| View |
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BR-1000
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Japanese Encephalitis Virus (Live, Attenuated)
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Imojev
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Formulation: After reconstitution, one dose (0.5 mL) contains 4.0-5.8 log Plaque Forming Units (PFU) live, attenuated, recombinant Japanese Encephalitis Virus.
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Powder for Suspension for Injection (SC)
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-
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Government Pharmaceutical Organization - Merieux Biological Products Co., Ltd.
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Thailand
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Initial (Variation)
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13 July 2022
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13 July 2027
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| View |
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BR-1004
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Heparin Sodium
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Heparin Leo
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1,000 IU/mL
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Solution For Injection (IV/SC)
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Anticoagulant
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Leo Pharma A/S
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Denmark
|
Automatic Renewal (Variation)
|
09 March 2023
|
09 March 2028
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| View |
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BR-1005
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Heparin Sodium
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Heparin Leo
|
5,000 IU/mL
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Solution For Injection (IV/SC)
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Antithrombotic Agents
|
Leo Pharma A/S
|
Denmark
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Initial (Variation)
|
23 March 2023
|
23 March 2028
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| View |
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BR-1008
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Human Insulin (rDNA)
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Actrapid
|
100 IU/mL
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Solution For Injection (Im/Iv/Sc)
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Antidiabetic
|
Novo Nordisk A/S
|
Denmark
|
Renewal
|
05 April 2024
|
06 May 2029
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| View |
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BR-1009
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Insulin Human
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Insulatard Flexpen
|
100 U/mL
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Suspension For Injection (SC)
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-
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Novo Nordisk A/S
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Denmark
|
Regular Renewal
|
08 March 2021
|
13 August 2025
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| View |
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BR-1010
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Isophane Insulin Human, Recombinant DNA
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Insulatard
|
100 IU/mL
|
Suspension For Injection
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Intermediate-acting Insulin
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Novo Nordisk A/S
|
Denmark
|
Renewal
|
02 August 2023
|
20 August 2028
|
| View |
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BR-1011
|
Insulin Detemir
|
Levemir FlexPen
|
100 U/ mL
|
Solution for injection
|
Antidiabetic
|
Novo Nordisk A/S
|
Denmark
|
Automatic Renewal
|
03 February 2022
|
22 December 2026
|
| View |
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BR-1012
|
Insulin Human
|
Mixtard 30 FlexPen
|
100 IU/mL (Soluble Insulin 30% and Isophane Insulin 70%)
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Suspension For Injection (SC)
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-
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Novo Nordisk A/S
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Denmark
|
-
|
08 March 2021
|
25 August 2025
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| View |
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BR-1013
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Somatropin
|
Norditropin SimpleXx
|
5 mg / 1.5 mL
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Solution For Injection (SC)
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-
|
Novo Nordisk A/S
|
Denmark
|
-
|
19 April 2021
|
15 November 2025
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| View |
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BR-1014
|
Biphasic Insulin Aspart 30
|
NovoMix 30 FlexPen
|
100 IU/ mL
|
Suspension for injection (SC)
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Antidiabetic
|
Novo Nordisk A/S
|
Denmark
|
Automatic Renewal
|
01 February 2022
|
21 December 2026
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| View |
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BR-1015
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Insulin Aspart
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NovoRapid Flexpen
|
100 IU/ mL
|
Solution For Injection (SC)
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-
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Novo Nordisk A/S
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Denmark
|
-
|
08 March 2021
|
13 August 2025
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| View |
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BR-1016
|
Liraglutide
|
Victoza
|
6mg/mL
|
Solution For Injection (SC)
|
-
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Novo Nordisk A/S
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Denmark
|
-
|
26 November 2021
|
07 February 2026
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| View |
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BR-1018
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Darbepoetin Alfa
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Nesp
|
20mcg/0.5mL
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Solution For Injection (I.V. / S.C.)
|
-
|
Terumo Corporation (Kofu Factory)
|
Japan
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Initial
|
09 October 2020
|
26 January 2025
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| View |
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BR-1019
|
Darbepoetin Alfa
|
Nesp
|
30mcg/0.5mL
|
Solution For Injection (I.V. / S.C.)
|
-
|
Terumo Corporation (Kofu Factory)
|
Japan
|
Initial
|
09 October 2020
|
26 January 2025
|
| View |
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BR-1020
|
Darbepoetin Alfa
|
Nesp
|
40mcg/0.5mL
|
Solution For Injection (I.V./S.C.)
|
-
|
Terumo Corporation (Kofu Factory)
|
Japan
|
Initial
|
09 October 2020
|
26 January 2025
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| View |
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BR-1026
|
Laronidase
|
Aldurazyme
|
580 mcg/mL (2.9 mg/5 mL)
|
Concentrated Solution for IV Infusion
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-
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Biomarin Pharmaceutical Inc.
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U.S.A
|
-
|
22 March 2022
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29 September 2026
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| View |
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BR-1046
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Insulin Glulisine
|
Apidra
|
3.49 mg/mL (equivalent to 100 Units/mL)
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Solution for Subcutaneous/Continuous SC Pump Infusion/
Intravenous Injection
|
-
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Sanofi-Aventis Deutschland GmbH
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Germany
|
-
|
26 February 2021
|
28 October 2025
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| View |
BR-1047_PI_01.pdf
|
BR-1047
|
Agalsidase Beta
|
Fabrazyme
|
5 mg
|
Powder for Concentrate for Solution for Infusion (IV)
|
Enzyme
|
Genzyme Ireland Limited
|
Ireland
|
Initial (from Monitored Release)
|
13 September 2024
|
13 September 2029
|
| View |
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BR-1048
|
Agalsidase Beta
|
Fabrazyme
|
35 mg
|
Powder for Concentrate for Solution for
Infusion (IV)
|
-
|
Genzyme Ireland Limited
|
Ireland
|
Renewal
|
21 November 2023
|
07 December 2028
|
| View |
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BR-1053
|
Insulin Lispro (rDNA origin)
|
Humalog Kwikpen
|
100 units/mL
|
Solution for Injection (IM/IV/SC)
|
-
|
Eli Lilly Italia S.p.A.
|
Italy
|
Initial (Variation)
|
25 October 2022
|
25 October 2027
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