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DRP-11484
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Thiamine Mononitrate (Vitamin B1) + Pyridoxine
Hydrochloride (Vitamin B6) + Cyanocobalamin
(Vitamin B12
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Ambiflex Plus
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300 mg/300 mg/1 mg
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Capsule
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Vitamin
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Fredun Pharmaceuticals Limited
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India
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Initial
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16 March 2022
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16 March 2027
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DRP-11469
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Multivitamins
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Vitgen
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Formulation:
Each film-coated tablet contains:
Ascorbic Acid......................500 mg Thiamine Mononitrate (Vitamin B1)........50 mg Nicotinamide (Vitamin B3)...................50 mg Riboflavin (Vitamin B2).......................20 mg Calcium Pantothenate (Vitamin B5)........20 mg Pyridoxine Hydrochloride (Vitamin B6)....5 mg Cyanocobalamin (Vitamin B12).............5 mcg
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Film-Coated Tablet
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Vitamin
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Azarias Pharmaceutical Laboratories Inc.,
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Philippines
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Initial
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15 March 2022
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15 March 2027
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DRP-11470
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Zinc
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Goldzinc
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10 mg (equivalent to 47.35 mg Zinc Picolinate)
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Film-Coated Tablet
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Mineral
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Lloyd Laboratories, Inc.
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Philippines
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Initial (OTC) (Correction)
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22 June 2022
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15 March 2027
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DRP-11473
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Zinc
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Picolin Z
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10 mg (equivalent to 47.35 mg Zinc Picolinate)
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Film-Coated Tablet
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-
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Lloyd Laboratories, Inc.
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Philippines
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Initial (OTC) (Correction)
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22 June 2022
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15 March 2027
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| View |
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DRP-11483
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Cholecalciferol (Vitamin D3)
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Saphciferol-1000
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1000 IU
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Softgel Capsule
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-
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Sapphire Lifesciences Pvt. Ltd.
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India
|
-
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16 March 2022
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16 March 2027
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| View |
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DRP-11485
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Cholecalciferol (Vitamin D3)
|
Saphciferol-2000
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2000 IU
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Softgel Capsule
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Vitamin
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Sapphire Lifesciences Pvt. Ltd.
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India
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Initial
|
16 March 2022
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16 March 2027
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| View |
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DRP-11489
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Piperacillin (as sodium) + Tazobactam (as sodium)
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Pipetasaph-2.5
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2 g/250 mg
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Powder for Injection (IV Infusion)
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-
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Kilitch Drugs (India) Ltd.
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India
|
-
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17 March 2022
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17 March 2027
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| View |
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DRP-11471
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Diphenhydramine Hydrochloride + Phenylpropanolamine
Hydrochloride
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Saphedryl-P
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12.50 mg/12.50 mg per 5 mL
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Syrup
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Antihistamine/Nasal Decongestant
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Azine Healthcare Pvt. Ltd.
|
India
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Initial
|
16 March 2022
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16 March 2027
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| View |
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DRP-11472
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Cholecalciferol (Vitamin D3)
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Sun-D3
|
400 IU/mL
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Oral Solution (Oral Drops)
|
Vitamin
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Lloyd Laboratories, Inc.
|
Philippines
|
Initial (OTC) Correction
|
11 May 2022
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15 March 2027
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| View |
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DR-XY47797
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Chlormadinone acetate + Ethinylestradiol
|
Belara
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2mg/ 30mcg
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Film-Coated Tablet
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-
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Gedeon Richter Plc.
|
Hungary
|
-
|
04 May 2022
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15 March 2027
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| View |
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DR-XY47768
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Ferrous Sulfate (as Heptahydrate)
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None
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75 mg/0.6 mL (equivalent to 15 mg Elemental Iron)
|
Oral
Solution (Drops) [Lemon and Peppermint Flavor]
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-
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St. Martin Pharmaceutical Laboratories
|
Philippines
|
-
|
11 March 2022
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11 March 2027
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| View |
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DRP-11426
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Clotrimazole
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Vagtizol 100
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100 mg
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Vaginal Suppositories
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-
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Farm aprim Ltd
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Republic of Moldova
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Initial (Reconstruction)
|
27 December 2022
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17 March 2027
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| View |
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DRP-11427
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Clotrimazole
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Vagtizol 500
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500 mg
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Vaginal Suppositories
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-
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Farmaprim Ltd
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Republic of Moldova
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Initial (Reconstruction)
|
27 December 2022
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17 March 2027
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| View |
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DR-XY47824
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Dapagliflozin
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DAPA-5
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5 mg
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Film Coated tablet
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-
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Micro Labs Limited
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India
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Monitored Release
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16 March 2022
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16 March 2027
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| View |
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DR-XY47825
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Dapagliflozin
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DAPA-10
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10 mg
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Film Coated tablet
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-
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Micro Labs Limited
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India
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Monitored Release
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16 March 2022
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16 March 2027
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| View |
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DRP-11481
|
Cefotaxime (As Sodium)
|
Kelxime
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1g
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Powder For Injection (I.M./I.V.)
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-
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Theon Pharmaceuticals Limited
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India
|
-
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16 March 2022
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16 March 2027
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| View |
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DRP-11439
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Sterile Water for Injection
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None
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10mL
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Sterile Water For Injection
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-
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Furen Pharmaceutical Group Co., Ltd.
|
China
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Initial
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25 May 2022
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14 March 2027
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| View |
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DRP-11438
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Pethidine Hydrochloride
|
None
|
50mg/mL
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Solution for Injection (I.M. / S.C. / I.V.)
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Opioid Analgesic
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Siegfried Hameln GmbH
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Germany
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Initial (Correction)
|
13 July 2022
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14 March 2027
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| View |
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DRP-11440
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Sterile Water For Injection
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None
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Solution For Injection
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-
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Hebei Tiancheng Pharmaceutical Co., Ltd.
|
China
|
Initial (Variation)
|
03 April 2023
|
03 April 2028
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| View |
DR-XY47815_PI_01.pdf
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DR-XY47815
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Cefotaxime (As sodium)
|
Sitixime
|
1 g
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Powder For Injection (IM/IV)
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Antibacterial (Cephalosporin)
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Zhuhai Kinhoo Pharmaceutical Co., Ltd.
|
China
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Initial
|
15 March 2022
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15 March 2027
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