Bosentan Sandoz

Medicinal product

(Invented) name

Bosentan Sandoz

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

Sandoz d.d., Slovėnija

Date of authorisation

2013-12-11

Date of renewal

Documents

3461_1_6 Bosentan Sandoz RPP 161205.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

CZ/H/0456/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	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
53326	67269	1067269	lizdinė plokštelė	N14		Receptinis	LT/1/13/3461/001	Netiekiama	-	-	No	-	-
58107	72233	1072233	lizdinė plokštelė	N56		Receptinis	LT/1/13/3461/002	Netiekiama	-	-	No	-	-
58108	72234	1072234	lizdinė plokštelė	N112		Receptinis	LT/1/13/3461/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-02-03	Išregistruotas
2013-12-11	Registruotas