SIRTURO

Medicinal product

(Invented) name

SIRTURO

Active substance (s)

Bedakvilinas

Strength

100 mg

Pharmaceutical form

tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

J04AK05, Bedaquiline

Marketing authorisation holder

Janssen-Cilag International N.V., Belgija

Date of authorisation

2014-03-05

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

Tablet	1 vnt.
Bedakvilinas	100 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
58753	72967	1072967	buteliukas	N188		Receptinis	EU/1/13/901/001	Tiekiama	-	-	No	-	-
67655	82210	1082210	lizdinė plokštelė	N24		Receptinis	EU/1/13/901/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2014-03-05	Registruotas