Esbriet

Medicinal product

(Invented) name

Esbriet

Active substance (s)

Pirfenidonas

Strength

267 mg

Pharmaceutical form

kietosios kapsulės

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

Capsule, hard	1 vnt.
Pirfenidonas	267 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
45460	59260	1059260	lizdinė plokštelė	N63 (7x3, 7x6)		Receptinis	EU/1/11/667/001	Netiekiama	-	-	No	-	-
45461	59261	1059261	lizdinė plokštelė	N252 (14x18)		Receptinis	EU/1/11/667/002	Netiekiama	-	-	No	-	-
45462	59262	1059262	buteliukas	N270		Receptinis	EU/1/11/667/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2011-02-28	Registruotas