Tracleer

Medicinal product

(Invented) name

Tracleer

Active substance (s)

Bozentanas

Strength

125 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)

C02KX01, Bosentan

Marketing authorisation holder

Janssen-Cilag International N.V., Belgija

Date of authorisation

2002-05-15

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.
Bozentanas	125 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
28794	31312	1031312	lizdinė plokštelė	N56		Receptinis	EU/1/02/220/004	Netiekiama	-	-	No	-	-
28795	31313	1031313	lizdinė plokštelė	N112		Receptinis	EU/1/02/220/005	Netiekiama	-	-	No	-	-
67207	81752	1081752	buteliukas	N56		Receptinis	EU/1/02/220/008	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2002-05-15	Registruotas