| View |
|
DR-XY46074
|
Epirubicin hydrochloride
|
Epicin
|
2mg/mL
|
Concentrate for Injection (IV/Intravesical)
|
Antineoplastic
|
TTY Biopharm Company Limited Li Factory
|
Taiwan
|
Renewal
|
16 August 2024
|
06 October 2029
|
| View |
|
DR-XY46075
|
Irinotecan Hydrochloride
|
Irinocan 40
|
40mg/ 2mL
|
Concentrate for Solution for IV Infusion
|
Antineoplastic (Cell-cycle specific agents)
|
Intas Pharmaceuticals Limited
|
India
|
Automatic Renewal
|
13 November 2022
|
06 October 2027
|
| View |
|
DR-XY46076
|
Levofloxacin (as Hemihydrate)
|
Oftaquix
|
15mg/ mL
|
Ophthalmic Solution
|
Anti-infective
|
Santen Pharmaceutical Co., Ltd.
|
Japan
|
Monitored Release (Correction)
|
31 May 2021
|
24 October 2025
|
| View |
|
DR-XY46077
|
Ciclosporin
|
Ikervis
|
1mg/ mL
|
Ophthalmic emulsion
|
Immunosuppresant
|
Excelvision
|
France
|
Monitored Release
|
19 October 2017
|
19 October 2025
|
| View |
|
DR-XY46078
|
Candesartan Cilexetil + Hydrochlorothiazide
|
Treatan-D
|
16mg/ 12.5mg
|
Tablet
|
Angiotensin II Antagonist + Diuretic
|
PharmEvo (Pvt.) Limited
|
Pakistan
|
Automatic Renewal
|
28 September 2022
|
19 October 2027
|
| View |
|
DR-XY46080
|
Diquafosol Sodium
|
Diquas
|
3% w/w (30mg/mL)
|
Ophthalmic solution
|
P2Y2 (Purinoceptor)agonist
|
Santen Pharmaceutical Co., Ltd. (Noto Plant)
|
Japan
|
Compliance MR
|
06 October 2017
|
06 October 2025
|
| View |
|
DR-XY46081
|
Montelukast (as Sodium)
|
Averkaz
|
4mg
|
Chewable Tablet
|
-
|
The Acme lab Ltd.
|
Bangladesh
|
Automatic Renewal
|
01 September 2021
|
09 October 2027
|
| View |
|
DR-XY46084
|
Gentamicin (as sulfate)
|
Purogen
|
40mg/ mL
|
Solution for Injection (IM/IV)
|
-
|
Shandong Shenglu Pharmaceutical Co., Ltd.
|
China
|
Automatic Renewal
|
13 December 2022
|
09 October 2027
|
| View |
|
DR-XY46085
|
Moxifloxacin (as hydrochloride)
|
Imox
|
5 mg/ mL (5%)
|
Ophthalmic Solution
|
Anti-infective
|
The ACME Laboratories Ltd.
|
Bangladesh
|
Automatic Renewal
|
03 January 2023
|
19 October 2027
|
| View |
|
DR-XY46086
|
Vitamin B1 + B6 + B12 + Zinc
|
Polynerv 250 + Zinc 20
|
250mg/ 250mg/ 1mg/ 20mg
|
Tablet
|
Vitamin/Mineral
|
Hizon Laboratories, Inc.
|
Philippines
|
Automatic Renewal
|
30 August 2022
|
06 October 2027
|
| View |
|
DR-XY46089
|
Ezetimibe + Atorvastatin
|
Atozet
|
10mg/ 10mg
|
Film-coated Tablet
|
HMG CoA reductase inhibitors in combination with other lipid modifying agents
|
MSD International GmbH (Puerto Rico Branch)
|
Puerto Rico
|
Compliance MR
|
17 May 2018
|
11 October 2024
|
| View |
|
DR-XY46090
|
Ezetimibe + Atorvastatin
|
Atozet
|
10mg/ 20mg
|
Film-Coated Tablet
|
HMG CoA reductase inhibitors in combination with other lipid modifying agents
|
MSD International GmbH (Puerto Rico Branch)
|
Puerto Rico
|
Compliance MR
|
17 May 2018
|
11 October 2024
|
| View |
|
DR-XY46091
|
Ezetimibe + Atorvastatin
|
Atozet
|
10mg/ 40mg
|
Film-Coated Tablet
|
HMG CoA reductase inhibitors in combination with other lipid modifying agents
|
MSD International GmbH (Puerto Rico Branch)
|
Puerto Rico
|
Compliance MR
|
17 May 2018
|
11 October 2024
|
| View |
|
DR-XY46092
|
Ezetimibe + Atorvastatin
|
Atozet
|
10mg/ 80mg
|
Film-Coated Tablet
|
HMG CoA reductase inhibitors in combination with other lipid modifying agents
|
MSD International GmbH (Puerto Rico Branch)
|
Puerto Rico
|
Compliance MR
|
17 May 2018
|
11 October 2024
|
| View |
|
DR-XY46094
|
Guaifenesin
|
Mucosin
|
100mg/ 5mL
|
Syrup
|
Expectorants
|
SCHEELE LABORATORIES PHILS., INC.
|
Philippines
|
Automatic Renewal
|
17 October 2022
|
10 October 2027
|
| View |
|
DR-XY46097
|
Pemetrexed (As Disodium Hemipentahydrate)
|
Pemirex
|
300 mg
|
Lyophilized Powder For IV Infusion
|
Antineoplastic (Folic Acid Analogues
|
Korea United Pharin. Inc.
|
korea
|
Initial (from Monitored Release status)
|
08 September 2022
|
12 October 2027
|
| View |
DR-XY46099_PI_01.pdf
|
DR-XY46099
|
Iron (as Ferric Carboxymaltose)
|
Ferinject
|
50 mg /mL
|
Solution for Injection (I.V.)
|
-
|
IDT Biologika GmbH
|
Germany
|
Initial (from Monitored release)
|
16 February 2023
|
13 October 2027
|
| View |
|
DR-XY46100
|
LACTATED RINGER'S
|
None
|
[see reverse]
|
Solution for Infusion
|
-
|
B. BRAUN MEDICAL INDUSTRIES SDN. BHD.
|
Malaysia
|
Automatic Renewal
|
29 September 2022
|
13 October 2027
|
| View |
|
DR-XY46101
|
Paclitaxel
|
Paclitero
|
6mg/mL
|
Solution for I.V. Infusion
|
Antineoplastic
|
Hetero Labs Limited
|
India
|
Renewal
|
28 May 2024
|
18 October 2029
|
| View |
|
DR-XY46104
|
Methylphenidate hydrochloride
|
Medikinet
|
5mg
|
Tablet
|
Centrally-Acting Sympathomimetic
|
Medice Arzneimittel Pütter GmbH & Co. KG
|
Germany
|
Automatic Renewal
|
11 February 2023
|
19 February 2028
|