Pirfenidone axunio [Pirfenidone AET]

Medicinal product

(Invented) name

Pirfenidone axunio [Pirfenidone AET]

Active substance (s)

Pirfenidonas

Strength

534 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

axunio Pharma GmbH, Vokietija

Date of authorisation

2022-06-20

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Tabletėje yra:	1 vnt.
Pirfenidonas	534 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
108939	95045	1095045	lizdinė plokštelė	N252		Receptinis	EU/1/22/1655/005	Netiekiama	-	-	No	-	-
108940	95046	1095046	dalomoji lizdinė plokštelė	N252×1		Receptinis	EU/1/22/1655/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-06-20	Registruotas