Baraclude

Medicinal product

(Invented) name

Baraclude

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

Bristol-Myers Squibb Pharma EEIG, Airija

Date of authorisation

2006-07-26

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Film-coated tablets	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
25074	27700	1027700	buteliukas	N30		Receptinis	EU/1/06/343/002	Netiekiama	-	-	No	-	-
25073	27699	1027699	lizdinė plokštelė	N30x1		Receptinis	EU/1/06/343/004	Tiekiama	-	-	No	-	-
42353	56120	1056120	lizdinė plokštelė	N90x1		Receptinis	EU/1/06/343/007	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2006-07-26	Registruotas