Teysuno

Medicinal product

(Invented) name

Teysuno

Active substance (s)

Tegafuras/Gimeracilas/Oteracilas

Strength

15 mg/4,35 mg/11,8 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	15 mg
Gimeracilas	4,35 mg
Oteracilas	11,8 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
46027	59833	1059833	lizdinė plokštelė	N42		Receptinis	EU/1/11/669/001	Netiekiama	-	-	No	-	-
46028	59834	1059834	lizdinė plokštelė	N126		Receptinis	EU/1/11/669/002	Netiekiama	-	-	No	-	-
54428	68424	1068424	lizdinė plokštelė	N84		Receptinis	EU/1/11/669/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2011-04-13	Registruotas