View |
BR-1324_PI_01.pdf
|
BR-1324
|
Somatropin
|
Genotropin GoQuick
|
12 mg/mL
|
Powder and Solvent for Solution for Injection (SC)
|
Anterior Pituitary Lobe Hormones and Analogues
|
Pfizer Manufacturing Belgium N.V.
|
Belgium
|
Monitored Release (MR) (Reconstruction) `
|
22 February 2024
|
16 July 2025
|
View |
BR-1325_PI_01.pdf
|
BR-1325
|
Somatropin
|
Genotropin GoQuick
|
5.3mg/mL
|
Powder and Solvent for Solution for Injection (SC)
|
Anterior Pituitary Lobe Hormones and Analogues
|
Pfizer Manufacturing Belgium NV
|
Belgium
|
Monitored Release (MR) (Reconstruction) `
|
22 February 2024
|
16 July 2025
|
View |
BR-1326_PI_01.pdf
|
BR-1326
|
Semaglutide
|
Ozempic
|
1 mg/0.74mL (1.34mg/mL)
|
Solution For Injection (SC)
|
-
|
Novo Nordisk A/S
|
Denmark
|
Monitored Release (Variation)
|
17 November 2022
|
17 November 2027
|
View |
BR-1327_PI_01.pdf
|
BR-1327
|
Semaglutide
|
Ozempic
|
0.5 mg/0.37 mL (1.34 mg/mL)
|
Solution for Injection (SC)
|
-
|
Novo Nordisk A/S
|
Denmark
|
Monitored Release (Variation)
|
28 October 2022
|
28 October 2027
|
View |
BR-1328_PI_01.pdf
|
BR-1328
|
Semaglutide
|
Ozempic
|
0.25 mg/0.19 mL (1.34 mg/mL)
|
Solution for Injection
(SC)
|
-
|
Novo Nordisk A/S
|
Denmark
|
-
|
29 September 2020
|
29 September 2025
|
View |
BR-1330_PI_01.pdf
|
BR-1330
|
Guselkumab
|
Tremfya
|
100 mg
|
Solution For Injection (Sc)
|
-
|
Cilag AG
|
Switzerland
|
-
|
21 October 2020
|
21 October 2025
|
View |
|
BR-1331
|
Emicizumab
|
Hemlibra
|
30 mg/ mL
|
Solution For Injection SC
|
-
|
Chugai Pharma Manufacturing Co., Ltd. (Utsunomiya
Plant)
|
Japan
|
Monitored Release
|
14 December 2020
|
14 December 2025
|
View |
|
BR-1332
|
Emicizumab
|
Hemlibra
|
60 mg/ 0.4 mL
|
Solution For Injection SC
|
-
|
Chugai Pharma Manufacturing Co., Ltd. (Utsunomiya
Plant)
|
Japan
|
Monitored Release
|
14 December 2020
|
14 December 2025
|
View |
|
BR-1333
|
Emicizumab
|
Hemlibra
|
105 mg/ 0.7 mL
|
Solution For Injection SC
|
-
|
Chugai Pharma Manufacturing Co., Ltd. (Utsunomiya
Plant)
|
Japan
|
Monitored Release
|
14 December 2020
|
14 December 2025
|
View |
|
BR-1334
|
Emicizumab
|
Hemlibra
|
150 mg/ mL
|
Solution For Injection SC
|
-
|
Chugai Pharma Manufacturing Co., Ltd. (Utsunomiya
Plant)
|
Japan
|
Monitored Release
|
14 December 2020
|
14 December 2025
|
View |
|
BR-1337
|
Bevacizumab
|
Mvasi
|
400 mg/16 mL (25 mg/mL)
|
Concentrate For Solution For Infusion (IV)
|
-
|
Amgen Manufacturing Limited
|
USA
|
Initial
|
28 January 2021
|
28 January 2026
|
View |
|
BR-1340
|
Follitropin Delta
|
Rekovelle
|
72 mcg/2.16 mL (33.3 mcg/mL)
|
Solution for Injection (SC)
|
-
|
Vetter Pharma-Fertigung
|
Germany
|
-
|
10 February 2021
|
10 February 2026
|
View |
|
BR-1341
|
Follitropin Delta
|
Rekovelle
|
36 mcg/1.08 mL (33.3 mcg/mL)
|
Solution for Injection (SC)
|
-
|
Vetter Pharma-Fertigung
|
Germany
|
-
|
10 February 2021
|
10 February 2026
|
View |
|
BR-1342
|
Follitropin Delta
|
Rekovelle
|
12 mcg/0.36 mL (33.3 mcg/mL)
|
Solution for Injection (SC)
|
-
|
Vetter Pharma-Fertigung
|
Germany
|
-
|
10 February 2021
|
10 February 2026
|
View |
|
BR-1343
|
Etanercept
|
Enbrel
|
50mg/mL
|
Solution For Injection (S.C.)
|
-
|
Pfizer Manufacturing Belgium NV
|
Belgium
|
Initial
|
15 March 2021
|
11 March 2026
|
View |
|
BR-1344
|
Etanercept
|
Enbrel
|
25 mg/0.5 mL
|
Solution For Injection (S.C.)
|
-
|
Pfizer Manufacturing Belgium NV
|
Belgium
|
Variation
|
11 March 2022
|
11 March 2026
|
View |
BR-1347_PI_01.pdf
|
BR-1347
|
Golimumab
|
Simponi
|
50 mg/0.5 mL
|
Solution For Injection (SC)
|
-
|
Cilag AG
|
Switzerland
|
-
|
07 May 2021
|
07 May 2026
|
View |
BR-1348_PI_01.pdf
|
BR-1348
|
Golimumab
|
Simponi Aria
|
50 mg/4 mL (12.5 mg/mL)
|
Solution For Injection (IV)
|
-
|
Cilag AG
|
Switzerland
|
-
|
07 May 2021
|
07 May 2026
|
View |
BR-1349_PI_01.pdf
|
BR-1349
|
Golimumab
|
Simponi
|
45 mg/0.45 mL
|
Solution For Injection (SC)
|
-
|
Cilag AG
|
Switzerland
|
-
|
27 May 2021
|
27 May 2024
|
View |
|
BR-1350
|
Pneumococcal Polysaccharide Conjugate Vaccine
(Adsorbed) (10-valent)
|
SII Pneumosil
|
Each dose (0.5 mL) contains:
Serotypes 1, 5, 9V, 14, 19A, 19F, 23F, 7F, 6A
2 mcg each
Serotype 6B
4 mcg
Conjugated to CRM197 carrier protein
Aluminum (as Aluminum phosphate)
0.125 mg
|
Suspension for Injection (IM)
|
Vaccines
|
Serum Institute of India Private Limited
|
India
|
Initial (Variation)
|
26 February 2024
|
26 February 2029
|