Zecatrin

Medicinal product

(Invented) name

Zecatrin

Active substance (s)

Fezoterodino fumaratas

Strength

8 mg

Pharmaceutical form

pailginto atpalaidavimo tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

G04BD11, Fesoterodine

Marketing authorisation holder

Zentiva k.s., Čekija

Date of authorisation

2021-06-02

Date of renewal

2025-07-31

Documents

4759_60_Zecatrin_perr2025-07-31.docx

4759(60)_pakuotes lapelis_2025-07-31.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

HU/H/0690/002/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra:	1 vnt.
Fezoterodino fumaratas	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
106630	92732	1092732	lizdinė plokštelė	N14		Receptinis	LT/1/21/4760/001	Netiekiama	-	-	No	-	-
106631	92733	1092733	lizdinė plokštelė	N28		Receptinis	LT/1/21/4760/002	Netiekiama	-	-	No	-	-
106632	92734	1092734	lizdinė plokštelė	N30		Receptinis	LT/1/21/4760/003	Tiekiama	-	-	No	-	-
106633	92735	1092735	lizdinė plokštelė	N84		Receptinis	LT/1/21/4760/004	Netiekiama	-	-	No	-	-
106634	92736	1092736	lizdinė plokštelė	N100		Receptinis	LT/1/21/4760/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-07-31	Perregistruotas
2021-06-02	Registruotas