| View |
|
BR-1438
|
Candesartan
|
Torcand-32
|
32 mg
|
Tablet
|
-
|
Baxter AG
|
Austria
|
Monitored Release
|
08 February 2023
|
08 February 2028
|
| View |
BR-1439_PI_01.pdf
|
BR-1439
|
Amivantamab
|
Rybrevant
|
350 mg/7 mL (50mg/mL)
|
Concentrate For Solution For Infusion (IV)
|
-
|
Cilag AG
|
Switzerland
|
Monitored Release
|
17 February 2023
|
17 February 2028
|
| View |
|
BR-1440
|
Bacterial Lysate
|
Broncho-Vaxom
|
7 mg
|
Capsule
|
Other Respiratory System Products
|
OM Pharma S.A. Meyrin
|
Switzerland
|
Automatic Renewal
|
14 April 2023
|
05 June 2028
|
| View |
BR-1441_PI_01.pdf
|
BR-1441
|
Herpes Zoster Vaccine (recombinant, adjuvanted)
|
Shingrix
|
Formulation:
After reconstitution, one dose (0.5 mL) contains:
Varicella Zoster Virus' glycoprotein E antigen23 50 micrograms.
Varicella Zoster Virus = VZV
2adjuvanted with AS01B containing plant extract Quillaja saponaria Molina, fraction 21 (QS-21) 50 micrograms
and
3-O-desacyl-4'-monophosphoryl lipid A (MPL) from Salmonella minnesota 3glycoprotein E (gE) produced in Chinese Hamster Ovarian (CHO) cells by recombinant DNA technology 50 micrograms
|
Powder and Suspension for Suspension for Injection (IM)
|
-
|
GlaxoSmithKline Biologicals S.A.
|
Belgium
|
Monitored Release (MR) (Re-application)
|
02 May 2023
|
02 May 2028
|
| View |
|
BR-1442
|
Oral Poliomyelitis Vaccine (Types 1 and 3)[ Live, Attenuated]
|
None
|
Formulation:
Each dose of 2 drops (0.1 mL) contains live attenuated poliomyelitis virus (Sabin strain).:
Type 1 ≥106.0CCID50 Type 3 ≥105.8CCID50
|
Solution for Oral Administration
|
Vaccines
|
Serum Institute of India Pvt. Ltd.
|
India
|
Monitored Release (MR) [Reconstruction]
|
07 February 2024
|
25 May 2028
|
| View |
|
BR-1443
|
Factor VIII Inhibitor Bypassing Activity
|
Feiba
|
1000 U/20 mL (50 U/mL)
|
Powder for Solution for
Infusion (IV)
|
-
|
Baxter AG
|
Austria
|
Monitored Release
|
19 June 2023
|
19 June 2028
|
| View |
BR-1444_PI_01.pdf
|
BR-1444
|
Tozinameran/Famtozinameran
|
Comirnaty Original/Omicron B.A.4-5
|
15 mcg/15 mcg/0.3mL
|
Dispersion For Injection (IM)
|
-
|
Pfizer, Inc.
|
Belgium
|
Monitored Release (MR)
|
08 June 2023
|
08 June 2028
|
| View |
|
BR-1445
|
Powder for Solution for
Infusion (IV)
|
Feiba
|
2500 U/50 mL (50 U/mL)
|
Powder for Solution for
Infusion (IV)
|
-
|
Baxter AG
|
Austria
|
Monitored Release
|
19 June 2023
|
19 June 2028
|
| View |
|
BR-1446
|
Rituximab
|
Acellbia
|
100 mg/ 10 mL (10 mg/mL)
|
Concentrate For Solution For Infusion (Iv)
|
-
|
Joint Stock Company BIOCAD
|
Russia
|
Initial
|
30 June 2023
|
30 June 2028
|
| View |
|
BR-1447
|
Rituximab
|
Acellbia
|
500 mg/50 mL (10 mg/mL)
|
Concentrate For Solution For Infusion (Iv)
|
-
|
Joint Stock Company BIOCAD
|
Russia
|
Initial
|
30 June 2023
|
30 June 2028
|
| View |
|
BR-1448
|
Rotavirus Vaccine (Live, Attenuated)
|
Rotarix
|
NLT 106.0 CCID50/1.5 mL
|
Oral Suspension
|
-
|
GlaxoSmithKline Biologicals SA (GSK Biolpgicals)
|
Belgium
|
Initial
|
18 August 2023
|
18 August 2028
|
| View |
|
BR-1449
|
Human Placental Extract
|
Laennec
|
112 mg/2 mL
|
Solution for Injection (I.M./S.C.)
|
-
|
Japan Bio Products Co., Ltd. (L'Atelier Fujimitsu)
|
Japan
|
Monitored Release (Reapplication)
|
02 October 2023
|
02 October 2028
|
| View |
|
BR-1450
|
Heparin Sodium
|
Unihepa
|
5,000 I.U./mL (25,000 I.U./5mL)
|
Solution for Injection (IV/SC)
|
Anticoagulant
|
Duopharma (M) Sdn. Bhd.
|
Malaysia
|
Renewal
|
23 October 2023
|
03 February 2029
|
| View |
|
BR-1451
|
Pneumococcal Polysaccharide Conjugate Vaccine, 13-
Valent (Adsorbed)
|
Pneumocon-13
|
Each dose (0.5 mL) contains the capsular polysaccharide of the following Streptococcus pneumoniae serotypes:
Pneumococcal Polysaccharide Serotype 6B
Pneumococcal Polysaccharide Serotype 18C
Pneumococcal Polysaccharide Serotype 4, 23F
Pneumococcal Polysaccharide Serotype 7F
Pneumococcal Polysaccharide Serotype 14, 19F
Pneumococcal Polysaccharide Serotype 1, 19A
6.0 με 3.25 μg
3.0 με
2.85 με
- 2.75 με
2.6 με
Pneumococcal Polysaccharide Serotype 3, 5, 6A, 9V Conjugated to Tetanus Toxoid carrier protein
2.5 με 41-150 με
|
Suspension for Injection (IM)
|
-
|
Yuxi Walvax Biotechnology Co., Ltd.
|
China
|
Monitored Release (MR) [Reapplication]
|
03 November 2023
|
03 November 2028
|
| View |
|
BR-1452
|
Pneumococcal Polysaccharide Conjugate Vaccine, 13-
Valent (Adsorbed)
|
Pneumocon 13
|
Each dose (0.5 mL) contains the capsular polysaccharide of the following Streptococcus pneumoniae serotypes: Pneumococcal Polysaccharide Serotype 6B
Pneumococcal Polysaccharide Serotype 18C
Pneumococcal Polysaccharide Serotype 4, 23F
Pneumococcal Polysaccharide Serotype 7F Pneumococcal Polysaccharide Serotype 14, 19F Pneumococcal Polysaccharide Serotype 1, 19A Pneumococcal Polysaccharide Serotype 3, 5, 6A, 9V
Conjugated to Tetanus Toxoid carrier protein
6.0 με
3.25 μg
3.0 με
2.85 μg
2.75 μg
2.6 μg
|
Suspension for Injection (IM)
|
-
|
Yuxi Walvax Biotechnology Co., Ltd.
|
China
|
Monitored Release (MR) [Reapplication]
|
03 November 2023
|
03 November 2028
|
| View |
|
BR-1453
|
Pneumococcal Polysaccharide Vaccine, 23-Valent
|
Pneumops 23
|
25ug/0.5ml Prefilled Syringe
|
Solution for injection (IM/SC)
|
-
|
Yuxi Walvax Biotechnology Co., Ltd.
|
China
|
Monitored Release (MR) [Correction]
|
09 January 2024
|
03 November 2028
|
| View |
|
BR-1454
|
Clostridium botulinum Toxin Type A
|
Botitox Up
|
100 Units
|
Lyophilized Powder for Solution for Injection
(IM)
|
-
|
Huons Biopharma Co., Ltd.
|
Korea
|
Initial (Reapplication)
|
07 November 2023
|
07 November 2028
|
| View |
|
BR-1455
|
Respiratory Syncytial Virus Vaccine (Recombinant, Adjuvanted)
|
Arexvy
|
120 mcg
|
Powder for Suspension for Injection (IM)
|
-
|
GlaxoSmithKline Biologicals SA
|
Belgium
|
Monitored Release (MR)
|
22 November 2023
|
22 November 2028
|
| View |
|
BR-1456
|
Insulin Aspart
|
Kirsty
|
100 Units/mL (equivalent to 3.5 mg/mL)
|
Solution for Injection (SC)
|
-
|
Biocon Sdn BHD
|
Malaysia
|
Initial
|
28 November 2023
|
28 November 2028
|
| View |
|
BR-1457
|
Insulin Aspart
|
Kirsty
|
100 Units/mL (equivalent to 3.5 mg/mL)
|
Solution for Injection (SC)
|
-
|
Biocon Sdn BHD
|
Malaysia
|
Initial
|
28 November 2023
|
28 November 2028
|