| L01XC03 |
Trastuzumab |
Herceptin |
Powder for concentrate for solution for infusion |
150 |
mg |
1 |
Roche Registration GmbH, Германия |
1 |
mg |
832.27 |
5.24333 |
786.5 |
100% |
|
C16.0,C16.1,C16.2,C16.3,C16.4,C16.5,C16.6,C16.8,C16.9,C50.0,C50.1,C50.2,C50.3,C50.4,C50.5,C50.6,C50.8,C50.9 |
КЦРР-609/18.05.2012 г.; КЦРР-2733/20.03.2013 г.; НСР-2315/13.01.2014; НСР-4814/ 13.10.2014; НСР-7412/10.11.2015; НСР-7767/28.12.2015; НСР-15121/01.03.2018 предварително изпълнение; НСР-16000/22.06.2018; НСР-18679/20.05.2019 |
02.07.2019 |
08.09.2012 |
Активен |
3259 |
| L01XC03 |
Trastuzumab |
Herzuma |
Powder for concentrate for solution for infusion |
150 |
mg |
1 vial |
Celltrion Healthcare Hungary Kft., Унгария |
1 |
mg |
825.54 |
5.24333 |
786.5 |
100% |
|
C16.0,C16.1,C16.2,C16.3,C16.4,C16.5,C16.6,C16.8,C16.9,C50.0,C50.1,C50.2,C50.3,C50.4,C50.5,C50.6,C50.8,C50.9 |
НСР-16956/12.10.2018 |
02.04.2019 |
|
Активен |
16309 |
| L01XC03 |
Trastuzumab |
Kanjinti |
Powder for concentrate for solution for infusion |
150 |
mg |
1 vial |
Amgen Eurоpe B.V., Нидерландия |
1 |
mg |
836.66 |
5.24333 |
786.5 |
100% |
|
C16.0,C16.1,C16.2,C16.3,C16.4,C16.5,C16.6,C16.8,C16.9,C50.0,C50.1,C50.2,C50.3,C50.4,C50.5,C50.6,C50.8,C50.9 |
НСР-16403/02.08.2018 предварително изпълнение |
02.04.2019 |
|
Активен |
16188 |
| L01XC03 |
Trastuzumab |
Kanjinti |
Powder for concentrate for solution for infusion |
420 |
mg |
1 vial |
Amgen Eurоpe B.V., Нидерландия |
1 |
mg |
2342.69 |
5.24333 |
2202.2 |
100% |
|
C16.0,C16.1,C16.2,C16.3,C16.4,C16.5,C16.6,C16.8,C16.9,C50.0,C50.1,C50.2,C50.3,C50.4,C50.5,C50.6,C50.8,C50.9 |
НСР-16403/02.08.2018 предварително изпълнение |
02.04.2019 |
|
Активен |
16189 |
| L01XC03 |
Trastuzumab |
Ogivri |
Powder for concentrate for solution for infusion |
150 |
mg |
1 |
Mylan S.A.S., Франция |
1 |
mg |
786.5 |
5.24333 |
786.5 |
100% |
|
C16.0,C16.1,C16.2,C16.3,C16.4,C16.5,C16.6,C16.8,C16.9,C50.0,C50.1,C50.2,C50.3,C50.4,C50.5,C50.6,C50.8,C50.9 |
НСР-18188/13.03.2019 |
02.04.2019 |
|
Активен |
16471 |
| L01XC03 |
Trastuzumab |
Trazimera |
Powder for concentrate for solution for infusion |
150 |
mg |
1 vial |
Pfizer Europe MA EEIG, Белгия |
1 |
mg |
832.27 |
5.24333 |
786.5 |
100% |
|
C16.0,C16.1,C16.2,C16.3,C16.4,C16.5,C16.6,C16.8,C16.9,C50.0,C50.1,C50.2,C50.3,C50.4,C50.5,C50.6,C50.8,C50.9 |
НСР-18187/13.03.2019 |
02.04.2019 |
|
Активен |
16472 |
| L01XC03 |
Trastuzumab |
L01XC03 Trastuzumab |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| L01XC03 |
Trastuzumab |
Herceptin |
Solution for injection |
600 mg/5 ml |
mg |
1 |
Roche Registration GmbH, Германия |
600 |
mg |
3234.52 |
3234.52 |
3234.52 |
100% |
|
C50.0,C50.1,C50.2,C50.3,C50.4,C50.5,C50.6,C50.8,C50.9 |
НСР-2727/17.02.2014; НСР-2915/07.03.2014; НСР-5074/21.11.2014.; НСР-6839/30.07.2015; НСР-7413/10.11.2015; НСР-7642/01.12.2015.; НСР-8628/31.03.2016.; НСР-10932/17.11.2016; НСР-16001/22.06.2018 |
02.08.2018 |
|
Активен |
3379 |
| L01XC04 |
Alemtuzumab |
L01XC04 Alemtuzumab |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| L01XC04 |
Alemtuzumab |
Mabcampath |
Concentrate for solution for infusion |
30 |
mg |
3 |
Genzyme Europe B.V., Нидерландия |
30 |
mg |
2822.81 |
940.93665 |
2822.81 |
100% |
|
Съгласно РУ |
КЦРР-1548/01.11.2012 г. |
05.12.2012 |
08.09.2012 |
Заличен |
361 |
| L01XC06 |
Cetuximab |
L01XC06 Cetuximab |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| L01XC06 |
Cetuximab |
Erbitux |
Solution for infusion |
2 mg/ml - 50 ml |
mg |
1 |
Merck KGaA, Германия |
1 |
mg |
463.33 |
4.5074 |
450.74 |
100% |
|
Съгласно РУ |
№ 122/ 09.12.2010; КЦРР-1446/02.10.2012. |
24.10.2012 |
08.09.2012 |
Заличен |
631 |
| L01XC06 |
Cetuximab |
ERBITUX |
Solution for infusion |
5 mg/ml - 20 ml |
mg |
1 |
Merck KGaA, Германия |
1 |
mg |
385.79 |
3.8579 |
385.79 |
100% |
|
C00.0,C00.1,C00.2,C00.3,C00.4,C00.5,C00.6,C00.8,C00.9,C01,C02.0,C02.1,C02.2,C02.3,C02.4,C02.8,C02.9,C03.0,C03.1,C03.9,C04.0,C04.1,C04.8,C04.9,C05.0,C05.1,C05.2,C05.8,C05.9,C06.0,C06.1,C06.2,C06.8,C06.9,C07,C08.0,C08.1,C08.8,C08.9,C09.0,C09.1,C09.8,C09.9,C10.0,C10.1,C10.2,C10.3,C10.4,C10.8,C10.9,C11.0,C11.1,C11.2,C11.3,C11.8,C11.9,C12,C13.0,C13.1,C13.2,C13.8,C13.9,C14.0,C14.2,C14.8,C18.0,C18.1,C18.2,C18.3,C18.4,C18.5,C18.6,C18.7,C18.8,C18.9,C19,C20,C30.0,C30.1,C31.0,C31.1,C31.2,C31.3,C31.8,C31.9,C32.0,C32.1,C32.2,C32.3,C32.8,C32.9 |
№ 136/ 20.01.2011; КЦРР-2425/22.02.2013 г.; НСР-3459/16.05.2014; НСР-5507/23.01.2015; НСР-7408/10.11.2015; НСР-7295/29.10.2015; НСР-7637/01.12.2015 (допуска предварително изпълнение); НСР-9939/29.07.2016; НСР-14603/08.12.2017; НСР-16703/30.08.2018 |
02.10.2018 |
08.09.2012 |
Активен |
3513 |
| L01XC07 |
Bevacizumab |
L01XC07 Bevacizumab |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| L01XC07 |
Bevacizumab |
Avastin |
Concentrate for solution for infusion |
25 mg/ml-4 ml |
mg |
1 |
Roche Registration GmbH, Германия |
350 |
mg |
565.63 |
1797.66667 |
521.32 |
100% |
|
C18.0,C18.1,C18.2,C18.3,C18.4,C18.5,C18.6,C18.7,C18.8,C18.9,C19,C20,C34.0,C34.1,C34.2,C34.3,C34.8,C34.9,C48.1,C48.2,C48.8,C50.0,C50.1,C50.2,C50.3,C50.4,C50.5,C50.6,C50.8,C50.9,C53.0,C53.1,C53.8,C53.9,C56,C57.0,C64 |
КЦРР-845/15.06.2012 г.; КЦРР-2732/20.03.2013 г; НСР-2317/13.01.2014; НСР-2917/07.03.2014;НСР-4816/13.10.2014.; НСР-6421/12.06.2015.; НСР-7405/10.11.2015; НСР-7644/01.12.2015.; НСР-9880/29.07.2016; НСР-15778/25.05.2018; НСР-16246/27.07.2018 |
02.09.2018 |
08.09.2012 |
Активен |
3221 |
| L01XC07 |
Bevacizumab |
Avastin |
Concentrate for solution for infusion |
25 mg/ml-16 ml |
mg |
1 |
Roche Registration GmbH, Германия |
350 |
mg |
2049.34 |
1797.66667 |
2049.34 |
100% |
|
C18.0,C18.1,C18.2,C18.3,C18.4,C18.5,C18.6,C18.7,C18.8,C18.9,C19,C20,C34.0,C34.1,C34.2,C34.3,C34.8,C34.9,C48.1,C48.2,C48.8,C50.0,C50.1,C50.2,C50.3,C50.4,C50.5,C50.6,C50.8,C50.9,C53.0,C53.1,C53.8,C53.9,C56,C57.0,C64 |
КЦРР-923/04.07.2012 г.; КЦРР-2800/20.03.2013 г; НСР-2316/13.01.2014; НСР-2917/07.03.2014; НСР-4815/13.10.2014.; НСР-6422/12.06.2015.; НСР-7406/10.11.2015; НСР-7643/01.12.2015; НСР-9884/29.07.2016; НСР-15777/25.05.2018; НСР-16248/27.07.2018 |
02.09.2018 |
08.09.2012 |
Активен |
3222 |
| L01XC08 |
Panitumumab |
L01XC08 Panitumumab |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| L01XC08 |
Panitumumab |
Vectibix |
Concentrate for solution for infusion |
20mg/ml - 5ml |
|
1 vial |
Amgen Eurоpe B.V., Нидерландия |
1 |
mg |
750.41 |
7.5041 |
750.41 |
100% |
|
C18.0,C18.1,C18.2,C18.3,C18.4,C18.5,C18.6,C18.7,C18.8,C18.9,C19,C20 |
№ 238/ 04.11.2011; КЦРР-1893/15.12.2012 и КП-228/06.06.2013; НСР-2211/20.12.2013; НСР-2700/06.02.2014; НСР-4862/17.10.2014.; НСР-7431/10.11.2015.; НСР-9798/14.07.2016г.; НСР-12148/27.03.2017; НСР-14665/20.12.2017; НСР-16635/24.08.2018 предварително изпълнение |
02.09.2018 |
08.09.2012 |
Активен |
3297 |
| L01XC10 |
Ofatumumab |
L01XC10 Ofatumumab |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| L01XC10 |
Ofatumumab |
Arzerra |
Concentrate for solution for infusion |
100 mg (20 mg/ml), 5 ml |
mg |
3 vials with 2 extension sets |
Novartis Europharm Limited, Обединено Кралство |
1 |
mg |
1444.56 |
4.58 |
1374 |
100% |
|
Съгласно РУ |
НСР-2265/27.12.2013; НСР-4324/05.08.2014; НСР-9196/05.05.2016 |
02.11.2018 |
|
Активен |
3106 |
| L01XC10 |
Ofatumumab |
Arzerra |
Concentrate for solution for infusion |
1000 mg (20 mg/ml), 50 ml |
mg |
1 vials with 2 extension sets |
Novartis Europharm Limited, Обединено Кралство |
1 |
mg |
4580 |
4.58 |
4580 |
100% |
|
Съгласно РУ |
НСР-2265/27.12.2013; НСР-4323/05.08.2014; НСР-6548/24.06.2015; НСР-8220/22.02.2016; НСР-10753/27.10.2016; НСР-14823/18.01.2018; НСР-16931/04.10.2018 |
02.11.2018 |
|
Активен |
3107 |
| L01XC11 |
Ipilimumab |
L01XC11 Ipilimumab |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| L01XC11 |
Ipilimumab |
Yervoy |
Concentrate for solution for infusion |
5mg/ml-40 ml (200 mg) |
mg |
1vial |
Bristol-Myers Squibb Pharma EEIG, Обединено Кралство |
1 |
mg |
26540.59 |
132.70295 |
26540.59 |
100% |
|
C43.0,C43.1,C43.2,C43.3,C43.4,C43.5,C43.6,C43.7,C43.8,C43.9 |
НСР-1792/25.11.2013; НСР-7438/10.11.2015; НСР-8218/22.02.2016; НСР-12577/05.05.2017; НСР-17766/17.01.2019 |
02.02.2019 |
|
Активен |
2252 |
| L01XC11 |
Ipilimumab |
Yervoy |
Concentrate for solution for infusion |
5 mg/ml-10 ml (50 mg) |
mg |
1 |
Bristol-Myers Squibb Pharma EEIG, Обединено Кралство |
1 |
mg |
6747.88 |
132.70295 |
6635.15 |
100% |
|
C43.0,C43.1,C43.2,C43.3,C43.4,C43.5,C43.6,C43.7,C43.8,C43.9 |
НСР-1792/25.11.2013; НСР-7437/10.11.2015; НСР-8219/22.02.2016; НСР-12576/05.05.2017 |
02.02.2019 |
|
Активен |
2253 |
| L01XC12 |
Brentuximab vedotin |
L01XC12 Brentuximab vedotin |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|