1. Empagliflozin Krka 10 mg filmsko obložene tablete

Empagliflozin Krka 10 mg filmsko obložene tablete

Empagliflozin

General information

Drug nameEmpagliflozin Krka 10 mg filmsko obložene tablete
Medicine nameEmpagliflozin
National drug code3017008
PMS ID—
SNOMED descriptive name code—
Legal statusZdravilo z dovoljenjem za promet
Drug groupChemical Medicinal Product
OriginatorNo
Orphan drugNo

Marketing authorization

Procedure typeNovo dovoljenje za promet
No. and date of decision/certificate1010-50/2023-9, 1. 2. 2024
Authorization validity date1. 2. 2029
Marketing end date—
Application type—
Authorization/certificate holderKRKA, d.d., Novo mesto

Drug safety monitoring

Additional safety monitoringNo
Precautionary measure/dispensing restrictions—
Pregnancy prevention programmeNo
Controlled access programme(s)No

ATC codes

AALIMENTARY TRACT AND METABOLISM
A10DRUGS USED IN DIABETES
A10BBlood glucose lowering drugs, excl. insulins
A10BKSodium-glucose co-transporter 2 (SGLT2) inhibitors
A10BK03empagliflozin

Route of administration

Route of administration name
Peroralna uporaba

Settlement data for compulsory health insurance billing

Substitute medicine

Preparation—
Valid from – to—

Clinical use data

Methods of use—
Indications—
Rounding factor—
DivisibleNo
Division for easier swallowingNo
Division for dosage adjustmentNo
Paediatric populationNo

Shortage actions

Substitute medicine in case of shortage - industrial medicine—
Substitute medicine in case of shortage - magistral or galenic medicine—
Prescribing restriction in case of drug shortageNo
Dispensing restriction in case of shortage or emergencyNo
Dispensing restriction for foreign prescriptions in case of shortage or emergencyNo
Export restrictionNo

Drug status

Ni podatka o razpoložljivosti zdravila

Last drug update date:9. 7. 2026
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