허가사항 변경

총 101개
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# 변경일자 변경항목 성분명
1 2025-05-16 사용상의 주의사항 acetaminophen
cefpodoxime proxetil
Dapagliflozin Anhydrous Lactose Mixture/Metformin Hydrochloride
ivosidenib
pegaspargase
2 2025-05-16 용법·용량 ivosidenib
3 2025-05-16 제품명 acetaminophen
bupropion hydrochloride
4 2025-05-15 사용상의 주의사항 acetaminophen
Difenidol Hydrochloride/Riboflavin/Scopolamine Hydrobromide Hydrate
empagliflozin
meloxicam
pregabalin
progesterone
rosuvastatin calcium(as rosuvastatin)
spesolimab
5 2025-05-15 용법·용량 levocetirizine dihydrochloride
Levocetirizine HCl
propofol
rosuvastatin calcium(as rosuvastatin)
spesolimab
6 2025-05-15 제품명 famotidine
7 2025-05-15 효능·효과 rosuvastatin calcium(as rosuvastatin)
8 2025-05-14 사용상의 주의사항 carvedilol
etanercept
ofloxacin
pelargonium sidoides 11% ethanol ext.(1→8~10)(as dried pelargonium sidoides ethanol ext.)
solifenacin succinate
somatropin
9 2025-05-14 성상 amlodipine besylate(as amlodipine)
10 2025-05-14 용법·용량 carvedilol
11 2025-05-14 저장방법 및 사용(유효)기간 mosapride citrate hydrate(as mosapride)
12 2025-05-14 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
13 2025-05-14 효능·효과 carvedilol
14 2025-05-13 사용상의 주의사항 acetaminophen
artemisiae argyi folium 95% ethanol ext.(20→1)
atorvastatin calcium(as atorvastatin)
bicalutamide
cefaclor hydrate
donepezil hydrochloride
Empagliflozin
olmesartan medoxomil
15 2025-05-13 성상 acetaminophen
adenine hydrochloride
atorvastatin calcium(as atorvastatin)
cefaclor hydrate
16 2025-05-13 용법·용량 Angelica Gigas Root/Atractylodes Rhizome White/Bupleurum Root/Gardenia Fruit/Ginger/Licorice/Mentha Herb/Moutan Root Bark/Peony Root/Poria
17 2025-05-13 저장방법 및 사용(유효)기간 bicalutamide
Clostridium Botulinum Toxin Type A
18 2025-05-13 제품명 Clostridium Botulinum Toxin Type A
lactobacillus acidophillus
19 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)
20 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