Baraclude

Medicinal product

(Invented) name

Baraclude

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

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 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
25071	27697	1027697	buteliukas	N30		Receptinis	EU/1/06/343/001	Netiekiama	-	-	No	-	-
25072	27698	1027698	dalomoji lizdinė plokštelė	N30x1		Receptinis	EU/1/06/343/003	Tiekiama	-	-	No	-	-
42352	56119	1056119	dalomoji lizdinė plokštelė	N90x1		Receptinis	EU/1/06/343/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2006-07-26	Registruotas