Tezulix

Medicinal product

(Invented) name

Tezulix

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

KRKA, d.d., Novo mesto, Slovėnija

Date of authorisation

2023-02-22

Date of renewal

Documents

5123_5125 Tezulix PCS 2023 11 27.docx

5123-5125 pakuotes lapelis_2023-02-22.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

HR/H/0224/003/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
110434	96544	1096544	lizdinė plokštelė	N30		Receptinis	LT/1/23/5125/001	Netiekiama	-	-	No	-	-
110435	96545	1096545	lizdinė plokštelė	N60		Receptinis	LT/1/23/5125/002	Netiekiama	-	-	No	-	-
110436	96546	1096546	lizdinė plokštelė	N100		Receptinis	LT/1/23/5125/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-02-22	Registruotas