Incivo

Medicinal product

(Invented) name

Incivo

Active substance (s)

Telapreviras

Strength

375 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)

J05AP02, Telaprevir

Marketing authorisation holder

Janssen-Cilag International N.V., Belgija

Date of authorisation

2011-09-19

Date of renewal

Documents

Search in EMA Europe

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Film-coated tablet	1 vnt.
Telapreviras	375 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
49121	62987	1062987	buteliukas	N168 (4x42)		Receptinis	EU/1/11/720/001	Netiekiama	-	-	No	-	-
51713	65610	1065610	buteliukas	N1x42		Receptinis	EU/1/11/720/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
	Išregistruotas
2011-09-19	Registruotas