Zilbea

Medicinal product

(Invented) name

Zilbea

Active substance (s)

Agomelatinas

Strength

25 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)

N06AX22, Agomelatine

Marketing authorisation holder

Zentiva k.s., Čekija

Date of authorisation

2021-04-19

Date of renewal

2022-10-31

Documents

4722 Pakuotės lapelis 2024 10 31.docx

4722 Zilbea PCS PL 2024 10 31.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

CZ/H/0731/001/E/001

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

Tabletėje yra:	1 vnt.
Agomelatinas	25 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
106324	92425	1092425	lizdinė plokštelė	N28		Receptinis	LT/1/21/4722/001	Tiekiama	-	-	No	-	-	Download
106325	92426	1092426	lizdinė plokštelė	N84		Receptinis	LT/1/21/4722/002	Netiekiama	-	-	No	-	-
108695	94801	1094801	lizdinė plokštelė	N56		Receptinis	LT/1/21/4722/003	Netiekiama	-	-	No	-	-
108696	94802	1094802	lizdinė plokštelė	N98		Receptinis	LT/1/21/4722/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-10-31	Perregistruotas
2021-04-19	Registruotas