Bosentan Norameda

Medicinal product

(Invented) name

Bosentan Norameda

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

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/0457/001/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
53328	67271	1067271	lizdinė plokštelė	N14		Receptinis	LT/1/13/3441/001	Netiekiama	-	-	No	-	-
58038	72161	1072161	lizdinė plokštelė	N56		Receptinis	LT/1/13/3441/002	Tiekiama	-	-	No	-	-	Download
58039	72162	1072162	lizdinė plokštelė	N112		Receptinis	LT/1/13/3441/003	Netiekiama	-	-	No	-	-

Stadijos

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