Risedronate sodium Actavis

Medicinal product

(Invented) name

Risedronate sodium Actavis

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

Actavis Group PTC ehf., Islandija

Date of authorisation

2008-12-30

Date of renewal

2015-01-27

Documents

1401_1_3 Risedronate sodium Actavis PZ PL 180323.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

EE/H/0228/001

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
22964	25697	1025697	lizdinė plokštelė	N2		Receptinis	LT/1/08/1401/001	Netiekiama	-	-	No	-	-
33146	5528	1005528	lizdinė plokštelė	N4		Receptinis	LT/1/08/1401/002	Netiekiama	-	-	No	-	-	Download
33147	35521	1035521	lizdinė plokštelė	N12		Receptinis	LT/1/08/1401/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-08-05	Išregistruotas
2015-01-27	Perregistruotas
2008-12-30	Registruotas