Teysuno

Medicinal product

(Invented) name

Teysuno

Active substance (s)

Tegafuras/Gimeracilas/Oteracilas

Strength

20 mg/5,8 mg/15,8 mg

Pharmaceutical form

kietosios kapsulės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01BC53, Tegafur, combinations

Marketing authorisation holder

Nordic Group BV, Nyderlandai

Date of authorisation

2011-04-13

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Capsules, hard	1 vnt.
Tegafuras	20 mg
Gimeracilas	5,8 mg
Oteracilas	15,8 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
46029	59835	1059835	lizdinė plokštelė	N42		Receptinis	EU/1/11/669/003	Netiekiama	-	-	No	-	-
46030	59836	1059836	lizdinė plokštelė	N84		Receptinis	EU/1/11/669/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2011-04-13	Registruotas