Tracleer

Medicinal product

(Invented) name

Tracleer

Active substance (s)

Bozentanas

Strength

32 mg

Pharmaceutical form

disperguojamosios 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

Dispersible Tablet	1 vnt.
Bozentanas	32 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
36994	50606	1050606	lizdinė plokštelė	N56		Receptinis	EU/1/02/220/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2002-05-15	Registruotas