| View |
|
DR-XY48468
|
Sugammadex (As Sodium)
|
Neuromard
|
100 mg/mL (200 mg/2 mL)
|
Solution For Injection (IV)
|
-
|
Immacule Lifesciences Private Limited
|
India
|
Initial
|
16 November 2022
|
16 November 2027
|
| View |
|
DR-XY48469
|
Pregabalin
|
Zonik
|
150 mg
|
Capsule
|
-
|
Kusum Healthcare Pvt. Ltd.
|
India
|
Initial
|
17 November 2022
|
17 November 2027
|
| View |
|
DR-XY48470
|
Pregabalin
|
Zonik
|
75 mg
|
Capsule
|
-
|
Kusum Healthcare Pvt. Ltd.
|
Indonesia
|
Initial
|
17 November 2022
|
17 November 2027
|
| View |
|
DR-XY48471
|
Dolutegravir (as sodium) + Lamivudine + Tenofovir
Disoproxil Fumarate
|
None
|
50mg/300mg/300mg
|
Film-Coated Tablet
|
Antiviral Combination
|
Sun Pharmaceutical Industries Limited
|
India
|
Monitored Release (Reconstruction)
|
12 August 2024
|
17 November 2027
|
| View |
|
DR-XY48472
|
Brigatinib
|
Alunbrig
|
30mg
|
Film-Coated Tablet
|
-
|
Penn Pharmaceutical Services Limited
|
United Kingdom
|
Monitored Release
|
18 November 2022
|
18 November 2027
|
| View |
|
DR-XY48473
|
Brigatinib
|
Alunbrig
|
90mg
|
Film-Coated Tablet
|
-
|
Penn Pharmaceutical Services Limited
|
United Kingdom
|
Monitored Release
|
18 November 2022
|
18 November 2027
|
| View |
|
DR-XY48474
|
Brigatinib
|
Alunbrig
|
180mg
|
Film-Coated Tablet
|
-
|
Penn Pharmaceutical Services Limited
|
United Kingdom
|
Monitored Release
|
18 November 2022
|
18 November 2027
|
| View |
|
DR-XY48475
|
Gefitinib
|
Gefitero
|
250 mg
|
Film-Coated Tablet
|
-
|
Hetero Labs Limited (Unit-V, Block-VB)
|
India
|
Initial
|
18 November 2022
|
18 November 2027
|
| View |
|
DR-XY48476
|
Leuprorelin Acetate
|
Luprodex
|
11.25 mg
|
Lyophilized Powder For Injection (IM/SC)
|
-
|
Bharat Serums and Vaccines Limited
|
India
|
Initial
|
18 November 2022
|
18 November 2027
|
| View |
|
DR-XY48477
|
Leuprorelin Acetate
|
Luprolex
|
11.25mg/mL
|
Powder for Prolonged-Release
Suspension for Injection (IM/SC)
|
-
|
Takeda Pharmaceutical Company Limited (Hikari
Plant)
|
United Kingdom
|
Initial
|
24 November 2022
|
24 November 2027
|
| View |
|
DR-XY48478
|
Leuprorelin Acetate
|
Luprolex
|
3.75mg/mL
|
Powder For Prolong-Release Suspension for Injection (IM/SC)
|
-
|
Takeda Pharmaceutical Company Limited (Hikari
Plant)
|
Netherlands
|
Initial
|
24 November 2022
|
24 November 2027
|
| View |
|
DR-XY48479
|
Leuprorelin Acetate
|
Luprolex
|
1.88mg/mL
|
Powder For Prolong-Release Suspension for Injection (IM/SC)
|
-
|
Takeda Pharmaceutical Company Limited (Hikari
Plant)
|
Japan
|
Initial
|
24 November 2022
|
24 November 2027
|
| View |
|
DR-XY48480
|
Pregabalin
|
Nervica 150
|
150 mg
|
Capsule
|
-
|
Unison Laboratories Co. Ltd.
|
Thailand
|
Initial
|
24 November 2022
|
24 November 2027
|
| View |
|
DR-XY48481
|
Piroxicam + Methyl Salicylate + Methol + Eugenol
|
FlanaxPlus
|
5 mg/ 102 mg/ 54.3 mg/ 13.7 mg per gram
|
Topical Gel
|
-
|
PT Taisho Pharmaceutical Indonesia Tbk.
|
Indonesia
|
Initial [OTC](Correction)
|
17 January 2023
|
22 November 2027
|
| View |
|
DR-XY48482
|
Rivaroxaban
|
None
|
20 mg
|
Film-Coated Tablet
|
-
|
Beker Laboratories
|
Algeria
|
Initial
|
22 November 2022
|
22 November 2027
|
| View |
DR-XY48483_PI_01.pdf
|
DR-XY48483
|
Indacaterol (as Acetate) + Glycopyrronium (as Bromide) + Mometasone Furoate
|
Enerzair Breezhaler
|
150 mcg/50mcg/160mcg
|
Powder For Inhalation In Hard Capsule
|
-
|
Novartis Pharma Stein AG
|
Malaysia
|
Monitored Release
|
22 November 2022
|
22 November 2025
|
| View |
|
DR-XY48484
|
Abiraterone Acetate
|
Abiravitae
|
250mg
|
Tablet
|
-
|
Atlas Pharm, S.A.
|
Nepal
|
Initial
|
21 November 2022
|
21 November 2027
|
| View |
DR-XY48485_PI_01.pdf
|
DR-XY48485
|
Peritoneal Dialysis Solution With 2.3% Dextrose
|
Peritoneal Dialysis Solution with 2.3 % Dextrose
|
Formulation:
Each L of Solution contains:
Glucose (Dextrose) 22.73 g
equivalent to 25.0 g glucose monohydrate
Sodium Chloride
5.786 g
Sodium Lactate
3.925 g
Calcium Chloride Dihydrate
257.3 mg
Magnesium Chloride Hexahydrate
101.7 mg
|
Solution for Peritoneal Dialysis
|
Peritoneal Dialytic
|
Fresenius Medical Care Production Sdn. Bhd.
|
Malaysia
|
Initial (Variation)
|
31 July 2024
|
31 July 2029
|
| View |
DR-XY48486_PI_01.pdf
|
DR-XY48486
|
Silodosin
|
Ureleve
|
8mg
|
Capsule
|
-
|
Ajanta Pharma Limited
|
India
|
Monitored Release
|
23 November 2022
|
23 November 2027
|
| View |
|
DR-XY48487
|
Entecavir (as Monohydrate)
|
Envira 1
|
1 mg
|
Film Coated Tablet
|
-
|
Unison Laboratories Co., Ltd.
|
Thailand
|
Initial
|
23 November 2022
|
23 November 2027
|