Pirfenidone MSN

Medicinal product

(Invented) name

Pirfenidone MSN

Active substance (s)

Pirfenidonas

Strength

801 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)

L04AX05, Pirfenidone

Marketing authorisation holder

MSN Labs Europe Limited, Malta

Date of authorisation

2026-07-24

Date of renewal

Documents

6106-7_Pirfenidone MSN.docx

6106-7_pakuotes lapelis_2026-07-24.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/5434/002/E/001

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Pirfenidonas	801 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
121758	107867	1107867	lizdinė plokštelė	N84 (4×21)		Receptinis	LT/1/26/6107/001	Netiekiama	-	-	No	-	-
121759	107868	1107868	dalomoji lizdinė plokštelė	N84×1		Receptinis	LT/1/26/6107/002	Netiekiama	-	-	No	-	-
121760	107869	1107869	lizdinė plokštelė	N252 (3×N84 (4×21))		Receptinis	LT/1/26/6107/003	Netiekiama	-	-	No	-	-
121761	107870	1107870	buteliukas	N90		Receptinis	LT/1/26/6107/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2026-07-24	Registruotas