Ranolazine Accord

Medicinal product

(Invented) name

Ranolazine Accord

Active substance (s)

Ranolazinas

Strength

375 mg

Pharmaceutical form

pailginto atpalaidavimo tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

C01EB18, Ranolazine

Marketing authorisation holder

Accord Healthcare B.V., Nyderlandai

Date of authorisation

2024-07-24

Date of renewal

Documents

5501-03 pakuotes lapelis_2024-07-24.docx

5501-03 Ranolazine Accord.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

IE/H/1208/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 mg
Ranolazinas	375 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
114265	100377	1100377	lizdinė plokštelė	N30		Receptinis	LT/1/24/5501/001	Netiekiama	-	-	No	-	-
114266	100378	1100378	lizdinė plokštelė	N60		Receptinis	LT/1/24/5501/002	Netiekiama	-	2028-03-31	No	-	-
114267	100379	1100379	lizdinė plokštelė	N100		Receptinis	LT/1/24/5501/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-07-24	Registruotas