| View |
|
BR-1352
|
Diphtheria, Tetanus, Pertussis (Whole Cell), Hepatitis
B (rDNA) and Haemophilus influenzae Type B Conjugate Vaccine (Adsorbed)
|
Combe Five
|
Each dose (0.5 mL) contains: Diphtheria toxoid ................... 25 Lf ( > 30 IU) Tetanus toxoid ...................... 5.5 Lf (> 60 IU) B. pertussis (whole cell) ........... 16 IOU ( >4 IU) Hepatitis B (rDNA) ................ 12.5 ug Purified capsular polysaccharide (PRP) of Hib covalently linked to 20 to 36.7 ug
of tetanus toxoid .... ............... 11 ug Alt+t (as AlPO4) ........ ............. <1.25 mg Thiomersal ............ ........... 0.01% w/v
|
Solution For Injection (I.M)
|
-
|
Biological E. Limited
|
India
|
-
|
08 June 2021
|
08 June 2026
|
| View |
|
BR-1353
|
Diphtheria, Tetanus, Pertussis (Whole Cell), Hepatitis
B (rDNA) and Haemophilus influenzae Type B
Conjugate Vaccine (Adsorbed)
|
Combe Five
|
Each dose (0.5 mL) contains: Diphtheria toxoid
25 Lf 30 IU) Tetanus toxoid....................... 5.5 Lf 60 IU) B. pertussis (whole cell ............ 16 IOU ( 4 IU) Hepatitis B (rDNA)................12.5 ug Purified capsular polysaccharide (PRP) of Hib covalently linked to 20 to 36.7 ug
of tetanus toxoid ..................11 ug Alt++ (as AlPO4)..................... 51.25 mg Thiomersal .......... 0.01% w/v
|
Suspension for Injection (IM)
|
-
|
Biological E. Limited
|
India
|
-
|
08 June 2021
|
08 June 2026
|
| View |
|
BR-1354
|
Diphtheria-Tetanus Vaccine (Adsorbed, Reduced
Antigen Content)
|
BE Td
|
Each dose (0.5 mL) contains: Diphtheria toxoid- 2 Lf (>2 IU)
Tetanus toxoid- 8.8 Lf (>20 IU) Adsorbed on Aluminum Phosphate-> 1.5 mg Preservative: Thiomersal BP-0.01% w/v
|
Solution For Injection (I.M)
|
-
|
Biological E. Limited
|
India
|
Initial
|
17 June 2021
|
17 June 2026
|
| View |
|
BR-1355
|
Diphtheria-Tetanus Vaccine (Adsorbed, Reduced
Antigen Content)
|
BE Td
|
Each dose (0.5 mL) contains: Diphtheria toxoid-2 Lf (>2 IU) Tetanus toxoid-8.8 Lf (>20 IU) Adsorbed on Aluminum Phosphate-> 1.5 mg Preservative: Thiomersal BP-0.01% w/v
|
Suspension for Injection (IM)
|
-
|
Biological E. Limited
|
India
|
Initial
|
17 June 2021
|
17 June 2026
|
| View |
|
BR-1360
|
Human Blood Coagulation Factor VIII
|
Green-VIII Inj.
|
500 IU (25 IU/mL)
|
Lyophilized Powder for Solution
for Injection (IV)
|
-
|
Green Cross Corp.
|
Korea
|
-
|
26 July 2021
|
26 July 2026
|
| View |
|
BR-1361
|
Human Coagulation Factor VIII
|
Green-VIII Inj.
|
250 IU (25 IU/mL) Lyophilized Powder for Solution for Injection (IV)
|
Lyophilized Powder for Solution for Injection (IV)
|
-
|
Green Cross Corp.
|
Korea
|
-
|
26 July 2021
|
26 July 2026
|
| View |
|
BR-1362
|
Atezolizumab
|
Tecentriq
|
840mg/14mL(60mg/mL)
|
Concentrate for Solution for IV Infusion
|
-
|
F. Hoffman-La Roche AG
|
Switzerland
|
Monitored Release
|
02 August 2021
|
02 August 2024
|
| View |
|
BR-1363
|
Bacillus Calmette-Guerin (BCG) Vaccine
|
None
|
0.5mg/1.0 mL
|
Lyophilized Powder for Injection (ID)
|
-
|
Institute of Vaccines and Medical Biologicals
|
Vietnam
|
Initial
|
05 August 2021
|
05 August 2026
|
| View |
|
BR-1364
|
Insulin Aspart
|
Novomix 30 Flexpen
|
100 U/mL (3.5 mg/mL)
|
Suspension for Injection (SC) (30% Insulin Aspart and 70% Insulin Aspart Protamine)
|
-
|
Novo Nordisk Production SAS
|
France
|
-
|
02 September 2021
|
02 September 2026
|
| View |
BR-1365_PI_01.pdf
|
BR-1365
|
Durvalumab
|
Imfinzi
|
120 mg/2.4 mL (50 mg/mL)
|
Cocentrate for Solution for IV Infusion
|
-
|
Catalent Indiana, LLC
|
United States of America
|
Monitored Release (MR)
|
07 September 2021
|
07 September 2024
|
| View |
BR-1366-PI_01.pdf
|
BR-1366
|
Durvalumab
|
Imfinzi
|
500 mg/10 mL (50 mg/mL)
|
Cocentrate for Solution for IV Infusion
|
-
|
Catalent Indiana, LLC
|
United States of America
|
Monitored Release (MR)
|
07 September 2021
|
07 September 2024
|
| View |
|
BR-1367
|
Bovine Lung Surfactant
|
Newfactan
|
120 mg
|
Powder For Solution For Intratracheal Infusion
|
-
|
Yuhan Corporation
|
korea
|
Renewal (Revalidation)
|
21 March 2023
|
28 December 2024
|
| View |
|
BR-1368
|
Human Normal Immunoglobulin
|
Eugamma SN 10% Inj.
|
5000 mg/50 mL (100 mg/mL)
|
Solution For Infusion IV
|
-
|
Green Cross Corp.
|
Korea
|
-
|
08 September 2021
|
08 September 2026
|
| View |
|
BR-1369
|
Insulin Aspart
|
Novorapid Flexpen
|
100 units/mL (3.5mg/mL)
|
Solution For Injection (IV/SC)
|
-
|
Novo Nordisk Production SAS
|
France
|
-
|
14 September 2021
|
14 September 2026
|
| View |
|
BR-1370
|
Tetanus Toxoid (Adsorbed)
|
Abhay-TOX
|
40 IU/0.5mL
|
Solution For Injection (IM)
|
-
|
Human Biologicals Institute (A Division of Indian
Immunologicals Limited)
|
India
|
-
|
16 September 2021
|
16 September 2026
|
| View |
|
BR-1371
|
Insulin Human (rDNA)
|
Mixtard 30 Flexpen
|
100 U/mL
|
Suspension for Injection (SC) (30%
Soluble Insulin and 70% Isophane Insulin)
|
-
|
Novo Nordisk Produção Farmacêutica do Brasil Ltda.
|
Brazil
|
Initial
|
24 September 2021
|
24 September 2026
|
| View |
BR-1372_PI_01.pdf
|
BR-1372
|
Somatropin
|
Norditropin Nordiflex
|
5 mg / 1.5mL
|
Solution For Injection (SC)
|
-
|
Novo Nordisk A/S
|
Denmark
|
-
|
06 October 2021
|
06 October 2026
|
| View |
BR-1373_PI_01.pdf
|
BR-1373
|
Somatropin
|
Norditropin Nordiflex
|
10 mg/ 1.5mL
|
Solution For Injection (SC)
|
-
|
Novo Nordisk A/S
|
Denmark
|
-
|
06 October 2021
|
06 October 2026
|
| View |
BR-1374_PI_01.pdf
|
BR-1374
|
Somatropin
|
Norditropin Nordiflex
|
15 mg/1.5mL
|
Solution For Injection (SC)
|
-
|
Novo Nordisk A/S
|
Denmark
|
-
|
06 October 2021
|
06 October 2026
|
| View |
|
BR-1375
|
Bevacizumab
|
Zirabev
|
100 mg/4 mL (25 mg/mL)
|
Concentrate For Solution For I.V. Injection
|
-
|
Pharmacia and Upjohn Company LLC
|
United States of America
|
Initial
|
19 October 2021
|
19 October 2026
|