Multaq

Medicinal product

(Invented) name

Multaq

Active substance (s)

Dronedaronas

Strength

400 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)

C01BD07, Dronedarone

Marketing authorisation holder

Sanofi Winthrop Industrie, Prancūzija

Date of authorisation

2009-11-26

Date of renewal

Documents

Multaq skyrimo gaires.pdf

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Film-coated tablet	1 vnt.
Dronedaronas	400 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
38897	52579	1052579	lizdinė plokštelė	N20		Receptinis	EU/1/09/591/001	Netiekiama	-	-	No	-	-
38898	52580	1052580	lizdinė plokštelė	N50		Receptinis	EU/1/09/591/002	Netiekiama	-	-	No	-	-
38899	52581	1052581	lizdinė plokštelė	N60		Receptinis	EU/1/09/591/003	Tiekiama	-	-	No	-	-
38900	52582	1052582	dalomoji lizdinė plokštelė	N100×1		Receptinis	EU/1/09/591/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2009-11-26	Registruotas