View |
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BR-1414
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Hepatitis B Vaccine (rDNA)
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Bevac
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10mcg/0.5mL (100mcg/5mL)
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Solution for Injection (I.M)
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Vaccines
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Biological E. Limited
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India
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Initial
|
23 August 2022
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23 August 2027
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View |
BR-1415_PI_01.pdf
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BR-1415
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Ustekinumab
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Stelara
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45 mg/0.5 mL
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Solution For Injection (SC)
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Interleukin Inhibitors
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Cilag AG
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Switzerland
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Initial
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31 August 2022
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31 August 2027
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View |
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BR-1416
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Adalimumab
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Idacio
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40 mg/ 0.8 mL
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Solution for Injection (SC)
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Tumor Necrosis Factor Alpha (TNF-a) Inhibitors
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Merck Serono S.p.A.
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Italy
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Monitored Release
|
02 September 2022
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02 September 2027
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View |
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BR-1417
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Adalimumab
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Idacio
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40 mg/ 0.8 mL
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Solution for Injection (SC)
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Tumor Necrosis Factor Alpha (TNF-a) Inhibitors
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Merck Serono S.p.A.
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Italy
|
Monitored Release
|
02 September 2022
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02 September 2027
|
View |
BR-1418_PI_01.pdf
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BR-1418
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Ofatumumab
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Bonspri
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20 mg/ 0.4 mL
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Solution for Injection (SC)
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Immunosuppressants
|
Novartis Pharma Stein AG (Technical Operations Schweiz, Stein Steriles)
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Switzerland
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Monitored Release (MR)
|
12 September 2022
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12 September 2027
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View |
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BR-1419
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Tildrakizumab
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Ilumya
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100 mg/mL
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Solution for Injection (S.C.)
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Interleukin Inhibitor
|
Vetter Pharma-Fertigung GmbH & Co. KG
|
Germany
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Monitored Release (Reconstruction)
|
24 May 2024
|
13 September 2027
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View |
BR-1420_PI_01.pdf
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BR-1420
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Insulin Degludec + Liraglutide
|
Xultophy
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100 U/3.6mg per mL
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Solution For Injection (SC)
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Antidiabetics
|
Novo Nordisk Pharmaceutical Industries, LP
|
United States of America
|
Initial
|
20 September 2022
|
20 September 2027
|
View |
BR-1421_PI_01.pdf
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BR-1421
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Quadrivalent Seasonal Influenza Vaccine (Split Virion, Inactivated) 2024 Southern Hemisphere Strain.
|
Fluquadri
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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
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Suspension for Injection (IM)
|
Vaccines
|
Sanofi Pasteur
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U.S.A
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Monitored Release (Strain Clearance)
|
27 March 2024
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27 March 2025
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View |
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BR-1422
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Inactivated Poliomyelitis Vaccine (Types 1, 2, and 3)
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Poliovac
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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
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Suspension for Injection (IM/SC)
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Vaccines
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Serum Institute of India Private Limited
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India
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Initial
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06 October 2022
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06 October 2027
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View |
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BR-1423
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Diphtheria, Tetanus, Pertussis (Whole Cell), Hepatitis B
(IDNA) and Haemophilus influenzae Type B Conjugate
Vaccine (Adsorbed)
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Shan 5
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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
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Suspension For Injection (IM)
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Vaccines
|
Sanofi Healthcare India Private Limited
|
India
|
Initial
|
07 October 2022
|
07 October 2027
|
View |
BR-1424_PI_01.pdf
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BR-1424
|
Daratumumab
|
Darzalex SC
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1,800 mg/15 mL (120 mg/mL)
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Solution for Injection (SC)
|
-
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Cilag AG
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Switzerland
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Monitored Release
|
07 October 2022
|
07 October 2027
|
View |
BR-1425_PI_01.pdf
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BR-1425
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Pneumococcal Polysaccharide Conjugate Vaccine, 15
Valent (Adsorbed)
|
Vaxneuvance
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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
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Suspension for Injection (IM)
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Vaccines
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MSD International GmbH T/A MSD Ireland (Carlow)
|
Ireland
|
Monitored Release (Re-application) [Correction]
|
08 February 2023
|
17 October 2027
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View |
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BR-1426
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Epoetin Alfa
|
Erysaa
|
2,000 IU/0.5 mL
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Solution for Injection (IV)
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Antianemic Preparations
|
PanGen Biotech Inc.
|
Korea
|
Initial
|
17 October 2022
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17 October 2027
|
View |
BR-1427_PI_01.pdf
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BR-1427
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Nonacog Alfa
|
BeneFIX
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250IU
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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
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BR-1428
|
Nonacog Alfa
|
BeneFIX
|
500IU
|
Lyophilized Powder for Solution for Injection (IV)
|
Blood Coagulation Factors (Coagulation Factor IX)
|
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)
|
Blood Coagulation Factors (Coagulation Factor IX)
|
Wyeth Farma, S.A.
|
Spain
|
Monitored Release (MR)
|
08 November 2022
|
08 November 2027
|
View |
BR-1430_PI_01.pdf
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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 |
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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
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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
|