| View |
BR-983_PI_01.pdf
|
BR-983
|
Ustekinumab
|
Stelara
|
90 mg/mL
|
Solution for Injection (SC)
|
Prescription Drug (RX)
|
Single dose. 1 mL Pre-filled glass syringe with a
fixed 27G, half-inch needle and needle cover (Box of 1's)
|
Interleukin Inhibitors
|
Cilag AG
|
Switzerland
|
N/A
|
Johnson & Johnson (Philippines), Inc.
|
Johnson & Johnson (Philippines), Inc.
|
Renewal
|
07 October 2024
|
14 October 2029
|
| View |
|
BR-986
|
Menotrophin
|
Gynogen HP
|
75 IU
|
Lyophilized Powder for Solution for Injection
(IM/SC)
|
Prescription Drug (RX)
|
2 mL USP Type I clear glass vial with grey bromobutyl
rubber stopper and aluminum flip-off seal (menotrophin as drug product) + 2 mL (Net content: 1 mL) USP Type I clear glass ampoule (0.9% sodium chloride as diluent) (Box of l’s]
|
Gonadotropins
|
Sanzyme (P) Ltd.
|
India
|
|
MedEthix Inc.
|
MedEthix Inc.
|
Initial (from Monitored Release)
|
27 July 2022
|
11 April 2027
|
| View |
BR-990_PI_01.pdf
|
BR-990
|
Insulin Lispro
|
Humalog Mix50 Kwikpen
|
100 Units/mL (3.5 mg/mL) Suspension for Injection (SC) (50% Insulin Lispro and 50% Insulin Lispro Protamine)
|
Suspension for Injection (SC)
|
Prescription Drug (RX)
|
3 mL Type I pre-filled clear glass pen [Kwikpen] sealed with red halobutyl plunger at the bottom of the cartridge + bilayer elastomeric disc seal [Product contact layer: grey halobutyl and non-product contact layer: red isoprene] at the top (Box of 5's)
|
-
|
Eli Lilly Italia S.p.A.
|
Italy
|
N/A
|
Zuellig Pharma Corporation
|
Zuellig Pharma Corporation
|
Monitored Release (Variation)
|
28 October 2022
|
28 October 2027
|
| View |
|
BR-991
|
Urofollitropin
|
Endogen HP
|
75 IU
|
Lyophilized Powder for Solution for Injection
(IM/SC)
|
Prescription Drug (RX)
|
2 mL USP Type I clear glass vial with grey bromobutyl
rubber stopper and aluminum flip-off seal (urofollitropin as drug product) + 2 mL (Net content: 1 mL) USP Type I clear glass ampoule (0.9% sodium chloride as diluent) [Box of l’s]
|
Gonadotropins
|
Sanzyme (P) Ltd.
|
India
|
|
MedEthix Inc.
|
MedEthix Inc.
|
Initial (from Monitored Release)
|
27 July 2022
|
11 April 2027
|
| View |
|
BR-992
|
Menotrophin
|
Menopur
|
Formulation: After reconstitution, 1 mL contains highly purified Menotrophin (human menopausal gonadotrophin, HMG) corresponding to:
Follicle Stimulating Hormone (FSH) Luteinizing Hormone (LH)
75 IU 75 IU
|
Lyophilized Powder for Solution for Injection (IM/SC)
|
Prescription Drug (RX)
|
One box contains two trays. Each tray holds five 2mL
Type glass vial with a rubber stopper and blue cap + five 1 mL Type I glass ampoules with blue and red ring (0.9% Sodium Chloride Solution as diluent).
|
Gonadotrophins
|
Ferring GmbH
|
Germany
|
|
Metro Drug, Inc.
|
|
Renewal
|
14 October 2020
|
24 September 2028
|
| 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 |
|
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-007
|
Diphtheria, Tetanus, Pertussis, Hepatitis B And Haemophilus Influenzae Type B Conjugate Vaccine (Adsorbed)
|
None
|
Each dose (0.5 mL) contains:
Diphtheria Toxoid ≤25 Lf (≥30 IU)
Tetanus Toxoid ≥2,5 Lf (≥40 IU)
Hepatitis B (rDNA) >2.5 mcg
Bordetella pertussis (whole cell) ≤16 OU (≥4.0 IU)
Haemophilus influenzae Conjugate Vaccine10 mcg
|
Suspension for Injection (IM)
|
Prescription Drug (Rx)
|
Single dose. 0.5 mL Type I clear, colorless glass vial (Box of 1's and 50's)
|
Vaccines
|
Serum Institute of India Private Limited
|
India
|
|
Medical Vaccines Online Deliveries
|
Medical Vaccines Online Deliveries
|
Renewal
|
18 September 2024
|
07 May 2029
|
| 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)
|
Antithrombotic agents
|
Rovi Contract Manufacturing, S.L.
|
Spain
|
Laboratorios Farmaceuticos Rovi S.A.
|
STADA Philippines Inc.
|
STADA Philippines Inc.
|
Renewal
|
30 June 2024
|
08 October 2029
|
| View |
|
BRP-012
|
Bemiparin sodium
|
Hibor
|
10,000IU anti-Factor Xa/0.4mL
|
Solution For Injection (SC)
|
Prescription Drug (Rx)
|
0.5 mL (Net content: 0.4 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)
|
Antithrombotic agents
|
Rovi Contract Manufacturing, S.L.
|
Spain
|
Laboratorios Farmaceuticos Rovi S.A.
|
STADA Philippines Inc.
|
STADA Philippines Inc.
|
Renewal
|
23 June 2024
|
08 October 2029
|
| 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)
|
Antidiabetics
|
Sanofi-Aventis Deutschland GmbH
|
Germany
|
|
Sanofi-Aventis Philippines, Inc.
|
Natrapharm, Inc.
|
Renewal
|
22 March 2023
|
26 February 2028
|
| 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-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
|