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Product Information
Registration Number
Generic Name
Brand Name
Dosage Strength
Dosage Form
Classification
Pharmacologic Category
Manufacturer
Country of Origin
Application Type
Issuance Date
Expiry Date
View BR-1414 Hepatitis B Vaccine (rDNA) Bevac 10mcg/0.5mL (100mcg/5mL) Solution for Injection (I.M) Prescription Drug (RX) Vaccines Biological E. Limited India Initial 23 August 2022 23 August 2027
View BR-1415_PI_01.pdf BR-1415 Ustekinumab Stelara 45 mg/0.5 mL Solution For Injection (SC) Prescription Drug (RX) Interleukin Inhibitors Cilag AG Switzerland Initial 31 August 2022 31 August 2027
View BR-1416 Adalimumab Idacio 40 mg/ 0.8 mL Solution for Injection (SC) Prescription Drug (RX) Tumor Necrosis Factor Alpha (TNF-a) Inhibitors Merck Serono S.p.A. Italy Monitored Release 02 September 2022 02 September 2027
View BR-1417 Adalimumab Idacio 40 mg/ 0.8 mL Solution for Injection (SC) Prescription Drug (RX) Tumor Necrosis Factor Alpha (TNF-a) Inhibitors Merck Serono S.p.A. Italy Monitored Release 02 September 2022 02 September 2027
View BR-1418_PI_01.pdf BR-1418 Ofatumumab Bonspri 20 mg/ 0.4 mL Solution for Injection (SC) Prescription Drug (RX) Immunosuppressants 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.) Prescription Drug (Rx) Interleukin Inhibitor Vetter Pharma-Fertigung GmbH & Co. KG Germany Monitored Release (Reconstruction) 24 May 2024 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) Prescription Drug (RX) Antidiabetics 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) Prescription Drug (Rx) 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) Prescription Drug (RX) Vaccines 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) Prescription Drug (RX) Vaccines 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) Prescription Drug (RX) - 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) Prescription Drug (RX) 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) Prescription Drug (RX) Antianemic Preparations 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) Prescription Drug (RX) - 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) Prescription Drug (RX) 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) Prescription Drug (RX) 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 BR-1430 Nonacog Alfa BeneFIX 2000IU Lyophilized Powder for Solution for Injection (IV) Prescription Drug (RX) - 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 Prescription Drug (RX) - 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 Prescription Drug (RX) - 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) Prescription Drug (RX) - Novo Nordisk Production SAS France Initial (Re-application) 25 November 2022 25 November 2027