Entecavir Viatris [Entecavir Mylan]

Medicinal product

(Invented) name

Entecavir Viatris [Entecavir Mylan]

Active substance (s)

Entekaviras

Strength

1 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	1 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
97860	83955	1083955	buteliukas	N30		Receptinis	EU/1/17/1227/006	Netiekiama	-	-	No	-	-
97861	83956	1083956	lizdinė plokštelė	N30		Receptinis	EU/1/17/1227/007	Netiekiama	-	-	No	-	-
97862	83957	1083957	dalomoji lizdinė plokštelė	N30x1		Receptinis	EU/1/17/1227/008	Netiekiama	-	-	No	-	-
97863	83958	1083958	buteliukas	N90		Receptinis	EU/1/17/1227/009	Netiekiama	-	-	No	-	-
97865	83960	1083960	dalomoji lizdinė plokštelė	N90x1		Receptinis	EU/1/17/1227/010	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-09-18	Registruotas