1. NovoSeven 5 mg (250 k.i.e.) prašek in vehikel za raztopino za injiciranje

NovoSeven 5 mg (250 k.i.e.) prašek in vehikel za raztopino za injiciranje

Eptakog alfa (aktivirani) + voda za injekcije

General information

Drug nameNovoSeven 5 mg (250 k.i.e.) prašek in vehikel za raztopino za injiciranje
Medicine nameEptakog alfa (aktivirani) + voda za injekcije
National drug code3003574
PMS ID—
SNOMED descriptive name code—
Legal statusZdravilo z dovoljenjem za promet
Drug groupBiological Medicinal Product
OriginatorYes
Orphan drugNo

Marketing authorization

Procedure typeNedoločeno
No. and date of decision/certificateEU/1/96/006/006, 23. 4. 2012
Authorization validity dateUntil further notice
Marketing end date—
Application type—
Authorization/certificate holderNovo Nordisk A/S

Drug safety monitoring

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

ATC codes

BBLOOD AND BLOOD FORMING ORGANS
B02ANTIHEMORRHAGICS
B02BVitamin K and other hemostatics
B02BDBlood coagulation factors
B02BD08coagulation factor VIIa

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

The medicinal product is present in wholesale distribution.

Last drug update date:9. 7. 2026
TEST APPLICATION