Esbriet

Medicinal product

(Invented) name

Esbriet

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

Roche Registration GmbH, Vokietija

Date of authorisation

2011-02-28

Date of renewal

Documents

Esbriet mokomoji medziaga sveikatos prieziuros specialistams.pdf

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Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Film-coated tablet	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
68558	83138	1083138	buteliukas	N90		Receptinis	EU/1/11/667/011	Netiekiama	-	-	No	-	-
68653	83235	1083235	lizdinė plokštelė	N84		Receptinis	EU/1/11/667/018	Netiekiama	-	-	No	-	-
68654	83236	1083236	lizdinė plokštelė	N252 (84x3) (daugiadozė)		Receptinis	EU/1/11/667/019	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2011-02-28	Registruotas