Pirfenidone Viatris

Medicinal product

(Invented) name

Pirfenidone Viatris

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

Viatris Limited, Airija

Date of authorisation

2023-01-10

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

Film-coated tablet	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
110204	96313	1096313	lizdinė plokštelė	N21		Receptinis	EU/1/22/1707/008	Netiekiama	-	-	No	-	-
110205	96314	1096314	lizdinė plokštelė	N84		Receptinis	EU/1/22/1707/009	Netiekiama	-	-	No	-	-
110206	96315	1096315	dalomoji lizdinė plokštelė	N21×1		Receptinis	EU/1/22/1707/010	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-01-10	Registruotas