Bosentan Sandoz

Medicinal product

(Invented) name

Bosentan Sandoz

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

Sandoz d.d., Slovėnija

Date of authorisation

2013-12-11

Date of renewal

Documents

3461_4_6 Bosentan Sandoz 125mg RPP 180309.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

CZ/H/0456/002/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	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
53327	67270	1067270	lizdinė plokštelė	N14		Receptinis	LT/1/13/3461/004	Netiekiama	-	-	No	-	-
58109	72235	1072235	lizdinė plokštelė	N56		Receptinis	LT/1/13/3461/005	Netiekiama	-	-	No	-	-	Download
58110	72236	1072236	lizdinė plokštelė	N112		Receptinis	LT/1/13/3461/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-10-02	Išregistruotas
2013-12-11	Registruotas