Pirfenidone Zentiva

Medicinal product

(Invented) name

Pirfenidone Zentiva

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

Zentiva k.s., Čekija

Date of authorisation

2022-05-18

Date of renewal

Documents

4954 Pakuotės lapelis 2024 03 01.docx

4954 Pirfenidone Zentiva PCS PL 2024 03 01.docx

Pirfenidone Zentiva kontrolinis sarasas sveikatos prieziuros specialistams.pdf

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

HU/H/0768/003/DC

Marketing authorisation procedure

Decentralizuota 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
108669	94775	1094775	lizdinė plokštelė	N84		Receptinis	LT/1/22/4954/001	Tiekiama	-	-	No	-	-
108670	94776	1094776	lizdinė plokštelė	N252		Receptinis	LT/1/22/4954/002	Netiekiama	-	-	No	-	-
108671	94777	1094777	lizdinė plokštelė	N252 (3×84)		Receptinis	LT/1/22/4954/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-05-18	Registruotas