허가사항 변경

총 17개
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# 변경일자 변경항목 성분명
1 2025-06-17 사용상의 주의사항 aceclofenac
Banhasasimtang Soft Extract(4.50→1)/Coptis Rhizome
cefradine hydrate
empagliflozin
Lenvatinib Mesylate Dimethylsulfoxide
megestrol acetate
meloxicam
omega-3-acid ethyl esters90(as EPA ethylester 0.46g, DHA ethylester 0.38g)
R-thioctic acid tromethamine
Zastaprazan Citrate
2 2025-06-17 성상 clarithromycin
ezetimibe
Lenvatinib Mesylate Dimethylsulfoxide
meropenem
3 2025-06-17 용법·용량 Banhasasimtang Soft Extract(4.50→1)/Coptis Rhizome
Cnidium Rhizome/Galgeuntanggacheongungsini Soft Extracts/Ginger
Daesihotang Soft Extract/Rhubarb
Gyejigajakyaktang Soft Extract
psyllium husk
Sosihotang Soft Extracts
Zastaprazan Citrate
4 2025-06-17 저장방법 및 사용(유효)기간 aspirin(enteric coated)(as aspirin)
ibandronic acid monosodium salt monohydrate(as ibandronic acid)
Lenvatinib Mesylate Dimethylsulfoxide
Telmisartan
5 2025-06-17 제품명 Magnesium Oxide/Sodium Chondroitin Sulfate/Thiamine Nitrate/Tocopherol Acetate Powder 50%
6 2025-06-17 효능·효과 Zastaprazan Citrate
7 2025-06-16 사용상의 주의사항 acebrophylline
acetaminophen
amoxicillin
atorvastatin calcium(as atorvastatin)
Coptis Rhizome/Ginger/Ginseng/Jujube/Licorice/Pinellia Tuber/Scutellaria Root
Empagliflozin Amorphous/Metformin Hydrochloride
imiglucerase
levodropropizine
Lutetium(177Lu) Vipivotide Tetraxetan Solution
meloxicam
metronidazole
R-thioctic acid tromethamine
terbinafine hydrochloride
vitis vinifera leaf ext.
8 2025-06-16 성상 montelukast sodium(as montelukast)
9 2025-06-16 용법·용량 Angelica Gigas Root/Atractylodes Rhizome White/Aucklandiae Radix/Citrus Unshiu Peel/Cnidium Rhizome/Coptis Rhizome/Cyperus Rhizome/Licorice/Massa Medicata Fermentata/Peony Root/Perillae Fructus/Pinellia Tuber/Poncirus Immature Fruit/Poria Sclertum Cum Pini Radix/Raphani Semen/Round Amomum Fruit
Coptis Rhizome/Ginger/Ginseng/Jujube/Licorice/Pinellia Tuber/Scutellaria Root
Lutetium(177Lu) Vipivotide Tetraxetan Solution
10 2025-06-16 저장방법 및 사용(유효)기간 atorvastatin calcium(as atorvastatin)
11 2025-06-16 제품명 당귀·목과·방풍·속단·오가피·우슬·위령선·육계·진교·천궁·천마·홍화 25% ethanol soft ext.(3.5→1)
amoxicillin
Empagliflozin Amorphous/Metformin Hydrochloride
12 2025-06-16 효능·효과 amoxicillin
13 2025-06-13 사용상의 주의사항 amlodipine besylate(as amlodipine)
calcitriol
celecoxib
clarithromycin
Delamanid
Difenidol Hydrochloride/Riboflavin/Scopolamine Hydrobromide Hydrate
talazoparib tosylate(as talazoparib)
tenofovir disoproxil fumarate
terazosin hydrochloride(as terazosin)
14 2025-06-13 성상 talazoparib tosylate(as talazoparib)
terazosin hydrochloride(as terazosin)
15 2025-06-13 용법·용량 aloe ext.
Difenidol Hydrochloride/Riboflavin/Scopolamine Hydrobromide Hydrate
talazoparib tosylate(as talazoparib)
tenofovir disoproxil fumarate
16 2025-06-13 저장방법 및 사용(유효)기간 amoxicillin
Ampelopsis Radix/Angelica Gigas Root/Apricot Kernel/Asini Corii Colla/Atractylodes Rhizome White/Bomeolum/Bupleurum Root/Cattle Gallstone/Cinnamon Bark/Cnidium Rhizome/Dioscorea Rhizome/Gazellae seu Saigae Cornu/Ginger/Ginseng/Glycine Semen Germinatum/L-Muscone/Licorice/Liriope Tuber/Massa Medicata Fermentata/Peony Root/Platycodon Root/Poria/Saposhnikovia Root/Scutellaria Root/Typhae Pollen
talazoparib tosylate(as talazoparib)
17 2025-06-13 효능·효과 Cholecalciferol Granules/Sodium Selenite Pentahydrate/Zinc Oxide
talazoparib tosylate(as talazoparib)