Oxycodone Vitabalans

Medicinal product

(Invented) name

Oxycodone Vitabalans

Active substance (s)

Oksikodono hidrochloridas

Strength

5 mg

Pharmaceutical form

plėvele dengtos tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N02AA05, Oxycodone

Marketing authorisation holder

Vitabalans Oy, Suomija

Date of authorisation

2013-02-08

Date of renewal

2017-10-09

Documents

3201 Oxycodone Vitabalans PCS PL 2024 06 27.docx

3201 Pakuotės lapelis 2024 06 27.docx

Stage

Išregistruotas

Controlled?

Yes

Controlled substance type

Narkotinis

Legal basis

10(1)

Procedure number

SE/H/1119/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Oksikodono hidrochloridas	5 mg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Type of packaging	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To	Mock-up
45974	59779	1059779	lizdinė plokštelė	N30		Receptinis	LT/1/13/3201/001	Netiekiama	-	-	No	-	-
55168	69201	1069201	lizdinė plokštelė	N100		Receptinis	LT/1/13/3201/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-02-27	Išregistruotas
2017-10-09	Perregistruotas
2013-02-08	Registruotas