| View |
|
BR-869
|
Human Rabies Immunoglobulin
|
Berirab P
|
300 IU/2 mL (150 IU/mL)
|
Solution for Injection (IM)
|
-
|
CSL Behring GmbH
|
Germany
|
-
|
27 April 2022
|
04 June 2027
|
| View |
|
BR-870
|
Filgrastim (Recombinant Granulocyte Colony-Stimulating Factor [Rhu-Gcsf])
|
Scilocyte
|
300 mcg/mL
|
Solution For Injection (Sc/IV)
|
Hematopoietic Growth Factor
|
Intas Pharmaceuticals Limited (Biopharma Division)
|
India
|
Renewal
|
27 June 2022
|
29 June 2027
|
| View |
|
BR-871
|
Follitropin Alfa
|
Gonal-F
|
1,050 IU/1.75 mL (77 mcg/1.75 mL)
|
Lyophilized Powder for Solution for Injection (S.C.)
|
-
|
Merck Serono S.p.A
|
Italy
|
-
|
18 March 2022
|
26 July 2027
|
| View |
|
BR-874
|
Human Normal Immunoglobulin (Igiv)
|
Humoglob
|
50mg/mL
|
Solution For Injection (Iv Infusion)
|
Immune sera and Immunoglobulin
|
SK Plasma Co. Ltd.
|
Korea
|
Automatic Renewal
|
06 September 2022
|
11 September 2027
|
| View |
|
BR-875
|
Cholera Vaccine (Inactivated, Oral)
|
Shanchol
|
Multicomponent/1.5mL
|
Oral Suspension
|
-
|
Sanofi Healthcare India Private Limited
|
India
|
Renewal
|
29 December 2022
|
28 September 2027
|
| View |
|
BR-877
|
Live Measles, Mumps and Rubella Vaccine
|
M-M-R II
|
Formulation: After reconstitution, one dose (0.5 mL) contains: Measles virus? Enders' Edmonston strain (live, attenuated).. Mumps virus! Jeryl Lynn TM (B Level) strain (live, attenuated) ...... Rubella virus? Wistar RA 27/3 strain (live, attenuated) ....
....
..
.NLT 1,000 CCID 50 ..NLT 12,500 CCID 50 ....NLT 1,000 CCID 50
() Produced in chick embryo cells. (2) Produced in WI-38 human diploid lung fibroblasts.
|
Lyophilized Powder for Injection (IM/SC)
|
-
|
Merck Sharp and Dohme Corp.
|
USA
|
Renewal
|
09 August 2022
|
24 July 2027
|
| View |
|
BR-879
|
Somatropin
|
Saizen
|
20 mg/ 2.5 mL (8 mg/mL)
|
Solution For Injection (SC)
|
-
|
Merck Serono S.P.A
|
Italy
|
Renewal
|
07 September 2022
|
05 November 2027
|
| View |
|
BR-880
|
Somatropin
|
Saizen
|
6 mg/ 1.03 mL (5.83 mg/mL)
|
Solution For Injection (SC)
|
-
|
Merck Serono S.P.A
|
Italy
|
Renewal
|
07 September 2022
|
05 November 2027
|
| View |
|
BR-881
|
Recombinant Human Epidermal Growth Factor
|
Easyef
|
50mcg/mL (0.005%w/v)
|
Topical Solution (Spray)
|
-
|
Daewoong Pharmaceutical Co., Ltd.
|
Korea
|
-
|
17 February 2021
|
20 November 2025
|
| View |
|
BR-884
|
Clostridium botulinum neurotoxin type A
|
Retox
|
100 units
|
Lyophilized Powder for Injection (IM)
|
-
|
Hugel, Inc.
|
Korea
|
-
|
26 February 2021
|
29 November 2024
|
| View |
|
BR-885
|
Measles, Mumps and Rubella Vaccine (Live, Attenuated)
|
None
|
Formulation
Each dose (0.5 mL) contains:
Measles Virus (Edmonston-Zagreb Strain)....NLT 1000 CCID50 Mumps Virus (Leningrad-Zagreb Strain).......NLT 5000 CCID 50 Rubella Virus (Wistar RA 27/3 Strain)..NLT 1000 CCID 50
|
Lyophilized Powder for Injection (SC)
|
-
|
Serum Institute of India Pvt., Ltd.
|
India
|
Initial (Variation)
|
11 November 2022
|
11 November 2027
|
| View |
|
BR-893
|
Alglucosidase alfa
|
Myozyme
|
50 mg
|
Powder For Concentrate For Solutions For Infusion (IV)
|
-
|
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)
|
-
|
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)
|
Immunoglobulin
|
Green Cross Corp.
|
Korea
|
BR-897
|
20 February 2023
|
04 April 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)
|
-
|
Pfizer Manufacturing Belgium NV
|
Belgium
|
-
|
21 April 2021
|
04 April 2026
|
| 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)
|
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)
|
-
|
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)
|
-
|
Celltrion, Inc. (Plant 2)
|
Korea
|
Renewal (Correction)
|
02 August 2023
|
14 May 2028
|
| View |
|
BR-909
|
Enoxaparin Sodium
|
Enoclex
|
60mg/0.6mL
|
Solution For Injection (SC)
|
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 )
|
VACCINE
|
Serum Institute of India Ltd.
|
India
|
Renewal
|
21 March 2023
|
21 May 2028
|