View |
|
BR-1438
|
Candesartan
|
Torcand-32
|
32 mg
|
Tablet
|
Prescription Drug (RX)
|
Packaging:
Each box contains: Type I clear and colorless glass vial with grey butyl rubber stopper and aluminum crimp cap with polypropylene flip-off disk (drug product) + Type I clear glass vial with bromobutyl rubber stopper and aluminum seal plastic flip-off cap (Sterile Water for Injection as diluent) + Twin set butterfly needle 22G (Venofix) and cannula 20G (Sterican) + Sterile needleless transfer device for reconstitution (Baxter II Hi-Flow) + Disposable syringe with luer lock (Omnifix).
|
-
|
Baxter AG
|
Austria
|
N/A
|
Takeda Healthcare Philippines Inc.
|
Takeda Healthcare Philippines Inc.
|
Monitored Release
|
08 February 2023
|
08 February 2028
|
View |
BR-1439_PI_01.pdf
|
BR-1439
|
Amivantamab
|
Rybrevant
|
350 mg/7 mL (50mg/mL)
|
Concentrate For Solution For Infusion (IV)
|
Prescription Drug (RX)
|
Type I glass vial with grey fluorotec-coated butyl rubber stopper and aluminum seal with white plastic flip-off cap (Box of 1's).
|
-
|
Cilag AG
|
Switzerland
|
N/A
|
Johnson & Johnson (Philippines), Inc.
|
Johnson & Johnson (Philippines), Inc.
|
Monitored Release
|
17 February 2023
|
17 February 2028
|
View |
|
BR-1440
|
Bacterial Lysate
|
Broncho-Vaxom
|
7 mg
|
Capsule
|
Prescription Drug (RX)
|
Alu/Alu Blister Pack x 10's (Box of 10's)
|
Other Respiratory System Products
|
OM Pharma S.A. Meyrin
|
Switzerland
|
N/A
|
Sandoz Philippines Corporation
|
Sandoz Philippines Corporation
|
Automatic Renewal
|
14 April 2023
|
05 June 2028
|
View |
BR-1441_PI_01.pdf
|
BR-1441
|
Herpes Zoster Vaccine (recombinant, adjuvanted)
|
Shingrix
|
Formulation:
After reconstitution, one dose (0.5 mL) contains:
Varicella Zoster Virus' glycoprotein E antigen23 50 micrograms.
Varicella Zoster Virus = VZV
2adjuvanted with AS01B containing plant extract Quillaja saponaria Molina, fraction 21 (QS-21) 50 micrograms
and
3-O-desacyl-4'-monophosphoryl lipid A (MPL) from Salmonella minnesota 3glycoprotein E (gE) produced in Chinese Hamster Ovarian (CHO) cells by recombinant DNA technology 50 micrograms
|
Powder and Suspension for Suspension for Injection (IM)
|
Prescription Drug (RX)
|
3 mL Type I colorless glass vial with bromobutyl rubber stopper and brown flip-off cap (lyophilized vaccine) + 0.5 mL in 3 mL Type I colorless glass vial with chlorobutyl rubber stopper and blue green flip-off cap (adjuvant as suspension)
|
-
|
GlaxoSmithKline Biologicals S.A.
|
Belgium
|
N/A
|
GlaxoSmithKline Philippines, Inc.
|
GlaxoSmithKline Philippines, Inc.
|
Monitored Release (MR) (Re-application)
|
02 May 2023
|
02 May 2028
|
View |
|
BR-1442
|
Oral Poliomyelitis Vaccine (Types 1 and 3)[ Live, Attenuated]
|
None
|
Formulation:
Each dose of 2 drops (0.1 mL) contains live attenuated poliomyelitis virus (Sabin strain).:
Type 1 ≥106.0CCID50 Type 3 ≥105.8CCID50
|
Solution for Oral Administration
|
Prescription Drug (RX)
|
Multidose (20 doses). 2 mL in 4 mL Type I clear glass
vial with grey bromobutyl rubber stopper and aluminum flip-off seal with Type 2 Vaccine Vial Monitor (VVM) + LDPE dropper (Box of 50's).
|
Vaccines
|
Serum Institute of India Pvt. Ltd.
|
India
|
N/A
|
Department of Health - Central Office
|
Department of Health Central Office
|
Monitored Release (MR) [Reconstruction]
|
07 February 2024
|
25 May 2028
|
View |
|
BR-1443
|
Factor VIII Inhibitor Bypassing Activity
|
Feiba
|
1000 U/20 mL (50 U/mL)
|
Powder for Solution for
Infusion (IV)
|
Prescription Drug (RX)
|
500, 1000, and 2500 units (U) per vial supplied with a diluent in a vial containing steril water for injection
|
-
|
Baxter AG
|
Austria
|
N/A
|
Takeda Healthcare Philippines Inc.
|
Takeda Healthcare Philippines Inc.
|
Monitored Release
|
19 June 2023
|
19 June 2028
|
View |
BR-1444_PI_01.pdf
|
BR-1444
|
Tozinameran/Famtozinameran
|
Comirnaty Original/Omicron B.A.4-5
|
15 mcg/15 mcg/0.3mL
|
Dispersion For Injection (IM)
|
Prescription Drug (RX)
|
Multidose (6 doses). 2 mL Type I borosilicate glass vial with a bromobutyl rubber stopper and aluminum vial seal with tamper evident polypropylene flip-off grey cap (Box of 10's).
|
-
|
Pfizer, Inc.
|
Belgium
|
N/A
|
Pfizer Manufacturing Belgium NV
|
Pfizer Manufacturing Belgium NV
|
Monitored Release (MR)
|
08 June 2023
|
08 June 2028
|
View |
|
BR-1445
|
Powder for Solution for
Infusion (IV)
|
Feiba
|
2500 U/50 mL (50 U/mL)
|
Powder for Solution for
Infusion (IV)
|
Prescription Drug (RX)
|
500, 1000, and 2500 units (U) per vial supplied with a diluent in a vial containing steril water for injection
|
-
|
Baxter AG
|
Austria
|
N/A
|
Takeda Healthcare Philippines Inc.
|
Takeda Healthcare Philippines Inc.
|
Monitored Release
|
19 June 2023
|
19 June 2028
|
View |
|
BR-1446
|
Rituximab
|
Acellbia
|
100 mg/ 10 mL (10 mg/mL)
|
Concentrate For Solution For Infusion (Iv)
|
Prescription Drug (RX)
|
10 mL USP/Ph. Eur. Type I colorless glass vial sealed with a fluorinated polymer coated bromobutyl rubber stopper with aluminum and propylene flip-off cap in a PVC blister pack (Box of 2's)
|
-
|
Joint Stock Company BIOCAD
|
Russia
|
N/A
|
Ambitech Pharmaceuticals Inc.
|
Ambitech Pharmaceuticals Inc.
|
Initial
|
30 June 2023
|
30 June 2028
|
View |
|
BR-1447
|
Rituximab
|
Acellbia
|
500 mg/50 mL (10 mg/mL)
|
Concentrate For Solution For Infusion (Iv)
|
Prescription Drug (RX)
|
50 mL USP/Ph. Eur. Type I colorless glass vial sealed with a fluorinated polymer coated bromobutyl rubber stopper with aluminum and propylene flip-off cap (Box of 1's)
|
-
|
Joint Stock Company BIOCAD
|
Russia
|
N/A
|
Ambitech Pharmaceuticals Inc.
|
Ambitech Pharmaceuticals Inc
|
Initial
|
30 June 2023
|
30 June 2028
|
View |
|
BR-1448
|
Rotavirus Vaccine (Live, Attenuated)
|
Rotarix
|
NLT 106.0 CCID50/1.5 mL
|
Oral Suspension
|
Prescription (RX) Drug
|
1.75 mL (Net content; 1.5 mL) Type I glass syringe with Type I bromobutyl plunger stopper, polystyrene plunger rod, and polypropylene backstop device (Box of 1's and 10's)
|
-
|
GlaxoSmithKline Biologicals SA (GSK Biolpgicals)
|
Belgium
|
N/A
|
GlaxoSmithKline Philippines, Inc
|
GlaxoSmithKline Philippines, Inc
|
Initial
|
18 August 2023
|
18 August 2028
|
View |
|
BR-1449
|
Human Placental Extract
|
Laennec
|
112 mg/2 mL
|
Solution for Injection (I.M./S.C.)
|
Prescription Drug (RX)
|
2 mL Type I amber glass ampoule (Box of 10's and 50's).
|
-
|
Japan Bio Products Co., Ltd. (L'Atelier Fujimitsu)
|
Japan
|
N/A
|
Racquel-Abbas Pharmaceuticals & General Merchandise
|
Racquel-Abbas Pharmaceuticals & General Merchandise
|
Monitored Release (Reapplication)
|
02 October 2023
|
02 October 2028
|
View |
|
BR-1450
|
Heparin Sodium
|
Unihepa
|
5,000 I.U./mL (25,000 I.U./5mL)
|
Solution for Injection (IV/SC)
|
Prescription Drug (Rx)
|
Type I Clear Glass Vial x 5 mL (Box of 10's)
|
Anticoagulant
|
Duopharma (M) Sdn. Bhd.
|
Malaysia
|
N/A
|
N/A
|
DB (Philippines), Inc.
|
Renewal
|
23 October 2023
|
03 February 2029
|
View |
|
BR-1451
|
Pneumococcal Polysaccharide Conjugate Vaccine, 13-
Valent (Adsorbed)
|
Pneumocon-13
|
Each dose (0.5 mL) contains the capsular polysaccharide of the following Streptococcus pneumoniae serotypes:
Pneumococcal Polysaccharide Serotype 6B
Pneumococcal Polysaccharide Serotype 18C
Pneumococcal Polysaccharide Serotype 4, 23F
Pneumococcal Polysaccharide Serotype 7F
Pneumococcal Polysaccharide Serotype 14, 19F
Pneumococcal Polysaccharide Serotype 1, 19A
6.0 με 3.25 μg
3.0 με
2.85 με
- 2.75 με
2.6 με
Pneumococcal Polysaccharide Serotype 3, 5, 6A, 9V Conjugated to Tetanus Toxoid carrier protein
2.5 με 41-150 με
|
Suspension for Injection (IM)
|
Prescription Drug (RX)
|
0.5 mL in 1 mL pre-filled glass syringe with grey
bromobutyl plunger stopper and polystyrene plunger rod with 27G stainless steel needle (Box of 1's).
|
-
|
Yuxi Walvax Biotechnology Co., Ltd.
|
China
|
N/A
|
2 World Traders Inc.
|
2 World Traders Inc.
|
Monitored Release (MR) [Reapplication]
|
03 November 2023
|
03 November 2028
|
View |
|
BR-1452
|
Pneumococcal Polysaccharide Conjugate Vaccine, 13-
Valent (Adsorbed)
|
Pneumocon 13
|
Each dose (0.5 mL) contains the capsular polysaccharide of the following Streptococcus pneumoniae serotypes: Pneumococcal Polysaccharide Serotype 6B
Pneumococcal Polysaccharide Serotype 18C
Pneumococcal Polysaccharide Serotype 4, 23F
Pneumococcal Polysaccharide Serotype 7F Pneumococcal Polysaccharide Serotype 14, 19F Pneumococcal Polysaccharide Serotype 1, 19A Pneumococcal Polysaccharide Serotype 3, 5, 6A, 9V
Conjugated to Tetanus Toxoid carrier protein
6.0 με
3.25 μg
3.0 με
2.85 μg
2.75 μg
2.6 μg
|
Suspension for Injection (IM)
|
Prescription Drug (RX)
|
0.5 mL in 1 mL borosilicate glass vial with chlorinated butyl rubber stopper and combined aluminum-plastic cap (Box of 20's)
|
-
|
Yuxi Walvax Biotechnology Co., Ltd.
|
China
|
N/A
|
2 World Traders Inc.
|
2 World Traders Inc.
|
Monitored Release (MR) [Reapplication]
|
03 November 2023
|
03 November 2028
|
View |
|
BR-1453
|
Pneumococcal Polysaccharide Vaccine, 23-Valent
|
Pneumops 23
|
25ug/0.5ml Prefilled Syringe
|
Solution for injection (IM/SC)
|
Prescription Drug (RX)
|
0.5 mL in 1 mL pre-filled glass syringe with bromobutyl
rubber plunger and polystyrene plunger rod with stainless steel needle (27G) [Box of 1's].
|
-
|
Yuxi Walvax Biotechnology Co., Ltd.
|
China
|
|
2 World Traders Inc.
|
2 World Traders Inc.
|
Monitored Release (MR) [Correction]
|
09 January 2024
|
03 November 2028
|
View |
|
BR-1454
|
Clostridium botulinum Toxin Type A
|
Botitox Up
|
100 Units
|
Lyophilized Powder for Solution for Injection
(IM)
|
Prescription Drug (RX)
|
5 mL USP Type I clear glass vial with grey chlorobutyl rubber stopper with aluminum seal and orange polypropylene cap (Box of 1's).
|
-
|
Huons Biopharma Co., Ltd.
|
Korea
|
N/A
|
Ambitech Biopharmaceuticals Inc.
|
Ambitech Biopharmaceuticals Inc.
|
Initial (Reapplication)
|
07 November 2023
|
07 November 2028
|
View |
|
BR-1455
|
Respiratory Syncytial Virus Vaccine (Recombinant, Adjuvanted)
|
Arexvy
|
120 mcg
|
Powder for Suspension for Injection (IM)
|
Prescription Drug (RX)
|
See packaging on the reverse side.
|
-
|
GlaxoSmithKline Biologicals SA
|
Belgium
|
|
GlaxoSmithKline Philippines, Inc.
|
GlaxoSmithKline Philippines, Inc.
|
Monitored Release (MR)
|
22 November 2023
|
22 November 2028
|
View |
|
BR-1456
|
Insulin Aspart
|
Kirsty
|
100 Units/mL (equivalent to 3.5 mg/mL)
|
Solution for Injection (SC)
|
Prescription Drug (RX)
|
USP Type I glass vial with bromobutyl rubber stopper sealed with aluminum flip-off seal x 10 mL (Box of 1's).
|
-
|
Biocon Sdn BHD
|
Malaysia
|
N/A
|
Viatris Pharmaceuticals, Inc.
|
Viatris Pharmaceuticals, Inc.
|
Initial
|
28 November 2023
|
28 November 2028
|
View |
|
BR-1457
|
Insulin Aspart
|
Kirsty
|
100 Units/mL (equivalent to 3.5 mg/mL)
|
Solution for Injection (SC)
|
Prescription Drug (RX)
|
USP Type I glass cartridge with dark grey plunger
stopper and aluminum seal integrated into a pen injector x 3 mL (Box of 5's).
|
-
|
Biocon Sdn BHD
|
Malaysia
|
N/A
|
Viatris Pharmaceuticals, Inc.
|
Viatris Pharmaceuticals, Inc.
|
Initial
|
28 November 2023
|
28 November 2028
|