1. OxyContin 10 mg tablete s podaljšanim sproščanjem

OxyContin 10 mg tablete s podaljšanim sproščanjem

Oksikodon

General information

Drug nameOxyContin 10 mg tablete s podaljšanim sproščanjem
Medicine nameOksikodon
National drug code3000034
PMS ID—
SNOMED descriptive name code—
Legal statusZdravilo z dovoljenjem za promet
Drug groupChemical Medicinal Product
OriginatorNo
Orphan drugNo

Marketing authorization

Procedure typePrenehanje veljavnosti dovoljenja za promet
No. and date of decision/certificate103-68/2023-3, 25. 9. 2023
Authorization validity date25. 9. 2023
Marketing end date25. 9. 2023
Application type—
Authorization/certificate holderMundipharma Gesellschaft m. b. H.

Drug safety monitoring

Additional safety monitoringNo
Precautionary measure/dispensing restrictions
Trigonik (absolute driving prohibition).
Dispensed on a special medical prescription.
Limited single-dispense quantity.
Pregnancy prevention programmeNo
Controlled access programme(s)No

ATC codes

NNERVOUS SYSTEM
N02ANALGESICS
N02AOpioids
N02AANatural opium alkaloids
N02AA05oxycodone

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

Trigonik (absolute driving prohibition).
Dispensed on a special medical prescription.
Limited single-dispense quantity.
The medicinal product is present in wholesale distribution.

Last drug update date:9. 7. 2026
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