| R03AK10 |
Fluticasone furoate, Vilanterol |
Relvar Ellipta |
Inhalation powder, pre dispensed |
92 mcg/22 mcg |
UD |
30 doses |
GlaxoSmithKline (Ireland) Limited, Ирландия |
1 |
UD |
61.34 |
2.04467 |
61.34 |
100% |
|
Съгласно РУ |
НСР-4581/15.09.2014; НСР-6382/03.06.2015. и КП-360/26.08.2015.; НСР-9363/19.05.2016; НСР-13589/25.08.2017; НСР-15732/25.05.2018; НСР-18154/07.03.2019; НСР-19271/18.07.2019; НСР-21198/03.04.2020 предварително изпълнение |
02.05.2020 |
|
Активен |
3177 |
| R03AK11 |
Fluticasone propionate/formoterol fumarate dihydrate |
R03AK11 Fluticasone propionate/formoterol fumarate dihydrate |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| R03AK11 |
Fluticasone, Formoterol |
Flutiform |
Pressurised inhalation, suspension |
125 mcg/5 mcg (120 впръсквания) |
|
1 |
Mundipharma GmbH, Австрия |
4 |
UD |
65.9 |
2.19667 |
65.9 |
100% |
|
Съгласно РУ |
НСР-3169/07.04.2014; НСР-5290/ 18.12.2014.; НСР-7184/09.10.2015.; КП-30/26.04.2018 и НСР-15071/23.02.2018; КП-41/25.04.2019 и НСР-17892/07.02.2019; НСР-20847/20.02.2020 |
02.04.2020 |
|
Активен |
3456 |
| R03AK11 |
Fluticasone, Formoterol |
Flutiform |
Pressurised inhalation, suspension |
250 mcg/10 mcg (120 впръсквания) |
|
1 |
Mundipharma GmbH, Австрия |
2 |
UD |
108.28 |
1.80467 |
108.28 |
100% |
|
Съгласно РУ |
НСР-3169/07.04.2014; НСР-5291/ 18.12.2014.; НСР-7183/09.10.2015.; КП-31/26.04.2018 и НСР-15070/23.02.2018; НСР-19671/29.08.2019 |
02.10.2019 |
|
Активен |
3457 |
| R03AK11 |
Fluticasone, Formoterol |
Flutiform K-haler |
Pressurised inhalation, suspension |
125 mcg/5 mcg per actuation (120 впръсквания) |
|
1 |
Mundipharma GmbH, Австрия |
4 |
UD |
68.57 |
2.19667 |
65.9 |
100% |
|
Съгласно РУ |
НСР-15803/08.06.2018 |
02.04.2020 |
|
Активен |
16144 |
| R03AL03 |
Umeclidinium bromide/ Vilanterol |
R03AL03 Umeclidinium bromide/ Vilanterol |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| R03AL03 |
Umeclidinium Bromide, Vilanterol |
ANORO ELLIPTA |
Inhalation powder, pre dispensed |
55 mcg/22 |
mcg |
1 inhaler (30 doses) |
GlaxoSmithKline (Ireland) Limited, Ирландия |
1 |
UD |
88.92 |
2.964 |
88.92 |
100% |
|
Съгласно РУ |
НСР-7453/10.11.2015.; НСР-9960/29.07.2016; НСР-12818/26.05.2017 г.; НСР-16690/30.08.2018; НСР-18473/22.04.2019 |
02.06.2019 |
|
Активен |
4097 |
| R03AL04 |
Indacaterol / Glycopyrronium bromide |
R03AL04 Indacaterol / Glycopyrronium bromide |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| R03AL04 |
Indacaterol and glycopyrronium bromide |
Ultibro Breezhaler |
Inhalation powder, hard capsule |
85 mcg /43 mcg |
|
30 x 1 capsules (unit dose) + 1 inhaler |
Novartis Europharm Limited, Ирландия |
1 |
UD (= 1 dose inhalation powder) |
88.61 |
2.65453 |
79.64 |
100% |
|
Съгласно РУ |
НСР-4636/15.09.2014; НСР-6138/29.04.2015.; НСР-11345/30.12.2016; Протокол 244/28.09.2017; НСР-14186/13.10.2017; НСР-15740/25.05.2018; НСР-16615/24.08.2018; НСР-17887/07.02.2019 |
02.04.2019 |
|
Активен |
3857 |
| R03AL05 |
Aclidinum bromide, Formoterol |
R03AL05 Aclidinum bromide, Formoterol |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| R03AL05 |
Aclidinum bromide, Formoterol |
Brimica Genuair |
Inhalation powder |
340 mcg/12 mcg |
mcg |
1 inhaler with 60 actuations |
AstraZeneca AB, Швеция |
2 |
UD |
89.22 |
2.974 |
89.22 |
100% |
|
Съгласно РУ |
НСР-14441/17.11.2017 |
02.01.2018 |
|
Активен |
15934 |
| R03AL05 |
Aclidinum bromide, Formoterol |
Duaklir Genuair |
Inhalation powder |
340 mcg/12 mcg |
mcg |
1 inhaler with 60 actuations |
AstraZeneca AB, Швеция |
2 |
UD |
89.24 |
2.974 |
89.22 |
100% |
|
Съгласно РУ |
НСР-11253/16.12.2016 (допуска се предварително изпълнение); НСР-13783/12.09.2017 |
02.01.2018 |
|
Активен |
15519 |
| R03AL06 |
Tiotropium bromide, Olodaterol |
R03AL06 Tiotropium bromide, Olodaterol |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| R03AL06 |
Tiotropium bromide, Olodaterol |
Spiolto Respimat |
Inhalation solution |
2,5 mcg/2,5 mcg |
|
Single pack: 1 cartridge, providing 60 puffs (30 medicinal doses) |
Boehringer Ingelheim International GmbH, Германия |
2 |
UD |
79.91 |
2.66367 |
79.91 |
100% |
|
Съгласно РУ |
НСР-19823/20.09.2019 - Предварително изпълнение; НСР-21483/22.05.2020 |
02.07.2020 |
|
Активен |
16702 |
| R03AL06 |
Tiotropium bromide, Olodaterol |
Spiolto Respimat |
Inhalation solution |
2,5 mcg/2,5 mcg |
|
1 Respimat reusable inhaler and 1 cartridge, providing 60 puffs (30 medicinal doses) |
Boehringer Ingelheim International GmbH, Германия |
2 |
UD |
79.91 |
2.66367 |
79.91 |
100% |
|
Съгласно РУ |
НСР-11252/16.12.2016 г. (предварително изпълнение); НСР-13795/12.09.2017; НСР-15684/17.05.2018; НСР-17850/31.01.2019 предварително изпъленение; НСР-19597/21.08.2019; НСР-19215/12.07.2019; НСР-21482/22.05.2020 |
02.07.2020 |
|
Активен |
15523 |
| R03AL08 |
Fluticasone furoate, umeclidinium, vilanterol |
R03AL08 Fluticasone furoate, umeclidinium, vilanterol |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| R03AL08 |
Fluticasone furoate, umeclidinium, vilanterol |
Trelegy Ellipta |
Inhalation powder, pre dispensed |
92 mcg/55 mcg/22 mcg |
|
1 inhaler (30 doses) |
GlaxoSmithKline Trading Services Limited, Ирландия |
1 |
UD |
119.36 |
3.579 |
107.37 |
100% |
|
Съгласно РУ |
НСР-18448/11.04.2019 |
02.05.2019 |
|
Активен |
16495 |
| R03AL09 |
Formoterol, glycopyrronium bromide and beclomethasone |
R03AL09 Formoterol, glycopyrronium bromide and beclomethasone |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| R03AL09 |
Formoterol, glycopyrronium bromide and beclomethasone |
Trimbow |
Pressurised inhalation, solution |
87 mcg/5 mcg/9 mcg |
|
1 inhaler with 120 actuations |
Chiesi Farmaceutici SpA, Италия |
4 |
UD (=4 doses inhalaer) |
119.36 |
3.97867 |
119.36 |
100% |
|
Съгласно РУ |
НСР-20481/20.12.2019 Предварително изпълнение |
02.01.2020 |
|
Активен |
16827 |
| R03BA01 |
Beclometasone |
R03BA01 Beclometasone |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| R03BA01 |
Beclometasone |
Ecobec 100 MCG Easi-Breathe |
Pressurised inhalation, solution |
100 mcg/dose - 200 doses |
mcg |
1 |
Teva Czech Industries s.r.o., Чешка република |
1.5 |
mcg |
26.57 |
1.11911 |
14.92 |
100% |
|
Съгласно РУ |
№35/21.08.2009; НСР-1804/25.11.2013; НСР-4307/05.08.2014; НСР-5554/29.01.2015. |
16.02.2015 |
08.09.2012 |
Заличен |
3123 |
| R03BA01 |
Beclometasone |
Ecobec 250 MCG Easi-Breathe |
Pressurised inhalation, solution |
250 mcg/dose - 200 doses |
mcg |
1 |
Teva Czech Industries s.r.o., Чешка република |
1.5 |
mcg |
37.3 |
1.11911 |
37.3 |
100% |
|
Съгласно РУ |
№35/21.08.2009; НСР-5072/21.11.2014; НСР-7130/24.09.2015 |
16.10.2015 |
08.09.2012 |
Заличен |
3354 |
| R03BA02 |
Budesonide |
R03BA02 Budesonide |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| R03BA02 |
Budesonide |
BUDIAIR JET |
Pressurised inhalation, solution |
0,2 mg/dose - 200 doses |
|
1 |
Chiesi Farmaceutici SpA, Италия |
1.5 |
mg |
22.04 |
0.8264 |
22.04 |
100% |
|
Съгласно РУ |
КЦРР-475/19.04.2012 г.; НСР-3957/30.06.2014; НСР-11908/06.03.2017; НСР-13983/25.09.2017 |
02.11.2017 |
08.09.2012 |
Заличен |
2980 |
| R03BA02 |
Budesonide |
BUDIAIR MDI |
Pressurised inhalation, solution |
0,2 mg/dose - 200 doses |
mg |
1 |
Chiesi Farmaceutici SpA, Италия |
1.5 |
mg |
30.92 |
1.1595 |
30.92 |
100% |
|
Съгласно РУ |
КЦРР-475/19.04.2012 г.; КЦРР-2342/21.02.2013. |
04.04.2013 |
08.09.2012 |
Заличен |
1186 |