Ivabradine Grindeks

Medicinal product

(Invented) name

Ivabradine Grindeks

Active substance (s)

Ivabradinas

Strength

5 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)

C01EB17, Ivabradine

Marketing authorisation holder

AS Grindeks, Latvija

Date of authorisation

2016-11-22

Date of renewal

2022-03-17

Documents

4006 Pakuotės lapelis 2024 11 04, VRA.docx

4006 Ivabradine Grindeks PL 2024 11 04, VRA.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

LV/H/0208/001

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Ivabradinas	5 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
64259	78740	1078740	lizdinė plokštelė	N56		Receptinis	LT/1/16/4006/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-03-17	Perregistruotas
2016-11-22	Registruotas