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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-893 Alglucosidase alfa Myozyme 50 mg Powder For Concentrate For Solutions For Infusion (IV) Prescription Drug (RX) - Genzyme Ireland Limited Ireland Renewal 26 April 2023 31 January 2028
View BR-896_PI_01.pdf BR-896 Panitumumab Vectibix 100 mg/5 mL (20 mg/mL) Concentrate for Solution for Infusion (IV) Prescription Drug (RX) - Amgen Manufacturing Limited United States of America Initial (from Monitored Release) 30 March 2023 04 April 2026
View BR-897 Human Norml Immunoglobulin I.V. - Globulin Sn Injection 5,000mg/100mL Solution For Injection (Iv) Prescription Drug (RX) Immunoglobulin Green Cross Corp. Korea BR-897 20 February 2023 04 April 2028
View BR-901 Trivalent Seasonal Influenza Vaccine (Surface Antigen, Inactivated) 2024 Southern Hemisphere Strain Influvac Each dose (0.5 mL) contains the following strains*: A/Victoria/4897/2022 (H1N1)pdm09-like strain 15 ug HA** (A/Victoria/4897/2022, IVR-238) A/Thailand/8/2022 (H3N2)-like strain 15 ug HA** (A/Thailand/8/2022, IVR-237) B/Austria/1359417/2021-like strain 15 ug HA** (B/Austria/1359417/2021, BVR-26) *Propagated in embryonated chicken eggs **Haemagglutinin Suspension for Injection (IM/SC) Prescription Drug (RX) Vaccines Abbott Biologicals B.V. Netherlands Monitored Release (Strain Clearance) 14 February 2024 14 February 2025
View BR-906_PI_01.pdf BR-906 Golimumab Simponi 50 mg/0.5 mL Solution For Injection (SC) Prescription Drug (RX) - Baxter Pharmaceutical Solutions LLC United States of America Initial 15 March 2022 14 May 2026
View BR-907 Infliximab Remsima 100mg Lyophilized Powder for Concentrate for Solution for Infusion (IV) Prescription Drug (RX) - Celltrion, Inc. (Plant 2) Korea Renewal (Correction) 02 August 2023 14 May 2028
View BR-898 Pneumococcal Conjugate Vaccine, 13-valent (adsorbed) Prevenar 13 Formulation: Each 0.5 mL dose contains: Pneumococcal polysaccharide serotype 1*.....2.2 mcg Pneumococcal polysaccharide serotype 3*..............2.2 mcg Pneumococcal polysaccharide serotype 4* ......... .............2.2 mcg Pneumococcal polysaccharide serotype 5*..............2.2 mcg Pneumococcal polysaccharide serotype 6A*............... ...2.2 mcg Pneumococcal polysaccharide serotype 6B*........4.4 mcg Pneumococcal polysaccharide serotype 7F*..........2.2 mcg Pneumococcal polysaccharide serotype 9V* .........2.2 mcg Pneumococcal polysaccharide serotype 14*.............2.2mcg Pneumococcal polysaccharide serotype 18C*..............2.2 mcg Pneumococcal polysaccharide serotype 19A* .....................2.2 mcg Pneumococcal polysaccharide serotype 19F*....................2.2 mcg Pneumococcal polysaccharide serotype 23F* .....................2.2 mcg *Conjugated to CRM197 carrier protein and adsorbed on Aluminium phosphate (125 mcg Aluminum) Suspension for Injection (IM) Prescription Drug (RX) - Pfizer Manufacturing Belgium NV Belgium - 21 April 2021 04 April 2026
View BR-909 Enoxaparin Sodium Enoclex 60mg/0.6mL Solution For Injection (SC) Prescription Drug (Rx) Antithrombotic Agent Shenzhen Techdow Pharmaceutical Co., Ltd. China Automatic Renewal 14 April 2023 21 May 2028
View BR-911 LIVE ATTENUATED MEASLES, MUMPS and RUBELLA VACCINE NONE 10 Dose Freeze- Dried Powder For Injection ( S.C ) Prescription Drug (Rx) VACCINE Serum Institute of India Ltd. India Renewal 21 March 2023 21 May 2028
View BR-912 Aflibercept Eylea 40 mg/mL (4 mg/100 mL) Solution for Injection (IVT) Prescription Drug (RX) - Bayer AG Germany Initial [Variation] 04 December 2023 04 December 2028
View BR-916 Choriogonadotropin Alfa Ovidrel 250 mcg/0.5 mL Solution for Injection (SC) Prescription Drug (RX) - Merck Serono S.p.A. Italy Renewal 31 March 2023 23 July 2028
View BR-917 Measles, Mumps and Rubella Vaccine (Live, Attenuated) M-M-R II REMARKS: Formulation: After reconstitution, each dose (0.5 mL) contains: Live, attenuated virus derived from Edmonston B strain of measles………………… 3.0 log TCID50* Live, attenuated Jeryl Lynn strain of mumps…………..4.1 log TCID50* Live, attenuated Wistar RA27/3 strain of rubella. …………3.0 log TCID50* *TCID 50 - Tissue Culture Infectivity Dose 50% Lyophilized Powder for Solution for Injection (IM/SC) Prescription Drug (RX) - Merck Sharp and Dohme LLC U.S.A Renewal 26 April 2023 26 January 2028
View BR-918 Clostridium Botulinum Toxin Type A HugelTox 100 Units Lyophilized Powder For Injection Prescription Drug (RX) Muscle Relaxant Hugel, Inc. Korea Renewal 22 March 2023 07 August 2028
View BR-919 Diphtheria, Tetanus, Pertussis (Acellular Component), Hepatitis B, Poliomyelitis (Inactivated) and Haemophilus influenzae Type B Conjugate Vaccine (Adsorbed) Hexaxim Formulation: Each dose (0.5 mL) contains: Diphtheria toxoid' Tetanus toxoid ' Bordetella pertussis antigen Pertussis toxoid' Filamentous hemagglutinin' Poliovirus (Inactivated)2.3 Type I (Mahoney) strain NLT 20 IU NLT 40 IU Hepatitis B surface antigen Haemophilus influenzae Type B Polysaccharide Phosphate) 10 mcg (Polyribosylribitol 12 mcg Conjugate to Tetanus protein 22-36 mcg 25 mcg 25 mcg 40 D antigen units Type II (MEF-1) strain" Type III (Saukett) strain1 8 D antigen units 32 D antigen units 'adsorbed on aluminium hydroxide, hydrated (Al(OH)3) 2produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology 3adsorbed on aluminium phosphate (AIPO4) *propagated in VERO cells Suspension for Injection (IM) Prescription Drug (RX) Vaccines Sanofi Pasteur France Renewal 04 September 2023 29 August 2028
View BR-920 Filgrastim (Recombinant Human Granulocyte Colony Stimulating Factor) White-C 300 mcg/mL Solution For Injection Prescription Drug (RX) Hematopoietic Growth Factor Shandong Kexing Bioproducts Co., Ltd. China Renewal 27 December 2018 03 September 2028
View BR-921 Human Rabie Immunoglobulin H-Ryg 100IU/mL Solution For Injection (IM) Prescription Drug (RX) Immunoglobulin Sichuan Yuanda Shuyang Pharmaceutical Co., Ltd. China Automatic Renewal 07 January 2022 03 September 2026
View BR-922 Human Tetanus Immunoglobulin H-Tyg 100IU/mL Solution For Injection (IM) Prescription Drug (RX) Immunoglobulins Sichuan Yuanda Shuyang Pharmaceutical Co., Ltd. China Automatic Renewal 07 January 2022 03 September 2026
View BR-923 Japanese Encephalitis Vaccine (Live, Attenuated) Imojev Formulation: After reconstitution, one dose (0.5 mL) contains 4.0-5.8 log Plaque Forming Units (PFU) live, attenuated, recombinant Japanese Encephalitis Virus. Powder for Suspension for Injection (SC) Prescription Drug (RX) - Government Pharmaceutical Organization - Merieux Biological Products Co., Ltd. Thailand Initial (Variation) 13 July 2022 13 July 2027
View BR-924_PI_01.pdf BR-924 Meningococcal Groups A, C, W-135 and Y Conjugate Vaccine Nimenrix Formulation: After reconstitution, each dose (0.5 mL) contains: Neisseria meningitidis group A polysaccharide* Neisseria meningitidis group C polysaccharide* Neisseria meningitidis group W-135 polysaccharide* Neisseria meningitidis group Y polysaccharide* 5 mcg 5 mcg 5 mcg 5 mcg * conjugated to tetanus toxoid carrier protein 44 mcg Lyophilized Powder for Solution for Injection (IM) Prescription Drug (Rx) - Pfizer Manufacturing Belgium NV Belgium Initial (Variation) 03 August 2022 03 August 2027
View BR-925 Human Papillomavirus Vaccine [Types 16 and 18] (Recombinant, adjuvanted, adsorbed) Cervarix Formulation: 1 dose (0.5 mL) contains: Human Papillomavirus type 16 L1 protein*. Human Papillomavirus type 18 L1 protein*. .20 mcg ...... 20 mcg *adjuvanted by AS04 containing 3-O-desacyl-4'-monophosphoryl lipid A (MPL) and Aluminum hydroxide, hydrated [Al(OH)3] Suspension for Injection (IM) Prescription Drug (RX) Vaccine GlaxoSmithKline Biologicals SA Belgium Renewal (Reconstruction) 22 February 2024 23 March 2027