Alendronic Acid/Colecalciferol Viatris [Alendronic Acid/Colecalciferol Mylan]

Medicinal product

(Invented) name

Active substance (s)

Alendrono rūgštis/Kolekalciferolis

Strength

70 mg/2800 TV

Pharmaceutical form

tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

ATC code (s)

M05BB03, Alendronic acid and colecalciferol

Marketing authorisation holder

Viatris Limited, Airija

Date of authorisation

2018-12-28

Date of renewal

2024-04-24

Documents

Stage

Perregistruotas

Controlled?

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/4689/001

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Alendrono rūgštis	70 mg
Kolekalciferolis	2800 TV

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
100717	86827	1086827	lizdinė plokštelė	N4		Receptinis	LT/1/18/4312/001	Netiekiama	-	-	No	-	-
100718	86828	1086828	lizdinė plokštelė	N12		Receptinis	LT/1/18/4312/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-04-24	Perregistruotas
2018-12-28	Registruotas