Sebivo

Medicinal product

(Invented) name

Sebivo

Active substance (s)

Telbivudinas

Strength

20 mg/ml

Pharmaceutical form

geriamasis tirpalas

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

J05AF11, Telbivudine

Marketing authorisation holder

Novartis Europharm Ltd., Airija

Date of authorisation

2007-04-24

Date of renewal

Documents

Search in EMA Europe

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Oral solution	1 ml
Telbivudinas	20 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
33802	36163	1036163	buteliukas	N1 ir dozavimo taurelė		Receptinis	EU/1/07/388/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-12-21	Išregistruotas
2007-04-24	Registruotas