| View |
|
DRP-11600
|
Esomeprazole (as sodium)
|
Essium
|
40 mg
|
Lyophilized Powder for Injection/I.V. Infusion
|
-
|
Aroma İlaç San. Ltd. ŞTİ
|
Turkey
|
-
|
31 March 2022
|
31 March 2027
|
| View |
|
DRP-11606
|
Nicardipine Hydrochloride
|
Nicarsaph
|
1mg/mL
|
Solution for IV Infusion
|
Calcium Channel Blocker (Dihydropyridine derivative)
|
Kilitch Drugs (India) Ltd.
|
India
|
Initial
|
06 April 2022
|
06 April 2027
|
| View |
|
DRP-11623
|
Norepinephrine (as bitartrate)
|
Norepinsaph-1
|
1mg/mL
|
Concentrate Solution for I.V. Infusion
|
Adrenergic/Dopaminergic Agent
|
Kilitch Drugs (India) Ltd.
|
India
|
Initial
|
06 April 2022
|
06 April 2027
|
| View |
|
DR-XY47909
|
Salmeterol Xinafoate + Fluticasone Propionate
|
Respiro
|
25 mcg/125 mcg
|
Metered Dose Inhaler
|
Adrenergic / Corticosteroid
|
Deva Holding A.Ş.
|
Turkey
|
Initial
|
08 April 2022
|
08 April 2027
|
| View |
|
DR-XY47916
|
Acetylcysteine
|
None
|
200 mg
|
Powder for Oral Solution
|
Mucolytic
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
08 April 2022
|
08 April 2027
|
| View |
|
DR-XY47910
|
Salmeterol Xinafoate + Fluticasone Propionate
|
Respiro
|
25mcg/50mcg
|
Metered Dose Inhaler
|
Adrenergic / Corticosteroid
|
Deva Holding A.Ş.
|
Turkey
|
Initial
|
08 April 2022
|
08 April 2027
|
| View |
|
DRP-11023
|
Olmesartan Medoximil
|
Olmenov-40
|
40mg
|
Tablet
|
Angiotensin II Receptor Blocker (ARB)
|
Evertogen Life Sciences Limited
|
India
|
Initial
|
06 April 2022
|
06 April 2027
|
| View |
BR-1397_PI_01.pdf
|
BR-1397
|
Brolucizumab
|
Vsiqq
|
120 mg/mL (27.6 mg/0.23 mL)
|
Solution for Injection (Intravitreal)
|
Antineovascularization Agent
|
Novartis Pharma Stein AG Technical Operations
|
Switzerland
|
Monitored Release (MR)
|
01 April 2022
|
01 April 2027
|
| View |
|
DRP-11654
|
Cefotaxime (As Sodium)
|
Accetaxime
|
1 g
|
Powder for Solution for Injection (IM/IV)
|
Third generation cephalosporin
|
Medisure Laboratories Pakistan (Pvt.) Ltd.
|
Pakistan
|
Initial
|
07 April 2022
|
07 April 2027
|
| View |
|
DRP-11607
|
Co-Amoxiclav
|
Amoclav
|
457 mg/ 5 mL
|
Powder For Suspension
|
Antibacterial (Penicillin Beta- Lactamase Inhibitor Combination)
|
Bilim Ilac San Ve Tic. A.S.
|
Turkey
|
Renewal
|
16 May 2022
|
15 June 2027
|
| View |
|
DR-XY41549
|
Celecoxib
|
Aubrex
|
400 mg
|
Capsule
|
Non-Steroidal Anti-Inflammatory Drug (NSAID)
|
Lloyd Laboratories, Inc.
|
Philippines
|
Renewal
|
18 August 2023
|
03 December 2028
|
| View |
|
DR-XY47887
|
Pemetrexed (as disodium)
|
Cartrexed
|
100 mg
|
Lyophilized Powder for Injection (IV Infusion)
|
Antineoplastic Agent (Folic Acid Analogues)
|
Shanghai Chemo Wanbang Biopharma Co., Ltd.
|
China
|
Initial
|
31 March 2022
|
31 March 2027
|
| View |
|
DRP-11559
|
Multivitamins + Minerals
|
Vita-M
|
Each softgel capsule contains: Ascorbic Acid, BP
50 mg Niacinamide, BP................
30 mg Tocopherol (Vitamin E),BP.............
...... 10 mg Thiamine Mononitrate (Vitamin B1) BP.....................5 mg Riboflavin (Vitamin B2)......... Pyridoxine Hydrochloride (Vitamin B6)BP............. .5 mg Folic Acid, BP............
..0.5 mg Cyanocobalamin (Vitamin B12) BP........ .......10 mcg
322 mg
Vitamin A (as palmitate) BP.. Cholecalciferol (Vitamin Dz) BP.. Dibasic Calcium Phosphate BP. Ferrous Fumarate BP. Magnesium Sulfate BP. Potassium Sulfate BP............. Copper Sulfate BP............ Potassium Iodate BP.......
5 mg
..76.06 mg
.30 mg ........... 10 mg
.2 mg
..1 mg
|
Softgel Capsule
|
-
|
Mascot Health Series Pvt. Ltd.
|
India
|
-
|
31 March 2022
|
31 March 2027
|
| View |
|
DR-XY47861
|
Ceftazidime (as pentahydrate)
|
Sitidime
|
1g
|
Powder for Injection (IM/IV)
|
-
|
Zhuhai Kinhoo Pharmaceutical Co. Ltd.
|
China
|
-
|
31 March 2022
|
31 March 2027
|
| View |
|
DRHR-1188
|
Hydrogen Peroxide
|
None
|
3% w/v (10 volumes)
|
Topical Solution
|
Antiseptic/Disinfectant
|
DANN'S AID LABORATORIES INC.
|
Philippines
|
-
|
11 April 2022
|
24 March 2027
|
| View |
|
DRHR-1548
|
Carbocisteine
|
Broncocent
|
100 mg/5mL
|
Suspension
|
MUCOLYTIC
|
Swisspharma Research Laboratories, Inc.
|
Philippines
|
-
|
07 April 2022
|
20 January 2027
|
| View |
BR-924_PI_01.pdf
|
BR-924
|
Meningococcal Groups A, C, W-135 and Y Conjugate
Vaccine
|
Nimenrix
|
Formulation: After reconstitution, each dose (0.5 mL) contains: Neisseria meningitidis group A polysaccharide* Neisseria meningitidis group C polysaccharide* Neisseria meningitidis group W-135 polysaccharide* Neisseria meningitidis group Y polysaccharide*
5 mcg 5 mcg 5 mcg 5 mcg
* conjugated to tetanus toxoid carrier protein
44 mcg
|
Lyophilized Powder for Solution for Injection (IM)
|
-
|
Pfizer Manufacturing Belgium NV
|
Belgium
|
Initial (Variation)
|
03 August 2022
|
03 August 2027
|
| View |
|
DR-XY47922
|
Peritoneal Dialysis Solution Low Calcium with 2.5% Dextrose
|
Dianeal PD-4
|
Formulation:
Each 100 mL contains:
Dextrose hydrous, USP
Sodium chloride, USP
Sodium lactate, USP
Calcium chloride dihydrate, USP
Magnesium chloride hexahydrate, USP
2.5 g 538 mg
448 mg
18.3 mg
5.08 mg
|
Dialysis Solution.
(Intraperitoneal)
|
Peritoneal Dialytic
|
Baxter Manufacturing (Thailand) Co., Ltd.
|
Thailand
|
Initial (Variation)
|
08 September 2023
|
24 August 2028
|
| View |
|
DR-XY47923
|
Peritoneal Dialysis Solution Low Calcium with 1.5%
Dextrose
|
Dianeal Pd-4
|
Each 100 mL contains:
Dextrose hydrous, USP
Sodium chloride, USP
Sodium lactate, USP
Calcium chloride dihydrate, USP
Magnesium chloride hexahydrate, USP
1.5 g 538 mg
448 mg
18.3 mg
5.08 mg
|
Dialysis Solution.
|
Peritoneal Dialytic
|
Baxter Manufacturing (Thailand) Co., Ltd.
|
Thailand
|
Initial (Variation)
|
24 August 2023
|
24 August 2028
|
| View |
|
DR-XY 45879
|
Osimertinib (As Mesylate)
|
Tagrisso
|
40 mg
|
Film-Coated Tablet
|
-
|
AstraZeneca AB
|
Sweden
|
-
|
08 April 2022
|
09 May 2027
|