| View |
BR-1346_PI_01.pdf
|
BR-1346
|
Semaglutide
|
Ozempic
|
0.25 mg/0.19 mL (1.34 mg/mL)
|
Solution for Injection (SC)
|
Prescription Drug (RX)
|
Multiple dose. 1.5 mL Type I glass cartridge with chlorobutyl rubber plunger and aluminum cap with a laminated rubber sheet assembled in blue PDS290 pen injector + 6 Novofine Plus 32G 4 mm needles (Box of 1's)
|
Glucagon-like peptide (GLP-1) Analogues
|
Novo Nordisk A/S
|
Denmark
|
N/A
|
Novo Nordisk Pharmaceuticals (Philippines), Inc.
|
Novo Nordisk Pharmaceuticals (Philippines), Inc.
|
Monitored Release (Variation)
|
28 October 2022
|
28 October 2027
|
| View |
BR-1347_PI_01.pdf
|
BR-1347
|
Golimumab
|
Simponi
|
50 mg/0.5 mL
|
Solution For Injection (SC)
|
Prescription Drug (RX)
|
1 mL (Net content: 0.5 mL) Type I borosilicate glass syringe barrel with gray plunger stopper, fixed stainless steel needle and needle shield, assembled in a pen delivery device (Smartject) (Box of 1's)
|
-
|
Cilag AG
|
Switzerland
|
N/A
|
Johnson & Johnson (Philippines), Inc.
|
Johnson & Johnson (Philippines), Inc.
|
-
|
07 May 2021
|
07 May 2026
|
| View |
BR-1348_PI_01.pdf
|
BR-1348
|
Golimumab
|
Simponi Aria
|
50 mg/4 mL (12.5 mg/mL)
|
Solution For Injection (IV)
|
Prescription Drug (RX)
|
4 mL (Net content: 4 mL) Type I borosilicate clear glass vial with butyl rubber stopper, aluminum seal and a dark blue colored flip-off button (Box of 1’s)
|
-
|
Cilag AG
|
Switzerland
|
N/A
|
Johnson & Johnson (Philippines), Inc.
|
Johnson & Johnson (Philippines), Inc.
|
-
|
07 May 2021
|
07 May 2026
|
| View |
|
BR-1350
|
Pneumococcal Polysaccharide Conjugate Vaccine
(Adsorbed) (10-valent)
|
SII Pneumosil
|
Each dose (0.5 mL) contains:
Serotypes 1, 5, 9V, 14, 19A, 19F, 23F, 7F, 6A
2 mcg each
Serotype 6B
4 mcg
Conjugated to CRM197 carrier protein
Aluminum (as Aluminum phosphate)
0.125 mg
|
Suspension for Injection (IM)
|
Prescription Drug (RX)
|
Single dose. 2 mL USP Type I clear glass vial with grey butylated rubber stopper capped with aluminum seal and burgundy polypropylene flip-off cap (Box of 1's, 10's, and 50's) [Net content 0.5 mL]
|
Vaccines
|
Serum Institute of India Private Limited
|
India
|
|
Faberco Life Sciences Inc.
|
Faberco Life Sciences Inc.
|
Initial (Variation)
|
26 February 2024
|
26 February 2029
|
| View |
|
BR-1351
|
Pneumococcal Polysaccharide Conjugate Vaccine.
(Adsorbed) (10-valent)
|
SII Pneumosil
|
Each dose (0.5 mL) contains:
Serotypes 1, 5, 9V, 14, 19A, 19F, 23F, 7F, 6A
Serotype 6B
Conjugated to CRM197 carrier protein
Aluminum (as Aluminum phosphate)
Thiomersal
mcg each 4 mcg
0.125 mg 0.005%
|
Suspension for Injection (IM)
|
Prescription Drug (RX)
|
Multidose: 5 doses. 4 mL USP Type I clear glass vial with grey butylated rubber stopper capped with aluminum seal and burgundy polypropylene flip-off cap with vaccine vial monitor (VVM) (Box of 50's) [Net content 2.5 mL]
|
Vaccines
|
Serum Institute of India Private Limited
|
India
|
|
Faberco Life Sciences Inc.
|
Faberco Life Sciences Inc.
|
Initial (Variation)
|
26 February 2024
|
26 February 2029
|
| View |
|
BR-1352
|
Diphtheria, Tetanus, Pertussis (Whole Cell), Hepatitis
B (rDNA) and Haemophilus influenzae Type B Conjugate Vaccine (Adsorbed)
|
Combe Five
|
Each dose (0.5 mL) contains: Diphtheria toxoid ................... 25 Lf ( > 30 IU) Tetanus toxoid ...................... 5.5 Lf (> 60 IU) B. pertussis (whole cell) ........... 16 IOU ( >4 IU) Hepatitis B (rDNA) ................ 12.5 ug Purified capsular polysaccharide (PRP) of Hib covalently linked to 20 to 36.7 ug
of tetanus toxoid .... ............... 11 ug Alt+t (as AlPO4) ........ ............. <1.25 mg Thiomersal ............ ........... 0.01% w/v
|
Solution For Injection (I.M)
|
Prescription Drug (RX)
|
Multidose: 10 doses. 5 mL USP Type I glass vial with
grey bromobutyl rubber stopper and aluminum flip off seal with vaccine vial monitor (VVM) (Box of 24's) [Net content: 5 mL]
|
-
|
Biological E. Limited
|
India
|
N/A
|
IP Biotech, Inc.
|
IP Biotech, Inc.
|
-
|
08 June 2021
|
08 June 2026
|
| View |
|
BR-1353
|
Diphtheria, Tetanus, Pertussis (Whole Cell), Hepatitis
B (rDNA) and Haemophilus influenzae Type B
Conjugate Vaccine (Adsorbed)
|
Combe Five
|
Each dose (0.5 mL) contains: Diphtheria toxoid
25 Lf 30 IU) Tetanus toxoid....................... 5.5 Lf 60 IU) B. pertussis (whole cell ............ 16 IOU ( 4 IU) Hepatitis B (rDNA)................12.5 ug Purified capsular polysaccharide (PRP) of Hib covalently linked to 20 to 36.7 ug
of tetanus toxoid ..................11 ug Alt++ (as AlPO4)..................... 51.25 mg Thiomersal .......... 0.01% w/v
|
Suspension for Injection (IM)
|
Prescription Drug (RX)
|
Single dose. 3 mL USP Type I glass vial with grey
bromobutyl rubber stopper and aluminum flip-off seal with vaccine vial monitor (VVM) (Box of 48's) [Net content: 0.5 mL]
|
-
|
Biological E. Limited
|
India
|
N/A
|
IP Biotech, Inc.
|
IP Biotech, Inc.
|
-
|
08 June 2021
|
08 June 2026
|
| View |
|
BR-1354
|
Diphtheria-Tetanus Vaccine (Adsorbed, Reduced
Antigen Content)
|
BE Td
|
Each dose (0.5 mL) contains: Diphtheria toxoid- 2 Lf (>2 IU)
Tetanus toxoid- 8.8 Lf (>20 IU) Adsorbed on Aluminum Phosphate-> 1.5 mg Preservative: Thiomersal BP-0.01% w/v
|
Solution For Injection (I.M)
|
Prescription Drug (Rx)
|
Multidose: 10 doses. 5 mL USP Type I glass vial with grey bromobutyl rubber stopper capped with Turkish blue aluminum flip-off seal with vaccine vial monitor (VVM) (Box of 24's) [Net content: 5 mL]
|
Vaccines
|
Biological E. Limited
|
India
|
N/A
|
IP Biotech, Inc.
|
IP Biotech, Inc.
|
Initial
|
17 June 2021
|
17 June 2026
|
| View |
|
BR-1355
|
Diphtheria-Tetanus Vaccine (Adsorbed, Reduced
Antigen Content)
|
BE Td
|
Each dose (0.5 mL) contains: Diphtheria toxoid-2 Lf (>2 IU) Tetanus toxoid-8.8 Lf (>20 IU) Adsorbed on Aluminum Phosphate-> 1.5 mg Preservative: Thiomersal BP-0.01% w/v
|
Suspension for Injection (IM)
|
Prescription Drug (Rx)
|
Single dose. 3 mL USP Type I glass vial with grey bromobutyl rubber stopper capped with Turkish blue aluminum flip-off seal with vaccine vial monitor (VVM) (Box of 48's) [Net content: 0.5 mL]
|
-
|
Biological E. Limited
|
India
|
N/A
|
IP Biotech, Inc.
|
IP Biotech, Inc.
|
Initial
|
17 June 2021
|
17 June 2026
|
| View |
|
BR-1360
|
Human Blood Coagulation Factor VIII
|
Green-VIII Inj.
|
500 IU (25 IU/mL)
|
Lyophilized Powder for Solution
for Injection (IV)
|
Prescription Drug (RX)
|
Each box contains Type I glass vial enclosed with
chlorobutyl rubber stopper, crimped with aluminum seal and blue flip-off cap (powder) + Type I glass vial enclosed with chlorobutyl rubber stopper, crimped with aluminum seal and green flip-off cap (20 mL Water for Injection as diluent)
|
-
|
Green Cross Corp.
|
Korea
|
|
Vizcarra Pharmaceutical, Incorporated
|
Vizcarra Pharmaceutical, Incorporated
|
-
|
26 July 2021
|
26 July 2026
|
| View |
|
BR-1361
|
Human Coagulation Factor VIII
|
Green-VIII Inj.
|
250 IU (25 IU/mL) Lyophilized Powder for Solution for Injection (IV)
|
Lyophilized Powder for Solution for Injection (IV)
|
Prescription Drugs (RX)
|
Each box contains Types I glass viak enclosed with chlorobutyl rubber stopper, crimped with aluminum seal and light blue flip-off (powder) Type I glass vial enclosed with chlorobutyl rubber stopper, crimped with aluminum seal and red- flip-off cap (10 mL Waer for Injection as diluent)
|
-
|
Green Cross Corp.
|
Korea
|
|
Vizcarra Pharmaceutical, Incorporated
|
Vizcarra Pharmaceutical, Incorporated
|
-
|
26 July 2021
|
26 July 2026
|
| View |
|
BR-1363
|
Bacillus Calmette-Guerin (BCG) Vaccine
|
None
|
0.5mg/1.0 mL
|
Lyophilized Powder for Injection (ID)
|
Prescription Drug (RX)
|
Multidose: 10 doses. 1 mL in a 2 mL Type I amber
glass ampoule; 10 ampoules in a plastic tray (Box of 20's)
|
-
|
Institute of Vaccines and Medical Biologicals
|
Vietnam
|
|
Medical Vaccines Online Delivery
|
Medical Vaccines Online Delivery
|
Initial
|
05 August 2021
|
05 August 2026
|
| View |
BR-1364_PI_01.pdf
|
BR-1364
|
Insulin Aspart
|
Novomix 30 Flexpen
|
100 U/mL (3.5 mg/mL)
|
Suspension for Injection (SC) (30% Insulin Aspart and 70% Insulin Aspart Protamine)
|
Prescription Drug (RX)
|
3 mL EP Type I prefilled pen [Flexpen] (Box of 5's)
|
-
|
Novo Nordisk Production SAS
|
France
|
|
Novo Nordisk Pharmaceuticals (Philippines), Inc.
|
Novo Nordisk Pharmaceuticals (Philippines), Inc.
|
-
|
02 September 2021
|
02 September 2026
|
| View |
BR-1365_PI_01.pdf
|
BR-1365
|
Durvalumab
|
Imfinzi
|
120 mg/2.4 mL (50 mg/mL)
|
Cocentrate for Solution for IV Infusion
|
Prescription Drug (RX)
|
2.4 mL net content in 10 mL capacity Type I glass
vial with chlorobutyl rubber stopper and a dark gray flip-off aluminum seal (Box of l's)
|
-
|
Catalent Indiana, LLC
|
United States of America
|
|
AstraZeneca Pharmaceuticals (Phils.), Inc.
|
AstraZeneca Pharmaceuticals (Phils.), Inc.
|
Monitored Release (MR)
|
07 September 2021
|
07 September 2024
|
| View |
BR-1366-PI_01.pdf
|
BR-1366
|
Durvalumab
|
Imfinzi
|
500 mg/10 mL (50 mg/mL)
|
Cocentrate for Solution for IV Infusion
|
Prescription Drug (RX)
|
10 mL Type I glass vial with chlorobutyl rubber
stopper and a white flip-off aluminum seal (Box of 1's)
|
-
|
Catalent Indiana, LLC
|
United States of America
|
|
AstraZeneca Pharmaceuticals (Phils.), Inc.
|
AstraZeneca Pharmaceuticals (Phils.), Inc.
|
Monitored Release (MR)
|
07 September 2021
|
07 September 2024
|
| View |
|
BR-1367
|
Bovine Lung Surfactant
|
Newfactan
|
120 mg
|
Powder For Solution For Intratracheal Infusion
|
Prescription Drug (Rx)
|
USP Type I colorless glass vial with gray rubber
stopper and aluminum seal with blue flip-off cap (Box of 1's)
|
-
|
Yuhan Corporation
|
korea
|
|
Unimex, Inc.
|
Largen Med., Inc.
|
Renewal (Revalidation)
|
21 March 2023
|
28 December 2024
|
| View |
|
BR-1368
|
Human Normal Immunoglobulin
|
Eugamma SN 10% Inj.
|
5000 mg/50 mL (100 mg/mL)
|
Solution For Infusion IV
|
Prescription Drug (RX)
|
Type I Glass vial with Type I Chlorobutyl rubber stopper closed with a flip-off cap
|
-
|
Green Cross Corp.
|
Korea
|
|
Vizcarra Pharmaceutical, Incorporated
|
Vizcarra Pharmaceutical, Incorporated
|
-
|
08 September 2021
|
08 September 2026
|
| View |
|
BR-1369
|
Insulin Aspart
|
Novorapid Flexpen
|
100 units/mL (3.5mg/mL)
|
Solution For Injection (IV/SC)
|
Prescription Drug (RX)
|
3 mL EP Type I prefilled pen [Flexpen] (Box of 5's)
|
-
|
Novo Nordisk Production SAS
|
France
|
|
Novo Nordisk Pharmaceuticals (Philippines), Inc.
|
Novo Nordisk Pharmaceuticals (Philippines), Inc.
|
-
|
14 September 2021
|
14 September 2026
|
| View |
|
BR-1370
|
Tetanus Toxoid (Adsorbed)
|
Abhay-TOX
|
40 IU/0.5mL
|
Solution For Injection (IM)
|
Prescription Drug (RX)
|
0.5 mL net content in 2 mL capacity USP Type I glass vial with grey bromobutyl rubber stopper and aluminum flip-off seal. Single Dose.
|
-
|
Human Biologicals Institute (A Division of Indian
Immunologicals Limited)
|
India
|
|
2 World Traders Inc.
|
2 World Traders Inc.
|
-
|
16 September 2021
|
16 September 2026
|
| View |
|
BR-1371
|
Insulin Human (rDNA)
|
Mixtard 30 Flexpen
|
100 U/mL
|
Suspension for Injection (SC) (30%
Soluble Insulin and 70% Isophane Insulin)
|
Prescription Drug (RX)
|
3 mL Type I prefilled pen [Flexpen] (Box of 5's)
|
-
|
Novo Nordisk Produção Farmacêutica do Brasil Ltda.
|
Brazil
|
|
Novo Nordisk Pharmaceuticals (Philippines), Inc.
|
Novo Nordisk Pharmaceuticals (Philippines), Inc.
|
Initial
|
24 September 2021
|
24 September 2026
|