Entecavir Viatris [Entecavir Mylan]

Medicinal product

(Invented) name

Entecavir Viatris [Entecavir Mylan]

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

Viatris Limited, Airija

Date of authorisation

2017-09-18

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
97855	83950	1083950	buteliukas	N30		Receptinis	EU/1/17/1227/001	Netiekiama	-	-	No	-	-
97856	83951	1083951	lizdinė plokštelė	N30		Receptinis	EU/1/17/1227/002	Netiekiama	-	-	No	-	-
97857	83952	1083952	dalomoji lizdinė plokštelė	N30x1		Receptinis	EU/1/17/1227/003	Netiekiama	-	-	No	-	-
97858	83953	1083953	buteliukas	N90		Receptinis	EU/1/17/1227/004	Netiekiama	-	-	No	-	-
97859	83954	1083954	dalomoji lizdinė plokštelė	N90x1		Receptinis	EU/1/17/1227/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-09-18	Registruotas