| View |
|
DR-XY45876
|
Cholecalciferol D-3 (Vit.D)
|
None
|
1000 IU
|
Tablet
|
VITAMIN
|
Nutra Manufacturing, Inc-USA
|
U.S.A.
|
Automatic Renewal
|
03 March 2022
|
09 May 2027
|
| View |
DR-XY45878_PI_01.pdf
|
DR-XY45878
|
Osimertinib (as mesylate)
|
Tagrisso
|
80 mg
|
Film-Coated Tablet
|
Protein Kinase Inhibitors
|
AstraZeneca AB
|
Sweden
|
Initial (from Monitored Release) [Variation]
|
29 August 2023
|
29 August 2028
|
| View |
DR-XY45879_PI_01.pdf
|
DR-XY45879
|
Osimertinib (as mesylate)
|
Tagrisso
|
40 mg
|
Film-Coated Tablet
|
Protein Kinase Inhibitors
|
AstraZeneca AB
|
Sweden
|
Initial (from Monitored Release) [Variation]
|
29 August 2023
|
29 August 2028
|
| View |
DR-XY45882_PI_01.pdf
|
DR-XY45882
|
Arginine Hydrochloride
|
Tivortin
|
42 mg/mL (4.2% w/v)
|
Solution For Infusion (I.V.)
|
Amino Acid
|
Yuria-Pharm Ltd.
|
Ukraine
|
Compliance
|
09 May 2017
|
09 May 2025
|
| View |
DR-XY45886_PI_01.pdf
|
DR-XY45886
|
Dolutegravir (as Sodium)
|
Tivicay
|
50 mg
|
Film-Coated Tablet
|
-
|
Glaxo Operations UK Ltd
|
United Kingdom
|
Initial (from Monitored release)
|
17 August 2023
|
16 August 2027
|
| View |
|
DR-XY45893
|
5% Dextrose in 0.9% Sodium Chloride
|
None
|
5 g/900 mg per 100 mL
|
Solution for IV Infusion
|
Parenteral Rehydration Solution
|
B. BRAUN MEDICAL INDUSTRIES SDN. BHD.
|
Malaysia
|
Automatic Renewal
|
26 July 2022
|
05 June 2027
|
| View |
|
DR-XY45901
|
Efavirenz
|
None
|
600 mg
|
Film-Coated Tablet
|
-
|
Hetero Labs Limited (Unit III)
|
India
|
Initial (form Monitored Release)
|
18 May 2023
|
23 May 2027
|
| View |
|
DR-XY45902
|
Lamivudine + Zidovudine
|
Zidolam
|
150/ 300mg
|
Film-Coated Tablet
|
Nucleoside Reverse Transcriptase Inhibitor Combination
|
Hetero Labs Limited
|
India
|
Renewal
|
26 May 2022
|
23 May 2027
|
| View |
DR-XY45903_PI_01.pdf
|
DR-XY45903
|
Lopinavir + Ritonavir
|
Ritocom
|
200 mg/50 mg
|
Film-Coated Tablet
|
Direct-Acting Antiviral
|
Hetero Labs Limited (Unit III)
|
India
|
Initial (from Monitored Release)
|
11 July 2024
|
23 May 2027
|
| View |
|
DR-XY45905
|
Nevirapine
|
Nevivir
|
200mg
|
Tablet
|
Non-Nucleoside Reverse Transcriptase Inhibitor
|
Hetero Labs Limited
|
India
|
Renewal
|
22 November 2023
|
19 February 2029
|
| View |
|
DR-XY45908
|
Fentanyl (as citrate)
|
Fresanyl
|
50mcg/ mL (100mcg/2mL)
|
Solution for Injection (IV/IM)
|
Opiod Analgesic
|
Fresenius Kabi Manufacturing SA (Pty) Ltd.
|
Republic of South Africa
|
Automatic Renewal
|
07 April 2022
|
24 May 2027
|
| View |
|
DR-XY45910
|
Cetirizine Dihydrochloride
|
None
|
2.5mg/ mL
|
Syrup (Oral Drops)
|
Antihistamine
|
Amherst Laboratories, Inc.
|
Philippines
|
Automatic Renewal
|
08 September 2022
|
05 June 2027
|
| View |
|
DR-XY45911
|
Cetirizine Dihydrochloride
|
None
|
5mg/ 5mL
|
Syrup
|
Antihistamine
|
Amherst Laboratories, Inc.
|
Philippines
|
Automatic Renewal
|
31 August 2022
|
05 June 2027
|
| View |
|
DR-XY45916
|
Paracetamol
|
None
|
125mg/ 5mL
|
Syrup
|
Analgesic / Antipyretic
|
Fortis Medi Pharmaceutical, Inc.
|
Philippines
|
Automatic Renewal
|
08 April 2022
|
29 May 2027
|
| View |
|
DR-XY45917
|
Adefovir Dipivoxil
|
Liverax
|
10 mg
|
Film-Coated Tablet
|
Antiviral
|
Cisen Pharmaceutical Co., Ltd.
|
China
|
Automatic Renewal
|
20 January 2023
|
11 January 2028
|
| View |
|
DR-XY45926
|
Meropenem (as Trihydrate)
|
Romepen
|
500mg
|
Powder for Injection (IV)
|
Antibacterial (Carbapenem)
|
Cosmas Research Lab Ltd.
|
India
|
Renewal
|
18 May 2022
|
06 June 2027
|
| View |
DR-XY45929_PI_01.pdf
|
DR-XY45929
|
Lamivudine + Tenofovir disoproxil fumarate
|
None
|
300 mg/ 300 mg
|
Film-Coated Tablet
|
-
|
Hetero Labs Limited (Unit III)
|
|
Initial (from Monitored Release) correction
|
21 March 2023
|
06 June 2027
|
| View |
|
DR-XY45929 (for DOH Use Only)
|
Lamivudine + Tenofovir disoproxil fumarate
|
None
|
300 mg/ 300 mg
|
Film-Coated Tablet
|
Nucleoside and Nucleotide Reverse Transcriptase
Inhibitor Combination
|
Hetero Labs Limited (Unit III)
|
India
|
Initial (from Monitored Release)
|
26 October 2022
|
06 June 2027
|
| View |
|
DR-XY45938
|
Ketoconazole + Zinc (As Pyrithione)
|
Dermazole Plus
|
2%/1% w/v
|
Suspension (Shampoo)
|
-
|
Kusum Healthcare Private Limited
|
India
|
-
|
30 June 2020
|
21 June 2025
|
| View |
|
DR-XY45940
|
Topiramate
|
Gentop-100
|
100mg
|
Film-Coated Tablet
|
Anticonvulsant/Antiepileptic
|
Genpharma International Pvt. Ltd.
|
India
|
Renewal
|
21 April 2022
|
21 June 2027
|