| View |
BR-1418_PI_01.pdf
|
BR-1418
|
Ofatumumab
|
Bonspri
|
20 mg/ 0.4 mL
|
Solution for Injection (SC)
|
-
|
Novartis Pharma Stein AG (Technical Operations Schweiz, Stein Steriles)
|
Switzerland
|
Monitored Release (MR)
|
12 September 2022
|
12 September 2027
|
| View |
|
BR-1419
|
Tildrakizumab
|
Ilumya
|
100 mg/mL
|
Solution for Injection (S.C.)
|
-
|
Vetter Pharma-Fertigung GmbH & Co. KG
|
Germany
|
Monitored Release
|
13 September 2022
|
13 September 2027
|
| View |
BR-1420_PI_01.pdf
|
BR-1420
|
Insulin Degludec + Liraglutide
|
Xultophy
|
100 U/3.6mg per mL
|
Solution For Injection (SC)
|
-
|
Novo Nordisk Pharmaceutical Industries, LP
|
United States of America
|
Initial
|
20 September 2022
|
20 September 2027
|
| View |
BR-1421_PI_01.pdf
|
BR-1421
|
Quadrivalent Seasonal Influenza Vaccine (Split Virion, Inactivated) 2024 Southern Hemisphere Strain.
|
Fluquadri
|
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
**Haemagglutinin
|
Suspension for Injection (IM)
|
Vaccines
|
Sanofi Pasteur
|
U.S.A
|
Monitored Release (Strain Clearance)
|
27 March 2024
|
27 March 2025
|
| View |
|
BR-1422
|
Inactivated Poliomyelitis Vaccine (Types 1, 2, and 3)
|
Poliovac
|
Formulation: Each dose (0.5 mL) contains: Inactivated poliovirus type 1, Mahoney strain*40 D antigen units Inactivated poliovirus type 2, MEF-1 strain* 8 D antigen units Inactivated poliovirus type 3, Saukett strain* 32 D antigen units *Cultivated on Vero cells
|
Suspension for Injection (IM/SC)
|
-
|
Serum Institute of India Private Limited
|
India
|
Initial
|
06 October 2022
|
06 October 2027
|
| View |
|
BR-1423
|
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-> 30 IU Tetanus toxoid- > 60 IU Bordetella pertussis (Whole Cell)-> 4U Hepatitis B (r-DNA) surface antigen-10 ug Purified capsular polysaccharide of Hib conjugated to 20-40 mcg Tetanus toxoid (carrier protein)-10 ug
|
Suspension For Injection (IM)
|
-
|
Sanofi Healthcare India Private Limited
|
India
|
Initial
|
07 October 2022
|
07 October 2027
|
| View |
BR-1424_PI_01.pdf
|
BR-1424
|
Daratumumab
|
Darzalex SC
|
1,800 mg/15 mL (120 mg/mL)
|
Solution for Injection (SC)
|
-
|
Cilag AG
|
Switzerland
|
Monitored Release
|
07 October 2022
|
07 October 2027
|
| View |
BR-1425_PI_01.pdf
|
BR-1425
|
Pneumococcal Polysaccharide Conjugate Vaccine, 15
Valent (Adsorbed)
|
Vaxneuvance
|
Formulation: Each dose (0.5 mL) contains: Streptococcus pneumoniae polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 197, 22F, 23F, 33F- 2 ug Streptococcus pneumoniae polysaccharide serotype 6B-4 ug CRM197 -30ug
|
Suspension for Injection (IM)
|
Vaccines
|
MSD International GmbH T/A MSD Ireland (Carlow)
|
Ireland
|
Monitored Release (Re-application) [Correction]
|
08 February 2023
|
17 October 2027
|
| View |
|
BR-1426
|
Epoetin Alfa
|
Erysaa
|
2,000 IU/0.5 mL
|
Solution for Injection (IV)
|
-
|
PanGen Biotech Inc.
|
Korea
|
Initial
|
17 October 2022
|
17 October 2027
|
| View |
BR-1427_PI_01.pdf
|
BR-1427
|
Nonacog Alfa
|
BeneFIX
|
250IU
|
Lyophilized Powder for Solution for Injection (IV)
|
-
|
Wyeth Farma, S.A.
|
Spain
|
Monitored Release (MR)
|
08 November 2022
|
08 November 2027
|
| View |
BR-1428_PI_01.pdf
|
BR-1428
|
Nonacog Alfa
|
BeneFIX
|
500IU
|
Lyophilized Powder for Solution for Injection (IV)
|
-
|
Wyeth Farma, S.A.
|
Spain
|
Monitored Release (MR)
|
08 November 2022
|
08 November 2027
|
| View |
BR-1429_PI_01.pdf
|
BR-1429
|
Nonacog alfa
|
BeneFIX
|
1000IU
|
Lyophilized Powder for Solution for Injection (IV)
|
-
|
Wyeth Farma, S.A.
|
Spain
|
Monitored Release (MR)
|
08 November 2022
|
08 November 2027
|
| View |
BR-1430_PI_01.pdf
|
BR-1430
|
Nonacog Alfa
|
BeneFIX
|
2000IU
|
Lyophilized Powder for Solution for Injection (IV)
|
-
|
Wyeth Farma, S.A.
|
Spain
|
Monitored Release
|
08 November 2022
|
08 November 2027
|
| View |
|
BR-1431
|
Faricimab
|
Vabysmo
|
6 mg/0.05 mL (120 mg/mL)
|
Solution For Intravitreal Injection
|
-
|
F. Hoffman-La Roche AG
|
Switzerland
|
Monitored Release
|
14 November 2022
|
14 November 2027
|
| View |
BR-1432_PI_01.pdf
|
BR-1432
|
Bacillus Clausii
|
Erceflora
|
4 billion / 5 mL
|
Oral Suspension
|
-
|
Opella Healthcare Italy S.r.L
|
Italy
|
Monitored Release (MR) (Re-application)
|
22 November 2022
|
22 November 2027
|
| View |
BR-1433_PI_01.pdf
|
BR-1433
|
Insulin Degludec + Insulin Aspart
|
Ryzodeg Flextouch
|
100 Units/mL (70% Insulin Degludec/30% Insulin
Aspart)
|
Solution for Injection (SC)
|
-
|
Novo Nordisk Production SAS
|
France
|
Initial (Re-application)
|
25 November 2022
|
25 November 2027
|
| View |
|
BR-1434
|
Rotavirus Vaccine, (Live
Attenuated)
|
Rotasiil-Liquid
|
Formulation:
Each dose (2 mL) contains:
Live, Attenuated Bovine - Human Rotavirus Reassortant
[G1, G2, G3, G4, and G9]*
*Grown on Vero cells
**FFU= Focus-forming Unit
***CCID= Cell culture infectious disease
≥105.6 FFU**/serotype (NLT 6.30 log10 CCID 50*** per dose)
|
Oral Suspension
|
-
|
Serum Institute of India Private Limited
|
India
|
Monitored Release
|
28 November 2022
|
28 November 2027
|
| View |
|
BR-1435
|
Heparin sodium
|
Ceparin
|
1,000 I.U./mL ( 5,000 I.U./5mL )
|
Solution for Injection (I.V.)
|
ANTITHROMBOTIC AGENT
|
North China Pharmaceutical Co., Ltd.
|
China
|
Renewal
|
05 January 2023
|
19 December 2027
|
| View |
|
BR-1436
|
Atezolizumab
|
Tecentriq
|
1200 mg/20 mL (60 mg/mL)
|
Concentrate for Solution for
Infusion (IV)
|
-
|
F. Hoffmann-La Roche AG
|
Switzerland
|
Monitored Release
|
11 January 2023
|
11 January 2028
|
| View |
|
BR-1437
|
Casirivimab + Imdevimab
|
Ronapreve
|
120 mg/mL
|
Concentrate for Solution for Injection
(SC)/Infusion (IV)
|
-
|
Genentech, Inc.
|
United States of America
|
Monitored Release (MR)
|
17 January 2023
|
17 January 2028
|