허가사항 변경

총 108개
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# 변경일자 변경항목 성분명
1 2025-08-25 사용상의 주의사항 amlodipine besylate(as amlodipine)
atorvastatin calcium(as atorvastatin)
fluconazole
melatonin
meloxicam
Opicapone
pitavastatin calcium
propiverine hydrochloride
Racecadotril
rebamipide
tofacitinib
Tofacitinib Aspartate(micronized)
Tofacitinib Citrate
tofacitinib citrate(as tofacitinib)
2 2025-08-25 성상 acetaminophen
Anhydrous Dibasic Calcium Phosphate/Ascorbic Acid/Biotin/Calcium Pantothenate/Cholecalciferol Concentrate Oil/Cyanocobalamin Powder 0.1%/Dried Ferrous Sulfate/Folic Acid/Magnesium Oxide/Manganese Sulfate Hydrate/Nicotinamide/Pyridoxine Hydrochloride/Retinol Palmitate/Riboflavin/Thiamine Nitrate/Tocopherol Acetate/Zinc Oxide
fluconazole
3 2025-08-25 저장방법 및 사용(유효)기간 amoxicillin
Ginkgo Biloba Leaf Dried Extract
Nicergoline
4 2025-08-25 제품명 lidocaine
pitavastatin calcium
5 2025-08-23 사용상주의사항변경(부작용포함) Mesalazine
6 2025-08-22 사용상의 주의사항 acetaminophen
aminocaproic acid
dimenhydrinate
esomeprazole magnesium(as esomeprazol)
pregabalin
ribociclib succinate(as ribociclib)
7 2025-08-22 성상 cetirizine dihydrochloride
dexibuprofen
esomeprazole magnesium(as esomeprazol)
ketoprofen
olopatadine HCl
olopatadine hydrochloride(as olopatadine)
sevelamer carbonate
8 2025-08-22 용법·용량 olopatadine HCl
olopatadine hydrochloride(as olopatadine)
pregabalin
ribociclib succinate(as ribociclib)
9 2025-08-22 저장방법 및 사용(유효)기간 ketoprofen
olopatadine HCl
olopatadine hydrochloride(as olopatadine)
ribociclib succinate(as ribociclib)
rosuvastatin calcium(as rosuvastatin)
10 2025-08-22 효능·효과 pregabalin
ribociclib succinate(as ribociclib)
11 2025-08-21 사용상의 주의사항 acetaminophen
Angelica Gigas Root/Gardenia Fruit/Licorice/Peony Root/Poria/Scutellaria Root
Baenongsangeubtang Dried Extract
benfotiamine
Benfotiamine/Calcium Pantothenate/Cholecalciferol Concentrate Powder/Inositol/Magnesium Oxide/Mecobalamin/Nicotinamide/Pyridoxine Hydrochloride/Riboflavin/Sodium Chondroitin Sulfate
clarithromycin
cyanocobalamin
fluconazole
guselkumab
infliximab
losartan potassium(as losartan)
pitavastatin calcium
12 2025-08-21 성상 acetaminophen
fluconazole
13 2025-08-21 용법·용량 Baenongsangeubtang Dried Extract
dexmedetomidine hydrochloride(as dexmedetomidine)
guselkumab
infliximab
14 2025-08-21 저장방법 및 사용(유효)기간 cetirizine dihydrochloride
fluconazole
Lenvatinib Mesylate Dimethylsulfoxide
mometasone furoate
tobramycin
15 2025-08-21 제품명 Lactulose Solution
pitavastatin calcium
16 2025-08-21 효능·효과 dexmedetomidine hydrochloride(as dexmedetomidine)
guselkumab
infliximab
17 2025-08-20 사용상의 주의사항 Calcium Citrate Hydrate/Cholecalciferol Concentrate Powder/Folic Acid/Thiamine Hydrochloride
cefpodoxime proxetil
celecoxib
infliximab
phendimetrazine tartrate
pitavastatin calcium
vedolizumab
18 2025-08-20 사용상주의사항변경(부작용포함) piperacillin sodium
19 2025-08-20 용법·용량 cefpodoxime proxetil
vedolizumab
20 2025-08-20 저장방법 및 사용(유효)기간 cefpodoxime proxetil
Denosumab
Metformin Hydrochloride/Pioglitazone Hydrochloride