| G03GA02 |
Human menopausal gonadotrophin |
Menogon |
Powder and solvent for solution for injection |
75 |
IU |
5 |
Ferring GmbH, Германия |
30 |
IU |
87.07 |
6.9656 |
87.07 |
100% |
|
Съгласно РУ |
№98/23.08.2010; КЦРР-1085/26.07.2012 |
28.08.2012 |
08.09.2012 |
Заличен |
450 |
| G03GA02 |
Human menopausal gonadotrophin |
MENOPUR |
Powder and solvent for solution for injection |
75 |
IU |
10 |
Ferring GmbH, Германия |
75 |
IU |
366.12 |
36.612 |
366.12 |
100% |
|
Съгласно РУ |
№ 115/19.10.2010; КЦРР-745/07.06.2012 г.; НСР-1439/10.10.2013; НСР-3676/06.06.2014; НСР-10291/15.09.2016; НСР-15151/02.03.2018; НСР-19239/18.07.2019 |
02.09.2019 |
08.09.2012 |
Активен |
2892 |
| G03GA02 |
Human menopausal gonadotrophin |
Meriofert |
Powder and solvent for solution for injection |
75 |
IU |
10 |
IBSA Farmaceutici Italia S.r.l., Италия |
75 |
IU |
375.78 |
36.612 |
366.12 |
100% |
|
Съгласно РУ |
НСР-9951/29.07.2016; НСР-19049/27.06.2019 |
02.09.2019 |
|
Активен |
15329 |
| G03GA02 |
Human menopausal gonadotrophin |
Meriofert |
Powder and solvent for solution for injection |
150 |
IU |
10 |
IBSA Farmaceutici Italia S.r.l., Италия |
75 |
IU |
751.56 |
36.612 |
732.24 |
100% |
|
Съгласно РУ |
НСР-10344/26.09.2016; НСР-19050/27.06.2019 |
02.09.2019 |
|
Активен |
15442 |
| G03GA02 |
Human menopausal gonadotrophin |
Merional |
Powder for solution for injection |
75 |
IU |
1 |
IBSA Farmaceutici Italia S.r.l., Италия |
75 |
IU |
23.29 |
23.29 |
23.29 |
100% |
|
Съгласно РУ |
№ 71/ 19.04.2010; НСР-7362/05.11.2016 и Отхвърлена е жалбата от Комисия по прозрачност с решение КП-85/16.06.2016; НСР-10889/10.11.2016 |
02.12.2016 |
08.09.2012 |
Заличен |
74 |
| G03GA04 |
Urofollitropin /FSH/ |
G03GA04 Urofollitropin /FSH/ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| G03GA04 |
Urofollitropin |
Fostimon |
Powder and solvent for solution for injection |
75 |
IU |
5 vial + 5 solvent 1 ml |
IBSA Farmaceutici Italia S.r.l., Италия |
75 |
IU |
192.95 |
38.59 |
192.95 |
100% |
|
Съгласно РУ |
НСР-10653/21.10.2016 |
02.01.2018 |
|
Активен |
15449 |
| G03GA04 |
Urofollitropin |
Fostimon |
Powder and solvent for solution for injection |
75 IU |
|
1 vial + solv. 1 ml |
IBSA Farmaceutici Italia S.r.l., Италия |
75 |
IU |
35.98 |
35.28 |
35.28 |
100% |
|
Съгласно РУ |
№ 71/ 19.04.2010; НСР-4716/26.09.2014. и КП-81/06.04.2015; КП-324/22.06.2015 и НСР-5940/01.04.2015; Решение на ВАС № 2679/06.03.2017 и НСР-4716/26.09.2014; НСР-14486/17.11.2017 |
02.01.2018 |
08.09.2012 |
Заличен |
3798 |
| G03GA04 |
Urofollitropin |
FOSTIMON |
Powder and solvent for solution for injection |
150 IU |
|
1 pre-filled syringe |
IBSA Farmaceutici Italia S.r.l., Италия |
75 |
IU |
70.56 |
35.28 |
70.56 |
100% |
|
Съгласно РУ |
НСР-632/29.07.2013; НСР-14487/17.11.2017 |
02.01.2018 |
|
Заличен |
2019 |
| G03GA05 |
Follitropin alfa |
G03GA05 Follitropin alfa |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| G03GA05 |
Follitropin alfa |
Bemfola |
Solution for injection |
150 IU/0,25 ml |
|
1 pre-filled pen and 1 injection needle |
Gedeon Richter Plc., Унгария |
75 |
IU |
84.6 |
41.45 |
82.9 |
100% |
|
Съгласно РУ |
НСР-6162/08.05.2015; НСР-9963/29.07.2016; НСР-14240/19.10.2017; НСР-17784/24.01.2019 |
02.03.2019 |
|
Активен |
3925 |
| G03GA05 |
Follitropin alfa |
Bemfola |
Solution for injection |
225 IU/0,375 ml |
|
1 pre-filled pen and 1 injection needle |
Gedeon Richter Plc., Унгария |
75 |
IU |
126.73 |
41.45 |
124.35 |
100% |
|
Съгласно РУ |
НСР-6163/08.05.2015; НСР-9962/29.07.2016; НСР-14239/19.10.2017; НСР-17785/24.01.2019 |
02.03.2019 |
|
Активен |
3926 |
| G03GA05 |
Follitropin alfa |
Bemfola |
Solution for injection |
75 IU/0,125 ml |
|
1 pre-filled pen and 1 injection needle |
Gedeon Richter Plc., Унгария |
75 |
IU |
41.45 |
41.45 |
41.45 |
100% |
|
Съгласно РУ |
НСР-6161/08.05.2015; НСР-9964/29.07.2016; НСР-14241/19.10.2017; НСР-17787/24.01.2019 |
02.03.2019 |
|
Активен |
3924 |
| G03GA05 |
Follitropin alfa |
Bemfola |
Solution for injection |
300 IU/0,5 ml |
|
1 pre-filled pen and 1 injection needle |
Gedeon Richter Plc., Унгария |
75 |
IU |
168.25 |
41.45 |
165.8 |
100% |
|
Съгласно РУ |
НСР-6184/08.05.2015; НСР-9961/29.07.2016; НСР-14238/19.10.2017; НСР-17788/24.01.2019 |
02.03.2019 |
|
Активен |
3927 |
| G03GA05 |
Follitropin alfa |
Gonal-F |
Solution for injection |
300 IU/0.5 ml (22 mcg/0.5 ml) |
|
1 pre-filled pen + 8 needles |
Merck Europe B.V., Нидерландия |
75 |
IU |
196.84 |
41.45 |
165.8 |
100% |
|
Съгласно РУ |
№16/24,06,2009 г.; КЦРР-2404/21.02.2013 г.; НСР-2136/14.12.2013; НСР-5690/18.02.2015.; Протокол 115/29.04.2015.; НСР-19714/29.08.2019 |
02.10.2019 |
08.09.2012 |
Активен |
3589 |
| G03GA05 |
Follitropin alfa |
Gonal-F |
Solution for injection |
900 IU/1.5 ml (66 micrograms/ 1.5 ml) |
|
1 pre-filled pen + 20 needles |
Merck Europe B.V., Нидерландия |
75 |
IU |
554.41 |
41.45 |
497.4 |
100% |
|
Съгласно РУ |
№16/24,06,2009 г.; КЦРР-2404/21.02.2013 г.; НСР-2136/14.12.2013; НСР-4599/15.09.2014; Протокол 115/29.04.2015; НСР-6325/28.05.2015; НСР-9941/29.07.2016; НСР-17077/26.10.2018; НСР-19714/29.08.2019 |
02.10.2019 |
08.09.2012 |
Активен |
3193 |
| G03GA05 |
Follitropin alfa |
Gonal-F |
Solution for injection |
450 IU/0.75 ml (33 mcg/0.75 ml) |
ml |
1 pre-filled pen + 12 needles |
Merck Europe B.V., Нидерландия |
75 |
IU |
295.25 |
41.45 |
248.7 |
100% |
|
Съгласно РУ |
№16/24,06,2009 г.; КЦРР-2404/21.02.2013 г.; НСР-2136/14.12.2013; НСР-5691/18.02.2015.; Протокол 115/29.04.2015.; НСР-9401/01.06.2016; НСР-19714/29.08.2019 |
02.10.2019 |
08.09.2012 |
Активен |
3590 |
| G03GA06 |
Follitropin beta |
G03GA06 Follitropin beta |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| G03GA06 |
Follitropin beta |
Puregon |
Solution for injection |
50 |
IU |
1 |
N.V. Organon, Нидерландия |
75 |
IU |
40.01 |
57.30833 |
38.21 |
100% |
|
Съгласно РУ |
НСР-1567/01.11.2013 |
02.12.2013 |
08.09.2012 |
Заличен |
539 |
| G03GA06 |
Follitropin beta |
PUREGON |
Solution for injection |
900 IU/1.08 ml |
|
1 cartridge + 3 packs with 3 pen needles |
Merck Sharp & Dohme B.V., Нидерландия |
75 |
IU |
598.09 |
42.185 |
506.22 |
100% |
|
Съгласно РУ |
НСР-1818/25.11.2013;НСР-3483/16.05.2014; НСР-4607/ 15.09.2014; НСР-4768/13.10.2014; НСР-6310/28.05.2015.; НСР-7914/28.01.2016.; НСР-10445/29.09.2016; НСР-13554/18.08.2017; НСР-15722/25.05.2018; НСР-16944/04.10.2018; НСР-18057/01.03.2019 |
02.04.2019 |
08.09.2012 |
Активен |
3239 |
| G03GA06 |
Follitropin beta |
PUREGON |
Solution for injection |
300 IU/0.36 ml |
|
1 cartridge + 2 packs with 3 pen needles |
Merck Sharp & Dohme B.V., Нидерландия |
75 |
IU |
168.74 |
42.185 |
168.74 |
100% |
|
Съгласно РУ |
№16/24,06,2009 г; НСР-1823/25.11.2013;НСР-3484/16.05.2014; НСР-4606/15.09.2014.; НСР-6367/03.06.2015.; НСР-8250/22.02.2016; НСР-9084/21.04.2016; НСР-14467/17.11.2017; НСР-16944/04.10.2018; НСР-18058/01.03.2019 |
02.04.2019 |
08.09.2012 |
Активен |
3194 |
| G03GA08 |
Choriogonadotropin alfa |
G03GA08 Choriogonadotropin alfa |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| G03GA08 |
Choriogonadotropin alfa |
Ovitrelle |
Solution for injection |
250 mcg/0,5 ml |
ml |
1 |
Merck Europe B.V., Нидерландия |
0.25 |
mg |
55.7 |
55.7 |
55.7 |
100% |
|
Съгласно РУ |
НСР-1998/06.12.2013; НСР-5523/29.01.2015; НСР-9116/27.04.2016; НСР-12500/28.04.2017 г.; НСР-16405/09.08.2018; НСР-18562/25.04.2019; НСР-19713/29.08.2019 |
02.10.2019 |
|
Активен |
3536 |
| G03GA08 |
Choriogonadotropin alfa |
Ovitrelle |
Solution for injection |
0.25 |
mg/0.5 ml |
1 |
Serono Europe Ltd., Обединено Кралство |
0.25 |
mg |
56.72 |
56.72 |
56.72 |
100% |
|
Съгласно РУ |
№20/15,07,2009; КЦРР-2254/11.02.2013 г.
НСР-4612/15.09.2014 |
16.10.2014 |
08.09.2012 |
Заличен |
1654 |
| G03GA09 |
Corifollitropin alfa |
G03GA09 Corifollitropin alfa |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|