RAENOM

Medicinal product

(Invented) name

RAENOM

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

Gedeon Richter Plc, Vengrija

Date of authorisation

2016-11-22

Date of renewal

Documents

4007_1_4 Pakuotės lapelis 180827.docx

4007_1_4 RAENOM tab PCS PL 180827.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

HU/H/0430/001/DC

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
64022	78469	1078469	lizdinė plokštelė	N56		Receptinis	LT/1/16/4007/001	Netiekiama	-	-	No	-	-
67172	81716	1081716	lizdinė plokštelė	N112		Receptinis	LT/1/16/4007/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-05-08	Išregistruotas
2016-11-22	Registruotas