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BR-990_PI_01.pdf
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BR-990
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Insulin Lispro
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Humalog Mix50 Kwikpen
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100 Units/mL (3.5 mg/mL) Suspension for Injection (SC) (50% Insulin Lispro and 50% Insulin Lispro Protamine)
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Suspension for Injection (SC)
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Prescription Drug (RX)
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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)
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-
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Eli Lilly Italia S.p.A.
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Italy
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N/A
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Zuellig Pharma Corporation
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Zuellig Pharma Corporation
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Monitored Release (Variation)
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28 October 2022
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28 October 2027
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View |
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BR-991
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Urofollitropin
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Endogen HP
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75 IU
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Lyophilized Powder for Solution for Injection
(IM/SC)
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Prescription Drug (RX)
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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]
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Gonadotropins
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Sanzyme (P) Ltd.
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India
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MedEthix Inc.
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MedEthix Inc.
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Initial (from Monitored Release)
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27 July 2022
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11 April 2027
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View |
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BR-992
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Menotrophin
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Menopur
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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
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Lyophilized Powder for Solution for Injection (IM/SC)
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Prescription Drug (RX)
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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).
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Gonadotrophins
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Ferring GmbH
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Germany
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Metro Drug, Inc.
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Renewal
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14 October 2020
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24 September 2028
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View |
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BR-993
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Insulin human (rDNA)
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Mixtard 30
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100 IU/mL (70% Isophane + 30% Soluble Insulin Human)
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Solution For Injection (SC)
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Prescription Drug (RX)
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10 mL Type I Glass Vial closed with Bromobutyl/
Polyisoprene Rubber Stopper and a Protective Tamper proof Cap
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-
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Novo Nordisk A/S
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Denmark
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N/A
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Novo Nordisk Pharmaceuticals (Philippines), Inc.
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N/A
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-
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09 June 2021
|
11 November 2024
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View |
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BR-995
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Insulin Human (rDNA)
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Insulyf-R (Regular)
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100 IU/mL
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Solution For Injection (Sc)
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Prescription Drug (RX)
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USP Type I glass vial x 10 mL (Box of l’s)
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Insulins and Analogues
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Biocon Limited
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India
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UNILAB, Inc.
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UNILAB, Inc.
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Automatic Renewal
|
14 October 2021
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05 November 2026
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View |
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BR-996
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Isophane Insulin
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Insulyf-N (Nph)
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100 IU/mL
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Suspension For Injection (Sc)
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Prescription Drug (RX)
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USP Type I glass vial x 10 mL (Box of l's)
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Insulins and Analogues
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Biocon Limited
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India
|
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UNILAB, Inc.
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UNILAB, Inc.
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Renewal
|
22 October 2021
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05 November 2026
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View |
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BR-997
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Insulin Human (rDNA)
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Insulyf-30/70 (Biphasic)
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100 IU/mL
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Suspension For Injection (Sc)
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Prescription Drug (RX)
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USP Type I glass vial x 10 mL (Box of l's)
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Insulins and Analogues
|
Biocon Limited
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India
|
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UNILAB, Inc.
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UNILAB, Inc.
|
Automatic Renewal
|
01 October 2021
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05 November 2026
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View |
BR-999_PI_01.pdf
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BR-999
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Insulin Degludec
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Tresiba Flextouch
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100 Units/mL
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Solution For Injection (SC)
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Prescription Drug (Rx)
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Cartridge (Type I Glass) with a Plunger (Halobutyl)
and a Stopper (Halobutyl/Polyisoprene) contained in a Pre-filled Multidose Disposable Pen made of Polypropylene
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-
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Novo Nordisk A/S
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Denmark
|
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Novo Nordisk Pharmaceuticals (Phils.) Inc.
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Novo Nordisk Pharmaceuticals (Phils.) Inc.
|
Initial
|
12 May 2021
|
16 December 2024
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View |
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BRP-002
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Hepatitis A Vaccine (Live, Attenuated)
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Mevac-A
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NLT 6.50 Lg CCID 50
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Vial
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Prescription Drug (RX)
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Glass vial + glass ampoule (Sterile Water for Injection
as diluent) x 0.5 mL (Box of 1's)
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-
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Zhejiang Pukang Biotechnology Co. Ltd.
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China
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N/A
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Vaxines Trading Inc.
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Vaxines Trading Inc.
|
-
|
27 April 2022
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30 March 2027
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View |
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BRP-004
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Diphtheria, Tetanus, Pertussis, Hepatitis B (rDNA) and
Haemophilus influenzae Type B Conjugate Vaccine
(Adsorbed)
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None
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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
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Suspension for Injection (IM)
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Prescription Drug (RX)
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Multidose. Type I clear, colorless glass vial x 5 mL (Box of l’s and 50's).
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-
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Serum Institute of India Pvt. Ltd.
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India
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N/A
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Medical Vaccines Online Deliveries
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Medical Vaccines Online Deliveries
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Renewal
|
02 June 2022
|
07 May 2027
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View |
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BRP-008
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Bemiparin sodium
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Hibor
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2,500IU anti-Factor Xa/0.2ml
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Solution For Injection (SC)
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Prescription Drug (Rx)
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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)
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Antithrombotic agents
|
Rovi Contract Manufacturing, S.L.
|
Spain
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Laboratorios Farmaceuticos Rovi S.A.
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STADA Philippines Inc.
|
STADA Philippines Inc.
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Renewal
|
10 July 2024
|
08 October 2029
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View |
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BRP-009
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Bemiparin sodium
|
Hibor
|
3,500IU anti-Factor Xa/0.2mL
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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)
|
Antithrombotic agents
|
Rovi Contract Manufacturing, S.L.
|
Spain
|
Laboratorios Farmaceuticos Rovi S.A.
|
STADA Philippines Inc.
|
STADA Philippines Inc.
|
Renewal
|
14 June 2024
|
08 October 2029
|
View |
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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)
|
Antithrombotic agents
|
Rovi Contract Manufacturing, S.L.
|
Spain
|
Laboratorios Farmaceuticos Rovi S.A.
|
STADA Philippines Inc.
|
STADA Philippines Inc.
|
Renewal
|
14 June 2024
|
08 October 2029
|
View |
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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 |
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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 |
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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 |
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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 |
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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 |
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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
|