Esbriet

Medicinal product

(Invented) name

Esbriet

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

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	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
68556	83136	1083136	buteliukas	N21		Receptinis	EU/1/11/667/009	Netiekiama	-	-	No	-	-
68557	83137	1083137	buteliukas	N90		Receptinis	EU/1/11/667/010	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2011-02-28	Registruotas