Bosentan Accord

Medicinal product

(Invented) name

Bosentan Accord

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

Accord Healthcare B.V., Nyderlandai

Date of authorisation

2015-08-06

Date of renewal

2021-03-05

Documents

3780 Bosentan Accord RPP 2022 12 01.docx

3780_Bosentan Accord_paciento_ispej_kort.docx

3780 Pakuotės lapelis 2022 12 01.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

SE/H/1906/001

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
57520	71636	1071636	lizdinė plokštelė	N14		Receptinis	LT/1/15/3780/001	Netiekiama	-	-	No	-	-
63381	77819	1077819	lizdinė plokštelė	N56		Receptinis	LT/1/15/3780/002	Netiekiama	-	-	No	-	-
63382	77820	1077820	lizdinė plokštelė	N112		Receptinis	LT/1/15/3780/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-03-05	Perregistruotas
2015-08-06	Registruotas