| View |
|
DR-XY47673
|
Letrozole
|
Brezole
|
2.5mg
|
Film-Coated Tablet
|
Antineoplastic (Aromatase Inhibitor)
|
|
|
Initial (Variation)
|
10 November 2022
|
25 January 2027
|
| View |
|
DR-XY47675
|
Ketoprofen
|
Ketotop
|
30 mg
|
Plaster
|
Non-Steroidal Anti-inflammatory and Antirheumatic
|
Handok Inc.
|
Korea
|
Initial
|
19 January 2022
|
19 January 2027
|
| View |
DR-XY47676_PI_01.pdf
|
DR-XY47676
|
Alpelisib
|
Pivikto
|
200 mg
|
Film-Coated Tablet (200 mg Daily Dose)
|
Antineoplastic Agent [Phosphatidylinositol-3-kinase
(Pi3K) Inhibitor]
|
Novartis Pharma Stein AG
|
Switzerland
|
Monitored Release
|
20 January 2022
|
20 January 2027
|
| View |
DR-XY47677_PI_01.pdf
|
DR-XY47677
|
Alpelisib
|
Pivikto
|
250 mg + 50 mg (250 mg daily dose)
|
Film-Coated Tablet
|
Antineoplastic Agent [Phosphatidylinositol-3-kinase
(Pi3K) Inhibitor]
|
Novartis Pharma Stein AG
|
Switzerland
|
Monitored Release
|
20 January 2022
|
20 January 2027
|
| View |
DR-XY47678_PI_01.pdf
|
DR-XY47678
|
Alpelisib
|
Pivikto
|
150 mg + 150 mg (300 mg daily dose)
|
Film-Coated Tablet
|
Antineoplastic Agent [Phosphatidylinositol-3-kinase
(Pi3K) Inhibitor]
|
Novartis Pharma Stein AG
|
Switzerland
|
Monitored Release
|
20 January 2022
|
20 January 2027
|
| View |
|
DR-XY47679
|
Tadalafil
|
Talafil
|
10 mg
|
Film-Coated Tablet
|
Urological (Drug Used in Erectile Dysfunction)
|
Lloyd Laboratories, Inc.
|
Philippines
|
Monitored Release
|
28 January 2022
|
28 January 2027
|
| View |
|
DR-XY4768
|
Amoxicillin (as trihydrate)
|
Moxydril
|
125mg/5mL
|
Powder for Suspension
|
-
|
Sydenham Laboratories, Inc.
|
Philippines
|
-
|
04 December 2020
|
28 February 2026
|
| View |
DR-XY47680_PI_01.pdf
|
DR-XY47680
|
Fosphenytoin Sodium
|
Aurantin
|
75 mg/mL Solution for Injection (I.M./I.V.) [equivalent to Phenytoin sodium 50 mg/mL after
administration]
|
Solution For Injection (IM/IV)
|
Antiepiletic (Hydantoin Derivative)
|
Pharmacia and Upjohn Company LLC
|
United States of America
|
Monitored Release (Compliance)
|
20 January 2022
|
20 January 2027
|
| View |
|
DR-XY47681
|
Cefpodoxime (As Proxetil)
|
Cefpo-200
|
200 mg
|
Tablet
|
Antibacterial (Cephalosporin)
|
Oman Pharmaceutical Products Co., LLC
|
Oman
|
Initial
|
21 January 2022
|
21 January 2027
|
| View |
|
DR-XY47682
|
Exemestane
|
Zymestan
|
25 mg
|
Tablet
|
Aromatase Inhibitor
|
Oman Pharmaceutical Products Co., LLC
|
Oman
|
Initial
|
21 January 2022
|
21 January 2027
|
| View |
|
DR-XY47683
|
Cefoperazone (as sodium) + Sulbactam (as sodium)
|
Razonam
|
1 g/500 mg
|
Powder for Injection (I.M./I.V.)
|
Antibacterial (Cephalosporin)
|
Theon Pharmaceuticals Limited
|
India
|
Initial
|
31 January 2022
|
31 January 2027
|
| View |
|
DR-XY47684
|
Caspofungin (as acetate)
|
Caspin
|
50mg
|
Powder for Concentrate for Solution for IV Infusion
|
Antimycotic
|
Jiangsu Hengrui Medicine Co., Ltd.
|
China
|
Initial
|
21 January 2022
|
21 January 2027
|
| View |
|
DR-XY47685
|
Thiamine Hydrochloride (Vitamin B1) + Pyridoxine Hydrochloride (Vitamin B6) + Cyanocobalamin (Vitamin B12)
|
None
|
100mg/5mg/50mcg
|
Tablet
|
Vitamin
|
Northfield Laboratories Inc.
|
Philippines
|
Initial
|
24 January 2022
|
24 January 2027
|
| View |
|
DR-XY47686
|
Docetaxel
|
Mydoce
|
10mg/mL
|
Concentrate Solution for IV Infusion : Antineoplastic
|
Antineoplastic
|
Mylan Laboratories Limited - OTL
|
India
|
Initial
|
25 January 2022
|
25 January 2027
|
| View |
|
DR-XY47687
|
Ascorbic Acid + Zinc
|
Proven-C
|
100 mg/10 mg (equivalent to 27.45mg Zinc Sulfate Monohydrate) per 5 mL
|
Syrup
|
Vitamin/Mineral
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
26 January 2022
|
26 January 2027
|
| View |
|
DR-XY47688
|
Salbutamol (As Sulfate)
|
Aerotamol
|
100mcg
|
Metered Dose Inhaler (200 Actuation)
|
Selective beta-2 adrenergic agonist
|
Inpac Pharma Co. Ltd
|
Thailand
|
Initial (Correction)
|
19 January 2023
|
26 January 2027
|
| View |
DR-XY47689_PI_01.pdf
|
DR-XY47689
|
Levetiracetam
|
Leveget
|
750mg
|
Film-Coated Tablet
|
Antiepileptic
|
Getz Pharma Pvt. Ltd.
|
Pakistan
|
Initial
|
26 January 2022
|
26 January 2027
|
| View |
|
DR-XY47690
|
Lemborexant
|
Dayvigo
|
5mg
|
Film-Coated Tablet
|
Orexin Receptor Antagonist
|
Eisai Manufacturing Limited
|
United Kingdom
|
Monitored Release
|
28 January 2022
|
28 January 2027
|
| View |
|
DR-XY47691
|
Lemborexant
|
Dayvigo
|
10mg
|
Film-Coated Tablet
|
Orexin Receptor Antagonist
|
Eisai Manufacturing Limited
|
United Kingdom
|
Monitored Release
|
28 January 2022
|
28 January 2027
|
| View |
|
DR-XY47692
|
Cholecalciferol (Vitamin D3)
|
None
|
1000 IU
|
Softgel Capsule
|
-
|
Northfield Laboratories Inc.
|
Philippines
|
-
|
28 January 2022
|
28 January 2027
|