View |
BR-1372_PI_01.pdf
|
BR-1372
|
Somatropin
|
Norditropin Nordiflex
|
5 mg / 1.5mL
|
Solution For Injection (SC)
|
Prescription Drug (RX)
|
1.5 ml cartridge (Type I colourless glass) permanently sealed in a plastic pen-injector; The cartridge is closed at the bottom with a rubber stopper shaped as a plunger and at the top with a laminated rubber stopper shaped as a disc and sealed with an aluminium cap; The push-button on the pen-injector is colour-coded according to strength; The pre filled pen is packed in a carton.
|
-
|
Novo Nordisk A/S
|
Denmark
|
|
Novo Nordisk Pharmaceuticals (Philippines), Inc.
|
Novo Nordisk Pharmaceuticals (Philippines), Inc.
|
-
|
06 October 2021
|
06 October 2026
|
View |
BR-1373_PI_01.pdf
|
BR-1373
|
Somatropin
|
Norditropin Nordiflex
|
10 mg/ 1.5mL
|
Solution For Injection (SC)
|
Prescription Drug (RX)
|
Packaging: 1.5 ml cartridge (Type I colourless glass) permanently sealed in a plastic pen-injector; The cartridge is closed at the bottom with a rubber stopper shaped as a plunger and at the top with a laminated rubber stopper shaped as a disc and sealed with an aluminium cap; The push-button on the pen-injector is colour-coded according to strength; The pre filled pen is packed in a carton.
|
-
|
Novo Nordisk A/S
|
Denmark
|
|
Novo Nordisk Pharmaceuticals (Philippines), Inc.
|
Novo Nordisk Pharmaceuticals (Philippines), Inc.
|
-
|
06 October 2021
|
06 October 2026
|
View |
BR-1374_PI_01.pdf
|
BR-1374
|
Somatropin
|
Norditropin Nordiflex
|
15 mg/1.5mL
|
Solution For Injection (SC)
|
Prescription Drug (RX)
|
Packaging: 1.5 ml cartridge (Type I colourless glass) permanently sealed in a plastic pen-injector; The cartridge is closed at the bottom with a rubber stopper shaped as a plunger and at the top with a laminated rubber stopper shaped as a disc and sealed with an aluminium cap; The push-button on the pen-injector is colour-coded according to strength; The pre filled pen is packed in a carton.
|
-
|
Novo Nordisk A/S
|
Denmark
|
|
Novo Nordisk Pharmaceuticals (Philippines), Inc.
|
Novo Nordisk Pharmaceuticals (Philippines), Inc.
|
-
|
06 October 2021
|
06 October 2026
|
View |
|
BR-1375
|
Bevacizumab
|
Zirabev
|
100 mg/4 mL (25 mg/mL)
|
Concentrate For Solution For I.V. Injection
|
Prescription Drug (RX)
|
5 mL USP Type I glass vial with chlorobutyl rubber
stopper and aluminum crimp seal with flip-off cap (Box of 1's)
|
-
|
Pharmacia and Upjohn Company LLC
|
United States of America
|
|
Pfizer, Inc.
|
Pfizer, Inc.
|
Initial
|
19 October 2021
|
19 October 2026
|
View |
|
BR-1376
|
Bevacizumab
|
Zirabev
|
400 mg/16 mL (25 mg/mL)
|
Concentrate For Solution For I.V. Injection
|
Prescription Drug (RX)
|
20 mL USP Type I glass vial with chlorobutyl rubber
stopper and aluminum crimp seal with flip-off cap (Box of l's)
|
-
|
Pharmacia and Upjohn Company LLC
|
United States of America
|
|
Pfizer, Inc.
|
Pfizer, Inc.
|
Initial
|
19 October 2021
|
19 October 2026
|
View |
|
BR-1377
|
Trastuzumab
|
Trazimera
|
150 mg
|
Powder for Concentrate for Solution for Infusion (IV)
|
Prescription Drug (RX)
|
15 mL Type I clear glass vial with chlorobutyl
stopper and crimp seal with flip-off cap (Box of 1's)
|
-
|
Pfizer Manufacturing Belgium NV
|
Belgium
|
|
Pfizer, Inc.
|
Pfizer, Inc.
|
-
|
16 November 2021
|
16 November 2026
|
View |
|
BR-1379
|
Inactivated Poliomyelitis Vaccine (Types 1, 2 And 3)
|
Poliovac
|
See Formulation on the reverse side
|
Suspension For Injection (Im/Sc)
|
Prescription Drug (RX)
|
Multidose vial. 2.5 mL in 3 mL USP Type I glass vial
with chlorobutyl rubber stopper, pink aluminium flip-off seal, and Vaccine Vial Monitor (Box of 50's)
ine Vial
|
-
|
Serum Institute of India Private Limited
|
India
|
N/A
|
Faberco Life Sciences Inc.
|
Faberco Life Sciences Inc.
|
Initial (Variation)
|
13 July 2023
|
13 July 2028
|
View |
|
BR-1380
|
Human Immunoglobulin
|
Pentaglobin
|
50 mg/ mL
|
Solution for Infusion (IV)
|
Prescription Drug (RX)
|
EP Type II glass vial with light grey bromobutyl
rubber stopper sealed with colorless aluminum pull off cap with center tear off (Box of l's) [Net content: 50 mL & 100 mL]
|
-
|
Biotest AG
|
Germany
|
|
EC Zuric Biotherapies
|
EC Zuric Biotherapies
|
-
|
16 November 2021
|
16 November 2026
|
View |
|
BR-1381
|
Calfactant
|
Infasurf
|
35 mg/mL
|
Intratracheal Suspension
|
Prescription Drug (RX)
|
Type I glass vial with grey bromobutyl stopper capped with aluminum center tear-out seal (Box of
l's) [Net content: 3 mL & 6 mL]
|
-
|
ONY Biotech Inc.
|
United States of America
|
|
Pacific Healthcare Philippines, Inc.
|
Pacific Healthcare Philippines, Inc.
|
Initial (correction)
|
29 July 2022
|
23 November 2026
|
View |
BR-1382_PI_01.PDF
|
BR-1382
|
Moroctocog Alfa
|
Xyntha
|
250 IU
|
Lyophilized Powder for Injection (IV)
|
Prescription Drug (RX)
|
Single dose. One Box contains Type I glass vial
|
Blood coagulation factors
|
Wyeth Farma, S.A.
|
Spain
|
|
Pfizer, Inc.
|
Pfizer, Inc.
|
Monitored Release
|
10 December 2021
|
10 December 2026
|
View |
BR-1383_PI_01.PDF
|
BR-1383
|
Moroctocog Alfa
|
Xyntha
|
500 IU
|
Lyophilized Powder for Injection (IV)
|
Prescription Drug (RX)
|
Single Dose. One box containes Type I glass vial
|
Blood coagulation factors
|
Wyeth Farma, S.A.
|
Spain
|
|
Pfizer, Inc.
|
Pfizer, Inc.
|
Monitored Release
|
10 December 2021
|
10 December 2026
|
View |
|
BR-1384
|
Cholera Vaccine (Inactivated, Oral)
|
Euvichol-Plus
|
Formulation Each dose (1.5 mL), contains
Vibrio cholerae 01 Inaba Cairo 48 classical biotype, Heat inactivated Vibrio cholerae 01 Inaba Phil 6973 El Tor biotype, Formalin inactivated Vibrio cholerae 01 Ogawa Cairo 50 classical biotype, Formalin inactivated Vibrio cholerae 01 Ogawa Cairo 50 classical biotype, Heat inactivated Vibrio cholerae 0139 4260B, Formalin inactivated
300 LEU* 600 LEU* 300 LEU* 300 LEU* 600 LEU*
*LEU: Lipopolysaccharide ELISA Units
|
Oral Suspension
|
Prescription Drug (RX)
|
1.5 mL plastic tube (Box of 50's) Single dose
|
-
|
Eubiologici Co., Ltd
|
Korea
|
|
Medical Vaccines Online Deliveries
|
Medical Vaccines Online Deliveries
|
-
|
31 December 2021
|
31 December 2026
|
View |
|
BR-1385
|
Bevacizumab
|
Avamab
|
400 mg/16 mL (25 mg/mL)
|
Concentrate for Solution for Infusion (IV)
|
Prescription Drug (Rx)
|
20 mL (Net content: 16 mL) Type I borosilicate colorless glass vial with chlorobutyl rubber stopper, crimped with aluminum seal fitted with plastic flip-off cap (Box of l's)
|
VEGF/VEGFR (Vascular Endothelial Growth Factor) Inhibitors
|
Sinergium Biotech S.A.
|
Argentine Republic
|
Mabxience Research S.L.
|
Globo Asiatico Enterprises, Inc.
|
Globo Asiatico Enterprises, Inc.
|
Monitored Release
|
02 February 2022
|
02 February 2027
|
View |
|
BR-1386
|
Bevacizumab
|
Avamab
|
100 mg/4 mL (25 mg/mL)
|
Concentrate for Solution for Infusion (IV)
|
Prescription Drug (Rx)
|
5 mL (Net content: 4 mL) Type I borosilicate colorless glass vial with chlorobutyl rubber stopper, crimped with aluminum seal fitted with plastic flip-off cap (Box of l's)
|
-
|
Sinergium Biotech S.A.
|
Argentine Republic
|
Mabxience Research S.L.
|
Globo Asiatico Enterprises, Inc.
|
Globo Asiatico Enterprises, Inc.
|
-
|
02 February 2022
|
02 February 2027
|
View |
|
BR-1388
|
Meningococcal Group A, C, W-135 and Y Conjugate
Vaccine
|
Menquadfi
|
Formulation: Each dose (0.5 mL) contains: Neisseria meningitidis group A polysaccharide* .... 10 mcg Neisseria meningitidis group C polysaccharide* .... 10 mcg Neisseria meningitidis group Y polysaccharide* .... 10 mcg Neisseria meningitidis group W-135 polysaccharide* .... 10 mcg *Conjugated to Tetanus Toxoid carrier protein... 55 mcg** **Tetanus Toxoid quantity is approximate and dependent on the polysaccharide to protein ratio for the conjugates in each formulation
|
Solution for Injection (IM)
|
Prescription Drug (RX)
|
Single dose. 0.5 mL in 2 mL USP Type I glass vial with gray chlorobutyl rubber stopper sealed with aluminum and black plastic flip-off cap (Box of 1's and 5's)
|
Vaccines
|
Sanofi Pasteur
|
United States of America
|
N/A
|
Sanofi Pasteur, Inc.
|
Zuellig Pharma Corporation
|
Monitored Release
|
04 March 2022
|
04 March 2027
|
View |
BR-1389_PI_01.pdf
|
BR-1389
|
Insulin Degludec
|
Tresiba Flextouch
|
100 Units/mL
|
Solution for Injection (SC)
|
Prescription Drug (RX)
|
3 mL Type I pre-filled pen (FlexTouch) [Box of 1's and 5's]
|
Antidiabetic
|
Novo Nordisk Production SAS
|
France
|
|
Novo Nordisk Pharmaceuticals (Philippines), Inc.
|
Novo Nordisk Pharmaceuticals (Philippines), Inc.
|
Monitored Release
|
10 March 2022
|
10 March 2027
|
View |
BR-1390_PI_01 NO RX SYMBOL.pdf
|
BR-1390
|
Romosozumab
|
Evenity
|
105 mg/ 1.17 mL
|
Solution for Injection (SC)
|
Prescription Drug (RX)
|
1 mL crystal zenith pre-filled syringe with chlorobutyl
elastomeric plunger-stopper and polypropylene plunger rod and flange extender with attached 276 x 12” stainless steel needle covered with elastomeric non-rigid needle shield and an outer plastic rigid needle shield cover (Box of 2's)
|
Drugs affecting bone structure and mineralization
|
Patheon Italia S.p.A
|
Italy
|
N/A
|
Zuellig Pharma Corporation
|
Zuellig Pharma Corporation
|
Monitored Release
|
29 March 2022
|
29 March 2025
|
View |
|
BR-1391
|
Heparin Sodium
|
Avirin
|
1,000 IU/mL
|
Solution for Injection (IV/SC)
|
Prescription Drug (RX)
|
5 mL Amber glass USP type 1 vial with 20 mm gray butyl rubber stopper (Box of 1's)
|
Antithrombotic Agents
|
2 World Laboratories
|
India
|
N/A
|
2 World Traders Subic Inc.
|
2 World Traders Subic Inc.
|
Renewal
|
30 March 2022
|
11 August 2026
|
View |
|
BR-1392
|
Rabies Vaccine (Inactivated)
|
Bioshoot
|
2.5 IU
|
Powder for Solution for Injection (IM)
|
Prescription Drug (RX)
|
Single dose. 2 mL Middle borosilicate glass vial
with chlorobutyl rubber stopper and aluminum plastic cap (Box of 1's and 5's).
|
Vaccines
|
Changchun Zhuoyi Biological Co., Ltd.
|
China
|
|
EC Zuric Biotherapies, Inc.
|
EC Zuric Biotherapies, Inc.
|
Initial
|
30 March 2022
|
30 March 2027
|
View |
|
BR-1393
|
Human Fibrinogen + Human Thrombin
|
TachoSil
|
5.5 mg/2.0 IU per cm2
|
Medicated Sponge
|
Prescription Drug (Rx)
|
Each medicated sponge is packed in PET-GAG and HDPE (Tyvek) blister foil. The blister is packed in aluminum foil sachet with a desiccant bag and enclosed in folding carton of the following pack sizes: (1) 3.0 cm x 2.5 cm (Box of 1's and 5's); (2) 4.8 cm x 4.8 cm (Box of 2's); and 9.5 cm x 4.8 cm (Box of 1's)
|
Local Hemostatic Agents
|
TAKEDA AUSTRIA GMBH
|
Austria
|
|
PE Pharma ENTERPRISES OPC
|
PE Pharma ENTERPRISES OPC
|
Renewal
|
07 April 2024
|
04 March 2029
|