Oxycodone Vitabalans

Medicinal product

(Invented) name

Oxycodone Vitabalans

Active substance (s)

Oksikodono hidrochloridas

Strength

10 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/1119/002/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Oksikodono hidrochloridas	10 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
45975	59780	1059780	lizdinė plokštelė	N30		Receptinis	LT/1/13/3201/003	Netiekiama	-	-	No	-	-
55169	69202	1069202	lizdinė plokštelė	N100		Receptinis	LT/1/13/3201/004	Netiekiama	-	-	No	-	-

Stadijos

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