Alendronic acid Accord

Medicinal product

(Invented) name

Alendronic acid Accord

Active substance (s)

Alendrono rūgštis

Strength

70 mg

Pharmaceutical form

tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

M05BA04, Alendronic acid

Marketing authorisation holder

Accord Healthcare B.V., Nyderlandai

Date of authorisation

2009-02-26

Date of renewal

2018-06-08

Documents

1476 Alendronic acid Accord PCS PL 2025 01 03.docx

1476 Pakuotės lapelis 2025 01 03.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/4550/002/

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Alendrono rūgštis	70 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
23001	25729	1025729	lizdinė plokštelė	N4		Receptinis	LT/1/09/1476/002	Netiekiama	-	-	No	-	-
39001	52684	1052684	lizdinė plokštelė	N12		Receptinis	LT/1/09/1476/012	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-06-08	Perregistruotas
2009-02-26	Registruotas