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허가사항 변경

총 104개

#	변경일자	변경항목	성분명
1	2025-05-12	사용상의 주의사항	aceclofenac acetaminophen betamethasone valerate cefaclor hydrate cefpodoxime proxetil dapagliflozin propanediol hydrate(as dapagliflozin) dimethicone donepezil hydrochloride L-carnitine levocetirizine dihydrochloride Linagliptin Linagliptin Micronized Magnesium Glycerophosphate/Nicotinamide/Pyridoxine Hydrochloride/Riboflavin Sodium Phosphate Momelotinib Hydrochloride Hydrate mosapride citrate hydrate(as mosapride) Omega-3-Acid Ethyl Esters 90 omega-3-acid ethyl esters90 omega-3-acid ethyl esters90(as EPA ethylester 0.46g, DHA ethylester 0.38g) omega-3-acid ethyl esters90(as EPA ethylester 0.92g, DHA ethylester 0.76g) pyridoxine hydrochloride rosuvastatin calcium(as rosuvastatin) terazosin hydrochloride(as terazosin)
2	2025-05-12	사용상주의사항변경(부작용포함)	asciminib hydrochloride(as asciminib) Dapagliflozin dapagliflozin anhydrous lactose mixturd(as dapagliflozin) Dapagliflozin Anhydrous Lactose Mixture dapagliflozin Anhydrous Lactose Mixture(as dapagliflozin) Dapagliflozin Bis L-proline dapagliflozin Bis L-proline(as dapagliflozin) dapagliflozin citric acid(as dapagliflozin) Dapagliflozin formate Dapagliflozin Propanediol Hydrate dapagliflozin propanediol hydrate(as dapagliflozin) Mercaptopurine mercaptopurine hydrate
3	2025-05-12	성상	betamethasone valerate donepezil hydrochloride d-panthenol ketoprofen loxoprofen sodium terazosin hydrochloride(as terazosin)
4	2025-05-12	용법·용량	acetaminophen Akebia Stem/Angelica Gigas Root/Asiasarum Root and Rhizome/Cinnamomi Ramulus/Evodia Fruit/Jujube/Licorice/Peony Root/Raw Ginger Alisma Rhizome/Angelica Gigas Root/Atractylodes Rhizome White/Cnidium Rhizome/Peony Root/Poria Alisma Rhizome/Cinnamomi Ramulus/Cornus Fruit/Dioscorea Rhizome/Moutan Root Bark/Poria/Prepared Rehmannia Root/Pulvis Aconiti Tuberis Purificaum bisacodyl Bupleurum Root/Jujube/Peony Root/Pinellia Tuber/Poncirus Immature Fruit/Raw Ginger/Rhubarb/Scutellaria Root chlorhexidine gluconate solution Cinnamomi Ramulus/Moutan Root Bark/Peach Kernel/Peony Root/Poria dapagliflozin propanediol hydrate(as dapagliflozin) Magnesium Glycerophosphate/Nicotinamide/Pyridoxine Hydrochloride/Riboflavin Sodium Phosphate Momelotinib Hydrochloride Hydrate
5	2025-05-12	저장방법 및 사용(유효)기간	cefpodoxime proxetil rosuvastatin calcium(as rosuvastatin)
6	2025-05-12	제품명	Anhydrous Dibasic Calcium Phosphate/Ascorbic Acid Coated/Calcium Pantothenate/Cholecalciferol Concentrate Powder/Cyanocobalamin Powder 0.1%/Folic Acid/Magnesium Glycerophosphate/Nicotinamide/Pyridoxine Hydrochloride/Retinol Acetate Granules/Riboflavin Sodium Phosphate/Thiamine Nitrate/Tocopherol Acetate Powder 50%/Zinc Oxide betamethasone valerate cetirizine dihydrochloride
7	2025-05-12	효능·효과	acetaminophen dapagliflozin propanediol hydrate(as dapagliflozin)
8	2025-05-09	사용상의 주의사항	acetaminophen atorvastatin calcium(as atorvastatin) azelastine hydrochloride Diastase·Protease·Cellulase/Glycyrrhiza Powder/Lipase/Magnesium Aluminometasilicate/Precipitated Calcium Carbonate/Scopolia Extract/Sodium Bicarbonate/Trimebutine Maleate donepezil hydrochloride Empagliflozin ropeginterferon alfa-2b
9	2025-05-09	성상	atorvastatin calcium(as atorvastatin) azelastine hydrochloride
10	2025-05-09	용법·용량	Chlorpheniramine Maleate/Oxymetazoline Hydrochloride ropeginterferon alfa-2b
11	2025-05-09	저장방법 및 사용(유효)기간	Carboxymethylcellulose Sodium/Glycerin onasemnogene abeparvovec
12	2025-05-08	사용상의 주의사항	atorvastatin calcium(as atorvastatin) Bangpungtongsungsan Dried Extract(4.64→1) donepezil hydrochloride L-Carnitine pelargonium sidoides 11% ethanol ext.(1→8~10)(as dried pelargonium sidoides ethanol ext.)
13	2025-05-08	성상	atorvastatin calcium(as atorvastatin)
14	2025-05-08	용법·용량	L-Carnitine
15	2025-05-08	저장방법 및 사용(유효)기간	desmopressin acetate Ginseng/Jujube/Licorice/Liriope Tuber/Oryzae Semen/Pinellia Tuber rosuvastatin calcium(as rosuvastatin)
16	2025-05-08	제품명	Ginkgo Biloba Leaf Dried Extract lactobacillus acidophillus
17	2025-05-07	사용상의 주의사항	acetaminophen aluminium hydroxide gel(dried) cefaclor hydrate cefradine hydrate clarithromycin dimethicone donepezil hydrochloride empagliflozin gadobutrol hydroxocobalamin acetate Lenvatinib Mesylate Dimethylsulfoxide levosulpiride Licorice/Peony Root Nintedanib Esylate oxcarbazepin oxcarbazepine rosuvastatin calcium(as rosuvastatin) Tofacitinib Citrate urea
18	2025-05-07	사용상주의사항변경(부작용포함)	Abiraterone Acetate Micronized/Prednisolone betamethasone Betamethasone Sodium Phosphate betamethasone sodium phosphate(as betamethasone) Betamethasone/D-Chlorpheniramine Maleate Betamethasone/D-Chlorpheniramine Maleate/Dexchlorpheniramine Maleate Betamethasone/Dexchlorpheniramine Maleate dexamethasone Dexamethasone Disodium Phosphate Dexamethasone Disodium Phosphate/Dexamethasone Sodium Phosphate Dexamethasone Micronized Dexamethasone Palmitate dexamethasone sodium phosphate hydrocortisone hydrocortisone sodium succinate(as hydrocortisone) lidocaine hydrochloride lithium carbonate methylprednisolone methylprednisolone acetate Methylprednisolone Sodium Succinate methylprednisolone sodium succinate(as methylprednisolone) Methylprednisolone Succinate Sodium·Dried Sodium Phosphate·Anhydrous Monobasic Sodium Phosphate Prednisolone prednisolone acetate vancomycin hydrochloride
19	2025-05-07	성상	cefaclor hydrate Dexpanthenol donepezil hydrochloride metformin hydrochloride urea
20	2025-05-07	용법·용량	cefaclor hydrate gadobutrol Tofacitinib Citrate