| L04AA40 |
Cladribine |
Mavenclad |
Tablet |
10 |
mg |
1 |
Merck Europe B.V., Нидерландия |
1 |
mg |
5001.53 |
- |
499.2715 |
4992.72 |
100% |
4992.72 |
експертиза по чл. 78 т.2 от ЗЗО |
G35 |
НСР-14744/22.12.2017 предварително изпълнение; НСР-16620/24.08.2018; НСР-18130/07.03.2019 |
02.04.2019 |
|
|
Активен |
15964 |
| L04AB01 |
Etanercept |
L04AB01 Etanercept |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| L04AB01 |
Etanercept |
ENBREL |
Powder and solvent for solution for injection |
25 |
mg |
4 vials+4 pre-filled syringes+4 needles+4 vial adaptors+8 swabs |
Pfizer Europe MA EEIG, Белгия |
7 |
mg |
- |
800.27 |
53.74554 |
768.02 |
75% |
576.01 |
За експертиза по чл.78 т.2 от ЗЗО |
L40.0,M05.0,M05.1,M05.3,M05.8,M07.1,M07.2,M07.3,M08.1,M08.3,M08.4,M45.0,M45.1,M45.2,M45.3,M45.4,M45.5,M45.6,M45.7,M45.8 |
№ 41/26.11.2009; КЦPP-1521/25.10.2012; Протокол 50/23.01.2014; НСР-73/07.06.2013 и КП-260/18.12.2013; НСР-4547/22.08.2014; НСР-5033/17.11.2014; НСР-8334/26.02.2016; НСР-12836/26.05.2017; НСР-15119/26.02.2018 (допуска предварително изпълнение); НСР-17297/22.11.2018 |
02.06.2019 |
08.09.2012 |
|
Активен |
3361 |
| L04AB01 |
Etanercept |
ENBREL |
Solution for injection |
50 mg/ml - 1 ml |
mg |
4 pre-filled syringes + 4 alcohol swabs |
Pfizer Europe MA EEIG, Белгия |
7 |
mg |
- |
1535.51 |
53.74554 |
1535.51 |
75% |
1151.63 |
За експертиза по чл.78 т.2 от ЗЗО |
L40.0,M05.0,M05.1,M05.3,M05.8,M07.1,M07.2,M07.3,M08.1,M08.3,M08.4,M45.0,M45.1,M45.2,M45.3,M45.4,M45.5,M45.6,M45.7,M45.8 |
№ 41/26.11.2009; КЦPP-1521/25.10.2012..; КЦРР-2426/22.02.2103 и КП-241/28.06.2013; Протокол 48/09.01.2014; Протокол 50/23.01.2014; НСР-3992/30.06.2014; НСР-4547/22.08.2014; НСР-5949/01.04.2015; НСР-7813/28.12.2015.; НСР-12379/18.04.2017; НСР-15120/26.02.2018 (допуска предварително изпълнение); НСР-17298/22.11.2018; HCP-18657/10.05.2019 предварително изпълнение |
02.06.2019 |
08.09.2012 |
|
Активен |
3736 |
| L04AB01 |
Etanercept |
ENBREL |
Solution for injection |
50 mg/ml – 1 ml |
mg |
4 pre-filled pens +4 alcohol swabs |
Pfizer Europe MA EEIG, Белгия |
7 |
mg |
- |
1535.51 |
53.74554 |
1535.51 |
75% |
1151.63 |
За експертиза по чл.78 т.2 от ЗЗО |
L40.0,M05.0,M05.1,M05.3,M05.8,M07.1,M07.2,M07.3,M08.1,M08.3,M08.4,M45.0,M45.1,M45.2,M45.3,M45.4,M45.5,M45.6,M45.7,M45.8 |
НСР-6072/23.04.2015.; НСР-7900/25.01.2016.; НСР-12377/18.04.2017; НСР-15118/26.02.2018( предварително изпълнение); НСР-17299/22.11.2018; HCP-18655/10.05.2019 предварително изпълнение |
02.06.2019 |
|
|
Активен |
3823 |
| L04AB01 |
Etanercept |
ENBREL 25 mg powder and solvent for solution for injection for pediatric use 25 mg/ml - 1 ml x 4 vials + 4 pre-filled syringes + 8 syringes + 20 needles + 24 alcohol swabs |
powder and solvent for solution for injection for pediatric use |
25 |
mg |
4 |
Pfizer Limited, Обединено Кралство |
7 |
mg |
- |
1090.94 |
74.5115 |
1064.45 |
75% |
798.34 |
За експертиза по чл.78 т.2 от ЗЗО
при лица до 18 год. |
M05.1,M05.2,M05.3,M05.8,M08.1,M08.3,M08.4 |
№ 41/26.11.2009; КЦPP-1521/25.10.2012..; КЦРР-2426/22.02.2103 и КП-241/28.06.2013; НСР-2010/11.12.2013 |
16.01.2014 |
08.09.2012 |
|
Заличен |
2136 |
| L04AB01 |
Etanercept |
ENBREL 25 mg solution for injection in pre-filled syringe 50 mg/ml - 0,5 ml x 4 pre-filled syringes + 8 alcohol swabs |
Solution for injection |
25 |
mg |
4 |
Pfizer Limited, Обединено Кралство |
7 |
mg |
- |
1065.68 |
74.5115 |
1064.45 |
75% |
798.34 |
За експертиза по чл.78 т.2 от ЗЗО |
M05.1,M05.2,M05.3,M05.8,M07.1,M07.2,M07.3,M08.1,M08.3,M08.4 |
№ 41/26.11.2009; КЦPP-1521/25.10.2012.; КЦРР-2426/22.02.2103 и КП-241/28.06.2013; НСР-2078/11.12.2013 |
16.01.2014 |
08.09.2012 |
|
Заличен |
2135 |
| L04AB02 |
Infliximab |
L04AB02 Infliximab |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| L04AB02 |
Infliximab |
Inflectra |
Powder for concentrate for solution for infusion |
100 |
mg |
1 |
Pfizer Europe MA EEIG, Белгия |
3.75 |
mg |
- |
477.89 |
17.91864 |
477.89 |
75% |
358.42 |
За експертиза по чл.78 т.2 от ЗЗО |
K50.0,K50.1,K51.0,K51.1,K51.3,K51.5,K51.8,K51.9,L40.0,M05.0,M05.1,M05.3,M05.8,M07.1,M07.2,M07.3,M45.0,M45.1,M45.2,M45.3,M45.4,M45.5,M45.6,M45.7,M45.8 |
НСР-1855/27.11.2013; Протокол 51/30.01.2014; НСР-4254/30.07.2014; НСР-4695/26.09.2014; НСР-5902/27.03.2015; НСР-9552/17.06.2016; НСР-14174/13.10.2017; НСР-16970/12.10.2018; НСР-17512/13.12.2018 |
02.01.2019 |
|
|
Активен |
3716 |
| L04AB02 |
Infliximab |
Remicade |
Powder for concentrate for solution for infusion |
100 |
mg |
3 |
Janssen Biologics B.V., Нидерландия |
3.75 |
mg |
- |
2430.14 |
17.91864 |
1433.49 |
75% |
1075.12 |
за експертиза по чл.78, т.2 от ЗЗО |
K50.0,K50.1,K51.0,K51.1,K51.3,K51.5,K51.8,K51.9,L40.0,M05.0,M05.1,M05.3,M05.8,M07.1,M07.2,M07.3,M45.0,M45.1,M45.2,M45.3,M45.4,M45.5,M45.6,M45.7,M45.8 |
НСР-18334/05.04.2019 |
02.05.2019 |
|
|
Активен |
16494 |
| L04AB02 |
Infliximab |
Remsima |
Powder for concentrate for solution for infusion |
100 |
mg |
1 |
Celltrion Healthcare Hungary Kft., Унгария |
3.75 |
mg |
- |
689.14 |
17.91864 |
477.89 |
75% |
358.42 |
За експертиза по чл.78 т.2 от ЗЗО |
K50.0,K50.1,K51.0,K51.1,K51.3,K51.5,K51.8,K51.9,L40.0,M05.0,M05.1,M05.3,M05.8,M07.1,M07.2,M07.3,M45.0,M45.1,M45.2,M45.3,M45.4,M45.5,M45.6,M45.7,M45.8 |
НСР-1853/27.11.2013; Протокол 51/30.01.2014; НСР-4694/26.09.2014; НСР-5646/18.02.2015. и КП-16/17.02.2015.; НСР-9364/19.05.2016; НСР-13896/25.09.2017; НСР-17569/20.12.2018 |
02.02.2019 |
|
|
Активен |
3592 |
| L04AB02 |
Infliximab |
Zessly |
Powder for concentrate for solution for infusion |
100 |
mg |
1 vial |
Sandoz GmbH, Австрия |
3.75 |
mg |
- |
645.41 |
17.91864 |
477.89 |
75% |
358.42 |
за експертиз а по чл. 78 т.2 от ЗЗО |
K50.0,K50.1,K51.0,K51.1,K51.3,K51.5,K51.8,K51.9,L40.0,M05.0,M05.1,M05.3,M05.8,M07.1,M07.2,M07.3,M45.0,M45.1,M45.2,M45.3,M45.4,M45.5,M45.6,M45.7,M45.8 |
НСР-18265/28.03.2019 |
02.05.2019 |
|
|
Активен |
16479 |
| L04AB04 |
Adalimumab |
L04AB04 Adalimumab |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| L04AB04 |
Adalimumab |
Amgevita |
Solution for injection |
40 mg/0.8 ml |
|
2 prefilled syringes |
Amgen Eurоpe B.V., Нидерландия |
2.9 |
mg |
- |
1380.32 |
38.13084 |
1052.03 |
75% |
789.02 |
за експертиза по чл. 78 т. 2 от ЗЗО |
K50.0,K50.1,K51.0,K51.1,K51.3,K51.5,K51.8,K51.9,L40.0,M05.0,M05.1,M05.3,M05.8,M07.1,M07.2,M07.3,M08.1,M08.3,M08.4,M45.0,M45.1,M45.2,M45.3,M45.4,M45.5,M45.6,M45.7,M45.8 |
НСР-17049/22.10.2018 предварително изпълнение |
02.04.2019 |
|
|
Активен |
16303 |
| L04AB04 |
Adalimumab |
Amgevita |
Solution for injection |
40 mg/0.8 ml |
|
2 prefilled pens |
Amgen Eurоpe B.V., Нидерландия |
2.9 |
mg |
- |
1380.32 |
38.13084 |
1052.03 |
75% |
789.02 |
за експертиза по чл. 78 т. 2 от ЗЗО |
K50.0,K50.1,K51.0,K51.1,K51.3,K51.5,K51.8,K51.9,L40.0,M05.0,M05.1,M05.3,M05.8,M07.1,M07.2,M07.3,M08.1,M08.3,M08.4,M45.0,M45.1,M45.2,M45.3,M45.4,M45.5,M45.6,M45.7,M45.8 |
НСР-17049/22.10.2018 предварително изпълнениe |
02.04.2019 |
|
|
Активен |
16304 |
| L04AB04 |
Adalimumab |
Amgevita |
Solution for injection |
20 mg/0.4 ml |
|
1 prefilled syringe |
Amgen Eurоpe B.V., Нидерландия |
2.9 |
mg |
- |
345.1 |
38.13084 |
263.1 |
75% |
197.33 |
за експертиза по чл. 78 т. 2 от ЗЗО |
K50.0,K50.1,L40.0,M08.1,M08.3,M08.4 |
НСР-17049/22.10.2018 предварително изпълнение |
02.04.2019 |
|
|
Активен |
16302 |
| L04AB04 |
Adalimumab |
Hulio |
Solution for injection |
40 mg/0.8 ml |
|
2 pre-filled pens + 2 alcohol pads |
Mylan S.A.S., Франция |
2.9 |
mg |
- |
1052.03 |
38.13084 |
1052.03 |
75% |
789.02 |
за експертиза по чл. 78, т. 2 от ЗЗО |
K50.0,K50.1,K51.0,K51.1,K51.3,K51.5,K51.8,K51.9,L40.0,M05.0,M05.1,M05.3,M05.8,M07.1,M07.2,M07.3,M08.1,M08.3,M08.4,M45.0,M45.1,M45.2,M45.3,M45.4,M45.5,M45.6,M45.7,M45.8 |
НСР-18258/22.03.2019 предварително изпълнение |
02.04.2019 |
|
|
Активен |
16456 |
| L04AB04 |
Adalimumab |
Hulio |
Solution for injection |
40 mg/0.8 ml |
|
2 (2 x 1) vials + 2 (2 x 1) syringes +2 (2 x 1) needles + 2 (2 x 1) vial adapters + 4 (2 x 2) alcohol pads (multipack) |
Mylan S.A.S., Франция |
2.9 |
mg |
- |
1161.26 |
38.13084 |
1052.03 |
75% |
789.02 |
за експертиза по чл. 78, т. 2 от ЗЗО |
K50.0,K50.1,L40.0,M08.1,M08.3,M08.4 |
НСР-18258/22.03.2019 предварително изпълнение |
02.04.2019 |
|
|
Активен |
16455 |
| L04AB04 |
Adalimumab |
Humira |
Solution for injection |
20 mg/0.2 ml |
|
2 prefilled syringes + 2 alcohol pads |
AbbVie Deutschland GmbH & Co. KG, Германия |
2.9 |
mg |
- |
904.78 |
38.13084 |
525.82 |
75% |
394.37 |
За експертиза по чл.78 т.2 от ЗЗО |
K50.0,K50.1,L40.0,M08.1,M08.3,M08.4 |
НСР-16859/21.09.2018 (предварително изпъленение) |
02.04.2019 |
|
|
Активен |
16273 |
| L04AB04 |
Adalimumab |
Humira |
Solution for injection |
40 mg/0.4 ml |
|
2 pre-filled syringes + 2 alcohol pads |
AbbVie Deutschland GmbH & Co. KG, Германия |
2.9 |
mg |
- |
1599.13 |
38.13084 |
1052.03 |
75% |
789.02 |
За експертиза по чл. 78 т.2 от ЗЗО |
K50.0,K50.1,K51.0,K51.1,K51.3,K51.5,K51.8,K51.9,L40.0,M05.0,M05.1,M05.3,M05.8,M07.1,M07.2,M07.3,M08.1,M08.3,M08.4,M45.0,M45.1,M45.2,M45.3,M45.4,M45.5,M45.6,M45.7,M45.8 |
НСР-14789/10.01.2018; НСР-16157/13.07.2018; НСР-16544/17.08.2018 (предварително изпълнение) |
02.04.2019 |
|
|
Активен |
16000 |
| L04AB04 |
Adalimumab |
Humira |
Solution for injection |
40mg/0.8ml |
|
2 pre-filled syringes + 2 alcohol pads |
AbbVie Ltd, Обединено Кралство |
2.9 |
mg |
- |
1725.38 |
62.53643 |
1725.38 |
75% |
1294.03 |
За експертиза по чл.78 т.2 от ЗЗО |
K50.0,K50.1,K51.0,K51.1,K51.3,K51.5,K51.8,K51.9,L40.0,M05.0,M05.1,M05.3,M05.8,M07.1,M07.2,M07.3,M08.1,M08.3,M08.4,M45.0,M45.1,M45.2,M45.3,M45.4,M45.5,M45.6,M45.7,M45.8 |
№ 41/26.11.2009; № 56/05.03.2010; КЦРР-468/19.04.2012 ; КЦPP-2859/20.03.2013; КЦРР-2819/20.03.2013 г.; НСР-605/23.07.2013; НСР-1072/02.09.2013; Протокол 50/23.01.2014; НСР-2398/21.01.2014; НСР-4440/15.08.2014; НСР-4812/13.10.2014.; НСР-6428/12.06.2015.; НСР-8024/08.02.2016.; НСР-10449/29.09.2016; НСР-14664/20.12.2017; НСР-16148/13.07.2018 |
02.08.2018 |
08.09.2012 |
|
Заличен |
3216 |
| L04AB04 |
Adalimumab |
Humira |
Solution for injection |
40 mg/0.8 ml |
|
2 carton pack (Each carton contains:1 vial +1 syringe +1 needle +1 sterile adapter, 2 alcohol pads) |
AbbVie Deutschland GmbH & Co. KG, Германия |
2.9 |
mg |
- |
1767.54 |
50.01449 |
1379.9 |
75% |
1034.92 |
за експертиза по чл.78, т.2 от ЗЗО; да се прилага при лица до 18 години . |
K50.0,K50.1,L40.0,M08.1,M08.3,M08.4 |
НСР-7034/03.09.2015 и НСР-7083/10.09.2015.; НСР-9120/27.04.2016; КП-138/06.11.2017 и НСР-13550/18.08.2017; НСР-16166/13.07.2018; НСР-16255/27.07.2018; НСР-17403/06.12.2018 |
02.01.2019 |
|
|
Заличен |
4064 |
| L04AB04 |
Adalimumab |
Humira |
Solution for injection |
80mg/0.8ml |
|
1 pre-filled syringe + 1 alcohol pad |
AbbVie Deutschland GmbH & Co. KG, Германия |
2.9 |
mg |
- |
1599.13 |
38.13084 |
1052.03 |
75% |
789.02 |
за експертиза по чл.78 т.2 от ЗЗО |
K50.0,K50.1,K51.0,K51.1,K51.3,K51.5,K51.8,K51.9,L40.0,M05.0,M05.1,M05.3,M05.8 |
НСР-17448/06.12.2018 |
02.04.2019 |
|
|
Активен |
16377 |
| L04AB04 |
Adalimumab |
Hyrimoz |
Solution for injection |
40 mg/0.8 ml |
|
2 pre-filled pens |
Sandoz GmbH, Австрия |
2.9 |
mg |
- |
1052.03 |
38.13084 |
1052.03 |
75% |
789.02 |
За експертиза по чл. 78 т. 2 от ЗЗО |
K50.0,K50.1,K51.0,K51.1,K51.3,K51.5,K51.8,K51.9,L40.0,M05.0,M05.1,M05.3,M05.8,M07.1,M07.2,M07.3,M08.1,M08.3,M08.4,M45.0,M45.1,M45.2,M45.3,M45.4,M45.5,M45.6,M45.7,M45.8 |
НСР-18191/18.03.2019 предварително изпълнение |
02.04.2019 |
|
|
Активен |
16454 |
| L04AB05 |
Certolizumab pegol |
L04AB05 Cetrolizumab |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|