| View |
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BR-1454
|
Clostridium botulinum Toxin Type A
|
Botitox Up
|
100 Units
|
Lyophilized Powder for Solution for Injection
(IM)
|
-
|
Huons Biopharma Co., Ltd.
|
Korea
|
Initial (Reapplication)
|
07 November 2023
|
07 November 2028
|
| View |
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BR-1455
|
Respiratory Syncytial Virus Vaccine (Recombinant, Adjuvanted)
|
Arexvy
|
120 mcg
|
Powder for Suspension for Injection (IM)
|
-
|
GlaxoSmithKline Biologicals SA
|
Belgium
|
Monitored Release (MR)
|
22 November 2023
|
22 November 2028
|
| View |
|
BR-1456
|
Insulin Aspart
|
Kirsty
|
100 Units/mL (equivalent to 3.5 mg/mL)
|
Solution for Injection (SC)
|
-
|
Biocon Sdn BHD
|
Malaysia
|
Initial
|
28 November 2023
|
28 November 2028
|
| View |
|
BR-1457
|
Insulin Aspart
|
Kirsty
|
100 Units/mL (equivalent to 3.5 mg/mL)
|
Solution for Injection (SC)
|
-
|
Biocon Sdn BHD
|
Malaysia
|
Initial
|
28 November 2023
|
28 November 2028
|
| View |
|
BR-1458
|
Tremelimumab
|
Imjudo
|
300 mg/15 mL (20 mg/mL)
|
Concentrate for Solution for
Infusion (IV)
|
-
|
Vetter Pharma-Fertigung GmbH & Co. KG
|
Germany
|
Monitored Release
|
20 December 2023
|
20 December 2028
|
| View |
|
BR-1459
|
Tremelimumab
|
Imjudo
|
25 mg/1.25 mL (20 mg/mL)
|
Concentrate for Solution for
Infusion (IV)
|
-
|
Vetter Pharma-Fertigung GmbH & Co. KG
|
Germany
|
Monitored Release
|
20 December 2023
|
20 December 2028
|
| View |
|
BR-1460
|
Infliximab
|
Remsima
|
120 mg
|
Solution For Injection
|
Immunosuppressant
|
Vetter Pharma-Fertigung GmbH & Co. KG
|
Germany
|
Monitored Release
|
22 December 2023
|
22 December 2028
|
| View |
|
BR-1461
|
Ocrelizumab
|
Ocrevus
|
300 mg/10 ml (30 mg/ml)
|
oncentrate for Solution for
Intravenous Infusion
|
Selective Immunosuppresant
|
F. Hoffmann-La Roche Ltd.
|
Switzerland
|
Monitored Release
|
22 December 2023
|
22 December 2028
|
| View |
|
BR-1462
|
Ocrelizumab
|
Ocrevus
|
300 mg/10 ml (30 mg/ml)
|
Concentrate for Solution for
Intravenous Infusion.
|
Selective Immunosuppresant
|
Roche Diagnostics GmbH
|
Germany
|
Monitored Release
|
22 December 2023
|
22 December 2028
|
| View |
|
BR-1463
|
Trastuzumab
|
Hertumab
|
150 mg
|
Powder for Concentrate for Solution for Infusion.
(IV)
|
-
|
Shanghai Henlius Biopharmaceutical Co., Ltd.
|
China
|
Initial
|
04 January 2024
|
04 January 2029
|
| View |
|
BR-1464
|
Trastuzumab deruxtecan
|
Enhertu
|
100 mg
|
Powder for Concentrate for Solution for Infusion (IV)
|
Human Epidermal Growth Factor Receptor 2 (HER2)
Inhibitor
|
Baxter Oncology GmbH
|
Germany
|
Monitored Release
|
15 January 2024
|
15 January 2029
|
| View |
|
BR-1465
|
Japanese Encephalitis Vaccine (Inactivated, Adsorbed)
|
Jeev
|
6 mcg/0.5 mL
|
Suspension for Injection (IM)
|
Vaccines
|
Biological E. Limited
|
India
|
Monitored Release (MR) [Reapplication]
|
08 February 2024
|
08 February 2029
|
| View |
|
BR-1466
|
Anifrolumab
|
Saphnelo
|
300 mg/2 mL (150 mg/ml)
|
Concentrate for Solution for
Infusion (IV)
|
Monoclonal Antibody.
|
AstraZeneca Nijmegen B.V.
|
Netherlands
|
Monitored Release
|
14 February 2024
|
14 February 2029
|
| View |
|
BR-1467
|
Avelumab
|
Bavencio
|
200 mg/10 mL (20 mg/mL)
|
Concentrate for Solution for
Infusion (IV)
|
Monoclonal Antibodies
|
Merck Serono SA
|
Switzerland
|
Monitored Release (MR)
|
22 February 2024
|
22 February 2029
|
| View |
|
BR-1468
|
Semaglutide
|
Wegovy
|
0.25 mg/0.37 mL (0.68 mg/mL)
|
Solution
Injection (SC)
|
Glucagon-like peptide (GLP-1) Analogues
|
Novo Nordisk A/S
|
Denmark
|
Monitored Release (MR)
|
28 February 2024
|
28 February 2029
|
| View |
|
BR-1469
|
Semaglutide
|
Wegovy
|
2.4 mg/ 0.75 mL (3.2 mg/mL)
|
Solution for
Injection (SC)
|
Glucagon-like peptide (GLP-1) Analogues
|
Novo Nordisk A/S
|
Denmark
|
Monitored Release (MR)
|
28 February 2024
|
28 February 2029
|
| View |
|
BR-1470
|
Semaglutide
|
Wegovy
|
0.5 mg/0.37 mL (1.34 mg/mL)
|
Solution for
Injection (SC)
|
Glucagon-like peptide (GLP-1) Analogues
|
Novo Nordisk A/S
|
Denmark
|
Monitored Release (MR)
|
28 February 2024
|
28 February 2029
|
| View |
|
BR-1471
|
Semaglutide
|
Wegovy
|
1 mg/0.75 mL (1.34 mg/mL)
|
Solution for Injection (SC)
|
Glucagon-like peptide (GLP-1) Analogues.
|
Novo Nordisk A/S
|
Denmark
|
Monitored Release (MR)
|
28 February 2024
|
28 February 2029
|
| View |
|
BR-1472
|
Semaglutide
|
Wegovy
|
1.7 mg/ 0.75 mL (2.27 mg/mL)
|
Solution for Injection (SC)
|
Glucagon-like peptide (GLP-1) Analogues
|
Novo Nordisk A/S
|
Denmark
|
Monitored Release (MR)
|
28 February 2024
|
28 February 2029
|
| View |
BR-1473_PI_01.pdf
|
BR-1473
|
Semaglutide
|
Wegovy
|
2.4 mg/0.75 mL (3.2 mg/mL)
|
Solution for
Injection (SC)
|
Glucagon-like peptide (GLP-1) Analogues
|
Novo Nordisk A/S
|
Denmark
|
Monitored Release (MR)
|
22 May 2024
|
22 May 2029
|