Sertralin Orion

Medicinal product

(Invented) name

Sertralin Orion

Active substance (s)

Sertralinas

Strength

50 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)

N06AB06, Sertraline

Marketing authorisation holder

Orion Corporation, Suomija

Date of authorisation

2009-12-23

Date of renewal

2012-05-28

Documents

1828 Sertralin Orion PCS PL 2024 05 30.docx

1828 Pakuotės lapelis 2024 05 30.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

FI/H/0818/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Sertralinas	50 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
30446	5662	1005662	lizdinė plokštelė	N30		Receptinis	LT/1/09/1828/001	Tiekiama	-	-	No	-	-	Download
38847	52529	1052529	lizdinė plokštelė	N100		Receptinis	LT/1/09/1828/002	Netiekiama	-	-	No	-	-
66662	81198	1081198	buteliukas	N100		Receptinis	LT/1/09/1828/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2012-05-28	Perregistruotas
2009-12-23	Registruotas