| View |
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DR-XY49134
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Citicoline
|
Kalbrain
|
125 mg/mL
|
Solution for Injection (IM/IV)
|
Psychostimulant and nootropic.
|
PT Dankos Farma
|
Indonesia
|
Initial
|
01 August 2024
|
02 August 2029
|
| View |
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DR-XY49135
|
Tenofovir Disoproxil Fumarate
|
Tenohope
|
300 mg
|
Film-Coated Tablet
|
Antiviral (Nucleoside/ Nucleotide Reverse
se Transcriptase Inhibitor)
|
Macleods Pharmaceuticals Limited
|
India
|
Initial
|
16 July 2024
|
16 July 2029
|
| View |
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DR-XY49136
|
Metformin (as hydrochloride) + Glibenclamide
|
Glucovance
|
500 mg / 5 mg
|
Film-Coated Tablet
|
Blood Glucose Lowering Drug (Biguanide/Sulfonylurea)
|
PT. Merck Tbk
|
Indonesia
|
Initial
|
31 July 2024
|
31 July 2029
|
| View |
|
DR-XY49137
|
Metformin (as hydrochloride) + Glibenclamide
|
Glucovance
|
500 mg/2.50 mg
|
Film-Coated Tablet
|
Blood Glucose Lowering Drug (Biguanide/Sulfonylurea)
|
PT. Merck Tbk
|
Indonesia
|
Initial
|
31 July 2024
|
01 August 2029
|
| View |
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DR-XY49138
|
Lidocaine Hydrochloride
|
Inocaine
|
20 mg/mL (2% w/v)
|
Solution for Injection (I.M./S.C.)
|
Local Anesthetic (Amide)
|
Pharmaniaga Lifesciences Sdn. Bhd.
|
Malaysia
|
Initial
|
31 July 2024
|
31 July 2029
|
| View |
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DR-XY49139
|
Dapagliflozin
|
Dapazin
|
10 mg
|
Film-Coated Tablet
|
Blood Glucose Lowering Drug
(Sodium-glucose co-transporter 2 (SGLT2) inhibitor).
|
Ajanta Pharma Limited
|
India
|
Initial
|
26 July 2024
|
26 July 2029
|
| View |
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DR-XY49140
|
Mecobalamin
|
Kalmeco
|
500 mcg
|
Capsule
|
Vitamin B12 (Cyanocobalamin and analogue)
|
PT. Kalbe Farma Tbk
|
Indonesia
|
Initial
|
31 July 2024
|
31 July 2029
|
| View |
|
DR-XY49141
|
Lidocaine (as hydrochloride)
|
Lignovell
|
10 mg/dose
|
Spray
|
Local Anaesthetic (Amide)
|
PT. Novell Pharmaceutical Laboratories
|
Indonesia
|
Initial
|
31 July 2024
|
31 July 2029
|
| View |
|
DR-XY49142
|
Clopidogrel (as bisulfate)
|
Platexan
|
75 mg
|
Film-Coated Tablet
|
Antithrom botic Agent (Platelet aggregation inhibitor incl. heparin)
|
Samjin Pharmaceutical Co., Ltd.
|
Korea
|
Initial
|
30 July 2024
|
30 July 2029
|
| View |
|
DR-XY49143
|
Betamethasone Dipropionate
|
Betaroid
|
500 mcg/g (0.05% w/w)
|
Cream
|
Corticosteroid
|
Yash Medicare Pvt. Ltd.
|
India
|
Initial
|
01 August 2024
|
31 July 2029
|
| View |
|
DR-XY49144
|
Silver Sulfadiazine
|
Silvirin
|
20 mg/g (1%) w/w
|
Cream
|
Antibacterial (Sulphonamide)
|
Raptakos Brett & Co. Ltd.
|
India
|
Initial
|
01 August 2024
|
08 March 2028
|
| View |
|
DR-XY49145
|
Metformin Hydrochloride
|
Aartmin 850
|
850 mg
|
Film-Coated Tablet
|
Blood Glucose Lowering Drug (Biguanide)
|
Pinnacle Life Science Private Limited (Subsidiary of
Aarti Drugs Limited)
|
India
|
Initial
|
31 July 2024
|
31 July 2029
|
| View |
|
DR-XY49146
|
Paclitaxel
|
Paxus
|
6 mg/mL (100 mg/16.7mL)
|
Concentrate Solution for IV Infusion
|
Antineoplastic
|
PT Global Onkolab Farma
|
Indonesia
|
Initial
|
31 July 2024
|
31 July 2026
|
| View |
|
DR-XY49147
|
Levofloxacin (as hemihydrate)
|
Levores
|
5 mg/mL (750 mg/15 mL)
|
Solution for IV Infusion.
|
Antibacterial (Fluoroquinolone)
|
PT. Novell Pharmaceutical Laboratories
|
Indonesia
|
Initial
|
31 July 2024
|
31 July 2029
|
| View |
|
DR-XY49148
|
Celecoxib
|
Novexib
|
200 mg
|
Capsule
|
Non-steroidal Anti-inflammatory and Antirheumatic
|
PT. Novell Pharmaceutical Laboratories
|
Indonesia
|
Initial
|
07 August 2024
|
07 August 2029
|
| View |
|
DR-XY49149
|
Terazosin (as hydrochloride)
|
Terasin
|
2 mg
|
Tablet
|
Alpha-Adrenoreceptor Antagonist
|
Y.S.P. Industries (M) Sdn. Bhd.
|
Malaysia
|
Initial
|
07 August 2024
|
06 August 2029
|
| View |
|
DR-XY49150
|
Glutathione (as sodium)
|
Tad-2500
|
100 mg/mL (2.5 g/25 mL)
|
Powder for Solution for Injection (IV Infusion)
|
Antidote
|
Biomedica Foscama Group S.P.A.
|
Italy
|
Monitored Release (Reapplication)
|
31 July 2024
|
31 July 2029
|
| View |
|
DR-XY49151
|
Cefotaxime (as sodium)
|
Luotaxime
|
1 g
|
Powder for Injection (IM/IV)
|
Antibacterial (Third-generation cephalosporin)
|
Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.
|
China
|
Initial
|
31 July 2024
|
31 July 2029
|
| View |
|
DR-XY49152
|
Atropine (as sulfate)
|
Lotrin
|
1mg/mL
|
Solution for Injection (IM/IV/SC)
|
Anticholinergic
|
Pharmaniaga Lifesciences Sdn. Bhd.
|
Malaysia
|
Initial
|
01 August 2024
|
01 August 2029
|
| View |
|
DR-XY49153
|
Multivitamins
|
Nuraxon Plus
|
FORMULATION:
Each Softgel Capsule contains:
Thiamine (as Benfotiamine) 100 mg
Pyridoxine hydrochloride (Vitamin B6)
3 mg
Folic Acid (Vitamin B9) 1 mg
Methylcobalamin (Vitamin B12) 1 mg
Alpha Lipoic Acid
Inositol 100 mg
|
Softgel Capsule
|
Vitamins
|
Softgel Healthcare Pvt. Ltd.
|
India
|
Monitored Release (Re-application)
|
06 August 2024
|
06 August 2029
|