Bosentan Zentiva

Medicinal product

(Invented) name

Bosentan Zentiva

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

Zentiva k.s., Čekija

Date of authorisation

2024-03-14

Date of renewal

Documents

5369_5370 Bosentan Zentiva PCS PL 2024 09 05.docx

5369_5370 Pakuotės lapelis 2024 09 05.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

DE/H/5531/001/E/001

Marketing authorisation procedure

Kartotinė 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
113084	99203	1099203	lizdinė plokštelė	N14		Receptinis	LT/1/24/5369/001	Netiekiama	-	-	No	-	-
113085	99204	1099204	lizdinė plokštelė	N56		Receptinis	LT/1/24/5369/002	Netiekiama	2025-01-09	-	No	-	-
113086	99205	1099205	lizdinė plokštelė	N112		Receptinis	LT/1/24/5369/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-03-14	Registruotas