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DR-XY47971 (For Export Use Only)
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Thiamine mononitrate (Vitamin B1) + Pyridoxine
hydrochloride (Vitamin B6) + Folic Acid (Vitamin B9) +
Cyanocobalamin (Vitamin B12) + Iron
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Fortifer-FA
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Each film-coated tablet contains:
Iron, elemental (as Ferrous Fumarate 300 mg) 98.6 mg; Folic Acid 500 mcg; Thiamine Mononitrate (Vitamin B1) 5 mg; Pyridoxine Hydrochloride (Vitamin B6) 5 mg; Cyanocobalamin (Vitamin B12) 15 mcg
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Film-Coated Tablet
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Anti-Anemia/Hematinic
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Amherst Laboratories, Inc.
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Philippines
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Initial
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28 April 2022
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28 April 2027
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DR-XY47972
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Gemcitabine
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Gemibine-2000
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2g
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Lyophilized Powder for Injection (IV)
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-
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Intas Pharmaceuticals Limited
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India
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-
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28 April 2022
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28 April 2027
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DR-XY47973
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Hypromellose
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Misty
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3 mg/mL
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Ophthalmic Solution
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Surgical Aids (Viscoelastic substances)
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Millimed BFS Co., Ltd.
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Thailand
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Initial
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28 April 2022
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28 April 2027
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DR-XY47974
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Empagliflozin + Metformin Hydrochloride
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Jardiance Duo
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12.5mg/850mg
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Film-Coated Tablet
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-
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Boehringer Ingelheim Ellas A.E
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Greece
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-
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29 April 2022
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29 April 2027
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| View |
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DR-XY47975
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Empagliflozin + Metformin Hydrochloride
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Jardiance Duo
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12.5mg/500mg
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Film-Coated Tablet
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-
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Boehringer Ingelheim Ellas A.E
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Greece
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-
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29 April 2022
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29 April 2027
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| View |
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DR-XY47976
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Empagliflozin + Metformin Hydrochloride
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Jardiance Duo
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5mg/1g
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Film-Coated Tablet
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-
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Boehringer Ingelheim Ellas A.E
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Greece
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-
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29 April 2022
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29 April 2027
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| View |
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DR-XY47977
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Empagliflozin + Metformin Hydrochloride
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Jardiance Duo
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5mg/850mg
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Film-Coated Tablet
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-
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Boehringer Ingelheim Ellas A.E
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Greece
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-
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29 April 2022
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29 April 2027
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| View |
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DR-XY47978
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Empagliflozin + Metformin Hydrochloride
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Jardiance Duo
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5mg/500mg
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Film-Coated Tablet
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-
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Boehringer Ingelheim Ellas A.E.
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Greece
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Initial
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29 April 2022
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29 April 2027
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| View |
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DR-XY47979
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Teneligliptin (as Hemipentahydrobromide hydrate)
Tenglyn
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Tenglyn
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20 mg
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Film Coated Tablet
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Antidiabetic Agent (Dipeptidyl peptidase 4 (DPP-4) inhibitors)
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Cadila Healthcare Limited
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India
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Monitored Release (MR)
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28 April 2022
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28 April 2027
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| View |
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DR-XY47980
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Norepinephrine (as bitartrate)
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None
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1 mg/mL (4 mg/4 mL)
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Concentrate Solution for IV Infusion
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Adrenergic and dopaminergic agent
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PT. Novell Pharmaceutical Laboratories
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Indonesia
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Initial
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28 April 2022
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28 April 2027
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| View |
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DR-XY47981
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Salbutamol (as sulfate) + Guaifenesin
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Izbrid
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1mg/ 50mg
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Syrup (Orange Flavor)
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Bronchodilator/ Expectorant
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Interphil Laboratories, Inc.
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Philippines
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Initial
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29 April 2022
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29 April 2027
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| View |
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DR-XY47982
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Quetiapine (as fumarate)
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Q-Mind ER 50
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50 mg
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Extended-Release Tablet
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Antipsychotic
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Torrent Pharmaceuticals Ltd.
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India
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Initial
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28 April 2022
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28 April 2027
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| View |
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DR-XY47983
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Budesonide
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Aeronide
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200mcg per actuation
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Suspension pressurized Metered Dose Inhaler
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Glucocorticoid
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Inpac Pharma Co., Ltd
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Thailand
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Initial
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28 April 2022
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28 April 2027
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| View |
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DR-XY47984
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Fenoterol hydrochloride + ipratropium bromide
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Aerobidol
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50 mcg/20 mcg per Actuation
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Solution Metered Dose Inhaler
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Selective beta-2-adrenoreceptor
Anticholinergic
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Inpac Pharma Co., Ltd
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Thailand
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Initial (Correction)
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17 October 2022
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28 April 2027
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| View |
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DR-XY47985
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Metronidazole
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Siti-zole
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5 mg/mL (500 mg/ 100 mL)
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Solution for I.V. Infusion.
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Antibacterial/ Antiprotozoal (Nitroimidazole Derivative)
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Shijiazhuang No. 4 Pharmaceutical Co., Ltd
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China
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Initial (Correction)
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14 May 2024
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28 April 2027
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| View |
DR-XY47986_PI_01.pdf
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DR-XY47986
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Olmesartan Medoxomil + Amlodipine (as besilate)
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Alzor CCB
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40mg/5mg
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Film-Coated Tablet
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Angiotensin II Receptor Blockers (ARBs) and Calcium Channel Blockers
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Ajanta Pharma Limited
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India
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Initial (from Monitored Release status) [Reconstruction]
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08 February 2023
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29 April 2027
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| View |
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DR-XY47987
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500mg (equivalent to 200mg Ascorbic Acid and 300mg Sodium Ascorbate)
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Khrizvitcee 500
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500 mg
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Chewable Tablet
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-
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Reyoung Pharmaceutical Co., Ltd.
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China
|
-
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29 April 2022
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29 April 2027
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| View |
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DR-XY47988
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Hidrosmin
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Venosmil
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200mg
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Capsule
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Capillary Stabilizing Agent (Bioflavonoid)
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Faes Farma, S.A.
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Spain
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Monitored Release (MR)
|
29 April 2022
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29 April 2027
|
| View |
DR-XY47989_PI_01.pdf
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DR-XY47989
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Olmesartan Medoxomil + Amlodipine (as besilate)
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Alzor CCB
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40mg/10mg
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Film-Coated Tablet
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Angiotensin II Receptor Blockers (ARBs) and Calcium Channel Blockers
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Ajanta Pharma Limited
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India
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Initial (from Monitored Release status) [Reconstruction]
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08 February 2023
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29 April 2027
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| View |
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DR-XY47990
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10% Dextrose In Water
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None
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100 g/L (10% w/v)
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Solution for Intravenous Infusion
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Parenteral Rehydration Solution
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Shijiazhuang No.4 Pharmaceutical Co., Ltd.
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China
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Initial (Correction)
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19 January 2023
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29 April 2027
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