| View |
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DR-XY49027
|
Febuxostat
|
Febulas 40
|
40 mg
|
Film-Coated Tablet
|
Anti-gout (Preparation Inhibiting Uric Acid Production)
|
Delta Pharma Ltd.
|
Bangladesh
|
Initial
|
26 March 2024
|
26 March 2029
|
| View |
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DR-XY49028
|
Rivaroxaban
|
Verxaban
|
20 mg
|
Film-Coated Tablet
|
Antithrombotic Agent (Direct factor Xa inhibitor)
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
26 March 2024
|
26 March 2029
|
| View |
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DR-XY49029
|
Irinotecan hydrochloride (as trihydrate)
|
Insvex
|
20 mg/mL (40 mg/2 mL)
|
Concentrate Solution for IV Infusion
|
Antineoplastic Agent
|
Venus Remedies, Limited
|
India
|
Initial
|
27 March 2024
|
27 March 2029
|
| View |
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DR-XY49030
|
Norepinephrine (as bitartrate monohydrate)
|
Nefrinor
|
1 mg/mL (4 mg/4 mL)
|
Solution for Infusion (I.V.)
|
Adrenergic/Dopaminergic Agent.
|
Mefar İlaç Sanayii A.Ş.
|
Turkey
|
Initial
|
27 March 2024
|
27 March 2029
|
| View |
|
DR-XY49031
|
Ceftriaxone (as sodium)
|
Ceftrash-1000
|
1 g
|
Powder for Injection (I.M./I.V.)
|
Antibacterial (Third-Generation Cephalosporin)
|
Shamshree Lifesciences Ltd.
|
India
|
Initial
|
01 April 2024
|
01 April 2029
|
| View |
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DR-XY49032
|
0.9% Sodium Chloride
|
None
|
9 mg/mL (0.9% w/v)
|
Solution for Injection (IV
Infusion)
|
Electrolyte Replenisher
|
Shijiazhuang No. 4 Pharmaceutical Co., Ltd.
|
China
|
Initial
|
02 April 2024
|
02 April 2029
|
| View |
|
DR-XY49033
|
0.9% Sodium Chloride
|
None
|
9 mg/mL (0.9% w/v)
|
Solution for Injection (IV
Infusion)
|
Electrolyte Replenisher
|
Shijiazhuang No. 4 Pharmaceutical Co., Ltd.
|
China
|
Initial
|
02 April 2024
|
02 April 2029
|
| View |
|
DR-XY49034
|
Rivaroxaban
|
Verxaban
|
15 mg
|
Film-Coated Tablet
|
Antithrombotic Agent (Direct factor Xa inhibitor)
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
04 April 2024
|
04 April 2029
|
| View |
|
DR-XY49035
|
Rivaroxaban
|
Verxaban
|
10 mg
|
Film-Coated Tablet
|
Antithrombotic Agent (Direct factor Xa inhibitor)
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
04 April 2024
|
04 April 2029
|
| View |
|
DR-XY49036
|
Meropenem (as trihydrate)
|
Aemero 1000
|
1 g
|
Powder for Injection (I.V.)
|
Antibacterial (Carbapenem)
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
Initial
|
05 April 2024
|
05 April 2029
|
| View |
|
DR-XY49037
|
Meropenem (as trihydrate)
|
Aemero 500
|
500 mg
|
Powder for Injection (I.V.)
|
Antibacterial (Carbapenem)
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
Initial
|
05 April 2024
|
05 April 2029
|
| View |
|
DR-XY49038
|
Valsartan + Amlodipine (as besylate) +
Hydrochlorothiazide
|
Valcare AH 160/5/12.5
|
160 mg/ 5 mg/ 12.5 mg
|
Film-Coated Tablet.
|
Angiotensin II Receptor Blocker (ARB), Other
Combinations
|
Macleods Pharmaceuticals Limited
|
India
|
Initial
|
16 April 2024
|
16 April 2029
|
| View |
|
DR-XY49039
|
Valsartan + Amlodipine (as besylate) +
Hydrochlorothiazide
|
Valcare AH 160/5/25
|
160 mg/ 5 mg/ 25 mg
|
Film-Coated Tablet
|
Angiotensin II Receptor Blocker (ARB), Other
Combinations
|
Macleods Pharmaceuticals Limited
|
India
|
Initial (Correction)
|
15 May 2024
|
16 April 2029
|
| View |
|
DR-XY49040
|
Valsartan Amlodipine (as besylate) +
Hydrochlorothiazide
|
Valcare AH 160/10/12.5
|
160 mg/ 10 mg/ 12.5 mg
|
Film-Coated Tablet.
|
Angiotensin II Receptor Blocker (ARB), Other
Combinations
|
Macleods Pharmaceuticals Limited
|
India
|
Initial
|
16 April 2024
|
16 April 2029
|
| View |
|
DR-XY49041
|
Valsartan Amlodipine (as besylate) +
Hydrochlorothiazide
|
Valcare AH 160/10/25
|
160 mg/ 10 mg/ 25 mg
|
Film-Coated Tablet
|
Angiotensin II Receptor Blocker (ARB), Other
Combinations
|
Macleods Pharmaceuticals Limited
|
India
|
Initial
|
16 April 2024
|
16 April 2029
|
| View |
|
DR-XY49042
|
Valsartan + Amlodipine (as besylate) +
Hydrochlorothiazide
|
Valcare AH 320/10/25
|
320 mg/ 10 mg/ 25 mg
|
Film-Coated Tablet
|
Angiotensin II Receptor Blocker (ARB), Other Combinations
|
Macleods Pharmaceuticals Limited
|
India
|
Initial
|
16 April 2024
|
16 April 2029
|
| View |
|
DR-XY49043
|
Glucose + Amino Acids + Electrolytes + Lipids.
|
Nutriflex Omega Special
|
|
Emulsion for Intravenous Infusion
|
Solutions for Parenteral Nutrition
|
B. Braun Melsungen AG
|
Germany
|
Initial
|
16 April 2024
|
16 April 2029
|
| View |
|
DR-XY49044
|
Hydroxyethyl Starch 200/0.5 Sodium Chloride.
|
HES-200
|
30 g/ 4.5 g (200/0.5) per 500 mL
|
Solution for Injection
(IV)
|
Blood Substitute and Plasma Protein Fractions
|
Shandong Qidu Pharmaceutical Co., Ltd.
|
China
|
Initial (Correction)
|
21 May 2024
|
16 April 2029
|
| View |
|
DR-XY49045
|
Hydroxyethyl Starch 130/0.4+ Sodium Chloride
|
HES-130
|
30 g/ 4.5 g (130/0.4) per 500 mL
|
Solution for Injection.
(IV)
|
Blood Substitute and Plasma Protein Fractions
|
Shandong Qidu Pharmaceutical Co., Ltd.
|
China
|
Initial (Correction)
|
28 June 2024
|
16 April 2029
|
| View |
|
DR-XY49046
|
Hydroxyethyl Starch 130/0.4+ Sodium Chloride
|
HES-130
|
15 g/ 2.25 g (130/0.4) per 250 mL
|
Solution for Injection (IV)
|
Blood Substitute and Plasma Protein Fractions
|
Shandong Qidu Pharmaceutical Co., Ltd.
|
China
|
Initial (Correction)
|
21 May 2024
|
16 April 2029
|