Entecavir Sandoz

Medicinal product

(Invented) name

Entecavir Sandoz

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

Sandoz d.d., Slovėnija

Date of authorisation

2017-05-10

Date of renewal

2022-04-22

Documents

4076 Entecavir Sandoz II PL 2024 05 05.docx

4076 Pakuotės lapelis 2024 05 05.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/3848/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	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
68194	82760	1082760	lizdinė plokštelė	N10		Receptinis	LT/1/17/4076/001	Netiekiama	-	-	No	-	-
68195	82761	1082761	lizdinė plokštelė	N30		Receptinis	LT/1/17/4076/002	Tiekiama	-	-	No	-	-	Download
68196	82762	1082762	lizdinė plokštelė	N90		Receptinis	LT/1/17/4076/003	Netiekiama	-	-	No	-	-
68251	82819	1082819	buteliukas	N30		Receptinis	LT/1/17/4076/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-04-22	Perregistruotas
2017-05-10	Registruotas