Bosentan Norameda

Medicinal product

(Invented) name

Bosentan Norameda

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

UAB Norameda, Lietuva

Date of authorisation

2013-11-22

Date of renewal

2019-03-25

Documents

Bosentan Norameda paciento kortele.pdf

3441 Bosentan Norameda PCS 2025 04 15.docx

3441 Pakuotės lapelis 2024 12 23.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

CZ/H/0457/002/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
53329	67272	1067272	lizdinė plokštelė	N14		Receptinis	LT/1/13/3441/004	Netiekiama	-	-	No	-	-
58040	72163	1072163	lizdinė plokštelė	N56		Receptinis	LT/1/13/3441/005	Netiekiama	2024-12-10	2025-01-31	No	-	-	Download
58041	72164	1072164	lizdinė plokštelė	N112		Receptinis	LT/1/13/3441/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-03-25	Perregistruotas
2013-11-22	Registruotas