1. Anexate 100 mikrogramov/ml raztopina za injiciranje ali infundiranje

Anexate 100 mikrogramov/ml raztopina za injiciranje ali infundiranje

Flumazenil

General information

Drug nameAnexate 100 mikrogramov/ml raztopina za injiciranje ali infundiranje
Medicine nameFlumazenil
National drug code3000004
PMS ID—
SNOMED descriptive name code—
Legal statusZdravilo z dovoljenjem za promet
Drug groupChemical Medicinal Product
OriginatorYes
Orphan drugNo

Marketing authorization

Procedure typeSprememba dovoljenja za promet
No. and date of decision/certificate10024-112/2018-3, 7. 2. 2019
Authorization validity dateUntil further notice
Marketing end date—
Application type—
Authorization/certificate holderCHEPLAPHARM Arzneimittel GmbH

Drug safety monitoring

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

ATC codes

VVARIOUS
V03ALL OTHER THERAPEUTIC PRODUCTS
V03AAll other therapeutic products
V03ABAntidotes
V03AB25flumazenil

Route of administration

Route of administration name
Intravenska 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 (relative driving prohibition).
The medicinal product is present in wholesale distribution.

Last drug update date:9. 7. 2026
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