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BRP-109_PI_01.pdf
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BRP-109
|
Epoetin Alfa
|
Wepox 4000
|
4,000 IU/mL
|
Solution for Injection (IV/SC)
|
-
|
Wockhardt Ltd
|
India
|
-
|
24 June 2022
|
21 April 2025
|
| View |
BRP-109-01_PI_01.pdf
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BRP-109-01
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Epoetin Alfa
|
Epo-Ace
|
4,000 IU/mL
|
Solution for Injection (IV/SC)
|
Antianemic Preparations
|
Wockhardt Ltd.
|
India
|
Renewal
|
26 July 2024
|
21 April 2030
|
| View |
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BRP-110
|
Rituximab
|
Rixathon
|
500 mg/50 mL (10mg/mL)
|
Concentrate For Solution For Infusion (IV)
|
-
|
Lek Pharmaceuticals D.D
|
Slovenia
|
Initial
|
27 June 2022
|
27 June 2027
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| View |
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BRP-111
|
Rituximab
|
Rixathon
|
100 mg/10 mL (10mg/mL)
|
Concentrate For Solution For Infusion (IV)
|
-
|
Lek Pharmaceuticals D.D
|
Slovenia
|
Initial
|
27 June 2022
|
27 June 2027
|
| View |
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BRP-112
|
Trastuzumab
|
Ogivri
|
150 mg
|
Lyophilized Powder for Concentrate for Solution
for Infusion (IV)
|
Monoclonal Antibodies (HER2 Inhibitors)
|
Biocon Biologics India Limited
|
India
|
Initial (Re-application)
|
22 July 2022
|
22 July 2027
|
| View |
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BRP-113
|
Trastuzumab
|
Ogivri
|
420 mg
|
Lyophilized Powder for Concentrate for Solution
for Infusion (IV)
|
Monoclonal Antibodies (HER2 Inhibitors)
|
Biocon Biologics India Limited
|
India
|
Initial (Re-application)
|
22 July 2022
|
22 July 2027
|
| View |
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BRP-114
|
Lactobacillus gasseri + Lactobacillus rhamnosus
|
Ecovag
|
Hard Vaginal Capsule
|
|
-
|
Deerland Probiotics & Enzymes A/S
|
Denmark
|
PCPR Conversion
|
16 August 2022
|
20 September 2026
|
| View |
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BRP-115
|
Filgrastim
|
Topneuter
|
300mcg/mL
|
Solution for Injection (IV/SC)
|
-
|
Xiamen Amoytop Biotech Co., Ltd.
|
China
|
-
|
01 September 2022
|
24 August 2026
|
| View |
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BRP-115-01
|
Filgrastim
|
Filgria
|
300 mcg/mL
|
Solution for Injection (IV/SC)
|
Immunostimulant
|
Xiamen Amoytop Biotech Co., Ltd
|
China
|
CLIDP Conversion
|
12 October 2022
|
24 August 2026
|
| View |
|
BRP-116
|
Filgrastim
|
Topneuter
|
150 mcg/mL
|
Solution for Injection (IV/SC)
|
-
|
Xiamen Amoytop Biotech Co., Ltd.
|
China
|
PCPR Conversion
|
03 October 2022
|
24 August 2026
|
| View |
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BRP-117
|
Urofollitropin
|
Endogen HP
|
75 IU
|
Lyophilized Powder for Solution for Injection
|
-
|
Sanzyme (P) Ltd.
|
India
|
PCPR Conversion
|
30 January 2023
|
11 April 2027
|
| View |
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BRP-118
|
Menotrophin
|
Gynogen HP
|
75 IU
|
Lyophilized Powder for Solution for Injection
|
-
|
Sanzyme (P) Ltd.
|
India
|
PCPR Conversion
|
30 December 2022
|
11 April 2027
|
| View |
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BRP-119
|
Human Chorionic Gonadotrophin
|
Pubergen
|
5000 IU
|
Lyophilized Powder for Injection (IM)
|
-
|
Sanzyme (P) Ltd.
|
India
|
PCPR Conversion
|
30 December 2022
|
11 April 2027
|
| View |
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BRP-120
|
Trastuzumab
|
Ogivri
|
420 mg
|
Powder for Concentrate for Solution for Infusion (IV)
|
-
|
Biocon Biologics India Limited
|
India
|
Initial
|
24 January 2023
|
24 January 2028
|
| View |
|
BRP-122
|
Bevacizumab
|
Bonmab
|
100 mg/4 mL (25 mg/ mL)
|
Concentrate for Solution for
Infusion (IV)
|
-
|
Joint Stock Company Biocad
|
Russia
|
Initial (Re-Application)
|
03 April 2023
|
03 April 2028
|
| View |
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BRP-123
|
Bevacizumab
|
Bonmab
|
400 mg/16 mL (25 mg/mL)
|
Concentrate for Solution for
Infusion (IV)
|
-
|
Joint Stock Company Biocad
|
Russia
|
Initial (Re-Application)
|
03 April 2023
|
03 April 2028
|
| View |
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BRP-124
|
Insulin Human (rDNA)
|
Scilin M30
|
30% Soluble Insulin + 70% Isophane Insulin 100 IU/mL
|
Suspension for Injection (SC)
|
Insulins and Analogues
|
Bioton S.A.
|
Poland
|
Renewal
|
07 April 2024
|
05 April 2029
|
| View |
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BRP-1263
|
Adsorbed Diphtheria-Tetanus-Pertussis-Hepatitis B (rDNA) and Haemophilus influenzae type b conjugate vaccine
|
Eupenta
|
[see reverse]
|
Solution for IM Injection
|
-
|
LG Chem Ltd.
|
Korea
|
Automatic Renewal
|
03 January 2023
|
13 March 2028
|
| View |
|
BRP-1264
|
Adsorbed Diphtheria-Tetanus-Pertussis-Hepatitis B (rDNA) and Haemophilus influenzae type b conjugate vaccine
|
Eupenta
|
0.5mL
|
Solution for IM Injection
|
-
|
LG Chem Ltd.
|
Korea
|
Automatic Renewal
|
04 January 2023
|
13 March 2028
|
| View |
|
BRP-130
|
Trastuzumab
|
Herticad
|
440 mg
|
Powder for Concentrate for Solution for Infusion.
|
Monoclonal Antibodies
|
Joint Stock Company Biocad
|
Russia
|
Initial (Reapplication)
|
09 November 2023
|
09 November 2028
|