View |
|
BR-1048
|
Agalsidase Beta
|
Fabrazyme
|
35 mg
|
Powder for Concentrate for Solution for
Infusion (IV)
|
-
|
Genzyme Ireland Limited
|
Ireland
|
Renewal
|
21 November 2023
|
07 December 2028
|
View |
|
BR-1049
|
Follitropin Alfa
|
Gonal-F
|
60 mg/0.6 mL 75 IU (5.5 mcg)
|
Lyophilized Powder for Solution for Subcutaneous Injection
|
-
|
Merck Serono SA
|
Switzerland
|
-
|
15 February 2022
|
09 February 2025
|
View |
|
BR-1050
|
Cetuximab
|
Erbitux
|
5 mg/mL
|
Solution for Intravenous Infusion
|
-
|
Merck Healthcare KGaA
|
Germany
|
-
|
01 September 2022
|
09 November 2024
|
View |
BR-1051_PI_01.pdf
|
BR-1051
|
Basiliximab
|
Simulect
|
20 mg
|
Powder for Injection or Infusion (IV)
|
-
|
Novartis Pharma Stein AG Technical Operations
|
Switzerland
|
|
02 November 2022
|
02 November 2027
|
View |
|
BR-1053
|
Insulin Lispro (rDNA origin)
|
Humalog Kwikpen
|
100 units/mL
|
Solution for Injection (IM/IV/SC)
|
-
|
Eli Lilly Italia S.p.A.
|
Italy
|
Initial (Variation)
|
25 October 2022
|
25 October 2027
|
View |
|
BR-1057
|
Insulin detemir
|
Levemir FlexPen
|
100 U/mL
|
Solution for Injection (SC)
|
-
|
Novo Nordisk Producao Farmaceutica do Brasil Ltda.
|
Brazil
|
-
|
26 November 2021
|
18 March 2025
|
View |
|
BR-1059
|
Somatropin
|
Scitropin A
|
5 mg/ 1.5 mL (15IU)
|
Solution S.C. for Injection
|
Anterior Pituitary Lobe Hormone and Analogue
|
SANDOZ GmbH
|
Austria
|
Renewal
|
01 November 2023
|
27 November 2028
|
View |
|
BR-1060
|
Epoetin Beta
|
Recormon
|
30000 IU/ 0.6 mL
|
Solution For Injection (IV/SC)
|
-
|
Roche Diagnostic GmbH
|
Germany
|
-
|
26 February 2021
|
03 December 2025
|
View |
|
BR-1062
|
Epoetin Beta
|
Recormon
|
10,000 IU/0.6 mL
|
Solution For Injection (IV/SC)
|
-
|
Roche Diagnostics GmbH
|
Germany
|
Renewal
|
12 May 2023
|
17 March 2028
|
View |
|
BR-1068
|
Trastuzumab
|
Herceptin
|
150 mg
|
Lyophilized Powder For Concentrate Solution For Infusion (IV)
|
-
|
Genentech, Inc.
|
United States of America
|
Initial (Variation)
|
11 October 2022
|
11 October 2027
|
View |
|
BR-1073
|
Filgrastim
|
Neubicyte
|
150 mcg/mL
|
Solution for Injection/ 150mg/ml
|
Hematopoietic Growth Factor
|
Harbin Pharmaceutical Group Bioengineering Co., Ltd.
|
China
|
Renewal
|
20 June 2022
|
26 May 2027
|
View |
|
BR-1074
|
Insulin Aspart
|
NovoRapid FlexPen
|
100 U/mL
|
Solution For Injection (SC)
|
-
|
Novo Nordisk Producao Farmaceutica do Brasil Ltda
|
Brazil
|
-
|
19 February 2021
|
20 March 2025
|
View |
|
BR-1075
|
Brentuximab Vedotin
|
Adcetris
|
50 mg
|
Powder for Concentrate for Solution for IV Infusion
|
-
|
BSP Pharmaceuticals S.p.A
|
Italy
|
-
|
19 May 2021
|
01 April 2025
|
View |
|
BR-1076
|
Heparin sodium (Bovine)
|
None
|
5, 000 IU/Ml
|
Solution for Injection (SC)
|
-
|
Ain Medicare Sdn. Bhd.
|
Malaysia
|
-
|
24 August 2020
|
05 January 2025
|
View |
|
BR-1077
|
Insulin Aspart
|
NovoMix 30 Flexpen
|
100 units per mL
|
Suspension for Injection (SC) (Formulation: 30% Soluble Insulin and 70% Protamine Insulin Aspart Crystals)
|
-
|
Novo Nordisk Producão Farmaceutica do Brasil Ltda
|
Brazil
|
-
|
19 February 2021
|
27 April 2025
|
View |
|
BR-1078
|
Trastuzumab
|
Herceptin
|
150 mg
|
Lyophilized Powder for Concentrate Solution for IV Infusion
|
-
|
Roche Diagnostics GmbH
|
Germany
|
-
|
08 March 2021
|
11 November 2024
|
View |
|
BR-1080
|
Tinzaparin Sodium
|
Innohep
|
10000 anti-Xa IU/mL
|
Solution For Injection (SC)
|
-
|
Leo Pharma A/S
|
Denmark
|
Initial (Variation)
|
12 December 2022
|
12 December 2027
|
View |
BR-1084_PI_01.pdf
|
BR-1084
|
Quadrivalent Seasonal Influenza Vaccine (Split)
Virion, Inactivated) 2024 Southern Hemisphere Strain.
|
Fluquadri
|
Formulation:
Each dose (0.5 mL) contains the following influenza strains*:
A/Victoria/4897/2022 (H1N1) pdm09-like strain
15 μg of HA**
(A/Victoria/4897/2022, IVR-238)
A/Thailand/8/2022 (H3N2)-like strain
15 μg of HA**
(A/California/122/2022, SAN-022)
B/Austria/1359417/2021-like strain
15 μg of HA**
(B/Michigan/01/2021, wild type)
B/Phuket/3073/2013 (B/Yamagata lineage)-like virus
15 μg of HA**
(B/Phuket/3073/2013, wild type)
*Propagated in embryonated chicken eggs
|
Suspension for Injection (IM)
|
Vaccines
|
Sanofi Pasteur
|
U.S.A
|
Monitored Release (Strain Clearance)
|
05 April 2024
|
05 April 2025
|
View |
|
BR-1085
|
Streptokinase
|
Thromboflux
|
1,500,000IU
|
Lyophilized Powder For Injection IV
|
-
|
Bharat Serums and Vaccines Limited
|
India
|
-
|
03 February 2021
|
21 September 2024
|
View |
|
BR-1087
|
Diphtheria, Tetanus, Pertussis (Whole Cell), Hepatitis B
(IDNA) and Haemophilus influenzae Type B Conjugate
Vaccine (Adsorbed)
|
Shan 5
|
Formulation: Each dose (0.5 mL) contains: Diphtheria toxoid->30IU Tetanus toxoid->60IU Bordetella pertussis (Whole Cell)-> 4 IU Hepatitis B (r-DNA) surface antigen-10ug Purified capsular polysaccharide of Hib conjugated to
20-40 mcg Tetanus toxoid (carrier protein)-10ug
|
Suspension for Injection (IM)
|
-
|
Shantha Biotechnics Limited
|
India
|
Initial (from Monitored Release)
|
07 June 2022
|
05 June 2025
|