Stayveer

Medicinal product

(Invented) name

Stayveer

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

2013-06-24

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10c

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Film-coated tablet	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
56650	70753	1070753	lizdinė plokštelė	N56		Receptinis	EU/1/13/832/001	Netiekiama	-	-	No	-	-
61818	76188	1076188	lizdinė plokštelė	N112		Receptinis	EU/1/13/832/003	Netiekiama	-	-	No	-	-
67211	81756	1081756	buteliukas	N56		Receptinis	EU/1/13/832/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2013-06-24	Registruotas