View |
|
BRP-002
|
Hepatitis A Vaccine (Live, Attenuated)
|
Mevac-A
|
NLT 6.50 Lg CCID 50
|
Vial
|
Prescription Drug (RX)
|
Glass vial + glass ampoule (Sterile Water for Injection
as diluent) x 0.5 mL (Box of 1's)
|
-
|
Zhejiang Pukang Biotechnology Co. Ltd.
|
China
|
N/A
|
Vaxines Trading Inc.
|
Vaxines Trading Inc.
|
-
|
27 April 2022
|
30 March 2027
|
View |
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BRP-004
|
Diphtheria, Tetanus, Pertussis, Hepatitis B (rDNA) and
Haemophilus influenzae Type B Conjugate Vaccine
(Adsorbed)
|
None
|
Formulation: Each dose (0.5 mL) contains: Diptheria Toxoid.............<25 Lfl> 30 I.U.)
Tetanus Toxoid.............> 2.5 Lf> 40 I.U.) . Bordetella pertussis (whole cell)............< 16 OU (>4 1.U.) . Hepatitis B (rDNA)....................10 mcg Haemophilus influenzae congugate vaccine............ > 10 mcg
|
Suspension for Injection (IM)
|
Prescription Drug (RX)
|
Multidose. Type I clear, colorless glass vial x 5 mL (Box of l’s and 50's).
|
-
|
Serum Institute of India Pvt. Ltd.
|
India
|
N/A
|
Medical Vaccines Online Deliveries
|
Medical Vaccines Online Deliveries
|
Renewal
|
02 June 2022
|
07 May 2027
|
View |
|
BRP-008
|
Bemiparin Sodium
|
Hibor
|
2,500IU anti-Factor Xa/0.2ml
|
Solution For Injection (SC)
|
Prescription Drug (Rx)
|
0.5 mL (Net content: 0.2 mL) Type I pre-filled glass syringe barrel with chlorobutyl rubber plunger, polypropylene plunger rod and 27 x 12" AISI Type 304 stainless steel needle and a rigid needle shield, enclosed in a plastic tray (Box of 2's)
|
-
|
Rovi Contract Manufacturing, S.L.
|
Spain
|
Laboratorios Farmaceuticos Rovi S.A.
|
STADA Philippines Inc.
|
STADA Philippines Inc.
|
Initial [revalidation]
|
10 October 2022
|
08 October 2024
|
View |
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BRP-009
|
Bemiparin Sodium
|
Hibor
|
3,500IU anti-Factor Xa/0.2mL
|
Solution For Injection (SC)
|
Prescription Drug (Rx)
|
0.5 mL (Net content: 0.2 mL) Type I pre-filled glass
syringe barrel with chlorobutyl rubber plunger, polypropylene plunger rod and 276 x 12" AISI Type 304 stainless steel needle and a rigid needle shield, enclosed in a plastic tray (Box of 2's)
|
-
|
Rovi Contract Manufacturing, S.L.
|
Spain
|
Laboratorios Farmaceuticos Rovi S.A.
|
STADA Philippines Inc.
|
STADA Philippines Inc.
|
Initial [revalidation]
|
10 October 2022
|
08 October 2024
|
View |
|
BRP-010
|
Bemiparin Sodium
|
Hibor
|
5,000IU anti-Factor Xa/0.2ml
|
Solution For Injection (SC)
|
Prescription Drug (Rx)
|
0.5 mL (Net content: 0.2 mL) Type I pre-filled glass
syringe barrel with chlorobutyl rubber plunger, polypropylene plunger rod and 276 x 12" AISI Type 304 stainless steel needle and a rigid needle shield, enclosed in a plastic tray (Box of 2's)
|
-
|
Rovi Contract Manufacturing, S.L.
|
Spain
|
Laboratorios Farmaceuticos Rovi S.A.
|
STADA Philippines Inc.
|
STADA Philippines Inc.
|
Initial [revalidation]
|
10 October 2022
|
08 October 2024
|
View |
|
BRP-011
|
Bemiparin Sodium
|
Hibor
|
7,500IU anti-Factor Xa/0.3ml
|
Solution For Injection (SC)
|
Prescription Drug (Rx)
|
0.5 mL (Net content: 0.3 mL) Type I pre-filled glass
syringe barrel with chlorobutyl rubber plunger, polypropylene plunger rod and 276 x 12" AISI Type 304 stainless steel needle and a rigid needle shield, enclosed in a plastic tray (Box of 2's)
|
-
|
Rovi Contract Manufacturing, S.L.
|
Spain
|
Laboratorios Farmaceuticos Rovi S.A.
|
STADA Philippines Inc.
|
STADA Philippines Inc.
|
Initial [revalidation]
|
10 October 2022
|
08 October 2024
|
View |
|
BRP-013
|
Insulin Glargine
|
Lantus
|
100 I.U./mL (3.64 mg Insulin glargine equivalent to 100 units Human insulin)
|
Solution For Injection (Sc)
|
Prescription Drug (RX)
|
10mL Type I clear and colorless glass vial
|
-
|
|
|
|
|
|
-
|
05 November 2021
|
17 February 2026
|
View |
|
BRP-013-01
|
Insulin Glargine
|
Podevta
|
100 I.U./mL (3.64 mg Insulin glargine equivalent to 100 units Human insulin)
|
Solution For Injection (Sc)
|
Prescription Drug (RX)
|
10 mL Type I Clear and Colorless Glass Vial (Box of
l's)
|
-
|
Sanofi-Aventis Deutschland GmbH
|
Germany
|
|
Sanofi-Aventis Philippines, Inc.
|
Sanofi Pasteur, Inc.
|
-
|
12 May 2021
|
17 February 2026
|
View |
|
BRP-014
|
Lantus Solostar
|
Insulin Glargine
|
100 Units (equivalent to 3.64 mg)/mL
|
Solution for Injection (SC)
|
Prescription Drug (RX)
|
3 mL Type I colorless glass cartridge assembled in a pre-filled pen (Box of 5's)
|
-
|
Sanofi-Aventis Deutschland GmbH
|
Germany
|
N/A
|
Sanofi-Aventis Philippines, Inc.
|
Sanofi-Aventis Philippines, Inc.
|
Renewal
|
17 February 2023
|
26 February 2028
|
View |
|
BRP-014-01
|
Insulin Glargine
|
Podevta
|
100 Units (equivalent to 3.64 mg)/mL
|
Solution For Injection (SC)
|
Prescription Drug (RX)
|
3 mL Type I colorless glass cartridge assembled in a pre-filled pen (Box of 5's)
|
-
|
Sanofi-Aventis Deutschland GmbH
|
|
Germany
|
N/A
|
Sanofi-Aventis Philippines, Inc.
|
Renewal
|
22 March 2023
|
26 February 2028
|
View |
|
BRP-014-02
|
Insulin Glargine
|
None
|
100 Units (equivalent to 3.64 mg)/mL
|
Solution for Injection (SC)
|
Prescription Drug (Rx)
|
3 mL Type I colorless glass cartridge assembled in a prefilled pen (Box of 5's)
|
Antidiabetics
|
Sanofi-Aventis Deutschland GmbH
|
Germany
|
N/A
|
Sanofi-Aventis Philippines Inc
|
Sanofi Pasteur, Inc.
|
CLIDP Conversion
|
09 January 2024
|
26 February 2028
|
View |
|
BRP-015
|
Insulin Glargine
|
Lantus
|
100 IU (equivalent to 3.64 mg)/mL
|
Solution for Injection (SC)
|
Prescription Drug (RX)
|
3 mL Type I colorless glass cartridge with bromobutyl rubber stopper (Box of 5's)
|
-
|
Sanofi-Aventis Deutschland GmbH, Bereich Handelsprodukte
|
Germany
|
N/A
|
Sanofi-Aventis Philippines, Inc.
|
Sanofi-Aventis Philippines, Inc.
|
Initial
|
17 January 2023
|
17 January 2028
|
View |
|
BRP-016
|
Heparin Sodium
|
Kabihep
|
1000 IU/mL
|
Solution For Injection (Iv/Sc)
|
Prescription Drug (RX)
|
USP Type I clear and colorless glass vial with green flip-off seal X 5 mL (Box of 25's)
|
-
|
Gland Pharma Limited
|
India
|
|
Fresenius Kabi Philippines, Inc.
|
Fresenius Kabi Philippines, Inc.
|
-
|
21 February 2020
|
21 November 2024
|
View |
|
BRP-017
|
Biphasic Isophane Human Insulin 30/70 (recombinant DNA)
|
Insulet 30/70
|
100 IU/mL
|
Suspension For Injection (Im/Sc)
|
Prescription Drug (RX)
|
USP Type II Clear glass vial with red flip-off seal x 4mL and 10mL (box of 1's)
|
Antidiabetic
|
Aristopharma Ltd.
|
Bangladesh
|
|
Sahar Internatioal Trading, Inc.
|
Amara Prohealth Solutions Corporation
|
Renewal
|
03 October 2018
|
24 October 2028
|
View |
|
BRP-018
|
Biphasic Isophane Human Insulin 50/50 (Recombinant DNA)
|
Insulet 50/50
|
100 IU/mL
|
Suspension For Injection (Im/Sc)
|
Prescription Drug (RX)
|
USP Type II Clear glass vial with red flip-off seal x 4mL and 10mL (box of 1's)
|
Antidiabetic
|
Aristopharma Ltd.
|
Bangladesh
|
|
SAHAR INTERNATIONAL TRADING, INC.
|
SAHAR INTERNATIONAL TRADING, INC.
|
Renewal
|
13 November 2018
|
24 October 2028
|
View |
|
BRP-019
|
Regular Insulin Human (Recombinant DNA)
|
Insulet R
|
100 IU/mL
|
Solution For Injection (Im-Iv-Sc)
|
Prescription Drug (RX)
|
USP Type II Clear glass vial with red flip-off seal x 4mL and 10mL (box of 1's)
|
Antidiabetic
|
Aristopharma Ltd.
|
Bangladesh
|
|
SAHAR INTERNATIONAL TRADING, INC.
|
SAHAR INTERNATIONAL TRADING, INC.
|
Renewal
|
13 November 2018
|
24 October 2028
|
View |
|
BRP-020
|
Isophane Insulin Human (Recombinant DNA)
|
Insulet N
|
100 IU/mL
|
Suspension For Injection (Im/Sc)
|
Prescription Drug (RX)
|
USP Type II Clear glass vial with red flip-off seal x 4mL and 10mL (box of 1's)
|
Antidiabetic
|
Aristopharma Ltd.
|
Bangladesh
|
|
SAHAR INTERNATIONAL TRADING, INC.
|
SAHAR INTERNATIONAL TRADING, INC.
|
Renewal
|
13 November 2018
|
24 October 2028
|
View |
|
BRP-021
|
Clostridium Botulinum Toxin Type A
|
Nabota
|
100 Units
|
Lyophilized Powder for Injection (IM/SC)
|
Prescription Drug (RX)
|
USP Type I Glass Vial with Rubber Butyl Stopper and Aluminum seal with white flip-off cap x 10mL (Box of 1's)
|
Muscle Relaxant
|
Daewoong Pharmaceutical Co., Ltd.
|
Korea
|
|
Daewoong Pharma Philippines Inc.
|
Daewoong Pharma Philippines Inc.
|
Renewal (Reconstruction)
|
08 March 2024
|
26 January 2025
|
View |
|
BRP-030
|
Insulin Glulisine
|
Apidra Solostar
|
3.49 mg/mL (equivalent to 100 Units/mL)
|
Solution For Injection (SC)
|
Prescription Drug (RX)
|
Pre-filled Pen in 3 mL Cartridge (Box of 5's)
|
-
|
Sanofi-Aventis Deutschland GmbH
|
Germany
|
|
Sanofi-Aventis Philippines, Inc.
|
Sanofi-Aventis Philippines, Inc.
|
-
|
26 February 2021
|
28 October 2025
|
View |
|
BRP-034
|
Biphasic Isophane Insulin (Rdna Origin)
|
Wosulin-30/70
|
100 IU/mL
|
Suspension For Injection (Sc)
|
Prescription Drug (RX)
|
10mL glass vial with rubber stopper and brown flip-off seal
|
Intermediate acting insulin
|
Wockhardt Limited
|
India
|
|
Ambica International Corp.
|
GX International Inc.
|
Renewal
|
21 May 2022
|
05 September 2027
|