NORIFAZ

Medicinal product

(Invented) name

NORIFAZ

Active substance (s)

Natrio rizedronatas

Strength

35 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)

M05BA07, Risedronic acid

Marketing authorisation holder

Adamed Pharma S.A., Lenkija

Date of authorisation

2008-12-30

Date of renewal

2014-12-23

Documents

1398 NORIFAZ 35mg tab PCS PL 2021_03_23.docx

1398_1_3 Pakuotės lapelis 2021_03_23.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

PL/H/0104/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Natrio rizedronatas	35 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
22965	25698	1025698	lizdinė plokštelė	N2		Receptinis	LT/1/08/1398/001	Netiekiama	-	-	No	-	-
33126	4998	1004998	lizdinė plokštelė	N4		Receptinis	LT/1/08/1398/002	Netiekiama	-	-	No	-	-	Download
33127	35501	1035501	lizdinė plokštelė	N12		Receptinis	LT/1/08/1398/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2014-12-23	Perregistruotas
2008-12-30	Registruotas