1. Fluzepam 30 mg trde kapsule

Fluzepam 30 mg trde kapsule

Flurazepam

General information

Drug nameFluzepam 30 mg trde kapsule
Medicine nameFlurazepam
National drug code3002130
PMS ID—
SNOMED descriptive name code—
Legal statusZdravilo z dovoljenjem za promet
Drug group—
OriginatorNo
Orphan drugNo

Marketing authorization

Procedure typeSprememba dovoljenja za promet
No. and date of decision/certificate10020-110/2015-3, 3. 11. 2015
Authorization validity dateUntil further notice
Marketing end date—
Application type—
Authorization/certificate holderKRKA, d.d., Novo mesto

Drug safety monitoring

Additional safety monitoringNo
Precautionary measure/dispensing restrictions
Trigonik (absolute driving prohibition).
Pregnancy prevention programmeNo
Controlled access programme(s)No

ATC codes

NNERVOUS SYSTEM
N05PSYCHOLEPTICS
N05CHypnotics and sedatives
N05CDBenzodiazepine derivatives
N05CD01flurazepam

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

Trigonik (absolute driving prohibition).
The medicinal product is present in wholesale distribution.

Last drug update date:9. 7. 2026
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