| View |
|
DRP-14137
|
Risperidone
|
Rispemind
|
1 mg/mL
|
Oral Solution
|
-
|
Biofarma İlaç Sanayi Ve Ticaret A.Ş.
|
Turkey
|
Initial
|
30 June 2023
|
30 June 2028
|
| View |
|
DRP-14136
|
Pantoprazole (as sodium)
|
Maxzole
|
40mg
|
Powder For Intravenous Injection
|
-
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
Initial
|
30 June 2023
|
30 June 2028
|
| View |
|
DRP-14153
|
Piperacillin (as Sodium) + Tazobactam (as Sodium)
|
P-Pertaz 2.25
|
2 g/250 mg
|
Powder for Injection (I.V.)
|
-
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
Initial
|
30 June 2023
|
30 June 2028
|
| View |
|
DR-XY48787
|
Co-Amoxiclav
|
Spotclav DS 312.5
|
312.5 mg/ 5 mL Powder for Oral Suspension
|
Powder Oral Suspension
|
-
|
Sparsh Bio-Tech Pvt. Ltd.
|
India
|
Initial
|
30 June 2023
|
30 June 2028
|
| View |
|
DR-XY48788
|
Co-Amoxiclav
|
Spotclav 625
|
625mg
|
Film-Coated Tablets
|
-
|
Sparsh Bio-Tech Pvt. Ltd.
|
India
|
Initial
|
29 June 2023
|
29 June 2028
|
| View |
|
DRP-14152
|
Dapagliflozin
|
Glyhart
|
10 mg
|
Film-Coated Tablets
|
-
|
Inventia Healthcare Limited
|
India
|
Initial
|
30 June 2023
|
30 June 2028
|
| View |
|
DR-XY48783
|
Ursodeoxycholic Acid
|
Ursosan Forte
|
500 mg
|
Film Coated Tablet
|
-
|
PRO.MED.CS Praha A.S.
|
Czech Republic
|
Initial
|
29 June 2023
|
29 June 2028
|
| View |
|
DR-XY48802
|
Candesartan Cilexetil
|
Aiiracan 8
|
8mg
|
tablet
|
Angiotension II Receptor Antagonist
|
Unison Laboratories Co., Ltd
|
Thailand
|
Initial
|
30 June 2023
|
30 June 2028
|
| View |
|
BR-1446
|
Rituximab
|
Acellbia
|
100 mg/ 10 mL (10 mg/mL)
|
Concentrate For Solution For Infusion (Iv)
|
-
|
Joint Stock Company BIOCAD
|
Russia
|
Initial
|
30 June 2023
|
30 June 2028
|
| View |
|
DR-XY48796
|
Losartan Potassium
|
Angisartan
|
50mg
|
Film-Coated Tablets
|
-
|
Novagen Healthcare Private Limited
|
India
|
Initial
|
30 June 2023
|
30 June 2028
|
| View |
|
DR-XY48794
|
Topiramate
|
Toramig 25
|
25 mg
|
Film Coated Tablet
|
-
|
Unison Laboratories Co., Ltd.
|
Thailand
|
Initial
|
30 June 2023
|
30 June 2028
|
| View |
|
DR-XY48793
|
Topiramate
|
Toramig 50
|
50 mg
|
Film Coated Tablet
|
-
|
Unison Laboratories Co., Ltd.
|
Thailand
|
Initial
|
30 June 2023
|
30 June 2028
|
| View |
|
DR-XY48790
|
Cetrorelix (as acetate)
|
Cetrotide
|
250mcg
|
Lyophilized Powder For Injection
|
-
|
Fareva Pau 2
|
France
|
Initial
|
30 June 2023
|
30 June 2028
|
| View |
|
DRP-14149
|
Fenofibrate
|
Finofen
|
200 mg
|
Capsule
|
-
|
Laboratorio Eczane Pharma S.A.
|
Argentina
|
Initial
|
30 June 2023
|
30 June 2028
|
| View |
|
DRP-14138
|
Azithromycin (as dihydrate)
|
Zytact
|
200 mg / 5 mL
|
Oral Suspension
|
-
|
S Kant Healthcare Limited
|
India
|
Initial
|
30 June 2023
|
30 June 2028
|
| View |
|
DR-XY48800
|
Metformin Hydrchloride
|
Panfor Pr-500
|
500 mg
|
Prolonged-Release Tablet
|
-
|
Inventia Healthcare Limited
|
India
|
Initial
|
30 June 2023
|
30 June 2028
|
| View |
|
DR-XY48799
|
Fulvestrant
|
Fresetran
|
50mg/mL (250 mg/5 mL)
|
Solution for Injection (IM)
|
-
|
Laboratorios Farmalan S.A.
|
Spain
|
Initial
|
30 June 2023
|
30 June 2028
|
| View |
|
DR-XY48789
|
Ketoanalogues + Essential Amino Acids
|
None
|
Film-Coated Tablet
|
see reverse for fomulation
|
-
|
PT. Soho Industri Pharmasi
|
Indonesia
|
Initial
|
29 June 2023
|
29 June 2028
|
| View |
|
DRP-14147
|
Telmisartan + Hydrochlorothiazide
|
Tsartan Plus
|
40mg/12.5mg
|
Tablet
|
-
|
Inventia Healthcare Limited
|
India
|
Initial
|
30 June 2023
|
30 June 2028
|
| View |
|
DRP-14146
|
Telmisartan + Hydrochlorothiazide
|
Tsartan Plus
|
80mg/25mg
|
Tablet
|
-
|
Inventia Healthcare Limited
|
India
|
Initial
|
30 June 2023
|
30 June 2028
|