허가사항 변경

총 105개
~
# 변경일자 변경항목 성분명
1 2025-12-01 사용상의 주의사항 Empagliflozin Amorphous/Metformin Hydrochloride
Empagliflozin/Metformin Hydrochloride
Empagliflozin/Metformin Hydrochloride with Colloidal Anhydrous Silica
2 2025-12-01 효능·효과 Empagliflozin Amorphous/Metformin Hydrochloride
Empagliflozin/Metformin Hydrochloride
Empagliflozin/Metformin Hydrochloride with Colloidal Anhydrous Silica
3 2025-11-27 사용상의 주의사항 Acetaminophen/Anhydrous Caffeine/Ephedrine Hydrochloride
ginkgo biloba leaf ext.
levodropropizine
methylprednisolone
minoxidil
spironolactone
4 2025-11-27 성상 Acetaminophen/Anhydrous Caffeine/Ephedrine Hydrochloride
ginkgo biloba leaf ext.
ibandronic acid monosodium salt monohydrate(as ibandronic acid 3mg)
ibandronic acid monosodium salt monohydrate(as ibandronic acid)
telmisartan
5 2025-11-27 저장방법 및 사용(유효)기간 adenine hydrochloride
6 2025-11-27 제품명 levetiracetam
Nintedanib Esylate Hemihydrate
Paclitaxel
rivastigmine
7 2025-11-27 효능·효과 Acetaminophen/Anhydrous Caffeine/Ephedrine Hydrochloride
8 2025-11-26 사용상의 주의사항 acetaminophen
acetaminophen(encapsulated)
biphenyl dimethyl dicarboxylate
Cefditoren Pivoxil
Dapagliflozin Propanediol Hydrate/Sitagliptin Phosphate Hydrate
doxylamine succinate
finasteride
peramivir hydrate(as peramivir)
9 2025-11-26 성상 aceclofenac
acetaminophen(encapsulated)
Cefditoren Pivoxil
cetirizine dihydrochloride
coptis rhizome dried ext.(8.93→1)
Dapagliflozin Propanediol Hydrate/Sitagliptin Phosphate Hydrate
doxylamine succinate
milk thistle fruit ext.
10 2025-11-26 용법·용량 acetaminophen
peramivir hydrate(as peramivir)
11 2025-11-26 저장방법 및 사용(유효)기간 adenine hydrochloride
amoxicillin
amoxicillin sodium
aspirin(enteric coated)(as aspirin)
doxylamine succinate
sodium hyaluronate
Thrombin
Vortioxetine Hydrobromide
12 2025-11-26 제품명 cerebrolysin concentrate
cetirizine dihydrochloride
choline alfoscerate
econazole nitrate
proteolytic peptide from porcine brain
13 2025-11-26 효능·효과 peramivir hydrate(as peramivir)
14 2025-11-25 사용상의 주의사항 acyclovir
amlodipine besylate(as amlodipine)
Arctium Fruit/Forsythia Fruit/Gardenia Fruit/Licorice/Mentha Herb/Phellodendron Bark/Platycodon Root/Scutellaria Root/Sihocheonggantang Soft Extract/Trichosanthes Root
atorvastatin calcium(as atorvastatin)
Macitentan Micronized
rosuvastatin calcium(as rosuvastatin)
tranexamic acid
15 2025-11-25 성상 dutasteride
esomeprazole magnesium(as esomeprazol)
rosuvastatin calcium(as rosuvastatin)
16 2025-11-25 용법·용량 Arctium Fruit/Forsythia Fruit/Gardenia Fruit/Licorice/Mentha Herb/Phellodendron Bark/Platycodon Root/Scutellaria Root/Sihocheonggantang Soft Extract/Trichosanthes Root
Macitentan Micronized
17 2025-11-25 저장방법 및 사용(유효)기간 Arctium Fruit/Forsythia Fruit/Gypsum Fibrosum/Licorice/Ostericum Root/Platycodon Root/Saposhnikovia Root/Schizonepeta Spike
clarithromycin
rosuvastatin calcium(as rosuvastatin)
18 2025-11-25 제품명 acyclovir
19 2025-11-24 사용상의 주의사항 Acetaminophen/Anhydrous Caffeine/Ephedrine Hydrochloride
calcium carbonate(as calcium)
cefaclor hydrate
Chlorhexidine Gluconate Solution
donepezil hydrochloride
eperisone hydrochloride
fluoxetine hydrochloride(as fluoxetine)
pegcetacoplan
20 2025-11-24 사용상주의사항변경(부작용포함) azathioprine
ifosfamide
meropenem
Meropenem Dried Sodium Carbonate
Meropenem Hydrate