Ranolazine Accord

Medicinal product

(Invented) name

Ranolazine Accord

Active substance (s)

Ranolazinas

Strength

750 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 Ranolazine Accord.docx

5501-03 pakuotes lapelis_2024-07-24.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

IE/H/1208/003/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Ranolazinas	750 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
114271	100383	1100383	lizdinė plokštelė	N30		Receptinis	LT/1/24/5503/001	Netiekiama	-	-	No	-	-
114272	100384	1100384	lizdinė plokštelė	N60		Receptinis	LT/1/24/5503/002	Netiekiama	-	2028-03-31	No	-	-
114273	100385	1100385	lizdinė plokštelė	N100		Receptinis	LT/1/24/5503/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-07-24	Registruotas