Ranolazine ELC

Medicinal product

(Invented) name

Ranolazine ELC

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

ELC GROUP s.r.o, Čekija

Date of authorisation

2022-08-08

Date of renewal

Documents

5007 Pakuotės lapelis 2025 02 19.docx

5007 Ranolazine ELC 375 PCS 2023 12 04, PL 2025 02 19.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/5342/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra:	1 vnt.
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
109118	95224	1095224	lizdinė plokštelė	N30		Receptinis	LT/1/22/5007/001	Netiekiama	-	-	No	-	-
109119	95225	1095225	lizdinė plokštelė	N60		Receptinis	LT/1/22/5007/002	Netiekiama	-	-	No	-	-
109120	95226	1095226	lizdinė plokštelė	N100		Receptinis	LT/1/22/5007/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-08-08	Registruotas