Entecavir Accord

Medicinal product

(Invented) name

Entecavir Accord

Active substance (s)

Entekaviras

Strength

0,5 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)

J05AF10, Entecavir

Marketing authorisation holder

Accord Healthcare S.L.U., Ispanija

Date of authorisation

2017-09-26

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.
Entekaviras	0,5 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
98058	84156	1084156	buteliukas	N30		Receptinis	EU/1/17/1211/001	Tiekiama	-	-	No	-	-
98059	84157	1084157	dalomoji lizdinė plokštelė	N30x1		Receptinis	EU/1/17/1211/002	Netiekiama	2024-12-31	2025-01-20	No	-	-
98060	84158	1084158	dalomoji lizdinė plokštelė	N90x1		Receptinis	EU/1/17/1211/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-09-26	Registruotas