Stayveer

Medicinal product

(Invented) name

Stayveer

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

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	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
56651	70754	1070754	lizdinė plokštelė	N56		Receptinis	EU/1/13/832/002	Netiekiama	-	-	No	-	-
61819	76189	1076189	lizdinė plokštelė	N112		Receptinis	EU/1/13/832/004	Netiekiama	-	-	No	-	-
67212	81757	1081757	buteliukas	N56		Receptinis	EU/1/13/832/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2013-06-24	Registruotas