| View |
|
BR-1080
|
Tinzaparin Sodium
|
Innohep
|
10000 anti-Xa IU/mL
|
Solution For Injection (SC)
|
Prescription Drug (RX)
|
2 mL colorless glass Type I vial with bromobutyl
rubber stopper and aluminum cap (Box of 10's)
|
-
|
Leo Pharma A/S
|
Denmark
|
N/A
|
Getz Bros. Philippines, Inc.
|
Getz Bros. Philippines, Inc.
|
Initial (Variation)
|
12 December 2022
|
12 December 2027
|
| View |
|
BR-1085
|
Streptokinase
|
Thromboflux
|
1,500,000IU
|
Lyophilized Powder For Injection IV
|
Prescription Drug (RX)
|
Type I borosilicate clear glass vial with yellow green
flip-off cap x 5 mL (Box of l's)
|
Anti-thrombotic Agent
|
Bharat Serums and Vaccines Limited
|
India
|
|
BSV Bioscience Phils., Inc.
|
Sandoval Distributors Inc.
|
Renewal
|
31 May 2024
|
21 September 2029
|
| View |
BR-1084_PI_01.pdf
|
BR-1084
|
Quadrivalent Seasonal Influenza Vaccine (Split)
Virion, Inactivated) 2024 Southern Hemisphere Strain.
|
Fluquadri
|
Formulation:
Each dose (0.5 mL) contains the following influenza strains*:
A/Victoria/4897/2022 (H1N1) pdm09-like strain
15 μg of HA**
(A/Victoria/4897/2022, IVR-238)
A/Thailand/8/2022 (H3N2)-like strain
15 μg of HA**
(A/California/122/2022, SAN-022)
B/Austria/1359417/2021-like strain
15 μg of HA**
(B/Michigan/01/2021, wild type)
B/Phuket/3073/2013 (B/Yamagata lineage)-like virus
15 μg of HA**
(B/Phuket/3073/2013, wild type)
*Propagated in embryonated chicken eggs
|
Suspension for Injection (IM)
|
Prescription Drug (Rx)
|
0.5 mL in 1.5 mL USP Type I borosilicate pre-filled glass syringe with bromobutyl plunger stopper, luer- lock adapter, and tip cap (Box of 5's).
|
Vaccines
|
Sanofi Pasteur
|
U.S.A
|
|
Sanofi Pasteur, Inc.
|
Zuellig Pharma Corporation
|
Monitored Release (Strain Clearance)
|
05 April 2024
|
05 April 2025
|
| View |
|
BR-1087
|
Diphtheria, Tetanus, Pertussis (Whole Cell), Hepatitis B
(IDNA) and Haemophilus influenzae Type B Conjugate
Vaccine (Adsorbed)
|
Shan 5
|
Formulation: Each dose (0.5 mL) contains: Diphtheria toxoid->30IU Tetanus toxoid->60IU Bordetella pertussis (Whole Cell)-> 4 IU Hepatitis B (r-DNA) surface antigen-10ug Purified capsular polysaccharide of Hib conjugated to
20-40 mcg Tetanus toxoid (carrier protein)-10ug
|
Suspension for Injection (IM)
|
Prescription Drug (RX)
|
Single dose. 0.5 mL USP Type I clear glass vial with
halogenated butyl rubber stopper and aluminum flip-off seal with Vaccine Vial Monitor (VVM) [Box of l's, 10's and 35's]
|
Vaccines
|
Shantha Biotechnics Limited
|
India
|
N/A
|
Sanofi Pasteur, Inc.
|
Sanofi Pasteur, Inc.
|
Initial (from Monitored Release)
|
07 June 2022
|
05 June 2025
|
| View |
|
BR-1088
|
Insulin Human (rDNA)
|
Insuget 70/30
|
100 IU/mL
|
Suspension for Injection (IM/SC)
|
Prescription Drug (RX)
|
Glass vial with white flip-off cap x 10 mL
(Box of l’s)
|
-
|
Getz Pharma Pvt. Ltd.
|
Pakistan
|
|
Getz Pharma (Phils.), Inc.
|
|
-
|
22 October 2020
|
06 January 2025
|
| View |
|
BR-1089
|
Measles, Mumps, Rubella and Varicella Vaccine (Live)
|
Proquad
|
Each dose (0.5 mL) contains: Measles virus (Edmonston B) 3.00 log TCID50* Mumps virus (Jeryl Lynn B level)4.30 log TCID50
Rubella virus (Wistar RA 27/3) 3.00 log TCID50
Varicella virus (Oka/Merck) 3.99 PFU**
*50% Tissue Culture Infectious Dose
**Plaque Forming Units
|
Lyophilized Powder For Solution For Injection (SC)
|
Prescription Drug (RX)
|
3 mL USP/Ph. Eur. Type I glass vial with grey rubber stopper and aluminum flip-off seal (as drug product) 0.7 mL in 1 mL Type I pre-filled needleless glass syringe with black rubber stopper and grey ribbed tip cap (as Sterile Water for Injection) [Box of 1's and 10's].
|
Vaccines
|
Merck Sharp & Dohme LLC
|
U.S.A
|
N/A
|
Merck Sharp & Dohme (I.A.) LLC
|
N/A
|
Initial (from Monitored Release) [Correction]
|
11 March 2024
|
09 June 2025
|
| View |
|
BR-1091
|
Epoetin beta
|
Recormon
|
2,000 I.U./0.3mL
|
Solution for Injection (S.C./I.V.)
|
Prescription Drug (Rx)
|
Pre-filled syringe of 0.3 mL with needle 27G ½" (Box of 6's)
|
Antianemic Preparations
|
Roche Diagnostic GmbH
|
Germany
|
|
Roche (Philippines), Inc.
|
Zuellig Pharma Corporation
|
Renewal
|
18 September 2021
|
05 November 2026
|
| View |
|
BR-1093
|
Alteplase
|
Actilyse
|
50 mg
|
Powder for Solution for Infusion (IV
|
Prescription Drug (RX)
|
Each box contains: Ph. Eur. Type I colourless glass vial
with bromobutyl rubber stopper and aluminium/ polypropylene, dark green flip-off seal + Type I glass vial (Sterile Water for Injection as diluent) x 50 mL
|
-
|
Boehringer Ingelheim Pharma GmbH & Co. KG
|
Germany
|
N/A
|
Boehringer Ingelheim (Philippines), Inc.
|
Boehringer Ingelheim (Philippines), Inc.
|
Initial (Variation)
|
19 September 2022
|
19 September 2027
|
| View |
|
BR-1095
|
Infliximab
|
Remicade
|
100 mg
|
Powder For Concentrate For Solution For Infusion
|
Prescription Drug (RX)
|
20 mL Type I Borosilicate Glass Vial with Stopper and Aluminum Seal and White Flip-off Cap (Box of 1's)
|
Immunosuppressant
|
Cilag AG
|
Switzerland
|
Centrocor BV
|
Johnson & Johnson (Philippines), Inc.
|
Zuellig Pharma Corporation
|
Regular Renewal
|
19 March 2021
|
19 January 2025
|
| View |
|
BR-1096
|
Menothropin
|
Menopur
|
1200 IU
|
Lyophilized Powder For Injection (SC)
|
Prescription Drug (RX)
|
Packaging: Each box contains: 2 mL Type I glass vial with halobutyl rubber stopper closed with a flip-off seal (Powder) + Two 1 mL Type I pre-filled glass syringe barrel with halobutyl plunger stopper (Water for Injection + Metacresol as diluent) + 1 separate needle for reconstitution.
|
-
|
Ferring GmbH
|
Germany
|
N/A
|
Metro Drug, Inc.
|
Metro Drug, Inc.
|
-
|
18 March 2022
|
26 June 2025
|
| View |
|
BR-1098
|
Enoxaparin sodium
|
Lomoh-60
|
60 mg/0.6 mL
|
Solution for Injection (S.C.)
|
Prescription (Rx) Drug
|
Clear glass USP type I in pre-filled syringe of 0.6 mL packed in a blister of film PVC clear and foil grid. lacquer paper (Box of 1's)
|
Antithrombotic Agent
|
Emcure Pharmaceuticals Ltd.
|
India
|
N/A
|
Macropharma Corporation
|
Macropharma Corporation
|
Renewal (Correction)
|
17 November 2023
|
30 June 2025
|
| View |
|
BR-1099
|
Enoxaparin Sodium
|
Lomoh - 40
|
40 mg/0.4 mL
|
Solution For Injection (S.C.)
|
Prescription Drug (RX)
|
Clear glass USP type I in pre-filled syringe of 0.4 mL packed in a blister of film PVC clear and foil grid lacquer paper (Box of 1's)
|
-
|
Emcure Pharmaceuticals Ltd.
|
India
|
|
Macropharma Corporation
|
Macropharma Corporation
|
-
|
16 September 2021
|
30 June 2025
|
| View |
BR-1101_PI_01.pdf
|
BR-1101
|
Tocilizumab
|
Actemra
|
162 mg/ 0.9 mL
|
Solution For Injection (SC)
|
Prescription Drug (RX)
|
Packaging: 0.9 ml Solution in 1 ml Pre-Filled Syringe (Type I Glass) with a Staked-in Needle. The syringe is closed by a Rigid Needle Shield (Elastomer Seal with a Polypropylene Shell) and a Plunger Stopper (Butyl Rubber with a Fluororesin Coating) (Box of 1's and 4's).
|
-
|
Vetter Pharma-Fertigung GmbH & Co. KG
|
Germany
|
|
Roche (Philippines), Inc.
|
Zuellig Pharma Corporation
|
-
|
08 March 2022
|
28 July 2025
|
| View |
|
BR-1102
|
Insulin Human (rDNA)
|
Insuget-N
|
100 IU/mL
|
Suspension for Injection (IM/SC)
|
Prescription Drug (RX)
|
Glass vial with yellow flip-off cap x 10 mL
(Box of l's)
|
-
|
Getz Pharma Pvt. Ltd.
|
Pakistan
|
|
Getz Pharma (Phils.), Inc.
|
|
-
|
22 October 2020
|
06 January 2025
|
| View |
|
BR-1103
|
Insulin Human (rDNA)
|
Insuget-R
|
100 IU/mL
|
Suspension for Injection (IM/IV/SC)
|
Prescription Drug (RX)
|
Glass vial with yellow flip-off cap x 10 mL
(Box of l's)
|
-
|
Getz Pharma Pvt. Ltd.
|
Pakistan
|
|
Getz Pharma (Phils.), Inc.
|
|
-
|
22 October 2020
|
06 January 2025
|
| View |
|
BR-1106
|
Insulin Human (rDNA)
|
SciLin R
|
100 IU/mL
|
Solution for Injection (IV/SC)
|
Prescription Drug (RX)
|
Clear and Colorless Glass Vial with Red Flip-off Cap x 10 mL (Box of l's)
|
-
|
Bioton S.A.
|
Poland
|
SciGen Limited
|
Metro Drug, Inc.
|
Metro Drug, Inc.
|
-
|
26 February 2021
|
28 January 2025
|
| View |
|
BR-1107
|
Insulin Human (DNA)
|
Scilin R
|
100 IU/mL
|
Solution for Injection (IV/SC)
|
Prescription Drug (RX)
|
3mL glass cartridge
|
-
|
Bioton S.A.
|
Poland
|
SciGen Limited
|
Metro Drug, Inc.
|
Metro Drug, Inc.
|
Renewal
|
18 October 2021
|
28 January 2025
|
| View |
|
BR-1117
|
Heparin Sodium
|
Heprin
|
5000IU/mL
|
Solution For Injection (IV/SC)
|
Prescription Drug (RX)
|
5 mL Type I Clear Glass Vial (Box of 10's)
|
-
|
Gland Pharma Limited
|
India
|
N/A
|
Endure Medical, Inc.
|
Endure Medical, Inc.
|
Renewal
|
14 May 2021
|
25 May 2025
|
| View |
|
BR-1121
|
Trastuzumab
|
Herceptin
|
600 mg/ 5 mL (120 mg/ mL)
|
Solution For Injection (SC)
|
Prescription Drug (RX)
|
6 mL (Net content: 5 mL)Type I clear glass vial with butyl rubber stopper laminated with a fluoro-resin (Box of 1's)
|
-
|
F. Hoffmann-La Roche AG
|
Switzerland
|
N/A
|
Roche (Philippines) Inc.
|
Roche (Philippines) Inc.
|
Regular Renewal (Compliance)
|
07 March 2022
|
29 September 2025
|
| View |
|
BR-1122
|
Rituximab
|
Mabthera
|
1400 mg/ 11.7 mL
|
Solution For Injection (SC)
|
Prescription Drug (RX)
|
Type I USP/Ph. Eur. colourless glass vial sealed
with butyl rubber stopper laminated with fluoro resin film and crimped with an aluminum overseal fitted with a plastic flip-off disk x 15 mL (Box of 1's)
|
-
|
F. Hoffman-La Roche AG
|
Switzerland
|
N/A
|
Roche (Philippines) Inc.
|
Roche (Philippines) Inc.
|
Regular Renewal (Compliance)
|
18 February 2022
|
29 September 2025
|