Pirfenidone Accord

Medicinal product

(Invented) name

Pirfenidone Accord

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

Accord Healthcare B.V., Nyderlandai

Date of authorisation

2023-06-21

Date of renewal

Documents

5190_5191 Pakuotės lapelis 2025 09 19.docx

Pirfenidone Accord mokomoji medziaga sveikatos prieziuros specialistams.pdf

5190_5191 Pirfenidone Accord RPP 2025 09 19.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

DK/H/3253/002/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
111187	97298	1097298	lizdinė plokštelė	N84 (12x7)		Receptinis	LT/1/23/5191/001	Netiekiama	-	-	No	-	-
111188	97299	1097299	dalomoji lizdinė plokštelė	N84×1 (12×7)		Receptinis	LT/1/23/5191/002	Tiekiama	-	-	No	-	-
111189	97300	1097300	lizdinė plokštelė	N252 (3×(12x7))		Receptinis	LT/1/23/5191/003	Netiekiama	-	-	No	-	-
111190	97301	1097301	dalomoji lizdinė plokštelė	N252x1 (3×N84×1 (12×7))		Receptinis	LT/1/23/5191/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-06-21	Registruotas