| View |
|
BRP-131
|
Trastuzumab
|
Herticad
|
150 mg
|
Powder for Concentrate for Solution for Infusion
|
Monoclonal Antibodies
|
Joint Stock Company Biocad
|
Russia
|
Initial (Reapplication)
|
09 November 2023
|
09 November 2028
|
| View |
|
BRP-132
|
Trastuzumab
|
Herthix
|
150 mg
|
Lyophilized Powder for Solution for Infusion (IV)
|
-
|
Reliance Life Sciences Pvt. Ltd.
|
India
|
Initial
|
25 January 2024
|
25 January 2029
|
| View |
|
BRP-132-01
|
Trastuzumab
|
Valen
|
150 mg
|
Lyophilized Powder for Solution for Infusion (IV)
|
Monoclonal Antibodies
|
Reliance Life Sciences Pvt. Ltd
|
India
|
CLIDP Conversion
|
08 July 2024
|
25 January 2029
|
| View |
|
BRP-132-02
|
Trastuzumab
|
Sadia
|
150 mg
|
Lyophilized Powder for Solution for Infusion (IV)
|
Monoclonal Antibodies
|
Reliance Life Sciences Pvt. Ltd.
|
India
|
CLIDP Conversion
|
08 July 2024
|
25 January 2029
|
| View |
|
BRP-132-03
|
Trastuzumab
|
None
|
150 mg
|
Lyophilized Powder for Solution for Infusion (IV)
|
Monoclonal Antibodies
|
Reliance Life Sciences Pvt. Ltd.
|
India
|
CLIDP Conversion
|
06 August 2024
|
25 January 2029
|
| View |
|
BRP-133
|
Trastuzumab
|
Herthix
|
440 mg
|
Lyophilized Powder for Solution for Infusion (IV)
|
-
|
Reliance Life Sciences Pvt. Ltd.
|
India
|
Initial
|
25 January 2024
|
25 January 2029
|
| View |
|
BRP-133-01
|
Trastuzumab
|
None
|
440 mg
|
Lyophilized Powder for Solution for Infusion (IV)
|
Monoclonal Antibodies
|
Reliance Life Sciences Pvt. Ltd.
|
India
|
CLIDP Conversion
|
11 August 2024
|
25 January 2029
|
| View |
|
BRP-134
|
Trastuzumab
|
Trastumed
|
150 mg
|
Lyophilized Powder for Solution for Infusion (IV)
|
-
|
Reliance Life Sciences Pvt. Ltd.
|
India
|
Initial
|
25 January 2024
|
25 January 2029
|
| View |
|
BRP-135
|
Trastuzumab
|
Trastumed
|
440 mg
|
Lyophilized Powder for Solution for Infusion (IV)
|
-
|
Reliance Life Sciences Pvt. Ltd.
|
India
|
Initial
|
25 January 2024
|
25 January 2029
|
| View |
|
BRP-136
|
Heparin Sodium
|
Nuparin
|
1000 IU/mL (5000 IU/5 mL)
|
Solution for Injection (IV/SC)
|
Antithrombotic Agents
|
Troikaa Pharmaceuticals Limited
|
India
|
-
|
07 February 2024
|
10 May 2029
|
| View |
|
BRP-136-01
|
Heparin (as sodium)
|
Hemolate
|
1000 I.U./ml (5000 I.U./5ml)
|
Solution for Injection (I.V./S.C.)
|
Antithrombotic Agents
|
Troikaa Pharmaceuticals Ltd.
|
India
|
CLIDP Conversion
|
30 June 2024
|
10 May 2029
|
| View |
|
BRP-139
|
Diphtheria and Tetanus Vaccine (Adsorbed)
|
None
|
Formulation:
Each dose (0.5 mL) contains:
Diphtheria Toxoid- 2 Lf (30 IU)
Tetanus Toxoid-7.5 Lf (40 IU)
Aluminum phosphate*-1.5 mg
Thiomersal*-0.05 mg
|
Suspension For Injection (IM)
|
Biologicals/ Vaccines
|
PT. Biofarma (Persero)
|
Indonesia
|
Initial
|
27 May 2024
|
27 May 2029
|
| View |
|
BRP-140
|
Diphtheria and Tetanus Vaccine (Adsorbed)
|
None
|
Formulation:
Each dose (0.5 mL) contains:
Diphtheria Toxoid -2 Lf (30 IU)
Tetanus Toxoid -7.5 Lf (40 IU).
Aluminum phosphate*-1.5 mg
Thiomersal*- 0.05 mg
*Aluminum phosphate and Thiomersal, used as an adjuvant and a preservative, respectively.
|
Suspension For Injection (IM)
|
Vaccines
|
PT. Biofarma (Persero)
|
Indonesia
|
Initial
|
30 May 2024
|
30 May 2029
|
| View |
|
DDRP-10662
|
Amoxicillin (As Trihydrate)
|
Vaxman
|
100 mg/mL
|
Powder for Suspension (Oral Drops)
|
Antibacterial (Penicillin)
|
J.M. Tolmann Laboratories, Inc.
|
Philippines
|
Automatic Renewal
|
13 May 2023
|
03 June 2028
|
| View |
|
DHRH-898
|
Carbocisteine
|
Fluifort-M
|
50 mg/mL
|
Suspension (Oral Drops)
|
Mucolytic
|
Lloyd Laboratories, Inc
|
Philippines
|
-
|
06 September 2022
|
25 October 2027
|
| View |
|
DMRO-75
|
Medical Grade Oxygen
|
None
|
N/A
|
N/A
|
None
|
Linde Philippines, Inc.
|
Philippines
|
-
|
01 July 2021
|
05 September 2026
|
| View |
|
DMRO-98
|
Medical Grade Oxygen
|
REI
|
None
|
Medical Gas
|
-
|
Ruakh Enterprises, Inc.
|
Philippines
|
Initial
|
24 October 2023
|
24 October 2028
|
| View |
|
DP-8507-01
|
Metronidazole
|
Merozol-IV
|
5mg/mL (500mg/100mL)
|
Solution for I.V. Infusion
|
-
|
AXA PARENTERALS LTD.
|
India
|
-
|
29 July 2021
|
22 October 2024
|
| View |
|
DPP-13902
|
Citicoline (as sodium)
|
Citisaph-500
|
500 mg
|
FIlm- Coated Tablet
|
-
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
15 May 2023
|
15 May 2028
|
| View |
|
DPR-089
|
Ramipril
|
Tritace
|
2.5 mg
|
Tablet
|
-
|
PT. Aventis Pharma
|
Indonesia
|
-
|
16 September 2019
|
27 October 2024
|