| View |
|
DR-XY48773
|
Sorafenib (as tosilate)
|
Soravar 200
|
200mg
|
Film Coated Tablet
|
-
|
Intas Pharmaceuticals Limited
|
India
|
Monitored Release
|
13 June 2023
|
13 June 2028
|
| View |
|
DR-XY48774
|
Topotecan (as hydrochloride)
|
Toponova
|
2.5mg
|
Powder for Concentrate Solution for Infusion
|
-
|
Venus Remedies, Limited
|
India
|
Initial
|
13 June 2023
|
13 June 2028
|
| View |
|
DR-XY48775
|
Ciprofloxacin (as hydrochloride)
|
Ciprobay
|
500 mg
|
Film-Coated Tablet
|
-
|
Bayer Healthcare Manufacturing S.R.L
|
Italy
|
Initial (Reapplication) (Correction)
|
17 October 2023
|
20 June 2028
|
| View |
|
DR-XY48776
|
Montelukast (as sodium) + Levocetirizine hydrochloride
|
None
|
5mg/5mg
|
Chewable Tablet
|
Leukotriene Receptor Antagonist-Antihistamine Combination
|
Ajanta Pharma Limited
|
India
|
Initial
|
18 July 2023
|
18 July 2028
|
| View |
|
DR-XY48777
|
Montelukast (as sodium) + Levocetirizine
hydrochloride
|
None
|
5 mg/2.5 mg
|
Chewable Tablet
|
-
|
Ajanta Pharma Limited
|
India
|
Initial
|
22 June 2023
|
22 June 2028
|
| View |
|
DR-XY48779
|
Dexmedetomidine (as hydrochloride) in 0.9% Sodium
Chloride
|
|
4 mcg/mL
|
Solution for IV Infusion
|
Hypnotic and Sedative
|
Jiangsu Hengrui Medicine Co., Ltd.
|
China
|
Monitore Release [MR]
|
23 June 2023
|
23 June 2028
|
| View |
|
DR-XY48780
|
Multivitamins Minerals
|
None
|
Each film-coated tablet contains:
4 mg
5500 IU
Iron
Vitamin A Acetate
10 mg
Vitamin B1
3.4 mg
Vitamin B2
30 mg
Vitamin B3
Calcium-D Pantothenate (Vitamin Bs)
10 mg
Zinc
3 mg
Vitamin B6
15 mcg
Manganese Calcium
Iodine Magnesium Copper
150 mcg 50 mg
1 mg
15 mg
1 mg
40 mg
Biotin (Vitamin B7)
20 mcg
Folic Acid (Vitamin B9)
0.4 mg
Selenium
9 mcg
Chromium
15 mcg
Vitamin B12
125 mg
Molybdenum
15 mcg
Vitamin C
Vitamin D3
Vitamin E
7.5 mg
400 IU 30 IU
Potassium
Chloride
7.5 mg
|
Film-Coated Tablet
|
-
|
Herbion Pakistan Private Limited
|
Pakistan
|
Initial
|
23 June 2023
|
23 June 2028
|
| View |
|
DR-XY48781
|
Paclitaxel
|
None
|
6mg/mL (30mg/5mL)
|
Concentrate Solution for IV
Infusion
|
Antineoplastic Agent (Taxane)
|
Venus Remedies Limited
|
India
|
Initial
|
23 June 2023
|
23 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-XY48784
|
Cilostazol
|
Cilosol 100
|
100 mg
|
Tablet
|
Antithrombotic Agent (Platelet Aggregation Inhibitor)
|
Unison Laboratories Co., Ltd.
|
Thailand
|
Initial
|
23 June 2023
|
23 June 2028
|
| View |
|
DR-XY48785
|
Gefitinib
|
Gefiset 250
|
250 mg
|
Film-Coated Tablet
|
Antineoplastic (Protein Kinase Inhibitor)
|
Genepharm SA
|
Greece
|
Initial
|
23 June 2023
|
23 June 2028
|
| View |
|
DR-XY48786
|
Clotrimazole
|
Mno-Each
|
100mg
|
Vaginal Tablet
|
-
|
Akriti Pharmaceuticals Pvt. Ltd.
|
India
|
Initial
|
29 June 2023
|
29 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 |
|
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 |
|
DR-XY48790
|
Cetrorelix (as acetate)
|
Cetrotide
|
250mcg
|
Lyophilized Powder For Injection
|
-
|
Fareva Pau 2
|
France
|
Initial
|
30 June 2023
|
30 June 2028
|
| View |
|
DR-XY48791
|
Gabapentin
|
Gabafast
|
300 mg
|
Capsule
|
-
|
Kusum Healthcare Pvt. Ltd.
|
India
|
Initial
|
30 June 2023
|
30 June 2028
|
| View |
|
DR-XY48792
|
Topiramate
|
Toramig 100
|
100 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-XY48794
|
Topiramate
|
Toramig 25
|
25 mg
|
Film Coated Tablet
|
-
|
Unison Laboratories Co., Ltd.
|
Thailand
|
Initial
|
30 June 2023
|
30 June 2028
|