1. Nilotinib STADA 200 mg trde kapsule

Nilotinib STADA 200 mg trde kapsule

Nilotinib

General information

Drug nameNilotinib STADA 200 mg trde kapsule
Medicine nameNilotinib
National drug code3006162
PMS ID—
SNOMED descriptive name code—
Legal statusZdravilo z dovoljenjem za promet
Drug groupChemical Medicinal Product
OriginatorNo
Orphan drugNo

Marketing authorization

Procedure typeNovo dovoljenje za promet
No. and date of decision/certificateH/25/03193/029, 3. 4. 2025
Authorization validity date3. 4. 2030
Marketing end date—
Application type—
Authorization/certificate holderSTADA Arzneimittel AG

Drug safety monitoring

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

ATC codes

LANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
L01ANTINEOPLASTIC AGENTS
L01EPROTEIN KINASE INHIBITORS
L01EABCR-ABL tyrosine kinase inhibitors
L01EA03nilotinib

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

Ni podatka o razpoložljivosti zdravila

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