Esprital

Medicinal product

(Invented) name

Esprital

Active substance (s)

Mirtazapinas

Strength

30 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)

N06AX11, Mirtazapine

Marketing authorisation holder

Zentiva k.s., Čekija

Date of authorisation

2005-06-07

Date of renewal

2009-10-20

Documents

0229_2 Pakuotės lapelis 200918.docx

0229_2 Esprital 30mg tab PCS PL 200918.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

CZ/H/0102/002/MR

Marketing authorisation procedure

Savitarpio pripažinimo procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Mirtazapinas	30 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
13911	4331	1004331	lizdinė plokštelė	N30		Receptinis	LT/1/05/0229/002	Netiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2022-05-02	Išregistruotas
2009-10-20	Perregistruotas
2005-06-07	Registruotas