1. Rupafin 10 mg tablete

Rupafin 10 mg tablete

Rupatadin

General information

Drug nameRupafin 10 mg tablete
Medicine nameRupatadin
National drug code3000019
PMS ID—
SNOMED descriptive name code—
Legal statusZdravilo z dovoljenjem za promet
Drug group—
OriginatorNo
Orphan drugNo

Marketing authorization

Procedure typeSprememba dovoljenja za promet
No. and date of decision/certificate10120-369/2022-7, 3. 4. 2023
Authorization validity dateUntil further notice
Marketing end date—
Application type—
Authorization/certificate holderNoucor Health S.A.

Drug safety monitoring

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

ATC codes

RRESPIRATORY SYSTEM
R06ANTIHISTAMINES FOR SYSTEMIC USE
R06AAntihistamines for systemic use
R06AXOther antihistamines for systemic use
R06AX28rupatadine

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

The medicinal product is present in wholesale distribution.

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