Irsamla

Medicinal product

(Invented) name

Irsamla

Active substance (s)

Vortioksetinas

Strength

5 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)

N06AX26, Vortioxetine

Marketing authorisation holder

Egis Pharmaceuticals PLC, Vengrija

Date of authorisation

2024-04-24

Date of renewal

Documents

5414-17_pakuotes lapelis_2024-04-24.docx

5414_5417 Irsamla PCS 2025 05 23.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

SI/H/0284/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra:	1 vnt.
Vortioksetinas	5 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
113473	99591	1099591	lizdinė plokštelė	N28		Receptinis	LT/1/24/5414/001	Netiekiama	-	-	No	-	-
113474	99592	1099592	lizdinė plokštelė	N98		Receptinis	LT/1/24/5414/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-04-24	Registruotas