| View |
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BR-1375
|
Bevacizumab
|
Zirabev
|
100 mg/4 mL (25 mg/mL)
|
Concentrate For Solution For I.V. Injection
|
-
|
Pharmacia and Upjohn Company LLC
|
United States of America
|
Initial
|
19 October 2021
|
19 October 2026
|
| View |
|
BR-1376
|
Bevacizumab
|
Zirabev
|
400 mg/16 mL (25 mg/mL)
|
Concentrate For Solution For I.V. Injection
|
-
|
Pharmacia and Upjohn Company LLC
|
United States of America
|
Initial
|
19 October 2021
|
19 October 2026
|
| View |
|
BR-1377
|
Trastuzumab
|
Trazimera
|
150 mg
|
Powder for Concentrate for Solution for Infusion (IV)
|
-
|
Pfizer Manufacturing Belgium NV
|
Belgium
|
-
|
16 November 2021
|
16 November 2026
|
| View |
|
BR-1379
|
Inactivated Poliomyelitis Vaccine (Types 1, 2 And 3)
|
Poliovac
|
See Formulation on the reverse side
|
Suspension For Injection (Im/Sc)
|
-
|
Serum Institute of India Private Limited
|
India
|
Initial (Variation)
|
13 July 2023
|
13 July 2028
|
| View |
|
BR-1380
|
Human Immunoglobulin
|
Pentaglobin
|
50 mg/ mL
|
Solution for Infusion (IV)
|
-
|
Biotest AG
|
Germany
|
-
|
16 November 2021
|
16 November 2026
|
| View |
|
BR-1381
|
Calfactant
|
Infasurf
|
35 mg/mL
|
Intratracheal Suspension
|
-
|
ONY Biotech Inc.
|
United States of America
|
Initial (correction)
|
29 July 2022
|
23 November 2026
|
| View |
BR-1382_PI_01.PDF
|
BR-1382
|
Moroctocog Alfa
|
Xyntha
|
250 IU
|
Lyophilized Powder for Injection (IV)
|
-
|
Wyeth Farma, S.A.
|
Spain
|
-
|
10 December 2021
|
10 December 2026
|
| View |
BR-1383_PI_01.PDF
|
BR-1383
|
Moroctocog Alfa
|
Xyntha
|
500 IU
|
Lyophilized Powder for Injection (IV)
|
-
|
Wyeth Farma, S.A.
|
Spain
|
-
|
10 December 2021
|
10 December 2026
|
| View |
|
BR-1384
|
Cholera Vaccine (Inactivated, Oral)
|
Euvichol-Plus
|
Formulation Each dose (1.5 mL), contains
Vibrio cholerae 01 Inaba Cairo 48 classical biotype, Heat inactivated Vibrio cholerae 01 Inaba Phil 6973 El Tor biotype, Formalin inactivated Vibrio cholerae 01 Ogawa Cairo 50 classical biotype, Formalin inactivated Vibrio cholerae 01 Ogawa Cairo 50 classical biotype, Heat inactivated Vibrio cholerae 0139 4260B, Formalin inactivated
300 LEU* 600 LEU* 300 LEU* 300 LEU* 600 LEU*
*LEU: Lipopolysaccharide ELISA Units
|
Oral Suspension
|
-
|
Eubiologici Co., Ltd
|
Korea
|
-
|
31 December 2021
|
31 December 2026
|
| View |
|
BR-1385
|
Bevacizumab
|
Avamab
|
400 mg/16 mL (25 mg/mL)
|
Concentrate for Solution for Infusion (IV)
|
-
|
Sinergium Biotech S.A.
|
Argentine Republic
|
-
|
02 February 2022
|
02 February 2027
|
| View |
|
BR-1386
|
Bevacizumab
|
Avamab
|
100 mg/4 mL (25 mg/mL)
|
Concentrate for Solution for Infusion (IV)
|
-
|
Sinergium Biotech S.A.
|
Argentine Republic
|
-
|
02 February 2022
|
02 February 2027
|
| View |
|
BR-1388
|
Meningococcal Group A, C, W-135 and Y Conjugate
Vaccine
|
Menquadfi
|
Formulation: Each dose (0.5 mL) contains: Neisseria meningitidis group A polysaccharide* .... 10 mcg Neisseria meningitidis group C polysaccharide* .... 10 mcg Neisseria meningitidis group Y polysaccharide* .... 10 mcg Neisseria meningitidis group W-135 polysaccharide* .... 10 mcg *Conjugated to Tetanus Toxoid carrier protein... 55 mcg** **Tetanus Toxoid quantity is approximate and dependent on the polysaccharide to protein ratio for the conjugates in each formulation
|
Solution for Injection (IM)
|
-
|
Sanofi Pasteur
|
United States of America
|
Monitored Release
|
04 March 2022
|
04 March 2027
|
| View |
BR-1389_PI_01.pdf
|
BR-1389
|
Insulin Degludec
|
Tresiba Flextouch
|
100 Units/mL
|
Solution for Injection (SC)
|
-
|
Novo Nordisk Production SAS
|
France
|
Initial (Variation)
|
23 November 2023
|
23 November 2028
|
| View |
BR-1390_PI_01 NO RX SYMBOL.pdf
|
BR-1390
|
Romosozumab
|
Evenity
|
105 mg/ 1.17 mL
|
Solution for Injection (SC)
|
-
|
Patheon Italia S.p.A
|
Italy
|
Monitored Release (MR)
|
29 March 2022
|
29 March 2025
|
| View |
|
BR-1391
|
Heparin Sodium
|
Avirin
|
1,000 IU/mL
|
Solution for Injection (IV/SC)
|
-
|
2 World Laboratories
|
India
|
-
|
30 March 2022
|
11 August 2026
|
| View |
|
BR-1392
|
Rabies Vaccine (Inactivated)
|
Bioshoot
|
2.5 IU
|
Powder for Solution for Injection (IM)
|
-
|
Changchun Zhuoyi Biological Co., Ltd.
|
China
|
Initial
|
30 March 2022
|
30 March 2027
|
| View |
|
BR-1394
|
Trastuzumab
|
Trazimera
|
150 mg
|
Powder For Concentrate For Solution For Infusion (Iv)
|
-
|
Pfizer Manufacturing Belgium NV
|
Belgium
|
Initial (Variation)
|
08 August 2023
|
08 August 2028
|
| View |
|
BR-1395
|
Trastuzumab
|
Trazimera
|
440 mg
|
Powder For Concentrate For Solution For Infusion (Iv)
|
-
|
Pfizer Manufacturing Belgium NV
|
Belgium
|
Initial (Variation)
|
08 August 2023
|
08 August 2028
|
| View |
|
BR-1396
|
Polatuzumab vedotin
|
Polivy
|
140 mg
|
Powder for Concentrate for Solution for
Infusion (IV)
|
-
|
BSP Pharmaceuticals S.p.A.
|
Italy
|
Monitored Release
|
01 April 2022
|
01 April 2027
|
| View |
BR-1397_PI_01.pdf
|
BR-1397
|
Brolucizumab
|
Vsiqq
|
120 mg/mL (27.6 mg/0.23 mL)
|
Solution For Injection (Intravitreal)
|
-
|
Novartis Pharma Stein AG Technical Operations Schweiz, Stein Steriles
|
Switzerland
|
Monitored Release (Variation)
|
27 February 2023
|
27 February 2028
|