Sylvant 100 mg prašek za koncentrat za raztopino za infundiranje
Siltuksimab
General information
Drug nameSylvant 100 mg prašek za koncentrat za raztopino za infundiranje
Medicine nameSiltuksimab
National drug code3017017
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/1/14/928/001, 13. 6. 2014
Authorization validity dateUntil further notice
Marketing end date—
Application type—
Authorization/certificate holderRecordati Netherlands B.V.
Drug safety monitoring
Additional safety monitoringYes
Precautionary measure/dispensing restrictions—
Pregnancy prevention programmeNo
Controlled access programme(s)No
ATC codes
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
This medicine is subject to additional safety monitoring. You can report any suspected adverse reactions yourself.
The medicinal product is present in wholesale distribution.
Last drug update date:9. 7. 2026