 Sandoz d.d., Словения Helm AG Nordkanalstr. 28 20097 Hamburg Германия; S.C. POLIPHARMA INDUSTRIES S.R.L. Sos. Alba Iulia nr. 156, Sibiu, Jud. Sibiu, cod 550052, Румъния 1758.06 351.61 2109.67 4% 10 1768.06 353.61 2121.67 16% 25 1793.06 358.61 2151.67 НСР-7722/17.12.2015; НСР-14165/13.10.2017 02.01.2016 02.11.2017 Заличен 4163
Bendamustine 20140098 Bendamustine Sandoz, Powder for concentrate for solution for infusion, 2.5 mg/ ml, mg, Pack: 100 mg x 5 Sandoz d.d., Словения Helm AG Nordkanalstr. 28 20097 Hamburg Германия; S.C. POLIPHARMA INDUSTRIES S.R.L. Sos. Alba Iulia nr. 156, Sibiu, Jud. Sibiu, cod 550052, Румъния 1758.06 351.61 2109.67 4% 10 1768.06 353.61 2121.67 16% 25 1793.06 358.61 2151.67 НСР-7722/17.12.2015 02.01.2016 02.01.2016 Неактивен 4163
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 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 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 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 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 Активен 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 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
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