1. Entyvio 300 mg prašek za koncentrat za raztopino za infundiranje

Entyvio 300 mg prašek za koncentrat za raztopino za infundiranje

Vedolizumab

General information

Drug nameEntyvio 300 mg prašek za koncentrat za raztopino za infundiranje
Medicine nameVedolizumab
National drug code3017006
PMS ID—
SNOMED descriptive name code—
Legal statusZdravilo z dovoljenjem za promet
Drug groupBiological Medicinal Product
OriginatorYes
Orphan drugNo

Marketing authorization

Procedure typePotrditev podatkov za CP zdravila (modro okence)
No. and date of decision/certificateEU/1/14/923/001, 5. 6. 2014
Authorization validity dateUntil further notice
Marketing end date—
Application type—
Authorization/certificate holderTakeda Pharma A/S

Drug safety monitoring

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

ATC codes

LANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
L04IMMUNOSUPPRESSANTS
L04AImmunosuppressants
L04AGMonoclonal antibodies
L04AG05vedolizumab

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