Tracleer

Medicinal product

(Invented) name

Tracleer

Active substance (s)

Bozentanas

Strength

62,5 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	62,5 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
28791	31309	1031309	lizdinė plokštelė	N14		Receptinis	EU/1/02/220/001	Netiekiama	-	-	No	-	-
28792	31310	1031310	lizdinė plokštelė	N56		Receptinis	EU/1/02/220/002	Netiekiama	-	-	No	-	-
28793	31311	1031311	lizdinė plokštelė	N112		Receptinis	EU/1/02/220/003	Netiekiama	-	-	No	-	-
67206	81751	1081751	buteliukas	N56		Receptinis	EU/1/02/220/007	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2002-05-15	Registruotas